The very first treatment to prevent type 1 diabetes for any length of time is in front of the FDA right now. Teplizumab has been show to prevent the onset of type 1 diabetes in people shown to be at high risk of developing it. Stacey talks to Dr. Henry Anhalt of Provention, the company behind the filing. Dr. Anhalt is a pediatric endocrinologist and has a lot to say about what this would mean to his patients.
Listen to our previous episodes on Teplizumab
In Innovations, a round table on insulin pricing with Congresswoman Katie Porter. It didn't have her famous white board, but participants pulled no punches.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels, increase your possibilities by Gvoke HypoPen, the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
This week, the first treatment to prevent type 1 diabetes for any length of time is in front of the FDA right now. We're going to talk about the clinical stuff. But there's a lot of emotion wrapped up in this development as well.
Dr. Henry Anhalt 0:40
I was trained to make people who have type 1 diabetes feel that they're never doing a good enough job, that they're at risk of developing all these complications. And you know, when you get to the point in your career, you realize that not only did that not help hurt, and then really being in a position to hopefully be able to make a fundamental difference and how that goes down. It's really hard to articulate, I have to say,
Stacey Simms 1:05
That's Dr. Henry Anhalt of Provention, the company behind Teplizumab. He's also a pediatric endocrinologist, we'll talk about Teplizumab what is in front of the FDA and why this treatment is so promising.
In innovations. A round table on insulin pricing with Congresswoman Katey Porter didn't have a whiteboard as She's famous for, but pulled no punches. You're gonna want to hear this.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am always so glad to have you here. As you know, we aim to educate and inspire about diabetes with a focus on people who use insulin. I'm your host, Stacey Simms, my son, Benny was diagnosed with type one right before he turned two, back in 2006. My husband lives with type two diabetes, I don't have diabetes, but I have a background in broadcasting. And that is how you get the podcast.
We are coming up on year six of the show. And I gotta tell you, I don't get I don't get too excited about breakthroughs or treatments anymore, because we've covered a lot of stuff that frankly hasn't panned out the way we had all hoped. But this is a little bit different. Because Teplizumab is a drug that has already been shown to prevent type 1 diabetes for three years. And for some people, they are coming up on four years. What does that mean? How do we know it's preventing it? Why is it so exciting? And you know, could this mean a breakthrough for everyone with type one, there's a lot to unpack here. So we'll get to that in just a little bit. But we've talked about Teplizaumab before with the folks from trial net, I'll link up this previous episodes at Diabetes connections.com. There's always an episode homepage for each and every episode, which more recently will have the transcription. But for every episode has important links and more information for you.
quick heads up. If you are listening as this episode goes live tonight, Tuesday, I will be with a JDRF with a couple of chapters. Or maybe it's just one chapter now things have moved around a lot for JDRF. But I'll be with the Nevada, Arizona and New Mexico chapters tonight, talking about the world's worst diabetes mom, we're going to have a fun discussion about the book. And if you are in one of those chapters, you're going to get the paperback for free. If you're not in one of those chapters come along. Anyway, I've got some audio books to give away. It's always just fun to talk to you. I'll be reading from the book but having a discussion as well type one talk, it's different times because of the different states and because of where I am. So it's 530 in Nevada and Arizona, and 630 in New Mexico, it will be 830 here in Charlotte, North Carolina, I may be in my pajamas, but I hope you can join me for that. And again, I'll put a link and I've got that out on my social. I've been talking about that on social media for a couple of days.
I've mentioned a couple of times this year that we're focusing on technology. And a lot of that is because 2021 is going to see a lot of FDA approvals, things have been backed up because of COVID. Um, so this year, and next year, I think we're going to see many things kind of bunched up. But some of that technology isn't mechanical, right? It's medical or what we would think of more as biological perhaps. And that's what we're talking about today.
But first Diabetes Connections is brought to you by Dario health. And over the years. I find we manage diabetes better when we're thinking less about all the stuff of diabetes tasks. That's what I love partnering with people who take the load off on things like ordering supplies, so I can really just focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door one on one coaching so you can meet your milestones, weekly insights into your trends, with suggestions on how to succeed. Get the diabetes management plan that works with you and for you. Darrius published study Demonstrate high impact clinical results, find out more go to my dario.com forward slash diabetes dash connections.
My guest this week is the executive director of medical affairs for Provention Bio. He's also a pediatric endocrinologist and Dr. Henry Anhalt is also very involved with Camp Nejeda. He's on the board there. I believe he was the medical director at one point, but we have spoken to Dr. Anhalt before in that capacity. My cousin goes to camp there he did growing up, I will link back on our episode about camp with Dr. Anhalt because it's a really good one. And especially if you're thinking about diabetes camp, if your local campus happening this summer in person, that's a good one to listen to as well. Provention is a biopharmaceutical company dedicated to autoimmune disease. And they are applying for what's called a biologics license application for to please him up for the delay or prevention of type 1 diabetes in at risk individuals that is in front of the FDA right now. There is a gold date here that the FDA has assigned to them of July 2. So we shall see what happens between now and then. But there's an awful lot to talk about unexplained. Here's my discussion with Dr. Henry Anhalt.Thank you so much for joining me and welcome back to Diabetes Connections, it's good to talk to you again.
Dr. Henry Anhalt 6:21
Likewise, Stacey, it's a delight to be back with you again.
Stacey Simms 6:25
Well, I'm so interested in this news, which you know, it's hard to get excited after all this time for me. But this is exciting news. But let's kind of set the stage. If I could talk to me a little bit to just start off here. My listeners are familiar with T one detect the program that JDRF came on the show and talked about in in late December about a new screening initiative and prevention is the company that is I guess, you know, doing the heavy lifting here and doing the work to screen people. Can you talk a little bit about the importance of this project?
Dr. Henry Anhalt 7:00
Well, Stacy, the first thing I wanted to do is to point out that in addition to the T one detect program, we have the type one tested.com website, which will also give people who are going to that website, additional information about screening, it's important that we take a shift in how it is that we look at type 1 diabetes. And as we all know, mostly everyone's experience. And certainly, that's been the case with my patients as a pediatric endocrinologist, they present and they come to attention when they've been having symptoms, when they're not feeling well, when they are noticed to be losing weight. And a parent says, gee, something's wrong, and they go to a doctor and oftentimes are going from one doctor to another until unfortunately, kids and adults are getting sicker and sicker and then ultimately end up in an ICU setting. That's what we used to think about as type 1 diabetes. But we now know that type 1 diabetes is really in three stages, we know it's an autoimmune disease. But the three stages are really important to highlight, because the first stage is when someone has two antibodies that are directed at the pancreas. And those two antibodies are amongst a number of antibodies. But if you have two or more, you have stage one diabetes, even in the absence of having any symptoms or abnormal blood sugars. And we'll come back to that in just a second. Stage Two is when you have those antibodies or more, and you'll have some abnormal blood sugars, but not high enough to either have symptoms, or for anybody to even recognize. And then stage three is, as I mentioned a moment ago, when typically people have symptoms and they end up sick unfortunately, and seeking medical attention. We won't know whether or not someone is in stage one, stage two or stage three, unless they do things like you just suggested and participate in the T one detect program or have their antibodies tested so that they can identify and understand where they are along that continuum. And so we now classify type 1 diabetes as soon as you have two more antibodies, but even in the absence of having abnormal blood sugar, so it's important because as therapies become more and more available, and we know that there are a whole bunch that are now coming along, some of them are pending approval. So for example, Teplizumab which is before the FDA right now. And we hope that the FDA will look at the body of evidence and the safety and the efficacy. And we currently are targeted to have an approval date in the first week of July. But it's also important to realize that there are lots of other medications that are soon to follow, that may also be of use to people who are along this continuum. for us and for the people that we care about. In the type one community, the ability for a drug like Teplizumab provided that the FDA looks at the data and says, yep, we believe it's safe and effective to prevent people from progressing from stage two to stage three. Without that, we won't know who would be a good candidate for that kind of intervention.
Stacey Simms 10:58
I always get a little confused. And I know that for somebody like me, who's a lay person, it seems like we're early on in the research. But the question I always have about the antibodies is I remember years ago with trial net, and they would say things to us like, well, years ago for me when I was learning about trial that they would explain it like, well, kids usually get tested more often than adults, because things can change with children. If somebody has the antibodies, do they always develop the symptoms of type 1 diabetes? Or do we not know that yet,
Dr. Henry Anhalt 11:28
the uptake of testing or the routine screening for people at risk has not been adopted widely. And that's important to highlight. And that's why the JDRF is in the middle of this educational campaign is because the fact is that for all intents and purposes, our colleagues that pediatric endocrinology adult endocrinologist are not thinking about getting antibodies, and certainly in children who you would expect, are at greatest risk. Those who have a first degree relative with type 1 diabetes, a sibling or a parent where we know that their risk of developing type 1 diabetes is 15 fold greater than the general population that it would be more widely adopted. But that's unfortunately not the case. And in adults, are point people don't think so one of the challenges with adults who ultimately develop type 1 diabetes is that the family practice dogs or the endocrinologists who may be are not involved, likely not to be involved, because they are in seeing people who are adults who develop diabetes until their 50s, or maybe their 40s. And they're not thinking about type 1 diabetes, the greater challenge with adults is around the assumption that if you're in your third decade or fourth decade of life, that you do not have type 1 diabetes, but we know that that's not the case, because people into their 50s and 60s are developing type 1 diabetes and are continuing to make insulin but unquestionably have type 1 diabetes.
Stacey Simms 13:21
I'm curious, when T one detect was announced, a lot of people in the diabetes community thought and I agree with them. It was so interesting, it was such a great idea. Like let's get more screening, let's get more screening. But when I talked to JDRF, they said no, we will we want everybody in the diabetes community. But we want people outside the diabetes community to start thinking about this, what can be done to try to push this message into families that you know, don't think that they have to worry about diabetes? How are you all doing that?
Dr. Henry Anhalt 13:49
Yeah, what I really focus on Stacey is the folks who are at risk, okay. And those are the ones with first degree relatives, because we know we have data from global programs where they're doing population screening, they're screening everybody, not only second and third degree relatives of people who have type one, or even first degree relatives, they're screening entire populations. And that's terrific within the context, at least right now, of research programs that are well funded. But we're facing a battle ahead of us as we get people to adopt. And we get the payers and the payer community to recognize the importance, which is part of the educational effort. However, we really need to focus right now for the hearing now, because that's achievable, attainable, and the therapeutic agents that are either before the agency now or that are coming are the ones that are going to be the most likely to benefit. And that's why I think right now at risk is the most important population to look at. Got it.
Stacey Simms 14:57
Let's talk about what's in front of the FDA. I remember A couple of years ago trying to pronounce Teplizumab, and then getting really I know, but getting really excited as it seemed to, and you please fill us in, but it looked like the research was showing this is preventing that movement, as you said, from stage two to stage three, so people have the antibodies that show that they have type 1 diabetes, but it kept them from progressing to showing symptoms for two years. And then it looked like three years recently, am I getting all that right?
Right back to the doctor and hold in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen, and almost everyone who takes insulin has experienced a low blood sugar that can be scary. A very low blood sugar is really scary. And that's where Gvoke Hypopen comes in. It's the first auto injector to treat very low blood sugar. Gvoke hypo pain is pre mixed and ready to go with no visible needle. That means it's easy to use in usability studies, 99% of people were able to give Gvoke correctly, I'm so glad to have something different, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit gvoke glucagon.com slash risk.
Now back to Dr. Anhalt. And I just asked him if I was kind of getting your right that Teplizumab had delayed the onset of type one in people for up to three years.
Dr. Henry Anhalt 16:29
You're getting that spot on Stacey. And I think that here, it's important to stress that how do we know that they're actually having this delay? Are there any markers that we can look at. And C peptide is the key, because for the listeners, it's important to highlight that this molecule or this protein c peptide is a measure of how much function your beta cells have, how much of your actual insulin is being produced. And the studies have shown and the authors concluded that in fact, those treated with Teplizumab had stabilization of their c peptide production, and in some cases actually improved c peptide confirming that the beta cell function is being preserved. And suggesting I may add that beta cell function is being restored. So it wasn't only this delay, but it was a delay that was marked by a direct measurable compound or protein that indicates beta cell health and beta cell function.
Stacey Simms 17:40
When we talk about Teplizumab, what is that? It's I assume it's more than, you know, a pill that you would take once and never have to do again. Is it a treatment? What how do you how do people take it?
Dr. Henry Anhalt 17:50
So Teplizumab and I had a really hard time pronouncing that I started working at Provention Bio in December. And I'm finally getting around to it right. And it wasn't only narrow, actually that I heard about Teplizumab when I was working back in 2008, at a hospital in New Jersey, there were these clinical trials ongoing with tech lism ab. And at the time, I became really familiar and saw what the potential that this drug had. But to answer your question directly Teplizumab is administered by IV infusion over a period, at least in the trials over a period of 14 days as one single infusion. So that's the way that the trial that we're talking about the data that we're discussing, that trial had a 14 day single infusion, so IV infusion every day for 14 days straight. That was the data that we talked about was the outcome of that trial. Ultimately, though, the FDA will make the decision of based on the data that exists, how many days of infusion, etc. Got it.
Stacey Simms 19:14
But to be clear, when we're saying it's three years later, those people that they're measuring three years later had, it's still from those first and only two weeks.
Dr. Henry Anhalt 19:23
That is correct. So people had a two week infusion, and this population was followed out. For quite some time, actually, the recruitment took seven years, but this population has continued and when you have this rolling admission into a trial, it becomes a little bit difficult to to characterize, but suffice it to say based on the appropriate data analysis, that's the conclusion that the authors came to and obviously incredibly encouraged by those results. So with the follow up time, We have nearly a year later, it shows now approximately three years,
Stacey Simms 20:05
I may be jumping to conclusions and correct me if I'm wrong. But I'm sitting here thinking, if my son Benny had gotten something like this at 23 months, and we could have delayed the onset of type 1 diabetes, until he almost went to kindergarten like that, to me, I know that there's more implications down the road, but just the idea that he would be able to communicate a little bit better. With me, maybe he could pronounce diabetes, there would be some other things that we could have some really difficult stages that we could have skipped. And I know that you're looking for a lot more than that going forward. But man, that's so remarkable to think about. And I know everybody listening is thinking in their own families, the milestones that can come in three years, it's really interesting stuff.
Dr. Henry Anhalt 20:49
Stacey, I have to pause when I listen to you tell that story. Because for me, I have only a glimpse of the burden that people living with type one, or parents or caregivers experience, I have a glimpse, because I have the privilege of stepping into the sanctity of a family and being open to hearing these things. But to your point, what is that? What does that mean to a child or to a family that you can have a delay of two years or three years? Or even longer than that? What does that mean? So this ability to do that the data indicating that this can do that can do exactly what you're talking about? It can delay to a time where kids can be more able to communicate signs of hypoglycemia, a kid in college, perhaps, delay until after college, and so on and so forth. So how do you put a measure on what that means for a family? You know, what that means? Two years or three years being insulin independent? How can you describe that to someone who doesn't quote unquote, get it? What that means to a family? So I know, just like you would, from personal experience, what I've heard from my patients and their families, how much that could potentially have meant, and how much that can mean to them going forward?
Stacey Simms 22:31
It really is. It's, I was gonna say, it's fun to think about, I'm not sure that's the right way to say it. Because in my mind, it's kind of fun, because I think about how silly my son was at that age, but it is really encouraging to think about, I'm curious, are there any concerns, side effects, anything that people need to be aware of when it comes to the prism app?
Dr. Henry Anhalt 22:54
So you know, I think that every drug has potential risk and benefit. And we have to be fair and recognize that, however, in the data that's been published, from the trial that we've been discussing the tn 10 study, it was shown that the side effects were manageable, that they were easy to address resolved on their own. And that's consistent with all the other studies that have used Teplizumab. So from our perspective, and looking at the data, we feel that it's appropriate to say, yes, there is always a risk, that the side effects that were seen in any of the trials were expected. And were easily manageable
Stacey Simms 23:48
as we wait to see what the FDA will do. Are you still looking for people to be in studies? You know, my audience is always very interested in that. Are there more studies that people can take part in?
Dr. Henry Anhalt 24:05
Yeah, so we currently have a study ongoing, it's a multinational study multi site in the US called protect. And this study, as opposed to the data that we've been talking about that showed you can prevent progression from stage two to stage three. This is a study for people who are newly diagnosed between the ages of eight and 17 within the first six weeks, and I would urge people if they have any questions, or they need any information to reach out and Stacey you and I can talk about what the best way to have that information or those queries directed because when we talk to people about going online and looking at clinical trials.gov it becomes As a very, very difficult website to navigate.
But suffice it to say that this is a trial where kids between the age of eight and 17, newly diagnosed are given an infusion or placebo of Teplizumab. And they are given another dose, about six months or a year later. Again, this is an infusion. However, it's a 12 day infusion, rather than a 14 day infusion. And there are two infusions over the year. And in that study, were measuring c peptide. And as I mentioned earlier in the podcast, c peptide, is a measure of beta cell function. And so the most important measure for us is beyond hemoglobin A1C how are those beta cells working? How is the residual beta cells producing insulin at this point? And how do they produce insulin after the treatment has given as measured by what we call area under the curve of C peptide production? The amount of C peptide over time, responding to drinking a whole lot of sugar, and seeing where it is that the that the C peptide is produced? I think that that's really an important piece.
I also, Stacey, if I may take liberty and talk about Provention Bio for just a moment. Yes, please do. Because it comes back to camp a little bit. And you may wonder, like, what's the connection? When I first started at Provention Bio, we had a town hall. And you know, if 45, 50 people I don't remember. And the CEO, Ashley Palmer was talking about the importance of us understanding the type one community and I was like, okay, you know, that's words, know, sounds good. And I said, Okay, is a company dedicated to type one? Okay, that sounds good. And so I chatted the group, and I said, you know, I'm on the board of Camp Nejeda, most of us live in the tri state area, I'd be more than happy to host you and to have you guys pink benches, and, you know, do all kinds of cleanup the garbage in between sessions. And he said, You know, that's not here. That's part of your job. And I said to myself, I've worked in other companies that have been in the diabetes space, I have never heard a CEO get up and say, this is your job. It was mind blowing. And I knew then, you know, I was in the right place. Right. So with that sort of as a backdrop, we are really committed to type one. The innovation here is, I think, a landmark in the fact that it will be the first disease modifying if we get the approval, which we hope, the first therapeutic intervention in type 1 diabetes, since the development of insulin, and potentially the only one that is going to be disease modifying. But we're not just there.
And as we spoke about, were in front of the FDA now with the hope that we'll get approval for the at risk population. But we're also in clinical trials to see the ones who are newly diagnosed. So if unfortunately, they've gone on to stage three or symptomatic, or we're also working on a vaccine for coxsackie virus. And so coxsackie has been thought of as a precipitating agent or, or an infection that could potentially provoke or create an immune response that ends up being adversely affecting the pancreas. And the crazy thing is that as a pediatrician, first we would see coxsackie virus all the time. But you know, I have the good fortune of working in a company with a lot of really smart immunologists and I joke and I say, you know, if I would have known immunology was so interesting, maybe I would have paid more attention in medical school. But the fact is, here's another way that we're looking at type 1 diabetes, and the commitment there to innovation is truly remarkable. And I would be remiss if I didn't have the opportunity to state that on this podcast, because I think that speaks to the motivation and it speaks to the genuine commitment to people and their caregivers living with type one.
Stacey Simms 29:53
You mentioned camp, and as we've mentioned a couple of times here you are a pediatric endocrinologist. So you Between the two of those things. You've seen a lot of families over the years, you have probably had a lot of nervous moms and quiet dads in your office with little kids too, grumpy teenagers and independent young adults. I'm curious when you talk about something like to please him on. And you mentioned, as you said, this could be the first therapy, disease therapy it for type 1 diabetes. I know you don't have type 1 diabetes, but boy, are you part of all of those families? Can you speak a little bit about what that means to you?
Dr. Henry Anhalt 30:31
Well, I often joke with people that, you know, I would be more than happy to do anything, including working in my parents’ lingerie store, then taking care of people with type 1 diabetes, not because I hate type 1 diabetes, I do. But it's because I see what happened, what families go through. So for me, what it means to me. If again, if we get approval, I'll feel like I've I finally was able to do something, you know, when you get to the point in your career, when you're working with families who have type one diabetes, and you come to the honest realization that you can't fix it, you no surgeon can go in there and cut it out. But you can't fix it. And the burden really sits with the family, the grumpy teenagers who didn't ask for this. So we're dealing with the intimacy issues, college issues, you name it, the high school kids who are trying to deal with their all the complex issues of psychosocial adjustment to high school and body image, etc. It's unbelievable. So for me as a treating physician, anything, anything. And it's not only templates, a map, but anything that could make them living with diabetes just a bit easier to lift, a little bit of the burden would be incredibly meaningful to me. And that's sort of how I got into this, I was trained to make people who have type 1 diabetes feel that they're never doing a good enough job, that they're at risk of developing all these complications. And you know, when you get to the point in your career, you realize that not only did that not help it hurt, and then really being in a position to hopefully be able to make a fundamental difference and how that goes down. It's really hard to articulate, I have to say,
Stacey Simms 32:31
Did your parents really own a lingerie store?
Dr. Henry Anhalt 32:33
They did. Olga’s corset and specialty shop two Eastern European immigrants who came here penniless trying to build a life for themselves in the golden land.
Stacey Simms 32:45
Isn't that marvelous?
Dr. Henry Anhalt 32:46
That's wonderful. It sure is. It sure is. Yep. Yep. All they wanted us to see their kids, you know, get an education. And of course, you know, me becoming a doctor. I mean, my dad almost ran up to the podium when I got my diploma. He just couldn't contain himself. So yeah, absolutely.
Stacey Simms 33:05
All right. I think we've got everything and more.
Dr. Henry Anhalt 33:08
Yeah, I mean, I would leave you Stacey with, if nothing else, to really, really get the word out for people to screen for dogs to really hear from their families. You know, why don't you screen, I have another kid that to us. And I think to the whole community, now, there's potentially something that can happen. You mentioned trial net, and trial net has done an amazing job in getting tech lism ab to where it is now. And they've done an amazing job at moving the screening field forward. But it's got to get out of the realm of research alone now because now where they're now where potentially at the threshold of a whole bunch of therapies that we hope will get approved and capitalism AB hopefully, if the FDA is happy with the data, and convinced that the drug is safe and effective, which we have great confidence that they will or others coming right behind. So the screening is so critical, Stacey,
Stacey Simms 34:15
thank you so much for joining me, we will link up all of the information and spread the word as best we can. But thanks for explaining everything and come on back, knock on wood. If everything goes through the FDA, come on back and share what's next.
Dr. Henry Anhalt 34:27
I would be delighted to do that.
Unknown Speaker 34:35
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 34:40
More information on everything we talked about at Diabetes connections.com. You can learn more about teplizumab and provention. It's really fascinating stuff. And you know, it's not as easy as you know, one shot and you're done or one pill a day. I mean, it is as he mentioned, a an in hospital procedure, but imagine two weeks of that And then two, three, maybe four years, maybe more of prevention of type one. I mean, what an incredible beginning. I don't get my hopes up often you know me if you've listened for a very long time I I wouldn't say I'm cynical, but I'm certainly not running after every development. But I feel like we've been watching this one for so long, I'm almost ready to put my rose colored glasses on, we'll see, I'll keep you posted on you know what comes out of this, what the FDA decides, and you know, there's going to be a lot more information down the road.
Up next in innovations. f It is time to get cynical again, I'm going to be talking to you and bring you some audio about a roundtable on insulin pricing. So stay tuned for that. But first Diabetes Connections is brought to you by Dexcom. And you know, when we first started with Dexcom, back in December of 2013, the share and follow apps were not an option. They hadn't come out with the technology yet. So trust me when I say using share and follow apps makes a big difference. I think it's really important to talk to the person you're following or sharing with, get comfortable with how you want everyone to use the system. And even if you're following your young child, these are great conversations to have at what numbers will you text, how long will you wait to call that sort of thing. That way, the whole system gives everyone real peace of mind. I'll tell you what I absolutely love about Dexcom share, and that is helping Benny with any blood glucose issues using the data from the whole day and night and not just one moment. Internet connectivity is required to access separate Dexcom follow app. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Last week, a new group or at least new to me called investigate insulin now partnered with the American economic liberties project and held a discussion about the impact of insulin pricing. I'm going to read you the description from their website.
“Nearly 7 million Americans suffering from diabetes need insulin to live but a cartel of drug companies who control the production of insulin, Eli Lilly Sanofi and Novo Nordisk have made the lifesaving drug criminally expensive by colluding with each other to hike prices in lockstep over and over and over for years.
On March 18, at 12:30pm, the American economic liberties project and the investigate insulin now campaign hosted a discussion focused on the dangerous impacts of the insulin cartel racial inequalities in insulin access, and what Congress and the new Biden administration must do to hold these corporations accountable and address concentration in this critical industry.”
And that is the quote from the website. I'm going to link this up, you can watch the entire discussion. It is less than an hour, but it features Congresswoman Katie Porter, who you may recognize from her whiteboard. Many people just know her from that. But she's part of the oversight Subcommittee on economic and consumer policy. And then the remarks here are from people with the American economic liberties project to an international insulin advocates, the executive director of Social Security works. So there's a lot of people talking here I want to bring you one short clip. This is about a minute long. And this is Matt Dinger. He is a patient, as you'll hear, he is an advocate, and he is a board member at T one International. He has just said that he doesn't know anyone who uses insulin, who hasn't rationed it at one time or another. And he sets up His comments here by saying that at one point he had no insurance for just one month he was switching jobs, and he knew that he would have no insurance for a month. And that resulted in him rationing insulin ahead of time. So he would have a stockpile, and then also rationing after he got the job and had the insurance because he knew his deductible would mean he would be paying $1,000 a month for insulin for the first few months.
Matt Dinger 38:51
I'm lucky to be in the position that I'm in. And even so I'm a job loss away from financial ruin. Because the concentration of economic power when it comes to the price of insulin lies almost entirely in the hands of three companies. I am completely beholden to them. And I'm terrified by that every single day. Corporate concentration and monopolistic behavior by the big three insulin manufacturers allow them to set prices as high as possible, with no fear of losing market share. This includes things like shadow pricing, which is increasing the prices in tandem with one another instead of competing to set the lowest price, pay for delay agreements, lawsuits, taking biosimilar insulins off the market, patent games to extend their product exclusivities long past when they would normally expire.
As someone who has worked in healthcare for the entirety of my professional life. I understand the price of innovation. And let me tell you leveraging anti-competitive practices in order to give your CEO a pay package of $23.7 million isnt innovative. and businesses that would do that while their consumers are dying aren't companies, they’re cartels,
Stacey Simms 40:01
it's pretty powerful stuff. I'll link it up. If you want to watch it, it is less than an hour. The investigate insulin now campaign is a coalition of a bunch of different organizations. And I think we're going to be hearing a lot more from them, because these are some pretty big names that are backing them. And while there's a lot of hope that the new Biden administration will move on some of these, there really has been no indication from Democrats or Republicans, in my opinion on the federal level that we will see strong action taken. So I'll continue to keep you posted on this one as well. I can't imagine the insulin companies are going to take kindly to being called a cartel. I thought that was some very interesting language.
Alright, before I let you go reminder that I will be speaking live to some JDRF folks out west tonight, that's linked up on social media and in this episode, as well. And if you know, if you're listening a couple of days or weeks after this episode airs, I'd love to come to your chapter virtually, or maybe in person down the road. So please reach out we do have an event tab at Diabetes connections.com. And you can always request me to come speak or just you can ping me anywhere, email me directly. I love talking to groups. It's always so much fun. I always learn something as well.
In our classic episode this week, we're going to be talking to a Broadway performer Maddie Trumbull, and she has played lead roles and Wicked and Newsies. And we'll check in with her and see how she has been doing this interview was five years ago now. And of course, the last year has been you know, we've seen Broadway completely shut down. So I checked in with her and I'll let you know what she is up to in our classic episode airing in just a couple of days.
Thank you, as always to my editor John Bukenas from audio editing solutions. thank you as always for listening. I'm Stacey Simms. I'll see you back here soon. Until then. Be kind to yourself.
Benny 41:57
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Julie Allred received two separate islet cell transplants ten years ago. How is she doing today?
Diagnosed at age 10, Julie was told she would never have children and she wouldn't live to see age 30. She’s proved her doctors wrong on both counts – her daughter was married a few years ago – but she did have a lot of trouble with unpredictable and debilitating lows in her 30s. These lows were so unpredictable and dangerous that she not only stopped driving, she barely left her house. Then she found out about a clinical trial of islet cell transplants.
This interview was first aired in January 2016
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode transcription:
Stacey Simms 0:00
This episode of Diabetes Connections is brought to you by Inside the breakthrough, a new history of science podcast full of did you know stuff.
Announcer 0:13
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:19
Welcome to a classic episode of the show. As always, I'm thrilled to have you here. Glad you could join me. And these classic episodes are where we revisit terrific interviews, really great guests from the early years of this show that you might have missed the first time around.
There is a new excitement right now about islet cell transplants, this thinking has been around for a while. But the problem has been that once the cells are transplanted, they're immediately attacked, you know, so the islet cell trials of the late 90s and early 2000s, didn't pan out the way that we had hoped. But new science, new technology is showing a ton of promise. And we're going to do some future episodes on what's in the works. There are at least two really big projects moving to clinical trials. I'm thrilled about this because it always seemed like it made so much sense. And this kind of stuff was around right as we were coming into the community, me and Benny and my family 14 years ago, it was kind of the tail end of when they realized that while it worked well for some, it wasn't going to be the cure type of research for many, many people that it had shown so much promise to be. But it really is important to remember that islet cell transplants worked really, really well for some people and you're going to hear from one of them today.
I spoke to Julie Allred in January of 2016. More than five years ago now. She was diagnosed at age 10. And she was told she would never have children and that she would not live to see 30. She has proved her doctors wrong on both counts. Her daughter was married herself few years ago. But Julie did have a lot of trouble as she moved into her 30s with unpredictable and debilitating lows. These low blood sugars were so unpredictable and so dangerous that she not only stopped driving, she barely left her house, you'll hear her talk more about that this was not your typical low that almost everybody who uses insulin has experienced. Then she found out about an islet cell transplant clinical trial. She shares the whole story and I'll give you more of an update on how she's doing in just a moment. Spoiler alert. She's doing amazing.
This episode of Diabetes Connections is supported by inside the breakthrough a new history of science podcast full of did you know stuff. The most recent show is all about unpopular science. One of the stories, it's bonkers. It's about a scientist who discovers the importance of washing your hands. The death rate at his hospital drops once he starts telling people to do this. But then they think he's insane. They discredit his theory and they lock him up and they stop washing their hands. You have to hear it. You can find inside the breakthrough wherever you found this podcast, and this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Judy Allred had two islet cell transplants, one in 2011 and one in 2012. She is going to tell the whole story here in just a moment. But I want to give you a quick update on how she is doing now. 10 years later, she says she still uses just a few units of basil insulin a day. She does wear an omnipod but she says she uses it just for basal. She very rarely boluses. And she says the only time she goes low is if she quote makes a bad decision when bolusing for food because she's so rarely does it anymore. This really changed her life. I should also mention that I know Julie because she was our elementary school nurse. That's who I got to send a little Benny to when he was in grade school. How lucky was I?
Julie Allred. Thank you so much for joining me.
Julie Allred 3:57
Thank you for having me, Stacey. I'm excited to talk with you. Yeah, I think this
Stacey Simms 4:00
is gonna be fun. It's always great to. For me, it's always interesting to learn things about people with type 1 diabetes, but it's also fun when I get to talk to to a friend. So thanks for agreeing to do this. Tell me your story. Yeah, tell me your story. You were diagnosed with type one, when you were just 10 years old, right?
Julie Allred 4:20
I was 10 years old and that was in the late 70s. So why can I tell people always that was before we had all the technology of course that we have today before we had manmade and storm. No glucometers we didn't even have Diet Coke. You know, what was that good old unsweet tea with a saccharin tablet. Those were your choice.
Stacey Simms 4:42
That's amazing to think about. How did you how did you manage diabetes before home meters.
Julie Allred 4:50
There was no homie here correct. So I use urine that we put in the test tube with some little tablet sets. He has done turn colors and it was a good gang. If you only do that, if you felt bad, there was no certain schedule to when you tested your urine. And as you're probably aware, urine sugar in your urine shows up about six hours after it shows up in your blood. So really, when you tested that urine and found out, you know, you had sugar there, it was well beyond the time that your blood sugar would have been half. And you didn't do anything about it. When you saw it there, you just made you aware, there was that insulin you took in the morning insulin, you took it bedtime. And in the middle of the day, there was nothing, there was no sliding scale, there was no carb counting. Nothing like that we ate by the exchange diet, which some people may be familiar with, and maybe not the day, but so many carbs, so many fats, and many fruits and vegetables. So all the things that everybody is familiar with now all the technology, all the things we have to keep ourselves healthier and and make things easier for non existent bands.
Stacey Simms 6:04
Now I've heard you speak and you've talked about how the doctor said you were not expected to live to 30 that you would never have children. Of course, you do have a great a daughter who I've met. But But did they really tell you that? Or was that something you were just aware of?
Julie Allred 6:20
They never told me I found that out and my 30th birthday party. Because my husband had a birthday party for me, of course, my family came my daughter was three at that time. So uh, my mom's sitting in the corner crying, you know, we're having a party, I'm like, what's wrong. And that's when I found out when she told me there, that when you were diagnosed, they shared with us that you were not expected to live to age 30. And that you definitely would not be able to have children that was just not in the cards for people who are diagnosed. And again, you know, diagnosis, disposable syringes were the new thing. So just all the technology that that has come about, exist in the time that I've been living with diabetes is amazing.
Stacey Simms 7:07
I'm just trying to have the perspective that your, your mom,
Julie Allred 7:10
your mom had? Well, I think about that. And you know, you mentioned I'm a school nurse, my school nurses, when I was a little girl that That being said, I didn't check my blood sugar at school. So mom packed my lunch, I ate that. But other than that there was not really anything, per se to do for me at school, you know, unless I complained about not feeling well, or something the teacher would call her but they're just the things that are available today. The things that we do today to manage things so closely. We're just not available Batman. So yeah, it was not a concern.
Stacey Simms 7:46
I'm just trying to think of her being told you would not live to be 30. And then being at your party, must have been an incredible ride for her. But as you got older, you began to have some real difficulties living with diabetes. I know you had a lot of episodes of low blood sugar. Tell me about that.
Julie Allred 8:05
My dad, so I did very well, I actually, you know, got a insulin pump in 1990, of course, glucometer in the early 80s. So I was kind of always trying to stay on the cutting edge with technology and have the newest latest and greatest thing to help me manage. And I did really well. I still was doing really well as far as how I had managed, not that I always did absolutely everything I should the best I should. But I had been fortunate enough to not to experience any of the complications that are a lot of times associated with type one didn't have any problems with my kidneys, I had great steel. None of those things that a lot of times people began to have problems with as they move into 30 plus years with type one. And I was 34 years with type one, the problem that I was experiencing, experiencing was those unrecognizable low blood sugars. And that started probably in 2007 or eight somewhere around there. It it became more difficult for me to know when I was having a low blood sugar, the symptoms changed. And they became less evident to me. And as time went on, they just eventually just went away. I didn't have any signs or symptoms until I was so low that I couldn't help myself. I would get to the point where I realized that I needed to do something that at that point, I couldn't do anything for myself. I had to rely on someone else. So you were in that slow traveling.
Stacey Simms 9:46
You were driving, right?
Julie Allred 9:49
I was driving. And many times I would even was married that's my daughter who was now will be 21 next week at that time she was you know in her Team so not driving yet but a couple times we'd get to a stop sign or a stoplight and she would put the car in park and take the keys away and call my husband because she knew you know that it wasn't safe. And I did have a couple episodes where I ran off the road. Fortunately for me, and others never hurt myself or anyone else. But it the discussion, the next discussion at my doctor's appointments going to be taking my driver's license away, because that was unsafe.
Stacey Simms 10:27
It's so scary to hear about.
Julie Allred 10:29
All that being said, I still had the latest and greatest, I still have the newest pilots. I had a dexcom CGM. At that point. I was doing all I needed to do. And of course, my medical team was doing all they need to do to help me. It was just that that was my complication. I guess you can put it that way. But I just was not able to feel those lows and do anything about them. And enough time to help myself.
Unknown Speaker 10:55
Is that how you get into work was
Julie Allred 10:57
not an option either. Yeah, I was working about 10 hours a week was all I could manage?
Stacey Simms 11:02
Is that how you were able to get a trial?
Julie Allred 11:05
Yes, that is how I was able to get into the trial because I laugh and tell you how to be a fairly healthy, unhealthy diabetic to qualify for the study that I participated in. That being said, you could not have any kidney issues, all those things that I talked about that I was fortunate not to have experience. But the low blood sugar. The hypoglycemic unawareness was the key to qualifying for the study I participated in. So they asked me about how many low blood sugars I thought I had in the past year, that one of my first visits, I have no idea. I was horrible. I was mad at writing down my blood sugars. But we went back and looked at at the month, at one month that had passed. And from that guesstimated that over a 365 day period, I probably had 300 I think we came up with 386. Wow. was until a by definition for them a low of anything. 54 below.
Stacey Simms 12:05
Oh my gosh.
Julie Allred 12:07
Right. Wow. How did you
Stacey Simms 12:09
feel during this time? Was this something that you were used to? Or was it did you feel lousy every day?
Julie Allred 12:17
No, I said, I felt bad. And and the left felt bad. But I didn't realize how bad I felt. A lot of it was my normal. I slept a lot. You know, when I was at home. I felt like I never slept well. And I guess I probably didn't two, between two and three a 3am was probably my worst time. That's when I would have the most severe loads. And of course, you know, everybody else is asleep, too. So that makes it even more difficult. But I just always my, my constant thought was when I could lay down if I got up to do something, it was how quick Can I get finished with it. So I can sit back down so I can lay back down. Because to me all I saw, you know, 15 minutes of laying back down, and I'll feel better. And that was just never the case.
Unknown Speaker 13:10
As
Julie Allred 13:12
I didn't do and the probably the year, year and a half before my transplants I was became pretty isolated. I didn't say that at the time. But I say that now, I just didn't go and do things. I didn't go out of the house a lot would find an excuse not to go to a party or you know not to go to dinner with somebody because I was always afraid of what was going to happen when I was there. And I of course didn't do anything by myself. Nothing. I didn't even go to the grocery store alone. Somebody was with me all the time. So that was very frustrating for me. And for my family. Of course, let's talk
Stacey Simms 13:50
about the clinical trial, you have been through two procedures right for transplanted pancreatic islet cells, the cells that produce insulin in 2011 and 2012. And I'm gonna I'm gonna walk through this, so tell me if I get this right. But this is the operation where basically they they put the islet cells into your into the liver, right, which helps. And then they take over the job of making insulin. When you went through this, did you know was it the kind of trial where and I forgive me for my ignorance? Are there people getting placebo islet cells? Or is it all everybody gets the real thing because you're going through surgery and you know,
Julie Allred 14:33
right? Everybody gets the real thing? That's correct, because these are human hours that are that are donated from organ donors just like any other organ would be donated. So they use the whole pancreas normally for a pancreas transplant. But a lot of times even when you have a donated pancreas, it can't be used because in the process of organ donation, you know, of course thanks at a higher level some things at a higher level level than others, the kidneys and pancreas work together in the body and to to isolate both of those organs. Of course, the kidneys are more useful, you have two kidneys, those can go to two separate people, all the necessary blood vessels that are needed to do those transplant go to the kidneys. First, the pancreas is next on the list. So a lot of times even though you have a pancreas that may be suitable to use, you don't have all the necessary blood vessels that go with them. So that keeps it from being available for transplant as a whole organ. So what they do is use that organ and isolate the eyelet sales from that pancreas and transplant them. And that is how I received the alpha cells I received. How, yes, that's what see those on the waiting list for a heart or, or lung or kidney or whatever, and the head has to be matched in the same way you have to go through all those all those same steps. And then check with your organ donor.
Stacey Simms 16:00
Do you then after the surgery take immunosuppressant medications?
Julie Allred 16:06
Yes. How is that because everyone that
Stacey Simms 16:09
I'm sorry, Julie, everyone that I've heard talking about this, they always say, Well, that sounds great. But the drugs you have to take to prevent rejection are so harsh. How is your life since then?
Julie Allred 16:21
Well, it took a little bit in the beginning to get all those things regulated. And and I'm not saying it was easy. But it was a lot easier than what I had been going through. So taking those five or six pills a day seemed like nothing to me, compared to the life I had been living compared to the to a low blood sugars to not being able to work, all those things that have, you know, had gone on before. I did have a little problem with Jia upset in the beginning. But again, it's just getting all their things regulated, you know, for each individual. And that happens with anybody with a transplant. And once that happens, I did not experience any terrible side effects. I still take those medications on two times a day on a daily basis. And they're just part of just part of my life. Now, a lot of people say, Oh, you have to take pills now. I do. But all those other things that were issues or are not issues anymore. And I guess it depends on how you look at it. And it was a wonderful trade off for me. I would do it 100 million times over again, all the all the bad parts, the good parts, were just a million times better. Well, here we are five years ago, there were issues right here we are almost five years later. And when I been here, kind of not participated in that study, I would say I would not be unfortunately. And I am I have a driver's license, I work a full time job I volunteer I'm engaged in, in the life of my child and able to participate and do things that I have always wanted to do. But always felt a little bit hesitant to do and especially in this, you know, four to five years prior to the transplants that I just didn't allow myself to do those things. So people say well, you have a normal life, not really life like I've ever known. That's a good point.
Stacey Simms 18:21
Tell me about what you do for diabetes because I remember reading that initially at least after the surgery you still worn insulin pump Do you still check your blood sugar? What do you do now? Do you consider yourself cured?
Julie Allred 18:34
If you can't say cure technically and no I'm not because I did were the insulin pump after the first transplant because even though those eyelets were working, I didn't get the equivalent number of hours to what you know a normal person would have. So I continue where my insulin pump I went from taking 75 units and on a day to 11 units between that first and second transplant and then after the second transplant I was insulin free for 96 days completely insulin free. Again I had a little issue with some of the medications and of course the major side effect to those medications or damage to your kidneys and or pancreas. So they did damage I had some toxicity to one of the medications and they believe they damage the islets a little bit. So I started back on insulin and June after the second transplant unsavoury of 2012. And I've taken a small amount of insulin at bedtime since then,
Stacey Simms 19:39
but that's it. You're not wearing an insulin pump currently.
Julie Allred 19:41
I'm not wearing it and so on top. I do not have low blood sugars. I do not have high blood sugars. Do I eat whatever I want. Not whatever I won't I just don't think that's in me. I mean, there's still that there's still always that After in the bathroom, I'm always thinking about what I'm eating, how many cards bed what you know, what would that do? What is it going to do now? Because that's part of being in the study? Is there not a lot of answers what to expect in the future? That's part of participating in the study is, we will let them know what to expect in the future just by following us. And there were 273 participants in the study that I've participated in. So we're part of what's going to happen in the future. They're getting all that information from us. So yes, they still follow me. Yes, I still check my blood sugars and provide them with that data.
Stacey Simms 20:36
But would you mind if I asked him, please don't answer if it's too personal. What is your typical blood sugar?
Julie Allred 20:42
And my last day once he was 6.20? Wow. Yeah, right there. Again, right on the edge. Technically, if you look at the textbook standard, Dima non diabetic, maybe not. But I'm a million times better than I've ever been absolutely. Great.
Stacey Simms 21:00
Before we leave this part behind, because I definitely want to talk about the school nurse component. Tell me about the
Unknown Speaker 21:09
visit the rosebowl
Unknown Speaker 21:11
talk, tell me about right.
Stacey Simms 21:12
Yeah, the Rose Parade. Tell me about the Donate Life. Rose Parade, the float that you were in for Donate Life.
Julie Allred 21:19
Right. So in 2000, January 2014, I was the first islet cell recipient to add on the Donate Life float in the Tournament of Roses Parade. And so I ratters on that. Riders on that float are all transplant recipients, and all the float as well, or floor graphs or pictures of donors that are honored on the float. And then there are also people who walk around the float and those people are living donors. So they've all usually donated kidney. And Donate Life has had a float in the rows pray for I believe this was the 12th or 13th year. So I was sponsored by Emory Transplant Center to go and represent Emory transplant and outsell recipients on the donate lifeflight. What was that? That was amazing. Very, that was an amazing experience. So you know, I've always watched the Rose Parade on TV and think how fabulous that is and and realize it Yeah, that's a big deal. That's a big parade. But I had no idea until I went participated in the whole event. And we were there for six days, you know, a few days leading up to the price. So I was honored to be able to help decorate the float place all those, you know, some of those roses on that float. So the donatelife float, the bottom of the float is always decorated with resins that are dedicated either in honor of memory or memory of someone. So they all have a personal tag with a handwritten note. And so I was honored to be able to place those verses on the float. And the rule is that you read every note on every rose before you put it on the float. So that was that was really a special experience for me, David, my husband got to go with me and help. As we decorated, we spent three days helping decorate the float. And then of course, I read it on the slide on New Year's Day. But again, a tremendous once in a lifetime experience to meet so many wonderful people from all over the country and other parts of the world as well. transplant recipients, donor families and those special living donors. Wow,
Stacey Simms 23:28
that's an incredible experience. I was so exciting to see you part of that. So Julie, we've known each other for few years, because of the local jdrf chapter, you've done so much work with them. And, you know, I was on the board for a while there and we've kind of circled around each other. But then a couple of years ago, you became our school nurse. And so I have to put a caveat out there as we begin this conversation, I promise I'm not going to ask you anything specific. I understand the HIPAA laws and I understand the constraints you may be in. Because you know people may know what school you work at. But I just thought it would be a great opportunity. Because I talked to a lot of parents who have difficulty dealing with their school, the school nurse or the school principal, or teachers don't seem to understand the needs of kids with type 1 diabetes, they they may insist that the kid go to the nurse for every single thing. They may be frightened of the kid. And I was just curious if you could share some advice. I know you and I have such a wonderful relationship and we never give you any trouble and our child is an angel so we'd have to go down that road.
Julie Allred 24:34
But they all of course,
Stacey Simms 24:36
what but you know, it's interesting before, I should point out, we have four kids at our school with type 1 diabetes, all of whom manage very differently. It was very different, right? Not even in terms of the technology because there's different pumps. One child has been on MDI until very recently, transitioning from injections, but every parent is so different. And it's been a lovely experience because the school has Never said to any of us, you need to do it this way. What's your advice for parents, though, for working with this, right?
Julie Allred 25:06
The biggest piece of advice I can give to parents is to meet with your teacher and meet with your school nurse. I guess I'm sort of at an unfair advantage when it comes to managing my children and helping them manage at school and the relationship I can have with them, because I've lived with type 1 diabetes, and that that does give me a very different perspective. As you know, and as most of the parents know, the understanding that the the general population has a type one is sometimes a huge misconception. And, and to help them understand the communication between between the parent, the teacher and the school nurse is the key. They have to be able to understand and you are the person to help them understand your child. The other part is that every child is different. And I think that's hard. Sometimes for teachers, especially a little bit hard for the nurses as well, because there is no black and white with type one. Every child is different, every day is different. Sometimes every minute is different. And you just have to be able to go with the flow a lot of times and so there's not all you can't always answer every question for them and give them give them an example of everything that might happen. You know, in a school day, it's all about communicating again, with a parent, the teacher, thing about that school nurse as a teacher communicating with the child. Like your son, a lot of these children are diagnosed at a very early age. And even sometimes by the time they get to kindergarten, they've been doing this a while. Yeah, they know a lot about type one. They know a lot about how domains things themselves. And sometimes that's hard for people to understand that a kindergartener really can't check their own blood sugar, they really do understand, you know, how this technology works, that these kids do. So having that relationship with the child, for the school nurse to have that relationship and the teacher, to have that relationship with the child and keeping the lines of communication open, I think is the most important thing. Again, because they all managed differently. Nobody way is right or wrong, nobody has better than another's. It's all based on that that particular individual child and what works best for them.
Unknown Speaker 27:35
What I love about you, and if you
Julie Allred 27:37
can continue what you do at home, if you can continue that at school, it just makes it so much easier for everybody, for the parents and for the children. And the teachers, I think and the nurses say eventually that it makes it easier for them as well.
Stacey Simms 27:50
Oh, yeah, you don't want to change management, I was just gonna say, what makes me laugh. And what I love about you, too, is you do know this so well, that, you know, My son has gone through times where he's been, oh, my diabetes, or he'll give somebody that puppy dog eyes. Oh, and you don't get into any of that. It's great. You're just like, Look, I know what you're doing. I know where I've been, you know, go back to class or, you know, we'll deal with it or whatever. And I think that that perspective is so valuable and wonderful, they really appreciate that. But if if a parent is, really, I think a lot of this comes from fear. That there there may be, as you said, misconceptions, and I see a lot of parents, especially online, who will write things and they're just on Facebook, they don't really mean it, I think half the time, like I'm going to go to school, you know, I'm going in swinging, or I'm really upset, and I'm going to give them a piece of my mind. Can you speak to that for just a moment, just in terms of, you know, trying to, I always tell people, you know, approach as a team, even if you hate these people, they got your kid for eight hours a day.
Julie Allred 28:52
Right? They do. And I can say, not as a parent of a child with type one. But as, as a type one who works with these children that have type one and, and I know, I feel like where they're coming from a little bit better, maybe then not better than a parent does. But in a different way than a parent. I get it that it's hard to trust someone the first time that you send them out of your sight. To know that they're going to be taken care of like you take care of them at home. So again, approaching it like you said, as a team, sit down with everybody don't have the separate meeting with the teacher and the nurse, everybody meet together so that you're all hearing the same thing at one time you come up with a plan that works for everybody, because a lot of times nurses not aware of every the schedule in every classroom, and a lot of times everybody in the second grade does things pretty much the same, but a lot of times they don't So again, it's knowing all the specifics of what goes on even hour to hour during the day and how we can best manage that during the day. And then what do we do? If there's a problem? You know, who's responding, who's gonna call Who? And then even comes down to sometimes, you know, does the nurse needs to call the parent? Or does the teacher need to call the parents? And just coming up with the sample the answers to questions like that, but don't get you bogged down during the day, when there's so many other things going on. Meaning as a team, listening, what the child has to say to is very important, because they're the one living in that environment. They know what they're comfortable with. They know how comfortable the teacher how comfortable they are with the teacher, how comfortable they are with the nurse, how long does it take them to get to the nurse? If they're not in their classrooms, if they're in another area of the building? You know, how long does it take to get there? What should we do then involve the child because again, these kids are smart. Most of them are very independent. And they have a lot of good ideas and information that I think we need to consider and take into, you know, taking into consideration when we're making the plan for the for the school day. It's great advice. A lot of it is to I think people are very intimidated by the fact you know, especially a new teacher, maybe who's never dealt with this. Again, sharing with him and showing them bringing the child before school starts if you can, if they're newly diagnosed tremor day or two before they're going to be there a whole day, and let them see the child checking their own blood sugar, administering their own insulin, using their insulin pump, that they really are independent. A lot of times when they do they need a second set of eyes. Do they need adult supervision? Yes, they do. But many times, that's just what it is supervision, double checking. These kids know what to do. Yeah, that's
Stacey Simms 31:59
a great point. We've done that with a lot of teachers. And once they realize that they're that they're not going to become a nurse or doctor while they're to die. That really assuages a lot of fear.
Unknown Speaker 32:09
So Julie, what's next for you? Does
Stacey Simms 32:11
this those trials continue indefinitely? Do you go back for periodic checkups? Are you scheduled for more surgery if I can be super nosy and ask
Julie Allred 32:20
right now, just yearly checkup? am considering another transplant that's kind of out there on the horizon? It may be a little while. And then there are all those things like encapsulated owlets that are going on right now. So there will be another adventure for me, let me just say that I'm just not sure what it is yet. But in the meantime, I'm happy to be working in school to be sharing my experience with these kids. And people say you know, you've had such success. Yes, I have. Has it changed my life? Absolutely. It has has it changed the life of my family? Yes. But it's also changed the lives of other people. I said, this goes way beyond me. Hopefully it's changed, eventually will change your life safety and the lives of all the kids and all these parents and they're dealing with this on a daily basis. And whatever they learn from me, whatever successes I have, whatever mistakes that we've experienced, we learn from it all. And so the hope is that down the road, we're all going to have the experience of living those days without type 1 diabetes. That's that's just what I'm looking forward to.
Stacey Simms 33:38
You know, I love doing this podcast, but it is hard to be a news interviewer when I'm trying not to cry. I tell you, Julie, when you talk about this, I don't know if it'll be this type of transplant, or it'll be encapsulation. But I know that the information that comes from people like yourself, who who sacrificed I know, you say it's good that you did it. It's wonderful. But you've sacrificed a lot to to get to this point. I know that information will help people and thank you so much for doing that.
Julie Allred 34:09
Absolutely, I would I would do it a million times again. Julie, thank
Stacey Simms 34:13
you for talking to me for sharing your story for making me cry. That wasn't fair. I really appreciate you joining me today.
Julie Allred 34:21
Absolutely appreciate you speaking with me and appreciate our friendship, and all that you do for the tight bond community. I mean, you are the go to person in this area. And we love hearing you and we we truly appreciate all the information that you get out to us, sometimes on a minute to minute basis. It's really it's valuable information. And if people ask me again, why I'm still you know, involved because it's, it's part of who I am. I want the best, not only for myself, but for all of you as well. And it's just it takes it takes the whole community to support each other and we need to continue that support and we thank key for all you do to provide support to the type one community.
Stacey Simms 35:03
I'm leaving it there because I'm gonna start bawling.
Unknown Speaker 35:10
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 35:16
I'm gonna link up some stories that were done on Julie in the past and some information on clinical trials and islet cell transplantation. I'll put that on the show notes at Diabetes connections.com. And the episode homepage as always has a transcription, I do have to share one embarrassing story. It's embarrassing for me. I remember hearing Julie speak for the very first time Vinnie was not yet in elementary school, so and she was not even at that school yet as a school nurse. But I heard her speak at a jdrf event. And I'm embarrassed because I kind of didn't believe her. I was in a moment of time. And I don't know how you reacted when your child was diagnosed, or when you had your own diagnosis. I did not want to hear about cure, I was very cynical, I was closing my heart to those things. I just didn't want to hear it. I just wanted to get through the next couple of years of learning how to do this and keeping him healthy. And that was just my reaction. And when she spoke about islet cell transplantation, I was not in the right place to hear the message, as some people might say, and I talked to her afterward, I don't think she even knows this. And I was just kind of politely nodding. And people were saying, you know, oh, you should talk to her for your blog, because I was blogging at that time. And, you know, it was on the local radio. So you talk to Julia, what a cool story in my head, I'm going well, I'm not gonna do this. This is false hope this is good for anybody. And this is going to work. You know, I think I was just in the wrong state of mind. And so I'm glad I spoke to her. I'm glad I learned more about her story. And that, of course, when I started the podcast, she was one of my first guests very excited about the future of islet cell transplantation. Sure what she went through is not a cure, and it didn't work for everybody. But you can hear how much her life changed. Absolutely amazing. I'm thrilled. Think about all the stuff that they learned from it. Just great.
Okay, coming up next week, I'm talking to the people from Pro vention. I say it very clearly, it's not prevention, it's prevention. This is the company behind to please him up, which I say as clearly as I can. That is the drug that is showing such promise of delaying the onset of type 1 diabetes. It is in front of the FDA right now. We'll be explaining the whole thing. But the great folks from prevention. By the way, the gentleman who works there that I'm talking to is not only a pediatric endocrinologist, he is a diabetes camp guy. He's the director of a big diabetes camp. And so he gets it and he gets emotional just like the rest of us. I really enjoyed talking to him. That's next week. Thank you so much to my editor john bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Benny 37:46
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Right now, the very first diabetes technology with roots in the do-it-yourself community is in front of the FDA. Tidepool CEO Howard Look joins us to talk about what, if approved, will be a prescription mobile app controller: Tidepool Loop.
We get details on the submission, including everything from how you’d actually get this app to whether you’ll be able to set your own blood sugar target ranges to which devices Loop could work with, international possibilities and much more.
Learn more about Tidepool Loop
Watch this interview on our YouTube channel
Our first conversation with Howard Look from 2016
Howard announces Tidepool will shepherd Loop to the FDA (2018)
Howard mentioned Tidepool documents. Find those here
In Tell Me Something Good a teenager with type 1 has a big idea about a Funko Pop character and some positive news for diabetes camps this summer.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels increase your possibilities by Gvoke HypoPen the first premixed auto injector for very low blood sugar, and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:26
This week, the first Do It Yourself based diabetes tech goes to the FDA. We will get details on the submission of Tidepool Loop , including everything from how if approved, you'd actually get this app to whether you'd be able to set your own blood sugar target ranges,
Howard Look 0:43
we did in our submission to the agency proposed flexible set point. We are in review right now. That is something new, and most companies before us have submitted with fixed set points or a limited set of set points. That is something that we are discussing with the agency we're not yet cleared, so I can't tell you how that discussion will go.
Stacey Simms 1:05
That's Tidepool CEO Howard Look. He also answers questions about which devices this version of Loop could work with, international possibilities and a lot more. in Tell me something good a teenager with type one has a big idea about a Funko Pop character and some positive news for diabetes camps this summer. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show always so glad to have you along. We aim to educate and inspire by sharing stories of connection with a focus on people who use insulin. My son was diagnosed with Type One Diabetes just before he turned to my husband lives with type two diabetes, I have a background in broadcasting. And that is how you get the podcast.
This week's subject is one that a lot of you are really excited about. I was going to say it's something that you've been waiting for. But I know a good portion of my listeners are part of the we are not waiting movement, and are using a DIY version of Loop already. For those who are not. What is Loop ? Well, that's a big question and I will direct you to a bunch of our past episodes. With the we are not waiting hashtag you can just go to Diabetes connections.com there's a search box on the upper right hand side of the website. And I have put all one word hashtag we are not waiting as a search term for any episode that deals with that with the DIY community. Of course, you can also Google Tidepool Loop , that sort of thing. But as simply as I can try to define it here, Loop is one of a couple of programs created by the community. This is not something that's commercially available, and it helps insulin pumps and continuous glucose monitors communicate. DIY Loop uses a Riley link another external piece of hardware to help with this. And it works with Omnipod and older Medtronic pumps. There are other programs openAPS Android APS, which work with older Medtronic pumps. That is a very quick and very light to say explanation of it.
So I urge you if you're interested, although Howard always does terrific job of explaining more when I do talk to him here, I just want to make sure that you understand kind of all of the groundwork, this is not something that have popped up in the last couple of months. In fact, in late 2018 Tidepool , which was well known by then as a nonprofit, open source, a call it an information hub for people with diabetes, they announced they would shepherd DIY Loop through the FDA making it a lot easier for non diy yourself types to access what is really life changing technology. And now just over two years later, they've submitted and I don't know if an information hub is the best way to describe Tidepool , but it was started because there was no place at the time to view diabetes data in one place, I don't believe there really is still you can see data from your pump, your CGM, your meter all in one uploadable place and use interactive graphs and see trends and patterns in a way that was never available before. And I don't think it's available as robustly anywhere else. And then you can share with your healthcare team and invite other people and your healthcare providers to look at your charts and your graphs and your data. So that's how Tidepool s started.
And if you want to hear the whole story about how they stepped up to take this new task on, again, I will link up these specific episodes at the homepage for this one at Diabetes connections.com. By the way, this is also a video interview, you can check that out at the Diabetes Connections YouTube channel, I'll put a link in the show notes there as well.
I do want to give a quick disclosure here. I did a project for title in the spring of 2019. I was helping out with some research interviews in the community, that sort of thing. I bring it up because they paid me as a freelancer. And while they've never paid me for the podcast, I think it's important to always let you know about that kind of thing. By the way, I'm very good at community interviews and freelance projects like So reach out if you ever need a hand.
Okay, Howard Look in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And you know, almost everyone who takes insulin has experienced a low blood sugar and that can be scary. A very low blood sugar is really scary. And that's where Gvoke Hypopen comes in. Gvoke is the first auto injector to treat very low blood sugar. Gvoke hypo pen is pre mixed and ready to go. With no visible needle. That means it's easy to use, how easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit gvoke glucagon.com slash risk.
My guest this week is co host Howard book here to talk about the very exciting submission of a Loop app to the US FDA, there is so much to talk about here. But Howard, let me just first welcome you to the show. Thanks for coming on.
Howard Look 6:05
Hi, Stacey. It is so great to be here. I'm so excited to see you again. And so grateful for you having me on your show.
Stacey Simms 6:12
Thank you. You know, it's funny to look back. And we have a lot to talk about. But I should say as we're getting started here, I have talked to you many times, but twice for the podcast and the first time was almost five years ago now. So as we go through this conversation, and as you're watching or listening, there's gonna be a lot of presumed knowledge, I think we're not going to try to explain everything. So I will link up the previous episodes where we talked about title and it's early days, and then the announcement a couple of years ago about this. But I think that even just a quick, cursory Google search will get you up to date before you listen to the interview. But there's a lot here. So Howard, thanks again. Let's dive right in. My
Howard Look 6:52
pleasure. Thanks for having me.
Stacey Simms 6:53
What did you all submit? Tell me about what actually went to the FDA.
Howard Look 6:58
I have learned more about how FDA submissions go than I ever imagined my whole life. So we submitted what is known as a 510 k application, which is a big set of documents that says to the FDA, here's what we have built. And here's how we built it. And here is the work that we did to show clinical evidence to show software cybersecurity, what's called verification data, how we know that the software is working as intended. It describes what it looks like, how it works, what the requirements are. And all of that ended up being about a 2000 page submission, which sounds like a lot, but I've heard that other submissions are far far bigger. So we feel like it was a well crafted submission. And we are now in the thick of what is called FDA interactive review. So we sent in our submission on December 17. Turns out that was a snow day in Washington DC. So that was our thing. So our lawyers office used a courier to get a DVD ROM and deliver it to silver springs, Maryland. And what the FDA got was a bunch of documentation about Tidepool
Stacey Simms 8:14
you submitted Tidepool Loop , this is an app, what is you know, what do you I guess we can fast forward what would the finished product be?
Howard Look 8:22
So Tidepool Loop is a mobile application once it is cleared by the FDA and I have to be super clear it has not yet been cleared by the FDA It is currently under review. So it is not yet available. But once it is cleared Tidepool Loop will be a mobile application for iPhone. And people will be able to get it just like you get any other iPhone app by going to the App Store and downloading it, it will be prescription required. So you'll have to go to your endo or your doctor and say this is something I would like and get a prescription code. And then people will be able to download that app from the App Store. And what Tidepool Loop will do is it'll connect to insulin pumps and continuous glucose monitors. And it's what's called an automated insulin delivery device or some people call it other people call it closed loop or artificial pancreas. But basically it's software that automatically controls insulin delivery based on glucose values. And based on predicting how your body is going to react to insulin and carbohydrates. And it automatically uses an algorithm or math a fancy word for math to decide how much insulin you should get. So long winded answer Tidepool Loop is a mobile app that controls insulin delivery.
Stacey Simms 9:40
Well, it's not long winded at all because I know there's a lot more to it than just that even But to be clear, when I think about this, and we'll go I would love to talk more about the history and DIY and and so much of that. It basically is the brains of the operation. So you have your pump, you have your CGM but you need that program. So you know, we have the controller queue we have horizon with Omnipod, if I'm getting that right used to be type zero, which we may see in other pumps, this is that
Howard Look 10:07
that's exactly right. There's there's three pieces to an automated insulin delivery system. There's the insulin pump, which I think most people are familiar with, but it holds a reservoir of insulin. And sometimes it's something that you clip to your belt, like a Medtronic pump or a Tandem pump. And sometimes it's a self-contained unit, like an Omnipod that sticks right on your skin. So that's component number one is the insulin pump. component. Number two is the continuous glucose monitor. And the one that I think a lot of people are familiar with is the Dexcom G6, that's a super popular continuous glucose monitor or CGM, but there are others out there as well. And then the third piece is this controller piece in the middle. And what the controller does is it reads the data from the CGM. It also takes other information such as what your insulin to carb ratio is, what your insulin sensitivity factor is, knowledge about your basal rates. And it combines all that information using math and determines how much insulin you should be getting. And what's cool about it, people living with type one diabetes are used to that and used to doing the math on a napkin to figure out what their dose should be. But what's cool about it is that the software does it for you. And in the case of most automated insulin delivery systems, it does it automatically every five minutes, which is great, because that's a lot of math, and it's doing it for you. And it's also paying attention to how your body is reacting to what happened previously. And that's why it's called a closed loop system. It delivers insulin it it determines information. And then that brings that information back into the system to determine what it should do on the next iteration of the loop .
Stacey Simms 11:49
And it really has been amazing. I mean, we use I mentioned control IQ. And I had no idea even though I had been told I could make you know, 300 decisions a day, one every five minutes, and then an additional one every hour. I remember the first morning I checked, and it kept Benny at like, let's say one 10th or 105. Great number I was so excited to see. And I thought oh, well, it didn't have to work very hard last night, because he was just cruising.
And I went into the pump.
Stacey Simms 12:12
And it had adjusted every five minutes. It's incredible. I don't know why I had, I hadn't thought about it that way that it would have to work just as hard right to keep him at that number. And it's not something that most people really have the inclination to sit there, you know, and do all day long. It was amazing to me just in a way. Howard, I gotta tell you, and you look at this as a parent of a child with type one, it kind of assuage my guilt of not being perfect all these years. Oh, yeah.
Howard Look 12:40
Yeah, I know exactly what you mean. So our daughter, Katie, she's 21 now but she was diagnosed with type one when she was 11. And I totally I know exactly what you're talking about, as a parent, that feeling of why can I get this right? How can I do more? What Why is this so hard? And the answer is, because it's frickin hard. It is really hard work. And these systems are taking that really hard work and bottling a whole bunch of it up into these decisions that it can make every five minutes. And even they have to work hard. If you actually look at what the systems are doing. They're adjusting insulin delivery up or down every five minutes. And they're doing their best. And it's still really hard. And so yeah, I know exactly what you're talking about, and realizing what we as parents did getting up multiple times during the night giving correction doses trying to get it right. Like we all deserve a gold star for that because it is frickin hard work. You know, and everyone living with type, of course will start to because not just as parents, like people living with type one, doing this
Stacey Simms 13:46
for decades, exactly with no breaks. So I have a lot of specific questions about title that my listeners have sent in. I'm cautious about getting too specific. I'm going to ask you, you may have to say can't answer that. Can you answer that? But before I do, I'd love to take a moment and talk about the significance of this being something that started as part of the DIY community.
I was looking back and my podcast started in 2015. But we are not waiting and started really that that same came in 2013. But people working on things like this before that. Yeah. What's the significance? As you see it, of my understanding is this is the first kind of crowdsource DIY diabetes component.
I'm not really sure what else to call it to go in front of the FDA. It seems like we should just kind of stop and mark that.
Howard Look 14:31
I agree. There is so much to celebrate about the story. And what you just mentioned, is one of the huge components. So Tidepool Loop is based on an open source project that was known as Loop. I usually call it DIY Loop just to differentiate it, but it was just known as Loop. And there's a wonderful medium blog post by Nate Ratcliffe, who is the original author of Loop and he talks about how the works He did was built on top of the work that people did before him, people like Ben West and john Costik, who figured out how to control diabetes devices over wireless communication protocols. And then Pete Schwab who's the, his daughter is named Riley and Pete went and taught himself hardware design so that he could invent the Riley link, which made it possible to control at first Medtronic insulin pumps and then later Omni pod pumps remotely from an iPhone over Bluetooth. So it's this really incredible story of innovation of people figuring out how to make this happened.
There's a whole other wonderful blog post that for your technically minded readers about the reverse engineering efforts that went into figuring out how to control the Omnipod, and how to add that functionality into Loop , which at the time only could control Medtronic pumps. And so it just goes on and on and on. There's a gentleman named Joe Moran, who was instrumental, he's been living with type one for decades, and he was instrumental to that effort. And so there's the open APS community and the Android APS community, Dana Lewis and Scott Liebrand, who I know you've met. And the story is that when the community really wants to do something, they just go figure it out, it's the most it to me the most incredible example of tenacity and innovation, and grit, and everyone working together for the greater good. And all of that transpired with people just doing their thing on their own, you know, nights and weekends, or, you know, none of them all of those names that I mentioned, it wasn't their day job to go do that. They did it because they wanted to help improve lives, their own lives, or the people they love living with with type 1 diabetes. And so what we did at Tidepool is we saw how popular Loop or DIY Loop was, my daughter started using it when she was still in high school, six years ago, and was getting incredible results, a bunch of other type coolers. Were using it.
And we thought to ourselves, you know, what, we're in a really interesting position as a nonprofit, as an open source organization that has chosen to engage deeply with the FDA that we could take this open source project built by the we're not waiting community, and we could actually bring it into our regulatory quality system. And we could take it to the FDA and say, Hey, FDA, we actually would like to make this broadly available, we would like to put it in the App Store. And we started floating this idea with everyone with the we are not waiting community, with the device makers that would have to cooperate with the FDA, with the funding organizations like JDRF. And the Helmsley charitable trust. And across the board. Everybody thought it was a great idea. And so that was really, to me, it was just so heartwarming to know that everybody agreed, yes, this needs to happen. It can't these great systems that are helping our kids sleep through the night and helping us achieve, you know, really great, lower burden control of our diabetes, that we want to do our part to now pay it forward and help make it broadly available. So I was just I couldn't be more thankful and grateful to that entire community. So I often say we are standing on the shoulders of we're not waiting giants.
Stacey Simms 18:30
That's great.
All right. So now let's get down to the nitty gritty because people want to know what this is really going to look like. Let's start by talking about understanding that things change. And I'm sure that you want to work with everybody down the road, when or if this is approved. What are they approving? Is it for use with just Omni pod? I know you have an agreement with Medtronic, what starts out of the gate?
Right back to Howard answering that question. But first Diabetes Connections is brought to you by Dario. Health. And over the years, I find we manage diabetes better when we're thinking less about all this stuff of diabetes tasks. That's why I love partnering with people who take the load off and things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you. All the strips lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends, with suggestions for how to succeed get the diabetes management plan that works with you and for you. Daria has published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash Diabetes Connections. Now back to Howard Look talking about what devices will pair with Tidepool Loop .
Howard Look 19:48
So the first thing I have to be super careful because this is not yet an FDA cleared product and the FDA has very strict rules about marketing a product before it's actually available. So I'm just gonna make a statement upfront that I will probably repeat over and over, I'm going to describe the process to you that we are going through. But I'm not yet describing a product that is cleared by the FDA. And we are not yet approved to market this. So I'm what what we can do because we're a nonprofit because we're radically transparent. We share everything that we're doing with the community. So all of our engagement with the FDA, for example, we've publicly, openly published on our website. So your listeners who want to actually see what we've talked to the FDA about can go to tidepool.com/ documents, and see all of the interactions we've had over the years that I'm about to describe. So here's what I can say, openly, transparently. publicly, we have announced that Tidepool , the organization has development agreements with Dexcom, with Medtronic, and with Insulet. What I can't say is the other device makers that we are also working with, I can just say that there are other device makers, every device maker has their own timeframe about when they are comfortable talking about it. And so the first pair of device makers that we announced where Insulet, Omnipod, and Dexcom, with the Dexcom G6. And that's really notable because they have already gone to the agency, and they themselves have submitted their devices for clearance in this interoperable ecosystem. So I should if you want me to, I should probably take a little sidebar here and talk about interoperability and how
Stacey Simms 21:36
you may certainly take us out into what I call the Mr. Potato Head. Diabetes technology, so the floor is yours.
Howard Look 21:43
Super. So the FDA really gets a huge amount of credit here, because they went to industry to all of us in the diabetes device business, and they said, Hey, all y'all device, diabetes device companies, this is way too hard when you come to us with these big giant submissions for these big giant systems that include all of those components that I talked about earlier, the pump, the CGM, the controller, and everything that has to go with it. So we the FDA would like you to start thinking differently. And what they did is they issued what are called de novos, which is where they make a new product classification de novo literally means from the new and so it's a new product classification for interoperable components, and they created three different components, the eye CGM, or integrated continuous glucose monitor, the ACE pump, or alternate controller enabled insulin infusion pump and the AGC the interoperable automated glycaemic controller. So those three de novos are critical because they allow a company like us to say, hey, FDA, I'm not coming to you with an entire system that does all three things together. I'm just coming to you with one piece. So we have submitted an AGC the interoperable automated glycemic controller Dexcom submitted the IC gm Insulet submitted an ace pump and has also been talking about their future Ace pump roadmap, Tandem did the same thing. what's notable about Tandem is they submitted an ace pump and an AI AGC. So you were mentioning the type zero algorithm earlier the algorithm that is known as control IQ started its life as the type zero algorithm. So they submitted both an ace pump, which is the Tandem x two platform and the AI AGC which is known as control IQ technology, which, as you know, started its life as the type zero algorithm. So we owe a huge debt of gratitude to the agency for creating that interoperable pathway.
Stacey Simms 23:48
I'm going to probably ask you a bunch of questions that you will answer just like that. And I'll try my best not to know that while there is a large component of people very interested in the history, and the alphabet, the alphabet soup and everything you went through. There's also a large amount of people who say, when this thing comes out, can I slap it onto my Omni pod and use it? Yes. So the question then becomes, does it matter what type and again, if you can answer this I totally understand. Does it matter what type of pod they're using? Because we have dash we have on arrows and we don't use Omni pod, so I may be getting this wrong. And then we have Octopod, five with horizon coming out later this year. So you know, people are saying Howard, what do I stock up on?
Howard Look 24:31
I see. So let me so I can't specifically say what will be cleared by the FDA because it hasn't been cleared yet, but I can tell you what the intent of Tidepool Loop is. So Tidepool Loop is intended to be an IEC and interoperable automated glycemic controller. And in order to be that type of device, it can only work with IC GM or Ace pumps. So it will not be able to work that with anything that does not have an ace pump does it And it will not be able to work with anything that does not have an IC GM designation. Got it?
Stacey Simms 25:06
Okay. And then my next question is, and this comes back to I think I asked you this the very first time when you announced, you know that you were hoping to shepherd Loop to the FDA. And it's an interoperability question that I still can't wrap my brain around. I'll give you the example of Omni pod. So I'm very excited this fall, I get my Omni pod five with horizon. It's got its own hybrid closed Loop system, or whatever they're calling it these days. And then I hear Oh, Tidepool is out. And I want to go to the app store and get Loop . Do I flip a switch on my Omni pod? PDM? Or do I have to? Do I have to right now, because I know you're talking to interoperability in the future and everything. But what happens now? Can I switch to it? Or do I have to pick one and then stay in that?
Howard Look 25:47
I don't believe people will be locked in the so there is no Well, I shouldn't speak for Insulet, right, there is no switch on the PDM pods. The way pods work is they can pair to one controller at a time. But pods are disposable. So if you pair one controller to a pod, you can pair the next pod to a different controller. So that would be the idea there, there's no switch that you flip, the idea with type will Loop would be as a different kind of controller that you wouldn't need to use your PDF, you would use type of Loop on your phone. Great.
Stacey Simms 26:19
I think everybody's gonna hopefully they all want to go to phone anyway. And that's what everyone seems to be working for. And I know most of my questions that are also for Omnipod. And you really can't answer them. So we will talk to Omnipod down the road and find out more. So let's go back to a bunch of questions about the targets because one of the things that people love so much about DIY, is that they can really set these target ranges for how they want and other things. Um, can you speak to that? What kind of flexibility as compared to what people understand with DIY Loop? May they experience the Tidepool Loop?
Howard Look 26:47
Yeah, it's a super question. The first thing I will say is, we totally understand how the community loves having the flexibility of choosing their own target range set points. And we believe in that as well. That is definitely something that type schoolers who use DIY lube, understand the value in that my daughter uses DIY Loop . I've been very public about that. We did in our submission to the agency proposed flexible set points. We are in review right now, that is something new, and most companies before us have submitted would fix set points or a limited set of set points. That is something that we are discussing with the agency, we're not yet cleared. So I can't tell you how that discussion will go. What I can tell you is the agency has been great. They have been so good. During this review. I know a lot of people like to dump on the FDA. I will not do that. Because my experience with the agency has been these are hard working really dedicated public servants that really want the best, safest and most effective solutions for the community. And the questions they have asked us about our clinical study day about how we built the product about cyber security is all completely reasonable. And so I know they are seriously considering it. And we're hoping we will know the answer to how
Stacey Simms 28:13
well it's interesting too, because as I mentioned kind of offhandedly. Everybody's working towards bullets from phone and control from I'm sure many of them the more I guess I can't say commercial and leave you all out now. But many of the traditional commercial systems are working toward that. Can you share a little bit how it looks on the phone? Because that's so novel for so many of us that haven't even thought about that before? Use it before in our phones?
Howard Look 28:35
Yeah, well, it's a little tricky. I wish I could just bring it up on screen. And what I will tell you is for your listeners that are used to what DIY looks like Tidepool Loop will look extremely familiar. There's there, you, you know, we've changed some colors and move some icons around but it'll still look extremely familiar to anyone who has seen DIY Loop before. For folks who haven't seen what Loop looks like, you can go to our website, there's a screenshot of the home screen. And obviously once it's cleared, we will publish all kinds of more information about what all the screens look like. But anyone who has seen DIY Loop and understands the home screen with the glucose chart, the insulin chart with the buttons that let you bolus and do target pre meal targets etc. It'll all look extremely familiar and type
Stacey Simms 29:28
is it Apple and Android
Howard Look 29:30
we submitted only for iPhone for now. And the reason for that is DIY Loop is only for iPhone. So the fastest path to us submitting and to getting it out into the community was to go with what already existed. That said we absolutely are committed to building an android version. We're also committed to going outside the US which is also the next question I usually get asked. And so we are a small company. We like any good small company. staying focused on one thing at a time and making sure we do that one thing well, so that one thing right now is getting it in the app store in the US, approved by the FDA, and then moving on to Android and outside the US is absolutely on our roadmap. And stay tuned. I don't want to over set expectations about when all that's gonna happen, we definitely will get to it.
Stacey Simms 30:21
Excellent. Yes, that was stuff. That was one of the questions. I'm curious, though, for somebody, you know, I don't even use my son's pump anymore. He's 16. I don't even see anything anymore. But I'm curious, in your studies with folks and somebody who's used DIY or your daughter is used for a long time. Is there anything different when you do use your phone as a controller? Other than convenience, I'm wondering if there's anything noticeable and different about it?
Howard Look 30:45
Well, I think what people report people who have been using DIY live, because no one has used a Tidepool Loop on their body yet, but people who use DIY Loop report that the freedom and convenience of having the interface on the thing that you're carrying anyway, is really wonderful. And Loop also includes an Apple Watch component. And I know a lot of people find that really liberating to be able to manage your diabetes right from your wrist. So I think what we've heard from DIY Loop users is, hey, look, I've got my phone with me all the time. Anyway, I'm looking at my phone all the time anyway. It's just so nice to be able to just interact with my diabetes using this thing that I use all the time anyway. Wow.
Stacey Simms 31:26
So just to be clear, you can control it from the watch as well, or That's it? Yes. Okay. Yes,
Howard Look 31:31
cool.
Stacey Simms 31:32
In the clinical trials, or the testing that you had to do for the submission, what came out, I mean, there was so much kind of, I don't know, it's off the record information for DIY. But I imagine that with tight pull Loop you really show did you have to demonstrate better control or just safety.
Howard Look 31:47
So this is another fascinating part of the story and how the community contributed to the success of Loop the FDA very early on, when we started talking to them about the possibility of submitting, we said to us very clearly, we love real world evidence. And so the clinical study data that we submitted with the 510 k application for Tidepool Loop , it's actually clinical data that came out of the Loop observational study of the Do It Yourself Loop community. And this is really an incredible study because it had over 1000 people in it, over 700 of whom were actively uploading data. And the amount of data in the study is staggering. As a matter of fact, the total person years or person days of study data in this study, if you take the control, IQ, pivotal study, the bazel, IQ, pivotal study, the Medtronic 670 g, pivotal study, and add it all up. The Loop observational study of DIY Loop has three times as much data submitted as those studies are three times as much data that's part that was collected during the study. So it's really a staggering amount of data. And we are really just overwhelmingly indebted to the community to all the people who participated in that study. And that was the foundation for the clinical evidence that we submitted with Tidepool , which is a pretty amazing thing. And I don't know that that has been done in that way before. Now, the data that is from that study has been published. So for your listeners who want to learn more, there are a couple places you can go the Job Center for Health Research to publish the paper, and I'm sure a quick Google search will turn it up. It's called the Loop observational study. It's also on clinical trials.gov. And if you want to see the presentation that was shown at last year's attd, and Madrid right before Coronavirus, broke, or was in full swing, February of last year, that's on our website@titlesearch.org slash documents. So to answer your question, what was interesting, what was interesting is how broad the use of Loop was, it was down to people under two years old and there were people in their 70s. There were people from all walks of life, it was just really fascinating to me, remember, this is a real world study. This was not a controlled intervention study. There wasn't a randomized control arm and people not using it. It was just observing life of people using it. And so to me that was the fascinating part is that so many people were willing to raise their hand and say, I want to help donate my data. And I'm going to show you how it works for me.
Stacey Simms 34:36
And we'll link up those studies that you mentioned, but I assume that they were good studies, in other words that people were happy with their agency, their time and range, ease of use safety, all that stuff,
Howard Look 34:46
the data, it looks great. There's some really fascinating outcomes. The way it works with the agency is only the FDA can say what's safe and effective. So we present the data to them. Here we say here's why We think it is safe and effective. But at the end of the day, the FDA is the one that gets to say, Yes, we agree. And therefore you are now FDA cleared. You know,
Stacey Simms 35:08
you've already mentioned this several times, but Tidepool has always stood out for being very open source, very open with information, publishing everything that you can saying as much as you can. I am curious that now that you have gone through something like this, are you happy that you did it that way? Would you do it that way again,
Howard Look 35:28
so the part about being an open and transparent organization I love, I think it is a great way to go. And I know it's not for every company, there's great value to big commercial companies like Apple choosing to keep their product plan secret, and then doing a huge launch and saying, tada, here's what we've done. For us as a small nonprofit with the mission of supporting the diabetes community, I think it's a great way to go. Because it allows us to be really clear that look, our motives are not about profit, our motives are about doing the right thing for the community. And to me, the openness and transparency just makes all that completely clear. There's another part of the story, which is doing it as a nonprofit, we happen to be doing both. We're open and transparent. And we're a 501 c three nonprofit, that part is tricky. I will be honest, especially during the pandemic, a lot of nonprofits including us have been hit hard. And that's been really challenging. It is much easier for a for profit company to weather a storm, if they've got a venture capitalist willing to give them funding or they can take out a loan as a nonprofit that has been challenging. Would I do it the same way? Again, I totally would, none of us could have predicted the pandemic. So it is what it is.
Stacey Simms 36:47
So with your nonprofit status, if I decide after FDA approval, and I can go to the app store with my prescription from my doctor, Uh huh. am I paying for it? Is my health insurance paying for it?
Howard Look 36:59
So here's where we are. And I will be open and transparent about this, which is we don't know yet. So as a nonprofit, our goal is to make the software as broadly available as we possibly can. We are engaging in commercial deals with some of these device makers so that they will actually give us money when people start using lube because obviously, we're bringing new customers to them that are going to keep buying supplies and pumps and cgms from them, we would love to keep the price as low as possible. And if there's any way we can do it, we want to make it free. We're not sure we can yet we've got to project out how it's going to go we do have a we we have people on staff and we have to pay them we're not going to do it has a way of making money the way a for profit company would we don't have to answer to investors, we don't have to answer to the stock market, we would only do that if it helps us be a self sustaining organization. And it helps us continue to deliver on our mission.
Stacey Simms 37:59
Somebody it's fascinating to think about the questions you start asking when you start going down this road of as you said, nonprofit and open source, everything else is an on that road. There are rumblings they're not really there yet of other possibly DIY routed projects that are waiting to see what happens with you guys. Right? So if you can, it's kind of like when Medtronic gotten sick, 70 approved. And then other people said, okay, we can now take our product. And we'll probably get it through the FDA with a lower, you know, time and range without calibration and things like that. Do you think that? Is this going to be the start of a different kind of diabetes technology? approved by the FDA? Like in five years? Could we have different like, you've already mentioned open APS and different things that you've built on. I wonder if there's somebody working on something today that because of the title submission would have an easier time coming through. So I asked about three questions in there. Sorry,
Howard Look 38:51
I, I sure hope that this is the start of a revolution in how new diabetes technology is created and delivered to market, whether it ends up being open source projects, or it's because we've shipped like we share all of our source code, we share our regulatory quality management system openly, we will publish our 510 k submission once we get through interactive review and clearance. And we're doing that because we want to help other people. Like for us, it's a win if there's lots more technology coming out that gives the diabetes community more choice. And that allows our kids and people living with diabetes and to have better solutions that fit better in their lives. That's a big win. Like we've got no ego invested in this. I want lots of companies, whether for profit or nonprofit, whether based on open source or closed source, it kind of doesn't matter. What I want to see happen is innovation. And I want that innovation to happen more quickly and get into the hands of people who can use it more quickly. So that's the wind for us.
Stacey Simms 39:57
As we start to wrap up here my interaction portability questions still are out there. And again, I know that you cannot speak to different products, and that's fine. I mean, you can and that's fine too. But when I think of true interoperability, and my ecosystem is limited just because of what my son uses, but I think of Okay, if I want to use this controller, but whether it's Tidepool Loop control, IQ, or Omni pod horizon, whatever, and I want to use a Libra, and I want to use this pump or I want to use a Dexcom. Or I want to use the Dana pump or whatever. There's, there's all these pumps, and CGM is coming to market. Are we going to see that anytime soon?
Howard Look 40:35
I am very optimistic that true interoperability is on its way. And one of the huge reasons we are doing what we're doing is to show that that is actually doable, you should be able to pick the pump that's right for you, you should be able to pick the CGM that's right for you, you should be able to pick the controller and the user experience that's right for you. I do imagine that there is a world where you can say you know what, I'm the pregnant mom living with type one, or I'm the athlete living with type one and I have very different needs, and the system should be able to adapt to you. And you should be able to choose which thing is stuck to your body to work best for you. So I am very, very optimistic that interoperability is happening. And we are pushing on it and we and I believe the FDA wants to tap into. That's why they made these interoperability pathways.
Stacey Simms 41:27
I remember when I saw one of your presentations on the shoulders of giants presentations A while ago, one of the things that people really like in addition to the the wonderful blood sugar control they get from DIY lube, they really like the icons, there's like ice cream and pizza. There's all this neat little stuff in the app Are you able to share it with you could just save any of the cute stuff.
Howard Look 41:48
Oh, there is a cute, the cute stuff is still there. Like I said the experience of Tidepool Loop will look very familiar to users of DIY Loop . And one of the things that people love about DIY Loop is the ability to use emojis to indicate the type of food you're having, whether it's the lollipop for fast acting carbs, or pizza for the very long acting carbs, and all the emojis in between. So that's something that people love about DIY Loop . And we have maintained that in in Thai polish.
Stacey Simms 42:22
I said it was my last question. I lied. I meant to ask you. The first time I talked to you in 2016. We were talking about Tidepool as an a data company. Right? I want to see my data I want to free the data is that still part of the mission? Is that still something that's part of the core of title moving forward?
Howard Look 42:41
It absolutely is. So at title we like to say Our mission is to make diabetes data more meaningful and actionable. And seeing all your data in one place is still absolutely part of our mission. pypo web and title uploader are incredibly popular. As a matter of fact, we have about three times as many users now as we had before the pandemic started. Because when there's a pandemic, it turns out, you need a way to upload your data remotely. And so that is absolutely still a part of what we're doing and making diabetes data meaningful. actionable is still absolutely part of what we do. Awesome.
Stacey Simms 43:24
Well, Howard, you've been so generous with your time I appreciate it so much. Just one more thing is your how's your daughter doing? You've got you've got three kids. Yeah, one child was dying with type one. But everybody You're like an empty nester, almost.
Howard Look 43:37
We are an empty nesters. But Katie is doing great. Thank you for asking. She's in college, and she is doing wonderfully. I will tell her you asked about her.
Stacey Simms 43:48
Oh, absolutely. Thank you so much for sharing all the information. Come on back, when and I will say when you get FDA approval, and we can share lots more details. But I think this is phenomenal. I'm so excited to just kind of be part of the information stream over the last couple of years. And it's just been so much fun to follow this. So thanks for coming on, Howard.
Howard Look 44:08
Well, thanks for all of your amazing questions. And it's just been so great to have you been with us and sharing our story over the years and so we're really, really grateful to you and all your listeners.
Howard Look 44:24
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 44:30
Lots more information at Diabetes connections.com. I know you had many more questions. I got so many questions in the Facebook group for this topic. But once I went down the road with Howard, I realized there were a bunch that he would not be able to answer. Frankly, most of them were for Insulet or for the makers of Omni pod. So I reached out to them and I will continue to ask them to come on the podcast. It's been a while I think they're waiting until they get FDA approval for their next product. But I'm working on it and I hope to talk to them as soon as I can. I Know You all have questions. And boy, it's a really exciting time. I hate that the technology. And title is not an example of this. I hate that a lot of the technology got backed up because of COVID. But man, this is going to be a very exciting year or two as things that have been kind of delayed, get released, which is why I'm doing this focus on technology this year. So I'm very excited about it. And I cannot wait to see so many questions there about what the FDA actually approves. And we know Tidepool with all of their wonderful open source and access to information we know that they will let us know. And I'll pass it along as soon as I learned anything.
All right, let's talk about Tell me something good. We're gonna have a story or two about summer camp diabetes camp, and a teenager with type one has an idea for a Funko Pop, that you're going to love. Diabetes Connections is brought to you by Dexcom. And one of the most common questions I get is about helping children with type one to become more independent. These transitional times are tricky elementary and middle school then middle to high school, you know what I mean? Using the Dexcom really makes a big difference. For us. It's not all about share and follow although that is very helpful. But think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four or five finger sticks at school, or for a second grader to just show the care team the number before Jim, you know, at one point Benny was doing up to 10 finger sticks a day, and not having to do that makes this management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at Diabetes connections.com and click on the Dexcom logo.
This is normally the time of year where people are signing up for camp. I know certainly for us, we're already our summer is planned by the end of February when my kids were younger with this both school aged kid and we both worked full time. You know I had summer programs done by this time, but of course it was COVID everything has changed. So it tells me something good. I was excited to share this week that I'm hearing about more summer camps that plan to be in person. And diabetes camps are certainly tricky, because while everybody should be taking lots of precautions because of COVID. You know, people with diabetes really need to take more precautions. So I was thrilled to find out just a couple that I'll pass along and I'll put more of these in the Facebook group. Hopefully we can get more as the information comes in. And as you learn what your local campus doing, we can share that info.
But Texas lions camp, which is the one that among other people, Dr. Steven ponder runs, they are doing something really interesting this summer, they have decided to open it up for family camp. And my understanding about this is that the whole family can come. But each family will stay in its own cabin, they will get together as socially distanced appropriate, if that's the right way to put it for activities and things like that. But within the cabin will be the family unit that's already spending time together. And so you wouldn't have to wear your mask within the cabin, you know, that sort of thing. And I think it's a really creative approach. I'm pretty sure they've had an amazing response to this. They may already be mostly filled, but you can definitely check it out. I'll put the link there. What a fun and interesting way to step up for this challenge
and camp kudzu in Georgia, which is a very close to my heart camp. I'll tell you about that. why in just a minute. But they have decided to have teen camps, family camps and four weeks of summer camp. So if all goes well, I'm sure things will look a little different, but they are going ahead with their camp program as well. And I bring up kids though, because I didn't know this for the first couple of years Benny went to camp. It's down the street from his regular non diabetes camps that I've talked about many, many times. Now camp kudzu is hosted at other camps. So it's not really their camp. I believe it's camp. Burnie it's their camp grass that they use in beautiful Cleveland, Georgia. And Benny goes to camp Coleman, which is just down the road. And I didn't realize that for the first couple years. I gotta tell you, I would have put My nervous heart at rest. To know that I was sending him away for a month and there were 100 people with diabetes down the street.
I did end up calling them I want to say was the last year Benny went so 2019 because of course he didn't go last summer. His insulin pump broke the very last day of Camp the last full day of camp. I don't know if he knocked it into something. We never figured out what happened but it just it just crapped out. And I called them to see if somebody could lend him a pump and they had their program had just ended a couple of days earlier. So he was fine. He did shots for the 24 hours before he came home and Tandem. I tell the story. By the time he got out of the shower, he came home he jumped in the shower, by the time he got out the pump was delivered. So we'd love how great they are with customer service. Our local diabetes camp hasn't made a decision yet as far as I know for what they are doing. But I'm sure that they are going to make that announcement pretty soon. So if you know what your camp is doing, you know we'll share it let me know I'm really hoping that as many kids as possible I can go back to diabetes camp this summer. But if your camp isn't having in person, I know it's not ideal. Do the virtual be part of this community however you can. It's so great for kids and for adults to certainly
our other Tell me something good is really cool. Now I am not the biggest follower of Funko Pop collectibles. I actually thought they were pop Funko which tells you all you need to know I have two in my office Actually I have Queenie Goldstein, from Fantastic Beasts and Where to Find Them from that Harry Potter spin off That's an inside joke with my family. I have Deathstroke because death strokes real name is Slade Wilson. My husband's name is Slade. So that's his funko pop and ended up here somehow anyway, all of this to say that I want to share the story of Ethan Savage. Ethan is 17 years old, and he was diagnosed with type one in September of 2019. He has a campaign to get the folks at Funko to create one of these figurines about type 1 diabetes. And if you haven't seen this, I'll put this in the Facebook group as well. But these are super popular, just about every pop culture character now has one of these. They're not bobble heads, but you know, the head is big, the body is smaller. They're very cute. And they're very popular. So Ethan has written to the company, he's got an Instagram account, he's showing them an example of what it could look like. And it's I guess it's Ethan. It's this kid, a guy. And he's got, you know, a pump on he's kind of lifted up a shirt and showing it off. I kind of say the guy looks cute, but kind of fierce, too. It's a really well done rendition of what this could be. And Ethan has been selling posters of the concept to raise money for JDRF. And he's got a diabetes educator who wants to give the figure here to newly diagnosed kids instead of as he says a lame stuffed animal from the kitchen.
In the letter that he shared with me that he wrote to Funko he says we're convinced this could make a great pop or series with a bigger opportunity. Most importantly, it'll raise awareness for good cause and bring you new fanatics. Haha, links below. I think this is phenomenal. I'm going to link up the Instagram account. And hopefully we can amplify the efforts here because I could see a whole line of kids with type one adults, even the celebrities that we've gotten the community Supreme Court Justice Sotomayor, what a great pop she would make. I think that'd be hysterical. I do have to tell you that one of the reasons that Ethan came to my attention is because I went to school with his dad. And it's unbelievable in the last couple of years to people off the top of my head, I can think of that I went to high school. I mean, really, I went to grade school all the way through high school with these folks, their kids have been diagnosed with three of us in the class of 1989 from York High School, have kids with type one now, I guess not that unusual, but it really brought it home for me. So thanks, Jonathan for sending this along and connecting me with Ethan and Hey, who knows what's gonna happen. If you have a Tell me something good, please send it to me Stacy at Diabetes connections.com, or post it in the Facebook group. And it's Diabetes Connections, the group.
Stacey Simms 52:23
Looking ahead next couple of days, we're gonna have another classic episode out for you. And that's coming on Thursday. And then we are continuing with the focus on technology have some really interesting stuff coming up in the next couple of weeks, I spoke to the people from City of Hope they've changed their name, but you probably know them both mostly by that and mostly by the claim they made a few years ago that they were gonna have a cure for type one within six years. I had to talk to them about that they have some really interesting new research going on. And I did talk to them about that claim. Because I actually think that did them a lot more damage than they should have set themselves up for to me that was a mistake. And they talked about it. They talked about why but we are almost really it's five years in now. So I'll be bringing you that story. I am talking to beta bionics the folks behind the islet damianos company about what's going on with them this year. And as I said, reaching out to Omni pod and helping to get a lot more technology stories for you in the weeks to come.
In the meantime, thank you as always to my editor John Bukenas from audio editing solutions and thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days until then, be kind to yourself.
Benny 53:33
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
You may know Jerry the Bear as part of Beyond Type 1. But this learning and companion toy for children with type 1 diabetes got his start as a college project. Ten students from Northwestern University entered the first every DiabetesMine Design Challenge back in 2009 and won the most creative design. A few of those students continued on and – as you’ll hear – started a new company called Sproutel.
In addition to Jerry the Bear, Sproutel makes My Special Aflac Duck for pediatric cancer patients and Purrble to help children self-soothe.
This interview with Sproutel CEO Aaron Horowitz and Chief Creative Officer Hanna Chung first aired in November 2015.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
This episode of Diabetes Connections is brought to you by Inside the Breakthrough, a new history of science podcast full of Did You Know stuff.
Announcer 0:13
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:19
Welcome everybody. This is going to be a fun classic episode of the show. I'm really glad to have you along. It's been fun this year to take a look back at some of these interviews. These classic episodes, as you likely know by now are from the very first year or two of the podcast. Most of them are from the very first full year of lunch. And it's great to take a look back and revisit some of the cool people that we talked to a lot of you are newer to the show, or at least haven't been here for every single one of these. What are we 355 episodes. So I'm really happy to bring these classic episodes back out with an update.
So hi, I'm your host, Stacey Simms, and my son was diagnosed with Type 1 14 years ago he is now 16 my husband lives with type two diabetes, I do not have diabetes, I have a background in broadcasting. That's how I came up with the podcast. And this episode is all about Jerry the bear a learning and companion toy for children with type 1 diabetes, you may be familiar with Jerry and I put some pictures in the Facebook group over Diabetes Connections of the group. But Jerry started out looking a little well a lot different and having different functionality. You may know Jerry has part of beyond type one. Now it's a program under them. They're helping with distribution and lots of other good stuff.
But Jerry got his start as a college project. 10 students from Northwestern entered the very first diabetes mine design challenge back in 2009. And they won the most creative design back then a few of those students continued on and as you'll hear started a new company Sproutel that continues to this day. And in addition to Jerry, the bear Sproutel makes my special Aflac Duck for pediatric cancer and purple for finding calm. I will link both of those up at Diabetes connections.com you can get more information and check them out. They are they're adorable. They're really helping kids and families who need them. And as always, you know, episode homepage will have all the details.
I did reach out to Aaron Horowitz. He is the CEO of Sproutel he's one of the people you'll hear from in this interview when I asked him for an update. And he says since this time, of course, they've added quite a few things. Most recently, they've added a continuous glucose monitor to Jerry. And they put in another software update that helps kids learn about washing their hands, and I guess washing Jerry's hands to about washing their hands more often that sort of thing. And he indicated that there is a big update coming later this year. So I will circle back with Aaron. And hopefully we'll do another interview and get some more info on Jerry. I will let Aaron explain much more about the history of the company in that classic interview in just a moment.
But first, this episode of Diabetes Connections is brought to you by inside the breakthrough, a new history of science podcast. And the latest episode goes in a very interesting direction using the TV show friends to reveal how we really feel about scientists. I'm not sure that Ross is really the best example of this, but they they get it done. Marie Curie was an outsider in ways you never imagined sort of like Ross on the show. I really do love this podcast. It's historical wisdom mixed with modern insight with quite a few laughs along the way. Really great production value. Search for insight the breakthrough anywhere you listen to podcasts.
And by the way, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
My guests in this classic interview are the CEO of sprout tell Aaron Horowitz. And Hannah Chung, who at the time was chief creative officer had a left Sproutel in the middle of 2020. I reached out to her I haven't heard back yet. So I will post an update in the show notes when I do hear from her and let you know where she is heading. Next is really fun to kind of go back in time and hear the story of Jerry, the team's appearance at the White House. And a lot more. Aaron and Hannah, welcome to Diabetes Connections. I am excited to talk to you both again.
Aaron and Hannah:
Absolutely. As are we,
Stacey Simms 4:25
Hannah and Aaron. Let's start at the beginning. Let's start with the idea. How did you come up with the idea for a stuffed animal that kids could play with and learn from?
Aaron Horowiz 4:35
So it actually started by talking to families of kids with type 1 diabetes. We we went into the homes of bunch of these families and as we were playing with kids, we observed that they were taking care of their teddy bears of their stuffed animals as if they also had diabetes. So they were pretending to prick the the paws of of their teddy bears pretending to give them insulin injections. Some kids were even actually taking little pieces of cardboard and paper and drawing insulin pumps that they would then staple to their bears first. So it that was kind of really this this lightbulb moment for us of wow, you know, these, these kids are mirroring everything that's that's going on in their lives that they don't yet have control of. So can we bring that play experience to life? And can we do it in a way that is educational, that is comforting. But most importantly, that's really fun.
Stacey Simms 5:28
You know, it's funny, I hadn't thought about this in a long time, Aaron, but when you bring that up, my son had an Elmo doll, and Elmo from Sesame Street, and he was 23 months when he was diagnosed, and that Elmo got checked and got juice boxes, which made a mess, and got insets put on him. So it makes perfect sense that playing kind of helped these kids get through what they couldn't understand.
Unknown Speaker 5:50
Absolutely. You know, like, as kids, we roleplay so many things, you know, right, we roleplay tea parties, we roleplay you know, dressing our animals up and making weddings for them. And for kids with with conditions like diabetes, like, like Benny did with Elmo to roleplay diabetes,
Stacey Simms 6:07
when it was the idea of spread towel always to help medically and to help with play. And then you come up with the idea for type one, play? No, actually,
Hannah Chung 6:16
the reason why I started spread tell was we really wanted to work on Jared the bear so and our mission was to really bring Jerry into the hands of all kids. And from there, we realized incorporating company allows erinite to work with this full time and you know, bringing awesome mentors, investors on board to help us feel the business. And from there just talking to a lot of families talking to a lot of kids, you have realized that the application of play into health can be so many different can help a lot of people not only for kids, but also for adults and the elderly. So from there, you know, working under the beret type 1 diabetes really allowed us to see the potential into coming into, you know, like applying this to help all kids to be healthy. And you know, and have a long term vision of helping all people to use play to help them to come healthy and well. So yeah, a little little Jared type 1 diabetes really allowed us to have the vision for scratch help. That's great. Okay.
Stacey Simms 7:15
So Jerry has changed quite a bit. There is a new Jerry right now still loyal to that wonderful idea of learning through play. But tell me about the first Jerry, what, you know, what did Jerry look like? And what did he do Aaron?
Unknown Speaker 7:30
Yeah, so well, I'll say that there are, quote unquote there two first Jerry's. There's the first Jerry the bear prototype. And then there's the first bear that we shipped. And I have a real soft spot in my heart for the first jar, the bare prototype. So I'll just touch on that for a second. Our first bear that we ever made, was when Hannah and I were still in school, we had no idea how to solder how to make a circuit boards, even even how to sew a bear. And so we were learning everything as we went along. And what we created I'm staring at it now in our office is like a two foot hard chested like behemoth of a bear eyes that we cut out of a Furby so that it blinked its head was attached to its body with with actually with metal nails. It was it was quite creepy looking. And we had made so many mistakes about our understanding of type 1 diabetes, because at that point, we didn't have kind of the intrinsic knowledge from the community. So for example, when we tested with our first our first user, Gerry's blood glucose level was only two digits. In fact, his screen was only two digits big. And actually, this, this little boy said, I would be hypoglycemic and go into the hospital. That was my, like, face total facepalm you know, we had missed the mark. But it taught us so so much about one, just the immense amount of knowledge that we had to learn so that we can then create something that actually had an impact. But it also showed us that despite the fact that Jerry was big and clunky and looked super scary, this this child was still really excited by the fact that there was a bear that also had diabetes. So that's, that's our technical for our first Jerry,
Stacey Simms 9:08
I'm looking at the timeline you recently posted on Facebook, and I'll link this up at Diabetes connections.com if it's okay, is that the first Jerry the one that's really big and kind of light colored all the way on the left? It is He is creepy looking
Hannah Chung 9:22
at that photo, because the girl is so cute, it makes the photo look really cute. But the bear itself is just take out the little kid part is kind of not that cute.
Stacey Simms 9:32
But I it's fabulous to see where you're going. I mean, even then, you know, this is a toy. This is a really sweet idea. And then it's changed. It was um, it became a little smaller and a little bit more responsive, I guess is what I'm looking for at least it had three numbers for the blood glucose.
Unknown Speaker 9:50
Absolutely. Yeah. So it got a lot more responsive. The bear that we ended up shipping. Really we went we had gone through 29 different iterations of product Type and the real difference between some of our early prototypes. And what we actually ended up creating and sending out to families was that the existence of a storyline. So the jury that that kind of existed in the world for the past few years, it has this curriculum with I say curriculum, but I mean animated storybooks. It's got 21 animated storybooks, where you train Jerry for the all star games, which are kind of like the Olympics. But the sports are things like climbing trees and diving with sharks. And we teach about diabetes skills, because each of these storybooks jargon meets up with a new friend like love with a monkey or George the vegetarian shark. And they teach Jerry about both a sport and a diabetes skill. So what we ended up sending out had this kind of all of these storybooks and the way that you unlocked the storybooks was that you had to care for Jerry correctly. So there's kind of this game mechanic that's built in where children are not only caring for Jerry, who, by the way, has a blood glucose level has fingers that you can prick to check, check that foods that you could swipe over his mouth and insulin injection spots. They're not only doing justice, what they did with their stuffed animals or with their Elmos, where they're mirroring all of their all of their care procedures. But they're doing it to unlock these the storybooks, which for them are kind of the carrot and the incentive at the end of doing this. But for us, that's that's really the way that we can convey some of the really complex things that that you need to learn.
Stacey Simms 11:23
That's really interesting. So the new iteration of Jerry, you've expanded from just type one, as Hannah mentioned a few moments ago, you're really trying to work toward overall good health. Hannah, tell me what's new about Jerry this time? Yeah, it's
Hannah Chung 11:38
a new Jerry. A couple of things. He's cuter, smarter, and with a more affordable price point. So the biggest thing that has changed is around this curriculum. So one, so the new Jerry, his base curriculum is around general health. So he touches social emotional development, nutrition, exercise, sleep and mindfulness. And from there families can customize Jerry to have a condition like type 1 diabetes, or food allergies, and yours were modular. And and it kind of allows families to kind of customize Jerry to mesh their own child. So you know, we can't so that we can build a world where everyone can have a Jerry but not all, Jerry is the same, which is really cool. And the way the new drivers interaction wise, Jerry had a belly device called a portal is kind of like a window to see what's going on in Jerry's world. So using this portal, you can kind of scan Jerry's brain and different body parts like the mouth and his stomach to see what is going on inside. Similar to the first year of the bear, you can still feed him, you can see how he's feeling. But if having the portal be detachable from the body, it kind of allows more physical movement for a child to interact with Jerry, which is really nice. And New Jersey also washable, which is a huge feedback that we've gotten from especially for educators, you know, if you want it to be used in a hospital setting, and washability is a big part was but we're wipeable with Clorox and things like that. Now this new Jerry is washing machine washable, which is really exciting. And
Stacey Simms 13:09
yeah, that is because who would think of that, but but you absolutely if you have somebody who's using it in a in a healthcare setting in an office or a hospital, or you know that Elmo went in the washing machine a million times because they get kind of gross.
Hannah Chung 13:21
Yeah. And then lastly, some of the looks of Jerry has changed. So the previous year was really cute. But we knew that Jerry could be the first Jerry was more geared towards kids who are younger, like five year olds, and now the New Jersey we want to help our age, the target age we're looking after is between three and four and nine. And even though that might be only a five years difference, it's a huge difference in the kids role and what kids can understand what kids are interested. So what we've done is we design a character that could be more appealing for all kids in that age range. So Jerry looks more expressive. And Jerry kind of have this longer arms like a monkey arm which I really love because he's more huggable. And so all in all, from design to interaction to the modular aspect of the curriculum has been the biggest part for us for ended up in designing the new dairy that we have.
Stacey Simms 14:17
Aaron Talk to me a little bit about food allergies, there are so many health conditions, unfortunately that affect kids. Why? Why did you move to include allergies?
Unknown Speaker 14:28
Yeah, when we look at different conditions that that kind of might be able to be addressed or to be helped out with with Jerry, we look at kind of two factors. One is the emotional implications and the other is the educational implications. And so food allergies very similar to type 1 diabetes, there's there can be unfortunately a lot of stigma for example, things like the peanut free table we've heard a lot of horror stories from families of isolation cause from eating at school. or children not understanding or really believing that other children have food allergies. So there's this whole kind of emotional and emotional coping component, which we really feel that Jerry kind of provides some of the biggest impact there just because of the comfort, because of this mirrored care that they have something else that is someone else. That's, that's just like that. And then the second is, is the educational component. And that really boils down, you know, for kids with food allergies, it's things like reading nutrition labels, and also very similar to diabetes and knowing how to articulate how you feel, and knowing when to to go and ask for ask an adult for help. This is really kind of universal across a lot of conditions. But you know, particularly in food allergies, there's every label or every piece of food that you put into your mouth, you're going to want to read the label, you know, see if it has whatever your allergen might be. And there is kind of this also really interesting correlation with, you know, an action that's tied in with mealtime, right. So for diabetes, you might be checking your glucose level and, and taking insulin for food allergies, you're doing it around mealtime, you're reading these nutrition labels, you're making sure that you're sitting in a place that's allergen free, you're making sure that the people around you don't have allergies, you you need to have washed your hands to make sure that you didn't touch anything. So there's all of these just kind of procedural things that we see a real alignment in the value that that we've seen Jerry provide for children with type 1 diabetes already.
Stacey Simms 16:26
And so far, how has it been? I know you've just put it out there. And you've been part of the diabetes community for a few years, where you've been very well received, how have you been received in the allergy community?
Unknown Speaker 16:37
So we've certainly had parents that are incredibly excited. I'll say this, we're kind of stole almost as funny term, but like making a name for ourselves in the food allergy community. We haven't yet gone to a conference dressed as teddy bears.
Unknown Speaker 16:50
Yeah,
Unknown Speaker 16:51
wait, what we did things like children with diabetes and ADHD,
Stacey Simms 16:55
I should stop you and say, This is how I met Hannah and Aaron a few years back when they were dressed like Jerry, the bear at a conference, which was so much fun. And you definitely had to stop by and talk to them to find out what was going on. So yeah, you need to go to food allergy conference and do that.
Unknown Speaker 17:11
Absolutely. That's kind of I think that that's how I think about kind of putting a stake in the ground. Moving into moving into new territory, we got to Don the bear suits, we got to go to a conference and maybe have a dance off with another mascot.
Stacey Simms 17:25
But But have you have you had any feedback from parents of kids with food allergies yet?
Unknown Speaker 17:29
So absolutely. So before we ever kind of decided to move into that into the food allergy realm, we actually interviewed, gosh, a range of families, a ton of families, and the people that we talked to were, you know, ecstatic that we were creating something for food allergies, and actually told very, very similar stories to the families that we had originally interviewed of kids with type one, that their children would pretend that their stuffed animals had a peanut allergy or a shellfish allergy. And they would pretend to have them go into anaphylaxis and give them an epi pen. And so we really saw this this need being presented and are excited by kind of the their excitement for for Jerry and and of course, it's jury's not out in in the world alive and kicking yet for kids with allergies. So we won't see kind of the rubber really hit the road until about june of 2016 when we're when we're shipping these bears, but the excitement is really good to see. And Hannah,
Stacey Simms 18:22
Aaron talked about the modules and the storybooks. To unlock the original Jerry Is this the same idea with the food allergies as well,
Hannah Chung 18:31
very similar. And so kind of similar to type 1 diabetes, you know, in the way we teach type 1 diabetes is around talking about your feelings and having a vocabulary, practicing the routines to help you you know, the daily routines you have to go through. And we also have different storybooks, I've touched upon social situation that you need to know to kind of apply the concepts that you have learned in the different social settings. It's the same framework, but that was more geared to the food allergies. So checking your blood sugar level and giving insulin might be around washing your hands, it also gives me an epi pen and you have the allergy reactions of seeing how your stomach is doing and how your body parts are having whether you have hives or not. that's similar to you know, seeing what is going on in Jerry's pancreas. And we still teach the same vocabulary. Similar vocabulary is to kind of explain how you're feeling what kind of symptoms you are having at that moment. And the same thing, storybooks around birthdays or Halloween trick or cheating and things like that, that touches upon the social emotional situation that kids need to know.
Stacey Simms 19:30
You know, I probably should have asked this at the beginning of our interview, but I want to make sure to bring this and you both have a personal connection to diabetes. And Hannah, could you talk a little bit about yours you have diabetes in your family?
Hannah Chung 19:42
Yes, I do. So both my father and my grandparents have type two diabetes and they were diagnosed in their 40s and 50s. Consider late onset. Both my grandparents passed away from the complications behind type two diabetes such as heart attack and hypoglycemia shot. To be honest, I was so young at the time. When my grandfather passed away, which I was in sixth grade, and I did not know anything about type two diabetes at that point until he, I saw he passed away, my dad a year after he was diagnosed, and he decided to change his whole lifestyle to exercise more and walk 15 miles without taking pills to really adjust his lifestyle to be healthy. And from the process. Of course, I saw him, you know, feeling frustrated and feeling isolated when he did everything possible, right. And his blood sugar level was not nice at the end of the day. Yeah. So from that, our whole family decided to change our diets too, because my dad had to support my dad emotionally to make sure he's getting the cheers that he needs to go power through the day. So two months after my dad lost about 40 pounds, and even 14 years today, he's still practicing the same routine, which is really amazing. Oh, yeah. And from the process. And you know, not only I learned so much what type two diabetes, but also the importance of having the community around you who can support you, and, you know, cheer for you regardless what the outcomes were. So from there, I just learned a ton about the people who are affected by this kind of cut credit conditions and want to help kids to help support them to
Stacey Simms 21:16
Wow, what a great story of family support that you were able to really rally around him and help out and proud to be still in that routine. All these years later is fantastic. That's great. And Aaron, your story's a little different. But you know what it's like to get injections. Tell us about that.
Unknown Speaker 21:31
Yeah, so when I was a child, I had another type of endocrine condition is called human growth hormone deficiency. And so basically, my, my body wasn't producing growth hormone, at least at the typical rate. And so for a period of time, my childhood, about five years or so i, i self administered injections every day to grow. So definitely, definitely taught me a lot and gave me a lot of empathy for kind of any type of chronic condition. And, you know, certainly, certainly a learning curve, I'm so inspired by kids with, with type 1 diabetes, because they were diabetes, like a badge of honor. And for me growing up, I felt so self conscious about this, it was something that I tried to hide from everybody. And in fact, I don't think I told anybody until I was writing our first grant application, or, you know, contributing to that for Jerry to bear. And so I'm continuously inspired by the kids that we meet with type 1 diabetes, and now with with food allergies, and kind of how much confidence and how empowered they are. And so I'm so excited about what we might be able to do with Jerry tea to enhance that even further.
Stacey Simms 22:39
You've mentioned a couple times that you were in college, and you were students together, when this all came up. How do you I mean, I was in college, I didn't have any big idea like this and change the world and help families. How do you do that? Where do you like 19 years old, and you're sitting around one night, everybody else is playing beer pong. And you're like, oh, we're gonna we're gonna make this huge thing. How did that happen? What are you both majoring in? And and how did the idea come about at that time,
Unknown Speaker 23:03
so I'll say, it started very, very small. Hannah actually co founded a nonprofit organization called design for America, which is all about using design thinking, to solve problems in your local community that have some type of a social impact with the potential to scale beyond. So lots of lots of boxes to check, but really, really exciting organization. And it's totally extracurricular. So there are teams, kind of interdisciplinary teams that are formed that go out in your free time after classes to go try to solve problems, everything from you know, sanity, sanitation, inside of a homeless shelter to things like type 1 diabetes education for kids. And Hannah and I kind of rallied around this problem while we were in school, and kind of through this through this extracurricular, these activities, we slowly but surely, pursued, pursued Jerry in it, you know, at first, we never had these grand intentions of starting a company, right? This was this was a passion project. It was, oh, let's make one prototype and see what happens. And it was like, oh, maybe we should make a second one. That second one looks kind of cool. And it reached a point at prototype number three, when I was like, Well, you know, like, all of our time is kind of going into making these bears and he's just classes aren't quite as interesting anymore. Why don't we Why don't we start to make these bears full time. And so it really, you know, is a was something that was just a passion of ours that spiraled out of control and into awesomeness.
Stacey Simms 24:36
That's great. And it sound right to you. But you both did graduate, right? You didn't just dump the dump the school and go off to do the bears.
Hannah Chung 24:43
We did graduate. We did. And we physically left a little bit early. And so Aaron and I both graduated in spring of 2012. And the last quarter, we moved to Providence. We've been displaying Northwestern in Chicago. So we are taking our classes over Skype, being in Providence working very full time. So there was a pretty awesome journey to do that. But it was cool because we have, you're very transparent about how you're billing Jerry and the type of mentors you're working with. So the school was very supportive to let us continue Jerry in a really unique method that any of our other students were doing. So I think having this approach was really great. And they did mention that we have to be highlighting us doing, you know, going through this route, we have to come back to graduation in person to get our diploma, which was not a bad deal at all. Um, but yeah, to your question about what we have studied, and I studied mechanical engineering with the emphasis on Human Centered Design, but I was a very, very weird engineer, where I was not too excited about bolts and nuts. And I loved illustrating and an animation. So in mechanical engineering, we do a lot of like computer aided design. And for me, that was just illustrating in 3d for a product, which is super fun. And I also have done some research around how to build products that is emotionally appealing for kids. So I was part of the research for for a little bit while I was a student, so I was a very a soft hearted, more, you know, I love people type of engineer in the group. So and Aaron, do you have Aaron, Aaron has a cooler major than I do. So we were both studying mechanical engineering, and then in our senior year, and, you know, throughout he and Jerry, Jerry, like Aaron really got excited about robotics. And he found that that's the area that he's really passionate about. So he ended up making up his own major called mechatronics, and user interaction design, which really helps people how to play with robots and different creating different robots that is really engaging with people. So that's a major dead air and creators. So. So that's our that's our backgrounds and what we have studied so far. Wow,
Stacey Simms 26:57
this story just gets cooler and cooler. And then, and then, in 2015, this year, you guys went to the White House? How did that happen? Aaron, tell me about meeting President Obama. And he's holding Jerry the bear.
Unknown Speaker 27:12
Oh, man. Yeah, I think not. Not in my wildest dreams. Did I ever think that was gonna happen?
Unknown Speaker 27:17
Same here.
Unknown Speaker 27:19
So we had, we had gotten a very mysterious email that they were putting together an event at the at the White House to honor it was called the first ever White House Demo Day. And it was to honor entrepreneurs from from diverse backgrounds, mainly companies with founded by either other women or people of color. And so we know the first step is a phone interview. And I was super nervous. And I was actually at the time on a on a bus, mega bus from New York to Providence. And so whispering into the phone, I delivered our little pitch and hung up and just like facepalm once again, because I was like, oh, man, like, that was probably the worst mistake I ever gave. I was like whispering on a Megabus. And about maybe a week before the event we were we were told that we were selected. And so had an eye or dancing around the office, we're so excited. And just a few days before the event, we got a call from from it from an unknown number. And the voice on the other end was somebody that was that was putting together the event and they said, Hey, we had this crazy idea. Can you can you program Jerry the bear? We were like, yeah, like, you know, that's that's what we do. And they're like, Can you can you make Jerry wish President Obama Happy birthday. And we were we looked at each other. We're like, yes, like, we can do it.
Hannah Chung 28:42
As a team, we're just a guess. Do we have to say yes to and we'll figure out the rest afterwards.
Unknown Speaker 28:47
And so we we they said they couldn't guarantee any anything would happen. We put together Hannah made an awesome little animation of President Obama dancing with Jerry. We had two different voice recordings. One is Jerry wishing. The President just happy birthday. The other was Marilyn Monroe singing Happy Birthday, Mr. President. We sent those to the communications team and they totally nixed Marilyn Monroe.
Unknown Speaker 29:11
And so
Unknown Speaker 29:13
they come to me and we go to the White House, and they were about 32 companies. We weren't sure, you know, up until a few minutes before that we would actually get to get to meet the president. But luckily, there were, I believe six companies that that have the 32 that that got him to meet him. And we were one of them. And we were just ecstatic. We're like looking at each other and they're sending out aids to us that are saying, Okay, give us your pitch. Like we're there, you know, making sure that it sounded good and that we weren't gonna say anything because it was televised. We're gonna say anything that was politically incorrect. And to be honest, I'll give I'll give my perspective on the actual meeting and I'll let Hannah share hers. Everything went by and like just such a surreal blur. And I think actually the most memorable thing for me was, you know, I we kind of split split up our presentation into Can I introduce what we're doing had a carried on and talked about the impact and give a demo of Jerry, and President Obama was standing in the middle of us. And so after I kind of finished talking to him, he was interacting with Jerry. And so his back was turned to me. And all I kept thinking is how close is too close to stand? So I was just like I was trying to lean in, and I was the entire time. I was like, the thought going through my mind and like, oh, man, how close is too close?
Unknown Speaker 30:31
tackle you.
Unknown Speaker 30:31
Exactly.
Stacey Simms 30:33
And what was your perspective?
Hannah Chung 30:35
I think for me, I remember I'm kind of going along with lo and Aaron's point, you know, up until we got the confirmation that we were meeting the President, we'd never really gotten the confirmation that we're meeting the President, it was more of a higher chance to meet the president. So an hour before when we were pitching it, I realized, you know, I never gave a picture president and Aaron, I have not practiced anything about this pitch. So it was either gonna go really authentically well, or we don't. But I realized, because I was holding Jerry, I felt less stressed because I was holding a teddy bear in public and Jerry was kind of absorbing all of my nervousness from my belly to tears comforting companion, so and I felt less nervous because I was holding a teddy bear. But uh, even the demo was really cool. And I was, like, part of me was, you know, speaking really well, explaining Jerry the bear, but also just making sure that the demo goes really, really well. And there's no mistakes. And but yeah, overall, it's similar to Aaron. Everything went by so quickly. And afterwards, it took me a couple of hours to really realize, Oh, yeah, like, we just met the president. And he really liked he was impressed with Joe the bear like that. That really happens. They took it took me like a good six hours to really digest that. Oh, that didn't really happen.
Stacey Simms 31:52
Did he wind up during the bear sing? Did you get him to sing the song?
Hannah Chung 31:56
He did? And the President? Really? Yeah. He was laughing. He was laughing and he really liked it. And but yeah, but the the aftermath is really cool, though. So you know, after the event, all this articles from a lot of different big press channels are coming out. And they actually used our photo with the president and with Jerry as a main photo for almost all the articles. And so from there, we had a huge exposure about the bear and, and that was really helpful for us. Because not only, you know, we got to represent our company as one of the startup companies pushing the diversity in tech force, but also got built a lot of awareness about kids health and what Jerry does in the community. So it was a it was a very awesome event.
Stacey Simms 32:41
That's amazing. I do love the picture. We'll link that up as well. So you can you can see it at Diabetes. connections.com. Hey, before I let you both go. I have to point out we did meet a couple of years ago at friends for life when you guys are dressed up like the bears. But it turns out Aaron and I have a crazy connection. We both went to the same high school. Different years as you heard him say he graduated college in 2012. You both
Unknown Speaker 33:05
both have the same teacher.
Stacey Simms 33:06
Yeah. We have the same favorite teacher from high school, our social studies teacher, Mr. Fagin. How crazy is that? Aaron?
Unknown Speaker 33:13
Oh my gosh, it is wild. I remember, the most of the fondest memory I have of Mr. Vega was that he would wear a different sweater to class every day of the year. That's so many sweaters.
Stacey Simms 33:28
And we grew up in New York. So he needed this sweater. So it was cold. But he was I mean such a great teacher and I took his AP history classes that would you took.
Unknown Speaker 33:35
That's exactly what I took. And it was what it was one of my favorites. My sister took it and she was that was, you know, the thing that she said was, you know, you got to take Mr. Fagles history class, I was like, Okay, yeah, I didn't know what I was getting myself into. But I knew it was gonna be good.
Stacey Simms 33:47
I love it. Thank you so much for joining me today for talking about Jerry the bear. Is there anything else that you wanted to make sure to mention before I let you go,
Unknown Speaker 33:55
we're so thrilled to have had for the past couple of years, just the immense support of the diabetes community in the diabetes online community. It's, it's really alarming not alarming. It's It's comforting. It's It's awesome to feel so welcomed as outsiders coming in so quickly. And I don't know if I can relate a similar experience any other time in my life. You know, the first time we went to friends for life, it was literally like we gained a new family. And so I think we're both so incredibly grateful for that and, and so excited to kind of keep all of those all of those relationships as we enter this next chapter of Jerry's life.
Stacey Simms 34:33
That's fantastic. Thank you so much for joining me, Hannah and Aaron. I appreciate it and I can't wait to see what's next. Thanks.
Announcer:
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 34:50
More info on Jerry and Sproutel and what's next for all of them at Diabetes connections.com. I will link up some articles that take a look back and others that do take a look. forward because as I mentioned, Sproutel has several other projects that they have been successful. And it's really remarkable when you think about the the start that these guys got when they were I can't call them kids anymore when they were in college and launching something like this. And now to have it not only succeed with one product, but others and really rolling along. It's a remarkable story and I'm really excited that I got to meet them in those bear suits way back when.
All right, our next episode coming out on Tuesday of next week, I am scheduled to talk to tide pool very excited to get back on the technology news. We are doing a deep dive into technology all this year on the show and title has submitted loop to the FDA. So will this be the first Do It Yourself routed initiative to get FDA approval in the United States. We'll talk about it and that episode is coming up on Tuesday. Thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I will see you back here on Tuesday. Until then, be kind to yourself.
Benny
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
When Swiss pump maker Ypsomed launches brings it's business to America, likely in 2022, it'll be with Lilly Diabetes as their partner. The Ypsopump will be the first pump in the US that only takes one brand of insulin. This week, we spoke with Mike Mason, president of Lilly Diabetes about that decision, more about how the actual pump system will work and their timeline.
Stacey also talks about how they were able to use a coupon to keep Benny on humalog - it wasn't as easy as some have said. And she has advice to make it work for you.
Plus, new A1C guidelines for kids with diabetes.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by Dario Health. Manage your blood glucose levels increase your possibilities by Gvoke HypoPen, the first premixed auto injector for very low blood sugar and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
This week, Swiss pump maker Ypsomed is teaming up with Lilly Diabetes to launch an insulin pump. Here in the US, it'll be the first pump that only takes one brand of insulin is Lily about the thinking behind that decision.
Mike Mason 0:41
We look at this ad we don't look at it necessarily as limiting options, we look at bringing up a new option to the marketplace that as an integrated solution can provide a new way to be able to control the blood sugar. So that's how we look at it.
Stacey Simms 0:57
That's Mike Mason, president of Lilly Diabetes, we talked about what that integrated solution is more about how the actual system will work, and of course more about its unique proprietary nature.
I'll also catch you up on our insulin coupon experience and talk about new A1C guidelines for kids with diabetes.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show where we aim to educate and inspire about diabetes with an emphasis on people who use insulin. This year, I'm doing a heavy focus on technology. So this episode is a bit of a follow up, or maybe a partner to the one we did in January with Ypsomed. As was announced late 2020 Ypsomed and Lilly diabetes are teaming up to bring the existing YpsoPump which is used in Europe and Canada and some other countries around the world to bring it here to the US hopefully to submit to the FDA later this year, and be in the marketplace in 2022. The Ypsopump, as you heard in that episode already has a lot of features that are very popular. It's a very lightweight pump, it has the hybrid closed loop system, similar to Tandem t slim, similar to what Omni pod is hoping to launch later this year. So there's a demand for this kind of pump. But the question is what's going to happen because of the proprietary nature, as you'll hear in this interview, and as we talked about with Ypsomed, this pump will only take Lilly branded insulin.
So to that end, and did you know that I have a weekly newsletter they do. And this year, I added a poll to it, which is really very popular. I'm so excited to see this. And when we did the episode with Ypsomed, I asked in the newsletter about your opinion on it, would you use a pump that only took one type of insulin? And I gotta say the results were really interesting and I thought kind of surprising. So 40% of people said yes if it's a great pump that is worth it 48% said maybe I'd have to feel confident about my insurance coverage and 12% said no way I thought the no way would be a bigger number so we'll keep those polls going I have a link always in the show notes about signing up for the newsletter it's very easy to do I don't spam you come on you know it's just me. I do send out a newsletter though with the week's show some thoughts about it that poll and some other information you know, as social media shows us all fewer posts frankly from the pages that we like and the people that we follow. This is a great way to make sure that you do not miss an episode and that you know what's going on with the show at all times.
Okay, Mike Mason from Lilly in just a moment but first Diabetes Connections is brought to you by Gvoke HypoPen and almost everyone who takes insulin has experienced a low blood sugar and that can be scary. A very low blood sugar is really scary. That's where Gvoke HypoPen comes in Gvoke is the first auto injector to treat very low blood sugar Gvoke HypoPen is pre mixed and ready to go with no visible needle and that means it's easy to use. How easy is it to pull off the red cap and push the yellow end onto bare skin and then hold it for five seconds. That's it. Find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke glucagon comm slash risk.
My guest this week is the Senior Vice President of Eli Lilly and company and the president of Lilly diabetes. Mike Mason has been with Lilly since 1989. we last talked to Mike on the show back in 2018. It was our first conversation about the price of insulin. And we of course bring that up here in this interview. But we are mostly focusing on the pump and the partnership with Ypsomed and what it's going to take to bring it to the US although I promise I do talk about pricing and accessibility and everything you want to know. Mike, thanks so much for joining I'm really interested to learn more appreciate you coming on and spending some time with me.
Mike Mason 5:04
Happy to do it, Stacy, appreciate what you do for people living with diabetes.
Stacey Simms 5:08
Let's just start by talking about the partnership here with Ypsomed. How did this come about? Tell me about that, you know, the basics. And I guess we could start with really just, you know, why are you at really excited about this?
Mike Mason 5:21
Now we're excited about it. I mean, what we do is we step back, and we take a look at where the unmet needs are in the marketplace, today, and then how science and technology is developing. And what we saw was that, unfortunately, a good percentage of people who who live with type one and type two diabetes for own insulin are not in good control. And so we saw an unmet need there. And we saw enough advancements in cgms, as well as technology that we felt that putting insulin together with a CGM, and in good software and analytics, that we hope can provide better outcomes with really less burdensome for someone who lives with type one or type two diabetes. So that's why we were interested in getting into this space. And as we were looking at options, we thought it was best for us to pursue a partner that had a good pump that was on the market today, who was an excellent developer and manufacturer of pumps. And we found the perfect partner in Ypsomed. So we we really liked their pump. They're an excellent Swiss bass manufacturer, and we think it's a good cultural fit for us, we think we really will work quite well together. And we're both very customer focused and want to make sure that ultimately, what's most important is helping people who live with diabetes achieved the control,
Stacey Simms 6:49
before I asked you about the functionality of the pump. And before I asked you about the features of the pump, and more about the partnership, I'm just curious if we could go back, I was at the blogger event that Lily had in Cambridge, in 2018, where you showed us kind of the prototype of a pump that you were working on with a different company, can I ask, What happened to that is that not going forward in any way, shape, or form now,
Mike Mason 7:13
oh, we very much hope that that product goes to the marketplace, the rights to the DEKA pump has gone back to DEKA, we really value our partnership with them. We think it's a very advanced pump. And we think it could really help people living with diabetes. And we know the DEKA is advancing, planning on, you know, advancing that pump to the marketplace. For us, we reflected back on how we can, you know, best use our capabilities to help people with diabetes and other therapeutic areas. And as we were facing COVID, we reflected on our ability to develop a new antibody in nine months and get that to the marketplace and manufacture that and we felt that as a company, our development, and manufacturing focus should really be on developing new medications versus new new pumps and new devices like that. So we decided our deck arrangement, we were responsible for the manufacturing and a good part of the development. And we felt it was better for us to find a partner who already had a pump, who is a manufacturer and developer, and for us to say primarily focus on building the integrated system and really having that experience with the people living with Type One Diabetes and type two diabetes.
Stacey Simms 8:34
So any DEKA pump that goes forward, will that still be used with the proprietary cartridges that we're going to talk about down the road? I mean, it's slowly still involved with the DEKA pump whatever comes to market, or is it basically all in their hands now,
Mike Mason 8:47
it's in their hands at this point.
Stacey Simms 8:49
Let's talk a little bit more about that. Ypsomed partnership. As you listen, we did an episode with them. They went through a lot of the factors and different functionality of the pump. So I'm not going to go through that all again here. But I am curious, Mike, if you could talk a little bit about the algorithms in the pump. In other words, how might it be different from the other pumps that are coming to market tandems control? IQ software is one the Omni pod horizon, that sort of thing.
Mike Mason 9:14
Yeah, I mean, I think algorithm will be critically important at the end of day what's what's most important is that you you build an integrated system and cannot help someone achieve better control. And what we think is we can use our 97 years of experience with insulin to build algorithms that that do a very good job of controlling insulin and blood blood sugar. And so that's our plans if we as we develop new products like Lyumjev our new ultra rapid insulin. This provides us to potentially provide unique algorithms that can really maximize the potential of a product like longevity.
Stacey Simms 9:52
So let me ask you the the biggest question for my listeners is all about the proprietary nature of the pump. And before we get into that, let me just ask you a few details about it. But only use humalog or will it use other insulins you mentioned, Lyumjev things like that.
Mike Mason 10:06
Yeah, let me tell you a little bit about the pump and why we were excited about the pump, we think it's a very good form factor. It's a small pump, it has a kind of icon based screen that makes it very easy to use for people who were. But one of the most interesting parts of the pump for us was the fact that they that uses a 1.6 millimeter cartridge. So it's a prefilled cartridge, that then gets plugged into the pump. And what that allows is allows someone to change if their reservoir goes down. So if the cartridge runs out, they can add new insulin independent of their infusion shed change. So if you think about the future of infusion sets, we think that will grow from three days to longer than three days, just like we saw the wear of cgms increase. Well, that doesn't help if your reservoir if you have to change your infusion set every time you use your your reservoir up. And so we believe that the 1.6 ml cart and the fact that they can, you could do kind of a hot change and change that independently. infusion pump should be a really nice feature for someone living with Type One Diabetes, or even in particular type two diabetes who uses larger amounts of insulin on a daily basis, be able to get the full life on an infusion set and be able to add insulin very easily into the pump. So that was one of the primary features that we liked. And so right now that 1.6 ml cartridge isn't on the market. And so in our press release, we communicated that we needed to make sure that we did launch that 1.6 ml cartridge in our insulins, both humalog and loon jet to make sure that that people could use our products in that pump.
Stacey Simms 11:51
When it comes to market. It will only let me ask it this way. Right now in Europe and in Canada, though it takes the prefilled cartridge the same pump of novo, right I mean, these 1.6 milliliter cartridges exists elsewhere. This is a US only type of modification. Is it a different kind of pump that's manufactured in the US? How does that happen?
Right back to Mike answering that question. But first Diabetes Connections is brought to you by Daario health. The bottom line you know you need a plan of action with diabetes. We've been really lucky that Benny's endocrinologist has helped us with that and that he understands the plan has to change has been he gets older you want that kind of support so take your diabetes management to the next level with Daario health they're published Studies demonstrate high impact results for active users like improved in range percentage within three months reduction of a one see within three months at a 58% decrease in occurrences of severe hypoglycemic events, try Darias diabetes success plan and make a difference in your diabetes management go to my dario.com forward slash Diabetes Connections for more proven results and for information about the plan now back to Mike about how the mechanics of the proprietary nature of the pump will work
Mike Mason 13:17
well in the us right now there's that 1.6 ml cartridge isn't on the market place so we'll have to see you know is that advances is still kind of early on in development so we don't really know what instance will be available in the US for this you know in this cartridge size. But what do you think is important is first of all, I don't think anyone should be worried if they're on novels insulin or any other instance there's going to be plenty of pumps really good quality pumps for them to use so I wouldn't have you know anyone be concerned about their ability to have a high quality pump to use with their insulin what what we see is we we see an opportunity to provide a you know, an integrated, very simple to use pop another option for people living with type one and type two diabetes to have a an integrated, simple experience to improve their their blood control.
Stacey Simms 14:08
Yeah, no, I think it's it looks like a fantastic pump. It's tiny, it's light. I know people in Europe who used to love it. I love the idea of having more pumps in the United States. But just to be clear, so I guess the the question about the proprietary nature that we keep referring to is it just because there's no prefilled cartridges of other insulins available in the United States? I mean you probably cannot answer this so I'm gonna say this out loud and you can say no comment or nothing but if I have a yep so mid pump that is approved in here and let's say 2022 and I bring in novo rapid or you know Novo Nordisk branded insulin from Canada in the same kind of glass insulin cartridge and I stick it in the pump I've made my IP so med Lily pump now compatible with other insulins.
Unknown Speaker 14:56
Okay, didn't you comment on that
Mike Mason 15:00
Wow, yeah, you're expecting a lot of people moving bringing product over from from Canada, I, you know, it's still we're still very early on in our apps is at this point, things are gonna have to develop and we'll get a better answer that question down the road.
Stacey Simms 15:14
Got it? Okay, I know, I know, you cannot speculate you have to be so careful on what you say. And I appreciate you coming on and answering these questions. But I mean, I'm sure you can understand in a market that has three available insulin pumps in the United States that when one comes in, people have questions about why should I switch to him? And the biggest question that I have seen is, well, pumps usually have a four year warranty. And my insurance changes every year, whether I have with the same insurance or not, the terms often change, including what insulin they want me to use, we just went through this with my son this year, we had been using one type of insulin for a long time, and they switched us to another brand. And, you know, it's disconcerting, and it's a little, you know, it's, it would make I'll be honest with you, Mike, it would make me hesitant with the United States healthcare situation being what it is right now, to go to a pump, that would lock me into one kind of insulin, you guys have got to be thinking about that. What are the discussions? Like? Can you share anything about that?
Mike Mason 16:12
Well, let me tell you kind of how we think about I mean, we, our goal is develop an integrated solution, I kind of look at it a little bit like the computer market, where, you know, early on, you know, you were able to and you still can today is build a an integrated system, you know, you can pick the monitor, you want the processor you want. And my brother continues to do that. And he has a great computer that works really well for him. And for myself, that's not what I'm looking for a computer, I've got four kids and a lot to do. And I want something that's just gonna work, I don't necessarily care what the processor is, or what the monitor is. And so that, you know, I kind of went to a Mac 1520 years ago, because it was simple solution. So it was another option out there, I think, you know, Apple provided a another option to people who needed to get work done and wanted to use a computer, we kind of look at that the same way. On the pump side, I think you're gonna have people who are want to have each component and be able to build that. But if we look at some segment of the market, and in particular those people with with type two diabetes, we believe a simple solution can provide, you know, a real good answer for those individuals. So what we look at this ad, we don't look at it necessarily as limiting options, we look at bringing a new option to the marketplace that as an integrated solution can provide a new way to be able to control their blood sugar. So that's how we look at it.
Stacey Simms 17:40
So let's talk a little bit more about that integrated system. When I spoke to Ypsomed, they talked about it using a Dexcom having a very robust app, it looked like you were able to bolus by phone or you would be by the time it comes to the United States. Is the partnership with Dexcom exclusive or do you think you might work with other companies like Abbott, you know, on their libri and different cgms that could be integrated into the system?
Mike Mason 18:04
Yeah, right now it's a three way partnership between us and and you have submit and then with your leveraging Dexcom CGM. At this point, we'll have to see how things progress and whether or not we bring Abbott or other CGM into the system.
Stacey Simms 18:22
Ypsomed is also very much a pen company. And when I remember in that 2018 event that I've talked about before, Lily was also talking about integrative pens and things like that. Is that part of this deal here too? Or is it just a pump?
Mike Mason 18:36
Now, this was just an exclusive partnership.
Stacey Simms 18:38
So when when you were looking at it, so med pump, as we mentioned, it's very light, it's very intuitive. Have you tested it? Or have they tested it in the US market yet? Is that something that you'll be doing in terms of, you know, human factors and how people respond to it? And that sort of thing?
Mike Mason 18:53
Yes, we have to, you know, it'll be submitted to the regulatory agencies in order to gain approval in the US market. And as part of that, it will be tested in the US through human factors. And we think it will, will do quite well. We've done a lot of market research and interviewed people who use pumps are who are interested in using pumps. And we think that the attributes of the product are going to be well received in the US market. You know,
Stacey Simms 19:19
again, I don't know how much you can answer on this question. But when you bring a pump like this that's been used in many other countries for several years, is the testing different than say, you know, what you were what you were originally planning from Cambridge with the DEKA pump, a brand new pump, something that hadn't been on the market yet. I would imagine that it's a I don't want to say a little smoother, but it's got to be different. When it's already been out there and used in 1000s of people.
Mike Mason 19:42
The information is helpful, but the application is similar for every pump, no matter where it's approved, or whether it hasn't been approved before. So you know, the FDA requirements are the same no matter what
Stacey Simms 19:52
got it. I'm curious to know the cartridge that we've been talking about that isn't available in the United States yet. Are there other applications For Lilly for that, I mean, that 1.6 unit cartridge? Is that something that could then be used in pens? Are there other uses for it? Or will you be making it just for this pump?
Mike Mason 20:09
I mean, initially it will be used for this pump or any other device that uses 1.6 volt cartridge, you will evaluate every time you put a new form factor of insulin out there, we'll look and see if there's other opportunities that better meets the needs of people living with type one and type two diabetes. So we'll see no immediate plans at this time.
Stacey Simms 20:28
Okay, are there other devices that use it currently, I'm not familiar, not currently.
Mike Mason 20:32
But it's no reason why someone couldn't produce a third party, you know, we usable 1.7 card. That is
Stacey Simms 20:42
it's interesting. You mentioned people with type two quite a bit in this conversation. And I know in my conversations with manufacturers with tech companies, more and more people with type two are using insulin pumps and are using devices like Dexcom. And you In fact, I'm really trying to talk about more people who use insulin rather than the specific types. We talk about devices like this, which honestly, it's kind of hard for me after all these years. Can you talk a little bit about the appeal to that market? How do they use this kind of pump? In other words, most people I know with type two who need insulin, don't bolus for every meal, they don't necessarily use the same amount of insulin as type with people with type one. I'm curious if there's any information you could share on that market?
Mike Mason 21:21
Yeah, I think what we see is, first of all the needs while the disease is different, the needs of someone to control their blood sugar, both for postprandial as well as for basil is still there, especially for those who are later stages other type two diabetes. And so we feel that no matter who someone is, if they're on insulin, the big thing they want is to kind of stop thinking as much about taking insulin three or four times a day, you know, that's something that weighs on a lot of people mind. And we think it's important to be able to reduce that burden, but also improve care. And that's what we think, integrated insulin management system can do that's wrapped around a pump, whether that's for type one, or type two. Now, your question around, you know, what's different about type two diabetes, the big difference is the amount of insulin that they take on a daily basis. And because of that, I think the reservoir size and the ability to change that independent of the infusion set is an important feature of this pop and one that we think both type one and type two, but in particular type two beddings can really,
Stacey Simms 22:33
you know, it's interesting, when I spoke to the folks at Tandem recently, they brought up their control IQ software for people with type two, and how it's really helped. Because most of the time, it's just that people with type two aren't bolusing for their meals, or for correction dosing. And so being able to have that automatically has really helped. It's something that I mean, just conversationally, it was something that I really hadn't thought of, with an automated system like that. It's interesting. Yeah, it's
Mike Mason 22:56
interesting, when we speak a lot with people using insulin, the needs on a daily basis aren't that different, and the thought process and how they manage that, you know, isn't that different, but you're right, you know, and unfortunately, taking insulin is very complex, and it changes on a daily basis, as you know, well, and that's what we hope, we hope we can alleviate some of that burden that people have of controlling their blood sugar and their and their diabetes. In the
Stacey Simms 23:24
United States. You know, anytime a new product comes to market, in addition to submitting to the FDA, you have got to work with the insurers to get these things covered. And I'm curious if your conversations about getting the med pump insured, also factor around making sure that anyone who ensures it can make sure going back to what we asked about at the beginning. We'll also cover Lilly insulin as a some kind of package. When I spoke to the CEO of episode med, he had kind of implied and this was speculative, and he admitted that, but he was kind of hoping I guess is the way to say it, that it would be more affordable in the United States because it could be packaged up with healthcare insurers. Any thoughts on that?
Mike Mason 24:05
Yeah, I mean, I mean, first of all, we'll make sure that there's obviously insulin supply for for the pump. And so we'll make sure that that comes hand in hand so that someone doesn't have a pump that they can't use their insulin on. So what will definitely solve that problem, as we go to the marketplace, I think, you know, we haven't had any specific discussions with payers on this particular product just yet. But what we've had, generally, in this area is you know, payers are frustrated with their ability to help their members get good control on insulin. And they believe that that better control on insulin can lead to better overall healthcare cost. If you look at the total cost of the therapeutic and devices as well as all the cost of office visits and the very costly, you know, company Patients have diabetes. And so they're excited to not only provide better care of the hope of better care, but also the hope of reduced total medical costs.
Stacey Simms 25:10
As we start to wrap up here, just a couple more questions. I got notification, we saw some ads on social media about this is separate from the pump about renewing any coupons for the new year. Can you speak to that a little bit? While I've got you here, you know, for 2021, the lily coupons that are out there? How do people do that?
Mike Mason 25:29
Yeah, all they need to do is call our Lilly diabetes Solution Center. If anyone has trouble paid for a Lilly insulin, you can call up early diabetes solutions center. It's staffed with people who are healthcare professionals who will understand the needs and be able to get your solution on the phone or to email that to you with without any paperwork to fill out or anything like that. And so if they do need if one of the things they need is that to get an updated coupon, they can just literally call them and we also are putting more and more options on the website. And we can get you more information on that. Stacey.
Stacey Simms 26:06
Yeah, that'd be great. If you could send me the links. And I'll I don't know, Mike, if you know, but I wound up using that coupon in the fall. Oh, yeah, as I said, My insurer switched us we switched in September to a new insurer. And they wanted us to switch to Nova log, which we hadn't used in many years. And I'll be honest, is a little bit of an experiment, I decided to try it. For whatever reason, it wasn't that easy. It took me a couple of weeks that I needed. prior authorization my pharmacist helped out it was we went back and forth quite a bit. But we did get it done. And I'm back to paying about $35 a month for Benny's insulin for my son's insulin, which was great. But it kind of brought me back to the conversation I had on a conference call with Andy Viacari Last March, I want to say when you know, COVID had first hit and we were all really concerned about and unfortunately, it would bore out with employment in the economy. And the question I asked him at the time was just why not do away with all of these coupons. And because it really while it was difficult, I was able to use it would not have been able to get the Lilly insulin without it with my new insurance. So it did work. But I asked him at the time, I'll ask you now, why not just lower the price across the board to $35? And make it easy for everybody?
Mike Mason 27:19
Yeah, I mean, for us, it's a complex healthcare system out there. And we lower lowest price which we have was Insulin lispro that's one of the options that we've had, we dropped our list price by 50%. And, you know, we think that the sweetest solutions that we have, you know, with lowering our list price with listen into the lice pro as well as all the options that we have that are very targeted at the gaps in a system, which is the uninsured people, high deductible plans. And Part D, that we can create the best possible out of pocket experience, no one should have to pay more than $35 for literally insulin 43% of people who usually insulin doesn't pay anything for based on the health insurance. So, you know, we've looked at the problem. And we believe that this is the best solution we have out there.
Stacey Simms 28:07
I mean, I hear you, I get it, it's very complicated. You're not operating in a vacuum. But you've said several times that you want to help people get better control, the insurers want to get people in better control. One of the reasons people aren't in great control is because it's really expensive, even though, you know, if you have insurance, you're paying for it, you're paying for the high deductibles. I don't need to tell you we've had these conversations many times before. But I got to believe that this is not a sustainable system. And you know, I don't really have a question there for you, Mike. But I really hope that next year, we're not having the same conversation. And I know you don't want to have it either. So you know, I'm not not because you don't want to answer the questions, but because I I imagine that you know, that even if the price was lowered to $35, that Lilly would be fine. In business.
Mike Mason 28:51
I mean, first of all, if anyone has any concerns with, you know, 40 million insulin, call our Lilly diabetes solutions center, you know, with the most recent Part D demo project that the CMS introduced in January this year, no one whether you're in Part D, or commercial or uninsured and have to pay more than $35 for the insulin. You're right. I don't think the healthcare system right now is sustainable, whether it be for diabetes or other chronic diseases, we shouldn't put the medications that are designed to improve quality of life and to reduce overall total healthcare costs. We shouldn't have those at a high price that people can afford. And so I hear you know, that we are advocating strongly and working with our other healthcare system partners, whether that be you know, pbms and insurance companies as well as employers and the government on this topic, and it is a very important topic. And I hope, you know, as the Biden administration comes in, that we can have very good conversations and make progress.
Stacey Simms 30:00
Mike, thank you so much for spending so much time with me. I know I kept you over a few minutes and I appreciate you you're hanging on and answering those questions. Thanks for being here.
Mike Mason 30:07
Thanks, Stacey appreciate it. appreciate everything you do for people living with diabetes.
Unknown Speaker 30:16
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 30:21
More information about Lily and Ypsomed their partnership at Diabetes connections.com. The episode homepage, of course, has a transcript and more information, lots of links. But this is a story that we will of course, be watching over the next two years until this pump comes to market who knows what it will really come to market as things change along the way. But I'm fascinated by the proprietary nature as you can tell, because I'll tell you our Insulin story and in just a couple of minutes, you know, if you're using one type, your insurance company can switch you to a different type, it can be very difficult.
So we'll see another point I just wanted to mention, I didn't bring this up during the interview. But when Mike talked about the uniqueness of being able to change the cartridge, independent of the inset, there is something unique there about the YpsoPump, and I'll talk about that in a second. But it's not exactly as he explained it, you can do that with any tube pump with the Medtronic that are out there right now with the Tandem t slim any tube pump the way we have done it and we have always done it since using atomists. Gosh, almost 14 years ago. Now, when the cartridge runs out of insulin, we change the cartridge. When the inset hits three days, we change the inset and we don't do them together. Not everybody does it that way. Many, many people change them together, they have worked out exactly how much insulin they need, or they just feel more comfortable doing it together. Whatever is your pleasure. But the thing about the episode med pump that is different. My understanding is that when you do that you do not waste the insulin that is in the pump tubing, there is a different way there is something about it. That means you do don't have to push through and prime all of that insulin because I know what the Tandem you do waste insulin because of all the priming. So I just wanted to kind of clear that up and address that. As you listen. I know many of you were thinking that's not unique, but that's what he's talking about.
I have also reached out to DEKA, that is the company that was originally partnering with Lilly, we mentioned that the interview to have a new pump and pen system in the US is very different looking pump, it was cylindrical that was I don't know if that's the right way to say it like a disk, it looked almost like a tiny tin, you know when that's coming to mind is like a tobacco chew tin. Or maybe maybe mints is a better way to put it like almost smaller than your palm, but small, thin and circular. And that was the pump that they were working on really interesting. So I've reached out to DEKA to see if they're going to continue that work. And DEKA, just as an aside is the company from Dean Kaman D. k. Dean came in. He is the person who invented the insulin pump years and years ago, very first one and he's invented a bunch of things, including the Segway. So I'll link up stuff about him to very interesting, I'd love to have him on the show. But that's neither here nor there about Lilly.
I do know that many of you get frustrated when we talk to them, because you want me to just talk about insulin pricing. As you can tell, you know, Mike says what he's going to say. And I will continue to ask about it. We'll continue to talk about it and send me your questions. I'll see whatever I can do our insulin story coming up in just a moment. But first Diabetes Connections is brought to you by Dexcom. And it really is hard to think of something that changed our diabetes management as much as Dexcom share and follow. It is amazing to me that it helps us talk less about diabetes. And that is really one of the wonderful things about share and follow as a caregiver, parent, spouse, you know, whatever, you can help the person with diabetes manage in the way that works for your individual situation. It's about communication, and finding out how they want to share the information. Even your kids this is a decision that you can make together and talking it out really, really helps internet connectivity is required to access Dexcom follow separate follow app required. Learn more at Diabetes connections.com and click on the Dexcom logo.
In our innovation segment this week, I'm going to get to our Insulin story. But I also want to mention that there's new guidelines for the A1C when it comes to kids. This was kind of quiet. I was surprised it didn't get a lot of attention. I posted it on social and it was kind of met with a big shrug. The American Diabetes Association has lowered the target A1C guidelines for children with Type One Diabetes. I will read from the summary here. The goal in recommending stricter glucose control was to ensure children with type one have better immediate and long term health outcomes with fewer health complications and reduced mortality rate. The number has gone from 7.5% for children to less than 7%. And I think as you listen you know, the podcast audience, frankly is extremely well educated you guys are up so much stuff. And many of you are already striving for less than seven, you're striving for less than six. We are not striving for less than six. But I think that this is something that many of you are saying, Well, of course, but I gotta tell you, I'm a little disappointed in the way they released this.
They talk about why they say things like these stringent measures are not always practiced by caregivers of 20 patients or diabetes providers due to concerns and fear, it may cause sudden or dramatic drops in sugar levels. And promise, I'm not gonna read the whole report, but they don't talk about better education. They don't talk about access to CGM, to insulin pumps to integrated systems. There's no wording here in the reports about cost, or making sure you have an a pediatric endo, who will give you these things and educate you. I got really annoyed, frankly, reading this, and we'll revisit this, I'll probably reach out to some of the endos who worked on it, I hope to and talk about Yeah, guidelines are great goals are great. But how are you really going to get us there? Because we all know that the A1C needs to be lower right? I am hoping that some of you who have kids with an eight or higher A1C are nodding and going, Yeah, well, what about help for me? How are we supposed to do this alone? I just don't think it's enough to say here's the number. I think they need to give much more help and support. Maybe that's a pipe dream. I know, most pediatric endocrinologists are great people who really want to help. And you know, they see us for this teeny tiny amount of time. But let's follow this one along because it's just it's, it's just so frustrating to know that we have a place we want to be, but how do we get there?
And you know, one of the reasons we get there, and Mike said this in our interview is, you know, we need to make sure people have better access to insulin, so they can live better with diabetes. Well, sure. We went through this recently in my family and I will not go through this beat by beat I did like 10 or 15 minutes on this as a Facebook Live and told the story about a when we were switched, our insurance company switched us from humalog to Novalog, I told the whole story very lengthy double not do that here. I'll tell it in a shorter way. If you want to see the whole story, I'll link it up. But I realized I never told the rest of the story here on the actual podcast.
So here we go. In the fall, in early September of 2020, we had a change in our insurance, a change of employment meant we were now buying our own insurance. And we actually had a great experience. We did this several years ago and had a disastrous experience. It was so expensive, and nothing was covered. I was really excited that this time around, we found something great. We used an insurance broker. And I would highly recommend that maybe we'll do a show on that I'm making all sorts of notes on future shows. But somebody helped us he didn't know a lot about diabetes, but he knew what we needed. So that was great. And my husband lives with type two as well, as you likely know. But this new insurance company did not have human blog as the one they wanted us to get. It was no vlog. And I posted the pricing on social media. It was like, you know, $35 a month for Nova log, and 13 $100 a month for human log. So it was quote covered, but you know, at a different rate. And we were going to go ahead and do that Benny had used Nova log for I want to say the first seven years of his diagnosis, and then our insurance switched us. But he's been doing really well. Everything's chugging along, and I thought, Gosh, I really don't want to switch him.
And I was kind of at sixes and sevens not really knowing what to do. And I was talking to my parents about this. And my dad said, I heard on your podcast that if you have commercial insurance, you can get any insulin with a manufacturer's coupon for $35 a month. And I thought Dad, you're the best. Thank you for listening to my podcast. And of course you are correct. And then that week, I spoke with beyond type one about their new website, get insulin.org. So I went on, get insulin.org and filled in all the information and a coupon popped up from Lilly. I printed it out and it said go right to the pharmacy and get your insulin. And I know how these things work. So I didn't go to the pharmacy, I called the pharmacy and said Is this legit, and they went, you know, tickety tickety tick and the computer. Sorry, Stacey, this isn't going to work for you. And I know the pharmacist there very well. We've been so fortunate. I've known him for all of Benny's diagnosis. I want to say all 14 years, it's been the same guy. So we really went back and forth and tried to figure out what was going on. It was a quirk in the way our insurance wanted to build it.
So I called Lily. They said no, it should be fine. Here's the codes to give the pharmacist everything should be fine. They called the pharmacist he said No, those codes are not going to work. And they didn't what he told me to do. And this is what worked. Our endocrinologist had to call it a brand new prescription. We were going off the old one that we'd been using, you know for the whole year many years. So he had to call it a new prescription. He had to call in a prior authorization. And then after that when they reran the coupon, it worked just fine. Everybody's different. The pharmacist and the folks that Lily told me that every insurance, every state, sometimes the pharmacies run these different ways. So if you run into a brick wall, definitely keep pushing. And I'm telling you as a listener of this podcast, if you do run into a brick wall Lily and their coupon, email me Stacey at Diabetes connections.com. Let's make sure you're talking to the right people, because it took me a while to find the people that really dig down and do this at Lilly. That's their job. And how ridiculous is this that this is somebody's job to figure out How to get around all these coupons and use them in the ways that they're meant to be used, rather than just dropping the list price. I mean, it makes me crazy to talk about, I'm already going too long. Bottom line is we got the coupon to work.
And then it worked a second time. I called my pharmacist the other day, because it was time to renew and I said, Hey, you know, I've heard that you have to renew in the new year, is it going to work? And he said, it's going through just fine. And then he laughed. He's like, let's run it without the coupon. I said, Why? Why? He was just curious. He's like, yep, it's still, you know, 13 $100 a month without the coupon. I said, Well, don't put it in without the coupon. Don't even bother. So that's the story. It leads me back to what happened if I was using the app, so pump with Benny. And then in September, my new insurance company said, No, you have to use no dialogue. And I didn't know, I didn't have a podcast. I didn't know I could do all that. I didn't know I could get the coupon or what if the coupon goes away, there's no guarantee it's going to be there. And then I'm stuck with a pump that I can't use the insulin that my insurance company makes me use. So obviously, we don't know. That's a lot of speculation. But those are the concerns I have. Have you used one of these coupons? How about the nofo coupon what's working for you guys? I'll start a thread in the Facebook group. But you can always you know, ping me and let me know what's up with you. Or if you need help that way. It's just ridiculous. Maybe next week, instead of innovations. I'll bring back Tell me something good. We need the good news stories, too.
As I mentioned last week, we are about to start classic episodes. The first one will be this Thursday. And that is an episode I taped almost five years ago with Ernie Prado. He is a rocket scientist for real at NASA. Great guy. It was so much fun to talk to him. He has a terrific story. What I love about his story is it's not the perfect diabetic. He really struggled. And he talks about why and how he kind of got out of that. I think it's one that as a parent of a child with type one. I love those kinds of stories because I don't expect perfection in my kid. And I really like to hear about other people who all due respect, Ernie, who really messed it up and are okay, are doing fine now. So that's on Thursday.
You don't have to listen to it on Thursday. Obviously, whenever you have time, we're going to be putting out a lot more episodes. So when you have time, listen to podcasts. We'll be here for you. thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. Until next time, be kind to yourself.
Benny 42:22
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
It's been a year since Tandem Diabetes Care released their Control IQ software, hybrid closed loop technology to help increase time in range. What have they learned about how people are using the system? Molly McElwee Malloy, Manager of Clinical Outcomes at Tandem Diabetes Care, is back on the show to answer your questions and to talk about what's next in the Tandem pipeline.
What diabetes tech to expect in 2021
Our innovations segment: using your CGM to get more out of exercise and.. a new study for people with rare forms of diabetes..
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by Dario health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen, the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:22
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
This week, it's been a year since Tandem diabetes released their Control IQ software, hybrid closed loop technology to help increase time it range.1 since that day, as we do around here. We've all been asking for changes. Tandem says they're listening,
Molly McElwee Malloy 0:43
can it be more aggressive? Could it be less aggressive? Good, you know, do this or that I pick my targets. Could I put a timer on exercise? Could I do all that? We are looking at all of those things. I would say nothing's off the table right now.
Stacey Simms 0:56
Molly McElwee Malloy, manager of political outcomes at Tandem is back to talk about possible changes to controlling q to answer your questions, and to look ahead at other tech in the Tandem pipeline
In our innovations segment using your CGM to get more out of exercise, and a new study for people with rare forms of diabetes.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome back to another week of the show. I am so glad to have here. If you are just finding us if you are new to Diabetes Connections, welcome. We aim to educate and inspire about diabetes with a focus on people who use insulin, my son was diagnosed with type one right before he turned two back in 2006. My husband lives with type two diabetes, I don't have any type of diabetes, but I am the broadcaster in the family. And that is how you get the podcast.
It's funny to look back on this year. Because not only did none of us have any idea what 2020 would really be like, but more to my point here, as I'm taping this on January 15. And planning to release on the 19th. This was a time when many of us in the community were just refreshing the Tandem page over and over again. Because Control IQ had been approved. And many of us had already talked to our endocrinologists about it and tried to get the prescriptions. And if you remember that time, especially on social media and some of the Tandem groups, it was a bit bananas. But we have been using Control IQ for a year. Now Benny got his set up at the very end of January, as I recall.
And they are not a sponsor of the show. They do not pay me to say this. But it's been absolutely amazing for us, it has really made a big difference. And you know, I don't share numbers. I'm not all about the numbers and straight lines with him. But I do want him to be healthy. And I think we were doing great before but just back from the endo this time around about a week ago as you're listening now, his lowest A1C ever. And the time before that was his previous lowest A1C ever. And the best part is he's doing less work. And I am I swear I'm doing less nagging. If you ask him, he will tell you otherwise. But I promise you it's true. So I'm thrilled to talk about control IQ. I'm really excited that all of the pump companies are moving in this direction, it would be amazing for everyone to have access to this kind of technology. That is a discussion for another time. Probably
Another little bit of personal news, Benny got his driver's license. I know I can't believe it either. Here in North Carolina, you get your permit. If you want at 15, you can actually take drivers at 14 and a half. But you get your permit at 15. And you can get your license at 16 right now, because of COVID. They are not even doing road tests. I know isn't enough bananas. But what happens is you get your basically your junior driver's license, you can't drive at night, which is what he would have been issued anyway, if he passed a road test. And they cannot move on to the next level the after nines until they get a road test. In fact, I believe what he has expired in six months without a road test. So he'll have to take one. He's a decent driver, you know how superstitious I am. So I'm not going to say more than that. But I'm confident we've got a whole system with diabetes we have we've had these discussions, and he's just so excited about it. And I'm really thrilled for him that this step has taken but as a parent, and for those of you who have known him since he was two, how did this even happen?
Okay, we're gonna talk to Molly from Tandem in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen and almost everyone who takes insulin has experienced a low blood sugar you know, that can be scary, but a very low blood sugar. It can be really scary, and that's where Gvoke Hypopen comes in Gvoke is the first auto injector to treat very low blood sugar. Gvoke is pre mixed and ready to go with no visible needle. That means it's easy to use. How easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it. Find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvokeglucagon.com slash risk.
My guest this week is the manager of clinical outcomes at Tandem diabetes care. And she lives with type one, Molly McElroy is I am grateful to say a frequent guest. And if you're a longtime listener, you know, her career and her life has been shaped by the technology that is now control IQ. That's not really an exaggeration. She was one of the first to test out an artificial pancreas system. And she changed her career path because of it.
And my first interview with Molly was in 2016, when type zero technology announced their partnership with Tandem, and I will link up the previous episodes, we've done a bunch with her all about this software, you can find those links, as always, in the episode, show notes, wherever you're listening, the app should have show notes. If it's difficult to find, just head over to Diabetes connections.com. And every episode now has a transcript and lots of links and notes to help you out. Please stay though, to the very end beyond the interview because there are a few questions Molly had to check on. She couldn't answer at the time. And they sent me that information. And I will give that to you later on in the show. Of course, as I said, there's a transcript so you can check it out that way as well.
Molly, thank you so much for coming back on to talk to me a year ago, you and I spoke about Control IQ it had basically just been approved. And you were kind enough to jump on that in late December. So thanks for coming back on.
Molly McElwee Malloy 6:26
Oh, you're welcome. I'm very excited to be back on this.
Stacey Simms 6:29
Yeah, well, lots of lots of questions, of course, from listeners and from me. But let's just start by taking a moment to kind of reflect what's the last year been like for you guys at Tandem?
Molly McElwee Malloy 6:39
You know, it's been really crazy great is the best way I could describe it. There's a lot of excitement for control IQ, and rightfully so. And there's a lot of the feedback via social media about people's experience. And it's been really, overwhelmingly positive. It's also been kind of emotional, because this has been a rough time for everybody, right? Like last eight months or so that we've been in. I've been calling it seclusion. But it's, you know, everybody working from home. And that's been a really high stress situation, particularly for people with chronic disease, and myself included. So I've really been grateful that control like has been out and approved. And a useful tool during this time. Because just you know, stress influences glucose. And so it's been a big, huge help for a lot of people, particularly during this time. So it's been crazy great. And it's been busy. But sure, I would love to experience control, like you and all the interaction with healthcare providers in person. But it's been great just talking to people on the phone or on video or teams. And it's been really good that we've been really busy. Yeah, sure. All right.
Stacey Simms 7:43
So what I'd like to do is take a look back, get some information from you about control IQ, and then kind of take a look forward because we know the product and the product line is evolving. So let's just start by asking you, what have you learned about control? IQ obviously had all the study information. But looking back at 2020? How are people using it? How is it working out? What is the data telling you,
Molly McElwee Malloy 8:07
you know that this is the funniest thing, and this is not something that you can plan or you could guess but our real world data is better than our clinical trial data. And I'll say that again, because it's just, it feels a little crazy to say that out loud, because that's usually not the case, right? clinical trials are very well managed. And you know, there's protocols and everybody's sticking to stuff. But it turns out when you put this put control, like you in the real world where people are experiencing significant hyperglycemia, or even hypoglycemia, it does even better. So I mean, the clinical trial population was pretty well controlled, right? And we were still able to improve on that. But when you put it into the real world where people are doing, you know, they're real people, they're doing all kinds of real things, and we're able to get even better outcomes. It's surprising. It's awesome. It's a really cool experience, and definitely unexpected.
Stacey Simms 8:59
Yeah. So let's dig into that. Can you tell us in terms of I guess you're measuring things like time and range? Can you give us a little bit more information about what you mean by they did better?
Molly McElwee Malloy 9:09
So for one, it's it's time and proven time and range, right. So in our pivotal trial, we had about 11% over baseline improvement on time and range from a very good well control group, which is awesome. But in real world, it seems to be closer to 13%. Sometimes a little bit better. We've got some results from D Q&A which is a third party vendor that does research and they're affiliated with Diatribe. And they did some survey results about time and range by insulin pump therapy and it's been really cool to have like a 33% getting 81 to 90% time and range 31% getting 71 to 80% of 11% getting 91 to 100% which is crazy. So you know all of that And it just is amazing because it really does. It whips up on the competition. But it also just shows that, you know, this works even better in the real world.
Stacey Simms 10:08
Any idea why? I mean, are people using sleep mode? Are people figuring out different ways to use it better? I'm just curious what you think might be happening?
Molly McElwee Malloy 10:19
Yeah, I don't think it's the using sleep, you know, 24, seven or something. I think using a sleep schedule has been very successful. But I think the reason for this is that largely, and not everybody was correcting aggressively, right. So while there are that subset on Facebook, or social media that are trying to get that, you know, super, super tight range, there are plenty of people who, between meals, we're not correcting, and now they're receiving those corrections. And there's some evidence that we were able to publish. And I think we showed an ADA, but that persons with type two diabetes are benefiting from this. And that's because they're getting the corrections between meals, which we don't typically ask people with type two diabetes to do that. So getting that tighter control is really, really helpful. And again, not everybody does that.
Stacey Simms 11:11
Yeah, I have one of those people in my house, who not everybody does that. I mean, we I tease Benny all the time, and he knows that I I talk about him on the show like this, he will happily, let me say that Control IQ has helped him significantly because he often boluses after he eats or forgets to bolus or didn't correct between lunch and let's say, bedtime, even if he gave himself insulin for dinner. And it really has made that burden lighter. And it's certainly not perfect. I have friends whose kids are much more engaged with their diabetes, I guess is a way to say it where they, they will you know, they'll bolus every two to three hours, or they're looking at their watch every 20 minutes. But he's never been like this. And it's really improved his quality of life. Because I'm not, I'm not willing to make him do that.
Molly McElwee Malloy 11:57
Well, and if you think about the long term, decrease the complications because of this going on in the background is sort of automating this. I mean, that's a huge improvement and quality of life. One of the things I'm really excited about is to watch this going forward to see how we can measure decrease long term complications from this, you know, the not just like seeming variability, but with those micro macrovascular complications. But this is long term complications from diabetes from having high blood sugars. And, you know, that's just something that we've never been able to really control for before. So this is going to be very cool to watch and see how it plays out.
Stacey Simms 12:36
No doubt. All right. We've gotten a little bit inside baseball, but I think most people listen to the podcast will understand some of the shorthand, I'll try to explain as much as I can. But if there are things that we mentioned, that you are not understanding, I'm going to link up lots of stuff in the show notes. But one of those things is sleep mode. And I just want to take a second to talk about that. Because you and I, when we talked last year, you said that there were some people using sleep mode, which will adjust basal but will not give you boluses, they were using a 24 seven in the studies, you called them sleeping beauties. And there have been many, many people in the real world settings who use that we do not we actually don't laugh at me, we stopped using sleep mode for sleep. Because as great as it was working for Benny with what you called a seclusion, we found that he was eating at interesting hours, you know, 1am 3am I mean, he went full nocturnal for about a month there way back when I want to say like June or July. And so we turned off sleep mode because we needed that bolus power at weird times. So it's been really funny how you can kind of use the system in a way that works for you. But getting back to my question, what have you learned about sleep mode? Is there anything you can share with us?
We'll get her answer to that question and what she can share in just a moment. But first Diabetes Connections is brought to you by Dario health and we first noticed Dario a couple of years ago at a conference. And then he thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed. You'll get a glucometer that fits in your pocket, unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports. Based on your activity. Find out more, go to my daurio.com forward slash Diabetes Connections. Now back to Molly answer my question - we were talking about what Tandem has learned about the use of sleep mode?
Molly McElwee Malloy 14:44
Yeah, yeah, there's lots like I've learned I just want to share quickly that I've seen in looking at lots of reports with lots of health care providers that during what I've been calling seclusion or hibernation this this COVID time that people schedules are very, very different. They're eating at different times. And that sleep, as originally intended right is not what it looks like during this time. So there's a lot of people who have benefited from not using sleep when they're eating right through the night, or snacking, or staying up extra late or, like really altered schedules, right. So we've seen that some people have turned sleep off, and that's been successful for them.
So sleep, what sleep is doing is it's based off of fasting metabolism. And it's using this 112 to 120 sort of target. And it's really, it's a really tight range. But it's doing this through modulating basal. And the reason it's only modulating basal and not giving corrections is because someone is sleeping, and they're not, we're not anticipating postprandial spikes, and we're not anticipating exercise or activity. And so it's really, really meant for when you are kind of static, and you are sleeping. Now, that said, Not everybody's sleeping normally, particularly during COVID. And so it doesn't always work that way. And then some people want to have sleep 24 seven, so that the basal is modulating, but that they're responsible for the corrections. And if you're willing to glance and see if you need a correction every two hours, that can work really well. But if you want to alleviate that burden, right, then, then sleep maybe isn't the best thing for you to use 24 seven, so it really depends on the user and the user's interaction.
But the other thing I wanted to mention about sleep for users is that one of the things that we've noticed, and how people are using sleep is that if their schedule have has changed drastically with COVID, that they may need to reevaluate that sleep pattern as to what time it is. So for instance, if someone previously wasn't snacking at 10pm, and now they are starting sleep a little later may make sense because they may need an additional correction before going to that, you know, that's one circumstance I've seen a lot of. And another one is, there are some patients who can't go to bed with a positive IOB. And what I mean by that is, you know, going to bed with any insulin on board that is not related to carbohydrates, right, so for correction, and for them starting sleep sooner, and you know, obviously not eating right before bed, makes sense, because they're not getting any corrections before bed. So there's sort of really two very different types of insulin sensitivities, right, the person who's eating and then needs the additional correction, who may want to start sleep later. And then the person who isn't eating after dinner, and really doesn't want any additional corrections before they go to bed, starting it sooner. So I've also seen that very interestingly playing out in the public realm, and it's it's interesting to see how people are using it to make it work for them.
Stacey Simms 17:44
Yeah. What about exercise mode? Have you learned anything about how people use that we don't often use exercise mode.
Molly McElwee Malloy 17:50
Yeah, exercise is interesting, because it's sort of like a temporary basal rate, if you will, which you set indefinitely, right? until you start it and you stop it. And we hope in future versions, we'll be able to put a timer on this. But for right now, you start and stop it. And so you could be in sleep for 24 seven, if you wish, I have seen that be useful when people want to keep an a higher target, and want to be a bit more aggressive and preventing hypoglycemia, right. So that's an interesting thing that has and can be used selectively, whether it's for exercise, or just because you would like to keep up, you know, you need to be a little bit more conservative on the hypo end. And you really do want to have a higher target, you know, and COVID times looking at how particularly the aging population is trying to stay at home rather than go into care, using something that's going to keep them a little safer on the lower end and elevate that glucose level a bit has been useful, and just allowing people to remain, you know, in a safer range with preventing hypoglycemia.
Stacey Simms 18:51
I'm curious to see if there are any best practices, or any advice for starting the system. A lot of people who switched from Basal IQ or other pumps or no automated system, you know, just a regular Tandem x2, and I'll put myself in this camp. We were one of the first people on this in late January of 2020. We started on Control IQ before my endocrinologist or shouldn't say that way. We started on Control IQ before Benny's endo was trained. So I was in touch with him, but he was like, tell me what you find out basically, like, show me Show me Benny settings like we're gonna adjust as much as we can. But what are people saying? What are what are the you know, what are the experts saying? Trust me, my endo doesn't take advice from Facebook. But you know, it was one of those situations where we're learning together. And luckily, he trusts us to do that. But then he had, you know, we put his regular settings in, and we had massive overnight lows. And we had to adjust because of that five hour increment. We had to adjust. Basically everything works like a dream now, but it was a different transition than I had anticipated. I'm curious if you learned anything from that and what your advice might be now?
Molly McElwee Malloy 19:56
Yeah, one of the things we noticed, particularly people going from Basal IQ to To Control IQ as in basal IQ, they'd sort of artificially inflated their basal rates to sort of hug that line at 80, right or, because because it can always turn off, right? It's always preventing hypoglycemia, so why not have that basal rate a bit more. And with control IQ, it really takes that information and says, okay, that's where you are at baseline. And if that's really overly aggressive for where you are at baseline, then you're going to have hypoglycemia. So getting optimized settings is super, super important. And we do still see that people going Basal IQ to control IQ, that they've had really aggressive basal rates, and you need to back off of that, or even really aggressive meal. boluses, right. So sometimes getting that reevaluated with your healthcare provider, or diabetes educator, can be really, really helpful. But also coming from other AI D systems where you may not have as much information about, you know, what's going on with your basal rates or anything like that. But really just going when in doubt, wipe it out, you know, go back to basics with your settings, and with your provider and making sure those are dialed in. Because control IQ is being a metabolic algorithm, it really does behave when we really did design it around sort of insulin titration as we know it. So it's not any, any crazy math, it's not an occult science, it's, you know, it's what your endocrinologist would use now, for titrating insulin and going back to those basics is is really necessary to get a good solid start.
Stacey Simms 21:23
So would you recommend maybe basal testing or just talking to your provider about what they think is best for your settings,
Molly McElwee Malloy 21:29
talk to your provider about what's best for your settings. I mean, I can't give any medical advice on on how to do that exactly. But there, there are known ways to do this, whether it's you getting your basal rate, or your carb ratio, and a correction factor all dialed in. Do that with your provider. I I personally hate basal testing, I will tell you that I don't like basal testing. The reason I don't like it is because when people are basal testing, they are altering their behavior from normal. And it is not a true test, right? They're trying to avoid hypoglycemia. They're not doing their normal schedule. Because if you get hypo right, you have to treat it's trashed, you have to do it again. And so beta testing is, in my personal opinion, a nightmare, and not a true representation of what the patient is actually needing during that time. So I would I would prefer to do is see how controller hue is changing baseline and then see what that looks like against what's programmed and kind of, you know, look at the difference between the two to get the feedback. So really think basal testing is, you know, in theory, it's a good thing, right? But nobody basal testing is doing exactly what they were doing before that because they're not eating, right, they're trying to be careful about hypoglycemia. Sometimes you're just staying home all day to try to test this out, because you have to do so many finger sticks or what have you. So I don't think it's a really good representation of what's actually going on, I think, you know, looking at your total daily dose of insulin and talking to your healthcare provider, you can get that dialed in much better, with much less frustration. What I did with Benny and
Stacey Simms 22:59
I agree with him on the basal testing, we haven't done it in years and years and years for many of those reasons. But what we did that work nicely is we made changes very slowly. And it can be very frustrating. But it really works well. For us. Again, this is not medical advice. This is me personally what we did. And it really helped, we made one change basically, like he went low at 2am. So I changed the basal rate and we waited like three days, then and even if we went low, we treated but we didn't change the basal rate, then we worked on the insulin sensitivity factor, then like it took us two to three weeks before we thought we might have it and then we adjusted again about a month later. And if you if you can be patient, which is so hard to do, you know, people especially especially, and I'll throw myself under the bus too, especially as parents, we get nervous if anything's out of whack, right? We want everything to be perfect. What happened to my straight lines, and it's really hard to dial into settings, unless you're willing to let some of that perfection slide for a few days or weeks. But I'm telling you do it slowly, it'll come out much better in the long run.
Molly McElwee Malloy 24:03
Right. And if you think about an experiment, like for instance, the one that often comes up in our household is meant to my husband likes to follow recipes. And I hate following recipes. Although I know it's absolutely necessary, right? Because if you don't get the flour and the sugar and everything else, right, it just tastes like dirt. So they when you're baking, because I have done that. But it's very important to follow those recipes because if you alter you know one thing versus another thing, you're gonna get a totally different result. So altering one thing at a time is very important in a scientific kind of experiment, which sometimes dialing and pump settings is absolutely like that. And you need to follow that recipe. You can't willy nilly. It's not an art, right. It's very much a science. There's no there's no artfulness in this.
Stacey Simms 24:51
So looking ahead, and I'm not sure how much you can tell us but I'd love to start by kind of asking you about changes planned to control like you bet He has the first question here. He wants to know when the auto correction, right that auto, I call it the auto bolus, but the auto correction, when that will be stronger, because right now it's 60%. automatically.
Molly McElwee Malloy 25:12
Yeah, 60% because we're also titrating. Basal. Right. So the combination usually gets you closer to 100%. We are currently working on what that looks like, and how we could do that safely. I don't know how quickly that comes to fruition. But I can tell you that we are working on trying to understand how you would increase aggressivity without increasing hypoglycemia
Stacey Simms 25:37
you need a teenager setting, I can tell you that
Molly McElwee Malloy 25:40
we need a teenager aggressivity setting that's, that's for darn sure. Yes, Yes, we do. Well, maybe
Molly McElwee Malloy 25:45
I should start
Stacey Simms 25:46
by really asking you what what are you looking at in terms of improving or changing control iQ?
Molly McElwee Malloy 25:52
So we've we've really listened towards to feed back, right. So one of the things we do at Tandem, which we do really, really well, is we do these surveys all the time, where I'm constantly asking you, and you probably get these, what do you think of this? What do you think of that? What do you want from this, what you want for that, and then we look at the glycemic data, and we do some comparisons, because you can't just take what somebody wants as the absolute that would be best for everybody without looking at glycemic data. So we're kind of looking at both of those things, to see how we could refine Control IQ for something in the future, that works better and something that people don't even more excited about. So we're looking at people's sort of concerns? Or how aggressive can it be? Can it be more aggressive? Could it be less aggressive? gonna, you know, do this or that, but I picked my targets? Could I put a timer on exercise? Could I do all that? We are looking at all of those things? I would say nothing's off the table right now. I don't have any promises as to what comes first. As far as the improvements go, I think, you know, the next thing that we've been working on sort of is that bolusing from your phone, and being able to bolus from the app? Because that's been a big request.
Stacey Simms 26:57
Oh, but I'm asking about that. Don't worry.
Molly McElwee Malloy 27:00
Okay, yeah, because the thing, the cool thing about working as you know, we're a software, pump company, right, software based insulin pump company, which is cool, because you can make changes to software a lot easier than you can make changes to hardware. And so since we're not reliant upon the hardware to change, to make major changes, we could kind of do this in an iterative fashion, you know, one thing and then another thing, and then you know, and build and build and build a better product as we go along. And like you said, before, doing it slowly, carefully, looking to making sure that the changes are appropriate and working for everybody. So we're gonna follow that sort of scientific process, but we're looking at a bunch of different things that we might be able to change or, or make better based on feedback that we've gotten from our users.
Stacey Simms 27:49
One of the things that the other pump companies are coming out with, or if they come out in 2021, is a lower and different range, target range, or target number, you know, Omni pod and Medtronic have said that it'll be lower than, you know, 115, or 110. It'll be down to 100. It might even be adjustable. Can you speak to what Tandem is looking on that?
Molly McElwee Malloy 28:12
I think we're looking at a lot of different things I do. And full disclosure, as everybody knows, I come out of the University of Virginia research school center for diabetes technology, and working with Dr. Boris kabocha, and working with Dr. Mark proton, and Sue brown and Stacy Anderson, and really getting familiar with what is safe, and where people can kind of push the limit and where you can't, I think that 112 point five that we've chosen as being a really safe glucose has been really safe for the majority of the population. And since we're designing for the majority of the population, it's been very successful. So I know there are people who want to choose differently and want tighter targets. Now, when you choose tighter targets, whether it's 100, you know, some people will want 80, things like that, you're going to have to trade off some hyperglycemia. And as a product that gets approved for vast majority of patients, when you increase hypoglycemia, you are inviting adverse events, right? You're inviting possible adverse outcomes. And so you have to be very, very careful and almost ginger with that, and what that's going to mean for your patients and for the whole population. So I approach that cautiously. And I think at Tandem, we're approaching that cautiously as to how do you do that without increasing hyperglycemia? I think other people choosing those targets, you're gonna see the trade off with increased hyperglycemia. At least that's what we've seen so far. And in clinical trials,
Stacey Simms 29:56
it's interesting because people listen to this podcast generally. We are found through the research that I've done, you know, are extremely well educated, you know, very much take control of their diabetes in terms of even willing to do DIY stuff, right? It's a different population.
So as you're listening and you're thinking, well, I want to ride at You know, all day long Give me that flexibility. and wondering, you know, how do we balance that, as you're saying, with the 99% of people with diabetes, type one and type two, who may use this pump, who don't have access to the education or the time to look into it, or you know, many, many, many factors that increased that chance of hypoglycemia, as you said, but the other hand, it's a selling point. And other pump companies are already saying, we were going to be better, right? Or we're going to be more flexible. And I don't know if that's even a question for you, Molly in the position you're in. But it is something that I guess you really have to take into consideration.
Molly McElwee Malloy 30:38
You do. And I can speak more philosophically about this than I can. Anything else. But you know, particularly as a diabetes educator, and as someone with diabetes, hugging that line at 80, or 82, or whatever someone wants to do, you do have increased hypoglycemia. So the most relevant experience I have to pull from is pregnancy, right? during pregnancy, we asked people to stay, you know, very controlled, which you know, is a little bit like magical thinking, because it's very, very difficult. When you get all these hormones raging and everything going on and you're sick this minute, you're hungry, the next and all this stuff is going on, I spent a miserable amount of time and hypoglycemia, this was before any automated insulin system, right? So my daughter just turned four, so we can do the math. And she's my youngest. So I know nothing was on the market at that time, that would have helped me. But that was preventing that, but in letting me ride that really close line, have you know, let's hang out at 72 all day, at personally thought that was a miserable experience, whether it's the neural glycopyrronium, right, so your the lack of glucose to the brain where you're like, I can't remember what's going on or what I need to think about next, or you're constantly tweeting hyperglycemia. Like, it's not a trade off, I would take lightly. It's a risky trade off.
And I would say for for people who are comfortable being in that space, that's fine. And that's a very small amount of people, right. And if you can hug 82 all day, with, you know, whether it's doing some sort of low carb diet and intense exercise or what what have you, that's awesome, you're also not the majority of the population, right? So while I can appreciate that people want that, and they want to be able to set a much lower target, you know, people with euglycemia, right, without diabetes, don't have that either. People with without diabetes do have, you know, 30 40 point range, sometimes with meals and things like that happening. So it's not, it's perfection that I don't know, is a realistic ask for someone with diabetes. Now, people who can do this and do this all the time, I guarantee you, they're spending a tremendous amount of time and thought on it. Again, if you want to do that, and you can do that. And that works for your sanity, then please, by all means, but for a lot of people, you know, like, we have other things that we are going to be focusing on, and it's not going to be diabetes 24. Seven, and the goal of an automated system is to relieve some of that burden. So, you know, it kind of depends on like, Are you okay, with the trade off being low? Are you okay, with more management with being more involved? A lot of that's just going to be decisions, personal decisions someone's going to have to make, but I wouldn't say that the lower target is necessarily advantageous for a large population.
Stacey Simms 33:24
Okay, as you listen, I know, you were screaming at me to go back to bolus by phone. Don't worry. I didn't let it slip by. Let's talk about that. Because the app came out spring-ish of last year for general users. And it's great to look at people love the information. Talk to me about if you can tell us a timeline or any information about bolus by phone?
Molly McElwee Malloy 33:46
Yeah, so one of the cool things about my job is that I get to work with the Human Factors department and we have really good human factors department at Tandem. And we
Stacey Simms 33:56
stop you there human factors, because that always confused me. That means how people actually interact like how stuff feels and looks and how you actually use it,
Molly McElwee Malloy 34:03
and how you understand it. And how logical is something to you? How intuitive is something to you, you know, something as simple as changing where and the menu structure you would put something we test to see if trained, can people find this? Is this intuitive? Does this make sense to you? If we use a new term, right, we test it to make sure that it's understandable the thing might, you know, this is a very much outside of the realm of insulin pump therapy. My favorite illustration of human factors is if you you know any hotel you've ever visited, you pick up the hairdryer that says do not use in the shower, right? Like someone did that there was someone I'm sorry, yes, somebody did that. Right. There's, you know, crazy warnings if you'd like pick up a pillow, it's like you know, do not use while smoking or do not, you know, things like that, but it did happen. So that warning has to occur. So if we change something with insulin pump therapy, or we Add a feature like bolusing. From iPhone, we have to test it very thoroughly to make sure it's safe, effective, understandable and intuitive, because not everybody is going to read the instructions. So we have just completed the mobile bolus testing. And we've done extensive work, testing it in a number of different scenarios, people with type one, type two pediatrics, where they are in charge pediatrics, where the parents in charge, you know, there's a wide range of people who are using the system. And we need to test in all of those different user groups and get feedback. And it went really, really well, which was excellent, which means that it can then get submitted to the FDA. So I suspect that that will be happening somewhat early in 2021, first half of 2021. But I don't have insight or line of sight as to when that is promised. Because the FDA is so so concerned with COVID right now as they rightfully should be, and approving vaccines and things like that. So there's a little bit of a backlog there. And I don't know how that's gonna affect our timeline. But we've been working really hard to get that out. We know people want it, we know people will need it. And it will be a really useful feature. But it's been tested really well.
Stacey Simms 36:08
So and again, I'm, I get a little fuzzy sometimes on the details here. What kind of submission is this? I have learned in the last few years that there are different ways of submitting to the FDA some take longer to approve. I mean, we never know how long it'll take to approve Having said that, but there are some things that are like building on previous submissions is bolused, by phone something so new, that they have to look at it in a new way, or is it building on something you've already asked them about?
Molly McElwee Malloy 36:32
It's a good question. And I'm not part of the regulatory team that is involved in that strategy. I believe that we are building on our previous submission, since this is an on an ace pump, an alternate controller enabled pump and the and the the way that the pump is built. And the way that that is structured for regulatory purposes, is that you build upon last submissions, but I can't speak with authority on that at this time.
Stacey Simms 37:12
The other thing that we are very interested in as a household and a community is that what has been called the T-sport, can you talk about where that is in the process, and that's the tiny tube pump, I guess I would call it, I'll link a picture, if you're not familiar with it, we will link up some more information. But it's not quite a patch pump, there is still a little tube on it. But it's much smaller than the x two and it's made to be worn kind of flush or flatter to the body.
Molly McElwee Malloy 37:28
Right. And the idea behind this is that you could have a variable to be linked right very, very short tube on your body to longer where you just put it in your pocket. So depending upon the patient needs, the reason that it is still has an infusion set is that we know right from feedback that if you have an occlusion with a patch pump, you take that patch pump off and you lose that insulin right, and you lose that whole thing. If you can replace a site, and not all of the insulin that's in you know in contained to their end, then that is an easier fix for somebody, it's also less expensive. So that's something that we've been very keen to keep. And addition, the the idea that you might need a different angle set. So not everybody can use the same sets as successfully as others. This will allow us for some variety there as well. And so we're pleased about that.
Stacey Simms 38:22
And I can just jump in and kind of translate because I know you're you have to be careful about what you can say. But as you're listening, if you're wondering what she's talking about Omnipod goes in one way, there's not an angled set, there's not a steel set, there's not a different set, there are a few more options if you're using a tube pump, if the inset on the pod pump doesn't work for you. And so there's also as you mentioned, the insulin that's in the tubing, you can do I don't know if this is Tandem approved, so maybe don't listen, Molly, but you can do separate site and tubing cartridge changes when you use a tube pump, which is what we have done for years. So when he said of insulin, the pump, we change the cartridge, when it's time to change the inset, we change the inset we don't do those together. So, you know, advantages and disadvantages for each pump. I know Omnipod people love the things that are great about their pump, but those are the differences that you're talking about. Just in case you can't get into the nitty gritty.
Molly McElwee Malloy 39:11
Right, absolutely. And you know, we're big fans of choice at Tandem. So if something works for you, great, excellent. And so one of the reasons that we're so big on choices, because not everything works for every person. So this book allows somebody some choice within that. That option.
Stacey Simms 39:27
So where are you in the in the test? I know you can, you can barely give us full details. But where are we in terms of T-sport? Is it? Is it in testing? Is it is it coming out soon?
Molly McElwee Malloy 39:37
I can't speak to the exact timeline. And part of that is because the FDA is bogged in and down in COVID right now, but we are working on it. I know we're working from a human factor perspective, we're working on what the difference is going to mean for the patient and training for something like this or from the healthcare provider and training and something like this. And that's the aspect that I'm involved in, is you know, how do you train on something that's a little But different like this, and how do you change the training to adapt to that, but everything is in development. The thing about Control IQ and and even basal IQ is right there already tested. So those can be implemented in a new form factor without any problems. So that's something that we don't have to worry about. So it's more of just form and function and things like that.
Stacey Simms 40:19
Here's a dumb question for you. I have heard that T-sport is the name that you all are kind of using internally, and it may not have that name when it's released. Any update on the name? Is there an update on the name? Oh,
Molly McElwee Malloy 40:31
I am not the person that would be able to tell you that. Oh, okay. But I appreciate the question.
Stacey Simms 40:38
I think you should have a contest and you could name it, you know, pumpy mc pump face or something. But yeah,
Molly McElwee Malloy 40:43
exactly. Yeah. Yeah,
Molly McElwee Malloy 40:45
we're shorting
Stacey Simms 40:46
Yeah, surely that's perfect. I was laughing when we talked about that this summer, because it's interesting. And it's such a wonderfully privileged place that I'm in I feel like we're we find out this information. So early in the process, that the branding isn't really even set. So it's when I heard that I thought, Wow, what a cool place to be in some very interesting stuff. Right. I have a few questions from listeners for you. I know you have some more information. We're getting kind of long here. But let me ask you, here's a quick Control IQ question. And this is more advice. I don't know if you can answer this. So this person says, sometimes I like to set a higher basal in advance of when I work out because adrenaline makes my blood sugar spike, can you change that. So we can manually adjust basal rates without having to turn off control IQ, I know my body better than the software having to manually adjust with boluses after and having to guess, since I can't do them based on blood sugar due to iob issues is tricky. And I will jump in and say Molly, Benny, and I do this too, we do some guessing with the manual boluses. So I'd love to hear what you think about this.
Molly McElwee Malloy 41:49
Sure. So there's a couple different directions we can go as one is you can turn Control IQ off and on and do temp basal rates. And there's no penalty, right for doing that. There's no learning time or restart up or, or anything like that, that impacts Control IQ if you turn it off and on for those periods of time. So that is absolutely an option. It's just it's super easy to do. Another thing that we've seen people do successfully is set up a secondary profile that is a bit more conservative or a bit more aggressive, depending upon the patient needs. And then switching into that profile for that period of time. And leaving Control IQ on so there's a lot of different ways you could do this, you could even do a secondary profile, and then put it into exercise, right? Like you could do conservative plus that temp basal, right, or you could do aggressive plus that 10 basal rate. So all of that is it's entirely possible. But knowing that you can turn it off and do the basal rate as you please and then resume it confidently, you know, that's still an option for you. I do know that people do want a bit more control over that. And so and, you know, allowing for some sort of ability to have a temporary basal rate is on the list of things that we would like to do. Great.
Stacey Simms 43:03
Another question was I am still using basal IQ. And this person is really curious about what percent of Tandem users are using control IQ. And and you've kind of touched on this. But do you have any statistics about user satisfaction rates for control? iQ?
Molly McElwee Malloy 43:18
Yeah, so D q&a, again, affiliated with diatribe, third parties who, you know, has done some user satisfaction surveys, and I will get you the exact number. But this user satisfaction with Control IQ is very high, very, very high. And I would say the majority of people have changed over to control like you. But there are still patients on base like you and I can't speak to the exact percentage, but there are reasons why somebody may want to choose based like you to just have that suspension rather than also, uh, you know, having the, the auto correction or something like that. So there's cases for both, and that's why they're both still being offered. But I can't speak to the exact number of people who have not switched over, but most people are switching over to control like you.
Stacey Simms 44:02
Are there any plans to make it more flexible in terms of switching back and forth? Because once you go from basal IQ we did this once you put the software in your pump and switch to Control IQ you can't go back to basal IQ. Are there any plans to change that?
Molly McElwee Malloy 44:16
Not at this time. The reason being is that you wouldn't need a script, write a prescription to do that. And when you upload your property went to your provider. If you went between one thing and another and another all the time, we would really have to differentiate those reports and make sure that the healthcare provider was familiar with why each was different because they would impact how you would titrate insulin so it adds a lot of complexity on the therapy end. And so we have not made a move to to make that something that you could toggle between. Got it.
Stacey Simms 44:51
And another question came in which I thought was really interesting about accessibility for people who are blind and I know in the past, there was a meter that I think talked about There was more audio is Tandem looking at more accessibility for people who don't have any vision or low vision.
Molly McElwee Malloy 45:07
Yeah, yeah. So Tandem is making technology user friendly for those with different abilities. And we're absolutely have this on our radar, persons with low vision or no vision, right, using a touchscreen could be difficult. And we're exploring ways to leverage apps and existing consumer technology that might be able to solve those unmet needs. It's definitely definitely something that we are looking at and can appreciate that that's something that we need to do.
Stacey Simms 45:32
Very cool. Another question came in, and this is based on an older press release. So I'm not sure if you can speak to it. But apparently JDRF in Tandem years ago, like eight years ago, put out a news release about a dual hormone, insulin pump. What we're seeing if you're familiar with the iLet beta bionics is because the only one at least in the US where they're trying to develop a pump with insulin and glucagon with more stable glucagon now on the market, any chance that Tandem is working on a dual chambered pump.
Molly McElwee Malloy 46:02
So the big message here is that that eight years ago, I think, for the press releases when Tandem was being used with two separate pumps in the iLet studies, right, right, they ran the Tandem pumps, and one was full of glucagon and one was full of insulin. And they were putting two pumps on one person,
Stacey Simms 46:13
I remember that picture. Wow.
Molly McElwee Malloy 46:21
So that's where that came from. So but our our micro delivery technology is really well suited for to hormone therapy, we currently are only approved for you 100, right? insulin and only indicated for insulin per FDA. But you know, it's a fundamental challenge for people developing dual chamber devices. And there's not an approved hormone available for use in pumps at this time. So it all be very investigational. But we do have, you know, this microdelivery technology, which is well suited for doing something like dual hormone, but I think there's a lot of things that need to get addressed before even that becomes something that we can put in a trial.
Stacey Simms 47:02
And then it's something that I started talking about this summer, I've mentioned this interview with I did with Steph Habif from Tandem. And I will link that up. It was kind of we call it the first look under the hood for Control IQ that we did this summer. And she's the Senior Director of Behavioral Sciences. But we brought up some of the questions about who gets into clinical trials and who actually tests these things out and the information that you get in terms of diversity. And so this question here, I'll read the whole question from a listener. I've heard some rumblings that most of the people who tested Control IQ were white, I would love to know that Tandem has plans to diversify this more. This is a huge issue in general for trials of any kind, and stuff this summer started to address that in terms of Tandem knows it. They're trying to be more diverse. Can you follow up on that? And let us know what's going on?
Molly McElwee Malloy 47:50
Yeah, and your listener question is totally right on, right. The FDA is on this as well. They recently told Moderna, you know, you have to go back with your COVID vaccine and get get more people, right, you have to get people of diverse backgrounds and and ethnicity. And so that's true in clinical trials overall, need to be all more inclusive. And it's true that most automated insulin delivery trials today have been largely white, and that includes our adult pivotal trial. One of the things we're seeing changing from both an FDA perspective, as well as research and industry is that there's active pivoting to change the approach. And there's more guidance on changing the approach. The FDA has issued guidance on diversity and inclusion in clinical trials, which I'm sure you could post in the show notes. But that's a really interesting sort of, if you will mandate from the FDA to please be more inclusive, but for those in the community who may have attended that D data event from diabetes mine, and I can send you a link to the YouTube video, Dr. brandmark, who's at Children's Hospital in Washington, DC presented on diversity inclusion, specifically in diabetes technology research, and it was very illuminating on how white those trials are right? And what we need to do to better accommodate and to be more inclusive in a lot of different communities.
From a Tandem perspective, we are very committed to this, particularly in our post market studies, we encourage principal investigators to do the same who are looking at different research and the FDA is mandating it so it absolutely will be happening right? The FDA says you will be providing a trial with this type of diversity you will be doing that so I think that the that everybody is aware that this needs to happen and we're trying to figure out how best to do it and be responsible stewards and industry but for a long time you're right I mean, you know diabetes technology and automated insulin delivery trials were largely white, you know, you have to be able to take off of work right? Whether you're bringing your kids to your appointment or not. And so those are jobs with that allow some flexibility. You have to be able to afford to miss work right? You have to have paid some sort Lead, whether it's sick or personal days and, and all of that does impact the person that you recruit. Right. So being able to alleviate some of that maybe it's provide compensation, the FDA suggested providing compensation for parents that can't take off time from work or, you know, meeting people where they're out whether it's in qualified public health centers, or at schools or wherever, to make it easier for them to attend, whether it's clinical appointments or whatnot, but meet people where they're at and have people run the research that look like the people who will be in the research, right? So diversified that field as well. There's a lot that needs to be done here. And Tandem is absolutely committed to making this a priority.
Stacey Simms 50:42
That's great to hear. I'm interested in following up more about it not just with Tandem, you know, I feel like it's also a question of finding people who, you know, I have the same frustration with this podcast, how do I reach new communities? How do I find people who would maybe benefit from the information but don't know why I exist? Because I don't run in those circles, right? I mean, we tend to run in the same circles, and we need to branch out and not make people find us. But But fight. Right. So it's really, I think it's also a question of finding more. Look, I'm not an expert on this by any means. I probably shouldn't speculate. But it's also a question of, you know, finding staff that is of different races, me finding more guests that are of different races and are, are in different communities. It's for us to do the work, not to ask them to come to us. And so I'm really glad that Tandem is doing that and is on top of that. So thanks for answering that.
Molly McElwee Malloy 51:37
Yeah, there's a sea change coming in society and diversity and inclusion, and that will absolutely be translated at Tandem.
Stacey Simms 51:45
we've been talking for a long time, you've been really generous with your time. Just another quick question from a listener. And that is about the mobile app. I'll be honest with you, Benny doesn't use it a lot. He says he's waiting for bolus by phone. But someone said it wasn't that fast. In terms of uploading. Have you heard about that? Is that something that you're looking at?
Molly McElwee Malloy 52:03
Yeah, absolutely. And the reason that I think some people are experiencing that is that they haven't downloaded, they're pumping some time in, right. So whenever it last downloaded, it's going to append that data going forward. And so if you have a year's worth of data, or you have six months worth of data, that's not gotten to the cloud, that takes a while to get up there. So if you could download your pump First, if you've not downloaded in a long time to connect, or upload your pump, rather than that sort of relieves that burden to append the all the data that has never been there before. So if you could do that, and then let it sync, day after day, it will be much faster. It'll be much, much faster,
Stacey Simms 52:45
And we did that I should probably get on that. But it's Yes. Good. Hey, really, before I let you go, Molly, we haven't spent a lot of time on this interview, because you've been generous in the past to come on the show for really many years now. But I haven't spent time talking to you about your personal experiences. But as you mentioned, you know, you've been in this community not just living with diabetes, but you've been in the testing for the artificial pancreas projects for for what has become Control IQ for a very long time. Would you mind if I asked you just one more time? What is this like for you? We've had this elusive piece of software in the market with real people using it for a year. You've been testing it for I want to say almost 10 years. What's it like for you?
Molly McElwee Malloy 53:30
Yeah, yeah, it's professionally, 10 years, and personally, for 14. So it's a bit of a surreal experience. But it's also it's very cool, because I can see the improvements that need to be made. And I can see how they can be made. And it's been really, really cool to teach health care providers, and particularly, which is a big part of my job about reading the data and looking at insulin needs. And how do you make this look like you are how do you make this work with bass like you are? How do you make this work? easiest for your practice. And it's just been just to put it into practice has been really awesome. Because it's, we do get notes from users on social media and otherwise about how it's impacted their life and that they feel like a normal person now and that's all I've ever wanted, right as a person with diabetes is to like, give me back my personhood, where I'm not thinking about diabetes 24 seven, and I feel like Control IQ does that. You know, it's not Is it the be all end all? No, we will improve upon that. But you're never done right. But the fact that so many people have expressed that has been really rewarding. And I really want to see that carry forward and in all of our products that we relieve reduce burden for people with chronic disease. There's no other disease in the world where we asked somebody to do all the things we asked in diabetes. You know, if you have a heart condition, we don't ask you to beat your own heart. You know, we don't there's nothing else that we ask this much of people and then that we possibly make them feel bad or shame them for not achieving these things, which is kind of crazy. So reducing that burden and making this a more realistic disease to manage, is all I've ever wanted.
Stacey Simms 55:06
Well, I can't thank you enough for your personal participation in testing this out for years and years, as you said, 14 years and for being so accessible and coming on to answer all of these questions. So Molly, thanks so much. I look forward to talking to you more. I look forward to more improvements and exciting releases from Tandem. I know you'll keep us posted. I really appreciate your time.
Molly McElwee Malloy 55:26
Absolutely. Anytime. Thank you.
Announcer 55:34
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 55:39
Lots more information in the show notes. I'll link up some helpful things from Tandem and more information for you. And I did have a couple of follow ups. As you heard, Molly couldn't answer every question I had. So I got a couple of notes for Tandem that I want to share with you. Now, bolus by phone was submitted in the third quarter of last year. That is called mobile bolus. I don't know if there's a branded name for it. I did ask about that. But I hadn't heard back. But that has been submitted. It's in front of the FDA right now they're hoping to hear back in the first half of 2021. You know, it's hard as Molly did save with COVID, delaying everything, it's gonna be really hard to tell, as always, when the FDA will approve these things. But I'm so excited about that.
And I'm interested to see what it looks like practically, I'm going to say this with no knowledge of what was submitted, I do not have an inside track on what it would actually look like. So this is my speculation. You know, I imagine you just take out your phone and use it like your pump. Right? You can you'll have the full functionality. I don't know if that's really the case, I would imagine the FDA might be cautious. I don't know. But man, I just envisioned Benny, you know, he's got his phone in his hand half the day anyway. So beep beep, you know, let's go. Maybe that'll be their branding: beep beep Let's go.
They also let me know that Tandem is still planning to submit the Tsport to the FDA in the first half of 2021. And they are hoping for a quick turnaround possibly launching by the end of this year, which would be really exciting and nice to have another option there.
And a listener asked me about this. I didn't get it in time for this interview. But I did have a chance to ask Tandem about their agreement with Abbott, if you'll recall, Tandem and Abbott have an agreement to integrate with the Libre not just with the Dexcom. So there is apparently no update on that right now. But they are anticipating having one in the fourth quarter of 2021. We talk a lot about interoperability on this show. And you know, of course the dream is if a certain CGM isn't working for you, and another works better, you'll be able to slap that on and press a button on the pump. I don't think it's going to be that easy. But maybe down the road, I really do hope that we'll have more options. But if you had asked me five years ago, if the pump market would look like it's about to look right now, I think I would be pretty happy about that not just because of the great technology that's here from Tandem.
And we've been talking about what's next for Medtronic and Omni pod. But because we have more pump players coming to market, I am so excited to be talking to the folks from beta bionics and from Big Foot later on this year. So we will keep you posted. Innovations coming up next. Speaking of moving forward, we're going to be talking about exercise and CGM new guidelines for that and rare diabetes Could this be you it's really interesting what they're saying here.
But first, Diabetes Connections is brought to you by Dexcom. And we have been using the Dexcom G6 since it came out and we love it. It is amazing. The G6 is now FDA provided for no finger sticks for calibration and diabetes treatment decisions. We've been using the Dexcom for seven years now and it just keeps getting better. The G6 has longer sensor where that 10 day were now the sensor applicator is so much easier to use than it was in the past. We do love those alerts and alarms and that we can set them how we want if your glucose alerts and readings from the G6 do not match symptoms or expectations use a blood glucose meter to make diabetes treatment decisions. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Ran Across something I thought was really interesting for our innovations segment this week, and that is the RADIANT study. I will link this up. But radiant is recruiting people who have been diagnosed with diabetes, but they don't fit the usual characteristics of type one or type two. Apparently, this is not uncommon. I mean, most people really fit into the type one diabetes or type two diabetes. You've heard of Lada and 1.5 if you've listened to this show, but many types of diabetes are unknown, called a typical diabetes, and I really have never heard anything about this. So there's a new study called radiant, which stands for rare and a typical diabetes network and they want to discover more about what's going on here. You know, how do we better help these people? How do we treat this stuff, there's a lot more information on who qualifies are, how do you know i will link that up in the show notes, please check it out. And let's spread the word. Because this is really something that I think could make a big difference for people who are, you know, misdiagnosed or aren't getting the most from their treatment like, oh, it sounds like you have type two, but this isn't working for you. Let's get the word out and check out that link.
The other story in innovations is about new guidance for people with type one, and using continuous glucose monitoring for exercise. So there hasn't been a lot of information about this, you know how to use your CGM to safely and really exercise well. So this is new guidance from the European Association for the Study of diabetes and the International Society for pediatric and adolescent diabetes, basically, the European counterpart to the American Diabetes Association, and that second group has a narrower focus on younger people as you would assume from the name. But there are a lot of American researchers that you've heard of as the co authors on this, like JDRF CEO, Dr. Aaron Kowalski and Dr. Bruce Buckingham, who we just adore on this show. So anyway, there's a lot of information on this, I'm not going to go through what it says because I will link it up in the show notes and on the episode homepage. But it really gives you guidance in terms of if this than that, but also allowing for the complexity, because everybody with diabetes is just a little bit different, especially your exercise is going to be different to what it really like is it's not just about the exercise in the moment, they also talk about what to do later in the day and overnight. So good guidance here. Our innovations segment is for tips, tricks, hacks, studies, new stuff in the community. I also have our Tell me something good, which will return next week, please make sure you send me your good news stories for that I have a bunch that I've been holding on to can't wait to share next week. But I always like to hear from you. You can reach me Stacey at Diabetes connections.com, or drop into the Facebook group Diabetes Connections, the group and let me know what's going on.
Before I let you go quick reminder that the Fearless Diabetic summit is happening at the end of this month. This is a virtual summit that is free, you got a bunch of speakers, the videos are made, I was so excited to participate in this. And you can watch them for free for a couple of days, as many as you want. And then after that there is a fee to access. But you can check it out. I'll put a link in the show notes. But I think this is a great idea you can get kind of the appetizer and see what you like about it. And then if you want to delve further, you can go ahead and you know and pay for the content. I was not paid for my involvement, I was excited to take part I do have some goodies and freebies and stuff like that for people who are participating. So you can check that out. Also, mine I think is the only parent video that's in there. But there's lots of great information from athletes and endos and CDEs, you know, regardless of age.
Also, if you have a podcast or you're thinking of launching a podcast, diabetes, or otherwise watch my social posts, because by the time this episode airs, my new venture should be out there I am taking the dive to help other podcasters learn how to talk to sponsors, how to make money, frankly, from their shows, and how to do it ethically. And well, there's a lot of snake oil out there hanging, it's a lot like diabetes, there's a lot of not so great players out there in the podcasting space. And I'm excited to kind of help give people good advice that can help them get great shows out there and make them solid and make them more than a hobby. So watch for that. All right, lots to come. We're getting a great response for this tech heavy emphasis in 2021. Because my goodness, there's a lot out there. But we have much more than that. I'll be talking to some people with some great stories as well. And as usual, if you've got one or you've have something or a topic you'd like to hear, please reach out. I'm here for you. This podcast is to help, you know share our stories and get great information out there in this community. And if I'm not serving you, then I am not doing my job.
thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. Say a prayer for me as Benny is now behind you. Oh, my gosh, I did not know how nervous I would be about this day. I think I'm doing all right. We'll see. All right. I'll see you back here next week. Until then, be kind to yourself.
Benny 1:04:15
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged.
For the first time in several years, a new pump company is making a reach into the US market. Meet Ypsomed, the Swiss company teaming up with Lilly Diabetes. Their device, The YpsoPump, is available in Europe and Canada and has some unique features. But when it launches in the US, likely in 2022, it will only use Lilly insulin. That kind of proprietary design is unique and is raising eyebrows. Stacey talks to Simon Michel, Ypsomed's CEO (she'll talk to Lilly in a separate interview airing in a few weeks).
In Innovations this week, what is an inverse diabetes vaccine? And could you be part of a trial for one?
Learn more about City of Hope's Inverse Vaccine trial here
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by Dario Health, manage your blood glucose levels increase your possibilities by Gvoke HypoPen, the first premixed auto injector for very low blood sugar and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:22
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:28
This week, my first interview with Ypsomed, the Swiss company teaming up with Lilly diabetes to bring a new pump to the US. A few features make YpsoPump unique, including their infusion sets which can help to cut back on insulin waste.
Simon Michel 0:43
Yes it's terrible. It's throw away so much insulin all the time. But you can disconnect Of course from your body, you change a cartridge, you put it back on. And that's how you don't lose your insulin in the tube.
Stacey Simms 0:54
That's Ypsomed CEO Simon Michel, we talked about more features and he answers questions about the partnership with Lilly in innovations. What is an inverse diabetes vaccine? And could you be part of a trial for one This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to our first full episode of 2021 Happy New Year. I'm so glad to have you here. Here we go. Another year of the podcast. My goodness, I'm your host, Stacey Simms. And as always, my goal here remains the same. We aim to educate and inspire about diabetes, with a focus on people who use insulin. any of that line sounds a little bit different if you're used to my intro where I talk exclusively about type one. But you know, more and more people with other types of diabetes are listening as the show is growing. And I think that's really important to acknowledge and to kind of dial back and see who we're serving here.
My son was diagnosed with Type 1 14 years ago, my husband lives with type two diabetes, I do not have any type of diabetes. I'm the broadcaster in the family. This year on the show, I'm going to be focusing a lot on new technology, I think the delays that we saw in 2020, because of COVID are going to result in a lot more news than was originally planned or expected for 2021. You know, a lot of that innovation, a lot of those FDA submissions and approvals are getting stacked up, especially as we're looking at the second half of 2021 and into 2022. So you know, why not get ready. And you all have told me that you are very interested in episodes about technology.
In this episode, we're gonna learn all about Ypsomed and their plans for the US market. I have an interview scheduled with their US partners, Lilly diabetes, to talk more in depth about the proprietary nature of this pump. You can only use Lilly insulin in it in the United States. That's interesting. We talk about that here in the interview. And then there are a bunch of questions that Ypsomed, really cannot answer that are more for Lilly. So I'm excited. I'll be talking to them soon.
And just in the technology front, you're going to hear from the folks from Tandem. I've got a Medtronic interview, I'm excited to share with you. And as we look forward, of course, I will still be doing the personal stories interviews because I love those too. But please let me know if there are companies that you would like to hear from this year, and we will get them on and yes, Big Foot beta bionics. I'll be talking to everybody.
Okay, Ypsomed in just a moment. But first Diabetes Connections has a new sponsor this year. Yes, I am so happy to welcome our newest partner Dario, I cannot wait to tell you all about them. You know, we first noticed Dario a couple of years ago at a conference and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed. You get a glucometer that fits in your pocket, unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports. Based on your activity. Find out more go to my daario.com forward slash Diabetes Connections.
My guest this week is the CEO of Ypsomed. And if someone is a leading maker and developer of injection and infusion systems, pumps and pens around the world, and not just for diabetes, as you'll hear, they've been in the space for a very long time. But we're talking to them because I know I have listeners around the world and I appreciate you all so much and many of you may have experienced with this pump, but we are us centric and Ypsomed announced that it is partnering with Lilly diabetes to bring their pump to the US market.
That announcement raised some eyebrows when it came out this fall because it will be the first pump in the US that will only be used With one type of insulin that can only be used with one type of insulin, and the US market is the only place where that will happen, this pump will be available in other countries that already is with different types of insulin. In other words, to be clear, you'll only be able to use Lilly insulin, such as human log in the US, if so, mid pump. Now, Ypsomed has been around for a long time before this, of course, many of you who've been in the space for a long time will recognize some of the technology names and the brands that come up here. I was really excited to talk to the CEO, of Ypsomed Simon Michel, for the very first time, he's been the CEO since 2014, at the company since 2006. And as you'll hear, he kind of grew up in the company. And here's our conversation.
Thank you so much for spending some time with me. I'm excited to have you on the show and learn more about this. Thanks for being here.
Simon Michel 5:53
Thank you, Stacey. I'm to give us a chance to talk and explain to what we're doing. Yeah.
Stacey Simms 5:58
So let's just start with the basics if you could tell me about Ypsomed because we're really not that familiar with it here in the US. So if you wouldn't mind taking me through. Let's start with the the company history before we talk about the product because you are not a new company. You've been around for a while.
Simon Michel 6:14
Yes, I'd love to Absolutely. Thank you. So my father in 1985. Around the time when MiniMed founded the first company, the first pump in in Europe Disetronic. Some of you might still remember the name. And we were quite a successful pump company. And we sold the pump company at the Disetronic to Rouche in 2003, Rouche is still a name in Europe, roughly 80,000 patients on the product. But as they didn't really innovate anymore, we decided to go back into pumping in 2010.
Stacey Simms 6:44
When you went back into the pump business, what was the product at the time.
Simon Michel 6:48
So we did two things in 2010, we signed with Insulet. We took over the DC distribution of the Omnipod in Europe. So basically build up the business for for Insulet. between 2010 and 2017. When we've given it back to them, and the parallel we have started to develop our own YpsoPump so in back into tubed pumping and thought what can we do better? What can we do better in terms of pumps? What is the community needing tomorrow? versus the old Disetronic pumps, what can we do better?
Stacey Simms 7:17
What did you find that you could do better? We're going to talk about what the pump looks like and what it does, but big picture.
Simon Michel 7:24
So when we look at Ypsomed today for a whole, we make roughly 400 million in revenue, we grow at roughly 15% per year. So quite a healthy company despite of COVID we still grow and we have two businesses and it's quite important to understand we do both pumps and pens. today. I'd say you're by far largest pen and auto injector manufacturers in the world. We close roughly seven out of 10 deals in the pen space that's pens for insulins, solostar pen some of you might know it's also many of the Chinese pens, pens all over the world but all the injectors for autoimmune diseases migraine Astham, osteoporosis, So this is our device business. And the other half of our company the other 12 million is where we are very invest in pen needles in blood glucose monitoring and heat pump systems. And this we sell in Europe very successfully now for the past years in Europe and our own brand was owned subsidiaries and own people.
Stacey Simms 8:20
I'd like to know more about maybe we'll talk more about the pens a little bit later on. But when you started talking about the pumps and the systems that you started making in the 2000s I'd love to get back to what was lacking in the pump market. What did you think needed to change that you could do differently and better.
Simon Michel 8:37
So a couple of things you know, I mean to the pump was very much medical device centric. It's a very strong technic focus site is designed by engineers, great engineers from America from Switzerland from Germany, great people that think about what features we can add. But in the end of the day, we use these devices daily we don't really want to know and hear and feel and about this device. So number one criteria for us was to make it small and light. Ypsopump is roughly 80 grams. I don't know what this is in American weight measures but it's a it's a roughly half the weight of a Medtronic pump. I mean that gives you some kind of feeling very important, you wear it all day. The other thing is simplicity. We don't need all those features. I mean if you look at the at the iPhone, some of these phones they have many features but they only show the features that you actually use. So really simple in a way what is really required you don't need eight basal menus, you need two or three. Some might use but the big, big majority of us don't need this vast opportunities.
Stacey Simms 9:38
When I look at the the pump that we're talking about today. It does look tiny, it does look light and I did the I had to convert as well using my iPhone and that weight that 80 gram weight is point .176 pounds so very, very, very light. It looks like it's smaller, it looks like obviously it's lighter and doesn't have a touchscreen. It Looking at his buttons?
Simon Michel 10:01
Yes, absolutely. So it has a touchscreen. It's used like your mobile phone, you have one button to turn it on and off. That's basically it. But other than that you have a regular touchscreen, which works at night perfectly.
Stacey Simms 10:13
It's basically white on black. So it's a very good contrast that you see, is the pump controlled by phone? Is it controlled remotely? Or is it still used as the touchscreen?
Simon Michel 10:22
So yes, very important. We are a compared to other manufacturers, we are a iPhone app centric company. So you everything you do we do from your phone. So you have your Dexcom data on your phone, you give your bolus from your phone, you do your basal rates from your phone, that's that's our strategy, we have the firmware updates that go via phone onto the pump and back. It's very much app centric. The reason is we can be much, much faster and adding elements and adding new functions, new features, you don't need to change the device, you know, you don't want to change device or every year, simply too costly. This is why we set it up that way.
Stacey Simms 10:59
So that's a huge deal. Because here in the States we're all waiting for, you know bolus by phone, we're waiting for pump control which Tandem and maybe Omni pod will have and hopefully 2021. But just to be clear, you have that already.
Simon Michel 11:12
So we have the apps and the whole app control features are now launched in q1 in all over Europe. Yes. All the other things integrate the integration. The data this is this is in place the apps is in the market. But the integration of this bolus button and the CGM together is Dexcom is launched now in the beginning of ‘21, q1.
Stacey Simms 11:32
But let's talk I brought up the United States market. Let's talk about this partnership with Lilly, what is that partnership going to look like? And we can talk about consumers in a moment. But what will that partnership look like? For you all? Tell me about the system? What will the Lilly IP so mad Dexcom system look like when you bring it to the States?
Simon Michel 11:52
Well, basically, for my relationship, it's simple Ypsomed innovates and be manufacturer really supports in innovation and does the marketing and sales it was for us crystal clear from the beginning Ypsomed is a European company, it would be very tough for us to enter the big US market. So if you're looking for a partner, and luckily Lilly was looking for a pump, so we found each other a year ago Ypsomed would be the is the comet actually registered a product to the FDA, the expected approval in the second half of 22. But it's a fully branded Ace pump. So Dexcom is integrated as a bolus calculator calculator, the remote bolus function as a Type Zero controller that will follow by mid 23. And it is a Lilly product from a user perspective, but it's manufactured in Switzerland.
Stacey Simms 12:35
It's so interesting to hear you say these things that a few years ago would have been very foreign to us. I think my audience is familiar now the ACE designation, Type Zero, which is the software that's inside. It's incredible, just to take a moment and think how far things have come
Simon Michel 12:52
across fast pretty fast. Yes,
Stacey Simms 12:53
goodness. But to be clear, Type Zero is the I would call that a hybrid closed loop software. So that's the software that will in very plain terms, work with the Dexcom to increase insulin or decrease insulin to try to keep people more in range. I just want to be crystal clear about that.
Simon Michel 13:11
None of those days. Absolutely. I mean, I mean, Type Zero belongs to Dexcom. And of course Type Zero is further working on on new versions of the controller. It's a constant enhancement. At the moment, the features that you described are the ones it's the low suspend function. It's the hybrid adaptation of the baseline rate. There's the micro bolus element, there are a couple of features which have one goal to bring us to bring patients with type 1 diabetes in in time and range
Stacey Simms 13:35
the ACE designation, and I get a little confused on this. So I apologize in advance. That's all about interoperability. Right That's about making these new technologies compatible with other devices.
Right back to our conversation, but first Diabetes Connections is brought to you by Gvoke HypoPen, and almost everyone who takes insulin has experienced a low blood sugar that can be scary. A very low blood sugar is really scary. That's what Gvoke HypoPen comes in Gvoke HypoPen is the first autoinjector to treat very low blood sugar Gvoke HypoPen is pre mixed and ready to go with no visible needle means it's easy to use. How easy is it, you pull off the red cap, push the yellow end onto bare skin and hold it for five seconds. That's it. Find out more go to Diabetes connections.com and click on the Gvoke HypoPen logo. g book shouldn't be used in patients with pheochromocytoma or insulinoma visit gvokeglucagon.com slash risk.
Now back to Simon talking about interoperability and the East controller.
Simon Michel 14:40
Well, I mean, the great thing is that it's much easier to add different devices or different controllers to it. Once you have the ACE type designation you can actually change or upgrade a controller as it only is doing a lot of research on on controllers. So think about the might use their own controller in the future. Together with their new insolence. You can Think about situations where you can do better therapy better time and range when you combine new insulins with new controllers to actually use the insulin data to make better controllers. And also on the sensor side, it's possible that other sensors would come to the system at the moment, we love our partnership with Dexcom. It's great. It's really works perfect. But it's just it just shows an openness, that it's basically easy to add something else.
Stacey Simms 15:22
I have another question you may not be able to answer. I will be talking to Lilly about this. And it's really a question about them. I was at Lilly's headquarters in Cambridge, the headquarters for this project a couple of years ago, where they showed us their pump prototype because at the time they were working on building their own hardware. And obviously that project, I don't know if it's put aside I'll ask them about that. But this is not that pump. Correct. This is not the the pump that Lilly developed their partnership with you is using your hardware? If so meds pump, not this Lilly, it was a little circle disk pump that they showed us at the time.
Simon Michel 15:56
Yes. If the pump is purely manufactured by IP summit, it is the product designed here in Switzerland, that will be the pump that Lilly will use. You're absolutely right, Lilly was working on our own pump program, patch pump type program for many, many years. But you have to ask them they recently paid to our knowledge, they recently recently stopped the project, and are now fully focusing on our joint partnership to bring a cement Lilly pump to US patients.
Stacey Simms 16:25
I appreciate you answering that. I know that's more of a question for Lilly, and we'll talk to them about that for sure. But you know, insulin affordability is a huge issue in the United States. And we are we are struggling with that and a lot of our health care system right now. But making a pump that only uses one type of insulin is going to limit options. And I gotta be honest with you, I think people are, it's it may not be seen as a very popular feature. You know, we have insurance issues in the United States. I just went through this with my son, where we'd been on one insulin for many years. And then my insurance company said, No, you you have to use this other insulin. And that can happen here. Are you concerned about that at
Simon Michel 17:02
all, this will happen, of course, but it is ultimately beneficial for a health care system. And I can make the comparison with mobile phones. So if you have a mobile subscription, and you have your fixed lens subscription or internet subscription, you get a better deal. Now, this approach is to really bundle all these elements, and it will ultimately very much be much better beneficial for people with diabetes, it will be better for the healthcare system as of lower cost. So it's definitely not increasing the cost. Yes, it is increasing, its increasing to some extent, your choice of insulin, whether it's a short acting insulin for novel from Lilly, I fully agree but it will lower costs for healthcare system because of the bundle approach. It's a really innovative partnership. Where is the entity manufacturer really decides to go the full way the first time in history? And this will be beneficial for us us healthcare system for sure.
Stacey Simms 17:49
That's really interesting. So they'll have to work with insurance companies to say if you cover this pump, you must cover this insulin. Again. Again, I have to talk to Lilly but I would imagine Yes,
Simon Michel 17:59
well, of course that's a fair question. But I mean really wouldn't invest so much in a partnership if they wouldn't want to sell their core asset which is their insulin and in a prefilled cartridge, it will work with our pump. So it is the way this relationship is built up. But again, for Americans and for the healthcare system, I personally only see benefits in the end of the day in terms of cost.
Stacey Simms 18:23
That prefilled cartridge is something that is not currently available on any pump system in the US It was here for a while with some older pumps that are not on the market anymore.
Simon Michel 18:33
Well it was our pump Yes, it was the Disetronic pump with the three ml humalog cartridge was available in America between I would say 1998 and 2004 ish before Rouche stopped it, it will come back but it will come back in 1.6 format in a shorter version. We basically have this in the market already in Europe together with Novo Nordisk . So there's a novel called pump cart that works with our pump that's available in the market now since 2017. And is going the same way now this is a huge benefit to work with prefilled you don't have to fiddle around and fill your cartridges you could just take it out of a fridge make it a bit warm, put it into pump and that's a huge benefit.
Stacey Simms 19:12
It was very popular I think I want to say the Asante snap pump also had it for a while and that's the one that I look at because
Simon Michel 19:20
yeah your idea right it wasn't it wasn't this one was not a market so it was not so successful. This pump You're right. I mean the issue was with the D Tron pump, it was a bit too big, you know, it's three ml cartridge, the 1.6 is shorter. That's how we can build such a small pump. And the good thing about a pump is with our infusion set, you can actually keep the tube on. So you can change the cartridge you can keep the tube on you don't have to throw away the insulin which is in your tool because you can change the cartridge. Keep the cube you're using and you don't lose insulin.
Stacey Simms 19:49
Okay, I have many questions. Wait, let's go through those all at once. And I will get to the keeping the inset on but staying with the cartridge for a moment. So that's 160 units In the cartridge and you said take it out of the fridge, pop it in the pump, is it good in the refrigerator for a long time, because right now if people kind of pre fill when they're not supposed to the cartridges that are available on the market will start to break down. I'm assuming that's not the case.
Simon Michel 20:15
Well, it's, as we are used with pens a single expired expired date of two to three years. It depends on market by market, but you can keep it as your pen,
Stacey Simms 20:23
I was thinking two to three weeks for a filled cartridge right now, we're not supposed to do that with the Tandem or the Medtronic pump.
Simon Michel 20:30
It's a prefilled closed system as we are used with prefilled three ml cartridge. Some of you may use a reusable durable pen. Of course there you need regular in Europe, quite a lot of people use durable pens. And now it's Medtronic coming this Companion, you will see more and more durable pens in America as well. This smart pen trend will definitely lead to more cartridge based pens where you exchange the cartridge. So it's a standard closed cartridge system. You can keep it for two or three years in the fridge.
Stacey Simms 20:57
So talk to me about keeping the inset on. When you're changing out the cartridge. You're not priming the tubing, you're not doing things like that,
Simon Michel 21:05
yes, we built in a valve in a way that you can take the connector off the pump, you exchange the cartridge, you put the connector back on the pump, and there's no air coming into the tube to kick can continue to pump Of course you would disconnect it, you orbit set has a nice feature disconnect at the head. It has a 360 degree rotation feature. So it never cranks. But you can disconnect Of course from your body. You change a cartridge, you put it back on. And that's how you don't lose your insulin in the tube.
Stacey Simms 21:35
That's wonderful people you know, it's very difficult when you're losing units upon units when your primary
Simon Michel 21:41
yes and no, it's terrible. You throw away so much insulin all the time. So you can use this tool for seven days. So two or three cartridges. Of course it depends. If you if you need more insulin, you use it for two or three colleges if you use less insulin, use it for so it's just I think seven days is what is what makes sense.
Stacey Simms 21:59
Tell me a little bit more about that inset because I I've said for years and years that insects are the weak link of pumping, they leak. They don't work so well. You mentioned it rotates. Talk to me about your inset
Simon Michel 22:10
is a fully agree it's definitely the space where part manufacturers have to spend much more effort in innovation. Our infusion set is today a three day infusion set we work on a five and seven day version to just keep it longer on it's also regulatory work that has to be done here. It has a skin color. plaster so it doesn't show so much if you wear it. When you're at the beach. It has a 360 degree rotation at the head. So it really doesn't crink that's quite nice. It pops up clicks very nicely. You can click it behind your back without looking at, you hear it and it's safe and close. It has a Blue tube so it doesn't show so much on black clothing. A couple of nice features.
Stacey Simms 22:52
Is the skin tone one skin tone?
Simon Michel 22:55
It is a I would say it's a as neutral as possible one skin tone. Yes. I mean, it's better than white. You know, I think White is really shiny like we are used from other part manufacturers. It's just a more neutral skin tone.
Stacey Simms 23:08
Yeah, I know. You know what I'm asking though? I mean, is a Caucasian. Is it more peach than brown?
Simon Michel 23:14
Yes, yes. Yes. Yes, it is.
Stacey Simms 23:17
All right. Well, your first feedback is you have to work on that for especially for the US market and other markets. So I'll give you that piece of feedback.
Simon Michel 23:23
But input Thank you. No, you're absolutely right. It's a very good remark. I think I guess we are not so much used. From a diversity perspective over here in Western Europe. I think it's a very, very important remark you're making. And I definitely think it's possible to do that. I think it's a great idea.
Stacey Simms 23:38
That would be wonderful. Because, you know, I chuckled as I said it, but I appreciate you taking it seriously. It's difficult to talk about these things. And I find myself sometimes I shouldn't have left, they're trying to defuse the situation a little bit. But we are a very large and diverse country over here. And we have lots of
Simon Michel 23:55
love. No, no, no, I fully agree. And they beat this doesn't stop bad skin color. I think it's a great idea. And I don't see a reason why we should innovate on that to something we have never seen over here. It's not a topic that we get from customer feedback over here in Europe, but it's a great input. Thank you.
Stacey Simms 24:10
I appreciate you taking it that way. So let's talk about the pens for a moment because we tend to focus on this show a lot about pumps. But at the same time, you have already mentioned so many interesting things about pens. Do you plan to bring you mentioned smart pens, you've talked about the different types of pens that Ypsomed makes already outside of diabetes? Is any of that available in the US market or do you plan to bring it here,
Simon Michel 24:34
so from the insulin pens today, only the Solostar pen from Sanofi is on the market. It's a disposable pen. Also the to chill pen so the for the other type of Sanofi insulin. Other than that we are at the moment in discussion with several parties. For our smart pen. We have a smart pen for a 1.6 ml version and a three ml version, which connects to the app and the cloud. Of course, you have all the benefits of a smart pen you can use the CGM data including all the injection data which we really need. I mean, you need both sides, you need to be GMC champ data as well as the injection data when you have injected IV correctly. In fact, we have a lot of nice features on the pen tells you if it's styled correctly or not. There's a lie. It shows your holding time. How long enough to hold on many nice features you can do with smart pens today.
Simon Michel 25:21
Yeah, because a lot of people don't still want pumps attached to them. And a pen is a real option
Simon Michel 25:26
Yeah, absolutely. I mean, worldwide, we have 50 million people that take shots every day, but only 1.5 million user pump. So I think a lot of the vast majority uses pens, so it definitely have to innovate more in that space. And I'm so happy now that Medtronic decided to do to make that step to make that move, and also Novo Nordisk making the move. Now Lilly will come with a solution and the space is now moving. And that's very important.
Stacey Simms 25:51
It's okay, if you can't answer this, but can you give us an idea of what an Ypsomed smart insulin pen would do? I mean, we've The only frame of reference we have here in the States right now is companion medical, as you mentioned with Medtronic, could you give us an idea of what features might be available?
Simon Michel 26:07
Yes, absolutely. I mean, this pen is available in the analog version, so the non digital version in China for over 10 years, it's a very robust pen the piston drop, push back with your finger, it has a bayonet coupling for the cartridge. It has a spring driven support for injection. So it don't need to force if you have, or if you're old or don't have strength anymore. You just put a button in checks with a spring support. Very nice feature, we have a large display, which works at night, you have a light that gives the signal whether your dial is correct or wrongly, it's red and green, it shows how long you have to check that it stops blinking when it's injected fully out of his holding time, I think is the old time is very important. You have its Bluetooth connection, of course to the app connects automatically, it stores everything on the pen and on the app.
So all the features that you are used from Companion are now in there, as a will be a great, great product that we are working on here. And hopefully be able to introduce to America, we will take two two and a half years to come. We have to go through registration program together and still need to make the decision what partner will be the one that will bring it to the market. You know,
Stacey Simms 27:14
I should have asked you right at the beginning. But I'm curious, do you have any kind of personal connection to diabetes?
Simon Michel 27:21
Well, not personally, not not nobody in our family has type 1 diabetes, we have a couple of uncles and aunts that are on insulin on type two. But you know, I spent my whole life with diabetes. I think when I was 10 years old, I was throwing the first insulin pump. I still have this picture somewhere I can check and send it to you. It was it was an H Tron pump. Remember 1987. So I was my whole life. I mean, we went to the factory pump factory with my father, when I was a boy, my brother and me We ran around. And so he was my whole life. And then I went to university and I started in telecom industry. And it was very clear for me that I will come back. So I'm in this in this industry now really, for almost two decades. But we don't have diabetes, but I'm very, very connected to it.
Stacey Simms 28:02
That's great. I would love to see that photo or anything that you might want to share for sure. So I guess that leads me to this question, which is what gets you excited. I mean, your family has been in this business for so long, you've seen it change, you're bringing something brand new to the United States in a couple of years. But what gets you out of bed every morning that you're still excited to work in this space.
Simon Michel 28:22
I believe we are extremely privileged here to be able to work on products and services that make life easier for people with diabetes. And this is our business for 30 years. It's a family business we are stock listed but the majority of the shares in our in our family. So we do have a large responsibility on it. It's just great to see we are 2000 people now here working every day tried to make better devices, better solutions for people with chronic diseases also outside of diabetes and it's it's a huge privilege and motivation to work on it.
Stacey Simms 28:53
Well I feel like I just scratched the surface starting to talk to you about the partnership with Lilly and the pump and the pens. So I hope I can circle back maybe next year and check in on the progress and and talk to you as you get closer to bringing this to the US.
Simon Michel 29:06
Yes, let's do that. That's right to give an update. Once we filed we tried to file in summer 21 we still sorority and they will definitely be a good time again to give you an update.
Stacey Simms 29:17
Wonderful. Thank you so much for your time. It was wonderful to talk to you and I'm so excited to learn more.
Simon Michel 29:22
It's a pleasure talking to you.
Simon Michel 29:29
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 29:34
So what do you think? I'll be posting in the Facebook group to get your questions for my upcoming interview with Lilly and that is Diabetes Connections the group Do you think it's possible that overall, this pump system will turn out to be less expensive as Simon thinks. I certainly hope so. But any kind of proprietary idea on a market that is already so limited just makes me nervous.
And I said this when I was at Cambridge a couple of years ago looking at their prototype for the pump that they're no longer developing, apparently, I think they got into this pump partnership, because they know the writing's on the wall for insulin price controls may be too strong a word, but limitations. I won't get into it too much here. But you know, we've had this conversation many times before, I think that there's going to be legislation at the state level, if not the federal level, to really change how insulin and other medications other treatments are priced. So we shall see.
And oh, my goodness, I hope our conversation about skin tone on the inset came off. Well, I mean, these things are awkward, as I said in the interview, but once he said skin colored, I mean, most of the inserts are just bright white. So once he said skin color, I had to ask, I had to follow up. I hope that came off. Okay. And look, we can seem to take it very seriously. So we shall see. Wouldn't that be nice if medical devices could be a little more discreet on the skin on any color skin tone?
Okay, up next, let's talk about an inverse vaccine for diabetes and explain what that is. But first Diabetes Connections is brought to you by Dexcom. Do you know about Dexcom clarity, it's their diabetes management software. And for a long time, I really did think this was just something our endo used. You can use it though on both desktop or as an app on your phone. And it is an easy way to keep track of the big picture. I try to check it no more than once a week. Although I'll be honest with you, there are times when I'm checking it every day, it really does help me and Benny dial back, I look for longer term trends. And I try not to overreact to what happened for just one day or you know one hour, the overlay reports help context to Benny's glucose levels and patterns. And then you share the reports with your care team, which makes appointments a lot more productive. managing diabetes is not easy. But I feel like we have one of the best CGM systems working for us find out more, go to Diabetes connections.com and click on the Dexcom logo.
In our Innovations segment, this week, I want to talk a little bit about something called an inverse vaccine. This is a City of Hope, phase one trial. And the City of Hope is an organization that is looking to try to find cures for type one, I will link up more information in the show notes about them. And we really should talk to them. I it's hard for me to believe we haven't had them on the show yet. So that's going on the list.
But basically, this would use someone's own immune cells, a beta cell protein, and vitamin d3 to potentially treat type one, I'm sure that is a very simplified explanation. But these inverse vaccines are trying to stop certain immune responses rather than activate them. When you think about a regular vaccine, right, like the flu shot are the COVID-19 vaccine that we talked about just last week, what they're doing is trying to stimulate the immune system, right, here's a germ learn how to fight it, go immune system, right, the inverse vaccine is, here's something coming in, don't do anything stand down. Again, this is a very simplified version of what they're trying to do. But they are recruiting, they can't start the actual trial, they say until the pandemic is under control a much more but they are recruiting and they are screening patients right now. So I'm going to put up a link in the show notes.
And as always, you can go to Diabetes connections.com. And look at the episode homepage. If you're listening on an app, a lot of them are great to listen to, but the show notes aren't so hot. So if you have any trouble, just head on over to the homepage. As usual. The trial I should say is open to adults with type one between the ages of 18 and 45. You have to have been diagnosed in the last one to four years. There's a lot more listing after that. And by the way, this is a follow up on a small study in the Netherlands where they they looked at safety. So you know if you get into this definitely keep us posted. I'd love to know more.
A couple of quick housekeeping things before I let you go this time around. I am taking part in a free summit at the end of this month. It is the fearless diabetic summit. And I will be posting more about that in the group. And on our website. This is a really interesting summit that is trying to answer the question, what would you tell yourself if you could go back to your first two weeks of diagnosis, and they talk to 30 different people in the diabetes space, you know, experts and educators and NGOs and athletes and I think I'm the only parent that they talk to. But it's a really interesting concept. And I'll talk more about that as the month goes on. I'll put a link in the show notes to the fearless diabetic summit.
Also, if you haven't seen it yet, I have a free ebook Diabetes Connections extra that I put out late last year and this is a set of transcriptions and they are proofed and they're beautifully laid out easy to read. They are the extra episodes that I did a little while ago all about the basics of diabetes management ketones. What is insulin? What are lows? How do you use a CGM to its best practice insulin pumps, all that kind of stuff. I think it's a really good read for newer diagnosed families and for you to give to people in your life that you would like to better explain diabetes to it is an email signup. But you know, I don't spam anybody, most of you are on the email list already. But if you want to send that out, I'll always put the link in the show notes to that as well. That is the free ebook.
And finally, I'm this close to announcing my new project. And it really doesn't have anything to do with diabetes. But if you're interested in podcasting, you'll want to sign up, I am going to be teaching a course this year, I'm teaching two courses actually, on podcast, monetization, get paid to podcast, I have been really interested in this subject, because I've helped a lot of people kind of behind the scenes for the last couple of years to do this, ethically to do this. Well to do it in a way that makes sense so that your listeners don't have to pay anything, but that if you want to spend enough time on your podcast to make it quality, you eventually are going to look at options like this. And you know, like diabetes, there's some snake oil in the space. There's some stuff out there. That's pretty questionable. And I want to help people do this with transparency with disclosures to do it right. So stay tuned for more than that. I will not be hammering you with this. You’re here for diabetes news, but I wanted to let you know, and I'm really excited about it.
Thank you so much to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Benny 36:32
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
The DiabetesMine D-Data Exchange is a great time to catch up on the latest technology and get a sneak peek at what’s coming. This is the conference where #WeAreNotWaiting was coined in 2013, which almost seems like ancient history now! We talk to founder Amy Tenderich about what's new and take some time to focus on their effort to reach more diverse voices.
Watch the videos from Innovation Days here
In Tell Me Something Good, a big diaversary to celebrate.. Stacey's son marks 14 years of type 1 diabetes this week.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke HypoPen the first premix auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
This week, the DiabetesMine innovation days is always a great time to catch up on the latest technology and get a sneak peek at what's coming. This is the conference where we are not waiting. The phrase was coined in 2013 which almost seems like ancient history now
Amy Tenderich 0:44
stuff that seemed like such a pipe dream at the time like this whole idea of a closed loop system it was like kind of eye roll or like but now we have a very viable do it yourself. Homemade pancreas closed loop system which I'm using By the way, I've been looping now for quite a while and it's a game changer.
Stacey Simms 1:00
That’s Amy Tenderich, founder of DiabetesMine who puts this conference on twice a year. This time around. There was also a big focus on inclusion and representation. Lots of info share
In Tell me something good a diaversary to celebrate 14 years of type one in my house. Betty was diagnosed the first weekend of December in 2006. And I just remembered a funny story from that week that I haven't told before. I was always the worst.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am so glad to have you here I am your host, Stacey Simms, and we aim to educate and inspire about type 1 diabetes by sharing stories of connection. As I said in that intro, my son was diagnosed with type one right before he turned to 14 years ago this week, my husband lives with type two diabetes, I don't have diabetes, I have a background in broadcasting in radio and television, local news. And that is how you get a podcast.
I'm going to be talking about Benny’s diaversary later on in the show, I will tell you a rather silly story that I just remembered about our first weekend home from the hospital. So about a week after we got home, and we went out we had theater tickets. I will tell you that story later on in the show. But stick around. It's a funny one. I think it just kind of sets the tone for how we manage diabetes and continue to this day. Oh my goodness.
I also want to let you know that friends for life is having another conference of virtual conference. And if you are listening as the show is first airing friends for life is happening this Friday, and through the weekend, December 4 2020. And along with the incredible educational opportunities and the wonderful social stuff that they have great meetups, I am also doing my annual game show I do a version of NPR is Wait, wait, don't tell me, which is a really fun game show. If you've ever listened to it. I do Wait, wait, don't poke me and I have taped that and we will be airing it and premiering it this Friday. So definitely come by and please check that out. I will link up all the registration information for friends for life from the wonderful folks that children with diabetes, just go to Diabetes connections.com and click on this episode. You know every episode has pretty extensive show notes where I link up information. And I also put a transcript now for every episode in 2020. And we're starting to work backwards. So hopefully eventually, I'll have a transcript for every episode of the show. Thanks for your patience on that.
All right, talking to Amy Tenderich from DiabetesMine in just a moment. But first diabetes Connections is brought to you by One Drop in One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drop glucose meter looks nothing like a medical device. It's sleek, compact and seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to One Drop to keep track of the big picture and easily see health trends. And with a One Drop subscription you get unlimited test strips and lancets delivered right to your door. Every One Drop plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doctor visit your personal coach is always there to help go to Diabetes connections.com and click on the One Drop logo to learn more.
My guest this week can be summed up I think in the motto of the conference. We're about to talk about learn, connect, collaborate, Amy Tenderich was diagnosed with type one as an adult in 2003. And not long after that she started the website DiabetesMine, which is a terrific source of news and information in our community. Seriously, if you're not reading it, I'll put a link in the show notes. Make it a bookmark. They even say that anymore. You know, put it in your reading list. They say that anymore. Make sure you check out diabetes mind because all kidding aside, they do a tremendous job on reporting in depth news information in our community if you're interested at all in technology if you want to learn personal finance stories to they do that it's a great deep dive and I rely on it for a lot of information, I share her on the show, of course, I always credit them. But in 2013, Amy started organizing the D-Data exchange twice yearly events that focus on technology and breakthroughs. This year, Amy added topics about diversity and representation in the diabetes community. It's something she was already working on, as you'll hear before, the events of this year brought it to the forefront for many people who maybe hadn't considered that before. But maybe it was already on it. Lots of information here and look forward. Of course, it's always great to catch up with Amy.
Amy, welcome back. Thank you so much for joining me to talk about D-Data. I really appreciate it. This conference is always so interesting to talk about. So thanks.
Amy Tenderich 5:46
Oh, thank you for having me.
Stacey Simms 5:49
first question really has to be just the difference this year in terms of making everything virtual. You know, I was in some of the conference presentations, I have to say this was a cool looking online conference. Do you mind share just a little bit about how were you pleased the way it went? I know at the beginning of the year, it must have been kind of crazy to regroup?
Amy Tenderich 6:09
Absolutely. It was it was been a big learning curve, obviously moving from in person to online, no matter what kind of event you do. I mean, first of all, there was this, oh, my God, I'm in the events business. And now we have COVID. And you know, what's going to happen? And there was some question about whether people would still be interested. But I feel like I found that people are really anxious to connect, because we're not going to all these in person events. You know, most of us feel like we're just sort of out there some kind of juggernaut on our own trying to keep up just by clicking on links. And so having a conference that allows people to connect, I think is you know, something that people are still really looking for, we had to do it the first time for our June event, because we do these D-Data events in June and then in the fall. And so you know, that was literally starting from scratch. Our event, as you may know, is sort of like a leadership forum, we always kept it at about 150 people Max, try to keep it somewhat intimate, so that it really put an emphasis on collaboration and interactive sessions. And you know that the networking part of it is really important. So we thought, how can we recreate that.
So it's not just people sitting and watching, you know, one presentation after another, especially when everyone's doing so much of that these days on zoom. So I've been working with the same event manager, actually, for years, a lovely woman who, out of San Francisco, who helped me find this platform that is really, in fact, they do use it for much larger events up to thousands of people. But the thing that's so special about it is it kind of recreates the experience of sort of walking into a live conference you like sit down at a table, and then you're able to immediately see and talk to the people who are at your table. And if you jump over to another table, then you're talking to that group. So it kind of looks like a zoom breakout room. But the idea is that it's you know, it's sort of oriented by table. And then what if you want to work together with the people at your table, there's even this whiteboard function that lets people have kind of a little sandbox to play in. And so that we do, again, a lot of interactive stuff, where we try to get people to talk with the group at their table and brainstorm things. So they were able to use that sort of shared space where you can draw pictures and you can post links and and you know, get creative. And you can actually capture whatever your your table does there as a, you know, an image and save it for later if you want. So it really it has this great functionality that allows both live presentations, pre recorded presentations, and then a lot of interactivity. Yeah, so again, it was a big learning curve. You know, it really helped me that we had done this once in June. So going into our two day event. Now in the fall, I had a better I didn't have to kind of recreate that whole wheel of just understanding how the online platform works. You
Stacey Simms 8:48
know, this conference is so well known, as you said, leadership technology, things come out. And we'll talk about this that, you know, years later come to market. But one of the things that you focused on early on and or even really, before the conference was this survey and discussion of representation.
Amy Tenderich 9:06
So yeah, what happened there? It's actually I'm kind of proud of myself and this was prior to the whole, you know, uprising around George Floyd and the big sort of, you know, visibility of the Black Lives Matter movement back in January, I was talking with Cherise Shockley and a few other people and said, You know, I feel like we should have a panel at our event to kind of delve into this I feel like this is a it's sort of something that's a little bit on the margins we talk about every now and then but this is so not solved, but I feel like people of color are really not represented and and Sharif was all over it said absolutely. We need to have this conversation and started recommending people and so I had already spoken to Mila Clark Buckley, who you may know and a few other people reached out to area Lawrence. And then of course, everything kind of exploded and it was like Okay, wow. And so, in our planning sessions, I basically kind of convened this group of advocates of And I said, Listen, you guys, I want to have a session, I think it'd be great to have a live kind of Roundtable. But, you know, what else can we do? Or how do you guys want this to run? What do you think would be meaningful? So what was so cool is that that group actually drove the whole content of it. So they said, Listen, we're happy to come and be on a panel and talk. But you know, we, again, people of color are not a monolith. Right? They can't represent everyone. And they sent me to get more voices involved.
So they had the idea, you know, can we do some kind of research? Can we do a survey so we can gather, you know, input from a larger, you know, swath of our community? And they also said, What about a video? What if we got people to, you know, because we had done this before for diabetes mind with our winners, and you're familiar with the Stacey, where we have these people who are patient voices winners, basically applied to have a scholarship. And then if they won, we flew them out to Northern California, and put them up to be part of the event. But in years past, we'd had those winners each do a little snippet, and just them talking about, you know, who they were and what their sort of advocacy soapbox was, was in the area of diabetes, if you will. So the idea was to do something along those lines, where we ask a larger group of advocates of color, to just say a few words about what they do and about their thoughts on you know, being a person of color with diabetes, you know, what's good, what's bad, what would they like to have changed, see change, I said, it's completely up to you guys. So I don't know if you got to see that. But we created this compilation video that started off our session. And it was really impactful, because it was just people saying, their bit, you know, what's disappointed them or why they do the work they do, or what they would like to see change. And it's just what, you know, I can't I talked about this session is sort of unveiling what's been left unsaid for too long. You know, I think that a lot of this was kind of going on behind the scenes.
And some of these people of color also told me that in the past, they kind of if they had a negative experience, they would kind of brush it off, they would just say, Oh, it's kind of a one off, it didn't. It's not necessarily racism, it's just, you know, I had a bad experience. But when they start to connect with each other and share these stories, they realize there's a lot of commonalities, you know, of getting brushed aside of being misdiagnosed of sort of not being proactively told about all of the latest, you know, technology options, because maybe a healthcare provider would sort of assume that they weren't going to be the ideal candidate for a pump or a CGM or something cutting edge. So, you know, it seemed that there were some themes. And when we saw this group of advocates, each recruited more people in their community. So we had a team of about 12 people who actually helped craft the survey questions and vet the survey, and then helped us get it out there to the community. So we had about about about 207 people who completed the survey, there's always some people who start and don't complete answers. And I did a whole presentation on sort of summarizing the results, which is also a video that's posted online that we'll be sharing with people. But yeah, it was just so eye opening. So so many of their concerns are similar to anyone with diabetes, right? They're worried about costs and access, and you know, finding a physician who's empathetic and, you know, who treats them as you know, as a partner in their own care, and all those things. I mean, those are things that I would say are across the board for anyone with diabetes or issues. But what also became very clear that they do not feel represented, we got very strong results that people said, both in marketing and in educational materials, they don't feel represented, they need to see more people who look like them. And that's everything from you know, skin. And he says to, you know, just, you know, seeing someone who looks like me, who might actually use that product.
Stacey Simms 13:43
Wow, I mean, so much going on there. And I know a lot of people were posting that they were really excited to not only be involved in it, but to see it. And I always hate this question. But what comes next for something like that?
Amy Tenderich 13:55
Is the million dollar question. And that's actually one of the things where you feel like you're sort of a victim of your own success because you have an event and people say, this was so great. What else you gonna do? I'm like, What do you mean, I'm still recovering from this.
Stacey Simms 14:12
Back to our interview in just a moment, but first Diabetes Connections is brought to you by Dexcom. And when you got a toddler with type one, you do hear rumblings for a long time about the teen years, you know, hit us full force a little bit earlier than most and I'm so glad that we had dexcom Benny's influence started going way up around age 11. He's almost 16. And it has been an absolutely remarkable transformation, I think is really the only word for it. He's so much taller, everything's different. I mean, I need to tell you what puberty does, but along with the hormone swings, I cannot imagine managing diabetes during this time without the Dexcom continuous glucose monitoring system. We've been able to react more quickly to highs and lows, see trends, adjust insulin doses with advice from our endo. I know using the Dexcom G6 has helped improved Benny's a one C and overall health, if your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. To learn more, go to Diabetes connections.com and click on the Dexcom logo. Now back to Amy, where I have asked her what's next.
Amy Tenderich 15:19
So I don't know. But you know what the fun thing is, I mean, not only the fun thing, but I think the important thing is to not try to decide that too soon, the world is changing. And these events are always about kind of what is timely and what you know, we try to sort of take the temperature of, you know, what is boiling up hottest in the in the patient community and in the industry. So especially with our D-Data day, with the technology side of it, you know, we try to let the dust settle from the existing event and see where things are going. What are people talking about? Is it suddenly that smart pens are all coming out to market? And people are buzzing about that? Is it some of the latest trials for the closed loop systems? You know, is it sometimes it was like accuracy of, you know, cgms, that became like a big hot button. You know, obviously right now a lot of it's just about affordability and access, it's an always an ongoing issue. But we really try to and again, especially for the day to day I try to check in with the community, you know, I'm a conduit, but I'm not one of the hardcore developers, or the people who work on loop who make these incredible tools. So I always check in with them and say, you know, what is the community buzzing about what else is you know, who's working on something new and cool? How are people feeling about the latest commercial products have come out, or a lot of people you know, chattering about that they have a lot of input, you know, and just try to sort of find out what's happening out there and then address those things. And, you know, really keep it fresh and timely. So that we're really having conversations about the things that are like currently on top of mind,
Stacey Simms 16:49
it's so hard to predict, certainly, right, what's going to take off because you always have devices and people at this event that are as you said, so cutting edge and, you know, certainly the DIY crowd is always well represented. So it's hard to figure out what's really going to hit Were there any products or standouts, I saw a non invasive CGM of some kind like a bracelet that was there. I know Dexcom spoke there was the there was a loop link. I mean, was there anything that really struck you or that you want?
Amy Tenderich 17:19
Thank you for asking. So the fall event is actually this two day thing where one day is kind of our broader Innovation Summit, it was our first event that we ever did. And then the second day is D-Data where we go really deep on the technology. So that's why this time, the first day, we did a featured panel on telemedicine and like whole person care. That was very cool. That included Vita Health, One Drop, health first, and what’s the fourth person, fourth group that was there. I can actually look it up. But yeah, but we really because obviously telemedicine is now just medicine. Right? Right. Right. You know, it used to be the sort of add on thing that you could do if you wanted to, but you know, now it's really how care is being delivered. And the whole notion of like, Can we get past just focus on glucose numbers and lots of coaching combined with technology. And then they're trying to help people with like a variety of health conditions while doing really high quality diabetes care. So we have this great talk about it. And I'm sorry, January AI was the fourth company and they are this amazing new machine learning based company out of the Stanford area that is actually doing a platform currently for type two diabetes, but I think they will be expanding. And that group also did a demo on day two, the first day again, was kind of this broad look at like what's going on in healthcare and diabetes care, that's when we had our inclusivity and diversity panel, we also had an interactive group problem solving exercise where we got people to we had a little It was kind of like choose your own medical adventure. It was this video of this, like a sort of mock patient and had her talk about her issues that she's facing. And then there were sort of three choices of what you could recommend for this woman to do as sort of her first line of defense with her diabetes care. And then we had people discuss that at their tables and decide and then vote on which one they would pick first. And then we showed what how they played out in real life, you know, and in order of what people chose as the first choice, so we'd have to do some really cool stuff to get put people kind of in the shoes of a health care provider but also in the shoes of the patient as in again, we have a mix of people at these events.
So you've got you know, diabetes educators there and endocrinologists and even some like nutritionists and other people who are recommending stuff to patients and then you have patients who are you know, walking the walk and so it was kind of a cool way for them to discuss like, Okay, if you recommend this to this woman, like what are the pros and cons gonna be? How is this gonna play out? That was really fun. I we like to put people in the driver's seat and kind of see what they do. And a lot of this event is about the fact that you might have someone who is like, You know, really big has big following online as a patient advocate sitting next to you know, the CEO of some major pharma company, sitting next to you know, someone from FDA, and then all these DIY folks mixed in. And you know, we've got healthcare designers, and we've got educators and someone who might be the head of the you know, Joslin Diabetes Center. And so they get a chance to kind of interact and great networking, and I think really gives people a lot perspective and helps to break down barriers between these groups. You know, it really does.
Stacey Simms 20:31
I was there two years ago, and it was the first time that I was in the same room as somebody from the FDA. And I remember thinking, This is amazing. And it turns out that part of it was my fault. Because as they explained to me, when I asked like, how come I haven't seen you before, you know, basically, you can come to us, and here's how, and I have put that information out, and I will again, but it was it was one of those situations that you know, I've been in the diabetes community for 12 years at that point. And it just hadn't occurred to me that I could have access to somebody like that. And this is a, you know, a public servant, really. And they explained how to do it. And you know, what the deal was, and it was funny to me, because I while I have a podcast, I'm a diabetes mom. Right? So it was a really nice, you know, lowering of by perceived at this as this boundary. And I'm sure that many other people feel that same way. It's It's nearly as you said, it's a lot of interesting people in the same room.
Amy Tenderich 21:21
Yeah, thank you. And I mean, that's why I had this little panic attack when we, you know, when they close down all the Yeah, person events, like, how can we recreate that but, you know, as much as it gets old, being on online stuff all day long. It's amazing what you can accomplish, really. And you know, there are some, like I said, Great platforms that are being improved upon. So after we use this platform in June, we actually gave them feedback about what we would like to see. And they've made some progress, like, yes, it's really great.
So you're asking about the non invasive cgms and whatnot. So CGM, obviously is this burgeoning area. So our opening speaker for D-Data this time on Friday, November 6, was Kevin Sayer, the CEO of Dexcom, talking about the future of CGM. And clearly, I mean, if anyone's qualified to do that, it's them. They've led the way. But there are dozens of kind of want to be you know, me to CGM companies coming out, they're doing all kinds of stuff from implantable to, you know, non invasive to semi invasive to just straight up Dexcom copies. We did a story diabetes might not long ago, something like 39 new companies working on cgms, you know, yeah, so there are many, many of them. Obviously, the non invasive or minimally invasive feature has been a dream for so many years. And there was this white paper written years ago called the deceitful Turkey, by an expert physician who had been researching it for so long, it's a very difficult thing to crack to be able to get something that is accurate and really usable. That doesn't penetrate the skin at all. But then you've got companies like bio link that are working on like they call minimally invasive with these like micro needles. So it's not drawing blood, but it's sort of like pokes into the skin very minimally. Mike Hoskins and I, who's my main man diabetes, mind, we were just talking about this the other day that it's probably time to do another story to sort of explain where we are with non invasive technology. Because Yeah, nobody's really done it yet successfully. But there are lots of companies that are just on the verge of having something really viable, which is exciting.
Unknown Speaker 23:27
I'd read that story. Yes, definitely.
Amy Tenderich 23:31
You know, especially now that you know, one of the big hot topics is the idea that CGM is going to become really, truly become standard of care and become more widespread use even among people who are not on intensive insulin regimen. So it's like what is going to help them be comfortable wearing it and get the most out of it. And we had another interactive session on Friday. And that was all about that it was a mock. We had people at their tables pretend that they were like a design group making a new CGM. And they had to pick their priorities for designing the CGM, and talk about why they did that. And were they trying to simplify data learnings for people? Were they trying to make it more motivational to use a CGM? Or were they trying to kind of like increase the consumer appeal and have it you know, have this kind of sexy look and feel. But I think a lot of people agree that especially for non insulin users, you know, the, the physical factor of the sensor is going to be a big deal breaker, right? But
Unknown Speaker 24:26
it Yeah,
Amy Tenderich 24:27
yeah, there's just so much going on. And you know, it feels like it never changes. But then again, if you look back, it's like, wow, things have really changed so much, even since we started doing this. And well,
Stacey Simms 24:38
and that's what I want to ask you about too. We are not waiting. The phrase, as you obviously know was coined at the D-Data exchange. I was at the first one in 2013.
Amy Tenderich 24:50
That's correct. So we started doing the Innovation Summit in 2011. So we had two of those events. And then the third year, it became clear that there were Are all these sort of people out there who were tinkering and you know, doing yourself the sort of technology savvy, it started with a group of D dads, basically diabetes dads who work in technology, who were like, Hey, we can do stuff with this. So and we decided that we would host a get together for those folks. And we were doing the summit at Stanford School of Medicine, that we just did it as a pre day to our summit, the day before, we got this sort of classroom, in this bio center directly across from the big hall, and just invited a bunch of people who were happened to be, you know, in or near the Bay Area, who would be able to come and we thought we'd have, you know, 25 people or something. And we were smashed in this classroom with like, 50 plus people, and there was all this excitement, and everybody was like, sharing their, what they're doing. And we kind of realized, like, wow, we're really onto something. And I want to give due credit to Howard Look, and Brandon Arbiter, from Tidepool, who really helped me I, you know, they were just coming on the scene then too. And so we were having all these conversations, and I said, Hey, you know, I really want to do this event, you guys want to help me, like get this group together? So we worked on it together. And what happened is the next day at the summit, I had asked Howard to get up and sort of summarize what happened at this D-Data exchange thing. And he kind of, you know, presented this term, which I believe the first person to utter it was Lane Desborough who is also a diabetes dad, as you know, and then worked at Medtronic for many years, and then was at Bigfoot for a while. But he basically said, what I'm hearing here is that we're not waiting. We're not waiting for the, you know, industry or for the FDA or for anyone to tell us it's okay to do this. We can do it. We're doing it. Yeah. And yeah. And then it's, you know, just as you know, absolutely blossom from there. So,
Stacey Simms 26:38
as you look back at that, and it's been seven years, and it seems like as you had said earlier, it seems like things are moving so slowly and things would never change. And now Surely, there's a long way to go, right. It's not perfect. But now we have hybrid closed loops. On the commercial level, we have more DIY stuff, we have DIY stuff that might be going to be FDA soon, thanks to type pool when you look at the last seven years and your own diabetes management. And if you don't mind me asking, what are your thoughts about how far we've come since lane said it, and Howard wrote it on the whiteboard, you know, we are not waiting. It's pretty remarkable to look back at these seven years.
Amy Tenderich 27:14
It's absolutely remarkable. And it's stuff that seemed like such a pipe dream at the time, like this whole idea of a closed loop system, it was like kind of eye roll or like, but now we have a very viable Do It Yourself homemade pancreas closed loop system, which I'm using, by the way, I've been looping now for quite a while. And it's a game changer, you know, and now the industry is coming out with them, it's a little slower. And obviously, on the industry side, you know, they have to, you know, there's so much risk averseness they need to be really careful. So they're, you know, have to make incremental changes. But we're getting there, I think soon. Again, you know, the idea of just getting a pump without a CGM, or even a smart insulin pan without something connected to it would just seem silly, because it's like, of course, you want to have the whole deal so that you can both continuously monitor your blood sugar and then also get help or have it automated to decide your dosing your ideal dosing amounts. So we've come a hugely long way.
Insulin pens were done back then and talked about connecting them it took, you know, it's only very recently that the pen came out. And that we're really going to be able to actually use pens in a larger system, again, connect them to CGM and whatnot. And the apps obviously, becoming incredibly long way they were pre primitive back in the day. And, you know, I like to say the biggest problem was that so much of the stuff was being designed by people who don't, you know, not only don't have diabetes, but don't have any patient experience at all, it was being designed, it was just engineering driven, or clinically driven. And it wasn't livable, and it didn't solve real world problems for people, any devices or apps that just add more burden, it's not going to be continued to be used. And it makes absolutely no sense. You know, no, no
Unknown Speaker 28:56
doubt,
Stacey Simms 28:57
if you could look into your crystal ball for us just for the next year. Really, I know a lot of things were held up this year, because of COVID, things that we kind of expected in 2020 might be pushed to 2021. Or further, I won't hold you to it, we're not going to really make a bet on this. But I'd love to get your take on what you're looking forward to in 2021.
Amy Tenderich 29:16
Oh, thank you so much. So we were privileged to be able to host the first ever closed loop system showcase at our fall event last year. So the end of 2019, we had six of the companies that are like getting closest to having or already have a system out. And it was just amazing. You know, they came and they talked about the details of their algorithm and you know, how they, what the targets are set out and whether the settings are customizable. And then we had patients there who had used the systems either in the real world or in studies. And I just think that there's going to be so much continued improvement on these systems. One very encouraging thing is that the studies are no longer being done in some kind of clinical environment or they are doing real world studies where they literally go out Follow people while they actually go out and do sports and eat food and do things that real people do, you know, so I think it's hugely important for kind of the form factor and just to understand how they can improve on the kind of day to day living experience with these systems. So I'm super excited about that. I do think also that insulin pens, again, gone from just being another sort of thing that you use to stick the insulin in your skin to an actual tool that can help people figure out their dosing and help people keep track of their, you know, their whole diabetes management, regime, and, you know, be connected to, you know, your stream of glucose data, which helps you understand what's happening. So, you know, all of this stuff is just getting so much more real world usable. And I think that's really going to be kind of the linchpin going forward. And it's already hard now for family for people who are newly diagnosed now, to even understand how good they have it. Compared to what it was, like, you know, even when I was diagnosed in 2003, I mean, it was a world away. I mean, right?
Stacey Simms 31:06
What is the next event for DiabetesMine, I know, things are up in the air with COVID.
Amy Tenderich 31:11
You know, so our, you know, traditional pattern has been that we do the D-Data exchange twice a year, so, so again, traditionally, pre COVID, it was in June, on the Friday before the big at a conference, wherever that happens to be. So we've done it in New Orleans, in San Diego, and Boston, Orlando, all the places, right. And then in fall, we would do this two day event, which was always in Northern California, it was at Stanford School of Medicine for years. It's also been at UCSF School of Medicine for the last couple years. And that was the called the Innovation Summit day, which was kind of this broader look. So it didn't only have to be technology, it could be anything that was innovative, whether that's a community program, or whether we were talking about innovations in like coverage, or community events, whatever, and just a variety of different things about improving care. And then the D-Data exchange day, which was always the deep dive into technology. And that event kind of has a pattern to it. At least we've always done it so that we have a featured DIY talk. So we try to always get some interesting speaker from the DIY community to come and talk about something that they're working on. That's cutting edge and new. And whether it be about the community itself for about a particular tool, that we traditionally had FDA come and speak because it's like, let's hear from them. They're so important in all of this. And then we have this lineup of demos that we always do kind of cutting edge stuff. And that's been everything from as you mentioned, new CGM systems to like apps that motivate teenagers to I mean, we've in the past, we've even had some I don't know things for diabetes complications, like socks that can monitor your feet for neuropathy. But right now, it's it's been also a lot of AI, you know, machine learning driven platforms that are trying to help people better calculate their insulin doses are better predict what's going to happen when they eat certain things, or do certain activities, different ways to be able to kind of glean meaning out of your data. Generally, we do June and then we do like early November, it kind of dawned on me that if if Ada does not go back in person, this coming June, which they may not, then we don't necessarily need to be tied to that date anymore. I mean, the the idea originally was, you know, everyone's in town. And it started that very first year that we did the bigger D-Data it was ADA was in San Francisco, which is my hometown. So we're like, oh, everyone's gonna be here. So we'll just do this kind of afternoon thing before and get everyone together. And that's worked really well. Because physically, people are, you know, in from all over the world. But right now, everything's kind of footloose. Because of COVID.
Stacey Simms 33:44
well, thank you so much for coming on. And talking about all this and sharing these stories and for doing the conference and putting it all out there. And we'll link up as much as we can. If anybody missed it and wants to read all this stuff. It was really well covered on Twitter, I was following along the hashtag when I couldn't be there. And we'll get the word out. But he thank you so much for joining me.
Amy Tenderich 34:02
My pleasure. Thank you so much. And thank you for being part of it. And I hope you will join us again sometime.
Unknown Speaker 34:07
You got it.
Unknown Speaker 34:13
You're listening to diabetes connections with Stacey Sims.
Stacey Simms 34:19
More information about DiabetesMine the D-Data exchange. And that video we mentioned near the top of the interview the video about representation what people had to say, it's only five minutes, it's well worth your time. I'm gonna put it in the Facebook group and I will also link it up here in the show notes. Really interesting people definitely worth watching and worth possibly a follow if you're on Instagram or social media as well check them out. And I love talking to Amy because we always learn something new and see what new technology is coming. So of course more to come in the new year. Boy, I feel like there's a lot coming in 2021 that we've been waiting for. So I don't wanna get too off track or into the future but I'm excited and I'm Hoping to do an episode or two about a summary of what's coming. And I should also let you know I've also got interviews lined up with some of the people that are releasing really cool stuff coming up. We've got a lot to look forward to when it comes to technology in the new here,
okay, tell me something good in just a moment. And it's an embarrassing personal story, but I will share because we're friends here, but first diabetes Connections is brought to you by Gvoke HypoPen, and you know, almost everyone who takes insulin has experienced a low blood sugar, and that can be scary. A very low blood sugar. It's really scary. And that's where Gvoke HypoPen comes in. It's the first auto injector to treat very low blood sugar Gvoke HypoPen is pre mixed and ready to go with no visible needle. That means it's easy to use in usability studies 99% of people were able to give Gvoke correctly. I'm so glad to have something new. Find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon comm slash risk.
Tell me something good. This week is about my family. We are celebrating a diaversary my son was diagnosed with type one, as I always say right before he turned two back in 2006. Which means as hard as it is for me to believe we are marking 14 years and that kid is going to be 16 pretty soon. So the story I want to tell you here for Tell me something good. And if you're a new listener, he is doing great. Maybe that's the good news story I should start off with he is happy he is healthy is independent. He drives me bonkers. I want him to do more in his care. I want him to change his sites on the spot every three days and pre bowl is 15 minutes. Every time he eats. He doesn't do that. But you know what he does so much. He's super responsible, as far as I'm concerned. And he is almost 16. So for where he is, and what I was told could happen during the teen years. I really keep my fingers crossed, I knock wood I'll swing a dead chicken if you make me. I mean, I really feel like we have a lot to be thankful for. So having said that, this is a story about how we did everything wrong.
14 years ago, let me set the table. When Benny was diagnosed, I have a daughter. She is three years older than him. So she was just five. their birthdays fall in such a way that she just turned five he was not yet to. And my brother in law. My husband's brother was living with us. It was a temporary situation. He was with us I want to say for about, I don't know, a year, year and a half. He was between jobs. We had two little kids. We both worked full time. He asked you know Hey, can I come stay with you for a little bit while I get things settled? And we said please come down and be like a nanny. We can't have you here fast enough. And it was amazing situation. It really was uncle David was just a godsend, great guy and, you know, left us and went back to a full time job and a great life and relationship in a situation where he now lives too far away. If you're listening, David, he's up in Pennsylvania.
But he was there when Benny was diagnosed, which made our lives kind of easier. He had another caretaker in the house when Slade and I took Benny right to the hospital on that Saturday morning. That first weekend in December December 2 I always have to look at the date December 2 2006. David stayed home with Lea until we were ready to trade off and have her come visit and that kind of stuff. And we all learned how to do things together. So we came home Three days later, we tried to go back with our lives. Haha, you know, we were all kind of in the thick of things. And that Saturday night, the following week, Slade and I had tickets to go see a show, you know, I'm a big Broadway fan, love that kind of stuff. And David said you should go I've got this. I know just as much as you guys do. And he really did. I'll watch the kids go and your phone call away. So the theater in Charlotte, you know, we have one of these regional theaters where the Broadway shows come traveling through. It's about 30 minutes from us. Yeah, you really put the pedal to the metal 25 but 30 to 35 minutes. So we thought okay, this is good. We're all our doctor says go on with your lives. We're going to go on with our lives. David's got this. The show was Spamalot. By the way. It was you know, very funny musical comedy. And we decided to go and enjoy ourselves. We got dressed up. We went not 20 minutes into the show, maybe 30 minutes of the show Slade's phone starts buzzing, and he gets up and leaves if you are familiar with the show, this is just after he is not dead yet. And the lady of the lakes. So I'm sitting there watching this very funny show, being amused being entertained. But my husband is no longer sitting next to me and I know something's up right. If he had come right back, it might have been something easy just to question, but he's not back. I think I made it about halfway through the song that goes like this. I remember seeing that which is the song that really just goes on and on. When that ended, because I wasn't gonna run out of the theater when someone was singing people applauded and I booked it out into the lobby.
And Slade was on the phone, pacing and talking and pacing and talking. Here's what had happened. David had given Benny an injection for dinner or snack, I don't even know whatever it was it gave me an injection. And remember, at this time, we're using a syringe and we're drawing up teeny, teeny tiny doses. He's getting like point two, five, maybe for 20 carbs, I think I mean, who remembers these doses, but they were minuscule. They didn't have half unit pens at the time. And they certainly didn't have quarter unit syringes. I don't think they have that. Anything like that now. So unless you're using diluted insulin, which nobody had mentioned to me during his whole toddlerhood, you know, you're really guessing at the dosage, and you're trying to eyeball these teeny, tiny poufs and wisps of insulin. So David had tried to draw up like half a unit, I don't remember the exact dose he was supposed to give was, but he gave him two full units, which was bigger than anything we had given before. It makes me laugh now because to like, it's like a speck of dust for him now, but two units
when you Wait, 27 pounds is a huge deal. So what David and Slade had already done while I was sitting there watching people singing, they had already called the endocrinologist. And they had actually already gotten a call back. And that's what the phone call and the pacing, that's what was going on. When I had walked out, he was on the phone with the doctor. And of course, they advised check the blood sugar, give more carbs if needed. You know, nobody was panicking. So we didn't panic. His blood sugar was fine. David had checked it before he called he checked it after the endocrinologist called back, he was fine. It gets a little weird, because the dose had been given Well, before the phone call. It was one of those situations where David did it. And then A while later thought, did I really do that? He absolutely swears that he gave the kid two units. But two hours later, his blood sugar hadn't dropped. So my suspicion at the time was you didn't give him two units, you probably drew it up and just misread the syringe, which was very easy to do at the time, especially when you're distracted by a toddler and a five year old or the child didn't go all the way in, or something really weird happened because his blood sugar stayed steady. You know, we were checking with a meter. We did have a dexcom at the time. But he was checking him every half an hour. We left the theater, we went home. We didn't want him to have to handle this by himself. And how are we going to enjoy Spamalot, right?
Stacey Simms 41:54
We're worried about Benny. We're now home, probably close to three hours after the dose is given. His blood sugar was steady. We called the endocrinologist back and they said look, it's three hours pass the dose. If he hasn't dropped, he's not going to drop you guys are okay. So we being the terrible parents that we are looked at each other and said, you know, our friend was having a holiday party that we couldn't go to because we had tickets to Spamalot. David, do you mind if we go to the party now? I swear we did. We left we went to my friend's party. And my friend is only 10, 15 minutes away from my house. And it was what 10 o'clock at night already. So we only went out for about an hour and a half. But yes, I left my sleeping baby and he never woke up. And he never even woke up with all those pokes all those finger sticks to check his blood sugar, which I'm sure David did 10 more times before midnight, he slept through the whole thing. We were all worried but not worried enough not to go to that party.
Ah, I am the worst. We have always been the worst. But you know what he was safe. And our endocrinologist gave us the correct information told us what to look for helped us through it. And there was no sense as we saw it, not going to the party. So I know I'm a terrible parent. That's why I always say I'm the world's worst diabetes Mom, I still have not seen Spamalot all the way through. So maybe when it comes back through shark, I'll go back and make it through the first half of the first act. Oh my goodness. And hey, anybody dealing with a toddler or baby with type one, and those teeny tiny doses, I salute you. It's not easy. Getting an insulin pump makes it a little bit easier. But anything under the age of five is a circus of you know, type one is never easy no matter what age you are. But we're heading into 16 year old with it. And that means driving, which is an adventure for another time.
Before I let you go quick reminder friends for life is this weekend, the virtual conference. And if you were able to attend in July, you know that did an amazing job. If you were there, the one thing I will say that surprised me in a very good way was how much just schmoozing. We were able to do. They had specific zoom rooms for different ages, you know, parents and teens and young adults with type one, it was great. And I really wish I had put aside more time in July to attend the conference. Because I didn't really understand how much just hanging out and socializing we'd be able to do. So I'm putting more time aside to attend this one. And I hope you can check it out as well again, link in the show notes.
Hey, in the weeks to come, we're gonna have a couple of more episodes in December probably take one off the week of Christmas, even though I celebrate Hanukkah, but you know, we go with the flow. And I also want to just point out that this time of year, there are often a lot of approvals. It just seems like that last week in December, there's usually a lot of news. So stay tuned. I know a lot of delays happened because of COVID. So, you know, I'm not even sure what's been submitted to the FDA that was planned for this year. A lot of delays that way, but we will definitely be talking about it. Make sure you follow on social media for the latest and greatest. And thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much as you listen and if you've listened this long, I really appreciate it got a little chatty this week with that story about Benny and Uncle Dave. But But I appreciate you listening. I'm Stacey Simms. I'll see you back here next week until then, be kind to yourself.
Unknown Speaker 45:10
Diabetes Connections is a production of Stacey Simms media, all rights reserved. All wrongs avenged.
Have you seen your doctor remotely this year? Turns out that endocrinology is the number one specialty using telemedicine in 2020. We talk to Dr. Peter Alperin from Doximity about their recent study that says about 20% of all medical visits will be conducted via telemedicine this year. We also talk about what this means going forward, how to get the most of a visit when you can't be in person and why the heck doctors' offices still use fax machines!
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke Hypo-pen, the first pre mixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:22
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:28
Hi, and welcome to another episode of our show. As this episode goes live, it is Election Day in the United States and we are not going to focus on that here. I am guessing many of you have actually found this episode in the days following its initial release. But whenever you are joining us I think this is a really interesting topic that you know many of us experienced for the first time this year. And that's telehealth.
If you are new to the show. I'm really glad you found us. I'm your host, Stacey Simms, and we aim to educate and inspire about type 1 diabetes. My son Benny was diagnosed when he was a toddler way back in 2006. He is now a sophomore in high school and we had one telehealth visit earlier this year. That was back in March, when everything started, we were able to go into the doctor's office for his summer and fall endocrinology appointments. I talked more about the experience, you know how it went some of the pitfalls that we ran into for that first telehealth appointment. And I do that in the interview.
Just a heads up this will be a shorter than usual episode is just the interview, we will have a regular episode with our segments with Tell me something good and all of that later this week.
For this episode, I am talking to the folks from Doximity. This is a professional medical network, sort of like LinkedIn for doctors. They had a study recently that said endocrinology is the specialty that uses telemedicine the most number one at everybody. And there are some interesting reasons why, of course remote or telehealth or whatever want to call it was huge earlier this year, it did peak around April or May. But there are some predictions that about 20% of all medical visits will still be conducted via telemedicine by the close of this year by the end of 2020. And that would represent about $29 billion worth of medical services. It is certainly worth watching.
So why endocrinology? What does this mean going forward? And why do doctors offices still use fax machines? Those are some of the questions I asked Dr. Pete Alperin, who joined us from Doximity. Dr. Alperin, thank you so much for joining me. I appreciate you spending some time with us today.
Dr. Peter Alperin
Thanks. Thank you so much for having me looking forward to it.
Stacey Simms
So a lot to unpack here with this study and why endocrinology but let me just back up first and ask you what is Doximity? What do you all do?
Dr. Peter Alperin 2:51
So Doximity is the largest online network of health professionals in the United States. And I think a great way to think about us is we're like a LinkedIn for healthcare professionals. We started off primarily with physicians, but we've expanded to include nurse practitioners, PhDs and a variety of other you know, healthcare professionals that range the gamut from, you know, optometrists, etc, to physical therapists and pharmacists and the like. We have over 70% of United States physicians have joined our network, and we have over, you know, 1.2 million members overall. And when I say it's like LinkedIn, you can think of it as LinkedIn, but tailored towards the healthcare professional. So we have a lot of features that are very specific to the needs of the people who work in the medical field. So we have HIPAA compliant communication, including faxing, we have our Doximity, dialer, video and audio products, which allow physicians to communicate easily securely and reliably with their patients. And then doctors can connect with each other much like you would on other social sites, and earn free continuing medical education. And they keep up on the latest Medical News. And we have a news feed, which is one of the biggest features on our site that allows the health care professionals to keep up on the latest and greatest in their particular fields, as well as just general information about the health care profession.
Stacey Simms 4:09
So one of the things that you've done with Doximity this year is well, I assume you do this every year is a state report, right? The 2020 state report and this is the state of telemedicine. I'm just curious, do you do that every year,
Dr. Peter Alperin 4:22
which is the second year that we've done this, and we've done studies in a variety of other areas. So we've done workforce studies, but we have a unique position in the market, being able to you know, call on the information and the opinions of like I mentioned over 70% of the US physician base and as a result, it gives us a really nice vantage point so that we can understand and really learn about these issues, particularly workforce issues.
Stacey Simms 4:48
So let's talk about the 2020 state of telemedicine report. And it's interesting because I have a great audience. I have a very smart audience but I also have an audience that is uniquely positioned to experience probably just as much if not more telehealth than anybody else in the country this year, so I'm really curious to hear these results because endocrinology was the number one specialty that utilizes telemedicine the most in that study, tell me a little bit more about that by number by percentage.
Dr. Peter Alperin 5:16
So it's by percentage, it probably isn't, it wouldn't be by numbers, mainly because there just aren't enough endocrinologist to make that a possibility. But the situation is that we surveyed, you know, 2000 of our physicians on our user base, and ask them a variety of different questions. And one of the things as you noted that that became clear was that endocrinology was one of the top professions it was the top profession, in terms of utilizing telehealth and it's that isn't surprising, mainly because endocrinologist take care of patients with diabetes, as well as other obviously, endocrine disorders, but it's a very chronic disease, heavy specialty and chronic disease is uniquely amenable to the telehealth platform, because patients with chronic disease need to be seen by their health care professionals on a longitudinal basis of you know, for many years forever. And it is something where you can have many light touches, so that you can have a dietitian who might touch the patient, the physician, you know, diabetes, education, and, you know, runs the gamut. And as a result, because endocrinologist obviously specialize and have more diabetes patients than the average doctor, it stands to reason that they would be the specialty that has been utilizing this the most. We've also noticed in our study, and you may have noticed this that chronic care visits were completed at a higher percentage on telehealth and other regular type visits, more acute care.
Stacey Simms 6:38
I'm curious, in the study, do you talk about the quality of these meetings because we've had telehealth this year, my son sees an endocrinologist, every quarter, we sometimes stretch it out, but we see every quarter. And we did one visit during this time that was remote, and it went fine. I had a little bit of you know, I have a we had a few issues, just getting some reports, it was fine. Did you talk about quality at all.
Dr. Peter Alperin 7:02
So the study didn't really dive into that I can tell you from personal experience, that you do need to learn how to do a telehealth visit, you need to prep your patients properly. And so it is very, very beneficial if you send patients at least the ones who have not had a visit before on using a telehealth platform to you know the different tips and tricks to be able to make that visit as ideal as possible. And then the physician themselves needs training to make sure that they understand how to interact, look at the camera, the variety of different things. So we didn't go into that in this study. But it is something that I know is important for all physicians and frankly, patients to have to kind of acclimate themselves to that communication platform.
Stacey Simms 7:46
Yeah, our biggest problem was the actual reports. My son uses an insulin pump, he uses a continuous glucose monitor, and they have separate reports that are you're able to get online. But you know, we had sent it or the office had called us. And here's the clarity report, login. Here's the T slim report, login. And then the doctor was online. He's like, nobody gave me anything. So I had to give him like my login while we were talking. It was really fun. We've known him for 14 years. So it was no big deal. But it was funny to have to. I think we were also his first visit that way. I'm sure it got better. But it was funny. You know, especially with diabetes, especially with type one, there can be so many technical things, if you're lucky enough to have access to the technology. Okay. Anyway, let's get back to the report. I know it's a little early to extrapolate, you know, from a report like this, but what do you think I mean, in on your network? Are physicians excited about telemedicine? Do they like it? Do they think it's going to continue?
Dr. Peter Alperin 8:38
So they do think it's going to continue? And I think they're excited as well. I think there was a little bit of trepidation in the beginning, because it was really thrust upon people. And I think there remains some unanswered questions. So let us sort of let me go into each of those. There's no question that telehealth is going to stay. I mean, we're the expectation is that there'll be $29 billion worth of telemedicine telemedicine visits by the end of 2020, and over 100 billion by the end of 2023. So this is something that is very, is absolutely not going to go away. And it's not going to go away because patients like it. And frankly, physicians are going to like it as well. The reasons that patients like it are is that it's it's quite convenient. And particularly for patients with chronic illness, or patients who have difficulty getting to the doctor's office, it can really be a lifeline. It's much easier to have additional visits over a telehealth platform and then have maybe a quarterly visit where the patient actually comes in to see you than it is to have that patient come to your office, you know, every few weeks, if I'm talking about patients who have you know, particularly brittle diabetes or you know, need to be seen on a more frequent basis for whatever particular reason. I think that if you look at the study, you know that it bears that out with the increase in the in the chronic care visits that you saw, and also just the satisfaction in general. Now, like I mentioned, there are a few kinks that need to continue to be worked out right now. As we noted in the study, the payments for these visits is not 100% certain going forward, although all indicators are that this is going to be made permanent. But you know, if I'm being accurate right now, CMS, for instance, is operating on waivers that allow you to build for the visit in the way that you would want to be able to all as I mentioned, all indicators are that's going to be made permanent. That's probably the biggest sort of thing that remains to be worked out. But private payers seem to be following suit as well.
Stacey Simms 10:27
Now, you're an internist. You're not an endocrinologist, but I know you've seen patients, people with diabetes. I'm curious what you think about the missing element of telehealth, especially as it pertains to chronic condition like this. And that's the person that's the in person relationship. And as a parent of a child with type one, as a wife of a husband with type two, the personal relationship that they have with their separate physicians is so important to their care. And well, I think telehealth is great, I would hate to see it take over. Right I really my my son, I were talking about this, and he felt the visit was worthless. It was not we actually made it he's 15. He thinks a lot of things are worthless. But we made basal rate changes, we checked in on certain things. But then when we were able to go back to the office over the summer, he thought it was a much better visit. I don't know from where I stood there was wasn't as dramatic a difference as he indicated. But I think he had a lot to say about it. I'm curious, from your perspective, as the physician, what you think about that,
Dr. Peter Alperin 11:27
you know, I think that there's never going to be a substitute for an in person visit full stop. But that said, I think it's like all pieces of technology, the key is finding the right place to use it. Because it's not about the technology. It's about the physician patient conversation and the care that you're delivering. And so the best technology is invisible, right, it disappears. And so that you really it's about that connection that you have. I think that like we talked about in your previous question, there does need to be some acclamation on the part of the patient and the physician in terms of getting used to this. But I still strongly believe that the overwhelming I guess you would call it, the fundamentals of it are really just on the side of telemedicine, it's efficient, you have the ability to touch more patients. Now, one thing that I've thought about is that a telemedicine visit is always easier with a patient that you already know. Yeah. So that's also another reason why I think that in the realm of chronic care which diabetes is squarely in the middle of, you're going to need to have that initial visit with the patient in person. But over time, having a phone call or a video visit is actually fine. Because you know, the patient and the patient knows you, it is a little trickier for an acute care visit, it's just a little bit the physical exam is a little bit more difficult. Obviously, in patients with chronic disease, you don't need to do a full physical exam with every single visit it really, you know, it obviously depends on why they're there and what their particular symptoms are. So I do agree that the inpatient visit will never go away, and, frankly, is probably a more satisfying visit, because I think humans are social creatures, and they really like that connection. But that doesn't mean that the telemedicine is somehow you know, inferior, or it doesn't mean that at all. And it also doesn't mean that that it's not going to stay, it's just going to have to be used in the right circumstance.
Stacey Simms 13:11
I hope they keep it in our local office, I think we could see switching our for yearly visits to to in person and to via computer, it was just you know, it's also a 45 minute drive. Yeah, it's a nice step to heart and you have,
Dr. Peter Alperin 13:25
obviously in a time of a pandemic, you are running the risk of infection of other people. And obviously patients with diabetes, many of whom are older, the run the risk of getting that infection are at higher risk of covid. And the whole nine yards. And the other thing is, is that you know, even when the pandemic is ending, let's fast forward, you know, a couple years, I still think it's going to be very beneficial for patients, particularly patients who don't have, you know, the means to come to the office that easily. So it's important to consider that as well.
Stacey Simms 13:54
I'm curious to one of the things that our doctor talked about was trying and this was way at the beginning, he was trying to figure out how to help patients do the kind of physical exam that he does in the office. In other words, looking at fingertips to make sure that you know, they're not poking the same finger or they're, you know, the fingers are doing okay for blood sugar checks, checking the sites, where a pump inset would go and teaching patients how to kind of do a self check, which a lot of people have never thought to do with diabetes. I haven't checked in with him because as I said, we went back in person and I know they're doing in person visits now. But I'm curious if things like that have come up maybe even in other practices in some of the chats and conversations that you've seen.
Dr. Peter Alperin 14:36
Yeah, I mean, both personal experience and then, you know, being at duck somebody I have a unique vantage point on the conversations that occur on our newsfeed where you'll see the you know, the the chatter back and forth about a particular article. The answer is there are great many things that you can do to help with the physical exam and this gets back to again, you know, having the patient be properly prepped, if you will, for that visit. So that they're in a comfortable seat so that there's good lighting, that they have loose fitting clothing, that they're aware of the things that you might do so that they have also, you know, the proper undergarments. So depending upon what the physical exam might be, but there are certain things you can't do like it's very difficult to palpate and do an abdominal exam right over the phone. And it's just it's a tricky part of the any, any physician will tell you, the abdominal exam has always been one of the trickier parts of any exam. It's also hard to listen to lungs, if you will, over the phone. But there are some things you can do. For instance, if a patient's complaining of abdominal pain you and they and their mobile, you can ask them to sort of maybe jump up and down and see whether or not that hurts, because really what you're looking for is a sudden jar, far from the exam that all of us learned in medical school, and probably far from the same level of sensitivity and the ability to diagnose things, but it certainly can help. But that's where the importance of triage comes in. And that's why having a front office that can understand when a patient needs to come into the office versus not come into the office is important.
And look, I've converted telehealth exams to in person ones where I've said at the end of the conversation, you know, this was great, but I think I still need to learn more, why don't you call the office and find out if there's a time you can come in in the next week, then that kind of thing. You know, it is being taken up by physicians of all ages. And I think that was a really interesting finding that, you know, typically technology is always adopted more more quickly, among younger people just across the board. Here's a case where that's not true, where it's physicians in their 40s and 50s, who are actually taking to telemedicine more quickly than physicians in their 30s, then one of the reasons that we think that that's true, is that physicians in the 40s and 50s are the busy physicians are the ones who see the, I hesitate to say in this in the those salad years of their life where they're raising families, and they have, you know, mortgage payments and life. And so they're working more, I also perhaps think that their practices are bigger, they're more comfortable with their patient base. And it takes a certain level of comfort, like we talked about with your patient panel, and the folks that you're caring for to have a telemedicine visit be just the most optimal thing that can be again, not that you can't do it when you're a younger physician. But when you're just starting out, you don't know quite as much. If you ask any physician, they'll tell you that the amount of learning that they did in their first three years after their residency training is just absolutely the most because that's when you can't turn to anybody else and say, hey, what should what would you do about this? It's your The buck stops with you. So you learn a tremendous amount when that happens.
Stacey Simms 17:29
You heard me laugh a little bit, because when you said older physicians, I was expecting you to say physicians in their 60s, perhaps even into their 70s I did not expect you to say physician 40s and 50s. I know, we're all well, you know,
Dr. Peter Alperin 17:44
it's a good point, you know, half of all US physicians are you know, over 50. And, you know, there's a probably a big wave coming of physicians or, you know, start to cut back.
Stacey Simms 17:56
Well, someone as someone who is pushing toward 50 very rapidly. I'm not happy to hear the older term being used.
Dr. Peter Alperin 18:02
I'm over 50. So it
Stacey Simms 18:05
is what it is. Hey, before I let you go, one of the very first things you said I made a note to come back to you were talking about Doximity and your type of the things that everybody can do. And then and you mentioned fax machines.
Unknown Speaker 18:18
Uh huh.
Stacey Simms 18:19
It says nothing to do with anything we've talked about. But I have to ask you, why are American doctors in our health care system still using fax machines? When nobody has been at home? nobody uses the technology anymore.
Dr. Peter Alperin 18:32
I mean, why? It's a fantastic question. And it has its roots. It's really it comes down to two things, but it has its roots in the HIPAA law. So most people on I imagine in your audience are familiar with HIPAA. A lot. Most people are familiar with it. But so that's the primary piece of federal legislation that governs patient privacy, it also governs communication. And when HIPAA was written in the late 90s, or mid to late 90s, the fax machine was ubiquitous. I mean, that was 25 years ago, but the fax machine was grandfathered. And therefore if I send a fax to another physician, or anybody that the communications and the security around that is just handled differently, legally, and there's more protections for it. So that's the first thing. So that's why faxes never went away. And then at the same time as electronic health records came about, and, you know, email became the primary sort of medium of communication that was not covered. And therefore there's all sorts of security protocols that need to happen. You need to use secure email and there's patient information. And because of those security issues, it's an a patchwork just to quilt of rules and regulations. physicians have just stuck with the fax machine because it's in every physician's office, and now it's on every physician's phone. It was the very first feature we created because it's the thing that positions us. I mean, I fax something this weekend, the sending orders to a nursing home for a patient who needed some medication changes and so from your phone from my phone And so that's what we offer on doximity is that ability to fax, receive, send sign and send it. So I never touch a piece of paper per se. But it all happens over a fax protocol. And that's actually what a lot of physicians do. So it's not always when you hear fax machine, it's still a ton of paper. But a lot of physicians have moved to E fax. So you see that as well. And I
Stacey Simms 20:19
guess as patients, we can do that, too. I had an effects account for a while, but I only used it for doctors. Exactly. I
Dr. Peter Alperin 20:25
know. It's a very interesting thing. And there you go.
Stacey Simms 20:30
I know you weren't expecting to talk about that. But it is
Dr. Peter Alperin 20:33
a great question. You know, we still have a huge number of our users who who use our fax machine. And it's the kind of thing that even if you're not a heavy fax user, you still need to have one because you need to be able to receive information from other physicians.
Stacey Simms 20:44
Well, Dr. Alperin, thank you so much for joining me, this was really interesting. And I hope you can come back maybe and let us know other things that you find in Doximity that are of interest to people with diabetes. Thank you so much.
Dr. Peter Alperin 20:54
Thank you so much for having us. It's an important study. It's an important time in medicine, and we appreciate you helping us get the message out.
Announcer 21:06
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 21:12
You can read that study from Doximity and some other information. I will link it all up on the episode homepage as usual at Diabetes connections.com. There's always a transcript for every episode in 2020. And we're starting to go back and fill those in for previous years as well. I'm asking in the Facebook group if you went to a telehealth or remote visit this year, and if so, would you do it again? I definitely would as you heard me say, you know Benny wasn't crazy about it. That's because he likes he's driving now he likes to drive down to the office he likes to see and be seen and he has a great relationship with our endo but I really think if we can get away with it we have to see the four times a year although I stretch it out probably like most of you so it's really three times a year just you know, you know you can work that calendar, but I think we could probably get away with one or two remotely and with Dexcom I don't need an A1C from him all the time. You can see the estimate, but we'll see how it goes. love to know what you think.
Thank you to my editor John Bukenas from audio editing solutions. Thank you for listening. We will be back in just a couple of days with a regular length episode with all the segments. I am doing a bit of a state of state with JDRF with Aaron Kowalski, who is the CEO of JDRF wanted to get his take on this really unusual year, what research is going to be stopped or or held up or even everything's going to progress but nothing is as normal with JDRF or anything else. And it was really interesting to talk to him and also let him respond to some of the criticism from the community that JDRF has been hearing recently. That will follow in just a couple of days, likely Thursday of this week. Until then, I'm Stacey Simms. Be kind to yourself.
Benny 22:58
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
It's been a busy fall already for Medtronic; they've acquired Companion Medical and the FDA approved their 770G pump. Stacey catches up with Diabetes Group President Sean Salmon to talk about that and much more. Find out the difference between the 770G and the upcoming 780G, their plans for longer-wear pump insets and when they might have a no-calibration sensor.
In Innovations this week, a new study showing the benefits of once a week basal insulin. It's called Insulin Icodec.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke hypopen, the first remixed autoinjector for very low blood sugar, and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
This week, catching up with Medtronic, we're talking about the newly approved 770 G, looking ahead to the 780 G, their acquisition of In Pen and how they think they've cracked the code on longer where pump in sets,
Sean Salmon 0:42
the things that are in insulin to keep it from going bad. The preservatives, if you will, are behind a lot of that sort of site actions that you get. So we're able to take that stuff out and have just filtered Insulet. a queue will deliver to the site. That's really the magic behind getting the extension of use.
Stacey Simms 1:00
That's Sean Salmon. He heads up Medtronic diabetes group. In innovations this week, a once a week basal insulin, how would that even work?
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am so glad to have you if you are new welcome. Glad you found us We aim to educate and inspire about type 1 diabetes by sharing stories of connection. My son was diagnosed right before he turned to back in 2006. And we have his high school sophomore 504 meeting this week. Yeah, it's virtual. His whole school is virtual. I've shared on the show before he is part of a very large school district in the Charlotte, North Carolina area. And the whole district has been virtual. younger kids are starting to go back to school in October. They're staggering it right now High School won't go back in person until January at least that's the plan.
So I'm really interested to see how they handle this 504 meeting. He's had one, you know, we've been diagnosed since he was two. So he's always had one. In our district. We have a separate DMMP a diabetes medical management plan that covers a lot of the basics that are maybe in your your child's 504, but I assume this will focus on testing. I don't know. I mean, he's home. So you know, he can go to the bathroom when he wants he can drink water when he wants. I'll share more about that though. Mostly, I think this is about keeping our place in the 504 for things like the ACT and the PSAT and all that testing and he is so thrilled, but it's going to be coming up.
Another thing I want to tell you about real quick is Hey, in September, we saw a big boost of sales of the audio book of the world's worst diabetes Mom, you know, this is my book, it's part memoir, part advice, stories, real life stories about raising a child with type 1 diabetes. And the audible version has been very popular. And I'm telling you September, I don't know maybe end of summer and everyone decided to get an audiobook, but audible loves when that happens. And now I have two free copies to give away, you do not need to have an audible account, you don't even need to really start one here, you're not going to be signing up for something you can't get out of you do need an Amazon account.
So if you want the copy, I'm not doing a fancy contest on social media, I probably should. But all you have to do email me Stacey at Diabetes connections.com put audio book in the subject line and I will give you the first two people who do so a free book will make it very simple there. If you're interested in perhaps the paperback or the ebook, you can head on over to Diabetes connections.com or it's on Amazon, whatever is easiest for you.
One more thing and it's an apology. Last week I apparently mixed up when I was talking about Medtronic 770 and 780 G. We do clarify that in the interview here with Sean Salmon. But to be clear, the 770 g was recently approved in the US. It is basically the same as the 670 g except for the addition of Bluetooth connectivity for data sharing and remote monitoring. And as you will hear, you'll be able to update the 770 G and future Medtronic pumps at home just like your phone. Alright, Sean Salmon. With that and a bunch more we go down a laundry list,
but first diabetes Connections is brought to you by One Drop, and I spoke to the people at One Drop, I was really impressed at how much they get diabetes. And it makes sense when you think about it. Their CEO, Jeff was diagnosed with type one as an adult. One Drop is for people with diabetes by people with diabetes, and the people at One Drop work relentlessly to remove all barriers between you and the care you need. Get 24 seven coaching support in your app and unlimited supplies deliver no prescriptions or insurance required. Their beautiful sleek meter fits in perfectly with the rest of your life. They'll also send you test strips with a strip plan that actually makes sense for how much you actually check One Drop diabetes care delivered. learn more, go to Diabetes connections.com and click on the One Drop logo.
My guest this week is Medtronic Executive Vice President and President for the diabetes group, Sean Salmon. And we spoke just as the deal for Medtronic to buy companion medical makers of the In Pen was closing. So that is a done deal. Now, In Pen is a smart insulin pen, you're probably familiar with it, it keeps track of dosing and recommended dosing, sort of like what you'd get with an insulin pump, you still have to inject, but the dosing can be automatic, the app will tell you exactly what to do. And keep track just like an insulin pump does as well. We talk about that. And a lot more here. Here's my talk with Sean Salmon.
Sean, thank you so much for joining me. There's a lot going on at Medtronic these days, I appreciate you spending some time with me and my listeners.
Sean Salmon 5:44
That's my pleasure. I appreciate the opportunity. Thanks, Stacey.
Stacey Simms 5:46
We're gonna go down pretty much a laundry list of technology and questions from listeners and things that they want to know. But let me start slow. And just ask you, how are you feeling about everything these days, we've got delays because of COVID. We've got, you know, a year like no other it's a cliche at this point. But you know, in your own words, how are things these days at Medtronic, and in terms of, you know, what you're looking at going forward?
Sean Salmon 6:09
Well, it's interesting, right? I think we're all living through some unprecedented times, just everywhere in the world right now. And it's certainly challenging. But at the same time across Medtronic, you know, I think we've got such a rich pipeline, and just about every single business, it's, it's exciting to see what you know, what the future is gonna bring, we get past some of these near term challenges. I've been here for 17 years, I can't remember a time where we had so much innovation all stacked up, ready to go
Stacey Simms 6:34
Well, let's jump in and talk about it. One of the first things I want to ask you about is the acquisition of companion medical. And this is the startup they've got the in pen. This is the I think my listeners are very familiar with it. And we've done episodes on it. So tell me a little bit about what the plan is, for companions in pen product with Medtronic, what are you gonna do with it?
Sean Salmon 6:59
Yeah, sure. Well, maybe I'll start out with, you know, why did we decide this was a good idea? And yes, I came into this role. Yeah, you whenever you start a new job, it's been about a year from now, the first thing you do is you formulate a strategy of how are you going to serve your patients in the market? And it's really, you know, strategy is really a question of, what are you providing for who, when you start asking those questions, it really narrows down what your focus should be in, and didn't take that long to sort of Peel apart? What is it that are people living with diabetes are seeking and how are they? How are they being treated today. And if you look around the world, it depends on the country you're in. But multiple daily injections is the most frequently chosen therapy, it's something that ranges between 60 and 90% of the treatments that are out there.
So you know, really the philosophy app is that for us to know, what are provided for whom we need to know, you know, where do people where are they on their journey? And where do they want to go. So, you know, injection in and of itself is a fine therapy. But there's just really variable outcomes that patients are being able to get from that. And a lot actually about just the, it's made difficult by the fact that you really don't always know how vigilant you are, how much insulin you've taken, how much you have on board. And it's very hard to keep track of all that. And what companion has done with the implant system, of course, is to track that insulin, so you know exactly how much is given at the right amount of time and have some estimation for carbohydrates, the ability to load that up. And then of course, the CGM data is there. So when you have those components, a lot of that difficult math calculation about how much insulin Do I need to take at a given time is made simpler. And we can extend that by adding a lot of what we have within our automated insulin delivery systems, algorithms, personalization of those algorithms into that experience with a pen.
So if you will, we're trying to close that open loop, or at least close it down some and what we do with automated insulin delivery systems as we have this track record, right, have you just recording CGM data over time, and knowing what the influent amount is, you can really get to an understanding of how individuals kind of respond to insulin, and more personalized, the amount of dosing that happens. So get an even tighter connection to how much insulin someone needs to take at a given point of time. Of course, on meal handling, that's the place, we're really pushing a lot of our technology, we have a very large and capable group that does data science and artificial intelligence. And all that really means is that we're able to take large data sets, and then put them into actionable insights that really simplify how people can get better control without having to do anything.
And one of the really interesting areas we're investing in right now is around meal handling. So we can with our technology have a really good sense of when you're going to eat. And we can confirm that some gesture control technologies that come from a wearable like a Fitbit, or an apple watch or something like that. That tell us can confirm that some is eating. So in that instance, you could, for example, remind people, there's been no bolus given that it's time to bolus. And if you miss just two boluses a week in a meal, that equates to about a half point increase on the A1C. So obviously, outcomes can be made better. But the important thing is that it's done in a sort of an invisible way or helpfully in the background way. We're not asking somebody to anymore, which I think is really the sort of driving principle behind what companion medical set out to do within pen spec, this least burdensome as possible? Well, we can add a lot of technology that isn't visible to the user, for the most part, but can really drive a better experience and better outcomes. So what we're trying to do with a closed loop we can bring to this open loops, I said, and that's really, I think how the two fit together can help it a lot of ways.
Stacey Simms 10:58
A couple of questions about You just said you. You mentioned the gesture technology. That's Klue, right. You all acquired Klue this year.
Sean Salmon 11:03
Yes, exactly.
Stacey Simms
Is that going to be part of a companion medical system?
Sean Salmon
Yes. So the idea is, we're going to have that for any means of insulin delivery, right. So it's the ability to detect that somebody is in the process of eating. And the absence of any kind of bolus is a great opportunity to say here, let me give you a helpful tip here and remind you to bowls, whether you're pushing a button on your pump, or you're, you're reminding yourself to bolus we can drive some improvement there. And it was evaluated in a recent study that we did. It's a small study. But we showed that we could fact drop a one suit by a fairly sizable amount just by bolus reminder. Now, ultimately, I think we can use Klue and that technology in a way that can actually automate the delivery of bolus so nobody has to do anything within a sort of closed loop system. But you know, that's, that's some more work than where, or whatever to do it. Absolutely. It's
Stacey Simms 11:53
you heard me laugh, because, you know, just by bolus reminder, parents around the world have children with Type One Diabetes would argue with you that a simple bolus reminder in the form of a parent does not make that much of a difference. Yeah. But I hear you, I
Sean Salmon 12:07
think it Yeah, I mean, the difference here is the bolus reminders, and just it's time to bolus what we can do. Knowing the history of how much insulin is on board. Get a quick estimation is the medium small, large amount of carbohydrates being consumed, we can tell you how much to bolus not just that you need the bolts, right? which we think is a helpful insight.
Stacey Simms 12:28
When you talk about Klue. It also makes me laugh as you listen. As I talked about Klue, we did an episode with them in the past if you'd like to learn more, and Sean , I laugh because every time I talk about Klue I do the gesture of eating food. I don't you can't see me but every time I mentioned it, I think that's because that's how it was explained to me when they first demonstrated it. It's a really interesting technology. But that'll be in not just pens, you're planning on using that in pumps as well.
Sean Salmon 12:53
Yeah, so you know, Klue actually runs on on a wearable. And then it talks to the algorithm that's either you know, on your phone for your pen, or can be the algorithm that's driving the automated insulin delivery system. So think of it like a sensor, and the sensor gives input so that the algorithm knows what's happening. And it lends itself to any means of insulin delivery.
Stacey Simms 13:15
One of the big concerns and you know this when a large company buys or acquires a small company or product the big concern is that you know, it'll be shelved or there will be big changes to make it more proprietary. The in pen is now used with Dexcom and the ever since implantable CGM. Can you reassure people who are using it right now that you're not going to change that I assume it'll be used with a with a Medtronic sensor, but will you continue with the sensors that it is integrated with right now?
All right, right back to Sean answering that question. But first diabetes Connections is brought to you by Gvoke hypo pen, and almost everyone who takes insulin has experienced a low blood sugar and that can be scary. A very low blood sugar is really scary. That's where Gvoke hypo pen comes in. It's the first auto injector to treat very low blood sugar Gvokek Hypo pen is pre mixed and ready to go with no visible needle. That means it's easy to use in usability studies 99% of people were able to give Gvoke correctly. I'm so glad to have something new. Find out more go to Diabetes connections.com and click on the G voke logo. gvoke should not be used in patients with pheochromocytoma or insulinoma visit gvoke glucagon comm slash risk.
Now back to Sean , talking about Medtronic plans to continue in Pen with its current partners.
Sean Salmon 14:44
Yes, we have no plans to take away anybody's sensors from them. But we're not entirely in control of that. So if if sensionics and Dexcom plan to maintain that access and then we're game we want to make sure that people have the support they need
Stacey Simms 15:00
When you say you’re not in control of it, you’re talking about what Dexcom and Eversense would do, you're not talking about something on your side.
Sean Salmon 15:07
No. So the way all this works is you have to have, depending on what platform of phone you're dealing with, you have to have a thing called an API, which is basically a hook of software into the algorithm. So somebody on Sony decides they don't want to have that access to the longer they can turn it off. But we're not going to turn it off. We don't have control over that. So our belief is that, you know, if we're meeting patients where they are, and they're on a Sensionics device, we should maintain that access for those patients. Of course, we want to open up access to our own CGM. So we have a lot coming in the pipeline for CGM, which is pretty exciting. But no, I understand the sentiment that when you a large company buy something that they want to shelf it This isn't like big oil buying biofuel. Right now we're, we think we're gonna bring a lot better experienced to patients by combining the best of what companion has developed an impact with what we're endeavoring to do with things like Klue and neutrino and a lot of other personalization algorithms that be used in the closed loop side.
Stacey Simms 16:08
So let's talk about sensors. Let's just pivot right to that first, though, before we let this whole thing go within any timeline and integration with the guide. assume it's with the Guardian, CGM.
Sean Salmon 16:17
Yes, so initially, we'll have Guardian, but there's no we have three or four, five actually different generations of sensors coming and it's going to be compatible with everything we develop going forward as well.
Stacey Simms 16:30
Let's talk about Guardian Connect. This is the standalone CGM doesn't need to be paired with an insulin pump. Tell me a little bit about the reception of that, what the plan is for it. And you know, Who is it for?
Sean Salmon 16:41
Yes, so I think a standalone Guardian has been sort of an on ramp to be able to use an integrated CGM with our pump. But frankly, I think the experience that we've provided with that needs a lot of improvement. That's what we're endeavoring to fix with the pipeline. And there's two parts to that one is finger sticks, you know, to, to calibrate or to confirm before dosing as required finger sticks, and that's something that we are trying to remove in the next generation. And the other one is on just the, the ease of putting it on. And it takes a lot of overtaken steps to insert, and generates a lot of trash in the process. So all of that's problematic. And we're, we're moving to an integrated platform where the sensor, and the transmitter all in one, easy to apply three step, just press it on your body kind of approach. And in the interim, reducing or eliminating the need for finger sticks. That's what the near term pipelines about and then longer term, we can take the size of that down even further, we're already taking about 50% of the volume down from one move to next, we can get a lot smaller than that we have some really interesting technology that uses something called a wafer fabrication, which just means you can make very small electronics in a very highly repeatable way. So you take a lot of variation out.
And then of course, you know, making sure that we're continuously improving the reliability and the wear life of these devices. There's a lot of technologies we have aimed at to to ensure that that happens. And simple things like we spend a lot of time money and effort developing patches is going to stay there, you know, the adhesive that won't interfere with the skin, but will stay there through very difficult conditions. And it took a lot of engineering, we actually did a lot of work in the fields in South Florida, just you know, high humid, very hot heat to make sure that we would have this he's up just right. So there's a lot going on in the CGM side of things. That's pretty intriguing.
Stacey Simms 18:40
I'm curious, and this is a very specific question. These future generations, any plan to go straight from a CGM sensor to a watch, that's something that just seems to be very difficult, you know, no phone involved in between? Nothing like that.
Sean Salmon 18:55
Yeah, no, it is difficult. And it's difficult for a lot of reasons, including power management of how that that Bluetooth connection is different than one to a phone. So I think as as watches evolve, and maybe that technology changes and the ability to kind of talk a lot of this on the kind of wearable side of things. It's not entirely just what can you do with your CGM, your algorithm said some, it is more complicated than you'd think, you know, hopping from phone to watch that takes the processing power and the connectivity that's already there. But think of it like a highway, right? There's like so many lanes have a highway that you can drive a car on. And if the watch is already tethered to one, one connection by Bluetooth to your phone, you've got fewer lanes available, other connections. So that's really, you know, it's I don't get too technical about it. But that's really the the near term challenge. But you know, I think there's strong interest in this. And as the wearables progress, I think we'll have the opportunity to to do things like that. But right now, it's just complicated.
Stacey Simms 19:56
All right, let's talk 770 g This was approved by the FDA in August, and it's down to kids as young as two, my understanding was for the approval. Now I'm this is gonna pardon my take on this. And this is for all of the pump companies. I wish you guys would call your pumps, something that told us more about it. I don't know if it's a medical device thing, and I have this problem with Omnipod and Tandem and everybody else. But you know, it's all numbers. So tell us a little bit about what's different from the 770 g to the 670. And then to the 780. Like, right, what's different about this pump?
Sean Salmon 20:33
Yeah, so the the biggest difference other than age education, which does, you know, it's still indicated for people over the age. I think there was some confusion at first said it's just for kids, and it's not Oh, kids. Yeah, so I, you know, I think that the biggest difference is really the inclusion of Bluetooth connectivity with this with this device. And that does a number of things. So first and foremost, it allows a person or a parent or caregiver to see the CGM pump date on a film. So we we've been lagging in that competency. Now that's available.
It also allows the carelink system which is our management system glucose to automatically update so that you can do things like telehealth visits, right. Or if somebody's going to the doctor's office, rather than that, that kind of interruption to the workflow where the pump has to be connected and then downloaded, that really slows down that visit for for the person that's, you know, at the visit, it slows down the workflow for the health care providers. So the ability to take that connection and automatically upload it at your convenience without having to do anything, is what that connectivity brings to us as well. And then finally, it goes all the way to we can when software becomes available, make upgrades. Or if you have to patch something knows you know how to get out of your phone, where they'll have a new version to patch up something, you can just push that over the air. So we have that capability to upgrade future algorithms without having to connect anywhere.
Stacey Simms 21:59
So just to be clear, this is like what we do with the Tandem X2, you plug it into the computer, you get the latest download, it changes the software in the pump, and then you're off and running. Same thing, plug it in,
Sean Salmon 22:09
that was what one big difference, we'll plug into the computer, it goes over the air, just like you can update your unit up to your phone over the air today. If you changing your operating system, it's the same idea. You can do this without having to have a computer or having to plug cable in,
Stacey Simms 22:24
do you need a doctor's prescription for changes? Or is that a change by change? I would assume there might be?
Sean Salmon 22:30
Yeah, it depends on the change. So if you're talking about, you know, a security patch, you don't need a prescription for that, if you're talking about moving to the next algorithm, like the difference from 770 to 780 is really an algorithm change. It's the same hardware platform that would require a prescription.
Stacey Simms 22:45
So let's talk about the 780 which is the I assume this is the next thing in the pipeline and following the numbers.
Sean Salmon 22:52
Yes, so we we have released the adult data for the 780G, which at is about the algorithm now at the American Diabetes Association began this year virtually. And really, there's a couple of differences here. What this device does now is it takes the Ability Beyond just basal insulin, but also to bolus where you can the situation where there's rising glucose, the algorithm can bolus every five minutes to control. Somebody maybe missed a meal bolus, so they miscalculated how many carbs they ate, for example, and blood sugar still rising, we can predict where it's going to go both correct it without stacking up insulin. So what all that means is we can drive better time and range when there's there's missed boluses or miss calculations on carb counting. That's one big difference.
The other big difference is the target that you set these two, so you can set a target, as you may know, on the 670 G, the target you can set is 120, we can still set a 120 target on this algorithm. But we can also set that target of 100. And the clinical results that we showed, were clear that you could take the target lower without increasing the risk of hypoglycemia. In fact, it was so numerically lower rate of hypoglycemia. So this, this algorithm, I think really gives a lot more freedom. And that's, I think the biggest thing that we were looking for all these are great, you know, time and range, we've been leading that the industry and being able to provide the best time and range, but the user experience got a lot better. And a lot of it had to do with alerts and alarms and all the things that we did. And I think To put it simply, there was a belief as the first hybrid closer algorithm out there, that whenever something goes awry, that you should kick somebody out of what was called auto mode and have them go confirm something with like a finger stick.
Because I think the belief at the time was that you know, you can't trust his algorithms take care of somebody, and a person is better off better able to manage their diabetes than a machine. And I think that was probably a fallacy. As it turns out the algorithm that what we change here is we just aren't kicking people out. We are waking people up in the middle of night do things the algorithm pretty good at smoothing things out without causing any new troubles prevention. So a lot of that, I think out of abundance of caution safety alerts, kicking people out asking for fingerstick calibrations was unnecessary. And we're seeing a big reduction in all of that and very high satisfaction among the people in a clinical trial. And we've launched it in a limited way in Europe so far, and feedback has been really tremendous. This is a very big improvement of what we had been offering a couple
Stacey Simms 25:25
of just questions for clarity, Sean , the you're talking about the algorithm in the 780? Right, the 770?
Sean Salmon 25:32
Yes, that? No, that's 770 is basically the 670 algorithm. The big difference is really that indication of age, as well as the the ability to upgrade
Stacey Simms 25:44
software. If you want a pump right now that you can then upgrade when the new 780 algorithm is available. It's got to be the 770 you can't upgrade. Yes,
Sean Salmon 25:54
yes, you're correct. Okay.
Stacey Simms 25:56
Um, to that end, just again, just to clarify, are there other ranges you can set? Is it totally customizable down to 100? Or is it 120, or 100.
Sean Salmon 26:06
So you can choose, you can choose either target, but you can adjust other settings like the part ratio like insulin sensitivity factor. So there's some customization that can get there. And we ran, I think, three clinical trials. And we're currently doing what we call a continued access study in the US where we're trying to optimize those settings, to make sure that we can get the very best experience for people with the pump. And I think what we've learned is there's a lot of these other settings that we can give more help to the endocrinologists to be able to set those but right now, those settings are, are the endocrinologist job to go fix, we can give them suggestions. But the user themselves can't make those adjustments as easily.
Stacey Simms 26:46
Wait, I'm confused. The endo can make some changes, but the users can't.
Sean Salmon 26:50
Yeah, so there's certain things again, it's about making sure that people are safe, where we could recommend changes, or the algorithms can change things along the way. But there are certain settings like these carb ratios and everything else that need to be dialed in. Yeah, but
Stacey Simms 27:03
the user can do that. Right. I don't have to bring the pump to my endocrinologist and say, I Well,
Sean Salmon 27:07
they can, but they should they should make sure that you're talking to
Stacey Simms 27:11
Got it, yes, no, no with it with the guidance of an endocrinologist, but you're not going to make me get a prescription to change my carb ratio.
Sean Salmon 27:17
No, no, no, I think it's just that we can really fine tune the system. But rather than experimenting on yourself, I think we can give some help to know what are the optimal settings for you. And that's know something we call personalized closed loop is, we could do that automatically in the background without anybody talking to anybody. That's one of our future pipeline projects, we can also tell you from the history of your glucose and insulin data, how you can get a little bit better precision for somebody. And I think that's what we're trying to do on the carelink side of things. Here's the ability to really dial this in the right way. I think that for some endocrinologist, that's not going to be helpful, right? They're very, very good at this to do it all the time. And then there's others who don't really have large type one populations. And they could use a little bit of light called the teachers edition of the textbook, to help them make sure that they're doing the best for patients.
Stacey Simms 28:08
I think that sounds wonderful. I just think, you know, this podcast audience is a little bit different, or I shouldn't, it's a lot different. This is an incredibly well educated audience that is going to get a pump like this, and mess around with it themselves at home and see how much they can change it. In fact, as you know, part of this audience is going to physically try to probably break into the pump and see what they can do with it. So I know you can comment on that you don't have to comment on it. But that's why my hackles went up when you said the endocrinologist can, but I get what you're saying for the vast majority of people with diabetes, the endocrinologist or even their general practitioner, which is different story altogether, is really going to be the guiding hand here. Just another question you mentioned with the 780. The change from, you know waking people up kicking out of auto mode, fewer calibrations, is that really in the works in terms of fewer or no calibrations or that's a hope for a future sensor?
Sean Salmon 28:58
No, that's absolutely in the works for the sensors. So we we have a product in that's complete as clinical trial and other ones very close to doing that. That eliminates or vastly reduces fingerstick calibrations? And then yeah, so it depends on the regulatory claims that we make on that specific device. And then we have two others in the pipeline that absolutely eliminate finger sticks altogether. Now, that doesn't mean that you know, if you get a reading, it doesn't make sense to you that you shouldn't go confirm it, the glucose, the blood glucose, then calibrate No, no perfect sensor. But yeah, our algorithm itself that goes into 770 cuts down by about half the number of requests for finger sticks with the same sensor. And then when we change the sensor, we can, we can largely eliminate that unless there's something that needs to be confirmed, because the reading doesn't make sense.
Stacey Simms 29:53
So is the hope that the 780G would launch with, I hate to compare it to Dexcom but let's just go ahead and do that. Cuz that's what we're all talking about here anyway, obviously, most people who use a Dexcom understand that it's not infallible, you do have to double check, sometimes, you know, you'll get a sensor error when it doesn't understand what the you know what it's getting the information that it's taking in, it'll stop working, that kind of thing. So is the hope to launch the 780G system with a sensor that's comparable to what I just described.
Sean Salmon 30:20
So it's gonna depend on where you are in the world. But the 780 is going to be compatible with past and future sensors. So you know that they may be on different timelines. And we really try to think about this like it's a system to so we've got the pump, we've got the algorithm, we've got that sensor. And the other thing we have is the tubing set and reservoir. And there's another innovation we're bringing that allows you to extend the use of that on label of that tubing set from the typical two to three days. At the seven days. We call that the extended wear infusion said that's also known as clinical trial. And the goal is to have that also compatible then 780G algorithm. So the algorithm that's on that pump, which can have all that connectivity Vantage can work with this current and future pipeline of sensors, and be upgradeable on the infusion set is all sort of in a suite of what we're trying to bring together.
Stacey Simms 31:14
Well, Boy, am I glad you brought that up. Because I have said for years, and my son has been using an insulin pump for I don't know, 13 years now that the inset is the weak link of pumping. And I know, you know, a couple years ago, we were all excited about the BD flow was supposed to be this the latest and greatest, it didn't work out so well. So that went away. Can you tell us a little bit about what you found? When I hear longer? Where insets? I think, Oh, my gosh, you know, we've all been warned about infection and scarring and don't use the same site for that long. What are you finding?
Sean Salmon 31:47
No, it's a really good question. And you know, what is it that's so magical about it? How do you get to extend it? And without getting too much detail to the simple answer is that things that are in insulin to keep it from going bad, the preservatives, if you will, are behind a lot of that sort of site reactions that you get. So we're able to take that stuff out and have just filtered insulin if you will deliver to the site. And that's really the magic behind getting extension of abuse. And you know, we did a study where we, we measured this and about 80% of the study participants were able to get seven days your body is going to react a little differently being who you are. You see that with CGM, right? Some people can wear those things for two weeks, and other people can't. Because their body's more aggressive at attacking that foreign body response, just by comparison, for three days, which was our control arm 70% of people got to three days, right? So we've got a higher proportion of people able to make it seven days, we think it's largely due to getting out those preservatives that are the insulin to keep it fresh.
Stacey Simms 32:50
That's fascinating. It's simple as a filter. I've always thought that yeah,
Sean Salmon 32:54
it's not it's no, it's also your insulin is a very sensitive molecule too sensitive to temperatures, you know, and it's also sensitive to you know, how it's contained in the reservoir. So our rigid reservoir system doesn't like mechanically damage the molecule either. So that's, you know, an advantage that we've always had with our reservoir design, then you add to this, the ability to filter out the preservatives, and you get this extension to where so you can preserve a lot of insulin, use a little more judiciously, and of course produced it. You know, the difficulty of having to change your set every day. Maybe it's a fusion set Sunday, you change it once a week, and maybe same time of changing your your sensor as well. Who knows?
Stacey Simms 33:34
Well, I think that would be pretty amazing to have a longer wear inset. That works. Because a lot of people have trouble as you said, getting to three days. Yes. One of the big questions that came up in with my listeners when I told them I was talking to you, and we've covered most of them. But one of the big questions came up was Medicare, in terms of this technology is great. Will it be covered? Can you speak to that at all?
Sean Salmon 33:53
Which which part of Medicare you asked about? Are you asking about the Well, let's talk Yeah, more of a?
Stacey Simms 33:59
Well, I think the real question is everything. But let's talk about the the system. As you mentioned, you talked about it as a system, the 780 will the system be covered? Or will it be piecemeal?
Sean Salmon 34:09
Yeah. So the rules of Medicare are really around the designation of the sensor, can you make a claim of what's called non adjunctive, meaning that you know, you don't you don't have to confirm the CGM ruling before you dose insulin. So when you're 64 years old, and your pre medic quick care and you're on like a 670 g system today, your commercial insurance pays for the sensors, the tubing sets, the reservoirs, of course, did initial investment in the pump. When you turn 65 and you move to Medicare, you no longer can get the Guardian sensor paid for because we don't have that designation. For Non exempt. They've even though it's clearly driving the pump all day long every day. So we have to get that labeled claim for the sensors for everything to be covered. And that's what we're trying to do right now with the Guardian sensors and of course, the future pipelines. themselves. But like I think it's a, there's a couple different efforts on that. But it is a little bit of an idiosyncratic thing that that exists in Medicare itself, just the way the payment law works. And we're trying to get that changed,
Stacey Simms 35:14
has COVID, delayed studies, submissions, things like that for you, while
Sean Salmon 35:19
at the branch of the Food and Drug Administration that regulates diabetes face is also involved in a lot of things COVID related, including like the in vitro diagnostic testing, and that sort of stuff. So yes, I'd say on the medical reviewer side, in particular, there's been just a difficulty for them to service all the kind of pre market or new devices that are coming through while doing this difficult work of making sure that all the COVID tests and things related to that are done. So yeah, there's been something that has been a little bit challenging. And of course, in the clinical trial environment, we actually had a couple of trials going on during COVID. And some of them have gone pretty well. Honestly, I think people are stuck at home and not willing to participate the trial. It's not been like that. In other parts of Medtronic, we've got a lot of the hospital based studies have been very difficult and highly impacted by understandably, people's fear of going to a hospital for for anything right now is pretty high. So I'd say it's been a mix. Like we've had really good collaborative conversations with FDA making sure that we streamline and make it as simple as possible as we submit new dossiers. But there is really a constraint at that medical reviewer level that's been, you know, difficult for the entire industry.
Stacey Simms 36:35
You've been so generous with your time. I really appreciate it. I just have one more question for you here. And that's about tide pool, about a year ago, maybe more now, Medtronic and tide pool announced that they'd be working together on a, you know, a future interoperable, closed loop. And it would be a separate system from the seven at any update on that.
Sean Salmon 36:55
Yeah, we're worth continuing to work with tidepool. There's a joint steering committee that we participate in. Our goal here is to create a Ace designated pump that runs the tide pool algorithm. But yeah, that collaboration is ongoing. We're working well with them. But I don't really have an update on that.
Stacey Simms 37:13
Well, Sean , I really appreciate it. There's so much going on. Do you know to talk about and thanks for keeping us straight with the numbers and everything else. I hope you come back on and you know, continue to explain all of these developments. But I really appreciate it. Sean , thank you so much for spending so much time with me for sure.
Unknown Speaker 37:28
Thank you, Stacey.
Announcer 37:35
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 37:41
We talked about a lot of stuff there. There is a lot more information as always over at Diabetes connections.com. You can learn more on the episode homepage about everything that Sean talked about. I'll link up some stuff to Medtronic into some other studies. I said a couple of weeks ago, there's something about September, October. It's like all summer long. Yeah, we have the ADA and we have the different conferences. But then every year at this time, I feel like oh, it's kind of slow, nothing's happening. And then I get all the tech companies in the fall. So I'm excited to continue to bring you as much information as I can. I have more interviews coming up. We just talked to Dexcom. I'll also be talking to Abbott. I'd love to get Omni pod that folks from Insulet back on here. So we'll we'll see what we can do. But in the weeks to come. definitely let me know if there's particular technology you want to hear more about. I love talking to these companies. It's always fun to get a kind of a peek under the hood. And I like hearing the voices and the stories of the people who are in charge of this stuff. I appreciate them coming on not everybody does you know that but it's great when they can answer your questions. And I love doing that. So let me know if you want to hear from and let me know what you want to know.
All right innovations in just a moment with that once a week basal insulin that's being tested. We'll we'll talk about that. But first diabetes Connections is brought to you by Dexcom. And when you have a toddler diagnosed with type one, you hear rumblings for a long time about the teen years when it hit us full force a little early. I was so glad we had Dexcom you know Benny's insulin needs. I've shared this. They started going way up around age 11. And when I say way up, I know some of you parents out there with little ones think maybe we increased by point two or something like that, because I remember those days Benny's first basal rate was 0.025. That's how much basically got an hour. But by the time between ages 10 and 12, his basal rates doubled. And between 12 and 13, they doubled again. So along with the hormone swings, I really can't imagine managing diabetes during this crazy time. Without the Dexcom continuous glucose monitoring system. We can react more quickly to highs and lows. see trends adjust insulin doses with advice from our endocrinologist. I know using the Dexcom g six has helped improve Benny's A1C and overall health. And by the way, he's almost 16 and those insulin needs have already started going down. This is wild. If your glucose alerts and readings from the G six do not match symptoms or expectations. Use a blood glucose meter To make diabetes treatment decisions to learn more, just go to Diabetes connections.com and click on the Dexcom logo.
Innovations this week, a once weekly, basal insulin. This is something that was announced earlier this summer. I don't know about you, but it's snuck by me It was announced at the ADA Scientific Sessions, Novo Nordisk announced that a once weekly insulin Icodec had performed as well as Lantus in a 26 week trial. Now, this particular study was done with people with type two diabetes. But before you dismiss it, there has already been a trial of people with type one diabetes, and novo expects to submit and get this and hopefully FDA approved for people with type one and type two diabetes, I couldn't find a lot of information about the previous trial with type one, there is another one that completed over the summer, hopefully, they'll release the information on that maybe some of you who are more savvy in the ways of clinical trials can dig it up the
Can you imagine once a week basal insulin, I mean, obviously, the benefits of that would be incredible. And also thinking about it for people who like to go untethered using basal insulin from an injection along with an insulin pump, which is something we did for two years. And even with control iq and you know, more advanced hybrid closed loops. Just talking to Medtronic about there's, I know a few people who like to use untethered with it, who find that there's just something about getting that always constant, steady, basal insulin smooths everything out. And certainly when you get into the enormous elephant doses that Benny was taking for a while, it helped tremendously to take that load off of the pump. I mean, between his weight loss and you come in at a puberty and I know he loves when I talk about this stuff, his insulin needs have come down incredibly, and certainly to the point where we didn't need to stay on untethered, but I think it's fantastic, it's a great option to have and once a week, basal insulin makes that a lot better. So I will keep you posted if I find out more about the type one trial, but is called insulin Icadec.
If you have something for innovations, please let me know this can be a hack that you thought up a tip or trick something with technology or new influence. You can always email me Stacey at Diabetes connections.com.
I mentioned Benny's 504 Review earlier in the show. And that happens later this week. He's also got an endo appointment this week. lots going on. I don't think the endo appointments going to be too exciting, hopefully. But you know, we do check in every quarter. And I think to mix it up, my husband is going to take him this time. Slade rarely goes to the endo usually because he's working in busy and and it's been on me for the last couple of years, which I love to do. I really like catching up with our endocrinologist who's become a friend. But I think I'll let the boys go. And gosh, you know, another reason not to go. I'm looking at making sure my door is closed. So Benny can't hear me. You know, the kid has this permit, and he's gonna be getting his driver's license if he passes in January. And I know Slade will let him drive to Charlotte, which is like a 40 minute drive. So he can do that. I don't need that stress of sitting in the front seat and putting the mom's seat belt right throwing my arm out, which I cannot believe I do. But I've done it with both of my kids. Oh, I remember my mother doing that clear as day. I don't even know if they're doing driving tests here. They haven't been. I know plenty of kids who got their licenses this year, because of COVID. They're not actually giving them a driving test. They're just saying, oh, did you do your hours? Alright, here's your license. And it's a graduated system here in North Carolina. So they can't get their afternoons they can't drive at night until they take an actual driving test. I don't mind goodness. All right. So let's keep you posted and updated on next week. We'll see how much he lets me share.
Thank you so much to my editor John Bukenas from audio editing solutions. Thank you so much for listening. Don't forget if you want the free audio book, email me Stacey at Diabetes connections.com subject line audio book, and the first two will get that promo code. Thanks so much for listening. I'll see you back here next week. Until then, be kind to yourself.
Benny 44:03
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Dexcom's CEO Kevin Sayer checks in with Stacey to answer your questions. He talks about their new pharmacy benefit for Veterans and why Dexcom would love to move everyone off of durable medical. Plus, a follow up on their hospital program we first discussed this spring, adhesive issues with the G6 and looking ahead to the G7.
Stacey also takes some time to talk about the interview process & which companies we feature on this show.
There is a video of this interview - you can watch it here.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke HypoPen, the first premixed autoinjector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
Welcome to a bonus episode of Diabetes Connections. I'm so glad to have you along for this. When we talk to the technology companies, especially Dexcom, we get a whole bunch of new listeners. So if this is your first episode, welcome, we aim to educate and inspire about type 1 diabetes by sharing stories of connection. Week after week, I talked to lots of people in the community sharing stories from athletes and celebrities and tech companies and regular people just living with diabetes. My son lives with type one. He was diagnosed almost 14 years ago when he was a toddler. And we've been doing the show for more than five years now usually release episodes on a weekly basis, we throw in some bonus episodes when the time is right. And this is one of those times
Dexcom had some interesting information to share. So I jumped on zoom with the CEO with Kevin Sayer. We talked about the new pharmacy benefit for the Veterans Administration. A follow up on their hospital program we first discussed this past spring, I answered your questions about adhesive changes for the G6. And looking ahead to the G7. I'm going to come back at the end and do some inside baseball stuff about the interview process. And about which companies I feature on the show why we feature them when we talk to them? What kind of questions I asked that sort of thing. I got some good questions about that in the Facebook group that I would really like to address. So I will do that at the end.
As you heard just a moment ago. Dexcom is a sponsor of the show. As longtime listeners know I say this every time we talk to a sponsor, but it's really important to get this out there. I do not allow sponsors to dictate the content. So they will not tell me what to say during an interview. They will not ask me to edit that's not part of the deal. They are a sponsor. We believe in them, they get a commercial, we like the product. It doesn't mean we don't ask questions. And we probably speak to Dexcom the most frequently. But I like to point this out every time we talk to sorry if you get tired of hearing it. But those disclosures are important.
You should also know there is a video version of this interview was a zoom interview, we taped it, it's on our YouTube channel Diabetes Connections, and I shared it on social as well. Toward the end, my son Benny stops by and we make reference to some appearance issues. All you really need to know if you don't want to watch it you just want to listen here is that his hair is now dyed. It's this crazy bleached blonde, and he's wearing a giant purple Snuggie. He makes quite the impression.
All right, let us get to what is important here. And here is my interview with Dexcom Kevin Sayer:
Different kind of way to tape an episode of Diabetes Connections, but we're going to give it a try. And joining me is the CEO of Dexcom, Kevin Sayer. Kevin, thanks for doing this. I appreciate it.
Kevin Sayer 3:01
Oh, you're welcome, Stacey, good to talk to you again.
Stacey Simms 3:04
So normally this time of year, you'd be in Europe for a EASD. That conferences is happening. But virtually,
Kevin Sayer 3:11
it was happening virtually. It's not quite the same. But I get notes from everybody who's listening to the presentations, gathering papers to find out what went on during the day. So are what we're trying, everybody's trying to do different things.
Stacey Simms 3:25
Well, I have a laundry list as usual to go through what is Dexcom presenting anything at this conference, because there are a few
Kevin Sayer 3:31
papers, supporting the strength of CGM and treating diabetes. Some of the results in the type two studies that have happened recently and some of the results and some of the studies with the senior community and things like that. Nothing earth shattering, but again, all supporting CGM and how well it works and helping people take care of their diabetes. So you know, a good show for us. Just typical.
Stacey Simms 3:56
Well, we've got a lot to cover just today as our speaking and news release came out about a new agreement with University of Virginia. And this is for as you're watching or listening University of Virginia as a bit of a history with Dexcom in terms of the place where type zero was developed. So what is this agreement all about?
Kevin Sayer 4:17
Well, and you're correct, yeah, we've had a relationship with the various teams in Charlottesville for quite some time, the type zero group that we actually acquired in 2018, or the algorithm for the control IQ system, and then control steady resided, we felt that was a tremendous asset going forward, not only in developing automated insulin delivery technology, but possibly for developing decision support tools. For those who don't want an automated insulin delivery system over time. In conjunction with that acquisition. You've got also always really smart people to still stay at University of Virginia and do Diabetes Research and they're very access to clinical trials, clinical networks, all the other things they've done.
We've had an informal relationship with them for a long time and we discuss could you guys help us with this or that and as our companies became more mature, and they got more involved in diabetes research that we felt was important to fund the things we were asking for, and give them an opportunity to do some good work on our behalf. So over the next five years, we'll target some leading edge new diabetes research project and use those brilliant minds to work on behalf of Dexcom, and ultimately, on behalf of our patients,
Stacey Simms:
is there anything specific that you can tell us?
Kevin Sayer:
first, you know, we have current generation, automated and some delivery algorithms out there will certainly work on next generations, and ones that will just fine tune what we've already learned and, and do better. On top of that, I think you'll see us work for decision support, like I spoke about earlier, what tools can we offer somebody that is treating their diabetes and using insulin that are meaningful, and not getting in a way all the time? So what constructive? Can we do there and predict now that we have all this data from all of our patients, because the data has been uploaded from the phone, we think that analytics capabilities of the team at UVA can certainly go through this and find a lot of things that could be helpful for us to offer to our patients. And you know, as we look at even over time, they develop simulators and all sorts of things and looking at diabetes data that we think it'd be applicable for the future with respect to working in the hospital, or gestational diabetes, even the type two non insulin take taking patients. So now that we signed this agreement, it's up to us and VBA team at the type zero team to figure out and say, Okay, here's the things we want to work on. And we're we're just excited to have the agreement in place.
Stacey Simms 6:39
For people who are hearing things like we have all the data from the phones for the first time you and I've talked about this before. But can you talk a little bit about Dexcoms use of data. In other words, you know, My son has used Dexcom for seven years now. So you guys know everything about him. But you don't really know about him? Well, blinded, right?
Kevin Sayer 6:57
We know that they're from transmitter 1765 G, here's the glucose signals that we received. And you can look at what is going on with your son. And we actually have data regarding how it performs as well to come to the app so we can service it. And we can use that information to make our product better. But we don't share anything with anybody without a patient opting in and saying, I would like to share my data with x, or I would like to share my data with the Southern Company. There's no data sharing, there's it's absolutely kept very confidential. we comply with all HIPAA requirements and keep things very buttoned up.
Stacey Simms 7:34
All right, again, like I said, there's a laundry list here. So the next thing I wanted to ask you about, and this is wonderful news for veterans that Dexcom G6 available at VA pharmacies, at no cost, it will, it's covered by the VA
Kevin Sayer 7:47
covered by the VA. You know, in the past, as many of your listeners and followers know, we've been trying to move away from durable medical equipment. As far as the coverage vehicle for our product, one of the things has been one of our biggest roadblocks is getting access to this product where people can get it easily and affordably. And within their normal course of their work. Rather than filling out a bunch of paperwork and having a bunch of Doctor notes and medical records and blood glucose logs and everything. And this coverage by the VA is going to make it accessible to veterans as long as they are on intensive insulin therapy type one and type two diabetes as a Pharmacy Benefits. So they would pick it up where they would typically pick up their drugs and and no copay. So this is a wonderful improvement for a group that really is troubled with diabetes, I think there's something like four times more incidence of diabetes in this group than the general population. So we really believe we can have a good impact here for this group of patients.
Stacey Simms 8:46
You know, again, I hate to ask stuff about our personal experience, because it isn't applicable to everybody. But I will say when our insurance switch to pharmacy Dexcom It is so much easier for whatever reason than going through Durable Medical, I don't know if it's the billing or just they're more efficient. I am now on a new insurance and in fact a durable medical so I'm not Yeah, thanks a lot. I got spoiled for a long time. But is is that the idea then to try to switch as many people as possible and as many insurers as possible to pharmacy and then my guess my question would be well, why? What's in it for you guys?
Kevin Sayer 9:20
Why is it good? for us is it's easier if we are going to have this therapy be used by all as one users and then later even type two knives when using patients. One of the keys is making it accessible and to meet patients where they are. It is not during the normal course of operations for anybody to go through the durable medical equipment process not only the patients but their caregivers. You know, endocrinologists are used to working with all the paperwork associated with durable medical equipment. While it's a hassle they understand it. Many people with diabetes using insulin don't see endocrinologist and in fact A good friend of my wife's she knew from childhood came and stopped by business not long ago. He's a year younger than me. He has type two diabetes, he went to his doctor and he said, I I'd like index calm, I can do really well with that. And his doctors and internist general practitioner, he goes, Yeah, I've heard the paperwork on that softball, I'm not going to do it. And that was the answer that he got. And that's not a good answer ever.
So the easier we can make it on everybody in the network, then the easier it is for patients to be compliant and easier to get patients on a system. And so we pushed very hard we have over 65% of lives in the US, covered lives and commercial insurance can go to the pharmacy now, but not all of them do. Most insurers insist that we have dual past durable medical equipment and the pharmacy but the most of our new patients and the majority of the new patients going on to Dexcom now are going through that channel. So we made a lot of progress. Would the advice be as people are watching or listening to if you are currently Durable Medical, call your insurer and see if it has changed. Or you can even call Dexcom or even call your insurance? See, we went again, when we get a new patient into our system, we try and determine if it's pharmacy. First, we try to determine where they can go and give them the path of least resistance to get their sensors, transmitters and everything else. So we do run a benefits check oftentimes for new patients, but not for the existing ones. They're buying product.
Stacey Simms 11:30
Well, I just went through that whole process. I won't bore you with the details. We have limited time.
Kevin Sayer 11:35
I'm sorry.
Stacey Simms 11:36
Thank you very much. I appreciate it. Your condolences are welcome. But it leads me we were talking about the VA and G6. This is a question you know, I'm going to jump to my listeners. We have lots of questions. And one that came up everyone of course is especially our listeners are so well educated, they're so up technically on everything. They're already waiting for the G7. I'm not even sure they want me to ask you about the G6 anymore. But the question that came up, and I think it applies to the VA as well as will Medicare cover the G7? Or should we anticipate issues with production? And all that that happened last time?
Kevin Sayer 12:07
know that? You know what? That's a very fair question. So I don't feel at all beat up by that we, we got an approval on G6 months sooner than we'd planned. We knew how much better it was in G5, we were planning on launching a system in the fall and instead lost it in the spring when we weren't ready. And we literally spent a year and a half trying to catch up. We have enough capacity now to build enough G6es to handle what we need very comfortably. And the factory looks so different than it was before. I mean, everything is literally automated robotic arms put every single thing together. And off we go. We are building that same infrastructure with G7 long before its approval. And the equipment we bought for G6 is not going to be applicable to G7. So we're starting over. But we are getting automated lines up and running for G7. Now we have equipment scheduled to come in over the course of the year. And in all fairness, we're not going to do that, again, we're not going to watch it for a group of people because we only have this much capacity, we're gonna when we go, we've got to be ready to roll the thing out, we will continue to produce the six because there will be use cases and geographies, then we won't flip to G7 immediately based upon our planning and our capacity, but we are going to we want to be ready to slip everything immediately. That's our goal. Right?
Stacey Simms 13:24
So the you're not anticipating a production issue. But in terms of and again, I know it's complicated when you're working with CMS. And when you're working with the VA, there's no reason to expect that there would be issues with those groups. Nope. Separate
Kevin Sayer 13:37
notion. We have been structuring our contracts in a matter whereby the G 6, 7 conversion, the simple what was difficult in the past are the durable components, the transmitter and the receiver, which he said and there's no transmitter everything's in the sensor, so we don't have to deal with that much anymore. And, and yet receivers, we will continue to sell them but it's getting much simpler, the same rules will be applicable. So we do not believe there'll be a big problem going from one sensor to the other reimbursement wise.
Stacey Simms 14:10
All right, so let's get to these questions. And some of these guys are very technical. So now I'm putting my glasses. Okay. I know you can't I don't know if I want to get it right. Okay, so Chris wants to know, what about plans for integrating data with reporting systems their partners use, for example, I have CGM going to my pump and the Dexcom app. Tandem has released t Connect. And the only reason that he's using the Dexcom app right now is the clarity, goal tracker. Any any ideas about further integration with the T Connect especially because people are going to start using that from their phones maybe next year.
Kevin Sayer 14:46
Yeah, we work with all of our partners, we were what we would like nothing more than to have all the data log into our clarity system to give patients that option. The the issue we have with it is we're all still Companies, you know, some companies believe this data is theirs, and they, they need it proprietarily it's been slow for us, quite honestly, to get data from all the other pump companies into our clarity system. We do have agreements in place where we're working on that we have that with Insulet. We're talking with Tandem about that. Now we're talking with other companies about it, we reciprocally are more than willing to give our data to be displayed into their app and their education systems. So we do share data with those who want it we have API's to whereby they can pull the data and display it if the patient gives them permission. And our criteria for accepting companies to take the data is not extremely difficult. If we view the something our patients want and need. We absolutely let them pull it through the API's. I think over time, you'll see us continue to share data and hopefully others will give us theirs. It isn't simple. Everybody has their own opinions.
Stacey Simms 15:53
Well, and that's another question that I've received in the past was kind of the API. I may not even be using this correct verbiage here, well, they remain open. Because there are lots of people who've developed secondary apps, some are fun, some are very useful to people. And I know that there has been a lot about open source in the community
Kevin Sayer 16:12
know our API interfaces are still there's a process one goes through to get that information. But by and large I there's a lot, I don't have a number 60. But I know it's certainly more than 50 could be over 100 companies who pull data from our API's into their system. And we have kept that relatively open and shared. Do I think you'll remain open? Yes? Will there be times when we say no? Sure. You always say no to something. So for example, if somebody says I want to dam the API, so I can compare you to all your competitors and say Dexcom isn't any good look at the other guys. giving you access to our API's, we don't we don't need that. We do view the data as the patients but we also view the infrastructure we build and the money we spent as investment we make for our shareholders. So it is a fine line to walk and we'll continue to look at it. Ultimately, we hope to have a live API and or whereby if you're running the Dexcom, Apple want the live data on your app, we can offer that option as well as certain partners. And you know, that's on fire with the FDA, we'd like to get approved relatively soon. So once that that's out there, we'll pick some companies and do it. But we also want it to be up to Dexcom standards. So don't we don't want to offer data to companies that are going to make horrible looking apps and great experience. We could tarnish our brand. So it's a balancing act.
Stacey Simms 17:33
All right. I may regret this. And we may I may run out of time, we'll have to see. Do you have a question? No, you want to say hi, my son has come in. And I'm on headphones now. So if you want to say hi, for real, he's just beautifully dressed for the occasion. And you say hello, real quick. This is the CEO of Dexcom you're making a wonderful impression
Kevin Sayer 17:51
Hey, hey, how are you?
Benny:
I'm good. How are you? I'm fine.
Kevin Sayer:
You got to ask me at least one question.
Stacey Simms 18:00
You’ve had the Dexcom since you were nine years old, really? No questions.
Kevin Sayer 18:03
What's your favorite Dexcom story that you could share with me
Benny:
Oh, my friend. And I were like messing around one time and we horseplay and he ripped the Dexcom off on accident but like just the the transmitter and like the the patch stayed on. So like the middle of it ripped off. But the the patch around it stayed on. And he freaked out and I like pretended to like die.
Kevin Sayer 18:31
That's awesome. Oh, wonderful. Thank you for contributing. Hey, it's nice to see you. Nice to see you. Mom's actually pretty cool. My mom would never let me grow my hair like that. So I'm gonna give your mom
Kevin Sayer 18:45
your mom, your cool.
Benny:
The CEO of Dexcom said you're cool mine. You have to use that.
Stacey Simms 18:50
Yeah. Yeah. I think quarantines gotten all of us. But I love you, sweetheart. I didn't mean it. That's what happens when you have a kid who takes care of everything he's supposed to take care of you let him wear a purple dinosaur snuggie, let his hair get crazy. You pick your battles. I appreciate that was very nice of you. (To Benny) Oh, see? We'll see if I don't cut any of it out. All right. Let me get back to the questions here.
All righty. Question about compression lows. Somebody asked me if they're if you are addressing this, I assume this will be as much of an issue with g7. But you know, you'll lean on it
Kevin Sayer: We don’t think that it will. That will be determined when we have more real world use than what we've had in clinical studies. Right now. We've got a number of of thoughts and technologies we're considering for compression. I can't give away all of it. But it is something we're working on addressing over time. Again, we have some ideas, I don't know that you can ever eliminate it because you're going to lean on it. And that's going to happen. We've looked at alternative platforms. We've looked at other technologies we've looked at longer insertion depth, shorter insertion depth, what is what are all these things do and some of the things that you think might fix it actually make it worse. So we'll look at it which Seven, you know, we are going to have an arm indication in addition to the abdomen with G7 running on both and for young children, the back of the box as well. So maybe there might be less patients on the arm for other patients, there might be more, but we we are looking at it, we do have some technology ideas that I won't give away, that might be able to fix it. So give us a little while and we'll see.
Stacey Simms 20:21
I’m just curious when you do these things, please tell me that you've got guys in the lab like taking naps laying on it. You know, it's not just a robotic simulation?
Kevin Sayer 20:30
Absolutely do we actually make go away on it for half an hour? Let's see what happens. We we do that, particularly at our feasibility studies, go away on us and see what we learn.
Stacey Simms 20:41
Tim wants to know, any plans for every minute data instead of just every five?
Kevin Sayer 20:47
I guess my question with that, and we've looked at this for years, what problem are you solving?
Kevin Sayer 20:53
is passing it along?
Kevin Sayer 20:54
When my no I'm so I'm gonna ask you the question I asked my team. So I'm letting your friend Tim be are the guys that work with me here? What problem you're solving by reading every minute? Well, you are solving a major problem, we would do that. And we've looked at that. Certainly you can possibly fine tune the algorithm better by recording video every minute or by transmitting every minute. Are you fixing anything for the patient? If we determined that that was a better experience for patient, we would absolutely address it. But right now, our patients are comfortable with five minutes. We haven't gone below that if you have an alert, you get it on a timely basis. Our alerts are very accurate in that timeframe. And so we're comfortable where we are we continue to research things like that. But our market research indicates that five minutes is absolutely fine for our patients right now.
Stacey Simms 21:44
I will devil's advocate by saying the response was from this is not Tim's case, but another person to chime in and say for very young children. They thought it would be helpful as someone whose child went ages two to nine with no CGM, I had don't have that perspective.
Kevin Sayer 21:58
Well, they're highly variable. And that could be a marker where it would be would be very helpful. Although that I learned every time we talk, Stacey
Stacey Simms 22:06
Well, you're more than welcome to use the Facebook group as a focus group anytime you'd like. We have some people you met one of them who thinks you know, looking at the Dexcom only when an alert is okay. And you have other people who have gone around the system because they don't like the two hour warm up. So some people can't get enough data. And some people who are 15 don't need any data. Yeah, there's a happy medium in there somewhere. I'm sure. I know we're gonna be running out of time. But I do have to ask the adhesive. It just seems that this year, there were changes. We've talked about it before. And while for some people it is getting better for some people, it is not. I know you're working on it.
Kevin Sayer 22:40
So let me walk you through that. We did change our adhesive. So let me be clear where and we talked about this before, we had what we felt was too many sensors fall off before the 10 days were up. And you know, if I bought a sensor, and it fell off today, and I want to I want to replace, and we replace a lot of sensors, we looked and studied a number of adhesives and arrived in one way arrived at based on numerous studies, we've not seen the irritation in our our trials that we've seen in the field. And in all fairness, the number of sensors falling off is decreased dramatically. And it is there many more sensors not falling off, and there are complaints about etc. So the trade off business wise, has been good, it has not been good for those patients who have that issue. We do have on the website, clinically proven alternatives and things that you can do to try and minimize that. There's anti allergy things you can put on your skin. There's a tape you can put on first and our tape over the top. We have studied the adhesive and the chemical composition of the adhesive a great length, we are doing some trials, just some in house studies to try some new patches to see if that helps. We've identified literally two agents that may be causing this. If we take those out, do we still have the same sticking power that we do now? So we'll look at it and if we can find a way to revise it, we will
Stacey Simms 24:06
when we talk to a couple of months ago, you were announcing CGM in hospitals. A lot of this was centered around COVID. Hoping to make it safer in hospitals. There's some newer information on that.
Kevin Sayer 24:18
How's it going? It has gone extremely well. You know, we've had over 200 hospitals reach out wanting CGM and we're in the process of getting it to tell them that eventually want to buy it. We're in over 100 now, we've now set up a registry so we can gather data from these patients. This was such for lack of a better words of fire drill, we started because there were so many people in hospitals, so many people so sick that we had to get it out there. And we literally learned new things every day. For example, the receiver really doesn't work because it's still there with the patient. They they needed phones. You don't want any individual nurses or caregivers phone, we had to give phones to the hospitals and we had to get through the IT systems and hospitals. Now that we have a pretty good idea how this works, we're creating a registry whereby we can gather data on these patients, you have to consent for us to gather your data, although you want to gather data about their healthcare experience in a hospital that came in with COVID, what drugs are they on? How are they treated, if they leave the hospital sooner or later, we want to gather that data. So we can use that to give us a basis later, at some point in time to go to the FDA and say, this will be a great hospital product.
Stacey Simms 25:26
This has nothing to do with hospitals, but it just occurred to me, there are a lot of diabetes camps over the last few years that have talked about maybe we could get every kid's Dexcom and put them on a screen in the infirmary or, you know, a generalized or, you know, a place where we could look at something like that. I'm curious. I don't know if that sounds like something that would even be possible.
Kevin Sayer 25:46
That's exactly what the hospital systems would want. They would want although CGM is going to one place, you know, we have to use the tools that we've got. So they would put sensors on patients, we'd hang phones next to them. And if they wanted to share follow on the hall on iPads or computers, they could and that was, that was literally all we could do. We got the clarity to whereby it could accept real time data. So we got that change as well to make this easier. But the right answer at the hospital, one of our learnings is we need that day to go to the place where it best impacts the workflows of the caregivers. And that would be a centralized app where you could watch numerous people at the same time.
Stacey Simms 26:25
Well, if you want a pilot camp, I could probably find several
Kevin Sayer 26:29
time we can try that. Maybe
Stacey Simms 26:31
before I let you go, I always have to nag you about follow, because Benny is now very responsible doing most of his care. And yet, when I look at the follow app, I would love to note transmitters dying, change this do that any plans to update follow to give a little bit more
Kevin Sayer 26:50
where we writing follow as, as I speak, I don't have released a party, but we are and put more of those same features in it. All right,
Stacey Simms 26:59
well, we'll circle back on that.
Kevin Sayer 27:01
We'll circle back. And I'm sure you'll have requests on follow even when we release the new one. And that's okay. I'm free is very clear, though. And your follow comment is perfect. This truly is becoming an experience, a consumer experience side product, what can we do to make this most engaging for you For you follow would be to have all that data. And I'm confident we can create that experience at some point in time, we need to find the experience that keeps people engaged and keeps them the safest. You know, we took a shot in the dark boy for started because nobody ever done this before. And here's what we can get done. And here's what we'll get out. I think over the next several years, what you'll see what next comments will create experiences that you can create more like your other apps whereby you can click on File, do you want the transmitted information? Yeah. Do you want that? No. Do you want in and literally create a menu and tiles and stuff similar to other software experiences that you have? So that you know that's a longer term goal? We can talk about that on another show.
Stacey Simms 27:57
I really appreciate it. I mean, Kevin, you've been accessible for many years to this podcast, and always answering our questions, whether they're the answers that people are hoping for or not, you're really upfront in a way that not every company is. And I do appreciate that. So thank you so much for spending time with me as usual. circle back around, we'll get Benny a haircut. And we'll talk soon.
Kevin Sayer 28:17
He can do whatever he wants. But yeah, thanks for having us again.
Stacey Simms:
You're killing me.
Announcer 28:31
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 28:36
Lots more information about Dexcom. And some of the other things that Kevin talked about at Diabetes connections.com. And as always, there is a transcript. We've been doing that for every episode in 2020. So if you want to share this with somebody who maybe doesn't want to listen would prefer to read or if that's you, and you're thinking, I want to go back and read all the episodes this year, you can do that, go to Diabetes connections.com. And click on any of the episodes from this year.
I mentioned at the beginning of the show that I would share a little bit of information about how I pick the guests book the guests and ask the questions. This came up in the Diabetes Connections Facebook group, it is Diabetes Connections of the group. I think it's a really good and fair question. And it came up because I posted Hey, Dexcom has asked if they can come on and talk about I believe it was the VA program and the hospital update. Do you have any questions for them? And a listener said if they're telling you what they want to talk about? Isn't that an announcement and not an interview?
Great question. I've been in broadcast journalism since I was 19 years old. And almost every time unless you're enterprising a story unless you're coming up with an idea and following it through. What happens is they will send a news release to you saying, here's what we want to talk about. Here's our big news. Here's what we want to announce. We are making the people available. And then you email back and say, great, I'm going to also ask about other questions. And if you don't agree to that, I'm not doing the interview. Sometimes you have to agree sometimes if you're going to get a particular kind of guest You know, everybody has their own guidelines for this. They make their own decisions for this. I don't think once on the podcast that I've had to do that. And that would be kind of silly. And I would certainly tell you if that was the case, you know, no one has ever said to me, You cannot ask about this.
I do give. And again, this is a little bit more inside information. I do give when I talk to the like, the real life people, when I talk to ordinary people living with diabetes, I tell them off air, hey, if something comes up, that's too personal. Just let me know. And we'll change direction. We won't ask about that. I don't believe I've ever had someone tell me No, I don't want to talk about that. But you know, you understand if I'm talking to just off the top of my head years ago, we talked to this great guy, he has type one, he owns an ice cream shop, his daughter has type one as well, they had a really interesting and kind of cute story. If I get too personal with him, if I started asking personal questions about his daughter, who was a young girl, and he may not want to share everything about their diabetes routine, or their school routine. I mean, we can think of anything he wouldn't want to share, that doesn't really matter to the issues at hand that I'm talking about with him that we're hoping to learn from him. But I don't do that. When I talk to the technology companies or the insulin companies or you know, leaders in our community when you have pressing questions. They don't have to answer the question. But I have to ask the question, and I don't edit that out.
In terms of who comes on the show. I regularly email when there's something in the news. Certainly, all the technology companies, if you have a question for you know, somebody, I'll fire it off to them. I'll say, will you come on. And you know what, I don't hear back from a lot of them. I have been trying to get Abbott to come on the show. Since the middle of the summer. I think we're gonna do it soon. But when Libre2 was approved, I tried to get them to come on. I think Libre3, they're coming on. Omnipod has told me no, we don't have anything to talk about right now. So we don't want to come back on the show right now. And there's nothing really wrong with that. It's frustrating for me, but I do reach out. And I try to get them on as much as I can. So you've let me know, I could do a tech diabetes podcast every week, ignore everything else, and still do great. I don't want to do that. I like talking to the into the wide variety of people that we do. But trust me, I know, they're popular episodes. And I try to get everybody on as much as I can. As I'm ticking off the names, I'm realizing I have to follow up with Tandem. We talked this summer about doing a second episode about best practices with control IQ. And we need to follow up on that as well. So I'm not trying to single anybody out and say they're the bad guys. It's just a matter of following up.
And if you don't know, and this is not an excuse, but just you know, again, as I'm just telling you everything here, this podcast is just me, I do have an editor who's wonderful. I don't have a producer, I don't even have an intern right now. It's just me trying to do everything I do and run other parts of my business as well. And you know, be a mom and do all those cool things. So no excuses. It's wonderful. I love doing it. But I think it's important to be open and honest about the process. I also do know there are groups that will not come on this show, because I asked tough questions. I mean, I think I'm nice. But it has gotten back to me that there are other outlets that are friendlier. There are people that will stick to a list of questions that will blur the line between sponsorship and content. And that's not what we do here. And I can't pretend otherwise.
Alright, if you have any other questions, let me know. I'm happy to answer them Stacey at Diabetes connections.com. I hope all of that made sense. I hope it was interesting to you. I think it's important information. Thank you so much to my editor John Bukenas from audio editing solutions and thank you so much for listening. We will be back in just a couple of days. Tuesday is our regular release day and hey, we have a new episode with Medtronic coming up. We went through all of the recent approvals what’s up next, what's up with their purchase of companion medical the makers of the in pen. So lots of info coming up in that episode, which will be released on Tuesday. Until then, I'm Stacey Simms and be kind to yourself.
Benny 33:54
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
There's new help for doctors who want to treat the person with diabetes and not feel overwhelmed with data. The people at DreaMed Diabetes are behind the brains of the Medtronic 780G system, but they're hoping to help thousands of people who may never use an insulin pump by making diabetes data a lot easier for doctors to use. This week, CEO and Founder Eran Atlas explains their Advisor Pro system to Stacey.
Study in Nature Medicine about DreaMed Diabetes
Join the Diabetes Connections Facebook Group!
In TMSG a big award for a doctor you all may know better as an Amazing Racer and I learn the word Soccerista.
Read about Emerson in her own words here
In Innovations – women and diabetes tech design. Read the DiabetesMine Article here
Sign up for our newsletter here
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's new book: The World's Worst Diabetes Mom!
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription (beta transcription - computer only)
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke. hypopen, the first premix autoinjector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:23
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:28
This week, there is so much data when it comes to diabetes that even your doctor would like an easier way to interpret numbers and make dosing recommendations. A new first of its kind technology called DreaMed may help
Eran Atlas 0:43
with the use of your system. I can stop being a technician I can learn to being a mathematical or an engineer, I learned how to be a physician and I wanted to continue to go and practice medicine. I don't want to go and practice engineering.
Stacey Simms 0:55
That's DreaMed co founder and CEO Eran Atlas, talking about the reaction he's getting from people who use their system will explain what it's all about and how it could help
in Tell me something good. A big award for a doctor you all may know better as an amazing racer, and I learned the word soccerista.
innovations. Let's talk about women and diabetes tech design.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I'm so glad to have you along. I'm your host, Stacey Simms, we aim to educate and inspire about type 1 diabetes by sharing stories of connection, as well as stories of technology. And that's what I'm talking about this week.
And I went into this episode, I gotta tell you sort of thinking it would be one thing, because I know many of you are very familiar with the technology and these companies. DreaMed is behind the algorithm that's inside the Medtronic 780 G, which was just approved in the US. And we actually are talking to Medtronic and our very next episode about that many other things. But the agreement with Medtronic and DreaMed was it was done several years ago. And DreaMed while I'm sure very proud of that algorithm, they've moved forward, they moved on they want to talk about something else. It was very interesting for me to go through this interview, and I hope you enjoy it as well,
for more of the mundane, less technology and more basic, how much more basic can you get with diabetes and insulin? I'll give a quick update at the very end of the show. I had mentioned in a previous show, we had some insurance changes, a bunch of you wants to know how that was going. Hey, yay, insurance changes are always fun. So I will talk more in detail about that at the end of the show. But in terms of insulin, yeah, we're switching types. Don't you love that? We had been on novolog for many years. And then when Benny was I want to say about eight or nine. We switched insurance and they switched us to human log and we have been on that ever since he's 15 and I guess it's time to go back to no vlog. So I'll talk more about that at the end of the show. Luckily, we don't have any issues or haven't had so far I know a lot of people do. Fingers crossed. So yeah, insurance update and more at the end of the show. All right. Interview with the CEO of DreaMed in just a moment.
But first diabetes Connections is brought to you by One Drop. One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drops glucose meter looks nothing like a medical device you've seen this. It is sleek, compact, seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to One Drop to keep track of the big picture and easily see health trends. And with a One Drop subscription, you get unlimited test strips and lancets delivered right to your door. Every One Drop plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doctor visit your personal coach is always there to help go to Diabetes connections.com and click on the One Drop logo to learn more.
My guest this week is the co founder and CEO of DreaMed and is really company with the slogan we treat the data you treat the person Eran Atlas talked to me about everything from their partnership with Medtronic. As I said they develop the algorithm that's inside the newly approved 780 G to their newer technology. And this is all about helping doctors better interpret the data they're getting from CGM and pumps. He mentioned a brand new study on this, comparing their algorithm very favorably to outcomes from Yale and Barbara Davis diabetes centers. And I will link that up in the show notes at Diabetes connections.com. I learned a lot from this conversation. I really hope you enjoy it as well. Here's my talk with Eran Atlas of DreaMed.
Eran, thank you so much for joining me. I'm excited to learn more about this. Thanks for coming on.
Eran Atlas 4:49
Thank you very much for having me.
Stacey Simms 4:50
All right. Tell me just generally, what is DreaMed What does this mean for the diabetes community?
Eran Atlas 4:56
Well, you know, for a certain amount of years A lot of effort has been invested on, let's get more accurate glucose measurements, let's get more continuous glucose measurements, let's get those glucose measurements and insulin measurements being connected. And everybody told us that if we will have more data, more accurate data, more accessible data, all the problems about managing people with diabetes will be solved, right, because the patient will be more knowledgeable, the providers will be more knowledgeable, will have the tools to get into a better decision.
Now DreaMed started as a technology team within one of the biggest Institute's that treat people with diabetes, Type One Diabetes here in Israel. And what we saw there is that data is not all and and sometimes in order to make this analogy, these logic thinking between data and decisions, there is a lot of gap that you need to jump in order to make that move. You need to be experience, you need to know what is important, what's not important, and you need to be able to make the right decision in the right time for the right patient. So what dreamed is taking on is we would like to take the responsibility of allowing providers and patients to make better decisions about insulin dosing.
When we started in 2007, the Holy Grail was okay, let's try to develop these automated insulin delivery algorithm that will make these decisions in real time. And we managed to do a prototype and we published these results as were the first publication in New England Journal of Medicine. And finally, after didn't several clinical trials send people home, we were the first group in the world that sent people home with automated insulin delivery, we licensed that to Medtronic diabetes. But the cohort of people that are going to be using are currently being using automated insulin deliveries pretty small depend on the amount of people with diabetes type one type two that needs to make decisions about insulin. So what dreamed is now focusing is on developing those and commercializing those algorithms that will be able to take all the vast amount of data that's out there, and it can be accessible from cloud to cloud, mobile and everything. And how do we get into the most accurate, personalized decision about how much insulin a specific person with diabetes need to infuse? Not just in terms of real time, but more about looking on the treatment plan? How to optimize carb ratios? How to optimize basal treatment, how to optimize insulin sensitivity factor? What is the difference between a patient on an insulin pump to a patient that is using multiple daily injections based on only different kinds of types of injection regimen? That's what DreaMed right now to do. So we would like to make sure that we will treat the data. So a person with diabetes can continue to live in a provider can start dealing with the person that is in front of them and not just looking into the computer, making himself a technician with numbers and decide what to do.
Stacey Simms 8:04
you have heard the podcast. So you know, I'm easily overwhelmed by data and information. I listened to everything you said. And here and I'm trying and here's what I heard. We want to make life easier for you. There's too much information that comes your way even with accurate CGM. Even with automated insulin delivery, there's so much data and information that unless you are a numbers person, you know, you may not be able to crunch it yourself. And I know you, you mentioned already a lot more down the road. But if I could focus on that the automated insulin for just a moment and come back to some of the other things. Can you just tell me as I'm listening and please correct me if I'm wrong, Vinnie, my son is using control IQ with the algorithm that's inside the Tandem pump using partnering with Dexcom. Is this sort of that? Is that the first step that you're talking about when you talked about automated insulin? Is it the algorithm that controls the pump in the CGM together?
Eran Atlas 8:56
Correct. We started in 2007. Building such an algorithm at the time we called him the medical doctor, the MD logic artificial pancreas. And the idea of what is different between the algorithm that we developed back then and the one that you have right now in control IQ, is how do you make these real time decision about how much insulin to infuse and, and while control IQ, as you may know, is using MPC technique, a Model Predictive Control, and you have that model of Medtronic that uses a different kind of type of control. It's coming from the engineering world, we were strong in understanding how physician analyze data and what we did is we took a technology called fuzzy logic, and I thought you know what fuzzy logic is but I'm sure you have it in your washing machine, and you have it in trains in China and everything. And the idea behind fuzzy logic is that you know why the world is not one and zero black and why there has to be a mathematical way to make decisions based on gray areas. And it's pretty much the way that we're thinking as a person.
So, we took his the way that physicians analyze data, make a decision and automated using dispatches fuzzy logic. And we develop these automated insulin delivery algorithm. And we tested it and when he got the the ability to communicate with Medtronic pumps, and now, we have our some part of our algorithm is going is inside the Medtronic 780G that they announced that they got to see mark for that in June DC or in there, I'm sure that they're going after that the FDA, the main difference between what we did and what happened in control IQ and Medtronic 670 G, is the fact that we were the first that play with the changing automatically both the basal and bolus. And we have the ability to predict glucose into the future and dose insulin based on the predicted glucose. Some of the elements that we have, you have also in control IQ. And I noticed Ctrl Q is working pretty well. But one of the things that we had in that time is the understanding that there's a lot of sensitivities off the patient that these AI D algorithm will need to use. So for example, when you are using your control IQ, you still need to go through your meals, right? So you need to optimize your carb ratios. And some of the safety limits are still dependent upon the insulin sensitivity factor off the pump or the open loop basal rate of the pump. So the algorithm is like riding on that basal rate. So we had a similar methodology. And we developed these what we call today, the DreaMed Advisor. It's that algorithm that optimize the sensitivity factors. So I back into the time we have two pieces of our technology. We only licensed one of it to Medtronic. And we continue to develop the other one because we believe that the other one will have a much more larger number of people with diabetes.
Stacey Simms 12:01
So tell me about that other one, where will it be used? Or you're talking about people with type two or people who use insulin, any type?
Eran Atlas 12:08
So that's an interesting question. So we just we started with an algorithm that basically optimize open loop pump therapy, and we took data from CGM at the beginning. And history of pump delivery basically did an automated way what any physician is doing in the clinic right now. And we developed that technology we got we won a grant from Helmsley Charitable Trust back then in 2015. I out of 70 applicant applicants got $3.5 million to evaluate the performance of this algorithm versus doctors from Joslin Diabetes Center, the School of Medicine yell, Barbara Davis in Colorado University of Florida, within three sites in Europe, with the intention to show that if you are a physician, any kind of type of physician that uses all algorithm, you'll get into the same clinical outcome as if that patient data was analyzed by doctors from these leading academic diabetes centers. And yesterday, the results of the study were published in Nature medicine, showing that we are doing the same outcome. As expert Doc's. If you can think about it, 60% of the cohort, we type 1 diabetes, the adults one are being treated by primary cares where we can do to the to the glucose control of these patients, if we will equip those primary cares with a technology that helps them analyze data and get the same performance as special endocrinologist, what we can do to the touchpoint of changing the insulin treatment of a patient, if instead of the patient will need to wait 3, 4, 6, 8 months to see his endo will have some sort of virtual place that he can send the data and share the data with the algorithm the algorithm will make all the calculation and recommend how to change the insulin dosage or the insulin treatment plan of that patient. So that was the what we did so far. And when we approach FDA, we that FDA didn't know how to regulate such a device. Yeah, because there was no predicate to what we offer to FDA to do. So what we managed to do with a very strong partnership with the FDA team is to decide and we will regulate this device as a new product. So in 2018, we got FDA clearance based on 510 k de novo. So we are the first in the US system that regulated a product that an algorithm can take continuous glucose sensor data and make recommendations to our healthcare providers how to optimize insulin treatment for our patients.
Stacey Simms 14:44
So I'm trying to break it down because that does sound like such a useful tool. I'm an adult with type one, I'm seeing a general practitioner who may not know the nuances of treatment, they take my CGM data, they take my dosing data either I'm assuming either from a pump or from me They send it to your service, the care provider, the doctor then gets the data back and can give the patient advice based on your technology using the expertise and you know, from the algorithm. And that new study said that advice is comparable to Yale and Barbara Davis and all the places that you indicated. Did I get that right?
Unknown Speaker 15:21
Exactly.
Stacey Simms 15:28
Right back to Eran in just a moment. And he's going to be explaining their agreements with other diabetes groups like Glooko, like Tidepool, but first diabetes Connections is brought to you by Dexcom. And do you know about Dexcom clarity, it's their diabetes management software. And for a long time, I just thought it was something our endo used, you can use it on both a desktop or as an app on your phone. It's an easy way to keep track of the big picture. I try to check it about once a week, it really helps Benny and me dial back and see longer term trends, and help us not to overreact to what happened for just one day or even just one hour. The overlay reports help add context to Benny's glucose levels and patterns. You can even share the reports with your care team, which makes appointments a lot more productive. managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at Diabetes connections.com and click on the Dexcom logo. Now back to my interview with Eran Atlas
Eran Atlas 16:27
And the way that it has been flowing in so we sign a data partnership with gluco. With Dexcom, we take all we have our own platform, so the patient can download the data at home, he doesn't have to get physically to see the provider, which is super important, especially now when it COVID-19 is and then the data is coming to our system, all the provider needs to do is just push a button request the recommendation here we'll get that recommendation and nothing's going to get you know, blurred the things you know, please consider looking on. He will get exact numbers that the algorithm will tell them listen at 6am change the call ratio, that specific patient from one to 15 to one to 10 exact numbers.
Stacey Simms 17:11
All right, I have two questions. From a very practical point of view. I'm curious if you've run into a provider who says I can do this better? I don't need this. Sure. I don't know the difference between Lantus and Tresiba. I'm a general practitioner. But why do I need something like this? Have you run into resistance from providers? Or are they I could see the flip side, thank goodness for taking this off my hands because I don't have the time to learn all of this.
Eran Atlas 17:37
So there are two types of providers. So first of all, that the approval that we have right now the clearance that we have with FDA is just for type one people on insulin pump, we are pursuing the advance of the indication for use for the injection cohort and with the intention to submit it by the end of the year. But in the study that we did, and right now we are we already deployed the system in several clinics around the US. You know, we are in Stanford University, University of Florida, New York University, Texas Children's so that we are already people who have already more than 1000 people that use the technology. And so when we heard for them, these couple of things. So number one, it became they curious, they want to check, we want to make sure that we didn't make any false recommendations. And they're not agreeing 100% with anything that we are recommending. So we always allow them to edit. If there's anything that they would like to edit, they can edit it before they share it with a patient. But as time goes on, and they building their confidence with a system, they are relying on the system, and they're really feeling how they've helped them. So for example, Dr. Greg Forlenza from Barbara Davis said, you know, what would you use of your system, I can stop being a technician, I can learn to be a mathematical or an engineer, I learned how to be a physician. And I wanted to continue to go and practice medicine, I don't want to go and practice engineering. So this is one of the feedbacks. And I think that when we'll code to the mass numbers of providers, there will be different kind of providers, some of them will be resistance, but I think that one thing we'll see the clinical benefit and the response of their patients, I think that it will endorse that and it will build our confidence with it.
Stacey Simms 19:17
I love that that he doesn't want to be an engineer, he wants to be a physician. We should all be so lucky to have a doctor who wants to do that. My other question on this and I'm apologizing just throw things at you to mess up the system. But the first thing I thought of was somebody like my son who's a not an unbiased person, but he's a great kid. He is not a perfect diabetes person. Perfect example that I think would mess up your algorithm. This morning. He had I don't even know coffee, hot chocolate glass of juice. I don't know what he had. But he had something as he's going to virtual school to. He's he's right down the hall for me so I could go ask him, but I can see that his blood sugar has already gone up to 140 it'll drift back down thanks to control IQ. I don't know if he bolus for that drink. If or If people just after, what is the algorithm do when people aren't, quote, perfect diabetics, because you can adjust the carb ratio and the basal rate all you want, but most people with type one aren't automatons who are going to fit an algorithm?
Eran Atlas 20:14
Oh, that's an excellent question. I think that at the end, if you are creating something for the use of people, you have to understand that nobody's perfect. And you have to make sure that the recommendation that you are providing will be a right on the spot, because otherwise it will cause safety issues. So what we are doing, when we're taking the data, number one that we are doing, we are trying to split that data into events, and understand, okay, that's a meal event, that's a bonus event, that is events that usually debatable could make an influence because there's no BOCES a meal. Before afterwards, we also apply different kinds of techniques to automatically detect places where the patient ate, and the bowls for that, or didn't report the name use these calculator in order to calculate the amount of light and and then for each one of the events, we are trying to ask the algorithm is asking himself Okay, is it a issue of dosing problem? Or is it an issue of behavioral problem? Do we see the high glucose posted meal because the carb ratio is wrong, or because the patient just deliveries, bolus 1520 minutes after the meal, and there's no way that the glucose could be down? So we are from our experience, because we are so much integrated with doctors that understand data. And because you know, I'm here, ces 2007 is closing my 14th. year on February, we know so much about people with diabetes, how they behave. So we programmed the algorithm in that way. So the recommendation that we are delivering is on the spot. If we're saying that we don't have enough events that imply on changing and dozing will not issue that we can personalize even the behavioral messages and calculate what is the most important behavioral that will improve the timing range. And we're not issuing 20 types of behavioral messages. Learn to be have a message note, we're issuing no more than three. And we're very specific. So if we're seeing something that happened specifically on the breakfast of Benny world, tell him listen, Benny, please pay attention on breakfast, deliver the insulin, 10 minutes before the meal, because that's what's set what makes your entire day being hot. Or if we're seeing that when he has an iPhone, you just eat whatever he finds in the refrigerator. And we see it from from the dynamics, we're trying to teach him how to compensate for a high pole in a better way.
Stacey Simms 22:46
It's absolutely fascinating. I think that's tremendous that you're building in the behavior as well. And you can really account for it back to the automated systems. And forgive me, Eran, you used a term open loop rather than closed loop and pardon my ignorance, you explain what that is?
Eran Atlas 23:02
Sure. So open loop is what we call using pump therapy with CGM or with self management blood glucose meters without any ID system. So though some people call it sensor augmented pump therapy, some people say just a regular insulin pump therapy. Some people say it's open loop, there is no algorithm that closed the loop in real time and command in real time how much insulin to infuse on an insulin pump based on CGM data.
Stacey Simms 23:33
Okay, if we go back to the algorithm that is more closed loop and kind of looking ahead for what you're planning on that we've already talked about mealtime, boluses, and how challenging they are for people, whether it's estimating correctly or remembering to do them or doing them late. What's your plan for that? I know there were a few AI systems that are looking to try to do away with a manual mealtime bolus is that in the cards here.
Eran Atlas 23:56
So for us is not on the cards at a moment. I think that what we are trying to look is is beyond the AIP system. It is how to help those with type two on insulin, how to have those on injections because think about it a couple of years ago, nobody knew what's going on with people that still doing injections, right? None of them knew CGM you didn't know what's going on with injections because they didn't record that or they just cheating and when they sat in, in the reception area of the clinic, they to complete the paper and and try to make lottery on when they did at those doors. They're instantly now these days been available thanks to the hard work that Dexcom you know avid Medtronic is doing on the CGM space and companies like companion medical and others they're doing you're connected to and and we know other efforts of other companies. You know, no voice is doing that Louie's doing that. So all of a sudden the same problem that we had a couple of years ago when people on CGM and pumps for the type one persons and depression And the amount of data, we're not going to have it in a much, much broader population, you have about 12 million people that dose insulin in the US, but only 1 million of them are on pumps with type one. So the question is, what are you going to do with these 11 million people? And that's where our focus on that's number one, another focus that we are looking at is going into contextual data? And how can we know and combine the fact that we can know where you are from your personal life in terms of you know, if you are driving or you are walking, or you are going into a restaurant? And how to combine that information with the glucose data? And what predictive real time notification we can give you in order to improve that, and the glucose control?
Stacey Simms 25:49
Alright, wait, wait, you're gonna know where I'm driving? I'm walking to a restaurant. Wait a minute back up? Are you in my this is something in my phone? Are you using cell data?
Eran Atlas 25:58
That's easy. You know, when you're driving? Do you have a Bluetooth in the car? Yes. So the phone knows that you are connected to the Bluetooth of the car, right? Yes. So for example, if you will give the permission, our application will be have the knowledge that you are driving? Are you using navigation software?
Stacey Simms 26:17
Yes. Do you have to lift or no, I don't mean to interrupt your train of thought here. But for some reason, I just thought of the Pokemon Go app from a couple of years ago, because it knew when my kids were in the car and not walking, right. I mean, I know I sent you're probably laughing because I sound so ignorant with this stuff. But yeah, with our cell phones, I'm sure that everybody knows where we are at all times. It's
Eran Atlas 26:37
amazing. That's right. But I think again, so I'm not talking about you know, poking your privacy and everything. And it's have to be on a certain things that that the user will need to authorize, or the benefit of the user, but but potentially, many will learn driving, like they will go into any driving license, I'm sure that nobody wants a person with diabetes, that these glucose is going down or predicted to be down in next 30 minutes to start driving.
Stacey Simms 27:05
So would it give in your system, would it then give a reminder, um, you know, I'm walking into a restaurant time to bolus Is that what you're envisioning.
Eran Atlas 27:13
So again, your glucose is dropping in the next 30 minutes it please take something before you start to drive. Or we're seeing that you're going into a restaurant and you're using glucose is sky high, or going high and the high trend, please correct your glucose now before start eating, because then it will be much more difficult to correct your glucose. These are the types of things that you know are examples of how you take context and combine it together with glucose and insulin data.
Stacey Simms 27:41
It's so interesting to me, because I think, especially with the type two community who use insulin, it's a very different world than the type one community where most people well, I'm biased, because my podcast audience is so well educated. But people are thinking about it so much more often. I have lots of friends with type two, who dose insulin who don't really think about it, who don't really know, just because they're, as you said, they're seeing a general practitioner, they're not as educated. It's not a it's not a personality flaw. And I could see where this would be so helpful. Just these reminders with people with type two, have you already learned any nuances of how they want to use this kind of system? Is it different than people with type one?
Eran Atlas 28:22
So I think that within the type two population is very much dependent when there are on multiple daily injection therapy, or they're just doing basic only. So that's one big difference between type two and type one another big difference is Yeah, like you said, they're thinking about the condition differently. They are denying the fact they have a condition. I think that's much stronger than people with type one, especially teenagers with type one that you know, try to break the system and try to see what's going on. But it's still you need to find other ways to do that. And we're still studying eighth, what is the best way to deliver that to people that have type two diabetes. And that's why initially we're focusing on their providers, and try to better understand what people that are treating people with type one diabetes would like to see how we can help the providers provide a better treatment for them. That will be our first step, then when we will get these endorsement and understanding about the actual users will be much more comfortable to offer something that will go directly to the user because as you said it truly it's a different population. I remember
Stacey Simms 29:31
years ago, there was a big push and I know you were you were around. If you started in the mid 2000s, there was this big push to almost gamify type 1 diabetes, right with apps that kind of gave you rewards for checking or here's a game that would help kids learn or even adults. And it turns out that most people didn't want to think that much about it. They just wanted the system to take care of it like stop reminding me to log stop reminding me to dose handle it. Talk to me about how DreaMed will do that. Even though You are talking about reminders,
Eran Atlas 30:02
because I think that the difference between the reminders that are in the market, they used to be in the market. And what I'm trying to talk about is that those reminders were based on general timeframe. So for example, you know, you're logging into the app that you need to take your basal insulin between seven and 9am. And and now it doesn't matter if you are going just to go into deliver that it will be some sort of mechanism to just ping that, that reminder to you and will drive your crazy, right? I think that what dreamin is trying to do is a couple of things. Number one, we're not just giving them regular reminders, we're giving actionable reminders, so it will tell you to do something, because this is the right time for you to do these actions. And number two, we are trying to take off the burden of treating diabetes, you know, taking the burden off thinking about your glucose and thinking about what you need to do right now, for people that use a ID system. This is exactly what he gave them, you know, you know that there is something that looks on your glucose on a regular basis every five minutes, analyze the situation and provide your the actual dozy, but on people with with multiple daily injections are not using pumps. So there is the only way to make the insulin injected is to make some sort of a partnership with a user. So that's what we're trying to do. We're trying to create all the mechanisms that will bring this partnership between the person with diabetes on injections and the algorithms, we're trying to make sure that wherever we are issuing some sort of reminder, it will be an actionable one. And and hopefully it will be within a certain timeframe that the user is willing to accept such a reminder, because for example, if you're driving and then the system is shouting out, give insulin right now there's no way that you're going to give that insulin right because right now you're driving. But if we're able to capture the exact moment that you're open to get that reminder, and this international reminder, it's not a general one, I hope that people with diabetes will find it useful. And I think that's the thing that we are trying to learn together with the community. And to be are we personally diabetes at work for us, because at the end, it's a partnership between the person, the provider and the industry. And that's what we're trying to create. It's important for people to know that there are companies that are not in the US and might be a little bit small, but they are trying to make a difference for you. And I hope that together with what we're trying to do and what the community is trying to do, when we are partnership, we really, really be able to make that difference. Because the culture of dream ed is coming from a clinic. It's a company that the importance of making lives better is on our culture. Another thing in our countries, make sure that whatever we're issuing has a clinical benefit. We're just not not just want to have a cool product and just get more money. And I really, really optimistic about the impact that we can do on people with diabetes. And we're committed to do that
Stacey Simms 33:14
around before I let you go. Do you mind if I ask about the population with type one in Israel? Sure. I'm trying to think I know in Scandinavian countries, it's very high.
Eran Atlas 33:23
it's debatable, but it's between 30 to 50 k people in type 1 diabetes in Israel, this is it. But we don't have a lot of people with type 1 diabetes. If you're looking on the pieds all the peas are being treated by you know, academic centers, big hospital clinics, the clinic that I'm coming from, is pretty much treating a very large portion of this of the kids and adults are usually go in the same way either to a specialist, but the most of them are going into two primary cares. Where were very techie we were had a lot of a lot of people on CGM and insulin pump. We currently don't have control IQ and ease rail. It's not approved so and 670 G is not reimbursed so the majority of the cohort here in Israel are on regular pump and CGM.
Stacey Simms 34:11
This is well as I said, before we started taping, my son is planning a long trip to Israel next summer. So maybe knocking at your door if you're just some hand holding.
Eran Atlas 34:22
I will be happy to I will be happy. Don't worry. Yeah, I think I can vouch for that.
Stacey Simms 34:29
Everyone, thank you so much for joining me in explaining all this. I really appreciate it. I hope we can talk again soon.
Announcer 34:39
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 34:45
More information in the show notes Just go to Diabetes connections.com. And every show has show notes we call them I call it an episode homepage as well because not every podcast player supports the amount of stuff I put There, every episode this year has a transcript. Every episode ever has links. And so sometimes if you go to Apple podcasts or if you listen on, you know, Stitcher or Pandora, or wherever you listen, and we are everywhere, right now, they don't support the links. So if you're ever curious, or you can't get to something, just go to the homepage and find the episode, there's a very robust search, because we're up to 325 episodes. So I wanted to make it easy for you to find what you were looking for. But when you do that, you can find more information about DreaMed, and I linked up the study as well that he mentioned, comparing their algorithm to doctors at Yale, that sort of thing. You know, I'm curious, as you listen, what you think about something like this, I feel like this podcast audience is so involved in their numbers in a way that most people in diabetes land are not. I mean, let's face it, there's very few people who are interested in DIY stuff like this audiences. I mean, I know you guys, you're very technical, you're very involved, even if you're listening, saying, hey, that's not me, the very fact that you're listening to a podcast about diabetes puts you in a different educational plane, then, you know, 90 95%, let's say, of all people with all types of diabetes, which is not a knock on them, it's just the reality of diabetes and education. So I'm really curious to see how this can help. Because as he's saying, you have a general practitioner, who's treating people who's dosing insulin, right, they're given the prescriptions out. And an algorithm like this can make it so much more precise and safe for the people who are getting those recommendations from these doctors who, you know, might really want to do good, but do not have the experience of the education in at a chronology. So that's my stance on it. We'll see what happens I'd love to know what you think. All right, innovations coming up in just a moment. And I want to share this article I found about women in diabetes a device design, but first diabetes Connections is brought to you by a new sponsor this week. I am so excited to welcome g Volk hypo pen. You know, almost everyone who takes insulin has experienced a low blood sugar. And that can be scary. A very low blood sugar is really scary. And that's where evoke hypo pen comes in Jeeva is the first auto injector to treat very low blood sugar. evoke hypo pen is pre mixed and ready to go with no visible needle. That means it's easy to use, how easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes connections.com and click on the G Vogue logo. g Vogue shouldn't be used in patients with pheochromocytoma or insulinoma, visit Jeeva glucagon.com slash risk.
saw a great article that I wanted to pass along to you from the wonderful folks at diabetes mine. And the headline on this is where are the women in diabetes device design? And I'm not going to read the whole thing to you I will link it up. But the question here was all about our the shortcomings of diabetes technology a result of just the the functional design requirements the way it has to be made? Or could it be related to the fact that there aren't enough women in the medical technology design field, they did a whole survey about you know wearing this stuff, and you know where to attach it, how to put it, you know, dresses, things like that, which you know, at first, listen may sound kind of silly. But when you think about it, wearing the device, the comfort of wearing the device, the mental stress about wearing the device, these are so incredibly important, because people with diabetes men and women, as you know where this stuff 24 seven, I mean, you think about the difference between something that is clunky, that looks outdated, that, you know, just doesn't feel right in your hand. I mean, these things make a big difference in terms of how I hate to use the word compliant, right, but you know, how well we use them how much we use them how comfortable we are with them, in addition to focusing on the pump companies, and in particular Omni pod, very, very interesting take on women who work at Omnipod there, they also focus on women designed accessories for diabetes tech, because when you think about it, and they list all of these companies, you know, we've talked about a bunch of them in the past myabetic and funky pumpers spy belt tally gear pump peels, one of my book to clinic sponsors, thank you very much pump peels, these are all founded by women, because they saw the need and wanted to make life easier and better. So I'll link that up. I really thought it was a great look at a topic that we hadn't thought a lot about before. We focus a lot on what patients need to be involved people with diabetes who actually wear the gear need to be involved. But what about people who wear the gear differently and have different expectations and that by that I mean women. My daughter when she was in high school, wrote a whole paper on pocket equality and did hard research into why women's clothing doesn't have pockets and rarely has pockets that are big enough. I mean, my son puts his phone and his palm I don't know, you know, a lunchbox in his pocket, and he can fit everything in there. He doesn't think twice about it. But sometimes I think about where the heck would I put a pump, if I was wearing what I'm wearing today, right, I have any pockets. Really interesting discussion and hats off to diabetes mine for focusing on that innovations is also your chance to share hacks and tips and tricks that work for you, you know, just little things that make life better with diabetes. So you can post in the Facebook group, or you can email me, Stacey at Diabetes connections.com.
Didn't tell me something good this week, a big award for a familiar face around here. Most of you remember Dr. Nat Strand from The Amazing Race. She was the in the team of Nat and cat. And that was The Amazing Race 17, which I can't believe was 10 years ago. We talked to Dr. strand, earlier this year about working as a physician. And during this time of COVID. And how she was treating her patients. She treats patients with chronic pain and that sort of thing. And we're talking about her on tell me something good, because she is the inaugural winner of the Lisa Stern's legacy Diversity Award from the American Society of pain and neuroscience. So congratulations, Dr. strand. Of course, the ceremony was virtual, but you could follow her on Twitter and see the pictures and see what nice things people are saying about her and I will link up her Twitter account if you don't follow her already. Also, in Tell me something good. Something that popped up in my local group. Brian shared a post about his daughter Emerson about diabetes and soccer. And he said I could share it. And it's actually a story about her. It's a story by her. It is Emerson's sucker rista story playing with diabetes. And this is a column that Emerson wrote that is published on the girls soccer network, I would really urge you to read it especially if you have a child who is a high performing or wants to be a high performing or elite athlete. She talks about no days off. And how well you know I'm sure your mind went to diabetes. That was her mantra in terms of sports. And it has really helped her she says deal with soccer. And with diabetes. I'm not going to read her words here. I just think it's a great column I would urge you to read it I'll link it up on the episode homepage and I'm going to put it in the Diabetes Connections Facebook group as well. Well done Emerson really great to see the incredible hard work that it looks like you've been putting in and what a wonderful column as well. So thank you so much Brian for sharing that and for letting me talk about it a little bit here. If you have a Tell me something good story could be a birthday a diverse serie, you know, your child has published in a national print publication, you know, anything you want to focus on, that is good news in the diabetes community, please reach out and let me know, just tell me something good.
Tell me something annoying, could be the name of this segment, I just want to talk a little bit about our insurance changes, mostly to commiserate with with many who have gone through this. So as I said at the top of the show, our biggest change is now that they're going to switch insulin on us. You know, I talked to Benny about this, we are so fortunate to have a frankly, have a pretty good stockpile of insulin that we've built up. If you follow the show for a long time, you know that I've discussed his insulin needs went way up. And they have gone back down to almost pre puberty levels. But we never changed the prescription. So you know, I have unfortunately or fortunately, I don't know I have shared insulin in the Charlotte area with adults in need. We have some great local groups. And it is ridiculous that we need to do this, but we do share with each other. And I've been happy to help out on that. But we are basically out of pins. And I like to use pins as a backup. And Benny likes to have them for flexibility. You know, he'll take them sometimes. And if something's wonky with his pump, he knows he can get himself a shot, that sort of thing. But I hate the idea of changing insulins right everything's cookin right now everything's chugging along really well. I don't want to rock the boat. But I also don't want to pay $300 for a pen. So I'm going to be talking to our endocrinologist, Vinny has an appointment in two weeks, as I'm taping probably more like a week and a half as you listen. And we know we'll talk about it, then maybe have some samples, but most likely we will be switching and we did not have an issue when we switched in the past. So I have fingers crossed that it will be fine. It'll be fine. But that is annoying. And I know I don't feel like appealing and fighting if we don't need to. It's possible that novolog will work just as well for him. So let's at least find out and we'll go from there. The other issue was, of course, that we are now dealing with edgepark. And I will spare you all of the details. But I tried to do a workaround. And I'm laughing because I should know better by now. I tried to get the Dexcom prescription to stay at our pharmacy because man we've been filling it at the pharmacy for the last couple of years. And if you have already been able to do that, you know, it's like a dream. At least it is for us. It may take an extra day to get it but it's a day. It's not like they're mailing it out for you and it takes three weeks. It's been wonderful. And I just had on auto refill. And it's been great. But edgepark told me, we don't filter your pharmacy, you only can do it mail order. Well, I didn't want to wait. I didn't want to be cut short. So I let edgepark go ahead and fill the order. But then I did some detective work. And I kept calling and talking to people, because what else do I have to do, but be on the phone with these people? And I finally got someone at my insurance company to admit they would fill it at the pharmacy. But here's what she said. She said, Well, we don't like you to go to the pharmacy, because they don't often have it in stock. And I said, Come on, you know, that's not true. They can fill it in a day. They've been filling it for four years. And she said, Okay, well, you can you do a pharmacy benefit and, you know, blah, blah, blah. So I hung up the phone, and I will fill it at the pharmacy next time. I already have the order from edgepark through the mail. And I thought you know, that's just because my insurance company has a deal with edgepark. That's all that is. She's trying to discourage me from going to the pharmacy because that's their business. I get it. But how stupid is that? How outrageous is that? Oh, now you know why I saved it to the end of the show. I will keep you posted on our many adventures as this moves forward. Because Up next, I have to fill Benny's tandem pump supplies. And we've never been able to do that at the pharmacy. So I'm sure it'll be more adventures with edgepark my new pals. Ah, goodness gracious. All right. Thank you to my editor john Kenneth for audio editing solutions. Thank you. If you are still here, listening to me rant. I love you. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Benny 46:35
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All rounds avenged
Transcribed by https://otter.ai
What do you use to treat lows on the go? One of the newest options is a flexible necklace, filled with 15 grams of fast-acting glucose. The Thrive Glucose Gel Medical Alert Necklace is easy to take with you, rip off and open if you need it. The idea came to first responder Kris Maynard after his own severe low had to be treated by paramedics. His family had tried to use the "red box" emergency glucagon kit but missed a vital step.
More about Thrive Necklace from Glucose Revival
Kris also shares that one of his teen sons has been diagnosed with type 1 via TrialNet and explains how their family is coping with that knowledge.
Listen to our first episode with Kris when the necklace was a prototype in 2018
Check out Stacey's new book: The World's Worst Diabetes Mom!
New segment this week! Innovations – focusing on hacks and tips and tricks to make our lives easier.
And Tell Me Something Good!
Join the Diabetes Connections Facebook Group!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Real Good Foods, real food you feel good about eating and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:20
This is Diabetes Connections with Stacey Simms
Stacey Simms 0:26
this week, what do you use to treat those on the go? One of the newest options is inside a necklace. The idea came to first responder Kris Maynard, after his own low had to be treated by paramedics because his son didn't know how to mix up the glucagon correctly.
Kris Maynard 0:44
Why am I not carrying this for something that we know that works, and as an EMT, for 100% of the calls that I've been on for low blood sugar 100% of the responses have always been glucagon is just too much and it expires,
Stacey Simms 1:00
we'll talk about Kris's solution, the thrive necklace, and his son recently was diagnosed with type one. He shares that story
new segment this week innovations, focusing on hacks, tips and tricks to make our lives easier and tell me something good. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am so glad to have you on. You know, we aim to educate and inspire about type 1 diabetes by sharing stories of connection. I am your host Stacey Simms. My son was diagnosed with type one right before he turned two back in 2006. My husband lives with type two diabetes. I don't have diabetes. I have a background in broadcasting and radio and TV news. And that's how you get the podcast.
Quick birthday shout out to my mom. If you are listening today. This goes live on September 1. It's My mom's birthday. And she had a great line recently that I wanted to share with you. I was talking about how amazed I was with control IQ. We traveled back and forth from New Orleans recently to drop my daughter off at college. And Benny came with us. We rented an RV. I told this whole story last week, but it was basically you know, 11-12 hours in the car there. Same thing on the way home. And if you've done a long trip of any kind, you probably know that you need to raise your basal rates. We have done lots and lots of car trips. My parents are in Florida, we're in North Carolina, they spent the summer in Delaware. So we're all over the place. Except, you know, in the times of COVID, where we haven't traveled at all this was our first trip. Gosh, since everything started since March, probably but we've always had to raise Benny's bazel rates at least 50% that may seem like a lot, but he's very active kid and you know, sitting still, we really needed to increase basal rates by quite a bit over the years.
And of course now with control IQ, we don't change them at all and it does all of the work for us. I was absolutely amazed. For the two days that we were on the road. I only grabbed a screenshot of our trip there. I didn't look on the way home. But he was 84% in range for that time with an average glucose of 139, which I will take hands down any day, which it would translate, I guess to a one see if like 6.4 or 6.5. I mean, it's only two days. But that's if you're if that's how you look at the numbers, that's what you would get. Now, of course, when we got to the hotel, he fell asleep and didn't have insulin and his pump. He wasn't in my room. He was in my husband's room, so I'll blame them for that. I wait a minute. I know that. Nope. We got two hotel rooms. So I stayed with my daughter. My husband stayed with Benny and it was kind of nice to just have it was two days that we stayed there and it was really nice just to have some time alone with my daughter. But yeah, that's that sounded weird about the separate hotel rooms.
So that 84% range didn't last for another 24 hours but it was pretty close. I mean control IQ once you put insulin in the pump control Q does some incredibly heavy lifting for us. I was telling my mom about this, he was texting her about how great it was going. And she said, quote, sh—y disease, great technology. And I said to her, you know, I'm gonna send that to Tandem, because I'm sure they'd want to use that slogan. Anyway, thanks, Mom and Happy birthday to you.
We have a lot to cover. This week, I've added a new segment called innovations which will be coming up after the interview.
So let's get to it. Diabetes Connections is brought to you by One Drop, and One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drops glucose meter looks nothing like a medical device. It's sleek, compact, and seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to one drug to keep track of the big picture and easily see health trends. And with a One Drop subscription you get unlimited test strips and lancets delivered right to your door. Every one drug plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doc Visit your personal coaches always there to help go to Diabetes connections.com and click on the One Drop logo.
I met Kris Maynard more than two years ago, it was July of 2018. We did an interview on the floor of the friends for life vendor area. I mean, you know what I mean? on the floor of the vendor area, that big open area, we were sitting at a table, but doing the interview various how I realized my microphones were not meant to be held. I will link back to that first interview, and you will hear a lot of that (microphone noise). That's why I bought microphones standards.
But Kris Maynard's product that he brought to friends for life in 2018 was the prototype for what's become the Thrive Glucose Gel Medical Alert Necklace. He was there to get feedback, see if there was a need for the product. Kris is a first responder who lives with type one. At that same conference. His family went through trial on that testing. One of his teenage sons was found to have the markers for T1D, we've got a lot to talk about with Kris Maynard. Kris, thanks for coming on with me. It's great to talk to you again. I can't believe it's been two years. How are you?
Kris Maynard 6:11
I'm doing good. It's I'm excited to be here.
Stacey Simms 6:14
So much has changed. And I want to talk about not only your product and your family, there's a significant change there as well. But you caught my attention recently, because it looked like you were on Mount St. Helens. Can you tell me a little bit about what you've been doing?
Kris Maynard 6:29
Yeah, well, it's something I've always wanted to do. I mean, it's really a way that I really wanted to be at a test or product. And I've learned over the last couple years, how much I love diabetics. I love being around other people that's living with the disease. So I wanted to be able to just challenge other diabetics to join us into making that hike. And I mean, it was something that physically was the hardest thing I've ever done in my life. But at the end of the day play it was so enjoyable. absolutely loved it. How long
Stacey Simms 7:01
was it?
Kris Maynard 7:02
round trip? It was a total of about nine to 10 hours.
Stacey Simms 7:06
Now pardon my ignorance, but when I think of Mount St. Helens I only think of I think like so many people. I think of it as a an active volcano.
Kris Maynard 7:15
Yeah, yeah. Okay, just make sure I'm not wrong. No, you're exactly right. 40 years ago is when it exploded here in Washington State. And we live about five hours away from it, and it just covered our city with ash. And so I was I don't remember five years old or so at the time. And I just remember wearing the masks really, of what we see being worn around today.
Stacey Simms 7:41
I'm a child of the 80s I remember it's one of the the significant news events of my childhood like when they say what do you remember when you were a kid? You know, that's one of them. So living around the area, and again, pardon my ignorance, but people are allowed to climb now and you can go up there, there's no restrictions,
Kris Maynard 7:56
correct. But you need permits to go there. We actually bought Tickets before co started because in April's when they start selling the permits, and those permits sell out within the first day or two. And so we got ours then to where they only allow 100 people to go up per day. And so it just happened to be that last week was our magical day.
Stacey Simms 8:22
And you had a look at the pictures. You had young people, you had diabetes educators, was almost everybody in the group, part of the diabetes community.
Kris Maynard 8:30
Yes, well, the most encouraging thing to me was two things is one person during the first mile was ready to call it a day. It was just too complicated in that first mile, and we'd kind of just gathered around and saw where she was struggling and she continued on was able to finish it, which was amazing in itself because when we look back, that first mile was 100 times easier than the rest and then 13 year old who's got type one. And I just physically think how hard and how exhausting it was for me. And to think that that 13 year old, was able to do it, because he had his struggles along the way as well. But for him to be able to enjoy that with his dad was just, I mean, encouraging and motivating. For the rest of us. It was amazing that he was able to finalize that exhaustive day.
Stacey Simms 9:29
Did anybody need the thrive necklace,
Kris Maynard 9:32
three people used it. In fact, the 13 year old ran out of supplies. That was the last thing that he had on the way back in about two and a half miles left, which was amazing because the cell service on that mountain was better there. And sometimes in the some houses or buildings that we go in and out. So he texts me saying, Hey, we just ran out of supplies. I'm worried for my son. Who just ran out of his food, his drinks and everything else. And so he said he just used the necklace. I don't know what his number was, but and then afterwards, he said it bounced back up to 157. But there was also other problems that he was also going through between the cramps running out of water. So it really wasn't about the necklace. It was being with other diabetics making that climb.
Stacey Simms 10:28
Well, yeah, and I guess that's a good point. It's a good place to run out of supplies. If you're surrounded by people who also have their own. I assume that they shared with him or he got down.
Kris Maynard 10:37
But I mean, by that time, we were separated, we were actually done. And so I we had to drive back to the finish line. And a friend of mine that was with me, I couldn't make the trek back because my legs were just cramped up and stiffened up and the buddy of mine who's in better shape, ran that last two miles to be able to get supplies. So, the buddy was amazing. He was the former firefighter. And another person was able to call 911, just in case, and then to see him walk that finish line to where you wouldn't have noticed that he was tired at all, or that his legs were stepped up at all. So yeah, I mean, it was fun to be able to embrace at the end and just cheer him on. And that's really beyond seeing him at the top of the mountain and then seeing him finish no one the struggles that he went through.
Stacey Simms 11:30
Alright, let's talk about the thrive medical alert necklace. Give me your elevator speech. What is this? Yeah,
Kris Maynard 11:37
well, it's funny because when I saw it a couple years ago, at the friends for life conference, really still at that point, it was just an idea. And we needed to figure out if it was something that was wanted or needed on the market that kind of helped formulate along with messaging that we're going through with other diabetics on now we need to make something out of it. And so learning that 80% of the diabetics Don't carry glucagon. And from the EMTs perspective 75% of the EMTs cannot administer glucagon can't give injections or can't give IVs. And so I look at it from the EMT side and from the diabetes side. So really the elevator pitch for us is we have the only wearable product to be able to help with the most common issue that diabetics face which is low blood sugar by using what EMTs use, being able to use it for any level of low blood sugar from a low to a severe state.
Stacey Simms 12:35
No, let me just clarify that because I've always confused when I hear that one of the EMTs do how do they treat low blood sugar if they come across someone who needs that kind of help?
Kris Maynard 12:44
Well, I'll take you from a time that I was unconscious camping with my kids is that they take the glucose gel, bring it and rub it on their finger and just massage it on the gums to become absorbed. And it was funny because that But it happened to me. I've administered it many times throughout my career, but I just never thought of carrying it myself because we always had glucagon. Well, that time that the ambulance was called for me, my son administered the glucagon for me called 911. What I thought that he knew was how to properly put it together. He didn't mix the two together. And so that was our failure on teaching him. But that's when I thought, why am I not carrying this for something that we know that works, and as an EMT, for 100% of the calls that I've been on for a low blood sugar 100% of the responses have always been glucagon is just too much and it expires. And so at that point, we're just thinking of a cheaper alternative that's really easier to find.
Stacey Simms 13:53
So what was the reaction when you went from idea to product because when I last talked to you, we're not shipping as He said this was something more of a concept. What was the reaction?
Right back to Kris. But first diabetes Connections is brought to you by Real Good Foods, introducing real good entree bowls, real ingredients, high protein, gluten free and low carb. So what are they're talking about here they mean Mongolian inspired beef, lemon chicken, lasagna, chicken. Real Good Foods is here to make delicious foods. We feel good about eating. And by adding these entrees, you can really see where they're going here. They want to make nutritious foods across every meal, snacks, even desserts, but they're delicious ice creams readily available at the local grocery store. We can get our products at the Harris Teeter, they have them at Walmart. Now not everything is in every store so you can find their guide. Just go to the website. You can even get a great coupon right now. And you can order online for everything that they've got. Find out more about Real Good Foods. Just go To Diabetes connections.com and click on the Real Good Foods logo. Now back to Kris and he is answering my question about the first reaction he got to the thrive necklace.
Kris Maynard 15:14
overwhelming. Because again, I was thinking and an idea that day worked for me. And that's really where it was going to go to until my endocrinologist came back and said, You ought to make that available to all diabetics because you don't know how many or who you can help. And so that's when we took it to friends for life after that, and then seeing the reactions of people touching it. There was fun to see, in really all of this. The most exciting thing for me is being able to meet diabetics because before I went to that conference, there was only one other diabetic at that point that I've ever met or known. And now since then, I've met thousands. Each one of them. I get excited to meet because I love hearing their stories. I love seeing what works for them. And I love being able to share how we can help them as well.
Stacey Simms 16:07
So tell me what the necklace actually is. Can you describe it because obviously, this is a podcast, we're not looking at it, although I will link up the website so people can see what it is,
Kris Maynard 16:15
yeah, thrive glucose aid. It's implemented as a medical alert necklace. And as it's pulled off, I mean, it's held on by magnetic connectors. So it can really I just say rip it off, and then it becomes uncapped, like a toothpaste container. And it's just squeezed out. And you can put the tube right onto the gums, if that's the state that the diabetic needs to be able to get the help. Or I can just take it off and put it in my mouth and really just squeeze it out myself to just get my blood sugar back up.
Stacey Simms 16:48
And when you say it's also medical alert, it's got the medallion on it. Tell me about that.
Kris Maynard 16:52
Well, I went through a two year process, we put the blue circle on it as the symbol of diabetes because I wanted people to be Got to recognize it knowing that this is for diabetics to be able to help diabetics. And I mean, it took me two years to be able to get permission to be able to use that from the International diabetes Federation to whereas on the backside, is where it says type one diabetes or diabetes, so that again, it signifies if an EMT or someone looks at it, if they don't recognize the blue circle, they can see that it is a person with diabetes.
Stacey Simms 17:26
I know you've heard this, so it's not criticism. But what do you say to people who tell you? Look, Kris, this is great, but I can just throw some Smarties in my pocket. Or, you know, I've got the icing with me, what do I need this for? I wouldn't argue with that at all.
Kris Maynard 17:43
Because I mean, when I learned that only 58% of diabetics carry something to treat with hypose that concerns me that concerns me that 80% of the people don't carry glucagon. So it's that 80% that I'm scared for and I want to To help if people can eat something, or drink something, that's what I want them to do. Matter of fact, if they're conscious enough to be able to take something else, we don't want them to use the necklace because there's more cost effective alternatives. Matter of fact, with me, I carry a, like a eight ounce juice really wherever I go to where I'm saving the necklace for my wife, kids or someone else to where if I can't administer it to myself, they know where to find something. They don't need to go look in a duffel bag, a drawer, a car, wherever it might be. They know where to find it, they can rip it off and now administer it to me. Is it refillable? It is and that was another process through our FDA attorney from the get go she said it cannot be bought. Why is the question
Stacey Simms 18:48
in the way I did you heard me like bracing. Can you kind of Yeah, because I remember it couldn't be at the time but
Kris Maynard 18:53
yeah, it took about six months to be able to figure out that on being able to have them Make it refillable, because from the get go when we initially started about, we wanted it to be refillable to be more cost effective for the diabetic. So that was hurtful news when our FDA attorney told us that it cannot be and then once we figured out how to make it refillable, then we got back on track with what our goal was.
Stacey Simms 19:22
So while back, you were making these available for healthcare providers, and now I see you're making them available for teachers. Yeah. Tell me about these campaigns. How did you decide to do this?
Kris Maynard 19:34
It's funny because you give me the chills when I hear that the health care workers as soon as COVID started, I'm all about the diabetic from the business side. I don't look at it, unfortunately, and I hate to admit that I don't look at it from the business side. I've never looked at coming into this business trying to make money from it. When COVID started, I wanted to be able to provide a way to all diabetic healthcare workers so that they have something And just because at the time and still today, we didn't want them to have to worry about a low blood sugar at a time that they're working their tail ends off on to helping us in our country trying to get it back to a normal state. And so I mean, we ended up giving about $70,000 worth of product during about a four month period. And now as schools are starting to begin now our goal is because the lack of school nurses and and the ones who can actually help administer anything, because ours is FDA a food product. Now, teachers, principals, friends, family, anybody can help with this. If it's needed. They don't need to wait for the EMTs fire trucks ambulance crews to arrive. Now they can help administer what's within our necklace knowing that that's what EMTs are going to use anyways.
Stacey Simms 20:57
Alright, so tell me the secret. How are you? able to afford all of this and how can we help?
Kris Maynard 21:03
I still have my firefighting job. And so time if you can afford me more time, I would love it. Fortunately, we did get some good press out there. And we are able to match really one per one on what we gave away versus what we're selling. And if I can continue that match in one for one, I will do this for the rest of my life, being able to get this out there until there's something else out there that can do better. And I know there's other products. In fact, one product I just picked up and I've been in deep discussion with with xirrus because I think their company that's offering one of the best solutions for low blood sugar, or a severe unconscious with their new GE Volk auto injector. I absolutely love that product. I brought that with me when I climbed Mount St. Helens just so I can have Security so other people can have that security as well. I don't look as a business that I'm trying to compete with anyone. I just want to be able to provide something for anyone that wants to wear a wearable or to have a product to where they feel more comfortable with. And I compare it to some people like apples, some people like peaches, some people like great. And that's what we are. We're one of those.
Stacey Simms 22:25
I love it. It's interesting when you're talking about xirrus and the G Volk hypo pen, you mentioned at the beginning of this, that your son didn't mix up the glucagon, the traditional that red emergency box right that glucagon correctly. And so many studies show that people do not do that correctly. I went to a training, it's probably four years ago now. And I'm, you know, I'm so well educated and every year I take out the old glucagon and mix it make sure I know what I'm doing. And the CDE laughed at me because he said I was holding it wrong. I had my thumb on the back of it. So I would have actually have pushed it too early, you have to throw it like oh, throw it you have to hold it like you're throwing a dart Do not throw your look. Yeah. So I was shocked that I would have been one of the many, many people who use it incorrectly. I kind of ask you, is your son okay about what happened? I mean, I know that you probably are fine. And you know, and you've got to reassure him, but after all this time is he is he's still upset about it.
Kris Maynard 23:23
Oh, he wasn't upset about it that next day. Oh, great. He knew and I knew that it was an educational thing that I neglected on, leading to him. But I mean, at the end of the day, nothing happened. I was able to after I got the glucose in my mouth, everything was fine. And so fortunately, he was able to move up and move on with his day, the next day. Wow,
Unknown Speaker 23:47
that's great, though. How's everybody doing? Now? You've got two sons. They're both just they're both off to college.
Kris Maynard 23:53
Yes, one just moved out this last few weeks and the other ones getting ready to move in about three weeks. And the scary part from my end is the one that's moving across the country is expected to be a type one within the next two years. And that's really something that motivates me encourages me to try to get heavily involved with the diabetes side. There's a lot of things that I don't think being done enough for diabetes, and I want to make sure that I understand the full spectrum so that I can get him the help he needs. Because really, when I was young into my firefighter career, I lost my job for two years because of a low blood sugar. I want to make sure that that doesn't happen to him. And that doesn't happen to any other diabetics.
Stacey Simms 24:41
When you say he's expected to become type one. I assume you've done trialnet correct. Wow. Tell me about that experience. Had you always taken the kids through or was it something you did that you tried newly Can you can you share a little bit about that?
Kris Maynard 24:57
Yeah, the friends for life conference really changed. Many things about me personally, and for the rest of my life, because that conference to me taught me so much. And that's where we were introduced to trial net. And that's where we brought our kids to get tested, including my wife, she got tested as well. And that's where we found out our son had to have the indicators that he's going to be a type one at that point was within the next five years.
Stacey Simms 25:24
Has he shown any signs? Is there anything that you have to do now? Or is it just something that you kind of monitor?
Kris Maynard 25:29
No, it's something we monitor, and he could have gone through some trial testing. But we left it up to him to decide if he wants to partake in that. So really, what I do is I'll take my decks and have him wear it for a few days so I can monitor him to see if his numbers are elevated at all. And fortunately, he's a good sport about it. He still doesn't like to get poked or prodded at but fortunately he's had me to figure out the ups and downs with a diabetes. So he's up for, I almost think that he's an expert in it just as much. But getting him to really, as I say, play my game so I can monitor him and see how he's doing. So the scary part for me is when he goes to college, because now we're apart from him. And so we've been in great discussions with the school nursing program, so that I mean, I'm asking them to test his blood sugar every time that he comes in for a doctor's appointment, so that they know and he knows where he's at.
Stacey Simms 26:35
Are you and your wife, glad that you went through trial net, knowing what you know now?
Kris Maynard 26:40
Yes, whether it's good news or bad news, I always like the truth. That just helps us to be able to prepare and educate him in the process, because I'd hate to find out in two years from now, without knowing that he's a type one thinking that we could have prepped him in some way and so He's really prepped now to become a type one at any point. I love the, of what trialnet is doing and what they offer.
Stacey Simms 27:07
Thanks so much for sharing that. I think people worry about doing trial net, you know, they're not sure what they're going to find out, but I would want to know, so what's next for you? You go on up any more volcanoes you coming up with any other products? Or are you just trying to get your kids off to college?
Kris Maynard 27:22
You know, going up that mountain, I said probably a good 20 times remind me never to do this again. Because of how hard it was. But now that I'm past it, I would love to go do another mountain climb. It's weird how the mind works and how forgetful it can be once you get past something. But at this point, I mean, the the group that we're with, they are more experienced than what I'm in on the mountain climbs. They want to start doing some annually. Whether we do that or not, I don't know at this point. The fun part of this journey too is that somewhere along the line Shark Tank, found us and reached out to us and interviewed me and said, Hey, would you like to be a part of the show? And thinking immediately, I would love to broadcast diabetes on a national stage. So, yes, and so they gave me one week to make a video. And that video that we made, we shared on social media and got tons of viewership tons more than what we normally do. The hard part that we've learned from that is that they said they would contact me by whatever date that it was, and we'd never heard back so we assume we didn't make it to the show. But again, what a fun experience to be able to go through trying to figure out how to put something together answering 50 questions, getting it done within one week and a video getting it back to them.
Stacey Simms 28:55
So you never know they may call and now you know for the next time too. had to do that even better. But we'll keep an eye out for you. Yeah, that sounds great. And I'd love to, is that video still online?
Kris Maynard 29:06
Yeah, we have it on our YouTube channel. I don't think it's on the website anymore.
Stacey Simms 29:12
I think Listen, it's a great experience, right? And you never know, they could call. But we'll leave that video up, you know, maybe somebody listening will see it be able to pass it along to the right people you never know.
Kris Maynard 29:23
Yeah. And again, it really I mean, two things is one I want to get diabetes on that national stage and to the blue circle. I've been in contact with the CEOs that beyond type one jdrf and the ADA on hoping that they will just put the blue circle around their emblem, I don't want them to lose their emblem, but really, each one of them has told me that they want to brand themselves and from that from the diabetes side. That's not comforting to me, because I know outside of the diabetes community, what I've learned is that the jdrf is really known as "the Walk" And the ADA is known as "the legal". And most people don't know what beyond type one is. And I think if the diabetes community got on the same page, how much efforts we can make, because the pink ribbon for breast cancer, I mean, it took them about 15 years to be able to build up that, but the funding for that from the government agencies skyrocketed. And so that's what my hope is with the blue circles to get the diabetes community whether it's type one or type two, because the power numbers coming together, and recognizing that blue circle is what's important to me. So that the fundings there so that I mean, if one out of every three in our world is going to eventually have diabetes, now's the time to come together so that it can get the funding that it needs. So that one out of three doesn't need to get diabetes.
Stacey Simms 30:51
I hear you. Well, Kris, thank you so much for jumping on and sharing your story and the update with us. I really appreciate it. It's great to talk to you again.
Kris Maynard 31:00
It's great talking to you, Stacey. I appreciate your time so much.
Announcer 31:08
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 31:14
And you could find out more about Kris and about the necklace. There's a couple of different kinds, mostly about sizes there. And there is a promo code, you can find that all at the episode homepage at Diabetes connections.com. Kris is generously giving my listeners 15% off using the promo code, blue circle, and that is all one word. And I really wish him the best. It's not easy to have both your kids going off to college, certainly in a year like this. And certainly at a time when the younger one you know, they're kind of waiting to see what happens in terms of diabetes, but I'm a huge fan of trial net. I really do think as he said, you know, you want to know and I have a lot more information on the website as well. If you want to search that up. We have a very robust search box if you're new to the show. This is Episode 320. And you can search by episode type. You can search by Subject keyword or by date, and we've done a couple of episodes on TrialNet that I would highly recommend.
Alright, my new segment Innovations coming up in just a moment. But first diabetes Connections is brought to you by Dexcom. And when Benny was very little, and in the bathtub or at the pool, a kid could have spent the whole summer in the pool. I always noticed his fingertips. I mean, you know exactly what I mean. They were poked so much, they were just full of little pinprick holes. You can really see when they got wet, although I don't know if people actually know this anymore. I mean, they were like little Franken fingers. But when when you have a little kid now, so many of you are already on Dexcom so quickly, I'm not sure if you've gone through this. This is fingertips basically look normal right now. We have been using Dexcom for almost seven years. With every new iteration we have done fewer and fewer finger sticks. The latest generation the G six eliminates finger sticks for calibrations and diabetes treatment decisions. Just thinking about doing the 10 finger sticks we did every day in the past makes me so glad that Dexcom has helped us come so far. It's an incredible tool. If your glucose alerts and readings for the G six do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Alright, let's talk about innovations. This is a new segment I'm starting because I have heard about so many fun things over the years that you are so smart to come up with. And I want to help spread the word. So let's start talking about your innovations. Now this segment will include everything from probably cool stuff coming down the pipeline that we hear from industry and tech companies and I really want it to include your innovations and that can be everything from the woman Gosh, I wish I remembered who this was years ago. She gave me the advice of if you're in a hotel and you have insulin in the fridge or if you're leaving your home and you have insulin in the fridge you want to bring on a trip. She leaves a shoe in the refrigerator the shoe she is going to wear in the morning So she does not forget. Now I use that but I put my car keys in the fridge. Because I'm not putting a shoe in my refrigerator. I'm not even putting my shoe in a hotel refrigerator. But I do put car keys in so that you don't forget, it really helps. You can't go anywhere without the keys. And when you get the keys, if you forget where you put them, hopefully you remember you put them in the fridge. There's the insulin. So that's the kind of stuff I'm thinking of for this segment. This week. Although I guess I just gave you one there.
I want to talk to you about happy Bob. Happy Bob is a new app. And it was created by a mom of a child with Type One Diabetes. Her son was diagnosed at age six. She lives in Finland, which by the way has the highest incidence of type 1 diabetes in the world. What is happy Bob, it is an app that connects to Apple Health kit, it streams CGM data. Now it gives you you know, stars that you can collect. And I think there's a bunch of apps out there that have tried to gamify diabetes, which really hasn't gone over that well because most people they just want to do less. They don't want collect points. Although that is a popular aspect of happy Bob, the big deal about it is that it gives you editorial for where you are. It'll say things like your blood sugar is 110. You are awesome. Or your blood sugar is 138. Your numbers today has been on fire. If I had a buddy, I'd be dancing right now. He was silly things like that. But the best part about happy Bob, in my opinion, is his alter ego snarky Bob snarky Bob enjoys making. I wouldn't say rude comments, but more sarcastic comments. And they're always changing. They're funny. It's just such a smart idea. Now I did mention that it links to Apple. I just found out that they are testing the Android app. So of course they are developing this. There's even a Facebook group I think or a Facebook page for sure. For happy Bob. So I will link all of that up in the show notes. I tried to get Benny to put it on his phone. But he as of this point is not interested although he did think that the snarky Bob It was pretty entertaining. kudos to them for doing this. I think it's fantastic. If you have an innovation like that, send me something I'll post in the Facebook group as well. You can always email me Stacey at Diabetes connections.com. I'm very interested to see what we come up with as a community. You've got some great fun hacks out there and some really useful stuff too. So let's help each other and spread the word.
All right, time for Tell me something good. And this one is really a nice one. We don't have any huge milestones. I don't have any marathons or 50 year diversities. These are all kind of a day in the life kind of things you'll understand what I mean. Caitlin says my tea Wendy got to have her first playdate with her best friend. Since lockdown began in March. They were so happy to see each other and only had to be reminded once to keep their masks on, which was pretty amazing to me. She writes since they are four and five years old. When we left she said it was her best date. Mike Joyce said the wild flowers on the Pacific Northwest trail are pretty great. And he sent a beautiful picture he posted in the Diabetes Connections Facebook group. Also Mike writes, I've walked a third of the trail to the Pacific Ocean from Glacier National Park. Mike keep the pictures coming. That said our six year old T1D jumped off a small Cliff into a mountain Cove this weekend. She has no fear of man, everybody's getting outside. I mean, that's one good thing. We're all spending more time outside and Shelley said the rain is finally filling up our new backyard lake. If you look closely in this picture, again in the Facebook group, you can see my four year old and his new favorite way to burn that glucose and this kid is splashing.
So if you have a Tell me something good. I think these are all great stories. Send it to me Stacy at Diabetes connections.com or post it in the group. Just something that makes you smile. I love sharing these stories. Before I let you go, I am working on a new episode. This will be out probably by the end of this week, and I'm a little nervous about it. So I really hope you give it a listen, I have a feeling. I've been working on this for a while that the philosophy of kid first diabetes second is really not working, actually never worked. So I'm going to be talking about that what I mean explaining it and dipping my toe into I think some pretty controversial borders. So I'm not asking you to agree with me. I mean, you haven't even heard it yet. I am asking you to give it a listen and let me know what you think that'll be out in just a couple of days. And then back to our regular you know, interview type episodes next week. big thank you to my editor John Bukenas from Audio Editing Solutions. A big thank you to you as you listen, I absolutely adore doing this every week. It is such a privilege to create the show for the diabetes community. Thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days for that bonus episode. Until then be kind to yourself.
Benny 39:07
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Why do you love your pump? We asked listeners to give us short reviews of the systems they use. This is sort of a companion piece to our last episode – when we went through how to choose a pump (click here to listen). That was more about process. We talked about how you can’t make a bad or wrong choice, and this episode really bears that out.
Spoiler – every pump has big fans.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Announcer 0:22
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:28
Welcome to a bonus episode of Diabetes Connections. We're going to talk about why we love the insulin pumps we use, or really you use. I asked listeners to give me short reviews of the systems they love. And I cannot thank you enough for sending these in. This is sort of a companion piece to our last episode, we went through in detail best practices of choosing a pump, right not which pump but that was really more about process. You know you really cannot make a wrong choice here. This episode really bears that out and might be a disappointment to some of you I'm sorry to say but spoiler alert here. Every pump has big fans.
I asked in our Diabetes Connections Facebook group who loves their systems, what do you love about it? Then I had one adult with type one and one parent of a child with type one to chime in on each pump system. So these are pump systems that are available in the United States. There are only three pump companies right now, Medtronic, Tandem and Insulet making pumps that are available in the United States. I decided no DIY for this because people who use DIY systems generally know enough and educate themselves enough about their options. And their options are different, right? So these are the commercially available pump systems and they're actually for all of them. the very latest, which I didn't expect and didn't ask for, but it turns out everybody who chimed in, is using the up to the minute latest system as we are recording here in the middle of July of 2020.
If it sounds like these folks are reading, they probably are. These aren't actors, as they say they're real people. They weren't actually interviews. I just asked them to send me the audio. I gave them a little bit of a prompt, and then said, just send me some short stuff. Some people are a little shorter. Some people are a little longer, but I think you're going to get the idea pretty quickly.
Let's start with Medtronic. And both of these folks are using the 670G system.
Shelby 2:30
Hello, I'm Shelby from Elizabeth City, North Carolina. My daughter Caroline was diagnosed with Type One Diabetes on Thanksgiving Day. 2017. And she's now 10 and a half years old and thriving with a Medtronic 670G insulin pump. We got this pump shortly after her diagnosis in January 2018. I love the automated feature that adjusts the basal rates either up or down based on how Her blood glucose is trending. The pump is waterproof, which is great, since we do a lot of swimming in the summer. And if we're going to have extra activity, we can tell the pump to set a temp target which helps keep her from going low. The CGMs the continuous glucose monitor that works with the pump does not have a share or follow feature at this time. But we found a do it yourself workaround called Nightscout, which in my opinion is superior to the typical share follow function on other CGMs systems. I'm definitely excited about the new upgrades that Medtronic is coming out with, but for right now we're very happy with the overall control that she has with her blood glucose with very little need for micromanaging on my part or her part. So that is my thoughts on the 670G
Phyllis 3:54
Hi, I'm Phyllis. I'm from the greater Boston area and Massachusetts. I've been living with diabetes for over 40 years and have been using the Medtronic Minimed 670G system for about three and a half years. Originally, I really was interested in the 670G because of auto mode. Although to be honest, I wasn't sure that the system could do better than I could with managing my diabetes. But I was pleasantly surprised. One of the areas that I was really looking forward to with some help is around exercise and the systems built in temp target of 150 really took the guesswork out of my workouts. So now three and a half years later, my time and range is generally about 85% with minimal effort when I put a little bit more time and pay attention to what I'm doing and eating that easily bumps up to 90% and that equals average A1C of about 6.2, 6.3 for the last three and a half years. I feel better about everything. I physically feel better and really excited about this system.
Stacey Simms 5:06
Next up is Tandem. And both of these listeners, just like with Medtronic are using the latest model. They're using a tslim X2 with Control IQ.
Chris Wilson 5:16
Hi, this is Chris from San Diego, California. I've had type one for almost 23 years and I've used a pump for five of those years. I use a Tandem tslim X2 with control IQ. I started with the original tslim upgraded to the X2 when it was released. And I've been through three major pump software updates in that time. The thing I like most about the pump is Control IQ, which is Tandem’s advanced hybrid closed loop software. I was initially drawn to the tslim by the touchscreen user interface and the rechargeable battery. The only thing I'd improve is the cartridge fill process which is a little complicated but gets easier with practice.
Beth 5:50
Hi, I'm Beth and I live near Denver, Colorado. Our six year old has had Type One Diabetes for three and a half years. She started on an insulin pump six weeks after diagnosis And has been on a Tandem tslim for approximately a year. She's been on Tandem tslim with Control IQ for seven months. We love that it communicates with her Dexcom CGM and gives her more or less insulin as needed. The exercise mode is great for bike riding and swim practice and the touchscreen is simple enough for her to operate herself. She loves that her blood sugar and trend arrows are visible directly on the pump. With Control IQ. My husband and I have had the most uninterrupted sleep since before our daughter's diagnosis. We couldn't be happier for this technology. This pump is the best choice for our family.
Stacey Simms 6:34
And finally, the people who are using the Omnipod dash system.
Lynette 6:39
Hi my name is Lynette and I live in the Atlanta area. My son was diagnosed with type one two years ago yesterday and we have been on a pump since October of last year. We started on Omnipod the biggest reason he chose Omnipod was because he did not want a tail as he said, or tubing. We went with the tubeless pump we love that it's waterproof we love that he can shower in it believe that he we can do smaller amounts than you can with pens because he tends to need smaller amounts than half units. We love just everything about it. To be really honest, our only major complaint is that it tends to come off on pool days and we've tried lots of different options for keeping it stuck and so far we haven't found something that works. But other than that we're super happy with our Omnipod dash system.
Sondra 7:30
Thanks. Hi, this is Sondra and I live in Tacoma, Washington. I was diagnosed with type one in 2006 when I was 57 years old. I did MDI for a year got the Dexcom in 2007 and still struggled with random overnight low lows in 2008. I started using the Insulet Omnipod. I chose tubeless as I had struggled with sleep since menopause, being able to have a very low basal rate overnight has helped me so much with my nighttime lows dialing in basal rate It says made managing my type one much simpler. I love being able to do watersports and not worry about being unplugged from basal insulin. I'm looking forward to the Omnipod five which will create a closed loop with my Dexcom six. I'm hoping the FDA approval for the Omnipod five and Tidepool Loop come soon.
Announcer 8:23
Your listening to Diabetes Connections with Stacey Simms.
Stacey Simms 8:29
Thank you so much for sending those in. Isn't it interesting that it's pretty easy to find people who love whatever system that they're using? I didn't have to hunt high and low I put an ask in the Facebook group and found a whole bunch of people. In fact, I had to cut off the comments. We had so many people who wanted to say how much they loved the system that they use!
Of course, there are personal factors and preferences that come into play. So just like we said in the previous episode, you got to see these systems you got to hold them in your hand. And I do think you need to know also as you listen and you we've assumed this but just in case, all six of those folks are using a system, not just a pump, so they're using a continuous glucose monitor.
In the case of Tandems tslim, they're using the Dexcom. Same thing with Insulet Omnipod, they're using the Dexcom. With the Medtronic 670G, they're using the Guardian sensor three, which is a Medtronic sensor. It's actually the only one with the same company. The other two are separate companies with working agreements.
You can use an insulin pump without a CGM. We did it for almost seven years. Between the ages of two and nine. My son Benny did not use a continuous glucose monitor but he did get an insulin pump six months into it, at age two and a half. He just used a pump and certainly you can use it that way as well. We now use, as you likely know, if you listen, we use the Tandem system we have the X2 with the Control IQ software. We've had that since January. Benny wears a Dexcom CGM and we love it. I think it's a fabulous system. There are aspects about it that he really enjoys and prefers that you know, friends of his don't feel the same way about.
I’ll lay it out here, I've said it before. What he likes about the tslim is that he doesn't have to have an external controller. There's no PDM for it as there is with the Omnipod. He likes that it's flatter on the body. And he absolutely loves the Control IQ software, which has not only lowered his A1C significantly, it's done it with less work from him and less nagging from me, although he still argues that I may like him too much. I mean, come on, man. But he's 15. I guess that's his job.
I will say though, in all fairness and knowing what I know about the diabetes community and the technology that's out there, a lot of people feel very differently, right? There are a lot of people who prefer the flexibility of sticking an Omnipod anywhere they want on their body. They don't care about schlepping a PDM. They like that. It's waterproof. They like that they can remote bolus their kid. That's a big deal. We talked about that last week.
And for Medtronic, people, there's a lot of people who like that it's all in one (note: I mean that it’s all one company. There is no “all in one” CGM/Pump device). They like that. They don't have to go to different companies, and they like that their doctor may be more familiar with it.
Is there a downside to every system? Sure, I went through a couple of pros and cons there. But it does come down to personal preference, I am going to link up a lot more information about these systems and what's coming. Unless something really bonkers happens. And you know, the delays from COVID, or something really goes wrong. They're all on track to be controlled by phone, if not by the middle of next year, then in the next couple of years. And once that happens, and you get true remote bolusing for all of these systems, then it's really going to be personal preference. I mean, once that happens, it's going to be absolutely amazing. But you cannot buy today on promises of tomorrow.
You know that it is of course worth noting that podcast listeners are more educated and have more money than the population overall, not just in diabetes, not just for this show. That's really just podcasting. So it's not really a big surprise to me that we easily found six people using the latest and greatest. Of course, there is so much to talk about in the diabetes community when it comes to access and affordability and insurance and affording the insulin that needs to go into these pumps. So I don't gloss over that. We've talked about that many, many times before and will continue to do so. But this particular episode, I hope is helpful in seeing what people think about the technology that is out there right now. There really is no one answer.
I'm going to tell you one quick story before I let you go here. And I'm sorry, I apologize in advance to all of my rep friends, the reps for all of these companies are just like everybody else. There's wonderful ones, and there's people in it for the money. And you have to be careful about claims. And I'm not singling anybody out. I'm not singling any company out. This happens here, there and everywhere. But I was at a conference years ago, and I went over to one of the booths just to check out and see when I go to all the booths see what's going on. And the rep for this pump company said to me, if you switch to our pump, I guarantee your son's A1C will come down half a point I asked him about that. And he gave me some cockamamie answer. If I tell you more about it, you'll know the pump company. So I don't want to go into it. But I mean, it was really a stretch. But if I had been a newer diagnosed family, I think I would have been very much influenced by that. I asked him if he had any literature and studies to back up his claims, and he did not. But he said he would email me something, I gave him all of my information. Of course, I never heard from him again, the idea that switching technology can lower your a one c by a certain point, and that's why you should switch. That's a tough one. I just said that control IQ dropped my son's A1C significantly, right. But you know what? It's the whole story of him. It's not just that pump system. If we were new to pumping, if we didn't have the settings right, if he didn't know how to, you know, do certain things if he was going through a phase or something where he didn't want to do anything. If he wasn't having success with the CGM if he was getting a rash if it wasn't working For him, if it was falling off, if the pump wasn't comfortable, if it wasn't the pump he chose, and he didn't want to use it, there's a lot of things that can happen there.
Pumps are not a panacea. And anybody who tells you that they are.. I want to be careful what I say here. But let's just say they may not have your best interest at heart. So my good guy reps, and there are so many of them. And we have one who is amazing, and I love and is one of our heroes in the diabetes community. I'm sorry for that. But I think it's really important that people understand it's just like the endocrinologist who says, I'm only going to learn this system. So you can't have a separate pump, because I don't want to learn another system. Right, man, we got to fight for so much in this community.
I hope this helped. If you have any more reviews or questions about pumps jump into Diabetes Connections, the group will have an ongoing discussion there. And I kind of hope this helps you think a little bit more critically when you see these discussions in other Facebook groups, but let me know what you think. And I will link up in this episode a whole bunch of guides from different And organizations who've done really good work comparing the technology that's out there pro and con, and please go back and listen to the previous episode about how to choose a pump if you haven't already. thank you as always to my editor John Bukenas from audio editing solutions and thank you for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Benny 15:24
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
“What insulin pump should we get?” is a really common question. But it isn’t the right question, at least to start. We're turning that around into, “If I want a pump, how should I choose one?” After all, every pump out there has devoted fans, which tells you there isn't a bad or wrong choice. Stacey is joined by long-time diabetes advocate Melissa Lee and together they lay out what adults and parents of kids with type 1 need to think about.
This show discusses insulin pumps available in the US, but the ideas and conversation can be applied to any make and model pump on the market.
If you like this episode you might want to listen to this one as well: In "Why I Love My Insulin Pump" we hear from listeners who love the system they use. All three commercial systems available in the US are represented in that episode.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Pump Comparisons from Integrated Diabetes Services
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:16
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:22
This week. What insulin pump should I get? You know what? That's not really the right question. You have to start with, if I want a pump, how should I choose one? After all, every pump out there has devoted fans
Melissa Lee 0:32
And what that means is that there's not a bad option. There are certainly options that might have a specific feature or style or might fit in with your lifestyle better, but there's not a bad option.
Stacey Simms 0:44
That's longtime diabetes advocate Melissa Lee, she's talked about this issue for years. And together we lay out what adults with type one and parents of kids with type one need to think about. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Welcome to another week of Diabetes Connections. I'm so glad to have you along. I am your host, Stacey Simms. And if you are new to the show, because you heard about us or saw me at Friends for Life, the virtual conference that happened last week, I am thrilled to have you here. What a great conference that was, oh, my goodness, I hope you had a chance to participate. They had so many more people because instead of being you know, in person in July in Orlando, unfortunately, they had to go online like everything else this summer. But the plus side of that was that so many more people could participate and learn about Friends for Life and learn about this community that we've been so fortunate to be a part of for many years. Now. This isn't an episode about that. I won't talk too much about it. I hope you've followed along on social media. And please reach out if you'd like to learn more. I'm really looking forward of course, to getting back to in person appearances, but I think Friends for Life has really set the gold standard on how to do these events virtually. It was really well done.
I've wanted to do an episode about choosing an insulin pump for a while I did one way back when, and I can link it up in the comments, but you have to know if you go back to it that it's pretty dated, but it was going through all of the options at that time. And I've realized since then, that it's really not about which pump, right, it's about choosing the pump. But I know that you want to know more about the different kinds of pumps and which one people think is best. So I'm putting out a separate episode in just a few days with what I'm calling true believers, people who love the insulin pumps that they're using right now. And that episode will have a little bit more editorial to it. This week, though, I want to talk about process, you know, beyond tubes or no tubes. There is so much more to it than that. If you even want to switch to a pump at all, which you know, you don't have to do I hope this episode clears some things up and gives you tools that you can use going forward as you make these decisions.
Diabetes Connections is Brought to you by One Drop and getting diabetes supplies, you know, pumps, supplies, meter supplies, whatever you're looking at. It's a pain not only the ordering and the picking up but also the arguing with insurance over what they say you need and what you really need. Make it easy with One Drop. They offer personalized test strip plants. Plus you get a Bluetooth glucose meter test strips lancets and your very own certified diabetes coach. Subscribe today to get test strips for less than $20 a month delivered right to your door. No prescriptions or co pays required. One less thing to worry about. not that surprising when you learn that the founder of One Drop lives with type one they just get One Drop gorgeous gear supplies delivered to your door 24 seven access to your certified diabetes coach learn more go to Diabetes dash connections dot com and click on the One Drop logo.
My guest this week is always terrific to talk to in fact I just had her on the show a few weeks ago. Melissa Lee is a longtime blogger and patient advocate dogs goes with type 1 diabetes at age 10. She is known for her extensive knowledge of diabetes technology and her role as a leader in the diabetes online community. She was the former tech editor of a sweet life. And that's where I first saw our technology reviews. She also did it on her personal blog, sweetly voiced and she'll talk about that she led diabetes hands foundation as its executive director before serving as Big Foot biomedical’s Director of Community Relations. And right now she's leading clinical training content development at tide pool. So Melissa has worn a lot of hats and she is very careful as she speaks to let us know which hat she is wearing. But I saw Melissa do a technology presentation years ago and I thought Yes, we've got to have her on the show for this. Before we jump in. I gotta let you know. We do talk about insurance and your medical provider and stuff that may seem boring in the beginning here, but it really is important. I mean, who's gonna pay for this right? What's your provider going to talk to you about? These are things we have to really get into if you are here for tubes or no tubes skip ahead to about 20 minutes in when we do talk about, you know, active kids and active adults and tubes and pumps and the nitty-gritty of what you have to carry with you. But really don't skip those first 20 minutes. I really do think these are topics that maybe aren't talked about in those Facebook groups when we're talking about pumps, but they are so important. All right, here we go. Melissa, thank you for jumping on. I'm really looking forward to this conversation. I feel like I learned something every time I talk to you. Thanks for being here.
Melissa Lee 5:31
And I will thank you so much for the invitation and for touching on this topic that so many people have questions about.
Stacey Simms 5:37
One of the reasons I wanted to talk to you, in addition to knowing you've done this presentation is to know that you have used a lot of different pumps, like a dozen different kinds of pumps. Is that mostly to get the experience from how do you do that?
Melissa Lee 5:50
Oh, well, that's it's a very good story. So I got my first pump. I was 20 years old, it was the year 2000. And there were only one or two options on the market now. I went with the one that my doctor said, well, all my patients are on this one. And it was a Medtronic, I followed a very traditional pathway, I think that many of your listeners probably follow, which is I got a pump from a company, when they released a new version or a new software upgrade, I upgraded. And I went through that process three or four times. And I stayed on Medtronic pumps for nearly eight years. And they served me very well. But what I also didn't do during that time was, you know, I was in my 20s. First of all, I wasn't watching the market to see what else was developing. And I would start to hear in my late 20s Oh, you know, there's some other options. I was married to Well, you've had us both on the show, married to a technology guy who is an early adopter of many technologies and, and I really have to, I mean, in so many ways, I credit Kevin with a lot of things, but my husband Kevin said if you want to try something else, like your warranties up if you want to try something else, and you don't like it, that's okay, like let's see what else is out there. There, and suddenly I had this. First of all, I had a husband, who had more income than I've had as a single teacher, but he, you know, we had good insurance and I could say, Okay, my warranties, I'm just going to see what else there is.
Now the sidebar of that conversation is that through that I found Amy Tenderich’s really amazing piece about this is this open letter to Steve Jobs that she was written about the state of technology and that launched my entire entree into the online world of diabetes, which is a whole other story, right? You know, going and finding out Okay, so what else is out there? And so I looked at some pumps that were available at the time this would have been on 2008 I looked at the Cosmo and the Animas ping was just coming to market and so I looked at these options and I started to bravely try something new and with every time you try something new, there's this anxiety about like, Oh, God, am I gonna like this thing? You know, I've had eight years As Medtronic paradigm pump in my, under my belt, and that was what I knew was something else going to be good.
[And from there, I like once you make the jump once you get a little bit more bold in like, Well, okay, I didn't die. I liked. I like things about this experience that I like things about my first experience. So again, what else is out there? And then I began to, to write up reviews of these things for other users to read, like many of us do now that I was one of the first bloggers to be writing about some of these products like I was on my blog that is now sort of frozen in time, but like so many bloggers, I would write it about, this is what I liked about it. This is what my expectations were, this is what I didn't like about it. I would reach out to the sales reps into the company is to be like, Well, I have a question about this. And so then as I began to review, more of these pumps, fast forward, maybe four or five years, then pump companies were reaching out to me to be like Like, Hey, will you try our thing and tell us what you think of it? Would you like to do a two week trial of it? Would you like to wear it for 30 days? And, you know, I was never in a position like some folks, I was never a paid spokesperson for a pump. I was not someone who was given free pump supplies for using the product or anything. But I did get experiences with these devices. And yeah, I've worn something like a dozen pumps from six companies over the years.
Stacey Simms 9:26
My story, which is really Benny's story about picking his pump way back when it's similar to yours in that I went to our care team and said, I have a two-year-old, we'd like an insulin pump. How do we choose? You know, what do we even do and at this point in 2007, as we knew there were a few more choices back then, which is kind of sad to think about, but I let our educator kind of guide us in terms of and I said I really did say this give me the idiot-proof one that works the best, right? I just need the one that a dummy can use and clip onto a two-year-old and that will also work well for him. We went and looked and held and touched everything and decided on the Animus 2020, which then became the Animus Ping. And we went from there. But we really leaned on our educator. And I'm glad in a way that I didn't have the amount of, I guess we'll call it anecdotal support that there is right now. Because if bring this question to a Facebook group. Let's face it, you're gonna get a lot of bands for certain brands. So if the question then becomes not which pump do I use? Because we all have our personal biases, but how do I choose? You already mentioned you had a change of insurance? You had a better situation than you'd had before? Let's start there. Let's talk about insurance. Because not every insurer covers everything.
Melissa Lee 10:44
Yeah, absolutely. And it's such an important point. And it's one that we as patients and particularly if you're in patient advocacy, like I have been, it can make you angry, but at the same time, you said something important. Every pump has its fan base, as well as its detractors. And I would say by enlarge, the fan base is huge compared to the number of detractors for every single pump product on the market. And what that means is that there's not a bad option. There are certainly options that might have, you know, a specific feature or style or bike fit in with your lifestyle better, but there's not a bad option. And I firmly believe that what that helps with is the if your insurance does not cover your first choice, it's important to note that the price differential between paying out of pocket for these really high touch high tech and expensive technologies, it is probably worth it for most people to consider that if my insurance will support my use of my second or third choice. I will be in a better position to be successful on this than if I have to pay out of pocket. For my first choice, and if you have the wherewithal financially to support your use of your first choice, and it's not on insurance then by all means, get your prescription for it and proceed. But I think that the majority of people fall into, I'm going to need support from an insurance payer to pay to support my use of this product. And that is not just the product, but also the supplies going forward. You know, if you have a situation where you have your first choice pump is maybe only available through your medical benefit through the durable medical equipment benefit, and you have a terrible plan that has only you know, 50% or less coverage of your durable medical equipment, then you might consider the choice that you could get through your pharmacy benefit because maybe for you on your insurance plan, your pharmacy benefit will cover 100% or 90%. And so, as much as we as particularly in the US value this I want to be able to choose my therapy, there's a reality of the cost I think it's really important to be able to say my insurance covers this pump, and this pump. And so I'm going to choose my best option from those.
Stacey Simms 13:09
And I would jump in and say 100% agree with that, that is worth a phone call for you. I know it's a pain. I mean, we all hate dealing with the insurance companies, but it really is worth calling and double checking this yourself. We love our reps. We love our healthcare teams, but I had boy Benny’s been on an insulin pump for 13 years and there was one time when everybody assured me it was okay. And it was not and if I had called myself and gone through those hoops which think I would have realized so it's worth calling that to double check as much of a pain that it is
Melissa Lee 13:42
well you know, and you bring up an important point because you say call myself call who you know many of us start with calling our insurance company and then we find out that they don't even do the representative you may be talking to from your insurance company covers deals with a lot of therapies and benefits and you say insulin pump and they may be actually looking at the wrong thing, or they may have the wrong information. If you have identified I want a product from company A call Company A, because Company A actually has every single company Dexcom, Medtronic, Tandem, Insulet. They all have people that are dedicated to what's called verification of benefits. And as soon as you give some information to these companies in terms of, here's who I am, you don't even necessarily need the prescription before they verify this, you can be doing that in parallel, because of course, you will need a prescription for whatever you choose. But they can be looking at your insurance plan. And they have experts on the inside who are able to look this up and say, Oh, well, actually, you could get it but we're going to have to order it from this other company that's closer to you because you have a thing that says you have to order within 50 miles of your zip code or Oh, we can get it but we can actually get it through the pharmacy channel. And so they can actually they have experts who do this and they have a vested interest in getting you on their product. So they're going to work really hard to find that out
Stacey Simms 15:00
I think back to my experience, right starting that insulin pump with Benny and I needed my care team so much. I know everybody has peer groups now and online support. But I needed a device that my care team knew how to operate. And while sometimes that limits you, I do think it's really important. I guess we can talk about the flip side of that. But let's start by talking about that question of what does my healthcare team have experience with why that important to you?
Melissa Lee 15:27
Well, and I do want to talk about the flip side of that as well, because I've challenged it several times. But on the one hand, your clinicians office is probably already set up with a representative for that, for that product they use, they probably already have the software installed for that product they use, they probably already understand how to both read and analyze the data that comes off of those devices, how to change the settings, how to troubleshoot with you, as well as how to also seek their own reimbursement for it because the time that They spend evaluating the data is actually part of their fee schedule. So I do think it can be a benefit to you both in getting you on the device faster getting you on boarded to the device more smoothly, because they already have a process in place, and they have a comfort level of supporting you with it.
The flip side is, I remember when I was living in North Texas and I had this amazing endocrinologist who would just let me run out and try whatever I wanted, and she'd absorb the cost of like, whatever new software she was going to have to install, she would let me be a guinea pig. What that also meant is that if I had a bad experience on something that soured her for the rest of, you know, her patient base. If I had a good experience, without overprescribed, I felt a lot of responsibility there. But at the same time, she said she would go to conferences, and she'd be sitting at a table with nine other clinicians, and nine of them had only heard of one insulin pump brand. And so by that same token, you if you're out here As a patient or a caregiver, and you're doing your own research on what your options are, you may have done the right research to find the right thing for you, and your insurance will cover it. And you know, you want it and you bring it to your caretaker or to your clinician, who says, Ah, you know, sorry, I'm an all XYZ shop. And you actually may need to advocate for Will you let me try it? What are your concerns about it?
And, you know, we see that especially, and Stacy, you've done so many podcasts about the DIY movement and do it yourself. You know, there are certainly clinicians who haven't heard of those options. And you may actually find yourself having to make a case for why you can be trusted to try this thing that they don't have experience with. And there also may be the case where they say, Listen, I can't absorb the liability of that or I can't buy the new software that would go with that. I remember, I was the first person in my clinicians office to try the insulin pump from isanti back when they were are around and my doctor's office had to buy a whole new piece of hardware to get the data off of my device. Like that's an expense that I'm asking my clinicians office to absorb for one patient out of thousands. So yes, find out what your clinician has familiarity with. They may have also anecdotal, good stories and bad stories about like, Oh, well, I had great success when so and so got on that, but also, it's okay. If they haven't, there are ways to convince them to consider allowing you to try this.
Stacey Simms 18:32
I wonder, too. I mean, right now, there's only unless I'm wrong. There's only three commercially available insulin pumps in the United States. Right. So three brands, okay. That is correct. So there's only three brands and we still hear about endocrinologist, and I think it's mostly adult endos. But we still hear some pediatric just anecdotally, who are, I'm only this guy. I'm only going to look at that stuff. And it can be hard I think for a parent of a young child or a young adult. Who's not used to advocating for themselves to say you? Well, I want this other one. I'm curious Lissa, someone who has advocated very well for herself. What do you do in those cases? I mean, I know what I would say. We're pretty outspoken people.
Melissa Lee 19:13
We are and many, many books have been written about sort of the paternalism of the medical community and how it can feel like what the doctor says goes and I don't want to challenge that I don't feel comfortable. When I'm like, half-naked with a paper gown sitting on butcher paper, do I really feel like fighting right now with somebody in a lab coat with a stethoscope and like a kid but there may be an increase to ask of you, in order to prove yourself to this clinician about this and in terms of Do you have blood sugar logs to give them Do you have CGM data to give them Can they see the data they would need to know that they can prescribe this product that is new to them and they would get insights Back to know whether they made a good choice for you. Do you have the kind of relationship with them or like, Listen, I'll schedule an extra phone call with you, I will prove, you know, I have this great literature I could send you and I've known people to sort of print off white papers and drag them into a, you know, a clinical paper, really, from a research journal and be like, Look, look, it's a valid option for my situation. And the same holds true for if you know, especially for parents who might want off label use, like maybe your child is below the indicated age, or there's some reason why, you know, same holds true if you're a person with type one and you want to take a drug that's indicated only for type two and how do you make that case often there is an ask of you that is, am I going to be able to give my glucose data and my maintenance and management visibility to this clinician so that they will prescribe this in a way that doesn't reflect poorly on them. And if they can feel like okay, I will have the information I need on this. And I would also say it's important to note that it's actually likely a minority of people with type one who were treated in these facilities where they even prescribed these products, right. So let's say you're treated by a general practitioner, and maybe they've heard of an insulin pump before, but maybe they don't even know what the brands are. And so you're going to need to be able to put something in front of them that allows them to feel confident in prescribing,
Stacey Simms 21:30
I was going to definitely talk about documentation, because we've already mentioned Facebook groups, I would not recommend the Facebook group printout to bring to your endo, that's not going to do it. And you laugh, but I know I know, sometimes that's the end. It's sometimes the best information. I mean, sometimes it's the worst information, but sometimes it's really good. But what I would recommend is, you know, find that diabetes forecast article that talks about all the pumps that are available, find the, you know, the diabetes minds to find the different comparisons that are out there, and I'll link up A few In this episode, you have to stay current on it because things are changing. But articles like that documentation. research articles, as you mentioned can be really helpful because then they have some meat. It's not just me going in and saying I heard about this cool thing. I want it for my son because it has a blah, blah, blah. You know, now I'm really backed up.
Melissa Lee 22:17
There are a couple of resources to use. Yes, absolutely. Like the diabetes forecast, diabetes, mind diatribe like where they've written about these products. But there's also a really cool, fairly new website that some behavioral health researchers out of Stanford like Cory hood, and the Helmsley Charitable Trust in New York City put together it's called diabetes wise.org. And you can go in and sort of say like, what am I looking for? What are my options? What's out there? How do I choose and so some of this is actually on diabetes wise, and I think they've done a really nice job. I think they plan to do more with it, but I really like what they have so far. And then as well, you can go each of the websites for instance, we said in the US it's Medtronic Tandem and Insulet each of those websites has a provider version of the website for your healthcare provider where they could go and get information as well. And you could give them that URL.
Stacey Simms 23:11
So let's start talking a little bit more about, you know, we were at this esoteric level and then just kind of dial it in a little bit more. Because, you know, the questions that I see the most are, you know, what would you recommend for an active three year old? You don't like there's no, I mean, that makes me laugh all the time. Because I don't know any three year old who's not super active and running around. So I always want to say what's the best pump for a chilled out? Relax three year old. Let's talk about type of pump. I always think that somebody should really think about how they will wear an insulin pump. And I do think you don't know until you do it, what you might like or what you don't like. But I mean, let's just talk about tubing for a moment because I personally feel and I've never worn insulin pumps. So I am a parent. I am not a person with diabetes. I feel like this seems to be much more of an issue than it actually is for most people, and that there are pros and cons of both, that most people don't think about at all. I mean, my son, gosh, was two years old when he started a tube pump bonkers kid, you know, super active, did tons of activities, and I would say probably got his tubing caught, you know, once in a while, just as much as his friend with a pod got his pod knocked off the first month that he was wearing it. But to me the tubing, I don't know, there's other things to think about. There's, you know, where on the body, you're gonna wear it, how much real estate it takes up, you know, that's why you have to kind of look at this stuff. And also, I'm getting in the weeds here, Melissa, but when you have a pump without tubing, right now, with the commercial availability, you need a separate controller. So these are all things to think about.
Melissa Lee 24:47
Such an important point I don't think people have ever I'll say honestly, I don't think people have ever believed me that tube versus no tube doesn't really matter. And what I will say is that That's a yes and. And to some people, it very much matters. And you know what, even if that is only in their perception of it, I absolutely grant that that is an important perception. What I will say is that there are what I often describe as, so I started I was on a tubed pump for nine years, then I was on a tubeless pump for three years. And I was on a tubed pump for two years that I was on a tubeless a year and like, so I've done both, right. And, you know, I think the folks at Insulet are fantastic, but I remember early on this is more than 10 years ago and me going to them and be like, Well, why is your pump great? And they're like it's tubeless and I'm like what else and they like it has no tube. You know, give me I'm okay with the tube. So give me another value props and now of course they have fantastic value propositions and they market that much better, but, you know, no dig on them. But the fact of the matter is, is that we wear glasses, wedding rings, wristwatches, smartwatches, earrings, there are many things we have To our bodies, that the first time you wear them, you're like, Okay, I'm so aware of this thing that I'm wearing. And then over time you feel naked without it, right? You know, you look down, you're like, I just I knew something was off, I'm not wearing my ring, or I'm not wearing my watch today. And a tube on an insulin pump is very much like that. And there are athletes in every sport, wearing every brand of pump available today. And so I don't believe that how active you are, should necessarily dictate whether you go tubed or tubeless route. I think that it's more about your perception of tubing and there is a real negative connotation about what it means to sort of, quote be hooked up to something like and so for if you are someone who can't like who that is a mental hurdle for your body awareness or for thinking about your child than great, you have a tubeless option, but what I would not ever say is that Having a tube is somehow limiting. Because like you say, there's the other side of that coin of, you know, if I'm wearing my tube pump, and I don't have my controller nearby, do I have access to do all the things I want to do? Or you know, the same thing, like just having the tubeless option make me feel like I'm freer or like, I don't have something attached to me, or does having the tube option make me feel like it's a lower profile, and I can tuck the thing away in my pocket. It's like, for many people, it's more about what your personal comfort level is. There is definitely not a huge difference in lifestyle, between a tube and a tubeless. And I think you and I are really aligned with that.
Stacey Simms 27:43
I would also add, we've said tubing and if you are listening and you have used the word or heard the word wire, instead of tubing, I do think it's an important difference, because to me, it's not a wire and wires are something completely different. And I do think that that's a really Interesting. I don't know how that started. I don't know if somebody's way back when I thought it was a wire, but it's a tube. It's a very thin plastic tube that if you're my son, you can swing your pump from Please don't do that. Why do you do that? You know, or it's it's but it's very thin, it doesn't conduct electricity. It's not a wire. So I just kind of want to get that out.
Melissa Lee 28:20
That that makes me think one of my favorite comedians Chelsea Reiss talks about he has a joke about the bedroom and getting a cot and a ceiling fan and having it swinging around. It's hilarious. I'll just leave that considering I don't know how general your user or your listener,
Stacey Simms 28:36
I appreciate that. I appreciate that. But
Melissa Lee 28:38
Yeah, so you know, there are things to think about many people when I was 20. And so my endocrinologist in the late 90s started pushing me to get a pump and I want to say that very clearly. I was pressured to get a pump. And he would say, well, all my type ones are on a pump. And I would say, Well, what does that do for me like That's good for you. Why do I have to fall in line? And for me, I thought it for about two years. And then I was in college and I met a girl with an insulin pump. And I suddenly found that I had this series of questions that I never would have asked my older male endocrinologist in his role. They were questions like, Well, how do you sleep with it? And what do you do with it when you're naked? And when you go to the bathroom? Like, do you have to move the tube out of the way? Like, how does that work? And do you lay on it? And does it hurt your back and like all of these questions that I needed to ask someone else who actually lived with it? So that's where I think our groups online things like Facebook and Instagram, where you can actually see what people's lifestyles are? and answer the question, you know, and short answers for everybody is you just deal with it. Like you just move it out of the way if you lay on it and it's uncomfortable, you roll over, you know, you toss it in the bed next to you, you unplug for a bit like there's lots of answers to lots of those questions but for me, but the important part was, I was being pressured to use one If I needed to speak to someone who knew what it was like to actually use it, and that was the trigger for me as soon as I met her, and I saw what her life was like, I was like, Oh, I can do this, this is no problem.
Stacey Simms 30:11
And we're going to get to the answer of I don't want to use a pump. And that that's okay. Let's talk about that. I'm gonna make a note. We'll talk about that quote towards the end of this, but to kind of flip around the tubing question. One of the other questions I think people need to address in terms of like, how they live or how they plan to use a pump, what they think about a pump is thinking about the remote bolusing and the remote operation of the insulin pump. Because I gotta say, Man, I missed that animus Ping. Now my son is 15. So I don't do as much with him. I mean, I never quote bolus him anymore. I mean, he does everything himself with our support. But there is something to having a toddler and not having to go over to them and take the pump out of the belt or out of the pocket and being able to just dose from across the room. Now I know and we should also talk about this, we should talk about future technology and processes and what's to come. But I think it's a really important thing to consider. Can you do it and be just fine? Yeah, Benny had a regular old pump that we had to touch from ages two to almost six, because that very first pump we had for four years was the animus 2020, no remote. So we bolused him in his car seat, and you know, in bed and did all that stuff. But when he was six, when we did get the remote meter, it was very freeing. And I have to say, I really liked having that. I'm glad we can, again, it's coming for the different pumps in the future. So I'm glad about that. But I think we do have to focus on what's available now. I thought we solicited an adult, I think of something like that. I mean, in terms of taking the pump out or wanting to remote bolus,
Melissa Lee 31:45
Yeah, that's huge. You know, when I was working for Bigfoot biomedical, we were doing some market research in social media where we asked people like where do you wear your pump and a lot of people reported I wear it clipped to my underwear, I wear it inside my skirt and wear it in a bra. And it was a significant population wasn't majority, but there are plenty of people who prefer to keep a device tucked away whether for their own personal discretion and their job, or maybe safety, you know, maybe they're likely to get tubing or a pod knocked out. And so I think that there were a lot of women for instance, who preferred who really liked the Animus ping and struggled with the decision to move up to the Animas vibe because the loss of that remote bolusing One of the things that I think is, you mentioned future technologies, and with full disclosure, I currently work for tide pool and tide pool is working on a product and development that would allow you to remotely bolus from your phone like so I need to fully disclose that that is literally what I work on for my day job. That you know, I think several things have happened both the Animus product and then which was commercially available, and then In many of these DIY solutions, and then of course Insulet Omnipod with the PDM, the personal diabetes manager that allows you to, to bolus, we've seen that there is a market need per se, as was we'd say in marketing, like there's a hunger for people to want to bolus with more discretion. And, you know, for those who aren't comfortable, let's deliver a dose of insulin at once, with this feature. And so these things are coming, you know, tandem diabetes just released an app that in future iterations they plan to include some degree of remote control. Insulet is of course iterating on their devices that allow for this, and Medtronic has put forward pipeline goals that they plan to get there and so and there are many products and development and products outside the US that allow for that remote bolusing like outside the US diableloop has that as well.
importantly though, and you said it, we have to base our decisions on what is available now and one of the things that I say With love in my heart for every sales rep I've ever worked for is never trust a sales rep. To tell you how soon something is coming. I remember so many adequate so many cases where people have been promised the next gen of whatever it is they use for going on 5,6,7 years. Oh, it's coming next spring, it's coming next spring. And the thing is, unless they can show you where they already submitted it for FDA review, it is more than a year away, right? And so and even then it might sit with the FDA for additional review for a longer period. And so unless there's a launch date, choose from what's available now. You can we get locked into this idea of like God, if I make a decision, I'm making this for the next four or even five years because of the warranty. Yes, you are, but you can't base it, on hope and dreams. You have to say if I'm getting one today, these are my options. And I can guarantee you that if there's a new option a month from now there will be at Upgrade pathway for you. But there is, you know, in many of these, all three of the companies that have stuff available today in the US have trade in options. And it might be, you know, you might not get the full value of the products with your trading, but I don't believe that you're stuck forever with the thing you chose. And we worry so much about buyer's remorse. Like if I get this thing, and then the thing I really wanted comes out in two months, I'm gonna be so miserable, and there's a pathway to get you to where you want to go. I believe that.
Stacey Simms 35:29
Another question I think people need to think about is, again, my perspective is as a parent, but it's what do I carry on a daily basis? You know, if I'm on multiple daily injections, or I'm using a particular insulin pump, what do I already schlep around with me and am I willing to carry more or do I want to carry less and I see this not as a good parent who makes her child take full diabetes stock with him everywhere he goes, but as the terrible parent that I am, that lets him run out of the house just with His Dexcom His pump and some hopefully Smarties or Skittles in his pocket, he would not want to have to carry extra stuff with him. Now, if he goes for an overnight or if he's gone for longer, he's got to take pump supplies, he’s got to take a backup insulin pen, he's got a whole kit. But just in terms of heading out for a little while, or, you know, being the 15-year old that he is he can get away with carrying less with the technology that he has. If you've got a teenage girl who perhaps takes a purse everywhere she goes anyway, that might not be an issue. But I do think it's kind of important to acknowledge that real-world kind of stuff, Melissa, that's one of the questions I urge parents to think about.
Melissa Lee 36:35
I'm smiling so big Stacey, I'm gonna put two hats on okay with my first hat. I work for a medical device software company and I'm writing the instructions for use for a future product and development. And I must say that it's very important to note that anytime you leave your place of residence you should take glucagon glucose tabs, a full meter kit, a backup, backup cartridge or reservoir pod. Some syringes, some insulin, your mother's maiden name like, Yes, I was really you should be prepared. And you know, I love blogger Scott Johnson talks about the caveman who lived and he talks about like, people with diabetes. We are the evolution of the caveman who lived the caveman who came out of the cave in the morning and said what do I need to do today to not die and we're really good, especially parents of kids with type one are so good about planning for the all those eventualities. Now I'm going to take that hat way off and toss it under the bed where it can't hear me and say that the reality is you or your child will find a way to screw this up. No matter what. You give me a pump that has batteries, I'll run them into the ground, you give me a pump that has rechargeable battery, I will forget to recharge it. I will lose the cable you give me a pump that needs to be thrown away at the end of three days and I will let it expire and then go six hours before I remember to change it. So trust in your teenager or your child to mess this up, it's fine, it's going to happen. There's no foolproof way to prepare for all of those individualities. At the same time, like you said, I feel confident leaving the house wearing only my pump and CGM, like I am, which I can look at on my phone. I choose not to carry a meter and a land set and strips and additional insulin. But I mean, I'm sure Benny has stories like this as well, that you know, there have been cases where that bites me, right. And one of my you know, I do music video parodies and one of the ones I did was about being at the office and running out of insulin and not being able to eat lunch until I go home and take care of it like these things happen. And you can just like with diabetes today, you can choose to leave your supplies at home and absorb whatever risk comes along with that. But the nice thing is, is that Yeah, you can wear your pump and leave your home and It continues to just pump along, pump right along with insulin.
Stacey Simms 39:03
But you made a great point, it doesn't matter what brand of pump or type of pump you decide on, you are going to mess it up. And you're going to have situations where it gets a little hairy and nine times out of 10 you're gonna just MacGyver something and be fine, regardless of pump type.
Melissa Lee 39:19
Yeah, you know, for me, I had a situation, you know, I mentioned I was 20 when I started on an insulin pump. And just to give you an idea of what I understood about diabetes as a very bright top of my class, 20 year old I'm just gonna say I was it wasn't completely brain dead. I was brand new to a pump. And I actually, I had, you know, as a musician, I had several gigs booked one after the other at this church where I was going to be singing for the day, and I arrived at 7am and booked until one o'clock, and I looked down and my pumps out of insulin. And I think to myself with my 20 year old brain and my knowledge of diabetes, I thought it should be fine because I used to go hours Between injections. And what I didn't understand was the difference between how a pump delivers insulin and how my long acting insulin that I had taken at the time would have had this undercurrent of coverage for me. And so I get sicker and sicker as the day proceeds. And by about 12:15 I'm standing up in front of, you know, maybe 800 people, and I just collapsed. Just done. My blood sugar was super high, I was out of energy. I was dehydrated, just, I just decided to lay down behind the pipe organ and you just see my feet sticking out the end like I'm the Wicked Witch of the East under the house, right. And, um, you know, the organist pops up off the bench and start singing the Gloria to the congregation of Catholic parishioners and, well, you know, I learned an important lesson that day Stacy. That you know, the fact of the matter is, is that we are going to make mistakes, especially your kids and I am fortunate that I you know, I was not in DC I did not end up at the hospital, and they will learn these things as we go. And as those frontal cortexes start to develop, those things will actually be able to be applicable to how they manage their diabetes.
And I think some people and this is an important point to make about, if you're new to pumps, some people are really afraid. Like, what if it fails? Yeah, it's another device like sometimes my phone doesn't power up like I want to sometimes my household robots don't respond when I say their wake word or whatever. And like, yes, it is another device. And that is why in here and putting my industries hat on, that's why they take a long time to get to market because so many fail-safes are put in so many considerations are made about what the risks to the users are. And that's why you carry backup supplies and that's why you have a backup solutions but at the same time, pumps can provide a lot of benefits for being able to kind of tweak your own care. You know, one of the things I often say in these presentations that I Do on technology is, if you are a pumper, you're actually in the minority of people with diabetes. And even with type one, even insulin users, you're in the minority. And so if you choose not to do it, you're choosing the standard of care, the standard of care is that it's perfectly appropriate. I spent my first 10 years with type one on injections. And that's a perfectly fine way to choose to do it. A pump affords you different options. And for me at age 20, the thing that a pump did most for me, was allowed me to, like choose not to finish a meal or to have seconds or to order dessert after the fact or to graze at a buffet like for me, it was about like, it was just less hassle at meals, and that's how it sort of started. And I liked that and I didn't mind the body image perceptions that it might change. It was that was not an issue for me. But for others it really might be.
Stacey Simms 42:57
I think a good reminder to about pumping is it's nothing surgically implanted. So if you change your mind, it is an expensive brick, you did use your insurance, you did go through a lot. But if you're six months or a year in and it's not what you want, and you prefer multiple daily injections, you can take it off, you can take a pump break, you can do what you've done, perhaps and tried different models, if you can figure out a way either way ensures we were able to switch once for medical necessity, we were able to talk to an endocrinologist and my son was using enormous amounts of insulin. I've talked about this, you know, just what he loves when I talked about puberty when he started into puberty, but he really did use a lot of insulin and the Animus didn't hold enough. And we were able to get coverage to switch to a different pump that held more so you're not always locked in but you're definitely not locked into not going back to shots. And I think that you know that just to make the point that it's okay and shot technology is improving every year. Absolutely. I think it's worth looking at to.
Melissa Lee 43:57
You bring up another important point like we and you said this early on with when you were in your buyers process your customer journey with Benny's first pump. Like, if you have not held that pump in your hand and pressed the buttons, then please do not buy that pump. There are representatives in your area that can meet with you from any of these companies, your CDE, your endocrinologist, somebody has a pump in a drawer somewhere. And you need to know what it's actually like to operate it. You know, for me, and this is a weird thing. And I've never met anybody else who felt this way. But for me, when I was first looking at the animus ping, there was something about the refresh rate of the screen that bothered my eyes. And like that's not something I would have known for their product literature. And I was just like, yeah, you know, it's I don't know, it's weird. I don't, there's something I didn't like about it.
Stacey Simms 44:43
Yeah, important.
Melissa Lee 44:44
But like if I had never pressed the buttons on it, I wouldn't have known. There are pumps that there are people who prefer a color screen or a lighted screen or a screen that's more visible in sunlight. You know, there's just so many things that until you've held the pump played with it. It's, it's like driving a car without a test drive. And this is a big commitment you're making. And I think it's perfectly appropriate to demand that you get that pump in your hand before you order it sight unseen.
Stacey Simms 45:12
We're getting long here, but I don't wanna let you go without asking. You had two points that I think really are wonderful. And that is the question to ask yourself, What do I love about technology you're currently using? and What don't you like about what you're using? Can you kind of touch on how to ask yourself those questions? Oh, absolutely. You know, a lot of people. And I think this is fair to assume when you see people out there, and maybe they're bloggers or influencers, or you've heard their name before something and you assume that they're out there, and they're being paid to promote the thing that they wear and I am not that and I have no problem with that. Like I believe companies should actually seek spokespeople who live their lives with the product and can speak to the experiences they're having. What I am, is a person who has used many of these products and I like to sort of break them apart and say these are the good things and these are the bad things and they all have good things or bad things about them. They've all nailed some features and failed some other ones. And so people approach me and they're like, what pump should I get? And they think I'm going to say you should get the pump I have. And I rarely say that and said, I say, Well, what are you looking for in a pump? What do you love about the thing you use now? And often like if you told me that what you loved about the product you're using now and it was the Animus ping and you're like, I love that I can bolus him when he's under the covers and I don't have to pull this pump out then I would say well then here are your options for that. Like there are DIY things where you can do that there's the Omnipod where you can do that and like those are the things you should go look at. And if you told me what you loved about it was what I really liked the security of a tubed pump because the way he's been able to use it and I like the color screen then I would say oh, you should definitely go look at tandem’s TSlim line because they have those things and so you know, depending on what you like about the thing that you use, look for that feature, specifically In your next thing because you're going to miss it terribly whatever that feature is that you love. And then the same thing. What do you hate about your current system? Like, are there too many lines on the screen? When you scroll through it? Do you hate all the confirmation screens that you have to go through? Do you hate the CGM that it pairs with? Like, what is it that you hate? Okay, we'll look for one of the pumps that actually resolves that and talk to people and find out whether that specific thing that you hate about it resolves it because if I go into a Facebook group, and ask 3000 people what pump should I get? Everybody's gonna say, you should get my pump and then a few people are gonna say, Oh, God, don't get the pump I got I hate it without thinking about what your individual situation is. And so I think it's more a case of we don't know what questions to ask ourselves. And so we just ask it broadly, and the questions are, what am I looking for? What am I looking to resolve? With what currently bugs me? You know, I had a friend reach out to me once and she said, you know, my child uses the Omnipod. And he's having lots of site infections with the canulas. So site changes, he was a very young child site changes have been horrible. And I was thinking about getting this other pump. And I said, Well, tell me about that more. And as she explained it, she was like, well, I thought if I got a pump that didn't have a hardcoded expiration at this 72 or 80-hour mark, that I could leave a site in for longer and go more days in between site changes so that it wasn't so anxiety-inducing for him. And I was like, okay, you just told me your child's having a lot of site infections, leaving a Canula in longer to go longer in between is actually not what you're looking for. Maybe you should stay on what you have. And it would be fine if she went the other direction, but it was what exactly are you trying to solve by changing?
Stacey Simms 48:53
Yeah, when we were looking for a pump, I knew what we were trying to do. Because Benny was fine with shots. I mean, the first two weeks, were called But after that he as long as we didn't stop him from playing or eating, he would like stick his leg out or close arm out. He didn't care at all. And he's ambidextrous, which we learned at this time. So he really didn't care. He was getting like eight shots a day we were on our endo had us on a routine where he could eat whatever he wants, and we just, you know, we bolused after and it was a routine that worked really well for us for six months. But I wanted an insulin pump because he was getting such teeny tiny doses that we were not even close. You cannot measure with your eye, a quarter unit of insulin in a syringe, at least I couldn't. And we were really struggling with big, you know, swings because of the dosing. And working with our endo, they recommended an insulin pump for the flexibility and precision. And that made sense to me. And boy, did it make a big change when we were able to really dial in a quarter of a unit of insulin as a dose for my little guy who's now almost six feet tall. But if you can't answer that question, right, why do you want to get an insulin pump if the answer is because everybody else has one, put it in a drawer, think about it later come back when you really have a need. And I'd also say, Melissa, and this especially for parents is if your child is old enough and old enough means different things to different people, they really have to help decide if not totally decide.
Melissa Lee 50:17
Absolutely, it just absolutely. And I would say, if your child is old enough to talk, they're old enough to have a say in this. And I have two children. So I know how early that starts to happen. But so my children don't have diabetes, and they do take medication for another condition. And the fact that they take medication like that is a constant conversation I have with them about the why and how do you feel about it? And the Do you feel like it's helping you and in these conversations that I think that we are, particularly as parents, we're so quick to want to solve things for our kids. We're like, oh, there's a technology out there and it's better than shots. So I'm gonna put this on them and Your children will do best on a therapy to which you have their buy-in. Like, if you really like that pump a has feature x and feature x is not important to them because feature y on this other pump is so much more like okay, that pump comes in pink and that's what I care about. Like Yeah, the pump that comes in pink, then honor that because again, they're all good options.
Stacey Simms 51:27
That's exactly that's a great point. It comes in pink,
Melissa Lee 51:31
But you know none of them do anymore to like now you have to get like a rubber skin right? Think about it Tandem 670 g like, there was a time you know, 10 years ago, every pump company had five or six colors that would come in and better believe I hate that. I can say that. You better believe that mattered to me. It's like oh, you know, I like purple but I don't like their purple.
Stacey Simms 51:53
But it's important because it is not just something that sort of this way it's important because think about how much stuff we do with our phones, right? We all decorate and put skins and screenshots and pop sockets. It's the same thing with an insulin pump. You know, some people don't care at all. But some people, if I were insulin pump, I would have different things for every day of the week. I mean, I get it. And my son used to care a lot more, we had different skins and he had pink and he had purple and camo. And now like I said, he just got makes me crazy just shoves in this pocket. So let's go from one, one kind of extreme, which is might, you know, pink to another. We mentioned earlier, don't buy anything, don't make decisions on future promises. But I do think it's important to listen to talk about the most recent stuff, and by the time this comes out, something else might have been improved, who knows. But the software, the inner workings of these pumps is changing. And thankfully, it's changing at a pace that we hadn't seen in the previous 10 years. And I think it makes it almost more difficult to figure out what to get right because somebody might really want a tubeless pump, but then they see that and I you know I am guilty of this too talking about how much I Love control IQ, which is only with the Tandem right now. And there's DIY stuff, which, you know, I'm very vocal about this. I love all the DIY people, but we have never used a DIY system. It's not something I'm comfortable with. So what's your advice for people who are just kind of intimidated or thinking about the different software systems now?
Melissa Lee 53:18
Sure. It's such an important question, I think. So it's only been and it's funny to those of us who are in the thick of this, especially myself, I've been in industry now for four years. It five years it's been a while there is this. We're in the very, very infancy stages of automation of insulin dosing. And so for years, this was a promise we were going to get there commercially. And now we have two systems commercially available. We have a third system, the one from Insulet, coming just out of clinical trials, so we can expect that we'll probably see it go to FDA in the near term. So there is this now it's not just get a pump. And a pump is a different way to take insulin, which that was my standard line for many, many years. It's just a different way to take insulin. It’s an electronic syringe. To now it's actually dosing you for you. It's actually it has some degree of intelligence, that is changing your doses, without your say, right. And so now it's like, well, now there's this whole, like, Is it a quality of life upgrade if I get this product? Or now what if I, I don't understand how to read like this algorithm? First of all, what does algorithm mean? And this one has an algorithm that does this, and this one has an algorithm that does this, and I don't know like, it could be green could be purple. I don't know how to, like, I don't know, I don't care, too, which I will say, as someone who has had to write extensive documents about these algorithms and such. I will quote my dear friend, Lane Despereaux, who says all these algorithms work. They're all the same. It's I mean, they're not, but they are. They all work. If it's coming to market, it's been deemed safe to use. And you have, there are tiny, tiny details where if you are the person who cares about those incremental details, you probably are the person who actually understands those incremental details like, you know, how will it drive me to a target glucose? And how do they do it differently from one another. And the fact of the matter is, they both do it. And so the goal of any of these systems is to try to keep you at a glucose level that's safe for you. And they do them differently. But they all do it. They're all fine. And if you are trying to get into the nitty gritty, you're going to hear people's success stories and you're going to hear people's horror stories, but they don't live your life. And there is no one out there who is the exact like copy of who you are with your situation and your child's situation, to know whether or not the experience they have is experience. You're going to have And to that end, you know, your, your doctor may have some information on these, do you really want to go through and read the clinical trial data? Would you understand it? If you did? And what would you actually extract from that that was important to you? And this is one of the things that I see in the sort of, you know, and I love my DIY brother in like, that's a cut my teeth in DIY in many ways, and but like if we're just going to slice up people's algorithms to try to decide which one's going to get you to a 6.5 instead of a 6.6. A1C, like, Is that what you care about? If that is what you care about? Go forth and slice, slice those algorithms read those white papers, that's fine. But what do you actually care about? And when you ask that of people, they're often going to tell you, I care about whether I can think about it less. Right. Okay, so what details about this system are going to tell you whether anything about that lesson or not. And it may be well, you know, my sister's kid has one and she really likes it. Okay, so great. Does your insurance cover it? Go forth? Yep. And that, if I'm trying to choose between a, like a Toyota rav4 and a Honda CRV, like I can get down into the nuts and bolts of the horsepower. And I'm gonna say a lot of words, I don't understand, you're gonna notice I'm maybe, like, what is the torque? I don't even know what torque is. But you know what I mean? Like right? If you're the type of person that cares about that, then great. Do you need to care about that for your insulin pump system? Or just really like the red one?
Stacey Simms 57:29
Like, there's also and there are a lot of people who will choose between those two vehicles on what's the safety rating and how close we live to the dealership? Yeah, right. You know, there's all sorts of different ways to choose these things, knowing that they all work really well. And then you're just talking I think a car is a great analogy.
Melissa Lee 57:45
It is, well you know, you either want that middle row seat or you want the extra cupholders. So which one is most important to you? sign the form and send it away and then don't freak out that you made the wrong decision because all decisions can be unmade. You can always go back to the thing you were doing before, you can always find a way out. And I say that even acknowledging the privilege that I have. And I do want to make that clear, like I have a privilege to be able to afford a different pump. If I, if I really wanted one and whined enough to my husband, he would be like, fine, fine. But the same thing is just like with a car. Okay, so you may have to drive it for a while. It's not the right thing. You can't Well, I can't say you can sell it because it's a prescription medical device. But you know, there are ways through this. And I think we get really caught up on whether or not we're making the right decision. And it may just be that there is not a wrong decision. And whatever you make is likely the right decision for you.
Stacey Simms 58:43
Melissa, thank you so much. We could definitely talk for another hour about this, but I think we've covered at least the first go-round as best we can. But I really appreciate you spending so much time with me. Thank you. It's
Melissa Lee 58:54
always lovely to talk to you, Stacy. And I hope that this can help people. At least take a breath And they'll still post but yeah, but should I get that and that's fine, that's fine. It's okay to ask.
Announcer 59:14
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 59:20
I'm so sad to know there aren't pink pumps anymore. I didn't even think about that. It was so important when Benny was little I mean he wanted the blue pump but then we got a bunch of skins and covers that he could change it to whatever he wanted to and Animus had great colors right that was part of their marketing all those that rainbow color scheme of different pumps. Oh my goodness, I guess it you know, you can bring out whatever you want. Any option of pump can be blown out. That's, that's not really what I was going for. Any option of pump on the market right now can be decorated any way you want. Please go ahead and share this episode. Yes, it was a long interview, but there is a transcript. And I do think this is a really important topic. That gets kind of skimmed over when people say, just this pump, or just that pump, or I love this one, or I hate that one, or should I even get a pump, and that bonus episode is coming with those true believers. Those super fans who do love the pumps that they use Diabetes Connections is brought to you by Dexcom. And it is hard to think of something that's changed our diabetes management as much as the Dexcom, share and follow apps. The amazing thing to me is how it helps us talk less about diabetes. It really is so wonderful. It's so great about sharing follow as a caregiver, a parent, a spouse, you know, a friend, whatever, you can help the person with diabetes manage in the way that works for your individual situation. Internet connectivity is required to access Dexcom follow a separate follow app is required. learn more, go to Diabetes connections.com and click on the Dexcom logo.
I mentioned Friends for Life at the beginning of the show, I need to let you know and I've put this in a Facebook group and elsewhere on social media but just so you know, I'm doing a special promo code for the world's worst diabetes mom for my book, if you order it from my website from Diabetes connections.com, use the promo code ffl2020. And you're going to see $4 off the cover price. This is a pretty big discount. I don't think I've done a discount like this. Since we launched the book last summer at Friends for Life. We did a pre-sale a couple of months before the book came out. And this is a big one. So it's $4 off promo code is f f l 2020. Of course, it's always available at Amazon and Barnes and Noble and target. There's an E-book and the paperback book and the audiobook. That's all over the place. But I wanted to make sure to let you know about the discount and the promo code for Friends for Life. All right, bonus episode coming in just a couple of days on those true believers in the pumps that they love and then back to our regular Tuesday drop if all goes well, I'm Stacey Simms. Until then be kind to yourself.
Benny 1:01:59
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged.
Tandem presented new studies at the recent ADA conference and got approval for some of the youngest people with diabetes to use their newest tech. Steph Habif is Tandem’s Senior Director of Behavioral Sciences. She shares what those studies found, gives us more information about Control IQ and touches on what products are up next for the company.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Listen to our previous episodes with Tandem Diabetes
In Tell Me Something Good, great news about college scholarships for students with type 1.
Join the Diabetes Connections Facebook Group!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcript:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom , take control of your diabetes and live life to the fullest with Dexcom .
Announcer 0:16
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:22
This week, Tandem presented new studies at the recent ADA conference and got approval for some of the youngest people with diabetes to use their newest technology. But Tandem is also keeping a close eye on including many more people in future studies.
Steph Habif 0:37
It's a shared responsibility across many communities to figure out how to make it easier for different types of people to be included in this research.
Stacey Simms 0:48
That's Steph Habif, Tandem’s Senior Director of Behavioral Sciences. We'll talk more about what communities she means there and why Tandem wants to reach out more. And of course, we talked about Control IQ And what's next for Tandem? In Tell me something good great news about college scholarships for students with type one.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I am so glad to have you along. I am your host Stacey Simms. We aim to educate and inspire about diabetes by sharing stories of connection. This time of year we are sharing a lot of stories about technology and studies and that is because the American Diabetes Association Scientific Sessions conference has recently concluded so every year at this time, there's new information.
Sometimes it is also timed with FDA approvals like we saw last week with the Libre 2 and with Tandems approval that we're going to talk about for the Control IQ software to be used down to age six. It means a lot of information. It means some bonus episodes, it means some playing with the schedule. Because just trying to get this information out in podcast form can be a little bit more difficult. But you know, that's what I am here for what I love to do
If you're new, my son was diagnosed with Type One Diabetes right before he turned to my husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting and local radio and television news. And that's how you get this podcast. And just a quick note about my son Benny, I realized the other day, so we're 13 and a half years in with type one, which means we're coming up July 4 which his 13 year anniversary of wearing an insulin pump, which I cannot believe and I remember it like it was yesterday. So I'm going to maybe do an episode or talk about that in another episode, looking back on what's changed and you know how to pick an insulin pump and all that kind of stuff, but oh my gosh, oh, I can't believe he's 15.
Speaking of Benny, the world's worst diabetes mom is now available in more places. My publisher reached out to me. We are now sold online at Target and Barnes and Noble and pretty much expanding to every place You can buy a book online, I didn't realize this was a thing that we started on Amazon and now we are elsewhere, which shows that it's a good thing that I have these people to help me out. But it's also available in library form. And I'm still investigating this. So as you listen, if you get ebooks, that's the library form, it would have to be an E book, you know, Kindle or something like that. If you have a service that gets you library books, check it out, let me know where it is. Because I haven't been able to exactly track that down with COVID. I think there's some issues. I'm trying to get the hardcopy into libraries too. So that's something that you could really help me out with.
And I have to give a big shout out to Molly Cooper. Molly lives in the UK. She sent me a message that she really enjoyed the book. It was so nice of her to reach out like that. So of course, I asked her a little bit about it. You know, I have some UK readers, but I'm interested in the process. There's a different Amazon site for different countries. So I was just interested in how it all worked. And then she posted in one of the diabetes parenting Facebook groups that she belonged in, and oh my god. Molly, thank you so much. A bunch of people talked about the book. And it was such a nice thing for you to do.
So if you've read and enjoyed the world's worst diabetes Mom, I always ask please leave a review on Amazon that helps us so much when people are looking to see if they want to buy the book or get the book. But if you could also post in your Facebook group or on your timeline about it and tag me, but it would be so helpful to spread the word because let's face it, this isn't gonna show up in the New York Times Review of Books, right we have the community to spread the word and it may be immodest to say but I do think it's a book that can help people it's not just our story. There's a lot of advice in there and a lot of learning that I did over the years, I believe very much in it and I really appreciate those of you who are already spreading the word if you're ready and you don't like it forget you know me!
In just a moment I'm going to be talking to Tandem’s, Steph Habif about Control IQ, new studies and lots more. But first diabetes Connections is brought to you by a One Drop and getting diabetes supplies. It's a pain let's face it. Not only the ordering the people up the arguing with insurance over what they say you need and what you really need. Make it easy with One Drop. They have our personalized tester plans, plus you get a Bluetooth glucose meter test strips lancets and your very own certified diabetes coach. Subscribe today to get test strips for less than $20 a month delivered right to your door. No prescriptions no co pays required. One less thing to worry about. not that surprising when you learn the founder of One Drop lips with type one, they get it One Drop gorgeous gear supplies delivered to your door 24 seven access to your certified diabetes coach learn more go to Diabetes connections.com and click on the One Drop logo.
My guest this week is Steph Habif. She is the Senior Director of Behavioral Sciences at Tandem which means she really advocates for the people who use the technology. She presented some of the studies we're gonna be talking about at ADA and of course has presented elsewhere and a quick note if you are new to the show, we use The Tandem system. They're not a sponsor of the show, but I know I am biased toward Tandem. So I want to make that disclosure. First thing I just love the way it works. Look, it's not perfect nothing is but we have been using Tandem for three years now. We switched from Animas insulin pump in August of 2017, just as the Dexcom G 5 update was approved for for Tandem. So basically we got a pump and then we immediately updated the software. We have done two other updates the basal IQ last year and we went to Control IQ in late January pretty much just as it hit the market. I can't believe it has been six months already. So well. I don't think that influenced the actual questions I'm asking. It certainly influences how I feel about the system. So here is my interview with Tandems, Steph Habif.
Steph, thank you for joining me. I'm so excited to talk about Tandem and learn more. Thanks for being here.
Steph Habif 6:55
Thanks for having me. I've been a listener of yours for a while so it's a real pleasure. Thank you very much
Stacey Simms 7:02
this year's ADA very different may start by just asking you what that was like for you to to present and have to do everything virtually.
Steph Habif 7:08
Yeah, it was definitely, I think unique and interesting experience for a lot of us especially people who regularly attend the ADA each year. And I'm not gonna lie. My favorite part about the event is getting to see people and kind of have very energized Creative Conversations together in person, I think a lot of brainstorming and some of the best ideas, birth from, you know, getting together with kids from all over the world at meetings like that. So that part was kind of missing, obviously this year. But given what's happening in the world, I think it was put on fabulously well produced really, really nicely. The excitement leading up to the conference was there that was a part of my experience this year for sure, like every year, and then it all happens through email and chat and tech So my eyes hurt. At the end of the conference, I think my eyesight has taken a little bit of a hit in the past couple months, like a lot of other people. But there was some very exciting information that got presented.
Stacey Simms 8:12
Yeah, let's talk about some of that. We've talked about Control IQ in depth before its launch or right as it was launched. Tell us about some of the presentations here. I know one of them was Control IQ in the real world, the first 30 days. Tell me about that.
Steph Habif 8:29
Yeah, so that was a proud moment for me and my team, the scientific posters that we presented at this year's ADA. I think one of the people you have had on your podcast to talk about Control IQ is Molly Malloy and she's on my team here at Tandem, we get to work together. She was one of the researchers whose name was on these presentations at ADA and the first 30 days. That was really our first look under the hood, so to speak. So one of the things that my team here at Tandem is responsible for is post market surveillance and user experience research. Meaning once the FDA approves or clears a medical device, like the T slim X2 and people start using it in their everyday lives, the job of my team is to observe, measure, learn, how's that going for people? whether it has to do with their glycemic outcomes, like time and range, or quality of life, things like how's your sleep? Those are all the things that we're responsible for researching and studying. Now, what we did for a DEA was we didn't have very much time with Control IQ in the market before the ADA deadline presented itself.
So Control IQ came to the US market starting mid January, and we had to have all of our materials submitted to ADA by the second week of March, so not a lot of time. So like I said, sort of first look Under the hood, meaning we went into our databases into our T Connect web application, back end systems, and we use some research methodologies to kind of see how it was going for people. What sort of glycemic trends and outcomes were we seeing for the early adopters right out of the gate, and we specifically focused on folks who software updated. So I think Benny's a software updater - he was on Basal IQ leading up to Control IQ. And how old is Benny? Again? He's 15. So he was probably included in our analysis. Absolutely. So sorry, no. Yeah, so anybody who was age 14 or older and had at least 21 days of use on control, IQ technology, leading up to march 11, was included in this analysis. So
Stacey Simms 10:52
he was he was definitely in there. And you would have seen a great response. I don't mind telling you.
Steph Habif 10:56
Yeah, so this information that we presented at ADA Like I said, we didn't have that much time. So really data mining to look at glycemic outcomes. So it was a retrospective data analysis exercise, essentially, which is a very common thing to do when it's your first look at sort of what's happening in the real world. And we were really pleased to discover that overall real world users are experiencing an increase in time and range of 10%. Before updating to Control IQ. The folks in this study had a time in range of about 68%. And throughout their first 30 days on controlling IQ, they experienced an increase to get that overall time and range metric to 78%. And what's exciting about that is that 10% jump matches what we saw in our control, IQ clinical trial.
Stacey Simms 11:53
Did you have any data about ease of use? In other words, do people continuously use it? Did people have sensor issues? If you have have problems figuring out how to adjust anything I know it's it's tough to glean in such a short time. I'm just curious if you learned anything else.
Steph Habif 12:06
So for the purpose of what we presented at ADA, we kind of kept it really simple. Again, because we didn't have very much time we mined data we we worked with what was available to us. And so we really focused on things like changes in time and range hyperglycemia hypoglycemia, and we didn't for the purposes of what was presented at ADA, talk about quality of life, things like sleep improvement, but what we do know is that for the folks who were included in this analysis, overall, they experienced the percent of time in closed loop automation was 96%. And that's really exciting. Now for the Control IQ technology system. The only reason a user isn't in automation is if they lose connection with their CGM for 20 or more minutes, that's it. And then once CGM is reconnected automatically, you're back in that automation close loop. So that's really elegant and simple. And that came through in these metrics that we presented at ADA.
Stacey Simms 13:17
Yeah. So that's interesting. I mean, not to jump to a conclusion. But let me just make sure I'm hearing you right. So we can pretty much conclude if 96% of people using Control IQ, excuse me, if people using Control IQ stayed using it 96% of the time in automation. That means that their sensors were working that things were chugging along just as they should.
Steph Habif 13:35
Yes. And thank you for bringing that up. So we have some consensus guidelines on data integrity for this type of research. When you're doing real world research like this, the guideline is for the purposes of data integrity, to include CGM rates that are 70 to 75% or above. So what that means is in our analyses for the ADA we included people who had at least 75% CGM connectivity over that 60 day period. Now in the clinical trial for Control IQ, the investigators reported CGM connectivity in the high 90s. That was a way that we could sort of control for that variable given that we were doing a retrospective data analysis, if that makes sense.
Stacey Simms 14:27
Yeah, it does. Because it's really important. And you know, this people in the diabetes community, there's separate issues here, right? There's Control IQ. There's the Tandem pump, but there's the Dexcom sensors, which Listen, it's not a Dexcom interview here. But we've talked a lot on this podcast about people who just have trouble with the sensors, and sensor failures and things. So I'm glad to hear you clarify because I'll be honest, that 96% number didn't really sound real world to me, but it makes a lot more sense when you understand that it's already looking at people who have good sensor luck. I don't know what to call it. Good sensor usage or It lasts.
Unknown Speaker 15:01
Connectivity.
Stacey Simms 15:03
Yes, connectivity, that’s what I was looking for. Yeah, that makes a lot more sense. There was another study, if I'm reading this correctly about people with type one and type two, use the Control IQ. I didn't know anybody was type two was was really using it. Can you speak to that?
Steph Habif 15:16
Yeah, that's pretty cool. So it turns out we have a fairly present segment of our customer base that have insulin dependent type two diabetes. And so again, first look under the hood, we sort of sat there and we were curious, and we said, well, we have some people who are updating software updating to Control IQ who report that they have type two diabetes, I wonder if they're experiencing things differently than folks with Type One Diabetes. And it turns out that both people with type one and type two diabetes are experiencing significant improvements in time and range with use of Control IQ. So the second publication that we presented at ADA was looking at glycine outcomes type one versus type two. Now you've heard me say that folks with type one in our analyses experienced a nine or 10% increase in time and range as a result of their software update. And for folks with type two, that was a 6% increase in time and range. But here's the really cool part, the analysis that we did for looking at the difference between type one and type two, we required a minimum of 14 days of use leading up to the software update, and then 14 days of use after the software update, which is half the amount of time from our first analyses. And so what that means is by seeing that our folks with type one got to a 9% improvement in time arrange, it means that those improvements are happening really quickly, right after the software update.
Stacey Simms 16:46
That's really interesting. I want a little dig a little deeper into some of these studies. But I also want to kind of do some bullet points here. So let's talk about Control IQ okayed for young children, because I just happened. Yeah, can you speak to what those studies found? Was there anything different or anything parents of children down to the age of six now should be thinking about anything different?
Steph Habif 17:06
I don't really think so. We recently, just a couple days ago, got our FDA clearance for the pediatric indication for Control IQ for children's six year old Jr. Before then it was previously approved for ages 14 and older. We know investigators have been doing research and even younger populations. But right now we're only approved down to age six. And what the clinical trial that focused on ages six to 13 using Control IQ saw was the sensor timing range increase to 67% from 53%. compared to those in the control group, and overnight children using Control IQ technology in the same study state and range an average of 80% of the time, those glycaemic outcomes match what we're seeing in the real world with a slightly older group, and so it's looking very consistent. So far across the board,
Stacey Simms 18:02
one of the things I wanted to ask you about these studies and in Tandem isn't the only one who does this. It looks to me like a lot of the automated studies that I'm reading from Insulet, Medtronic and some of the other companies, was that 68% in range number that you mentioned, like the people who started when from 68 to 78, which is fantastic. But we know that so many people with diabetes have like 30%, time in range, right? They need this technology so badly. And I'm wondering, can you just speak to that in terms of I don't know why the studies, and I was glad to hear the kids study was 53% to 67%. That seems a little bit more realistic to me. I mean, God forbid you study teens. What, you know why? Why do you? Why do most of these studies take people who frankly, have relatively decent control, right, we're talking about the whole sphere of diabetes, that just people who have great technology, I would think you'd want somebody who's got an A1C of 10 and you can say, look, we knocked them down to six.
Steph Habif 18:55
That is a great question and you are speaking my language. I'm so thrilled To hear you ask that question. That was actually one of the biggest themes to emerge from this year's ADA. And it certainly isn't a new theme, but it was a very prominent theme this year. The call for more diversity in research studies diversity, whether it has to do with baseline A1C or baseline time and range where somebody lives. There was a really exciting study presented at the ADA by researchers in New York who looked at inner city urban teenagers onboarding to the T slim x two with Basal IQ. And that was very cool to see. And so you're absolutely right. It is on us as researchers, as scientists, as clinicians to figure out how to be more inclusive in this type of research. And that's certainly one of our goals here at Tandem.
Stacey Simms 19:49
It's interesting because I thought you were going to say, I don't know I thought it was going to be more on the medical side of it. So in other words, is it more of a question and I'm pardon my ignorance here because I wasn't really even sure what I was. Asking there. Is it just harder to find people to be in these studies? Or is it the study criteria that excludes people?
Steph Habif 20:07
So at Tandem, we try to have the most inclusive criteria that we possibly can for this year's ADA, again, because we had such a short amount of time, and we really only could take quote, unquote, the first look under the hood, we had to work with the data that was available. When you consider early adopters of any technology really, but certainly early adopters of Control IQ technology, like you said, a lot of those folks were already doing pretty well, especially because most of them were on T slim x two with basal IQ leading up to their Control IQ technology update. It's a loaded question, you know, why isn't there more diversity in this type of research? And there's no one simple answer to that question. I think it's a shared responsibility across many communities to figure out how to make it easier for them. Different types of people to be included in this research. So I think the medical community, the research community, the scientific community and the diabetes community sort of at large, we just need to be better about being more inclusive.
Stacey Simms 21:13
Well, and I think it's very easy. Once you set the parameter that you looked at people who are early adopters, we know who those early adopters were there us, there are people who listen to podcasts, there are people who are super educated, they went for the portal before the email came to them. So it's a it's a very self selected group of highly educated people. So I'm not being critical. I get it. It's just Gosh, like I said, I'd love to see what happens when you start people who have a very high A1C and don't have a lot of time and don't have a lot of perhaps access to get a technology like this and see what it can do. Because, you know, I'm such a cheerleader. Listen, my bias is showing, but my son has always been in very good health with diabetes. We've been very lucky. You probably know we don't share numbers, but we're on track to have probably his lowest A1C ever and he has never done less work. It's amazing. So I just hope everybody gets a technology like this.
Steph Habif 22:05
Yeah, you know, the psychologist and behavioral scientist in me is just thrilled to hear you say that. I mean, for somebody like me who has studied social science her entire career and has also worked in health technology and medical technology, my entire career, I like to say that my purpose professionally is to advocate for the humans using the machines. And so I want the science to be able to tell the most insightful stories, whether powerful stories like one you're experiencing with Benny, where he's having to do less and less work but experience better and better outcomes, or whether it has to do with, you know, somehow shining a light on underserved populations who could be the greatest beneficiaries of this type of technology, and how can we make that happen? So all of that, to me is very exciting.
Stacey Simms 22:56
It's gonna be fascinating for somebody with your background to work in this field, where the mental side of diabetes is just as important. The Human Factors on pumps. It's, we could talk all day.
Steph Habif 23:05
Absolutely, yeah. So the easiest way to think about it for in terms of what I do and my team's do here at Tandem is, as you know, the FDA requires very rigorous Human Factors testing in order to submit and receive clearance on a medical device. And so my teams do all of the usability and Human Factors testing prior to our FDA submissions. And then other parts of my teams are the psychologists and the social scientists responsible for doing all the work to understand how the machines are functioning and the everyday lives of everyday users. I feel very blessed to be able to do that for work.
Stacey Simms 23:39
So moving to, you know, heaven forbid, we left to let you rest on your laurels at all moving ahead to what may be next. We know that COVID-19 has delayed a lot of things, you know, in all medical fields, but can we ask about the T sport and the Tandem mobile app? Can you talk about where those are right now?
Steph Habif 23:57
Of course you can ask. So a lot of you know We have a new insulin pump system that we're working to bring to market next year, we typically refer to it as the T sport. That's our internal project name for it. That's what we've kind of affectionately been calling it while it's been in development. It's about half the size of the T slim x two. It's being designed to be controlled either entirely by a mobile app or by an independent controller. And you're right due to the current COVID-19 environment. We have had some delays in some of our human factors testing. Because the data is required for our regulatory filings. The target submission timing for the tee sport will be pushed out until protective government restrictions are lifted. And because I am the person that oversees our human factors team, let me just say that trying to plan and carry out to actors testing during a pandemic is one of the most unique challenges of my career. And I know for anybody out there who's attempted to plan anything right now it's been particularly difficult.
Unknown Speaker 25:04
Before we go on, do you believe the Tsport will have a different name when it launches?
Unknown Speaker 25:08
Oh,
Stacey Simms 25:10
I won't hold you to it. It's just the first time I've heard somebody say that. Like with Omnipod, you know, they said, Oh is Omnipod horizon? And they said, No, it's Omnipod five. Yeah. Sometimes we sometimes we find ourselves getting ahead, right. We're ahead of marketing. We're ahead of labeling we we follow these projects. So early that we kind of assigned we as a community assign names to things that don't even have a name yet, right?
Steph Habif
Yeah, I am not a betting woman. And so I would be afraid to put money down on what t sport is officially going to be called when it gets commercialized.
Stacey Simms
Alright, fair enough. Fair enough. We'll just know that that's the working title. And then the mobile app. I know there's some people beta testing the phone app, which is more of a observant app, you look at things you can't do anything really yet. Is that the same timeline as the tee sport, whatever that timeline turns out to be?
Steph Habif 25:58
No, the mobile app is happening on In a different timeline. So we're developing a mobile app platform that is the foundation of our digital health strategy. The first generation of the app had a beta launch in the first quarter of 2020. And it will be rolled out more broadly in the upcoming weeks. So the first generation of the app will include remote data uploads so that patients can send their hcps important pump data without an office visit. We know that right now we've kind of been forced into this telehealth world. So that's going to be a really critical part of the user experience. And future iterations of the app will include remote bolus capability due to COVID. For sure. We've had some delays in human factors testing on the remote bolus features. And again, because data is required for our regulatory filings, we have to work with that the best we possibly can.
Stacey Simms 26:48
I'm so excited about that. I mean, obviously, the idea of bolusing from the phone seemed like the holy grail for a long time, but that is exactly what you're saying. right that the idea here is that you would take out your phone, bolus using pump, you'd be able to control it from your phone.
That's right. I give you the impression. I want to talk to you much more about that.
Steph Habif 27:09
You know, it's, I will say, being a scientist who's in charge of doing all of the research makes me an interesting candidate for a podcast interview.
Stacey Simms 27:20
All right. Well, I have so here's a question for you. And again, no answers a fair answer. I'm curious. When you you start doing things like that. The remote monitoring capability of the Dexcom , obviously, has been very, very popular. I'm curious if I wouldn't expect to bolus my son from my phone. Right? You wouldn't expect a caregiver to be able to do something like that. But what a caregiver be able to see more about the pump? Will there be more information available to people who want to, let's say follow, I don't know what kind of language we'll be using, like the pump battery, the insulin onboard, all of that kind of stuff. Will that be
Steph Habif 27:54
available? Yeah. So that's a great question. So follow capabilities through a mobile app. is certainly a part of our product roadmap, there are plans underway for that. I can't speak to when that would come to the market specifically, but it is being worked on.
Stacey Simms 28:11
Okay. And one more thing if you can't answer this is fine too. Would it be possible I'm just thinking out loud when my son was was younger and we did do everything for him? If like I could use you could designate like, this is the bolus phone, and it wouldn't necessarily be the phone that's with the kid.
Steph Habif 28:25
Great question. You know, cybersecurity is such a critical consideration in this land of remote anything. I can't tell you one way or the other, whether or not you as the parent would be able to use your smartphone to bolus you know from your son's pump. We'll have to wait and see what the FDA decides in the land of you know, security and safety and cybersecurity. For sure. Right now we're focusing on doing the necessary Human Factors testing for enabling the pump wearer to be able to use his or her smartphone
Stacey Simms 29:00
I'm trying to keep track of the timeline here. So forgive me for clinical trials underway for the T sport yet,
Steph Habif 29:06
right. So for the T sport project, we are not yet doing active clinical trials. But as many of you know, being a medical device company, we have a robust r&d department, and our engineers are experimenting on a regular basis.
Stacey Simms 29:22
Ooh, sounds intriguing. You should do all of your studies in Charlotte, North Carolina, you should include 15 year old boys. Yeah, let's move on. Do you know this isn't really your department, a bunch of my listeners had questions about insurance. And a lot of insurers were making noise a few years ago about only going with one pump company. And of course, the big one was United Health and Medtronic does tend to make any progress in that, you know, that deal. Right? So like
Steph Habif 29:53
what you said is true. It's not my department. So we don't provide individual payer updates, but we We believe having continued positive data on our technology, like what we presented at the ADA helps with all of our payer discussions.
Stacey Simms 30:08
So I would say to paraphrase that Tandem is not going to give up on working with as many insurance companies as possible.
Steph Habif 30:14
That is correct. We believe in doing whatever we can to create access for as many people in the world as possible.
Stacey Simms 30:21
another bit of news that came out right around ADA was FDA approval of Libre 2 and you all have had an agreement already with Abbott. I don't I don't know the parameters of the agreement. I don't think there's a lot of public the timeline or how it will work. Can you speak to anything about that about how sometime in the future I suppose the Libre will work with a Tandem pump?
Steph Habif 30:42
Yes, so Abbott and Tandem share a common goal to provide people with new ways to manage their diabetes that can integrate easily into their daily lives. The interoperability landscape is is very promising in Tandem is working with Abbott on an agreement to integrate a future generation of their glucose sensing technology with our insulin pumps. We haven't announced a timeline for the completion of the agreement, but we're working on it.
Stacey Simms 31:08
so dumb question because I always get confused with interoperability. Would this be a situation where I flip a switch on my pump and one week, I could use a Dexcom sensor and the next week, I could use a Libra sensor.
Steph Habif 31:17
I think for some people, that is what the vision is, like, I think we're all playing an active role right now in forming what this interoperable landscape could be. But conceptually, the idea is you could mix and match your technologies and they would be able to speak to one another. Now, that requires business agreements between the companies as well. So don't forget that part because that's an important part.
Stacey Simms 31:42
Yeah, yeah. Yeah, let's keep dreaming. Let's forget. So what are you studying? Now? Obviously, this isn't the end of the studies on Control IQ or Tandem products. Can you give us a glimpse into what what you're looking at in the next couple of months?
Steph Habif 31:55
Yeah, sure. Well, as you know, we currently offer the TCM x two with basal IQ technology and Control IQ technology. We had some pretty exciting research debut at the ADA on basal IQ in that we followed folks who on boarded to basal IQ during their first six months on basal IQ. And that was what we call a prospective study, meaning we were able to follow people in real time over the course of several months to see how it was going for them. The research we presented at ADA related to that specifically focused on self reported severe hypoglycemia episodes, and we were thrilled to tell the world that basal IQ is doing a phenomenal job of decreasing adverse events related to severe hypoglycemia. So basically, like he's seemingly doing a very good job at keeping users safe. And you know, safety is always at the top of our priority list.
So as we continue to see more people take on Control IQ technology if they choose to do that. We will Do these long term studies where we follow people if they opt in and want us to, we'll follow them while they onboard to and get to know and continue to use Control IQ technology so that we can learn from them. Again, not just the glycemic outcomes, things like time and range and hypoglycemia, but sleep quality, or other things like is it a hassle to use? Is it making your life better? One of the things that I'll never forget is a couple months after phase like q hit the market, I had the chance to briefly talk with a father who had a 16 year old daughter, and she had been on basal IQ for about six weeks. And he looked at me and he said, this is the most under promised, over delivered diabetes technology Our family has ever experienced. And I said wow, tell me more about that. And he said, We're finally sleeping. You know, we can sleep through the night. And you know, sleep is a precursor to everything for everybody. So we're going to be doing a lot more research on the sleep front to see how we can be better continue to improve sleep quality for people with diabetes. That's a very big topic of interest for us.
Stacey Simms 34:19
I'm curious to if you're looking at how people on board and adjust to Control IQ, because most people and again, we're biased because we think we're very well educated, right? When we were in Facebook groups, we talked to each other. Most people kind of went through the training, talk to their endo and then did all the troubleshooting themselves over the first two to three weeks. We're experiencing lows we didn't experience before so we decreased bezel or we increased ISF or whatever, whenever people had to adjust. Are you following like common practices to find out how to better teach? Okay, I'm sorry, we are
Steph Habif 34:51
we are and in fact, next week we're putting on a couple of webinars specifically for healthcare providers first because it's We've been hearing from them even before we launched into market when we started training healthcare providers on the control acute technology system. We have some best practices now to share now that it's been out there for a couple of months. And we've been able to connect some dots. We'll be putting on several webinars next week for health care providers, where we'll be talking about these best practices and tips and tricks. And we know that not just health care providers, but users and their family members want to be able to ask these questions, too. So I think Molly told me that maybe she'll be getting together with you again, Stacy for a future podcast.
Stacey Simms 35:36
Yes. So I'm going to be asking her all of these questions. As the webinar we can kind of see what the what the research shows people with right we're gonna be doing another episode in the near future about best practices. That's great.
Steph Habif 35:46
Yes. And so Molly's just such a great person to talk with about that. But for sure, I'll send you the information on the webinars next week. If you want to chime in and watch they'll be recorded as well. And we are starting to roll out all of that message. Now,
Stacey Simms 36:00
oh my gosh, that's wonderful. Because I gotta tell you, we laughed. We got ours so early, like I said, who waited for the email? Right? We just logged into the portal that my son's endocrinologist said, Hey, let me know what you've learned. Let me know how you adjust.
Steph Habif 36:15
Yeah, that's true. That's true for my family members as well. So one of my niece's has type one, and she's now I think, gosh, almost 12 that blows my mind 11 or 12. I can't believe it. And her dad reminds me on a regular basis that she teaches him, you know, about how to use the pump, and how to use the technology. And I've heard that from other families as well, like, well, we went to our endo appointment, and I'll say, How was it? Well, we taught her a lot, you know, we were able to teach her a lot.
Stacey Simms 36:47
It's so funny. Well, it's also new. It's it's amazing to realize that we're all kind of doing this together.
Steph Habif 36:52
The energy and enthusiasm for good that is in the diabetes community is so special and so unique.
And so I feel very lucky to be a part of it and to play some small role in trying to make it better for everybody.
Stacey Simms 37:07
I can't thank you enough for jumping on. As I said, I'm kind of a fan. So I don't think this was an unbiased interview. But your information is fantastic. And I thank you so much for jumping on and sharing some of it with us. Thank you so much stuff.
Steph Habif 37:19
Absolutely. And I look forward to continuing to listen to hear how other people you know, share their experiences and tell Benny to keep us informed.
Unknown Speaker 37:30
No doubt
Unknown Speaker 37:36
you're listening to diabetes connections with Stacey Simms.
Stacey Simms 37:42
More information at Diabetes connections.com. The episode homepage always has the transcript and other links that you may need. And I will link up our last episode with Tandem there as well which was all about the launch of Control IQ. And as Steph mentioned, we're going to be talking to Molly Malloy and Others from Tandem. I'm in discussions with them this they've already agreed. It's just a question of scheduling, about getting someone to talk about best practices and other questions. You had so many questions for Tandem, that are more mechanical about how Control IQ works, that we want to do a second interview and really dig into the nitty gritty right, how do I know whether I need to adjust Bazell? How do I know whether it's the carb ratio issue and a bunch of questions of what you'd like to see in the next iteration of Control IQ. So that is coming. Thank you for your patience.
But it's always interesting, right to get a high level view of what's going on in these companies, and to try to look at the timeline as best we can. So that was really interesting that the reminders Steph gave me about how we do kind of get ahead of the curve around here, you know, not just on this podcast, but those of us who are engaged enough to be in Facebook groups and be on conference calls and listen to the investor calls these companies make and feel like we are familiar with the language and the labeling before it's even submitted to the FDA. So I'm in interested to see if the name of the T sport does change. Frankly, I really like it. But hey, that's I'm not in their marketing department. So we'll see.
Okay, tell me something good coming up in just a moment. But first, do you know about Dexcom clarity, it is their diabetes management software. And for a long time, I really thought it was just something our endo used, right? It was something we went there and he looked at it, but you can use it on the desktop or as an app on your phone. And it is an easy way to keep track of the big picture. I check it about once a week. Well, to be honest with you, I check it more now ever since we flipped over to Control IQ. I really like to look at it because and I noticed a psychological, right because it gets better and better. But it really does help me and Benny dial back and sees longer term trends. And it does help me not overreact to what happened for just one day, or even just one hour. The overlay reports help context to Benny's glucose levels and patterns. And then you can share the reports with your care team which makes appointments a lot more productive and it was essential for a remote appointment that we have Back in March, it was amazing. managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at Diabetes connections.com and click on the Dexcom logo.
Tell me something good this week all about diabetes scholars, we talked about this, I try to let you know when it opens up. This is something that comes from Beyond Type 1 and they give more than 50 scholarships to students living with Type One Diabetes. So it's a combined $250,000. And these are for students who are in the high school class of 2020. entering their first year of college. This was a record number of scholarships for the organization. So a little bit about the kids 54 outstanding students representing 26 different states. They are advocates, student athletes, scientists, writers, actors, mathematicians, and leaders. Each of them of course lives with Type One, two beedis there is a list of the diabetes scholars class of 2020 that I will link up so you can peruse and see all these fantastic students who aren't going to change the world as they head off to college at a very uncertain time. Oh my goodness. And these are significant scholarships, they range from $1,000 for individuals to $5,000. If you have a student who is in high school, and you want to check this out, I will also link up how to enter they do not open again until January.
And I should mention that diabetes scholars was an independent organization for a long time. But when it kind of seemed like it for I don't know the reasons behind it, I hope I'm not privy to the inside information. But a couple of years ago, it seemed like they were going to go under and beyond type one scooped him up and put them under their umbrella. And now they are part of the big beyond type one family. And that's one of the really interesting things not to get off the subject here about beyond type one. You know, when they first started, a bunch of us who've been around for a while, kind of thought, Well, what is this fancy new social media feed going to do? Right? What is there Legacy going to be what kind of changes are they're going to make? And while I think that they have still differentiated themselves by appealing, perhaps more to young adults, and focusing a lot, I mean, their social media is amazing. They've also now really made a name for themselves by being an umbrella organization for smaller diabetes groups that it's really hard to survive with a low budget when you try to go yourself safe sitting as part of them. I think slipstream now is part of them. Lots and lots of be on type run lots of little organizations that make a big difference, but needed their help so I guess that's a Tell me something good as well for beyond type one.
If you haven't Tell me something good story. I'm in the process of gathering more I've been putting up the posts in the Facebook group and elsewhere. If you have some good news, I want to share it just let me know you can also email me Stacey at Diabetes connections.com and tell me something good.
I mentioned at the top of the show that we are going to be marking 13 years with an insult pump in July, really just late next week, July 4. Yeah, we were geniuses and decided to start it over Independence Day weekend, when we were not even at home. That's a story for another time that I have told that I tell in the book too. But we are also next week headed to the endocrinologist for the first time since January, we did not get an A1C when I had a telehealth appointment for Benny in March. So I'm really interested to see I mean, I know the drill from Dexcom . And while I don't share numbers, I think we are going to have one of if not the lowest A1C’s Benny's ever had thank you to Control IQ. But there's always more to talk about when we see the end, other than just the numbers. So I will keep you posted.
If there's anything that Benny wants me to share, or that we want to talk about, but I'm really looking forward to that appointment just because Gosh, we've never gone six months without seeing our endocrinologist and while I know a lot of people think it's a pain to go every three months i mean i think it's a pain to but I'd like checking in I love Dr. v. I always learned something we always ask about Questions, even though he except it was asks me questions now, which is really funny and I do enjoy. I think that when you have a kid who changes as much as my kid has over the years, just physically, you know, and everything else, it's really important, at least for me to have that kind of touchstone, so I am really looking forward to it. And I think Benny's grown an inch. He thinks he hasn't grown at all. Anyone. Let me measure him. I mean, how ridiculous so we'll get a bite, which is what I'm looking forward to as well.
Okay, we have so many great episodes on tap. I have all this technology stuff. I have some personal stories that I've been holding, always a mix around here about the technology, the news, the great stories from our community camp. Oh my gosh. So there's lots coming up. It's just a question of what comes next. If there's any breaking news, we'll do our very best, but please join Diabetes Connections, the group on Facebook, that is the best way to stay up to date as to what's coming and I often ask you all questions as well, which helps me figure out what episodes are really important to you. Thank you to my editor John Bukenas from audio editing solution. And as always, thank you for listening. I'm Stacey Simms. I'll see you back here next week until then be kind to yourself.
Unknown Speaker 45:12
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Digging deeper into recent news from and about Dexcom. Stacey talks to Chief Technology Officer Jake Leach about the news that competitor Abbott has received approval for it's Libre 2 CGM. What does that mean for the marketplace? She also asks Jake about G6 sensor issues, data gathering and more.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Dexcom statement on data and privacy:
Patient safety is a top priority at Dexcom, and we design our products to be as safe and secure as possible, as the data that comes into our system from CGM devices is extremely important for patients and physicians in understanding and improving diabetes management. Dexcom works with government agencies, industry partners and security researchers to apply current best security practices for medical devices to help ensure the integrity and availability of our systems.
Our terms of data use are laid out for patients to consent or opt-out when they first set up a Dexcom account, so they know exactly how their data could be used and who will have access to it. In order for healthcare providers to access patient data, each patient must approve the sharing of their data to the healthcare provider through the CLARITY app. Another way patients can opt-out of sharing any of their data is by using the dedicated Dexcom receiver to view their glucose levels instead of a smart device.
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:16
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:22
Welcome to a bonus episode of Diabetes Connections. So glad to have you along as always. A bit of an unusual situation this week in the very last episode, and hopefully you've heard it. I spoke to Dexcom CEO Kevin Sayer. we taped that episode before the ADA conference actually took place. You know, the time shifting nature of podcasting. we taped these interviews ahead of time and then a couple of days or a week later, generally, the interviews air. A a couple of days after taping that interview, the FDA approved Abbott's Libre2 and this is a different CGM is able to continue transmit glucose data every minute. And users can now set the system to send alarms when their glucose is too high or too low. And previously, you had to scan the sensor in order to get any kind of glucose reads. So that is a big change, and frankly, more direct competition to Dexcom.
I have reached out to Abbott in the hopes of learning more and asking them any questions that you may have Dexcom though, immediately reached back out to me and asked if we wanted to talk more about CGM and how they stack up in the marketplace. Now, I am not going to pass up the opportunity to ask more of your questions. And that's why we have sort of a Dexcom double feature this week.
My usual disclaimer Dexcom as you have heard, and longtime listeners know Dexcom is a sponsor of this show. That means they pay me to have a commercial in the show. That sponsorship gets them a commercial, it does not get them any kind of approval over content. And so what does that mean? It means I don't send them all the questions. I have of time, we don't plan out what we're going to say. I hope you know, as you've listened that I don't hold back on questions and criticism from them. But we do have that relationship. And it's really important that you you know it right because we were doing news interviews here.
And this interview is with Dexcom CTO, Jake Leach. I will link up more information at the episode homepage. And as always, there is a transcript. So here is my interview with Dexcom’s chief technical officer.
Jake, thank you for jumping on and spending some time with me and my listeners. We always appreciate learning more about what's going on at Dexcom. So thank you.
Jake Leach 2:36
It's a pleasure to be here. Stacey. Thanks for having me.
Stacey Simms 2:38
Absolutely. So I just talked to Kevin Sayer. We did kind of a high level, you know what's new, what's next? How are things going? Talking about the G7? It he's of changes that have happened to the G6 COVID delays, that sort of thing. My listeners had a bunch of questions as this is the backdrop of course of the Libre news that came out Abbott's Libre 2 have got approval for use of the United States. The number one question that my listeners had was, can they talk about the price difference? I don't know if that's a CTO level question.
Jake Leach 3:11
Yeah, as much as you know, I'm involved in it. We basically, when we think about the cost of the product, the most important thing to be thinking about is making sure people have access to it. So insurance coverage, we feel really good about the fact that 98% of the private insurance companies do cover the product, as well as Medicare started covers it. And in states, many Medicaid systems do also cover the product as insurance. That's where we focus our time is really on on that. And we very few of our customers actually pay cash for the product. The vast majority of everybody gets it through insurance coverage.
Stacey Simms 3:48
When I look at the Libre, and full disclosure here, my husband has type two diabetes and he uses the Libre and Benny my son has used the Dexcom since 2013. Now, wow, yeah, it's funny to think about how much time has gone by. But one of the things I look at with the G7 coming and the you know, the bit that we know about it is that it will be much more like the Libre in terms of the sensor and transmitter in one. Can you speak to that in terms of the G7 in terms of size, insertion, that sort of thing?
Jake Leach 4:25
Yeah, so the G7 is, as you pointed out as an integrated sensor all in one, so it's the wearable device that goes on the body includes both the sensor, the transmitter, as well as the electronics inside the wearable that are both monitoring the center and then taking that signal and sending it via Bluetooth to the different integrated display devices whether that's a mobile phone, so a smartphone with an app on it, Android or iOS, or a insulin pump for automated insulin delivery systems. Other display devices, we have our receiver that is our proprietary handheld, some people really like that as their way to access the information. So our goal is to make it as interoperable as possible, which is one of the key important points about IC GM is that it's interoperable device
Stacey Simms 5:16
you And with that, I always get hung up on it. Because when I heard about interoperability A few years ago, in my head, it seemed like, Okay, well, I could switch out my pump, or I could switch out my sensor, I could use a different brand with this thing and kind of mix and match. And of course, insurance for most of us is the biggest problem for getting different devices. But it doesn't really work like that, does it? I mean, if a Dexcom g seven works with say, Omnipod five horizon, and with a T slim X to control IQ, people aren't really going to be able to just switch out devices like that and use the same sensor, are they?
Jake Leach 5:51
Yeah, as usual, it's more complicated as you look at it under the hood. But the key thing about the integration is that systems have to be designed To be able to be integrated. And so one of the big moves that we made when we transitioned between Gen four, and Gen five, and then subsequently Gen six, and as well as Gen seven, we moved to Bluetooth technology, which is a much more readily available technology within the display devices. So we moved to that. And when we did that, we designed an architecture that the intelligence of the system is all on the the wearable. So all the glucose calculations, all the information that you need is actually on the little transmitter device in G6, and will be in G seven as well. And so that is the device that can be accessed by multiple displays. If you think about it, you can use your mobile phone and the whole share feature that comes along with our mobile system, the remote monitoring feature, you can use that and at the same time, you can use a tandem controller to pump doing automated insulin delivery. And so the system is really designed to have that type of integration where you've got the right information in the right places and makes it interoperable. The systems have to be designed To be connected, for example, horizon five Omnipod five, the system that is in development by insolate is being designed to be integrated with both G6, that's what they're doing their studies with as well as G seven. So you have to do the design work and do the testing to ensure that it operates safely. But interoperability is a great thing. But it isn't as simple as just pulling and pulling everything it has to be designed and tested.
Stacey Simms 7:22
Yeah, it was interesting. I in my head, I always had it as well, this, you know, I can mix and match, I can figure out what I want. But when I talk to technical people, they always kind of smile at that because they understand more of the intricacies, I think of what it takes within the technology to make that kind of stuff happen. Whereas as the user, I just want to hokey pokey it around and use what I want. But we'll see as it goes down the road. Some other G7 basics that my listeners asked was, will the G7 have a shorter warm up and does it have a lower MARD? Is it more accurate than G6?
Jake Leach 7:55
Great questions. The warm up time is designed to be shorter than g6. And so we're As we're landing exactly how much shorter it's going to be, but it's definitely going to be a faster warmup. Also, the mard is the average difference between the sensor and the reference measurements that we measured the performance of the device and so on. That way, we want to ensure that we hit those iCGM standards. And so I think G7 definitely has the opportunity to perform better, but it definitely will meet those CGM standards, which are rigorous and important to ensure the product performs accurately throughout its life.
Stacey Simms 8:30
Can you give me a hint on the warm up? Is it going to be more an hour and 45 minutes or more?
Jake Leach 8:35
No, no, no, it's gonna be It'll be an hour or less.
Stacey Simms 8:40
You know, just had to double check on that.
Jake Leach 8:42
Yeah, no games there. We're just we're still trying to dial in exactly what's going to be to ensure we you know, the system has to be accurate. Second, it starts up but we do value short warmup time because we know how important it is when you know you're without the sensor data for that warmup period. So you want to make sure it starts up as fast as possible.
Stacey Simms 8:59
Yeah, it's interesting too. Because I'm probably an outlier but previous to we use the control IQ system with tandem previous to using that the two hour warmup really didn't bother me too much. I mean, it was only two hours especially if you came from like we did seven years with no CGM. It's really did not seem to be that big a deal. But now that we're using this algorithm, and the pump relies on the Dexcom data, two hours just seems like way too long to be without it.
Jake Leach 9:27
I agree. Really interesting.
Stacey Simms 9:29
Speaking of wear time, we've been very fortunate. Again, as I said, we've used Dexcom for a long time we do not really have a lot of issues knock on wood with it. He's of sensitivity which Kevin mentioned in his in our interview together, we went over that, but also with where time, but a lot of my listeners wanted me to ask if you are really checking into the people who can and there are many who can never seem to make it to 10 days on a sensor. Right who really was it whether it's because they have a young child or the body chemistry for whatever reason, it does seem to be an issue that many people can't get the full life out of a sensor.
Jake Leach 10:07
Can you address that? I know you're looking at it.
Jake Leach 10:09
Yeah, yeah, I've got, of course. So a couple things there. There's quite a few things we've done over time. And we continue to research on this. There's two aspects to sensor longevity. One of them is how long the sensor can remain accurate. And so within our device, we have algorithms that are checking the performance of the sensor at all times. And so there are times when we detect that that sensor signal is not accurate and not meeting the CGM standard. And so we we actually shut it off and that's when you get on the display, you get the sensor failed signal. That's basically we detected that that sensor is not working properly, and it's not going to return to functioning based on the data that we're seeing from it. As you mentioned, most people are able to get 10 days out of the sensor particularly now that we've made some changes with the adhesive as well. But there are some people who don't and with those folks, we often spend some extra time with our tech support, and kind of walk through what their issues are. And there's quite a few things that can be done to help sensors last longer. I mentioned the adhesive, we recently updated our adhesive, we've added an overlay. that's optional, people can ask if you have access to the clear adhesive that goes over the top of the white one that comes with the product. And so we're looking at lots of different ways.
Because what we found is everybody's a little different in terms of what their needs are and what works for them. And so we're trying to do is have as many options that we can to make the sensors stay on and heared. And it's really that's our philosophy around sensor longevity is if I really wanted to I could I could run a study and claim that G6 goes 15 days because I know the performance would meet that the problem is not all the centers would last that long. And so what we're really after is making sure all the sensors, as many as we can get out to the labeled timeframe, not just some of them. And I think that's one of the key differences that you'll see over time between different CGM companies is we're very focused on a high level liability, you're never going to get 100%. You know, sensors will come off and they'll get knocked off. It's a challenge. But it's one that we're very focused on trying to ensure that we can have the highest flow reliability possible.
Stacey Simms 12:12
Let me just follow up on that, because sensor sticking is one thing, right? I mean, I know that that's an issue in everybody's skin is different. And you have the overlays now, and the adhesive does seem to be sticking better to many people. Butwhat about people who have no trouble getting the adhesive to stick in the wire to stay in, but get recurrent sensor failure? Are there any best practices for people who seem to get that over and over again,
Jake Leach 12:36
there are and it's actually often comes down to, you know, sensor placement and you know, the sensors indicated for abdominal use. And so, we often instruct folks to try at different locations. We've also, if someone's really having repeated challenges and where they're getting those sensor failures, we do have specific capability with our tech support to work with that customer and look at their data and To help determine exactly what is going on, there's a number of things to we tend to see, that happens when people are more dehydrated. So you know, kind of making sure they're well hydrated and drinking water. But if someone's having consistent problems all the time, then we really want them to reach out to us and talk to our tech support. And we can get someone who is experienced, but you know that those types of issues to talk to them and look at their data and help work through it.
Stacey Simms 13:22
I don't mean to harp on it. But I've just, and I'm, I know, you may not be the right person to try to pin down on this, so forgive me, but I'm thinking like, Is it an insertion thing is it I mean, we've, anecdotally, the community has said, drink water, stick in the fattest place you possibly can maybe rock the sensor a little when you're inserting it so it doesn't go as deeply in like it's more shallow. I'm just curious with all the data that you will collect in these phone calls. If there's any, like I said, a best practice that would help or if it's just you know, you've got to talk to your local rep, maybe get an in person or zoom call lesson or talk to tech support, but you know, just a more concrete business advice, I think would be so helpful.
Jake Leach 14:01
Yeah, I think a lot of it does have to do with that insertion saying, like you said, you want to put it into a place where you've got good interstitial tissue. The other thing I've seen, too, is, um, you want to make sure that it's not at a place where you're going to compress the center a lot, you know, if it's under compression, you're not getting the same amount of perfusion there have glucose under the skin. And so that can also lead to issues. There is something recently that we've released in a product that has really solved a number of issues in that people were getting sensor failures during really high glucose excursions. We've sent some solved that problem with a new version of our transmitter that is now out in the market, almost everybody has that device. Now, it did make quite a dent in those we were detecting the algorithm was detecting that really high glucose as a potential issue. And over time, we've learned through looking at the data that that wasn't an actual issue until we were able to correct that in a recent version of the device. But yeah, it does come down to kind of working through sensor insertion and placement in Don't have data that validates, you know, some of those techniques that you mentioned that says it will work if you do these things. But we have heard from the community, and in our own times speaking with patients that it has been very helpful. And some of those concepts you just mentioned.
Stacey Simms 15:14
Jake, I'm sorry, can I ask you to clarify? It may have gone over my head. But when you were mentioning the newer transmitter that is out, can you just clarify what you meant by when it was reading very high blood glucose? And that was affecting the sensor? And then it sounded like you said, but that wasn't the case. Can you just clarify that?
Jake Leach 15:31
Yeah, sure. So what it was, was that during really high glucose excursions, the device was detecting a potential sensor failure where it wasn't the sensor failure. There's nothing wrong with the sensor. It was working. But you know, it's one of those things that once you once you get a product on the market, you learn more about it. And so we've made several iterations to the G6 even since it's been in the market for several years to improve it. And that is one of the cases that we saw patients running into, that we resolved with the newest version of the device is that it doesn't give The sensor error when when there was really high glucose excursion,
Jake Leach 16:03
and I'm just curious cuz it does sound like you've resolved it. What is really high glucose? Like over 400?
Jake Leach 16:10
Oh, well north of 4, 5, 6 hundred.
Stacey Simms
Oh my goodness,
Jake Leach 16:14
yeah, we're really, really high glucose.
Stacey Simms 16:16
So if somebody has a teenager who's like bumped up to 250 and getting sensor failure, that's not the issue.
Jake Leach 16:21
That's not the issue. No, no, no, not in not in those,
Stacey Simms 16:24
because everybody has a different idea of really high glucose. So Thanks for clarifying.
Jake Leach 16:27
Yeah, that's a good thing to clarify. Because, like you mentioned,
Stacey Simms 16:32
you know, another question that my listeners had was about data. And we've talked a little bit here about some of the data that you collect. And I don't know if it's different internationally, but to speak about the data.
Jake Leach 16:43
Yeah, sure. Of course, first of all, data privacy is very important, both just fundamentally and philosophically as well as to be in compliance with all the global regulation we're seeing in this area of data privacy. There's a lot of advancements in the laws and regulate Around consent, and users granting access to their data, because in the end, it's the users data. We're just a steward of it. And so we take it very seriously. And so in our processes and our controls, that's how we proceed. So the data that comes into our systems from the CGM devices are used for things like share. So we provide the share system, the remote monitoring, that connectivity is super important. The data is also through that same system made available to the clarity application for use by the patients or customers or their physician. And then we also have that data in a safe lockdown repository that can be used by our tech support agents. If users are having track challenges, like we talked about tech support agents can actually log in and work with that user on their specific data. But
Stacey Simms 17:48
hey, it's Stacey jumping in here. I need to insert myself into the interview with the episode here because we hADAn audio issue right there and it was completely my fault. So apologies. Dexcom is going gonna give you a full statement on data and privacy, and I will link it up in the show notes. So Jake can kind of continue his thought that way and give you the full statement. One thing he said that I thought was very interesting though was if you are concerned about privacy and want to opt out, you can just use the receiver all by itself. They don't collect any data that way. But then you can't use clarity or share the information online with caregivers or your health team. But if you want to opt out, that is one way to do it and still use the Dexcom system. I did follow up the data question with one about transmitting data and why it's limited to certain devices. If you use a tandem pump like we do, for example, the transmitter can send data to your phone and to the to the mix to pump but then not also to the receiver.
Jake Leach 18:52
Yeah, the ad goes down into the specific engineering of the device deep down inside the wearable, for example to the transmitter producer. There's a battery in there. Every connection to a display device takes a Bluetooth communication channel. And so today, which is six, we support two channels, one for mobile phone and one for a medical device such as the insulin pump, or the Dexcom. receiver, it can support to have those connections to the med devices, because we need one available for a phone. We are looking in the future to allow multiple different types of devices you can imagine watches and other things. And so that technology is we're working the architecture of that. But the key there is that circuitry has to be low enough power that it doesn't use up the battery. We specifically designed G6 to be reliable for that 90 day period for the mere life. And so we couldn't put that system you can't support more than those two connection.
Stacey Simms 19:45
Yeah, practically speaking for us. It's plenty. I was just curious about the thinking behind it. And is that going to be the same thing with the Omnipod five? horizon? I'm laughing because I have to figure out how to say that Omnipod five. will it be the same thing Work goes phone and PDM or something, or is that a different setup altogether?
Jake Leach 20:04
It's a little different. But it's it with the G6 integration, G6 will support the Omnipod five as well as a mobile app like a G6 app. So it does support that. And as we look into the future towards things like g seven and future versions of G7, we are looking at architectures that could support even more display devices, more than just two.
Stacey Simms 20:24
And I'll hope to talk to Insulet in the future to get the specifics. But as I'm asking you this question, that sounds a little ridiculous, because where would it show up on the pod? I guess it would show up on a PDF if you use that instead of a phone.
Jake Leach 20:34
Yeah, I think one way to look at it for all of these automated insulin delivery systems is you want good communication between the algorithm that is doing all of the calculations for how much influence to deliver, you want a good connection between that and the glucose signal and the pump that's doing the delivery. That's part of the system engineering of the of the product and part of G6 was designed specifically for interoperability with so that it can support use cases like that
Stacey Simms 20:59
you mentioned To watch, I did talk to Kevin about this. So I'm sorry to bring it up again. But my listeners are really waiting for that direct to watch component. Can you speak to that from your perspective?
Jake Leach 21:11
Yeah, sure. So, you know, it's a it's a feature that we've been working on in development for for quite a while. And as we've worked through it, well, it turns out, you know, on our side, as well as on the leaves, Apple Watches is one of the one of the examples other than a significant amount of engineering. I think that we all underestimated when we first started talking about that product in the way that it interacts with the G7, as well as the phone app. And so we've been working with Apple closely know, over the last couple of years, actually, when when they announced this feature, it was really kind of a prototype feature. We started working with them closely on it, making quite a few updates on both sides to support that type of a feature. And so while we don't have any dates, where we're going to launch it, it's important feature that we know, adds flexibility to users lives and so we will continue to work on it. But at this point in time, we don't have a specific comment.
Stacey Simms 21:57
Yeah, I'm curious um, before I let you go here, DiabetesMine, which is a really great news source, if as you listen, you're not familiar, I always read them. I think they're fantastic. They recently, earlier this year, put out an article, headline “39 potential new continuous glucose monitors for diabetes,” as some of these are never going to happen. A lot of these are, you know, non invasive wearables that, you know, look at a headline, and we may never see again, but some of these are going to happen. Jake, I know you all are watching the competition. You know, I know that, you know, Dexcom has enjoyed a long time here of not having a lot of competition, especially the United States. I'll give you the floor. Are you guys ready to take on these companies?
Jake Leach 22:39
Absolutely. I think the just notion that there's that many different companies and working in this space is kind of validating the concept that continuous glucose monitoring is the standard of care for diabetes management and so perfectly comfortable with Mark people working in this space and we continue to drive forward all of our efforts on advancing the technologies, whether it The performance of the sensor the longevity of the sensor, particularly the ease of use, and the integration of our CGM with other devices. And you know from what we've seen, it's a very large opportunity. There's a lot of people who could benefit from CGM, so we're comfortable not being the only player. And we actually going to welcome expansion of CGM space across the globe with other companies as well as tech from
Jake Leach 23:23
Well, thank you so much for jumping on. I feel like I got a double feature of Dexcom this week. So thank you for the info. It's always great to catch up.
Jake Leach 23:29
I appreciate it. Stacey. Thanks for having me.
Jake Leach 23:37
You're listening to diabetes connections
Jake Leach 23:39
with Stacey Sims.
Stacey Simms 23:43
More information in the show notes as always, the episode homepage and there is a transcript there there are important links. Same thing if you're listening in a podcast app, you should be able to get to the show notes. But you know some apps are weird and they don't post links and Apple podcasts which is the most common one. Used as kind of bad for that sort of thing. So I always put it on the episode homepage, which you can find at Diabetes connections.com.
And a little bit on that audio error if you're interested. I mean, here's some inside baseball. But here's basically what happened. Whenever I do a remote interview, and probably 90% of the interviews on this podcast are remote, right? We're not together, I do them generally through Skype. And my computer is set up so that it automatically records when a Skype call is placed. I have a backup recorder. For those of you who are technical and want to know it's an h5 zoom, and it's fabulous. But it's an external recorder that's plugged into the computer and has an SD card inside of it. So this call like a couple I've done recently, our zoom calls, my computer is not set up to automatically record and you know, everybody knows zoom by now if you're not the host, you don't have the power to record well 99% of the time, I asked the host to please record it on their end and then send it to me as a backup and I just roll the h5 zoom over here. forgot to ask them To hit record, there's always a PR person on these calls, you know, Jake doesn't have to worry about it, they'll take care of it. But I forgot to ask her to do that. So I'm rolling on my end, but they weren't rolling on there. And then and this has never happened before, the SD card was full. And it's a huge SD card. I don't know what the data is. I'm not going to pop it out. Now, look, but you know, I cleared out periodically, but probably only once every six months. And oh, my gosh, I completely forgot to do it. So it just clicked off and stopped recording. I share this with you. Because I mean, we're more than 300 episodes in right. We're close. You know me, I know some of you, but I thought you might appreciate it behind the scenes look at some of the nonsense that goes on here. I was able to stop the interview, ask them to start rolling and then restart. But we did lose that part, which I hate about the data. I have talked to Dexcom in the past about data.
I will link up the specific interview where I talked to them about that. And I will link up the statement that they gave me after the fact I asked them to email me some information about that. But you know, hey, we're not perfect around here and we don't pretend to be the next Episode shouldn't be an interview with tandem. if things work out. We're still in the process of moving some things around with ADA and breaking news, we always like to do the best we can. So tandem should be up next, please join the Facebook group Diabetes Connections, the group to stay up to date. And that's the best way to get your questions into these interviews. When I have something like this, I always ask and you guys are amazing at getting me great questions and letting me know what you want to talk about. So I appreciate that very much. Thank you as always to my editor john Buchanan's from audio editing solutions. And thank you very much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself, even if your SD card is full.
Benny 26:45
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Dexcom is featured in a lot of headlines coming out of this year's just-completed ADA Scientific Sessions. Stacey talks to CEO Kevin Sayer about everything from how COVID has impacted the G7 timeline, what the G7 will actually feature, adhesive changes and more. She asks why Europe got approval for back of arm placement and when we might see that in the USA and, once again, we check in on direct to watch progress.
Check out Stacey's new book: The World's Worst Diabetes Mom!
In Tell Me Something Good, a major league dream comes true.
Read about Garret Mitchell here
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Unknown Speaker 0:17
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:23
This week catching up with Dexcom at the ADA Scientific Sessions a time when a lot of new studies are presented. But this year COVID-19 means delays for expected tech, including Dexcom G7, which was moving ahead with trials.
Kevin Sayer 0:38
It was in full force in March it was gonna continue throughout the rest of the year that came to a grinding halt. We are in the process now of resuming and replanting that schedule.
Stacey Simms 0:50
Dexcom CEO Kevin Sayer goes more in depth about the G7 we also talk about adhesive changes, working with European pump manufacturers and what else Coming down the line and tell me something good a major league dream comes true. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I am so glad to have you along. I'm your host Stacey Simms and you need to educate and inspire about diabetes by sharing stories of connection. My son was diagnosed with type one right before he turned two. He is now 15. My husband lives with type two diabetes. I don't have any kind of diabetes. I have a background in broadcasting and local radio and television and that is how you get the show.
The American Diabetes Association Scientific Sessions is a conference where every year many studies many many studies are released and thousands of people gathered to hear what's new and to do some serious schmoozing Of course this year the entire conference was virtual, which is a terrific opportunity. You know maybe you're able to register and jump online. A lot of new media outlets offered their own platforms for you to kind of take part into the virtual conference. I've never been to a da. And while I don't plan on reading every study, you really can go online and see just about everything. I'm going to link up some of the major links, including the one right to the conference, and some of the abstracts. I think every abstract was on one of the pages I saw. So I will link up all of that information on the episode homepage. And I've already put a lot of it out on social media. And chances are good that as this episode airs the Tuesday after ADA that you may have read about a lot of these things you may have seen some of the studies, but I really like going in depth with the the newsmakers as we call them as I used to work in News Radio, but you know, the people who are putting out these studies, so this is the first of what I hope are many interviews over the next couple of weeks. I have confirmation from several of the pump manufacturers. I've reached out to some of the other tech people and people doing these studies and we'll have more information on And follow up on some of the information that came out.
A quick disclaimer. As always, I always like to make this clear. Dexcom is a sponsor of this show, you'll hear their commercial later on, but they don't have any editorial control. And that means they don't tell me what to say or what to ask when I have Kevin Sayer or anybody on from Dexcom. longtime listeners know the drill. But I just like to make that clear. I'll also add we just had Kevin on the show a few weeks back, it did a whole episode when they announced that they were going to have CGM access to hospitals because of COVID-19. And I asked our Facebook group if it was a little too much Dexcom. But overwhelmingly, they said no, give us as much information as you can. So we will get to Kevin in just a moment.
But first Diabetes Connections is brought to you by One Drop. You know, I spoke to the people at One Drop and I was really impressed at how much they get diabetes. It really makes sense because their CEO Jeff was diagnosed with type one as an adult. One Drop is for people with diabetes by people with diabetes, the people Let One Drop work relentlessly to remove all barriers between you and the care you need. Get 24 seven coaching support in your app and unlimited supplies delivered, no prescriptions or insurance required. Their beautiful sleek meter fits in perfectly with the rest of your life philosophies send you test strips with a plan that actually makes sense for how much you actually check. One Drop diabetes care delivered, learn more, go to Diabetes connections.com and click on the One Drop logo.
The ADA Scientific Sessions this year pretty different all virtual, but the information is still coming out. There's so much of it as always, and I was able to talk to Dexcom. now this interview happened Friday just as ADA began. And while we were able to talk about things that were going to be presented over the weekend, there's always a chance breaking news happens since the interview follow along on social media for more information if anything changed, of course we'd put it out that way. And I will link up more information in the show notes.
Quick bit of housekeeping, there are a couple of terms that we throw around here that I want to make sure to just to define really quickly and kind of loosely, most of you are familiar. MARD is a measurement for CGM, the lower the MARD, the better, the more accurate and we talked about that. We also mentioned iCGM. That is a new we're just about two years old classification from the FDA here in the United States, where an integrated continuous glucose monitoring system can include automated insulin dosing systems, you know, insulin pumps, it can integrate other devices like the Dexcom G6 does with the tandem pump, that sort of thing. It also classifies it as a new type of device in a different class for the FDA, which means different things for approval going forward. I will link up more information on that but when he says iCGM, that's what he's talking about. Here is my interview with Dexcom’s Kevin Sayer.
Kevin, thanks so much for talking to me. It hasn't been so long. Since we last spoke, but with the ADA once I get a roundup of everything that was happening, thanks for jumping on.
Kevin Sayer 6:06
Well, thanks for having me again, Stacey. It's always fun,
Stacey Simms 6:09
we have a lot to catch up on some things that we just talked about a few weeks ago. I'm going to start if I may, with something that may seem very mundane, but really caught my eye. And that is the approval in Europe, of placement on the upper back of the arm. We are a largely US based podcast, we do have large international listeners who are very interested in Dexcom. But can you talk a little bit about how that came to be? And as we have talked about before, many people here in the US were on the back of their arm, even though it's not FDA approved. So I guess the second part of that question is, are you submitting for approval here too?
Kevin Sayer 6:48
Well, I'll answer all those questions. And let's start with your You are correct. People have been wearing this thing on the back of their arm for a long time, even though legally and regulatory, I cannot encourage that on a podcast. The fact is when you go to, in particular to like a kid's diabetes meeting, that's where you see all the sensors. And so we've seen that a lot in Europe, we had done some studies and there was some evidence presented that was compelling enough to the authorities that we can get that arm indication. And so we filed that and we got it. Also combining that in Europe, we got a pregnancy indication as well. So we were in a really good position with with respect to C mark. With US regulations, we have that iCGM standard. And the evidence that we presented in Europe for approval isn't strong enough to meet those iCGM standards that we have with our G6 system. But we are working on putting together some evidence in the US that we think would work and will be good enough. So we will ultimately seek a G6 arm indication. I think the other thing to look forward to as far as that when we run our G7 pivotal study, we're going to run the study on In the back of the arm and on the abdomen and on for pediatric patients and on the upper medics as well. So we'll have three labeled sites there. And that will give our patients literally the optionality labor for label indications where the center and the in the most popular places.
Stacey Simms 8:17
It's interesting, when you have a chance, I understand why you wouldn't go back with the G6 and redo things like that, you know, I would imagine the cost alone would be prohibitive. But with the G7 in new systems, it must be interesting to hear from customers, not only things like arm placement, or I wonder if there are other things that you might test. In other words, I have always heard and I guess you can confirm I don't know if it's the case, that the reason that pumps and CGM should not be put through airport scanners is because it wasn't tested there. Is that the kind of thing that in the future we might see you You trying? You know, hey, let's test it with this condition. Let's test it under that condition. I mean, does that come into play?
Kevin Sayer 8:55
we do all of the testing required under federal regs. For those things, I mean, I've worn my CGM through scanner, never worn anything through the scanner through the suitcase, mind you better but I will tell you some of the things we do there is, you do have a very good question there. Because you do ask, do we listen and what are some of the things we try before we lock in on our product design and what do we test and some of the things we've we've talked through and thought about what G7 because we've been at this for quite a while we've had multiple size configurations. Before we locked in on what we did.
We've made it smaller, we've made it bigger. We've liked it on the size we like it on because that was the optimal configuration for the electronics and you get to a point sometimes when things are so small, you can almost lose dexterity or the ability to use it properly. We know people want a smaller less visible sensor. As we look going forward. We will continue to focus on that. we tried numerous adhesives with G7 in our research work, what sticks the most without causing problems, etc. We, we even experiment, not just from a customer standpoint or customer feedback standpoint, but from a scientific standpoint, what's the shortest we can make the sensor and still get the outcome and the accuracy that we want. So we've spent enough time on the G7 system, to whereby we've tested a number of things of that nature to figure out what the best configuration we can get is. And we balance that with getting the product approved, and again, through the iCGM standards. So there will always be when we launch a new product, there will always be some features that we leave on the table that we don't put in it that we would like to put in the next generation. But ultimately, we have to stop and say that this is good enough. It's my job to make them stop. I promise you, the guys have more great ideas than you could ever imagine. But that is a very important part of our process to really listen and test those things. As we go.
Unknown Speaker 11:00
Okay, so you mentioned you've brought up now the G7. So let's jump ahead. I do have some G6 questions, but let's jump ahead and look at that. Where are you on the G7? Did the has COVID delayed things? I know you hate to put dates out there..
Kevin Sayer 11:13
All right, and I won't put a final date out there. But COVID has delayed things on a couple of fronts. The major one is the clinical study any of your listeners and involved in one of our pivotal studies where our patients go into the clinic for you know, at least half a day, at least 12 hours to have blood drawn and tested in the lab instrument is glucose values are raised and lowered. All those types of activities have ceased due to the COVID situation and we had a very aggressive clinical trial schedule. Literally, it was in full force in March and was going to continue throughout the rest of the year that came to a grinding halt.
We are in the process now of resuming and re planning that schedule, but we still don't know all the dynamics of the schedule and the best example I can give you if you go to a large Diabetes Center They might have had four or five patients at the same time in the room being monitored, while the social distancing Are we going to have to? Are we going to be able to have four or five? And what protocols are the various centers going to be running with respect to those clinical trials? So we are really literally out there rescheduling the pivotal study for the G7 system. That is the biggest delay. The other thing we have experienced, and it's to a lesser extent, is just the effect of COVID-19 on all of the people involved in this process. You know, I was talking to somebody the other day, and they used to quote, it takes a village to raise a child it sure as heck takes a community to build a product. And we do depend on a number of other suppliers who encountered their own COVID difficulties, the easiest one that comes to mind which you summon the molds for the plastic or an 18 month lead time and the molding company was hit by COVID and literally shut their whole factory down for a month. And that's not the mold makers. That's not a problem that just does Just reality, we put all of the operational pieces of the schedule back together. We're comfortable with those timeframes.
Now we've got to get the pivotal study up and running and get it big enough. And I will go back to you know, I've talked about iCGM and the bar that the FDA has said, This isn't a study, we can go run with 80 patients and call it a day, there's going to be several hundred patients here. To the extent statistically we can come up with models to decrease the size of this study, we will, but we do analyze it, because the criteria are such and the one that they explained to me that rang the truest in the mid range of the good range of sensors, you know, timing range between 70 and 180. If we have 1000 data points, and if seven of those are off by 40 points, or 40%, the whole trials done, and our biggest source of error in the studies is not the sensor, and it's not because the centers aren't great because they are, there's just so many pieces of paper and so many things that have to happen. So we are really refining that process. Given the fact that we can't run studies now, we're very optimistic once we get them going, and we'll do well. We're going to run a study for Europe, in addition to that, and file that separately, so you'll hear more timeframes from us. But it's going to take longer than even a couple of months to have the perfect schedule laid out a timeframe is not coming for a while.
Stacey Simms 14:17
Can you share anything about the G7? In terms of what makes it different? And why move ahead with a new type of sensor?
Kevin Sayer 14:26
and I'll go back to my first statement to listening. The one feature our patients have all said they want a smaller, and that's pretty universal. When we embarked on this many years ago, we literally started with something the size of an m&m. Now the G7 is a little bigger than a nickel. It's not as small as an m&m, but it's still pretty small. And we wanted to do that. We wanted to eliminate some of the difficulties with respect to transmitters and pairing the whole G7 system is disposable. We also when we looked at G7, and when we started down this path We designed this from the very beginning to manufacturer in an automated manner. There will be humans manning the machines but these aren't going to be human lives. Everything else we've done we designed around the fact that we manually put everything together or have many manual processes now G6 is about to the point where that will be pretty much all automated or manual lines will go away but we wanted to build a product that we could build 10s if not hundreds of millions of in a repeatable manner and our previous generations or product, even G6 up until now I think G6 has now crossed the barrier where we can build lots of them but build g five system says you could have never got to the volumes we anticipate getting to as as technology continues to expand and explode and i and i think what we've created and our goal which he said is to give us a product configuration that anybody can wear and then it will have multi uses. It's as big a step forward from G6 is G6 was for G five.
Stacey Simms 15:56
When you say the whole system is disposable in the size of a nickel Retreat you want to avoid transmitter issues? Is it all in one is the transmitter and the sensor
Kevin Sayer 16:04
transmitter and sensor all built into one unit yes
Stacey Simms 16:07
I'm you know, having been with Dexcom for more than six years now and I think we started in the g4 Platinum I'm trying to visualize
Kevin Sayer 16:16
No, it's much smaller and much thinner and it literally if you wear a G7 you have no idea it’s on your body.
Stacey Simms 16:25
Really interesting and you anticipated having a similar more similar you know accuracy as the G6
Kevin Sayer 16:31
yes, yes, it has to meet the iCGM standards and and so we've we're designing it that way. We're designing the algorithm the pivotal studies along those lines. And right now what what is becoming very clear to us as we go through these statistics, while MARD is always important from an overall perspective, the iCGM standards are more important than than just the margin number is important that these things be reliable and offer the same experience every time. So we Certainly you have to have a good MARD to be approved on those iCGM standards, but the reliability of the sensors is every bit as important. We're focused on both.
Stacey Simms 17:09
Well, as we look forward to that, as you said, it'll be a while because of COVID and other delays. My listeners, as always have questions and one that has come up quite a bit. We'll go back here to the G6 and current manufacturing is a question about whether the adhesive had changed recently on the G6. As always with me, it's anecdotal. I don't have access to studies or thousands of people. But we've noticed within the Facebook group that I run for the podcast that more people are reporting, rashes and problems with the adhesive with the G6 than they had in months and years past and the question came up is has something changed?
Kevin Sayer 17:43
Yes, it has. There's a very fine balance. On the adhesive side. We warranty our product for 10 days. We say this as a 10 day sensor, and one of our most common occurrences of replacing a sensor as it falls off, in fact, the most common one so for years, we have studied adhesives and wanted to make an adhesive change that would give patients a better experience and have that sensor last the entire 10 days. And so we did change the adhesive out to something that was more sticky on the one and we are very happy to report that we are seeing a great reduction in the number of sensors that fall off people. So we are delivering on end to the experience. On the other side of that we have seen an increase in allergic reaction to that new adhesive. We have some data on our website. And we have done some clinically based work for those patients to give them some options to whereby the adhesive will not have that same effect that there's some mitigate mitigations that you can make to do that. So if you contact us, again, I believe it's on our website or also you can contact our tech support. There are some clinically based solutions that we can offer.
Stacey Simms 18:46
All right, so I will refer people to the website and we'll keep helping each other but I think people wanted to make sure and just get confirmation that something had changed.
Kevin Sayer 18:53
Well we did change it we did
Stacey Simms 18:54
Dexcom offers the free over patch when people request it you know to help it be more simple. Has that changed at all? Or that seems to be the same?
Kevin Sayer 19:02
I believe, yeah, the over patches are the same.
Stacey Simms 19:04
Okay, I feel like this is almost like when I used to ask you about Android, but it popped up in my timeline that three years ago, the Apple Watch product came out and it was a huge press release from Apple about this is gonna change your health, this is going to change you know, everything. And in that article was, of course, and you'll be able to see your blood glucose from your Dexcom. They also would hope to get on your watch on your watch.
Kevin Sayer 19:27
We're always supported it. We're not direct to watch it yet. That project has has proved to be extremely difficult. The architecture of a watch is different than the architecture of the of the mobile phone. And in the middle of that I believe there have been changes made to the watch architecture as well. We as we've looked at and prioritized our projects and our resources and we look at software things we need to work on. While that project is still on our list, getting more reliability went to patients each and every day has been above that. And this taken some precedent to it, we will eventually get there.
But there's also some interesting issues with the watch that we didn't even contemplate when that release came out. And I'll give you the perfect example. You've got to charge your watch every day. How do you get that alert on your wrist? When your watches charging, and things of that nature, there is a different experience, and different safety features are going to be required to be implemented over time. We're working through it and thinking about it. We aren't ready and in all fairness, as we've looked at resources, if we're picking for example, between G7 and the watch, look, I love to watch you use I use all these tech gadgets all the time, and I put different ones on, we will eventually get there is a lot more complex than we envisioned when we started down the path. Probably the most loyal Apple Watch, customers are Dexcom patients. If you're an apple watch on an Apple phone and use an apple watch those patients use the Dexcom app on that watch a lot. Even through the phone. The watch experience has been a very good experience for our patients who use it
Unknown Speaker 21:00
What about other watches like Fitbit or devices like that
Kevin Sayer 21:03
we display on the samsung watches or some of the Android platforms now we've had discussions with Fitbit. Fitbit just got acquired. And I think they're regrouping and figuring out where they go. I think it'd be wonderful to offer our patients solutions along those lines, it becomes a question of do you get the whole device safety experience on that display? And how do we label it and what do we do? But these are the things we're looking at and pursuing?
Stacey Simms 21:27
Another question I got from a listener was all about can Kevin talk about other Dexcom partnerships with newer pumps, at least new to the US like, Ypsodmed if I'm saying it correctly, and other you know, European and worldwide, pump companies, is there anything new to talk about with those partners?
Kevin Sayer 21:45
You know what? We just signed an arrangement with Ypsomed to work with them, their pump will pair with our sensor. It'll be in Europe first. They will bring it to the United States at some point in time. They have also signed an agreement to license, our type zero technology, the algorithm that we have that has been involved in numerous studies around the world and is the basis for control IQ as well. So they will use that algorithm and it will continue to work with our sensor. I don't know all their US plans, I won't speak on their behalf. So we'll see where that ends up.
We do have research relationships with a number of entities getting to commercialization, we'll just have to see these partnerships. You know, I would tell you that the 10 of joint product offering is doing extremely well we get great feedback. The Insulet study has started back up. I look forward to the day when all these things are on the market. Stacey, giving patients the choice to have these automated systems will be a wonderful thing for patients and they've been very patient waiting for us and for our partners to get them out. I think when the day comes it will be fabulous but we cannot pair with every single. It is kind of a hard balance. pairing with every single pump is a lot of work to support in house but we want To be interoperable, that we want to get products out, we really want to get solutions out there. And we're happy with the partners that we have. In the US, I think initiatives like the loop initiative where they're gonna develop an algorithm that could work on a number of pumps and number systems might be a very good option for Dexcom to pair with others because the pairing is done by them in the app, not necessarily by work by us. So over time, the interoperability strategies one will continue to challenge and we are prepared to work with anybody that can enhance patient's lives and help our business
Stacey Simms 23:32
it just a clarification question you mentioned Dexcom owns the type zero algorithm, which is the brains let's say of control IQ really are the basis of it if it's used in another pump, if it's in the Ypsomed pump, is it the same exact bit of software? Or do they are there changes or
Kevin Sayer 23:50
tweaks? No, I'm I know that Tandem has made changes to the app and how it works, but the fundamental math and the algorithm will more than likely be the same. I can't speak Exactly. To what Tandem’s done, but I'm pretty confident it'll be a similar experience from an accuracy and from a patient perspective is the way it works. And then we're working with our type zero team to develop other algorithms, and advanced versions of what they've learned in the past. We are free to license to others as well.
Stacey Simms 24:15
It'll be interesting to see how that evolves. And when we talk about interoperability, I actually have a little bit of trouble with that, because in my head, and I've described it like this before, it seems like it should be more like Mr. Potato Head, right? Like I have the base, and then I get to put the ears on that I want the eyes on that I want the feet or whatever. But it's not exactly that easy, right? It wouldn't be a question of like, grab a Medtronic pump, but I get to slap a Dexcom sensor on or you know, buy or anything like that, right? It's not No,
Kevin Sayer 24:42
no, it's not that simple at all. And in all fairness, I think Dexcom has done a better job and design our product to be interoperable better than anybody else. And I can give you a very simple example. I tried to close this many years ago. Our transmitters designed to talk to multiple devices at this Same time to more than one. And that took a lot of time and a lot of engineering and a lot of dollars. And so I raised the question, why are we talking to multiple things? Let's just talk to one. They all kind of like I should know. Well, now think about things. Now you can talk to your tandem pumpers. You can also talk to a phone app at the same time. What a wonderful feature for our patients. And what a wonderful feature as our software changes or gets an advanced feature, that maybe our pump partners or a pen partner or somebody else doesn't have be able to talk to both is a wonderful opportunity for our patients if they want to use both apps. And I think over time, particularly as we look at refining your software experience, it seems to be more important.
Stacey Simms 25:41
Last listener question was about compression lows. I don't know if what they're really called. But anecdotally you sleep on the place for the Dexcom is the circulation slows or for whatever reason you get a fake low. I'm sure you're all aware of this. are you addressing it you think it will be cleared up with the G7
Kevin Sayer 25:59
I don't know. It'll be completely cleared up for G7, I would hope it decreases because, and I can only speak from a theoretical perspective, the sensor is smaller and the transmitter is less bulky. So there might be less pressure pressed on it. But compression has existed in all sensors forever. I have asked the team to look at other ways to deal with the compression issue and come up with some ideas. And they have some very good ones. It wouldn't be in the first version of G7. But I we've got a couple of thoughts that I won't share, because they're very proprietary. I think we have some good answers for compression over time. The question becomes, though, Stacey, and this gets back to the patient experience. And since your listeners are familiar with us, if it's compression low, do we still alert you and wake you up and tell you to roll over? Or do we guess what your glucose value should be and just keep going? What is much safer is to alert you and wake you up and say you're having a compression error roll over? It's not a real low. But do you all want to be woke up for with that type of error or would you rather is Wait for a half an hour and say I was just compressions con, these are the kind of things we shouldn't talk about, and contemplate within the engineering group, which is why these guys want to work here. It's really interesting.
Stacey Simms 27:10
Hey, there's so much information that is coming out at ADA that we haven't even touched on. And I you know, as you listen, I will link up a lot of the information. There's the G6 two year anniversary study. There’s a lot of information about the hybrid closed loop partnerships that's coming out. I'm curious, the launch of the G6 Pro. Honestly, I'm not sure that too many listeners of this podcast would use a product like that, whether it's blinded or they just get it temporarily from their their provider. But talk to us a little bit about that. Who is that for? What was the demand like for that?
Kevin Sayer 27:42
Well, the demand on that has been huge. And the demand starts in the physician offices. And literally, if you think about Dexcom, our pro product right now is a g4. It's not even G5 and our physicians have never had the opportunity to be able to say to a patient, let me Let you have a CGM experience similar to what you would have if you're one. So for your audience in particular for patients who would like to know what CGM is like the physician can output a unit on it. This is exactly the G6 system. The G6 Pro is a transmitter to sensor in a single box. Patient wears it and it's disposed of at the end of the sensor where period, the reason you have the blinded app physicians have asked for it. We think for patients unblinded is obviously the way to go because they can learn what to do with their own management. But the fact is, for a physician, there's a baseline check as to, hey, how's my treatment working? Or how's this treatment working in a type two non insulin taking patient in particular, you can put that sensor on blinded for a 10 day period and get a readout and go, wow, this is working.
the audience is very much from an educational and therapeutic perspective. In the professional environment. We have priced it in a manner to whereby the physicians can really acquire this at a reasonable cost. It will also be you know, at As you look at what's happened with COVID, as well, taking newly diagnosed patient and telemedicine, you can put a patient on this professional system. And if the patient uses the date alive, the physician can use the data live. As we've gone through the the virus situation, the the learnings we've had from our physicians about how CGM actually works. It's been really interesting. I mean, I get phone calls, do you know I can watch my patients from home I didn't know you could watch your patients from home and clarity, we reduce the three hour time lag, we've got near real time. And that's helpful. So you know, in this new age, where you have telemedicine and all the information that physicians need to get, we think G6 pro fits in very nicely and we want patients to be able to have that experience and learn what index comm is like rather than than other things and learn the information they can get ultimately for us as timing range becomes the measure. Now let's take it a step further. If you're a physician and your key measure Simon range Your patient doesn't wear a sensor, you can just put a blinded Dexcom on him, send him home for 10 days and come back, download it, you can read it. And you know what that patient assignment ranges. It has a number of great uses for us and will be a platform for growth going forward, we think is going to be very, very, very important.
Stacey Simms 30:16
I didn't realize it hadn't been updated since g4 that makes a lot of sense. No. And then before I have to go one more quick question. Last time we talked, we talked about CGM in hospitals. I know how long but how is that program going? What is the feedback? And can you talk about how widespread it's been
Kevin Sayer 30:33
able to come? We've had interest from many, many well over 100 hospitals close to 150. And we're in quite a few of them. The interest has been great. It has taken more time for us to do this than we would have thought when we started. when everything started happening very quickly. We were getting requests from hospitals and people didn't quite know what CGM was but read about it that we literally thought 10% of our production might be going to the hospital and it hasn't been that great of a demand. We've learned the intricacies of hospital operations with respect to it and GE, we're sending you free phones fuse the sensor and you guys don't want to use them because you don't know if they're HIPAA safe. We've had to learn all these steps along the way. But where are we got it, and where it's up and running? Well, the results have been everything we'd hoped for the sensors performing the way we want it to it's accurate. We haven't seen major problems due to drug interference, which was a concern that has been an FDA concern over time, the ability of the healthcare providers to monitor from in the hallway, a finger stick administered by a healthcare professional, somebody timed it for many other days, about 15 minutes because you got to gown up, put on gloves, go stick the finger, okay, if you're doing a finger stick an hour, you're saving 15 minutes of nurse time every hour. For every patient, they don't have to stick the finger on. There's been a huge reduction in PPE.
The patients are getting off the insulin drip faster because their diabetes can under control more rapidly. are leaving the ICU faster. They're going home healthier, all the outcomes. We hope for happening, the speed of which the uptake has been slower than we would like, but it is still going on and people are still expressing interest. And I, I think based on the places where it has been, I don't think anybody's going to let it leave. Particularly while we sit and anticipate what could possibly happen in the fall, we are going to gather data. And when we can gather data and get enough data to whereby there's a meaningful submission, or at least a discussion, we'll take that and we'll discuss it with the FDA and decide what next steps would be to get the labeling and to get a hospital usage approved. I think the products always belong there. I went through an experience personally with my mom many years ago, she had a heart valve replaced and it took them longer to get and she had type two diabetes. It took them longer to get her glucose under control than it did to get her heart valve and all the other pieces of her recovery then it was fascinating. I mean, they kept coming in adjusting insulin dosage, taking it up taking it down. And I kept saying I have something we could put on her to make It's easier, and no, no. So I do think it belongs here. It's a great use for the product.
Stacey Simms 33:06
That's really interesting. Well, Kevin, thank you so much for taking some time to talk to me about this. A lot of things happening at once. And I always appreciate your time. And when you start the G7 trials, I know that we all go through the official channels, but you know, call me We'll get my son and
Kevin Sayer 33:24
hey, we appreciate I always love to come on on your show. We always have a great discussion, and I'm happy to deal with any questions that come up. You know, I don't hide.
Stacey Simms 33:33
Yeah, I appreciate that very much.
Unknown Speaker 33:40
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 33:46
For information at Diabetes connections.com. As always, at the episode homepage, we do have a transcript as well if you prefer to share it that way if that's helpful for people that you know, easier to read it than to listen and just to be crystal clear, if it wasn't paying 100% choking. At the end of that interview, I could no more get into a clinical trial by talking to Kevin Sayer than I could, I don't know, get Benny a better wrestling birth by going to the NBS Linux department of his high school. I mean, I don't know about you, but that's not how it works for me. And we joke all the time being Penny never been able to get him in a clinical trial. We keep trying, I'm signed up all over the place. Maybe the word is out on what a pain in the butt I am. But I would love to get him in one of those. So we'll keep trying, but interesting information there. And I will link it all up at the episode homepage. Tell me something good in just a moment. Let's talk about baseball. But first diabetes Connections is brought to you by Dexcom. And you know, when we started using basal IQ a couple of years ago, that's the Dexcom G 610. to pump software program. I was so happy with it. And then with control IQ. It's just amazing. less work. better results with diabetes with a teenager. I mean, Benny always liked seeing his face GM numbers on the pump, right? We got that pretty much right away with tandem. But honestly, it was just more of a cool feature he really took us pump out to just look at it. There's some secret sauce, though, in first basal IQ and now control IQ, right? That just really is incredibly helpful. His range time and range has increased significantly, his agency has come down significantly, you know, I don't talk about specific numbers. Holy cow. Of course individual results may vary. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Intel Tell me something good this week. This is a cool story that just because it's a cool story on its own, but I was alerted to this because in one of the Facebook groups I'm in, a mom posted a picture and this picture had to be at least 10 years old, maybe 1215 years old, of her son on a baseball team with another little boy both kids with type one and the other little boy was just dropped By the Milwaukee Brewers, Garrett Mitchell was selected 20th overall in last week's draft. Now, there's a lot of information here about baseball, I don't know. But I like this sentence, many heads a left handed hitter projected as going into the top 10. So the early take is the Brewers got a gym who dropped further than expected. And then they go in about like, well, his power numbers, and there are questions about this. But Wow, I'll link up one of the articles where Garrett Mitchell is quoted, and he really did talk about it. He said, You know, a lot of these teams, it did come down to diabetes, what teams want to deal with that, you know, what teams are comfortable with that? And he says, personally, I don't really see this challenge. You know, there are a lot of people who questioned him, but he says, I know how my body works. I know what I need to do. And he has been dealing with it since he was a young child. And I think it was really interesting that the story I'm reading this from isn't from a diabetes publication. It's not a profile on jdrf. There's lots of those and I hope we hear much more about Garrett Mitchell, but this is just a regular sport. story where the diabetes stuff comes way, way, way down in the article, so congratulations to him. Thank you for those of you who alerted me to this on Twitter, which is always great if you see something good like this, please tag me let me know. And of course we are efforting an interview with Garrett Mitchell because why not? I would love to talk to him. If you have Tell me something good story. If your child is starting to play sports, and I mean, forget about hitting a home run, you know if they just get through the game, and you don't run on the field. I'm kidding, but I'm not kidding. The parents know what I'm talking about. Right? If you have a Tell me something good story big or small. Let me know this is my favorite part of the show. Every week. I love sharing your stories. You could email me Stacey at Diabetes connections.com or just tag me on social media and tell me something good. Before I let you go more Ada stuff is coming. I am excited to have interviews on tap with a lot of other technology companies and we'll be sharing those in the weeks to come. There's a lot of stuff to unpack here. I also want to let you know and this is kind of selfish and I hate that these are all the same time every year but I guess this is a word season so I want to give you a heads up that the we go health and the independent podcast awards are coming up in a thankfully it's not a vote everyday situation I hate when people do that just just awful that they asked you to get your listeners to vote every single day What a pain in the ass for I'm not gonna win anything with that attitude. But I have been nominated for a we go health award on the voting for that, which is basically just please go ahead and like me on the wiegel Health site will open up in July. And I will be putting that out on social media, the independent podcast awards. We've been very lucky where some wood that I can knock. We have been named a top 10 Health podcast. That's a nationwide independent podcast award every year since the podcast launched and I love keeping that streak going. So I will be asking for your help there as well. Again, it's just a vote once please. And there's lots and lots of podcasts to vote for. Same with legal health. There's lots of categories to vote for. So if you know somebody else in the diabetes community or there's a podcast Guess that you like you'll be able to nominate and vote for them there. So more to come on that just thank you very much. I hate asking but that's the only way to do it. All right, thank you to my editor jump, you can start audio editing solutions. Thank you very much for listening. And Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Unknown Speaker 39:25
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Melissa and Kevin Lee played an important role in what we know now as NightScout and the DIY movement. Their interest was initially sparked because they wanted to have children. Melissa lives with type 1 and Kevin has an engineering background. They jumped in with many other "hackers" to create what we know now as Nightscout and other DIY systems. By the way, the Lee's children are now ten and eight!
Check out Stacey's new book: The World's Worst Diabetes Mom!
In Tell Me Something Good, wedding bells for a T1D couple – which spark some fun stories from others in the community.. and an update on a change my son made after our last episode.
Join the Diabetes Connections Facebook Group!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Sign up for our newsletter here
Find all of the "We Are Not Waiting" episodes of the podcast here
#Wearenotwaiting
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes. By Real Good Foods, real food you feel good about eating and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:19
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:25
This week, Melissa and Kevin Lee played an important role in what we now know is Nightscout and the DIY movement. It's kind of hard to remember but those early days very different. Melissa remembers what it was like the first time Kevin for husband followed her numbers and acknowledged what a hard day she'd had.
Melissa Lee 0:45
And I didn't realize I just looked at him and he said, this is how every day is, isn't it? And like I still get chills thinking about it. They say it was the first time that anybody outside of me or another person with diabetes looked at I said I see you. This is hard.
Stacey Simms 1:02
Melissa and Kevin were interested initially in the DIY movement because they wanted to have children. Their kids are now 10 and eight. We have a lot to talk about.
And tell me something good wedding bells for a couple who live with type one. And that sparked some fun stories from others in the community. plus an update on a change my son made after our last episode.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I'm so glad to have you here. I'm your host Stacey Simms we educate and inspire about type 1 diabetes by sharing stories of connection. And this is a story of connection. Melissa and Kevin have so many wonderful anecdotes to share about finding the DIY community about those early exciting days about the projects they worked on. And we talked about what it's like as a married couple to go from not sharing any information. about diabetes to being some of the first people to be able to see CGM information, you know, how does that change your relationship? How do you talk about it? And we'll get to that in just a couple of minutes. It was great to talk to them.
I wanted to bring you up to speed first, though, on something that I mentioned. Well, Benny mentioned it when I spoke to him last week. So Benny is my son, if you're new, he was diagnosed right before he turned two. He is now 15 and a half. And we talked last week about changing a bit of our routine, he has been taking a long acting insulin called Tresiba for almost two years along with using an insulin pump. It's a method called untethered, I'm not going to rehash the whole thing. I've talked about it many times. But if you are new, that will link up more information in the show notes and you can go back to listen to last week or previous episodes with Benny about why we did that. bottom line he was using so much insulin because of puberty and maybe some other issues genetics who knows that it was very, very helpful to add an additional basal source that took the pressure off the pump inset, but Over the last month, his insulin use has gone way down. And that is because of three factors. He's probably coming out of puberty, he has lost a lot of weight. And we are using the control IQ system, which we noticed right away meant we were doing far fewer big corrections and we just used it so much less insulin on it.
So during the show that the last endocrinology appointment, Dr. V, had said it was fine to go off the Tresiba, no problem, do it when you want if you want, and Benny said that he did want to do that. So as I'm taping this, it's probably about eight days since we made this switch. It takes about two to three days everybody's a little different to get Tresiba out of your system. It works a little differently than some other long acting so it takes longer to get out of your system. We did have a rocky three days but we were used to that we knew that was coming and just as I had hoped control IQ the software system with the tandem pump and the Dexcom just has worked even better than it did before and I don't talk about specific numbers with my son. That's not how we Roll, but just to give you some perspective has been about 70% in range, you know, it goes up, it goes down very happy with that number. He has been 80% in range, I think 82% in range for the last seven days as an average and two days where he was like 98% in range. It's crazy. So I don't think that'll continue because that's how diabetes works. Right? Don't you find sometimes it like lulls you, when you make a switch, it always starts out great, and like a week or two later floor like the rug just pulled out from under you. So we'll see.
I want to get to Melissa and Kevin. But at the end of the show, I'm going to talk a little bit more about some changes we've made recently, in addition to Tresiba, we have changed how we use sleep mode. So stay tuned at the very end. I'm going to talk about that. But I know not everybody uses control IQ. So standby
Diabetes Connections is brought to you by Real Good Foods. It's really easy to compare and see what we love about Real Good Foods. If you put them side by side to other products, I mean their breakfast sandwiches, six grams of carbs, 18 grams of protein compared to like, you know 2636 grams of carbs in other products and a lot less protein and a lot more junk. If you look at their cauliflower crust pizza, you It's amazing. Not every cauliflower crust pizza is actually low in carbs, you know this you got to read the labels. So Real Good Foods, nine grams of carbs in there cauliflower crust pizza. Some of the other ones have 3540 grams of carbs. I know everybody eats low carb, but you know, you want to know what you're getting. You want to really be able to see, well if I'm eating a cauliflower crust pizza, you might as well eat you know, a bread crust if you want 40 carbs per serving. Real Good Foods is just that they are made with real ingredients, you know stuff you can pronounce. It's so easy to find. They have that locator on their website, it's in our grocery store. It's in our Walmart, and you can order everything online, find out more, go to Diabetes, Connections comm and click on the Real Good Foods logo.
My guests this week are part of the history of the diabetes DIY movement. longtime listeners know that I am fascinated by the we are not Waiting crowd. And I can't say enough about what they have done for our community. In fact, I'm actually trying to put together an oral history. And we've talked to a lot of people since 2015. When I started the show about this movement. The big problem is a lot of these wonderful engineering and tech types are a little spotlight adverse. You know who you are, but I'll get there. I did reach out to Kevin and Melissa, because, you know, I've talked to Melissa a few times about pregnancy and type one and other issues. I think that the show we did as a panel with other guests about pregnancy in type one and Steel Magnolias is frankly, one of the top 10 episodes, not because of me, but the guests are so amazing. And that night gets so much praise on that episode, people, you know, women pass it around. I'll link that up in the show notes.
But you know, I hadn't heard Melissa and Kevin's story, and their names always come up when we hear about the early days of the DIY builders. So our talk today is about much more than the technology it's also about marriage and kids and diabetes and sharing data. You know how that affects your life. Quick note, Kevin now works for Big Foot biomedical and Melissa works for tide pool. If those names don't mean anything to you, if you don't know what those are, or you know what they do, might be a little bit of a confusing interview. There's some presumed knowledge here, I will put some links in the show notes, you may want to go back and listen to previous episodes about the we're not waiting movement or just check out the links. Also, it is really hard to get people to acknowledge the difference they've made. These are all very modest people. God loves them, but I do try. So here's my interview with Kevin and Melissa Lee,
Melissa and Kevin, I am so excited to talk to you two together. Thanks for making time to do this. I know how busy you both are.
Melissa Lee 7:43
Thank you for having us on. This is a fun thing to get to do.
Stacey Simms 7:47
I don't know if Kevin's gonna think it's that fun. We'll see. And I say that because in the small way that I know you you don't seem like you're quite as conversational and chatty is as we Melissa, well, we'll see how it goes. Kevin, thanks for joining us and putting up with me already.
Melissa Lee 8:04
Well, you know, he actually is until you stick a microphone in front of his face. Oh, okay. You know, beyond that, yeah.
Stacey Simms 8:12
Well, let's start when when you guys started, and Melissa, I will ask you first How did you meet?
Melissa Lee 8:17
Oh, this is a story I love to tell. And Kevin's gonna already be like, why did I agree to do this? So this was like 2006 and I spent a couple of years doing internet dating. And you know, I'm very extroverted and and like a go getter. And I had just been on, like, 40 bad days, basically, on the internet. Basically, I was broke from spending money on lots of different dating sites, and I found a free one. But during that one, it turns out that this guy was on it because one, it was free. And two, he liked their matching algorithm that tells you a little bit about why you needed so we met online and then What a year and a half later, we were married. Wow. So yeah, we were married in late 2007. At the time, I was a music teacher. And Kevin, how would you describe what you did in the world?
Kevin:
I was working at Burlington, Northern Santa Fe, just deploying web applications as a contractor to IBM. And then in our early years, you worked for capital, one bank doing infrastructure architecture, and then later for American Airlines doing their instructor architecture. So we like to say, you know, we've been in finance he's been in travel is been in transport. He's been in lots of different fields doing that same thing that I just said infrastructure architecture, which I will not explain.
Stacey Simms 9:44
So, Kevin, when did you go from checking out the algorithm of the dating app, to noticing that perhaps the diabetes technology that your girlfriend and fiancé and wife was using, when did you notice that it really could be done better. And then you could do it
Kevin Lee 10:02
became a little bit later. And it first I kind of just let her her do her own thing. She managed it. She managed it well. And then as we started to progress, and we both wanted kids,
Melissa Lee 10:16
yes, we got back from the honeymoon and I had babies on the brain and two of my bridesmaids were pregnant. And then I have this whole, you know, in our pregnancy podcasts that we did together, I had babies on the brain, but I had this diabetes hanging over me. And I think that that was a huge motivator for both of us. So like mid 2008, my insulin pump was out of warranty.
Kevin Lee
And so that's that's whenever I really started to encourage her and I started getting involved and saying, hey, let's let's go experiment. Let's find what's what's right. Let's look at what else what other options exist and didn't find too many other options but no, we I did switch I switched insulin pump brands and we started talking about this new thing that was going to be coming to market called the CGM.
Melissa Lee
So I got my first CGM within the next year. And Kevin immediately started trying to figure out how it works. So this was the freestyle navigator. And this was like 2009. I think I was maybe already pregnant or about to be pregnant. And Kevin was trying to hack this device.
Stacey Simms 11:25
So what does that mean? When you said you started to figure it out? What did you do?
Kevin Lee 11:29
Well, it bugged me that the acceptable solution was the we had this little device that had a range of measured in the 10s of feet. That was it. And I had a commute. At the time, I was working at American Airlines and my commute was 45 miles one day daily, and she was pregnant, and I just wanted some sort of assurance that she was safe and there was no way to get that and I just wanted to be able to You know, it was obvious that this center was sending the data that I wanted on the available through an internet connection. How do I get that? Ultimately, that effort was unsuccessful. And that's when we started going to friends for life. And there, that's where we saw I guess Ed Damiano’s connected solution where there's remote monitoring, and we saw the Dexcom. And that's whenever I thought, hey, if that's an option, and so we started looking into the Dexcom and switched over.
Stacey Simms 12:39
I'm gonna jump in because I'm a little confused. When you said you said Damiano’s connected set up, I thought that he was showing off what is now called the iLet and the new the bio hormonal insulin pump. What was the Dexcom component to that that you hadn't seen before?
Kevin Lee 12:54
So it was just a simple remote monitoring, you know, he needed to be able to as part His research to be able to remotely monitor the patients that were well,
Melissa Lee 13:05
specifically, he had an early version of the bionic pancreas had a Dexcom that was cabled to a phone. Oh, and so if you look back at like, 2012 And so like he I remember Kevin holding the setup in his hand and looking at it and being like, you know, this is fascinating. Like, I have an idea.
Stacey Simms 13:30
Because at the time and I'll find a picture of it, but it was cable to a phone. And there were at least two insects from the pump. So you had to have the the CGM inset and then you had to have two pumping sets and then the phone cable for the bionic pancreas at that time. Am I thinking of the right picture?
Kevin Lee 13:45
No, I really should
see all of that.
Melissa Lee 13:49
You know, like we're so old at this point.
Like, like eight years ago now I wasn't realizing because how have my children are but this You know, I want to say that this was even before we'd have to go back and back with them.
Kevin Lee 14:05
Yeah. And that was just the moment that hey, okay, this is another alternative. And we were, we were actually looking to switch at the time because I think that's when the note and I switched.
Melissa Lee 14:17
Okay, we had to switch because navigator went off the market in 2011. So this is right around the time, we just switch to that.
Unknown Speaker 14:24
So what did you do with the Dexcom ,
Kevin Lee 14:26
whenever we noticed that there was a little port that was also used for, for charging and for data, I connected to it and started reverse engineering it sending data and seeing what we got back and trying to get that data off. It was first connected to my little Mac MacBook Pro. And I just had a goal over Thanksgiving to be able to get that data out of the CGM. And it took three or four days and I was able to get basic data out of the system. In premiere, it was just as simple as uploading it, and then visualizing it.
Stacey Simms 15:06
So for perspective, and I want to be careful here because I know there were a lot of people working on a lot of different things. I'll be honest with you. I'm not looking for who was first or when did that happen? Exactly. But just for perspective, is this basically the same thing that we then saw, like john Costik, put up on Twitter when he said he got it like on the laptop? Or, like, what would we have seen if we had been sitting in your house that day?
Right back to Kevin and Melissa, but first, you know, it is so nice to find a diabetes product that not only does what you need, but also fits in perfectly with your life. One drop is just that it is the sleekest looking and most modern meter I family's ever used. And it's not just about their modern meter setup. You can also send your readings to the mobile app automatically and review your data anytime. Instantly share blood glucose reports with your healthcare team. It also works With your Dexcom Fitbit or your Apple Watch, and not to mention, they have that awesome test strip subscription plan, pick as many test strips as you need, and they'll deliver them to your door. One drop diabetes care delivered, learn more, go to Diabetes connections.com and click on the one drop logo.
Now back to Kevin answering my question about what does it look like when he figured out how to reverse engineering the free the Dexcom data.
Kevin Lee 16:30
Absolutely that we would you would have seen a little text flying by saying this is the the glucose number. Yeah, on the on the computer. It wouldn't have been very exciting to most. And from there, Melissa tweeted out saying hey, we have the data available from our Mac and I guess that's where Joyce Lee picked up on it and wanted some more information.
Stacey Simms 16:55
All right. So Melissa, take it from there.
Melissa Lee 16:56
Yeah, you know, Joyce has been a real champion as those early days. Why date and so I remember her reaching out to me and saying this is this is really interesting. I want to know more. And in this was the same year that Dana and Scott were bringing their thing to life with what was then DIY APS. This is around the same time, same era in history that, that john Costik was doing his great stuff and with Lane Desborough and the early days of Nightscout, so all of these things were happening in these little pockets, and we were just another little pocket at the time. One of the things that concerned us was whether we were doing something that was going to be shut down really quickly, like there's something that you find knowingly or unknowingly, it's kind of like when you agree to the terms on iTunes.
So when you use these devices, there's something called an EULA and End User License Agreement. And these eu la say, you're not going to reverse engineer this product. And so we were a little cautious about what we wanted to diseminate in terms of like your take this and run with it, but that culture was still developing. And so at the end of that year was the big d-data event at the diabetes mine summit, where there were a few really key DIY influencers sort of in the room. This is where Lane first coined the we are not waiting and, and the next day I was at that summit, and I was hearing Howard Look speak about what had happened at the d-data summit the day before. And I was like, Oh, my God, Kevin has to plug into this. So we want to help this initiative. Like we want to be a part of this. We have so much to offer we this whole remote monitoring setup that he had built for me. And at the time, like by then I think one of the biggest things we have done is Kevin has developed do you want to talk about glass.
Kevin Lee 18:51
Yeah, it was just a another way to visualize the data. So Google Glass, I don't know if you remember that. It was a kind of a connection eyeglass. Yeah, in some ways, it was ahead of its time in other ways. It was just a really interesting idea. I got a pair, and I was able to have it alert me when she crossed the simple threshold. And I was able to see historically three hours or 12 hours or whatever it was without having to pull up a web page. It was just kind of always there and on available for me if and when I needed it. So it was just kind of an ambient thing in the background that I didn't feel like a I had to worry about.
Stacey Simms 19:38
Interesting. Kevin, I'm curious in those early days, so if I could just jump in. You know, you you don't have type one. You care very much about someone with type one and you're doing this because you care about her and want to make sure she's safe. When you started meeting other people who were doing the same thing. What was that like for you? I know it's chancy to ask an engineer about how they feel but it had to have been nice to get kinship with these other people who basically spoke your language and also understood the importance behind what was going on.
Kevin Lee 20:07
Yeah, so that was actually really kind of interesting whenever we first started sharing that we wanted to share it just with a small group of people. And I think it was Manny Hernandez that introduced me directly to Wayne and Howard and a few other Brian Maslisch.
Melissa Lee 20:28
yeah, so I like to tell the story that I chased Howard Look down in the hallway after that, and was like, you have to connect with my husband. And then that didn't seem to work. So that's when Manny was like Manny Hernandez, who was the founder of Diabetes Hands Foundation. He is a good friend of ours and he was like, No, I have to connect you to these guys.
Kevin Lee 21:15
And so there's this pivotal email thread from January of 2014, where we started exchanging The well, here's the project that I've done and Lane says, Well, here's a project that that we've been working on and we call it Nightscout. And so we, we kind of exchange notes. And then it was a little bit later that Lane, well, maybe not lane. Exactly. But that's when the the whole CGM in the cloud and the Nightscout. Early foundations started to show up on on Facebook.
I think that's whenever another engineer had published the code on GitHub, and started to set appears. Here's how you set it up. Well, there weren't many in my situation, you know, one of the engineers was a parent. And I think we actually made a really great mix. And I think that that's part of what made the successful so one of the engineers working on the project was A father of a type one I represented the spouse and some of the other engineers were personally affected by by type one, and definitely added a different level increase the camaraderie between us. Those are early days we were were on the phone almost nightly. As soon as I get off my my day job, I'd go home and work on the evening job of trying to get the next set of features out or to fix some new fixes. I love to describe this day because throughout 2014 he would walk in the door and he was already on the phone with the other devs from night out. And if I walked in the room where he was working on the computer, I would be like, Hey, Kevin, and then I'd be like, hey, Ross Hey Jason, because I assumed that they were on the phone. Hey, Ben.
Melissa Lee 22:56
Like it was staying up all night long. They didn't sleep. They did this all day long. Kevin talk a little bit about the pieces you brought in tonight that from our system that we created, and then we like I, I have two producing diabetes data. I'm not gonna, I'm not gonna claim a lot of that. But I was just plugged into it. If people are familiar today with Nightscout, which many listeners may be like, what piece did they hold in their hands? That was yours.
Kevin Lee 23:26
So the the piece that I was so connected with was the what we refer to as the uploader. It was just a piece of extracted the data from the CGM and then uploaded it to the Nightscout website. The early days. I don't know if you remember it was the little 3d printed case with a phone that you got that happened to have a data plan and a wire connected to the the CGM. Right whenever Nightscout first came out, I was I was hesitant to start I mean, this was like the first few months I was hesitant to contribute. I wanted to see What I could do, but as it started to pick up be there, it was obvious that the pace of development that I was doing on my own was not going to equal what the rest of the community could be doing. But then he and I had these other features, which I'll go into in a moment here that I felt the community could benefit from.
So we started having early conversations with Ben and others. How do we fold in functionality that I had into the current uploader, that functionality was essentially the early ability to follow on a native phone app, it was decreasing the size of the packet and uploading more so using less data. It was an Android watch, being able to get the latest data on an Android watch. It was used in camping mode. I don't know if you're familiar with that. But the early days of knights count we had the pebbles that We're kind of Bluetooth connected smartwatch, that use the little EEG displays. Those required you to be connected to the internet. And one of the devs Jason Calabrese had said, I'm going camping next week. And I'm not going to have internet connectivity. And I sure wish that that I could. So I thought about it for a minute. And were able to quickly reconfigure it the existing code to be able to get that data on the watch without an internet connection. So
Stacey Simms 25:32
camping mode literally came from a camping trip. Yes.
Kevin Lee 25:37
Jason Calibrese’s says camping trip.
Melissa Lee 25:40
So well, and then the code that became xdrip which like thousands of people use today.
Kevin Lee 25:46
So that's, that's a great thing about open source community, whatever ideas reverberating off of each other and become more pronounced and it essentially becomes the sum is greater than the whole.
Unknown Speaker 25:59
Let me ask about xdrip, though, was it originally called Dexdrip? was that one of the first times Dexcom got involved and said No thank you, or did I miss remember that,
Melissa Lee 26:10
that was all part of Emma Black’s history. Emma took the code that Kevin and created and, and created built on top of that to create Dexdrip. And Dexcom did say you can't use our name and became accept yeah that you're remembering correctly. It was a very friendly discussion. And so it was renamed to xdrip.
But you bring up an important point about how industry was reacting to all of us in late 2014. The team at Medtronic actually invited many of the community members who were working on that into sort of the belly of the beast, and to come in and talk to them about the why and the challenges and the what could industry do and and What are we not hearing and just sort of like a meeting of the minds. But what was so cool about this is this is the first time that many of us had met one another in person. So here, people have been working on this for a year or two. And now suddenly, it's a table with Dana Lewis and Scott Lybrand with john Costik with Ben west with me with Kevin, with Jason Calabrese, like we're sitting around a table for the first time and talking with industry as this United Community. So it felt a little less, to me, at least as someone who's been really involved in fostering community, right? It felt to me like there's the start of something here. And that was a really exciting meeting. We like to joke that nothing came of it. I was gonna ask about that. But to me like that was exciting. It was this energy of like, we all came to the table and said like, these are the needs of the community. This is why we need remote monitoring. And this is what we're gonna do next. And you can either help us or understand we'll do it anyway. And so that was that we are not waiting spirit.
Stacey Simms 28:08
Well, and that was a very pivotal time. And, Melissa, let me just continue with that thought if I could, it was such a pivotal time, because you all could have said, we are not going to continue without you. Right? We need this. But it seemed to me and again, it's hard to for me, you know, it's funny that it's so long ago now. But it's only four. It's like, it's only five or six years ago, really? The seeds of that community. And you can see it just in the Facebook group with CGM in the cloud and everything else. There's 10s of thousands of people now who are part of this community. You know, did you saw the seeds if it Then did you ever imagine it was gonna get as big as it is now?
Unknown Speaker 28:48
Is it crazy to say yeah?
Kevin Lee 28:54
to directly answer the question. Yes. And that's where we were actually Faced with a another really tough decision of how do we continue to solve these problems? And we started to see the scalability problem that what we viewed as a scalability problem within the community. How do we continue to support it? And how do we deliver this safely to masses? It was a choice that we had to make of if we're doing the industry and we, we try to do it this way. I don't know there, there isn't really one right or wrong way to do it, but it was just a another way. And we believe that by joining the industry that we could deliver something simple, easy, and we could make it scalable and supportable for the masses.
Melissa Lee 29:44
I think those things like those meetings with Medtronic or, or Dexcom, early on. I mean, I remember sitting in Kevin Sayers office at Dexcom and I was there for a completely other reason. I was there on behalf of Diabetes Hands Foundation said and I just like went off about night prayer. But those conversations gave us a really like I want to recognize my privilege in that to be able to be in a position to go sit with leadership at these big diabetes device companies. But let us see that there was a way to bring the change we were doing outside. I don't want to use the word infiltrate because that sounds
to infuse what industry was trying to do with community perspective and patient perspective and and the change that we knew was possible. And that resulted in both of us for huge career changes.
Stacey Simms 30:43
And we will get to that for sure. Because it's fascinating when you mentioned and you know, we're doing a lot of name dropping here. And if you're if you're new to this and you've listened this far, I promise. I will be putting a lot of notes on the episode homepage and you can go back and listen to other episodes, but there's a lot of names that have Gone By. And a lot of names that you mentioned are people who either founded or were instrumental in the founding of newer independent companies that came out of at least as I see it, this DIY wave that happened in the mid 2010, that you all are talking about. And now you both, you know, you work with these companies and for these companies, but I want to continue this the scalability, as you mentioned, because it's remarkable that even as all those companies, I mean, Big Foot tide pool, you know, even as these companies came out of this, you're still servicing all these, and I'll call us lay people. I mean, I, you know, most of the people who were early adopters of Nightscout or things like that seem to have some kind of engineering background or something that helps software makes sense. But then the floodgates opened, and it was just easy for people or easier than it seemed for people to do that. Kevin, was there a point that you kind of remember looking at this and thinking, you don't have to be an engineer.
Kevin Lee 31:59
That's actually part of the reason why I continue to contribute with Nightscout and in the early days, we decided we were going to go ahead and launch on the Play Store. So we set up an account. And you know, instead of having to go out download the source code, compile it, we distributed it is via the channel that users were used to receiving their their app from. Another thing that we introduced was the barcode scanning. So what we found out was set up of the app was a little more complex than it needed to be. And so we introduced the the concept of barcode scanning to set that up,
Melissa Lee 32:42
which now exists in the commercial like every time you start a new transmitter on a Dexcom system today, you scan a barcode on the side of the box. Kevin did that. I remember, I'm not claiming but next time did not develop that on their own. I am just claiming Hey, we.. yes.
Unknown Speaker 32:59
out Yeah.
Stacey Simms 33:02
Yeah, that's wild. I did. Yeah, I was thinking about that. Because now that's, of course, that's how we do it. And Melissa, I know I'm kind of jumping around here, but I have so many questions. I wanted to ask you earlier. What was it like for you? At this time? You said, Well, I just provided the data. I mean, what was it like for you during this time other than, you know, just popping in and saying, Hey, honey, how were the phone calls going? It had just been exciting and a little nerve racking for you. What was it like,
Melissa Lee 33:30
by my count, and again, Not that it matters? I think I was the first spouse to be followed.
Sounds creepy, doesn't it? I was the first CGM stocks 4000. Now, um, but one of the things, it did a few things for me, and I'll never forget one day I was in the kitchen and I've got babies and toddler and lay like it had just been a day right when you're a young mom, and you've got Little ones and it has just been a day and Kevin walks in and he said, and you've had a really hard day and I just looked at him like, Are you an idiot? Yes.
And I was like, What are you talking about? And he was like your numbers. Oh, and I just looked at him and I didn't realize I just looked at him and he said, this is how every day is, isn't it? And like I still get chills thinking about it Stacey I like it was the first time that anybody outside of me or another person with diabetes looked at me and said, I see you this is hard. And I didn't even know like I probably said yes, you idiot I've had a hard day
Unknown Speaker 34:46
I doubt it.
Kevin Lee 34:48
I had worked on some some code to make Nightscout available via personal assistance. Think the Alexa and Google Home and, and other things. And while I was experimenting and testing it, it became very clear that I was not allowed to ask what what those values were.
Melissa Lee 35:14
He was like, it’ll will be so handy. And if you're in the middle of cooking and you've got like, you know, stuff on your hands, you can just ask it. But like, what you don't do is you know, your wife snaps at you. And you say, Alexa, what's her blood sugar right now? Like, that is not what you do. So now the story I was going to tell Oh, Stacey, you're gonna love this one. So this is like early 2015. And I am the Interim Executive of a nonprofit and I'm representing patients at this endocrinologist a meeting, and I'm alone in a hotel, and I had been out with all these endocrinologists and we've had tacos at a bar and I have no idea what my glucose was, but I had calibrated my CGM with probably tacos all over my hands. I go to bed. Well, this poor man, I'm in Nashville. He's in Dallas. This poor man is getting
Kevin Lee 36:09
the blood sugar was reading his 39. Yes, for those who don't know, is the world. The CGM can read anything below that he registered
Melissa Lee 36:19
as low. I have my phone on silent because I've been out with all these professionals. So he had called me 18 times. It didn't go through Sunday night disturb so far in two hours reading, like a 39. So hotel security burst into my room. Mrs. Lee, Mrs. Lee, are you okay? Do we need to call an ambulance, this string of expletives that came out of my mouth? I will not repeat on this good family show. But I was so mad and you know, I'm calling him and I'm like, I'm like 130 right now. Fine. by that same token, I have lots of like really lovely stories where You know, I'm alone in a hotel in New Jersey, and he wakes me up in the middle of the night to say, you know, wake up and eat something, honey. So, yes, there is a good story, but I must prefer the story where he had security break into my room. Oh, my God over over what nights? That was it.
So, you know, but to your question, we really were on the very bleeding edge of understanding things that you actually already deal with, with your son today and that people deal with today in terms of how will we actually establish boundaries on how much of my data you get to react to and for all the times that it is a benefit? Where are the times where it's like, no, I actually have to cut you off. We're now like seven years into him following my data. And so in some ways, I think we both see where people will get to when following data is the norm you know, should it ever scale by Live in terms of now, he doesn't look at my data all the time. Now he knows when to respond when it weren't so good. But it made me feel understood. It also made me feel a lot safer to know that just have somebody else watching my own back. I'll be celebrating 30 years with type one this year and celebrating is, you know, you've been
away there. But like to know that like somebody else is just there to pick up a little bit of slack you have for someone like where you are, it can be hard because I know when teams don't always appreciate or show their appreciation in the same way. But there is an appreciation for the fact that that you're there to pick up a little bit of slack just as much as there is resentment and issues with boundaries. And in times when they really need to just shut your assets off. And so I feel like we're just a little bit further down that road in some ways, you know, we'll let you know when we have it all figured out. But Exactly.
And what's right for us as a couple is not necessarily going to be right. For every couple, you know, there are couples that really feel like, no, my data is mine. And I don't trust you not to react to it in a way that's going to make diabetes any harder for me. And I think that that's what we 100% have, that I'm very fortunate to have is that I trust Kevin, to react to my data, the way that I'm comfortable with him reacting to my data.
Stacey Simms 39:33
So both of you, through this process wound up not only having two kids, but you made big job changes. And you now both work in the diabetes sphere. And I hope you don't mind I'd really like to talk about that a little bit. Because I mean, you mentioned the beginning. Listen, you're a music teacher. And you're right, your background, your music professional. You are Bigfoot for a couple years and now you are a tight pool and you're basically I'm going to get a But you're helping tide pool so that they can better train people and kind of explain to healthcare professionals and the public to kind of I look at that as translating, is that sort of what you're doing there?
Melissa Lee 40:12
Yes or no. So for instance, I know your family has just started with a new piece of diabetes technology. There were certain training modules that were there to support you. There's certain learning materials that were provided to your child's doctor so that they understood what they were prescribing. There's a user guide that comes with the stuff that you use in your family today, if you're buying things from companies off the shelf, and what the DIY community when we're talking about scalability, and how important that is to each of us having a knee accessibility, scalability availability like these important, how do we bring this to people in a way that they will actually be able to access tide pool announced about a year ago that they were going to take one of the DIY, automated insulin dosing systems and actually bring it through FDA review. Part of that is it has to have the kind of onboarding and support materials that your insulin pump he buys a medical pump and has today. So I am leading the development of all of those materials for both the clinics and the doctors, as well as for the end user to learn the system.
Stacey Simms 41:30
And Kevin, you're still a big foot. So you're a principal engineer there. What excites you about what you're doing there? Is it again about the accessibility because I know you know, Bigfoot is not yet to market but people are very excited about it.
Kevin Lee 41:41
Yeah. Accessibility is one of the large parts and reliability going through the DIY stuff. It's happening at an incredible pace change is happening there and things break things don't always go the way that you intended. There has to be balance there somewhere? Well, you have to have services. I mean, look at what happened recently with server outages and different companies, you have to be prepared for how am I going to support this time, I'm going to keep it running, you know, whatever the it is, it's that the reliability, we're all we're all human, that's humans behind the scenes, making the the changes and improvements that we rely on. So how do we do that safely and effectively as possible to minimize the impact and continue to increase the value to the user?
Stacey Simms 42:37
This might be a very dumb question. But Kevin, let me ask you, Melissa mentioned the the new software that we're using, and she's talking about control IQ from tandem, which is the software that we've got now. And there are other commercial quote solutions. There's other commercial systems coming out when you look back at all the stuff that the DIY community did, and is continuing to do. Do you feel like you guys really, really pushed it along? I mean, I gotta tell you and I know nothing. And I never even used Nightscout and people laugh at me. But I think we would never be close to where we are commercially. Does that add up to you?
Kevin Lee 43:12
Yeah, it adds up. It's not for everyone. You know, it is bleeding edge, the community, in a lot of ways drives industry.
Stacey Simms 43:21
You I'm not asking you to say specifically without this wouldn't have that. But it just seems to me that we would have gotten there eventually. But I don't know that the people behind Knight Scott and so much of the other things you've mentioned, really either got into industry and help push things along or helps with the FDA. You know, is it as kind of an outsider on this. Can you speak to whether that's true?
Kevin Lee 43:44
Yeah, absolutely. I think that it had you I mean, that's the nature of competition. There was an unmet need in the community and the unmet need was was fulfilled.
Melissa Lee 43:55
Well, what I would say is industry needs to see that something viability as an idea and so, I firmly believe that many of these things were floating around in companies as potential developments in the pipeline. What the community did with our DIY efforts is say, we are so desperate to this thing, we will just build it ourselves if you can't deliver. And so I think it helps prioritize like I've seen almost every company in the industry actually skip over other things that were in their pipeline to get to these things and reprioritize their own product roadmap to try to deliver. And I don't think it's, I it's not in a Oh, we better get this or the community is going to do it themselves way. It's a, okay, this is a real need, and we should, we should focus our resources on this. A lot of ways it's a playground for industry to concepts, live and die much more quickly in the DIY community than they do and it allows you to to iterate faster and find out what does and doesn't work, open source communities have existed outside of diabetes, obviously, it's a and throughout the last few decades, we've seen what happens in the open source world actually drive change in the industries to which they're associated. And so I think there are analogies to this in terms of like, what happens in the software industry, with personal computing with consumer electronics, so I don't, I don't find it at all odd or ridiculous to say that the DIY community and diabetes has actually resulted in change within industry. I mean, if only if, like you pointed out so many of those names, but we, you know, we're dropping them because we want to see people recognized for their extraordinary contributions, right. But all of those people, many of them have gone on to found companies, invent new things, join other companies. What's your Modeling about open source communities, regardless of field or genre or whatever is that you see that you see new people roll in with new ideas and lay new work on the foundations of code that were left behind and innovate and continue to innovate. And so we will see the DIY community around forever, they will continue to innovate. And we will also see many of those innovators move on into the industries in which they're working. This is a personal choice that they have to make them they'll go through the same decisions that we did. And not everybody. Well, I mean, Dana lewis is not associated with the company. We're not saying that that's an inevitability, right? But it's pretty common. You have to be pretty geeky probably to know of other open source communities. And I'm, you know, Kevin is way more well versed to speak about that, but in the way of fan
Stacey Simms 46:56
before I let you go, this all started because you wanted have kids, right? This this is the timeline that you set out from your weight the beginning here, and your kids now they're both in grade school, your daughter's 10, your son is eight. I'm curious, do they know their part in this story? Because it's not an exaggeration to say, and I'll say for you, it's not an exaggeration to say that you wanting to have kids sparked action in Kevin, that, frankly, has helped thousands of people. I know you didn't do it alone. I know. I know. I know. But your kids know the part that they played
Melissa Lee 47:31
to a degree like they know that we help people with diabetes. And they take that really seriously. As a matter of fact, when I was changing roles from my role at Bigfoot to my role at tide pool, my daughter's first question was like, but you'll still be helping people with diabetes, like will Bigfoot still be able to help people with diabetes like yes, it's all it's all good. We're all good. We're all still helping people with diabetes
and they've grown up with these things in the sense that we love to tell the story of when our son was about three years old and he would hear the Nightscout song that would was basically the alert that would play. And he knew that when I was low, there was a bag of sour ball candy on the top shelf of the pantry that came down. So he would hear that sound that Nightscout song and that song was sour balls to him and he was “sour balls sour balls!” he was all in or maybe like two I mean, he was little It was too and so like it became the sour balls song, right? You know, the other day he heard the Nightscout will song play and he said mom who undid that song and I posted something to Facebook. Well basically lane desborough and better that song or found it. I wrote something about like I just set my son down. I said, let me tell you the story of our people and how we came to the valley of silicon you know, which is of course not the way I said it to an eight year old but as you know amusing myself But essentially, you know, there is some of these folks that they literally do talk about uncle lane and Uncle Manny and Uncle Ben and like my daughter thinks she has a lot of uncles. But, you know, so they know that we've helped a great many people. And as they as they get older, and we can sort of expound on that, then I think, well, let's be honest, they won't care.
For a while, right? teenagers will be like we shut up about, oh, they'll care.
Unknown Speaker 49:30
They just want to know they care.
Melissa Lee 49:34
Someday, they'll appreciate it, and a different way, but that's what they know. Now,
Stacey Simms 49:40
Kevin, you also said this was about your commute, making sure Melissa was safe. Knowing that Melissa is a very strong and independent woman. Do you feel like she's safe? Did that check that box for you all this hard work?
Kevin Lee 49:53
Yeah, absolutely. This is kind of something that she went into earlier, but I really view the monitor. That I've done and the work that I've done is really just augmenting and trying to simplify and make her life easier. We first started dating, I actually told her that you will never find somebody work harder at being lazy than than me. And, you know, that was just the testament of I wanted to automate all the things that are just repetitive and predictable and easily managed to try to get that out of the way. And that comes from the background of operations and managing online sites. Being able to automate those those aspects have helped me feel like it's more safe. And then you know, other times like with with monitoring, it's great to be able to just see that you know, she's about to go out for a walk and then I happened to look over at Nightscout see how much insulin she has on board and where she is and say, you might want to run a temp basal. So it's just there. To try to augment and help her navigate it. And so yeah, it does give me a sense that she's safer because of this.
Melissa
Yeah, that's right. I got really mad at him the other day, he was right. I was like, whatever. And I left the house and I went massively low. I was walking the kids to school. I was like, Yeah, well, fine. So you know, there's that two parents completely unfamiliar to you. And
Stacey Simms 51:21
it sounds more like my marriage actually diabetes or not. That's just a component of marriage. Yeah, she was right again. Oh, oh, well, you know, thank you so much for spending so much time with me. I love your story. I just think that there are just amazing people that I hate have diabetes. But I'm glad if you had to that you've done so much for so many others who have it as well. And I really appreciate you spending some time to tell us these things from years ago now because they're really are important as we move forward. So thanks for being with me.
Melissa Lee 51:56
Thank you so much for being interested in the story and for help. Others here are cranky, Stan.
Unknown Speaker 52:08
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 52:14
Much More information at Diabetes connections.com you can always click on the episode page and find out more transcript is there as well. I just adore them. I know the interview went longer than usual, but I couldn't help myself. And as I said in Episode 300, when I looked back on 300 episodes, Melissa really helped change my place in the diabetes community by inviting me to speak at master lab in 2015. That really did change how I felt about where I want it to be helped me find and focus my voice. I really can't overstate that enough. So thanks Melissa, for doing that.
And again, lots of information went by very quickly let them name dropping there in a good way. And I promise I will keep on the Nightscout crew. I may ask some of you as you listen to lean on your friends, I'm not going to mention any names here. But people that I have reached out to, and they're the usual suspects. If you search, we are not waiting, or Nightscout on the website, you'll see some big omissions. So I'll talk more about that on social media, we'll get them as a community. Maybe it's just me, you know, who's fascinated by this. But I do think it's a very important part of our history that we need to document because in a few more years, many of the solutions that people like Kevin were working on are going to be all commercial and all FDA approved. And isn't that wonderful, but I don't want to forget what happened. And I think it'll be great to look back.
Okay, enough about that. I got Tell me something good coming up in just a moment. And then stay tuned. Later, I'm going to tell you another change we made to how we use control IQ with Benny, but first diabetes Connections is brought to you by Dexcom. And it is really hard to think of something that has changed our diabetes management as much as the Dexcom share and follow apps. I mean, what really amazed me we started it when Benny was about nine years old, the decks calm and we got shareable. little less than two years later, and the most immediate change was how it helped us talk less about diabetes. And boy did that come just in time for us because that's the wonderful thing about share and follow as a caregiver, parent, spouse, whatever, you can help the person with diabetes managed in the way that works for your individual situation, and going into those tween and teen years. It sounds counterintuitive, but being able to talk about diabetes less what's your number? Did you check what's your number? You know, so helpful. Internet connectivity is required to access Dexcom follow separate follow app required learn more, go to Diabetes connections.com and click on the Dexcom logo.
I am cheating a little bit this week for Tell me something good because while I usually read you listener submissions, I saw this on beyond type ones Facebook page, and I just had to share they did a whole post about people with type one getting married and they wanted Hear the wedding stories. So they started out with a a big Congrats, by the way to Kelsey, her husband Derek, and this adorable picture of them. They're both low at their wedding and they're sipping some juice boxes. And Kelsey is part of the beyond type one Leadership Council. So congratulations to you both. It's a really adorable picture. I'm gonna link up the whole Facebook thread because people share stories like you know, I had my pump tucked into my bra and I didn't think I needed during the wedding or I was a bridesmaid and I had it there and I had to reach in, um, you know, other people who went low trying on wedding dresses. I mean, I remember this. So this person writes, I went low in David's bridal trying on wedding dresses. It's a lot more physical than you think getting in and out of dresses and slips, hot lights and just emotions. My mom had to run across the street and grab a Snickers. I was standing in the doorway of the fitting room and inhaling a Snickers, praying I didn't get any on the clothes, which just added an extra level of stress. I remember a Polish ties into the employee helping me and he was like I don't even worry about it. And he stayed with me to make sure I was okay. Another woman writes my mom came up to me right before we were set to walk into the reception. She told me she had hidden a juice under our sweetheart table in case I went low. I've been diabetic 30 years and my mom still carry snacks for me in her purse. Sure enough, right after dinner, I ended up needing it. And the last one here, being excited, nervous and unable to sit still. I did a long and intense bike ride prior to my evening wedding. Luckily we had a chocolate fountain at our reception and I spent a large chunk of the night at or near it, and this goes on and on. So what a wonderful thread congratulations to everybody who is talking about their weddings and their their wonderful stories of support. And the humor that's on display here is amazing. So I will link that up. You can go and read there's there's dozens of comments.
If you've got a story like this Hey, that's what Tell me something good is for send me your your stories, your milestones, your diversities, your good stuff, you know anything from the healthcare heroes in our community. With cute who put his first inset in to a person celebrating 70 years with type one I post on social media just look for those threads. Or you can always email me Stacey at Diabetes connections.com.
Before I let you go, I had promised to share the other change we made to control IQ. In addition to eliminating the long acting basal that we had used, you know, untethered for almost two years, we decided recently to completely turn off sleep mode. I know a lot of you enjoy sleep mode 24 seven, as we said back in our episode, gosh, in late December, when control IQ was approved in the studies, they called you folks sleeping beauties, because you enjoy that 24 seven sleep mode. But I found that since school has ended, and we're trying to figure out what to do with Benny for the summer, there is nothing really that's keeping him on a regular sleep schedule, and it's gotten to the point where he is now so nocturnal, and I'm hearing this about a lot of my friends with teenagers. Maybe I sound like a tear. Parents go to bed at like four or five, six o'clock in the morning. I walked into his room at eight o'clock in the morning the other day, I wanted to ask him a question. I was like, I gotta wake him up and he was awake can come to sleep yet. You know, it boggles my mind. It's all topsy turvy. And we'll get back into a routine at some point, but I'm not really willing to make a big fuss about it. He's key is keeping busy overnight. I guess his friends are up, I don't know.
But anyway, the point is, he's eating it really weird hours. And when he was in sleep mode, we noticed that it wasn't helping as much right because it doesn't bolus you in sleep mode. It only adjusts Faisal. So if you under bolus for his you know, Pad Thai at two in the morning, it wasn't helping out and true story. I asked him about that. Like, what's this line? And what happened overnight here, were you sleeping He's like, No, I was in the kitchen eating leftover Thai food.
So we decided that his numbers during the the quote, day when he was sleeping, we're hovering right around 90, maybe a 110. I mean, it was very in range, right? No need to mess with that. So I didn't think we needed to add sleep mode. And I did want to predict when he would actually be sleeping. So we just turned it off. And that has made a big difference too.
So I guess the bottom line is figure out what works for you for your individual situation, the weirdo wacko situation, if it's us, but you know, use this technology to benefit you, whatever way that is, if it's sleep mode right now, 24 seven, if it's no sleep mode, it's exercise mood all the time. And it'll be so fascinating to see. And this ties back into the DIY movement, right? It'll be great to see the flexibility that we will get in the next couple of years because, you know, Medtronic had a tie a higher target range, because they were first with the hybrid closed loop. tandem has a lower one Omni pod, we'll have a more flexible target, you can set your own target when they come out with horizon and of course, tandem and everybody else is going to be moving to that direction as well. And it just keeps getting better.
But it gets better because people like Melissa and Kevin Lee pushed and pushed and without these folks, and there's so many of them, of course, right who said we can do it better, we would not be where we are. I truly believe that technology companies would be five or six years behind and if you're new To the show new to the community and you're excited about, you know, control IQ or horizon or whatever you're using. Or maybe you're using, you know, loop off label with Omni pod, I would urge you to go back and check out our earlier episodes from 2015 and 2016. And learn about the really early days of the community, obviously, by 2015. We're talking about things that happened in the early 2000s. You know, I don't want you to misunderstand that. That happened in 2015. But you know what I mean,
okay, obligatory book commercial. And if you've listened this long, you maybe you own a copy of the world's worst diabetes mom, if you own it and love it, do me a favor post about it. The best way to word of mouth about the podcast and the book is always if you could tell a friend post in a diabetes group post on your own Facebook page, you know, I love this book. It's on Amazon, highly recommend it. If you've read it, and you don't like it. Forget that, you know, you know, just recycle the book. It's thanks as always, to my editor, john Buchanan's from audio editing solutions. And thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Unknown Speaker 1:01:09
Diabetes Connections is a production of Stacey Simms media.
Unknown Speaker 1:01:13
All rights reserved. All wrongs avenged
We started the show in Summer of 2015. This week, Stacey takes a look back at what was happening in diabetes technology at that time. Tandem had just announced you'd be able to upgrade without getting a new pump, Dexcom gave up on the Share cradle an Bigfoot & Beyond Type 1 were just coming on the scene.
Check out Stacey's new book: The World's Worst Diabetes Mom!
In Tell Me Something Good, we share your stories! What was happening with your diabetes in 2015?
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Lilly Diabetes announced they were getting into the pump and pen business almost two years ago. How’s it going? We get an update from Marie Schiller, Vice President of Product Development for Connected Care and Insulins at Eli Lilly – Connected Care is what they’re calling this platform of pumps and pens – now to be integrated with Dexcom.
Check out Stacey's new book: The World's Worst Diabetes Mom!
We’ll also have a bit of an update on some other pump companies’ plans for the near future.. bolus from your phone?!
In TMSG a big fish, a hula hoop winner and a chance meeting over a foot?
Join the Diabetes Connections Facebook Group!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcript:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Real Good Foods, real food, you feel good about eating, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is diabetes connections with Stacey Simms.
Stacey Simms 0:27
This week, Eli Lilly announced they were getting into the pump and pen business almost two years ago. How's it going? We get an update. And of course I asked about price and access.
Marie Schiller 0:38
Look, we're not here for the sake of having this innovation sit on a shelf somewhere, not why I'm here. It's not why others are here. And so it is really important for us to be laser focused on how people act. So
Stacey Simms 0:53
that's Marie Schiller, Vice President of Product Development for connected care and insulins at Lilly We'll also have a bit of an update on some other pump companies plans for the near future. Well, let's sing from your phone in Tell me something good a big fish, a hula hoop winner, and a chance meeting over a foot. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am your host Stacey Simms, so glad to have you along for another week. As always, we aim to educate and inspire by sharing stories of connection. My son was diagnosed 13 years ago with Type One Diabetes. My husband lives with type two. I do not have diabetes, but I have a background in broadcasting. And that's how you get the podcast.
I'm excited to catch up with Lilly. I know a lot of people don't want to hear anything from them until they address the price of insulin. And I do understand that I want to be sensitive to that. And I definitely asked Marie all about that. Even though she has nothing to do with the price of insulin but she doesn't work at Lilly and this system. I can't be really separated from that, let's be honest. But I also think I have a responsibility to share what's going on in terms of diabetes technology, and Lilly plans to be a big player in this space. So that's what the interview is all about. We'll be talking about their system. We'll be talking about their partnership with Dexcom and other things as they move forward.
Before we get to that, I want to thank Kerri Sparling and the folks at children with diabetes. We replayed the interview that Kerri did with me this was on their YouTube channel and then last week in the kind of the mini episode although it wasn't really a mini we replayed the audio from that interview. It's always a little weird for me to be on the other side of the microphone, but it's always a lot of fun to I bring it up not to hammer on the interview again, if you wanted to see it or listen, you know, you know where to find it and I will link it up in this episode. But because they are doing a contest. The contest is open until March 20. And to enter you do have to email them so I will link that As well, it's over on the children with diabetes a website. But all of these links will be in the episode homepage. They're giving away a paperback of the world's worst diabetes mom and the audio version. So I'd love for you to go and enter and find out more on their websites.
Speaking of the book, I am having such a blast on the book tour that I'm doing this year. You know, we'll see how it goes. Obviously there are some health scares out there right now. And I'm not sure that all the events are going to stay as scheduled for right now. They're all on the books that's on the website as well. And if you're interested in the world's worst diabetes mom, that's an easy place to find out more but I have to share with you that I got a great note from a woman in Australia who listens to the show and you know, has read my book she bought it you can get it on Amazon really in so many countries now print on demand is absolutely amazing. And she got it in Australia and she reached out to me because her local group wants to do a bulk order. So we are doing that. And if you have a situation like that where you would like a little large number of books for your group. please reach out to me directly. You don't have to just buy it on Amazon for the full retail price. I am happy to work with you. My publisher has given me some ways to do this. That really makes sense. It's an amazing thing to think about people all over the world reading the world's worst diabetes mom. It didn't say America's worst diabetes mom. So I guess I have to stand by that now.
All right. We will have the interview with Marie Shiller from Lilly coming up in just a moment. But first let me tell you about Real Good Foods Diabetes Connections is brought to you by them. Have you tried their cauliflower crust Margarita pizza. They have a full size and a personal size as well. So yummy. It is low carb high protein real simple ingredients. And you know you gotta be careful because some cauliflower crust pizzas are made with corn starch. You know rice flowers, processed grains. And if you're looking for something that is 100% grain free and gluten free, this is what you're looking for. I love how Real Good Foods keeps creating Eating new products, they keep coming out with new yummy foods for us. It's the kind of thing where you as soon as you don't feel like cooking, sometimes you want the convenience. And when you go for convenience, you really don't want to sacrifice nutrition, right? I mean, you don't want to just pull out some junk food. I love Real Good Foods, it tastes terrific. And the people behind them are solid. They get involved in our community. They listen to what we have to say. It's really nice, find out more, go to diabetes, connections comm and click on the Real Good Foods logo.
My guest this week is Marie Schiller Vice President of Product Development for connected care and insolence at Lilly. Two years ago, I was part of a group of writers and reporters from the diabetes community invited to Cambridge, Massachusetts, to take a look at Lilly's entrance into the pump and pen market to give feedback on those plans and to hear from their partners. We did an episode back then and I'll link up what I and others wrote at the time. No pictures still of what they show. Very briefly that day, they showed us kind of the prototype, but it is a tiny pump. It's kind of like a fat little disc. It's much smaller than an omni pod pod. It's maybe about the size of the tee sport that tandem is coming out with. I'm actually going to talk more about that after this interview a pump update from tandem some news from Omni pod. We'll get to that after this interview, but I'll put up some photos of the T sport, but this is thinner than that the Lilly pump is just a small thin disc. It is tubed. So the idea is that you can stick it to your body or use longer tubing and put it in your pocket. We do talk about that. It'll fit in the palm of your hand very easily. Of course we do talk about the price of insulin, and what that means for access of anything coming from Philly. So here's my interview with Marie Schiller. Marie thanks for talking to me. I'm excited to catch up. It's been about almost two years since we've MIT in Cambridge, thanks for coming on the show.
Marie Schiller 7:02
Thanks for having me. I'm excited to be back.
Stacey Simms 7:05
All right, so give us the update. I know we're going to talk about the partnership with Dexcom and some other things that Lilly is working on. But when we last left this episode, the last time we talked at least in person, you over talking about the device that Lilly had been working on, can you give us an update on that
Marie Schiller 7:25
I can and maybe to be helpful Stacy just to remind the audience of what we've been working on. So Lilly has a personalized diabetes management system that is incorporating inform delivery devices, software and analytics. And obviously that will be combined with glucose data and other contextual information in order to hopefully to improve diabetes management. We have two parts of that system. So we obviously have a pen based platform where we'll be using our refill disposable insulin pen, with data coming in from glucose monitoring devices and be able to combine that with different elements of care in that platform. And then the pump based platform, which would be a hybrid closed loop system, integrating the the pump itself in with a continuous glucose monitoring and an algorithm as well. So that's the journey we started on. I think we were we had not just kicked off the program when we last talked a couple years ago, but it was certainly early in the development program. It's been a frankly, an awesome couple of years is advancing both of those areas we had started I know when we last talked, but with the development agreement with Dexcom, which we have continued to advance our relationship with Dexcom and now have entered into a global commercialization agreement with them. We continued our clinical trials with the pump based system we'll be talking about Some of the first clinical data will be shared this coming February at the the conference in Madrid at TCU. And on the connected pen side we have, so we secured a supplemental drug approval for the pen that will be compatible with the personalized diabetes management system. And we're in the midst of working with the FDA on the other components of the system that we will need to bring forward and launch the entirety of that integrated solution.
Stacey Simms 9:35
So there's a lot of moving parts, there are a lot of different things going on. You mentioned the clinical trials, and let's kind of take this step by step. I'm sure you can share the information ahead of the release. But what were you looking for this was for the pump system. Was this a safety trial? Was this an outcome trial? Can you share any information
Marie Schiller 9:55
for you know, I won't go into any details that we will be sharing at the conference, but As has been seen with other products going through on that hybrid closed loop system, we are focused on showing that the system is functioning accurately. So we are looking at that first stage looking at different you know, stress situations with the system making sure the system is responding as we would expect it to respond. And obviously as part of that is the safety of the system.
Stacey Simms 10:27
So, as we're talking about this system, what's so intriguing about it to me is that it is a pump, but it acts more like a pod. At least it did when I last saw it or I saw a mock up of it even so is it still that way it's very teeny tiny, but it it acts as a tube pump with a very small tube that goes into a traditional inset Is that still the hardware?
Marie Schiller 10:47
It is so we what we like to call it is that is a hybrid system meeting on the days that you want to carry it and put it in your pocket or wherever is your choice of carrying it. You could use a standard length infusion set or a long infusion set, whatever your preference, but on days that you wanted to wear it, and adhere it to your body, you could do that. And so it would still work with a standard catheter infusion set, but you would obviously be using a shorter tube in that instance, if you choose to wear it on those days.
Stacey Simms 11:24
You know, it's funny, Marie, I've I didn't ask this when I first saw it two years ago, and I keep thinking about it, because now tandem has a I don't know where they are in their development stage. They have the T sport which sounds very similar that they're hoping to come out with. How do you actually were these tubes, tiny tubes, pumps, the hybrid pumps on the body? Did they just kind of dangle from the tube? Do you stick them to your skin? Does it work?
Marie Schiller 11:47
Yeah, I can't comment on tandem. It's a great question though. Stacey, you know, obviously with our so there's an adhesive component where you are wearing the pump. It's not obviously on the infusion set right? But ours is where you would be adhering to the pump itself.
Stacey Simms 12:04
And my frustration was I thought you're gonna say I can't tell you anything. But that's great. There's like a sticky on the pump and it sticks to your skin. does it stick to the body? Like a? Is it like a Dexcom? sticky? Or is it like the ever since which is more like what I call a color forms? Remember those color forms? You could take them on and off and on and off? Is it more like that? Or is it once it's stuck to your skin? Then you kinda have to pry it off.
Marie Schiller 12:34
Yeah, I may, at this point, just pull back a little bit because I think I may be going down. I may be going down the rabbit hole as if I'm trying. I feel like I'm going to be playing a game of charades as I try to walk you through how the system works. And it may be more confusing than helpful. So yeah, as I mentioned that you have the ability to wear it and there's an adhesive system and we'll leave it at that.
Stacey Simms 12:59
All right. But it's very interesting. So then my next question is, do you know if Lilly is going to be developing new infusion sets? And I asked this because I've shared for years and years, and I'm not the only one, that I really think that the traditional infusion sets are the weak link of any pump. They're just not great. And I'm always hoping that somebody is going to come up with a better one. Any chance, this is part of your plan?
Marie Schiller 13:24
as we've talked about, look, we are looking at all components of the system. Right. And so we are starting with our core system, we're looking at all aspects of the system. I would say, you know, it's hard for me to say yes or no, on that side. I think we're looking at the need in the marketplace. Right. I think on that infusion set side. I'd be curious to sort of hear your experience with that. I think in in some of the research we've seen, it's different sort of aspects where people would say they'd like improvement. Clearly. Extended wear is something that we're hearing a lot I know jdrf and others Groups are focused on that. But what areas are high on your list
Stacey Simms 14:03
that they work better, that that you can push more insulin through them that they don't get kinked and they don't get occluded. And they don't need to know that they're, they're not as damaging to the skin that they're not as painful that I feel I could go on and on. But truly, I really think they're the weak link of pumping and you know that they even what was the one from BD for a while like it had a better flow, it didn't just float the bottom of the canula even to be able to rotate it there was one you used to be able to spin you know, that would go with that would turn you know, there's there's so much so sure, I'll be in a focus group anytime or recall me.
Marie Schiller 14:38
I'm taking furious notes here to make sure I get all of this feedback because this is exactly what we need to hear, you know, and exactly what we're excited about. I think we just continue to feel that there are so much room for improvement on these systems. Albeit we've made a ton of progress today. But these are all of the nuances right then each of us I deal with every day and why, you know, the more innovation the better and space where we can continue to look at all of these elements and make progress.
Stacey Simms 15:09
So let's talk about the pen system too, because that's very useful and very fascinating. The pen is, as you had already said, It is not just an insulin pen, it is part of a connected system. Can you talk a little bit about what that means? We've mentioned Dexcom. already. I assume you use your phone. You can see where you've been it recommends dosing, that kind of thing.
Right back to my talk with Marie but first One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drops glucose meter looks nothing like a medical device. It is sleek, compact, and seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to One Drop to keep track of the big picture and easily see health trends. And with a One Drop subscription you get unlimited test strips. lancets delivered right to your door. Every One Drop plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doctor visit your personal coach is always there to help go to diabetes connections calm and click on the One Drop logo to learn more. Now back to Marie answering my question on what a connected system means and whether the pins help keep track of dosing
as we expect.
Marie Schiller 16:28
It does so as we mentioned, it's based on the the quick pen platform is is a core component of it. So if you look at the quick pen platform that we offer in forums and we have our current basic lar influence and humor log both in the half unit one unit and two units, and then we have our ultra rapid insulin that's under review today. So as in and I don't know what's your son ever on 10 before you move to pump,
Stacey Simms 16:58
he was actually uncertain Because the dosing was so teeny tiny, and they didn't even have half units, but he was on quarter units. But we have since we use pens a lot, because it's a backup for him. If he gets to fly and feels like his infusion set isn't working, he'll take a shot. And he is also a little unusual in that we use. We use a long acting shot with the pump. So he does use a pen every day.
Marie Schiller 17:25
Okay, well, then you're familiar with it. And I can share with you that I was a pumper for years. And now I'm back to two shots, as we all sort of go through those journeys, but what I was going to describe is when you're taking those informs, especially as you know, you're taking the long acting in the short acting. There are just some basic elements that we still don't have today, right? You're running out the door, you're trying to get your son to school or I'm trying to get to work that I did I just take that shot or not again, remember right and just some of the most the simplest aspects of being able to be like up there. If I took that dose, right, and being able to have that check in place, but there are, you know, as you move down that level of sophistication, most people on informer fire some level of glucose testing, whether that is blood glucose monitoring, or as we're doing with the continuous glucose monitors. So the idea is, is that you would have the informed data from the pen, you would have your glucose data, whether that's blood glucose or CGM data, and you would take that in integrate them into this diabetes management system that depending on what you want, is how you would interact with that system. So some would have a preference of saying, you know, when I'm doing okay, or my regimen maybe easier, I don't need as much variation. So, for me, it's a place that I can capture that data and not have to go to different places to get that data for others having some different elements of support in that system. will be beneficial, right? If you think about things on the Faisal influence side for people with type two diabetes faisel, type tration as you get started on the insulin, or maybe after I'm on insulin for a couple years, how do I make sure I'm optimizing? Right? You can go through sort of that journey and see all of these different places where how we can do better than we're doing today. And I'm honing in on the glucose data and the informed data. So we all know I sometimes say life gets in the way right exercise and food you know, all those things that are pretty standard, but for a lot of us can make the road pretty bumpy as we're out there. So you know, over time being able to get the system smarter and smarter with that exercise data and then learning system. So, you know, we all talk about the algorithms that are out today are very much rule based systems right if my glucose is going up by default Like take this action and then be informed is delivered in the future. It may be well for Marie, her level is going up at x rate. And that's, that's not good for Marie versus for Stacey, that might be okay. Because I've trended back and looked at that data and say, you know, we're going to predict that she won't get to an elevated level as an example. Right. So if you start thinking about the personalization of these algorithms over time, it will not be day one, as we all know, it's going to take a lot more research and beta for us to be able to continue to get to that ideal state.
Stacey Simms 20:41
So I'm trying to read between the lines. So the plan sounds like it is to launch with a more let's call it a more static algorithm. Like we just started using control IQ from tandem which is a hybrid closed loop software system. It is a great system for us so far, but it doesn't learn anything. It's probably If This Then That, but it doesn't learn my size. Okay, it's not personalized. So I assuming you're kind of saying that Lilly will launch in a similar way, but the idea would be to eventually get to a learning algorithm.
Marie Schiller 21:11
Yes, I think that's a fair statement.
Stacey Simms 21:14
All right. So let's talk about the announcement that you're gonna be working with Dexcom. Just if you could spend a minute talking about what that means. It's not exclusive as I read the release that y'all sent over. So it sounds pretty interesting. Let's start with what it means first to work with Dexcom are they making? Sometimes there's, I hear special transmitters for certain things, certain software for certain things. Is this a Lilly Dexcom? Original?
Marie Schiller 21:39
no meaning we are basing it off of the transmitter that Dexcom has. So we will be compatible with the G six and we'll continue to work with Dexcom in our development arrangement as they continue to iterate and we continue to iterate to make sure we've got access to each other's latest technologies right because the last thing any of us want to do in these collaborations is to be behind in generation integration, right? I mean, that's what was happening and some of the first generation systems, right, you got people still on, I think it was what g4, and they'd want to be moving to the G six, and there was no way to do those updates, or the G five. So we've established our development, work with them and ability to make sure that we can continue to be running in parallel, as each of our platforms evolve over time. So it will be based on their latest transmitter based on our latest pump in our latest pen, and be able to integrate the the CGM data from Dexcom system into the diabetes management system, where some of the functionality that I talked about before could be available.
Stacey Simms 22:53
So I'm always trying to read between the lines You'll have to forgive me but when I see a press release that says non exclusive, I'm always thinking, you know I don't know of too many, or any pump systems. Gosh, it's so funny to say that Marie, because there's really only a couple in the US. But I don't know if I hear we hear a lot about interoperability, but it isn't here. Yeah. So my question, I guess, is when I see now exclusive, I'm thinking, Okay, are you do you have an eye to working with other CGM companies? And is that practical in the short term? When we all know FDA approvals, things like that, you really kind of have to stick with one system, at least so far, to get it through?
Marie Schiller 23:29
Yeah, you know, it's an interesting way you sort of posed the question, I think, let me say big picture and then sort of dive down to where we are right now. You know, at the end of the day, we believe having access to sort of the latest and greatest technologies is really important, right. I mentioned even with dex comm that we want to be on the same innovation curve that they're on. So people using our system can have access to that. It's really important that all of us, keep pushing For this innovation, right, and the way that you do that is to make sure that I have the ability to integrate other technologies into my system. And I think both of us hold that premise that keeping as a non exclusive allows both of our team to be able to, you know, have access, or have our users of our system have access, I should say to the latest and greatest technology. We have started our program with the XCOM and are really excited about the progress. But we think it's important to make sure that we will have the opportunity to bring different technologies in for different users, even on the systems available today. Right. There are differences in the system, and people are choosing different platforms because of that. Sure.
Stacey Simms 24:51
Yeah, it's really interesting. I mean, I keep hearing about interoperability, which I know is going to come someday but my interpretation of that which is I always call it the Mr. Potato Head. system is not the realistic system. So I try to temper my expectations but why not? Come on? I want to mix and match as much as possible. Why not?
Marie Schiller 25:10
I don't know. Did you like playing Mr. Potato? I was never a huge fan.
Stacey Simms 25:16
It's a it's an easier thing to explain, right? Why can't I use the lead Ray? With the tandem pump? Why can't I use a Dexcom with a barefoot pen? Why can't right i mean if it works better for me and my skin and my kid and my like, why can't I and I, I get it. But at the same time, I really hope that someday we're working towards that, hey, look, it could be worse for you. They could make us play operation or perfection or something terrible like that.
Marie Schiller 25:39
Those are worse. Yeah. But you know it, baby. I think there are a lot of people were having that sort of turnkey solution is, you know, where it's all comes in on and I just understand it and it's all designed to work together. They prefer that and other people would would like that choice, right. So I think we're gonna probably see both of those emerge over time. And the FDA to be fair, has opened the door to that event, right? I mean, they're trying hard to separate the approval of each of the components. We saw that with the ACE ban. We've seen that with IC GM, and now with AI controller that can pass. So, you know, I think, at least from the FDA perspective, they've worked hard to try to enable some of that.
Stacey Simms 26:25
I agree. Alright, so from interpretability. Let's talk about the proprietary aspect of this. Because I think when a company like Lilly, that makes insulin gets involved with the hardware in which the insulin goes, a lot of questions come up, and you mentioned the quick pen. So can you just confirm again and correct me if I'm wrong? Will other insolence be able to be used in either of these systems pen or pump?
Marie Schiller 26:52
Yes. So on the pen side, the system is being built around our quick pen platform. So it will be a system that work with really insulin on the pump side of the equation. In addition, we'll have a first generation that will be a patient built component, but over time, that may shift as well. So on the life cycle plan for that pump, we're looking at the ability to have Lilly insulin in that system, as well.
Stacey Simms 27:27
Okay, so to be clear, and not say, not putting a judgement on this, but just to be clear with the idea is that this would be a proprietary pump, that Lilly would make the pump and Lilly would want its own insulin. We've been human lock used in the pump.
Marie Schiller 27:38
Yeah, I think the system is being designed around Lilly's insulin.
Stacey Simms 27:43
Alright. So you know, we've Marie, we've known each other for a while now and I know you know, this question is coming, but I think it has to be asked in a day and age where people are so angry about the pricing of insulin. Why should we get excited about systems like this when people are worried about But affording the stuff that goes in the hardware, let alone affording the hardware, whatever it is, and how great it is. There's a lot of concerns about cost. I know it's not your department, but I can't have you on and not ask about it. Can you comment on that?
Marie Schiller 28:14
And no and not and I appreciate you asking it. And you have no need for a while as well. So I appreciate the service candid question. Look, you know, and I've said this before, and I'll say it again, you know, we are committed to be able to let people with diabetes, access our medicines, and in the future, disconnected diabetes system that will include sort of the pen based system and the pump and other components. I know you'll be frustrated at this next part of it. But I can't fit here in sort of the position I'm in and where we all want this platform to be any, you know, give you any speculation of the details of how that will happen, or how that reimbursement will be in the marketplace. It just wouldn't be fair to you or your user's to speculate on that, except to say that we are 100% committed to making sure that that access is available. Look, we're not here for the sake of having this innovation sit on a shelf somewhere, not why I'm here. It's not why others are here. And so it is really important for us to be laser focused on how people access the system.
Stacey Simms 29:24
And I mentioned in the introduction, but you live with Type One Diabetes, I definitely have another question for you. But it just occurred to me, are you allowed to even say this, have you tried this system? Like, are you in the trial? Can you trial your own? unprepared?
Marie Schiller 29:38
I sure how to answer that. I have no, I'm not in the trial, but I can give you that answer. So I am not in the clinical trials that have occurred today.
Stacey Simms 29:50
I'll tell you as a person who doesn't have diabetes, obviously, you know, it's just something that I always wonder about when I talk to researchers or clinicians or I know there's there's obviously rules for clinical trials. But you've got to think, alright, I want to try this on myself. I know a lot of people have done that. Okay. So the real question I wanted to ask
Marie Schiller 30:05
is okay, I can't wait. I can't wait. That's why there's no, we're pushing hard to justice available. I, I'm waiting, like out there to make sure that I get this.
Stacey Simms 30:18
Alright, so I've got a difficult question. So my real question about living with type one is difficult is it right now to work at Lilly, when people are so angry, and a lot of that is directed? We've seen protests separately headquarters, you know, and again, it's not you, you're not in the price department. Even if there is one. This is not something I know you can control. But is it difficult and frustrating for you to see the problem, frankly, with insulin pricing at all of the insulin companies?
Marie Schiller 30:46
And the answer to that they see and I think we may have talked about this, either the last time on the phone or when I saw you it's like how do you not feel the pain in you know from people, right? I mean, this dishes, dish issues difficult issues people are dealing with. So of course, you know, what I would say is is that worse from, you know, being here? You know, I look at what we're trying to do. And And And again, I'm not the person to sort of comment on this, but it's a priority for Lilly. And I'm really proud that Lilly has made it a priority to make sure that access is there.
Stacey Simms 31:25
Going back to two devices that we've been talking about. I always hate to ask about timelines, but I always have to ask about timelines. Can you give us a goal timeline here? Is there any indication of when it might be submitted to the pen or the pumping, which will kind of go in first?
Marie Schiller 31:42
Yes. So let's talk about the pen first. So as I mentioned, and you can see on the FDA site the supplemental approval for the pen has gone through. We are working with the agency on the other components of the systems. We are not giving an update right now. on the timeline for that system, but we expect to be giving updates over the next couple of months on the pump. As I mentioned, we'll be sharing the first clinical data and our signaling that we're still over the next couple of years hoping to get that system to market
Stacey Simms 32:16
where we thank you so much for joining me. I know it's a difficult conversation to have when you've got, you know, a lot of things about to come out and then other things that I'm asking that aren't really your department. But I appreciate your frankness. Before I let you go as a person who lives with type one, what is it like to work in the diabetes sphere? I mean, I think part of me would be kind of tired, like my whole day is diabetes. My whole life has diabetes, but it's got to be exciting as well. What's
Marie Schiller 32:41
it like? It's an interesting question. For me. I just don't know any different facing effects? The answer is, I don't know my kids would probably answer the same way. I don't know what I would do with myself if I wasn't doing this all day. My weekends are spent so much in the diabetes space as well. It's just something that that is it's just a part of me, right? so much a part of all of us who are living in this space. And I'm impressed every day by all of the people working so hard to make these advancements. And it's amazing, right? As you've seen, we're actually getting some of these solutions out and reading about the improvements that are there. And I'm excited and want to keep staying focused on doing what I can to get these products out and having my team man. I mean, everybody here is just so passionate about what we're trying to do to make these advancements. So it's, um, I know it's a it's like one of those questions someone would ask what would you do if you worked with your spouse? You know? I don't wanna say I love my diabetes so much because I'm not sure I'd answer that way. Am I cursed my diabetes maybe as much as I do other things in life, but it's data reason that probably keeps That's all motivated if we know how much better we can make life.
Stacey Simms 34:03
Well, thank you so much for spending some time with me. I really appreciate and I hope we get a snapshot of the devices soon enough, Marie thanks again.
Announcer 34:15
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 34:21
Of course, more information at diabetes connections.com. I always link up a lot more info at the episode homepage and a transcript. I'll be interested to see how this episode is received. As I mentioned at the start of the show, there are some people who do not want to hear anything from Lilly, if it's not about lowering the price of insulin. And I respect that I hear that I know that there's a lot of anger in our community and a lot of frustration at all the insulin makers and you know, I do share a lot of that, but I would be curious to think if we should not be following the other technology advances that are coming out of these companies, because I'll be honest with you, I said this two years ago, I think Lilly is seeing the writing on the wall. That the price of insulin is going to be mandated to come down in the next few years. And they are, they don't wanna lose money. They want to find other ways to continue to be competitive. And I certainly don't think that insulin will be free. But I do think that going into the pen and pump business is a move on their part with an eye on the price of insulin coming down. Look, I'm not an economist. I'm baby way off base. But that is something that makes sense to me.
up next Tell me something good. And then a little bit later on. I want to talk about some other pump companies and news that came out recently, diabetes Connections is brought to you by Dexcom. Do you know about Dexcom clarity, it is their diabetes management software. And for a long time, I just thought it was something or endo used. You can use it though both on the desktop or as an app on your phone. It's an easy way to keep track of the big picture. I check it about once a week. It really helps spinny and me dial back and see longer term trends and helps us not overreact to what happened for just one day or just whenever Our the overlay reports help with context of Benny's glucose levels and patterns. You can even share the reports with your care team, which makes appointments a lot more productive for managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at diabetes connections dot com and click on the Dexcom logo.
I love the Tell me something good stories this week. Honestly, I love them every week, but I got a bunch that are so fun to share. And one that frankly is pretty important. Alright, so first, Candace says my son was just diagnosed January 23. This year with a hospital stay. By February 13. He was dancing away and winning a hula hoop contest at his first school dance since diagnosis. He's 11 and he was so proud of his accomplishment winning the contest. And we as parents were so happy that his diagnosis wasn't holding him back. That is so cool. I didn't Kansas for a picture shockingly, an 11 year old did not want pictures of him hula hooping to be displayed. I'm actually not sure if she had any, but we respect that we hear it. I just think it's fantastic that he did it and that he's doing so well. This soon after diagnosis way to go Candace!
Alison said this is a tiny thing. But today my child was type one went to get her foot x rayed her shirt, rode up and showed her Dexcom and the text said, Hey, do you have diabetes? I do too. Then she pulled out her pump. It was super cool. Allison says her child was diagnosed in early December. I think that's great. Is there anything better than that diabetes in the wild citing, right? You know, you're with people who get it. It's just so great.
And then this one you may have seen on social media. I posted a picture of Isabella with her fish, not her pet fish a fish she caught. Isabella is nine years old and she loves fishing with her dad and boy she beaming in this photo with a fish that's like as big as she is. Her mother, Heather says she was diagnosed with type one at age four. Again, she's nine. Heather says, I will tell you this little girl is amazing. Her dad got diagnosed with lupus almost four years ago. He is on dialysis. We are on a kidney transplant list. I'm currently trying to be his donor. And a lot goes into that. This is her and her daddy's favorite thing to do. They live life to the fullest, and nothing stops them. Heather, thank you so much for sharing this story for letting us share the picture of Isabella, you guys are carrying a heavy load right now. And I'm so glad to hear that you're finding enjoyment in things like this. It's kind of trite. As I'm hearing these words, leave my mouth. I mean, there's really not much to say when you're in a situation like that. But I'm happy to share your story. And I hope you keep us posted. Let us know what's going on. And definitely send more fish pictures. I would love to see that I really would even if we don't share them. You can definitely send them our way are posted the Facebook group.
Our final Tell me something good is a little bit of a different story. It's more of an news story. But this is really important. And I think very good news. Beyond type one announced that they are collaborating with the National Association of School nurses to raise awareness of the warning signs of type one diabetes. So this is a new collaboration that means that 10s of thousands of school nurses around the country are going to get these awareness materials from beyond type one, if you haven't seen these we did in North Carolina push a few years ago. And they're just simple and straightforward. And they tell you the signs, and they talk about what to look for. I don't think those of us in the community had any idea what DK a was what it looked like, how deadly it could be, you know, before we our children were diagnosed, right? How would you know? So this education campaign is absolutely going to save lives. Huge thanks to be on type one. And a big thanks to the Helmsley Charitable Trust which is funding it. I will keep you posted. I will put up links in the show notes on how you can get involved because you know ordinary people state to state are getting involved. We sit around my dining room table here outside of Charlotte, North Carolina and stuffing envelopes and sent them out really can make a difference. Tell me something good happens every week around here. Give me your stories post in the Facebook group, email me Stacey at diabetes dash connections dot com. I would really love to hear from you. We got to get the good news out in our community. Tell me something good.
All right. We're getting a little long here. But I wanted to bring you some news from the other pump companies. I know I don't usually do a news update this far down in the show, but because I put the coronavirus episode out a little early. There was some news I was going to put into that episode that has gotten pushed here. Let me get right to it. We had an earnings call from tandem. And the really interesting bits from that were that the T sport hybrid patch pump is now expected later this year, possibly probably early 2021. The CEO of tandem says they plan to file with the FDA for t sport approval. This summer with a new mobile app, which means you'll be able to bolus from your smartphone. So apparently, they're going to submit this in two different ways two different filings. One would be a separate handheld device, right like a dummy phone or a dummy controller of some kind that you'd bolus from. I'm dummy and that it doesn't do anything else but control the pump. But the other filing would be remote bulleting by the smartphone app. And apparently the CEO said they will not launch t sport until both have been okayed by the FDA. So you would have the option of using your phone or of using the singular let's call it singular controller rather than the dummy controller. So that's really exciting. I'm gonna post some pictures diabetes mine posted this update and posted some pictures of the tee sport. It is a little patch pump that can be worn on the body or it has a tube so it can be put in your pocket again. I don't know how it sticks to the body. Did you hear me talking to Maria about that? Is it reusable? Like ever since or is it like a dexcom to rip it off or a pumping set. So we'll find out more about these things as they go forward. But that was some really interesting news from tandem.
The other bit of news comes from Insulet. They are in the middle of clinical trials for horizon, they had hoped to be filing for that approval. This summer horizon is the hybrid closed loop for the Omni pod. They did have a software issue. That means they are pausing the pivotal study, and it's going to delay things, not really sure how long, of course, they're really hoping that it won't be too long, you know, maybe a month or so. But they are now pushing the anticipated launch of horizon to early 2021. And I know there's a lot of disappointment because people really want this system. I will say to you that tandem had a similar issue with their software during the last pivotal trial for control IQ. It was very quickly fixed. I don't think it affected the timeline that much. Maybe it was just a month, but it still hit its goal of the end of the year. So hopefully Omni pod insolate can get back on this and get back to their timeline but I will link to More information on that, because I know these things just cannot come to market soon enough.
tank you for staying with me. This was a long bit after the interview and I appreciate it, but I wanted to get some information out there. I really appreciate you listening. There's a lot going on right now. All right, I'm gonna stop right here and thank my editor John Bukenas from audio editing solutions. If you have an audio project, I highly recommend john, you know, if he puts up with me, and my rambling that he can do wonders for you. All kidding aside, john is great. I love working with him. He never asked me to say anything in the show. But he really is such a strong part of what makes this podcast successful. And boy, is he nice to me and doesn't leave in all of my papers. So thank you, john. And thank you so much for listening. I'm Stacey Simms. I will see you back here next week.
Benny 43:55
Diabetes Connections is a production of Stacey Simms media. All right. reserved all wrongs avenged
Transcribed by https://otter.ai
This week, catching up with Dexcom CEO Kevin Sayer – overseas at the ATTD conference. We talk about everything from a G7 update, new partnerships, in-app notifications and those sensors that you’ve probably heard about getting stuck. We also talk about competition, customer service and a lot more.
Join the Diabetes Connections Facebook Group!
In Tell Me Something Good, a Miss America contestant with T1D has pretty stellar week – and it has nothing to do with her crown and sash.. this is about engineering .
Check out Stacey's new book: The World's Worst Diabetes Mom!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode transcription (we're in beta so please excuse grammar, spelling, punctuation and the fact that AI can't figure out Dexcom speak)
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Real Good Foods, real food, you feel good about eating, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:26
This week, catching up with Dexcom CEO Kevin Sarah overseas at a big diabetes Technology Conference. We talk about everything from the g7 new partnerships in app notifications. And those stuck sensors that you've probably heard about or seen on social media.
Kevin Sayer 0:45
There's a freak out factor but Let's face it, if that's your last sensor, that's not fair. And that's not right. So we noted it, we've seen it, we've read it. We've done everything we can to mitigate it. I'm very comfortable we’ll see this come down.
Stacey Simms 0:57
We also talk about upcoming CGM Competition, customer service, direct to Apple Watch and a lot more.
in Tell me something good on Miss America contestant with Type 1 diabetes has a pretty stellar week and it has nothing to do with her crown and sash. This is about engineering. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your healthcare provider.
Welcome to another week of Diabetes Connections. I am your host Stacey Simms, we aim to educate and inspire about type 1 diabetes by sharing stories of connection. My son was diagnosed with type one, just before he turned two. That was more than 13 years ago. My husband lives with type two diabetes. I do not have diabetes. I have a background in broadcasting and local radio and TV news. And that's how you get the podcast. longtime listeners know what the show is all about. letting some new people know because let's face it anytime we talked to dexcom or talk about anything New technology, we get a lot of new listeners. So welcome!
If you've come for that, I hope you stick around and go through our almost 300 past episodes. Now, you can find everything at Diabetes Connections. com, we have a very robust search, there's the regular old search box on the upper right hand side. Or if you click on the episode page, there is a way to sort them by category. So if you want to see all the technology episodes are all the ones with athletes are all the ones about family or advocacy, you can sort them that way as well.
Before we talk to Kevin Sayer, it is important to point out that as you heard the very top Dexcom is a sponsor of this show, and has been for a few years now. Our agreement means I talk about them in a commercial, which you will hear later on the show. But it doesn't mean that I don't get to ask hard questions. I really try to serve you as you listen, I try to serve you first. And if I'm not doing that this show doesn't work ethically. It's really important to disclose these things. And I always get upset when other either podcasters or bloggers or speakers don't do that. If you're a longtime listener, you understand how it works around here. Hopefully, I am doing a good job of serving you. But just to be clear, the advertisers in the show pay for the advertisement. And I believe in them, and I'm glad they're here. But they do not tell me what to say, in the show anywhere else on social media, or when I write a blog, that sort of thing. It's not that kind of relationship.
So we're talking to Kevin coming up in just a couple of minutes asking your questions. I took a whole bunch of them from the Facebook group. We do have a Facebook group, it is Diabetes Connections, the group, very original, but very easy to find that way I thought, and that's really the best way if you want to ask these newsmakers questions I usually ask in the group and you can always contact me that way. That's coming up in just a minute.
But first Diabetes Connections is brought to you by another sponsor, One Drop. It is so nice to find a diabetes product that Not only does what you need, but also fits in perfectly with your life. One Drop is that is the sleekest looking and most modern meter My family has ever used. And it's not just about their modern meter setup. You can also send your readings to the mobile app automatically and review your data anytime, instantly share blood glucose reports with your healthcare team. It also works with your Dexcom Fitbit or your Apple Watch. Not to mention they're awesome test strips subscription plans, take as many test strips as you need, and they'll deliver them to your door. One Drop diabetes care delivered, learn more, go to Diabetes Connections calm and click on the One Drop logo.
My guest this week is Dexcom CEO Kevin Sayer. He is joining us from the International Conference on Advanced Technologies and Treatments for diabetes, which this year is in Madrid. So as we're talking to Spain here, please pardon any glitches or weird phone sounds that might pop up but hopefully all will go away. Kevin, thank you so much for joining me. I appreciate it.
Kevin Sayer 5:02
Oh, thank you, Stacey. It's good to be back again.
Stacey Simms 5:05
All right, let's start with the news that has already come out of the conference. And that is this official partnership with Insulet. With Omnipod. Can you start by talking a little bit about? And I'll be honest with you, I'm a little confused. I they're already in clinical trials for Horizon. I thought this agreement was a done deal. Tell us about the agreement with Insulet.
Kevin Sayer 5:23
Actually, we've been working with Insulet since 2007. This is a long time relationship. And most of our work in the past was then under the form of a development agreement to jointly develop products together. The announcement this week is the culmination of all that development work over time to basically say, look, we've entered into an agreement whereby we know how we're going to commercialize our joint systems. And also, as we have entered into these development agreements with our partners, we typically do it one generation of technology at a time, we made the g7 system available to the Insulet team as well. So once they get a rising launch with G6, as the G7 system gets ready to go, it will be will be able to migrate over to that system as well. So that that was the purpose of this announcement and the other. You know, the other reason for it, there is so much going on in the interoperability world right now. We index coms as well, it's important that everybody knows that we have these relationships. And this relationship is very close and near and dear to us. So we therefore thought the announcement was good on something we have been working on for a very long time.
Stacey Simms 6:29
When we look at interoperability, you've mentioned already G6, G7. Can you just take a step back and give us a little bit of an update on that so Insulet will go with their horizon, which is not out yet. That'll be g six and G seven tandem with control IQ also g six mg seven
Kevin Sayer 6:50
Tandem has access to G6 right now. We've not yet signed a G7 agreement with them, but we'd expect to do that and then they're very near future. We've also signed a relationship with Lily and their connected pens and their platforms, whereby they'll have access to G six and G seven as well. We have several other smaller relationships with some of the smaller pump companies or others where they have to six, access not a lot of g7. At this point in time, we have to look at that strategy over time and decide what approach we're going to take with partners. The interoperability world creates some very interesting business scenarios, which I wish I knew the answer to all of that, but it ranges anywhere from let's say, one person and go or two people and just work with them to maybe a few or just open it up to everybody. And I think it evolves over time. For us right now. We think it's important that we support certainly as many as we can, but offer even a heightened level of support to those who are going to have commercial offerings in the near future as speaking towards Tandem and Insulet. In particular, the control IQ uses g six and we read certainly very good things about that is that since we've been out there. And so we'll work with them all. This is going to evolve over time. All the answers are available. Sure.
Stacey Simms 8:07
Okay, so let's talk about control IQ quickly, because that's been in the news quite a lot lately. We just started it about three to four weeks ago. It's been working very well for my son, but Dexcom owns the algorithm, but used to be called or maybe still is type zero.
Kevin Sayer 8:23
So let me give a little clarity on the fundamental or the underlying science and the calculations behind the algorithm are in fact, developed a type zero and owned by Dexcom. Tandem has filed that as their controller. They have done some user experiences some modifications as to how it is integrate into their pump, but the fundamental algorithm is owned by Dexcom. And type zero. That's correct. So the sensor in the algorithm driving it are Dexcom properties.
Stacey Simms 8:49
This is a little bit more esoteric than I expected to get in so quickly here, but what's it like being in the algorithm business and Do you have plans to perhaps get some other algorithms in Your tool kit, if you're like us, not the only one out there
Kevin Sayer 9:02
know when we've looked at those, and we love our team in Charlottesville, we have some decisions to make there too. So what we're going to do long term with the algorithm and how available we're going to make it, it is a great business opportunity is a great skill set for us to have as well. With that team in Virginia, we've learned a lot about our sensor, their opportunities to take the science has been developed for automated insulin delivery and apply it to decision support for those who really don't want to use a pump all the time that we could possibly provide some good decisions along the way that would help them better manage their diabetes in the manner that they want to. I think there are a lot of opportunities to do that here.
What we're going to let it play out, we're still early on in in that one. They're certainly next generation algorithm to come after they control iq version of it, which is kind of a step up or there's even less user interaction where you possibly won't have to announce all the meals and Everything that will be a little more aggressive on treatment and require a little less user interaction. And we got to figure out what our strategy is going to be to do that and how we're going to go with that.
So we're kind of in the algorithm business, but sensors are still our biggest, you know, that's where we pay our bills, the most important thing for us, when we saw that asset was kind of available out there that we felt it was something that we just needed to control. And then we're thrilled with it. And quite frankly, it's worked out well for me, too, because they're right away from us in San Diego. And we can very much collaborate very quickly, since we have access to those scientists and they have access to us.
Stacey Simms 10:39
So let's talk about the g7. We've talked about it before. Can you give us an update, what the features will be? What makes it different and the timeline?
Kevin Sayer 10:49
Well, as we've talked, I'll start with the timeline, as we've said in our public statements, will be starting a typical study this year. Our hope is have a limited launch in 2020 The limited line for that have a significant impact on our financial results. So in the public world, we don't say a whole lot about the limited launch, we intend to do the full ride in 2021. And I don't have a perfect time frame yet, I will tell you, the mitigating factor will more than likely be our ability to scale it up. As you know, from your community. We learned a lot in 2019, about scale and all those lessons were not necessarily positive, the Dexcom. But they were good learnings. It was hard, we underestimated some things when we rolled to six out the way we did and I don't know that even if we delayed three or four months like to its original plan launch date, that we would have solved those problems because the demand for G six was so much higher than we anticipated.
It would be you know, in the past, we could overcome 20% more demand than we have because we didn’t fill that many sensors. So yeah, if you’re manufacturing 2 million sensors. We can come up with another 200, 300 thousand, that's not a problem. But when you use the numbers we're at today. becomes a problem. So if anything, we learned anything from the big six launch, we are going to be prepared to scale g7 when we launch it, because when it comes, nobody's going back, just like nobody's going back to G five g six
features of the product, as we've talked about before it much thinner, smaller profile, disposable electronics. So there's not a transmitter component anymore. There's no assembly of anything before you put it on, you literally take it out of the box, press the insertion device into your skin and hit the button and you're gone much smaller plastics profile. from an environmental perspective, patients will be glad to know that we get that comment frequently on our current system about all the plastics length of where we're shooting for an extended wear period.
I have to tell you, we will balance the extended wear period against the accuracy and performance of the system with respect to iCGM standards. We know we have to have this as an iCGM to talk to these automated delivery systems and sometimes you make trades offs. Length of wear versus accuracy, as most people know, at some point in time, the longer you wear a sensors, the more difficult it is for to perform perfectly. One of the things that I often that isn't understood about g six, I can give the perfect example, these standards set by the FDA on iCGM are difficult. They're not simple to meet. And literally the way that g six algorithm works is if through our and our analytics, we look at the sensor signal and determine that that sensor is about to become less accurate than it should be, under iCGM rules, we turn it off. So there's a perceived lack of reliability from some of our patients on the sensor, when in fact that's not the case at all. We're turning it off intentionally.
And that's very often associated with physiology. You know, people's bodies are different, and even sensor sessions can be different based on how much activity you have or where, the place you insert the sensor. So we're hoping for an extended To 15 day, where it certainly wouldn't be less than 10. We will go either way, but we need to make sure we meet the criteria. The sensor is much shorter than g six. So it will be a shorter sensor from our user experience so far and our preclinical work we've had nothing but great feedback on that.
Stacey Simms 14:17
What does that mean? Is it a shorter wire or a shorter device, smaller, shorter wire
Kevin Sayer 14:22
Shorter wire with the direct insert, not angle, but it is straight in but it's very, very short.
Stacey Simms 14:33
More to come on the g7 and many other Dexcom issues. But first Diabetes Connections is brought to you by Real Good Foods, good foods, and their philosophy is all about keeping it real with food with community and with each other. And if you go on their website, you can find out so much more about the product real food, high protein, it's not about chemically made protein powders. This is about food, chicken cheese Right, low carb, grain free and zero added sugar. They keep adding products. We are big fans of the original pizza and the poppers but they've added a breakfast sandwiches with sausage or with bacon, cauliflower crust pizzas, chicken alfredo, other Italian entrees. They just keep adding more great stuff, find out more, go to Diabetes Connections calm and click on the Real Good Foods logo. Now back to my interview with Kevin and we were talking about the g7.
You mentioned the the longer were balanced with their performance Do you expect the g7 to perform differently to perform I hate to say better but to use the criteria you were talking about with the iCGM? Do you expect fewer issues with either Physiology or the sensor sensing that something is wrong and then turning off.
Kevin Sayer 15:57
That is our hope and our belief? We have learned So much from G six, as to what we can improve and make better It's been one of the scientists said to me the other day, he feels like he's working in a semiconductor factory. We're learning that much about sensors these days, as we're preparing for this setting to launch this product, we may not even be able to get all the things we've learned into the first version. But I think there'll be a couple of iterations whereby I know the extended wear will come and I know that that the reliability will be there. One of the things that we put around ourselves as a criteria is to significantly improve the reliability percentages. And we were experiencing on G six today, both on G six going forward and on g7. It just doesn't work. Patients have to return to the sensors, because they fall off or don't last long enough. We have to make that experience more consistent. So we're very focused on that. Not just with you seven, but with the six improvements as well.
Stacey Simms 16:51
All right, this next one, I just have to get it out. Kevin, I feel like a broken record. But can we talk about direct to watch what's going on? I know there's been a lot of holdups but is that something that’s happening?
Kevin Sayer 17:03
No, and we're working on it I appreciate you asking again, is technologically very difficult a Bluetooth protocols on the watch are not the same as the phone. And I go down to r&d and I asked the guys a question, every time I talk to you tell me what's going on. And it's not only difficult from the Bluetooth perspective, there's an experience perspective, it's also difficult with respect to the alerts Can we make it worse, audibly loud enough for by somebody can hear them? What happens when you take your watch and you put it on your charger and it's your primary displaying walk away, there's some where issues and some issues around the watch to create a little bit different experience and required a bit more fun on our part, and quite candidly, a lot more complex engineering. And we have done firmware updates to get us closer there.
When we're done. We'll announce it. The other thing I would tell you is even if we weren't finished today, I wouldn't tell anybody I'm not trying to tell anybody till every transmitter in the field is was compatible because it will be different. version of the firmware on the transmitter. And while it was still be seamless on your iPhone or your Android phone, it will look the same if we announced direct to watch, and then we have a bunch of transmitters in the field that don't go director will watch, we're creating a tech support issue that will just again lead to patients being upset. So we're working on it, it's just a ways out and all these opportunities or engineering, things we have to get done are not just caused by Dexcom, either. There's Apple things that we just have to understand better. They work very closely with this. They're very helpful. It's just taking a lot of time. Sure.
Stacey Simms 18:34
Well, thanks for the update on that. It's nice to know, you know, there's always a fear that these features may not get rolled out right. There's always a fear that and I know you know, this is the type one community that we see CGM makers and other technology companies looking at the the enormous type 2 market which has very different needs very different wants, and that we will be left behind so the watches I mean, it's a little bit dramatic to put it in that way. Looking at direct watch, but you understand what I'm talking about, right?
Kevin Sayer 19:03
Yeah, I do. And I let me respond to that a little bit, please do. You're right. There are a lot more people with type two diabetes, type 1 diabetes, but there is nothing that we do for people with type 1 diabetes, that can't create a great experience for people with type two diabetes. I would argue that the good things we do for type one patients translate better over to type two then heading down a path with lesser accuracy, or lesser connectivity or fewer features. You're much smarter to make a product performance is superb level and then make the changes software related rather than then system related. And rather than sensor related, which is the way we're doing it now.
Or you know, there was a big fear that g7 would be a type two product only hired that from a lot of patients because barely our partner been a great partner has been very much focused on type two where they're on duo, a managed diabetes management program, but that's not the case. We We will launch our g7 system with his ice ice jam label current plans are a legit person in the type one space. After that, even with G six, we can adapt the G six platform to a type two patient that has a different software experience. It doesn't detract at all from what we do for our core market. And where we sit today, the most important thing to do is to get a like if you get accuracy and performance and reliability and consistency, you can take that anywhere. And that meets our type one patients need and will also gives us the business flexibility that we need to go forward. But we're not going to do that if we were looking at something for another market.
And I'm speaking way out in the future. today. It might be another platform that would measure multiple analyze that wouldn't have ice jam accuracy for glucose, but you'd have some combination of pick for analytics glucose, ketones, lactic acid, some other one where it's maybe 20% lack less accurate all four but you get a picture of everything. That's more of a diagnostic As we look at sensors in the future, that's something we would consider. But that's, you know, that's advanced r&d and something that we would look at. We don't have an intention of going a different direction right now. We believe that the features we have we can migrate to type two without compromising our current patient base.
Stacey Simms 21:18
All right, let's talk about some specific type one stuff. And let's talk about following up. And no pun intended there. I apologize on the share and follow issues from late last year, you put out a very sincere apology, you really seem to have taken some steps. I appreciate that. I'm sure it couldn't have been too easy to put that video out, and we appreciate it.
Kevin Sayer 21:40
But no, actually, I didn't tell you that that did not bother me at all. We couldn't put it out until we knew the answers. But that's the way we run this company. And that's the way I will always behave. If we do something that doesn't work. You own it. You don't hide and I wanted to do the video of the day with day one and Gemma calming me down, I wanted to write a letter or reduce something I was wasn't happy that we could not go faster. But now we will always behave that way will never behave any differently.
Stacey Simms 22:13
I have some questions. Go ahead. Alright. Alright. So my first one is, you've updated the website and I'll put a link in the show notes where people can go to check in just last week, there were a couple of issues that were resolved quickly. But I noticed that what happened to me I'll give you my personal story. I noticed on my follow app for my son that we had lost signal, there was a brief notification, I apologize. I can't remember what it said. But something like you know, server error, but something came up a little teeny red line on the app. I cleared it without even looking at it too closely. And I went on my way because I don't My son is 15 I don't look at the follow up as much as some other parents do. But then on a Facebook group, someone said go and check the Dexcom page because They're updating the situation there is an issue. Great. So we all went. But my first question is, you will have announced, I believe that you're working on push notifications of some kind, because it didn't occur to me and maybe shame on me to go to the website. So can you talk about the timeline for that and what those in app notifications will be?
Kevin Sayer 23:19
Sure. But let's go back a step we said and I said in the video, two things we're working on it immediately is a server status page and a product status page on our on our website. So you can go to the Dexcom website, and you can see how the system is functioning. And you can see that clarity is functioning Share and Follow how they're functioning, and we give an update to those in real time, will then implement before in the first half of the year, we're two months into the year almost before the end of June, we will have in app messaging to whereby if there is a share or follow or clarity or whatever issue we can send a message directly to the patient and are the followers servers are down, this is what's going on and it will come in the app won't come through text messaging yet. That'd be something we would do a little bit later. And in all fairness, I don't know that we have everybody's phone numbers to whereby we can push text, but we can't push to the app into the app users. So that'll be here by by mid June.
As far as anything going on Recently, there were a couple times when the status page was yellow. And they worked through those quite quickly learning from what's gone on in the past and got that resolved. And we're now establishing the boundaries for what example what yellow server status means, on our webpage. Because when we started this and just adding totally, one of the the apps had yellow and it's happened to two clinics in the whole country. But since it happened to two clinics, we made it yellow, just in case it happened anyplace else on reality. That was the two words had happened and we dealt with it so we're being rather cautious is causing anything that we We will make it yellow over time, we'll put, you know tighter boundaries around that. But we will make it yellow. We'll work through the issues. We've improved our internal communications, I knew something was going on from the minute that thing went yellow, I was getting notifications. And I was I was traveling, so it's going much better. And we'll build a structure up and continue to make it better. That's all I can tell you. So we'll keep improving.
Stacey Simms 25:24
And I know that you'll be researching this, but I'll give you some patient feedback real quick is that please don't text me. You don't need my phone number in app notification.
Kevin Sayer 25:34
Okay. Yeah, I would rather not understand. balance that with everybody else because
you're catching a flight for the airport, what happens? You get a text message. So the expectation since we're on your phone is we have the same infrastructure we just don't
Stacey Simms 25:53
do what I don't get a text message from the airline. I get a notification from the app. It shows up on my similarly you get a text from Because you probably,
Kevin Sayer 26:01
I guess it depends I Yeah, I know. Anyway, you have to be more like everything else that people experience.
Stacey Simms 26:08
Exactly. Okay, so I have a couple of questions. Many of these questions that I've asked have actually already come from my listeners. Of course, we all have a lot of the same questions. But here are a few that people sent in. Rachel, as we're staying here on the follow up. Rachel wanted to know, if you're still working on having the follow app getting same notifications as the primary app, because all of us parents, especially with older kids, now, we never know when the sensors is expiring when the transmitters expiring, is there any work being done to get the follow up to be a little bit more robust for parents work any caregiver?
Kevin Sayer 26:43
Yeah, we're continuing to work on the follow up and add add more to it. I think it'll be continual development cycle and will continue to add more. I will tell you from the teenager or the college students share a perspective the last thing they want is their parents. Getting The alerts from their app. I know that firsthand, because I talked to a couple of No, no, no, no. And so we try and balance it all. We will make the the share system more robust as time goes on. Because if we learned anything thing from the server outage, we learned how important share was. It is very important to everybody.
Stacey Simms 27:19
Yeah. And all due respect, when you have the first update, when you could make it for 10 followers. You know, not every kid wants everybody their school following them either. I mean, but these have to be parental decisions with good education. So, you know, I think I get what you're saying. But these are all, let's just see, these are wonderful problems technology has created. I try to leave them alone. Alright, so.
Okay, the next question came from a few people. And Gosh, I don't know if you can answer this, because this is more anecdotal, but we've been using the G six since May or June of 2018. And it seems to me Just in the last two months, I have seen pictures and heard anecdotal reports of sensors getting stuck at insertion to the point where in my smaller I have a smaller local Facebook group. People are posting the things they have used to whack the sensor because you're supposed to, apparently on Facebook, you whack it with a wooden spoon to get it to release or there might be a button underneath that you can push a pin in. But this is something that we haven't experienced, but that I've seen in the last two months. Are you aware of this? Is this an actual problem that
Kevin Sayer 28:33
just so you understand, we monitor every complaint and everything that's coming very closely, we have seen a rise in those instances. Fortunately, it doesn't result in a patient getting bad data or anything bad happen. We just have to replace their sensor. We've identified the root cause of that and we've taken mitigations to correct that and that should come down going forward. We have this this Not this specific issue, but the fact is when we see things rise in the complaint base, we have a group of sustaining engineering group that jumps on these issues and determines where they came from. we've analyzed this, this specifically and we've implemented improvements and you will see that decreasing significantly over the next several months that should go away.
Stacey Simms 29:20
Okay, cuz I know the good news is there isn't as readings issue, but the bad news is there's a freakout issue.
Kevin Sayer 29:26
There's a freakout issue and let's face it, if that's your last sensor, yeah, that's not fair. And that's not right. So we notice it, we've seen it we've read it and we have we've done everything we can to mitigate that I'm pretty I'm very comfortable we’ll see this come down.
Stacey Simms 29:41
Okay, but I'm glad to hear that. Is there actual advice of what to do if it happens? Is there the release underneath? I'm assume whack it with a spoon isn't something that you recommend?
Kevin Sayer 29:54
Now we’re in anecdotes and I can’t speak to that. The easiest thing is call us and we’ll get us a new sensor as fast as we can.
Stacey Simms 30:02
I gotta ask. I got a couple of questions from listeners who are asking about outside the United States. Obviously our listeners are USA centric, but there are many, many, many in the UK and Australia and Canada. Can you talk a little bit about jif six and G seven, internationally.
Kevin Sayer 30:19
So g six is in Canada now. We launched it there in the fourth quarter. We also launched in Canada, any commerce platform reimbursement is not brought in Canada. Many of the patients have to cover the costs on their own. So we have tried to make it easier and Canada is the first place we've ever had an e commerce platform where patients can literally go online and buy their sensitive transmitters have them shipped directly to them without having to deal with this has been a very efficient and a tremendous growth driver up there. A lot more people are getting access to speech him in Canada because of that. That's been a great experience. g six has been available in the UK for quite some time. And again, the UK business is I want to say three reacts when it was two years ago. So we're doing very well there also, reimbursement is coming, but it is sporadic. It isn't everywhere. We spent a lot of time with government authorities pleading our case, the importance of CGM, and we found that educational process great. they've jumped on board and learn a lot Australia, g six is coming. I know it's not broadly rolled out, but it will certainly be a 2020 product there and should do very well in Australia as well. Government reimbursement, for CGM in Australia has gone very well. Here today. It is growing nicely, are all US strategy. We really have three pillars that we're working on, you know, first those countries we're reversing, that is good. We gotta broaden there. We have to increase access in countries where reimbursement is sporadic. And the UK, Spain where I am Italy, some of those places is very sporadic. Some regions it's reimbursed others it's not. Yeah. And then there is where we don't play it all. Yeah, we're very well In Central and South America, or Mexico, where we've got a filing in Japan virtue six, but we're not launched there yet.
Stacey Simms 32:08
I'm gonna start this question right here. And it's my fault because I'm running over time. And I want to get one more question in. So I apologize. One more question. Okay, so diabetes mine ran a column recently that was headlined 39 potential new continuous glucose monitors for diabetes. Now a lot of these are pie in the sky. We know many won't come to market, but they went through and listed a bunch of new CGM that are going to be your competition. My last question is about customer service. Talk to us about how you're going to improve, maintain, really try to over serve in terms of customer service, because you know, that in the last year or two as the launch of the G six was a challenge, because of supply, customer service has got to be a challenge too. So my last question is, assure us that it's going to be okay from a customer service standpoint.
Kevin Sayer 32:58
Well for us, it will be Well, I will tell you the one thing we've learned this year, more than anything else is scale. It's very difficult. And I just throw some numbers at you. Two years ago, we announced that the JPMorgan conference we had 270,000 active patients. That means we have patients that we know are buying and using sensors. Okay. I announced in an earnings call a week ago that we have 650,000 active using sensor patients. You can imagine the number of sensors we have to produce above and beyond that the number of phone calls we take, we will make customer service priority but scale is a huge challenge here and it is not cheap. We will spend hundreds of millions of dollars getting the g7 factory up and running before you see a sensor. We will invest hundreds of millions of dollars in G six at the same time, getting the factory automated getting the sensors more reliable. At the same time as we looked at the customer experience. There's a lot of things we can do.
We have formed an entire customer experience Team at Dexcom over the past 12 months To go back and look at how we interact with people is 43 screens to start up the G six, new from scratch. Why is it 43 screens was because it was 43 screens and we did seven plus or G for whatever, we did the same thing. We're go back and re evaluating all those things to make it easier. I believe also on the customer service side, we do need to get better. But we need to get better a couple of ways. Product reliability is the first thing if we make it so you never have to call them customer service gets that much easier. But inevitably patients are going to, I believe personally that software can alleviate a lot of customer concerns. As we look to the future we look at putting tech support in the app to whereby I'll give you an example if your sensor poops out at eight days, it says Hey, your sensor quantitate days hit yes and we'll send you a new one. We're looking at things like this to make it much easier for our patients to work with us. We We purposely went offshore to set up a customer service center because quite frankly, we could not hire enough resources here to Do so that is going better as well on the distribution channel and make it simpler. We're going to the drugstore with future products and moving g six there. So there's not as much interaction as well. But I can tell you the customer service piece is every bit as hard if not harder than the technology piece. And we take it that seriously and we will over the next several years.
Stacey Simms 35:18
Seven, thank you so much for spending some time with me. I apologize to your people because I kept you too long. But I always appreciate talking with you.
Kevin Sayer 35:25
Thank you very much.
Unknown Speaker 35:32
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 35:38
I couldn't get to everybody's questions from the Facebook group. I apologize for that. But as you heard, we ran out of time he was doing back to back to back interviews. I don't know who was next in the queue. I'm sorry. I did make him a couple of minutes late. But just a couple of quick thoughts on on my talk with Kevin they're listening back and I do listen back to almost every interview before we air it. I sounded so offended about the text messages. Do not like that I don't know about you. I want text messages to be from my family, friends and emergencies. I'll take text messages from school, and maybe some alerts. But I want my apps to notify me through the app. And I want to be able to opt in and out of that. I know a lot of people disagree. You know, if you listen to the show for a long time, we don't use share and follow like a lot of parents, I have never let any school personnel follow my kid. We do not see the need, but that is us. So you know, I understand Dexcom has to do its market research and make everybody as happy as they can.
The other thing that occurred to me is that when he talked about going direct to watch, and not announcing it, right, waiting till all the transmitters are out there and then announcing it. My first thought was and so many of us who listen are part of the DIY community. I don't know what you do or how you do it. But the first thing that occurred to me was it's going to take five minutes for these DIY folks to figure out that different transmitters are out there. So I'm relying on you to let us all know because I have a feeling As soon as they start shipping whenever that is and he didn't indicate when, you know, I mean really how long it's going to take people to notice that it's direct to watch because I know there are people out there who every time they get a new transmitter their check
up next, tell me something good with one of my favorite past guests, Sierra Santa said, we will tell you what she is up to now she was in the Miss America Pageant just a few years back. But first, as I mentioned, Diabetes Connections is brought to you by Dexcom. And here's what I have to say about Basal IQ. Now, you know, we switched over to control IQ. But the first iteration of this the first software was basal IQ, the Dexcom g six tandem pumps software program. And when we got it, we started doing less work for better results. Should I say that again? less work, better results with diabetes. Vinny always liked seeing his CGM on his pump. But you know, before this change that was really just kind of a cool feature. I mean, he really didn't pull this pump out just to check a CGM. He looked at his phone, but there was some serious sauce and the basal IQ that kept many more steady. His timing range increased significantly when we started on basal IQ. And his agency, you know, we don't share specific numbers, but not only did it come down, it stayed down. It has been the same, really for more than a year. Now, as I think about it, it's just been great. Of course, individual results may vary. To learn more, just go to diabetes, connections dot com and click on the Dexcom logo.
Right, tell me something good. Really My favorite part of every show. Send me your good news stories for those of you not familiar with Sierra Sandison, and I think most of you probably are, she was in the Miss America Pageant in 2014. I had to look that up because I can't believe it's it's been that long already. But she went on stage first in the Miss Idaho pageant in July of 2014, with her insulin pump, clipped to her bikini bottom, you know, when they had the swimwear competition, and then she created the hashtag Show me your pump, which went viral. And I didn't know this till recently, it was NPR as most popular online story that year. Well, then she walked the runway again at the Miss America Pageant with the insulin pump again on her bathing suit. And you know, we all went bananas.
Well, since then Sierra has gone back to school. She's at Boise State University. She's at the College of Engineering there. And last week, she won her team. She's on a team for this, she won invent for the planet. This is a competition where engineering teams come up with inventions and solutions to make the world's a better place. So they only had 48 hours to do this. It's a pretty wild competition. I will link up more information about it so you can see exactly what happened there. And I'll put some pictures in the Facebook group too. But it's a team looks like a team of five people and Sierra posted. We slaved away at the 48 hour event for the planet competition this weekend and it paid off. We had so much fun and so little sleep, but then it gets even better. Couple of days later, she was recognized by the Idaho Society of Professional Engineers. As the number one student in her class of mechanical engineers, she writes, I am so humbled and still in shock this week seems too good to be true. Thank you to everyone who helped me get to where I am today. I hope to make you proud and keep wearing pink while doing it.
Every time I talked to Sierra, you know, it's easy to forget that she is brilliant, right? We look at the bathing suit, which is how most of us first saw her and we're distracted by that. I mean, I'll be honest with you. When I look at Sierra, I'm always thinking about how bad my hair looks because she always looks gorgeous. Her hair looks great. Her makeup looks great. I have joked with her about setting her up to do a clinic for moms at like a friends for life conference that because we all need to walk around with a ton of makeup. I don't know she doesn't all the time either. Just because it's fun, right? It would be kind of fun to learn how to do pageant makeup like that. I'm getting way off topic, but it's So easy to forget when a woman is beautiful that she is also brilliant. And I think that that is so important to keep in mind. And I'm so thrilled that she is so far forward in sharing all of these accomplishments and not compromising what she enjoys, which seems to be engineering and wearing pink and looking fabulous. So Sierra, thanks for continuing to include us in your journey. I cannot wait to see what you do next. Just let us know when you're taking over the world who would appreciate a little bit of a heads up
if you have a Tell me something good. Please send it my way. You can email it to me Stacy at Diabetes Connections. com reach out through social media the Facebook group is a really easy way to do it every once in a while I'll post and ask and other Facebook groups but please seek me out I would love to hear from you. Help me spread the Good News in our community.
As this episode goes live, it is the last week of February I don't know January dragged by February flew by I'm afraid to The page to March that we have a lot going on. I have three appearances for the book tour. I'm going to be in Wilmington, North Carolina, Winston Salem, North Carolina, and then over to Indianapolis, for the friends for life conference there. I am getting requests for the fall already definitely booking things in September. I think I have something in December already. So if you'd like me to come speak to your group, reach out. I'm trying not to do too many of these a month. I'm trying not to travel every single weekend because I still do have Benny at home even though my daughter's in college. So it's a lot of balancing juggling going on, but I'm loving every minute of it. Our next episode is coming up on Thursday, I'm going to be talking about a little bit of a Twitter kerfuffle. I don't know if any of you saw this if you're on Twitter, but there was a bit of a disagreement started by an eye doctor, a disagreement between how many doctors see their duty to give patients a wake up call and how people with diabetes actually view that wake up call and a real big gulf between these two groups on this One Twitter chat, unfortunately. So I want to share that with you and maybe how we can get our doctors to listen a little bit more. Alright. Alright, thanks as always to my editor john Kenneth from audio editing solutions. Thank you so much for listening. Joining me, please spread the word about this show. Word of mouth is the best way to grow a show like this. We can get more good information into the hands of people who really need it. So post it on your Facebook page, tell a friend who's touched by diabetes about it. I'd really appreciate it. I'm Stacey Simms. I'll see you back here on Thursday.
Unknown Speaker 43:37
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All rounds avenged
Transcribed by https://otter.ai
Watch your language! That's what Stacey is trying to tell herself this week. When you're a parent of a child with a chronic condition, it's hard not to say things like "our diabetes" and "our CGM graph." But it's not "ours" exactly, so how do we better talk about this?
Check out Stacey's new book: The World's Worst Diabetes Mom!
Stacey also shares her frustration as she finds herself falling into the trap of perfect numbers and trends. While her and Benny's experience with Control IQ has been wonderful so far, it's also bringing back some of that perfection trap she thought she'd left behind.
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription
Stacey Simms 0:00
This episode of Diabetes Connections is brought to you by the World's Worst Diabetes Mom: Real Life Stories of Parenting a Child With Type 1 Diabetes. Available as a paperback eBook and audiobook. Learn more at Amazon or diabetes dash connections.com.
Announcer 0:15
This is diabetes connections with Stacey Sims.
Stacey Simms 0:26
Welcome to another week of the show. I am so glad to have you here! This is one of our minisodes the shorter episodes that have become sort of the editorial page. If you look at the podcast as a newscast, as I often do. That's my background. I'm a broadcaster local radio and television for many, many years before I started the podcast. So the Tuesday episodes which runs longer and usually have an interview with a newsmaker. That's the news. And then these episodes have kind of become the editorial. And this week, instead of the headline stop doing this or think about before you do that, which I've been Doing a lot lately. I'm going to talk about why I think what I'm doing is wrong. And maybe you could help me with that. I know I'm not alone. But I'm going to tell you straight up here. I don't really have the answer for what I'm going to talk about today. And this is really about parents. But I'm hoping that if you're an adult with type one, you will listen to this as well. Maybe it'll sound familiar to you, maybe your experience can help us.
So this is all about my struggle, to, in a nutshell, stop thinking about it as my diabetes. It's not I know this in my brain. My son has type one diabetes, he was diagnosed right before he was two. We have been living with this for 13 years. And sure, my family is affected by diabetes. My family has to deal with diabetes, but my son HAS diabetes. And I'm kind of exaggerating, but you'll get a better idea in a minute why I'm saying it in such strong terms, because I know this is not helpful. So I'm going to tell you a story. This story happened in December, a couple of weeks before we got control IQ, the new hybrid closed loop system from Tandem. It does tie in, I'm going to tell you about our experience with control IQ, and then how it relates to all of this.
If you've seen me talk or you read the book, you know that I'm really fighting against this pressure for perfection. And I think and it makes me laugh that a lot of people like I was just in Raleigh this past weekend talking to parents about this. A lot of people think that I now have this down pat that I know, that I that I am perfect at not being perfect. And I think what's really funny is, it never ends, right. There's no finish line to parenting, where you're like, Whoa, great job. I'm, I'm all set. right good for me. I did it. I mean, there are big milestones, like college and when your kid moves out permanently, but I really don't think that there's a point at which we can say, that's it. So we're all trying to improve. And I think this story will highlight really just What a dingaling I can be sometimes, because this stuff isn't easy, right? And we're always trying to improve. So let me tell you the story, and then you tell me how to improve.
Alright, so this happened, as I said, in early December, so almost two months ago now, Benny was right in range before bed. He was hovering right around 125. And for the last few weeks before this, he'd been dropping about 15 to 20 points overnight. That was it. Right? Just a little drop and then steady. So that was a fine number to just leave alone. But he texted me because this is how we communicate in my house, even if we're in different rooms. Right across the hall. He texted me a few minutes before I was gonna go in and turn out his light. And he texted me I feel really low. In my head looking at the dexcom I said, You're not low. You're 125 I don't want to treat that. You're going to mess up our great trend. And you're just going to go high. You're going to mess up our great numbers. I didn't say that out loud.
I went into his room and this is what I said. I said, “Really? Because Dexcom says 125. You feel low?” And he said, “I feel like I'm dropping. See now I'm 117.”
Even without the Dexcom number moving down a smidge. I knew my hesitation was selfish and misguided. Alright, it was dumb. He's not foolproof, but Benny knows his body. He has been living with diabetes for 13 years. And he felt low. And in my head, I'm like, “Stacey, come on. These are his numbers.” Did you hear me earlier when I said, you're gonna mess up our great numbers? I mean, I, it hurts me to admit that. But it's his number. It's not mine. It's not ours. So I said, “Okay, I trust you. Let me grab you a drink. Do you think you need more than that?” “Nope, just a juice box should be fine.”
Benny sleeps with an apple juice bottle by his bed. But it's it's a full like 25 or 30 carbs and he didn't need that much. So I grabbed Little can of pineapple juice, and I poured about 12 to 15 carbs, like a juice box, basically, over ice in a highball glass, because sometimes it's just gotta be fun. And in my head, I was kind of feeling guilty, even though I hadn't shared with him. I'm trying to make up for that by the splashy cocktail. So he loved that. And he drank the juice and he went right to bed. Now, I assumed I was going to hear that Dexcom high alarm pretty soon. I mean, I went to bed, but I just figured out right, I guess I just gave him 15 carbs he didn't need but instead, I woke up at 5:50am like I do every day. It showed that he had stayed between 100 and 130 all night long. He had been feeling low, he did need that juice.
While I am thankful that I didn't go into his room and say, “don't mess up our numbers” I didn't say what I was thinking out loud. It bothers me that I thought it at all. I mean, after all this time I do trust Benny with diabetes. I do respect his decisions. And I know that even though he is from perfect, right? He really is safe and happy. So why do I still have those thoughts at all? It's not about the good health outcomes. I mean, that's the first thing we think of as parents, right? We want our kids to be happy and healthy. And I would be lying if I said, Well, it was out of health concern. It was because I wanted to make sure that he felt good, and could sleep well and have a great day at school the next day. That's what I'm supposed to say. But it was about the straight-line graph. It was about wanting, I don't post them, but it was about wanting to not mess up the pattern we were on. I mean, what, would I really rather my son feel crummy and ignore what he has to say to me, showing him I don't trust him. I don't respect him to see that kind of graph. Ah, so how do we get past that?
Not only am I not answering that right now, I'm going to tell you another example of how it's now getting worse. And this is because of control IQ. First, let me say I love this system. tandem is not a sponsor of the podcast. They're not telling me what to say. Not that they ever did. But man, this is an incredible piece of software for us. I am so excited. We've had it as I'm taping the podcast, we've had it for about 10-11 days now. And in the last seven days, Benny's blood sugar has been in range 70% of the time at minimum, I think only for two days. For the most part, he's been in range with less work a lot less work. I don't think in the last seven days he has bolused for a correction, it's only been for food. Now the first couple of days we did have to do a lot of adjusting. And this is very typical. If you are on any kind of hybrid closed loop system and this is includes the DIY systems is my understanding the people I've talked to, you realize right away that most of your pump settings that have worked pretty well for you all this time are wrong. It's just that we are manually compensating for defaults. We're paying attention like we're supposed to, we're checking that Dexcom, we're poking the fingers a million times a day, right? We're really manually using the pump to get the most out of it. And not letting it run on its own. Because it's dumb, right? It's not a smart pump. Most of these pumps, most of the programs that we've had until recently, they're just a dumb brick that gives you insulin when you tell it to.
And when you switch over to the automated systems, you really have to trust and you really have to adjust. Because not only is the insulin duration all for most of us, but your basals are off, your sensitivity factors. I mean, I'm not going to go into too much detail here of all of the changes we had to make. But you do have to take your time with this. In fact, as I'm telling you this, we are still at the very beginning of making the changes here, even with those great outcomes we're seeing. I haven't changed anything in about five days. I've talked to Benny's endo, and we're going to wait another week probably just to kind of let it play out and see what really needs to adjust cuz it gets harder, right? The more in range you are, the less you want to tweak, but I know we can make it even better. But in a nutshell, we had some incredible lows like sustained under 50 lows that we hadn't seen and of course we overtreated for those. And then we had the perfect storm over a weekend of a birthday party that was an overnight party, huge dinner that he completely forgot to bolus for and then tried to make up for half an hour later at a bent canula. So that was high, high, high high for hours and hours and hours, which you know, of course, messed up my control IQ graph. And I am not kidding. Yeah, I know he was high. I know that he said he felt fine, but you know, he didn't feel great. I know that while Yes, his health is my number one concern in my little brain. I'm thinking, well, I want to show our control IQ graph and how great it looks. And I want to be like all those other people I'm seeing with their great results right away and isn't this supposed to be amazing and I want better results. And that's what I was mad about.
You know, I feel like a dummy admitting to this. But I know I'm not alone, because I am seeing a lot of my mom friends. And a lot of people I don't know, on Facebook, who are not necessarily saying it as plainly as I am, but who are definitely struggling. And sure we're struggling with the actual numbers. But I think we're also struggling with the expectations and we're struggling with our kids are old enough to do a lot of this themselves. So we're struggling now. With How do I and I'm doing this to Benny? How do I not helicopter, right? How do I not say to him five or six or seven times a day? Did you bolus? What did you do? What's going on? What do you think? How about this? Did you check? I mean, we don't talk about diabetes all that much in a day to day basis. But with control IQ and wanting to know what's going on with it, and wanting to be able to tweak it and make the adjustments. You have to talk about it. And we're out of practice. So I said to Benny, a couple of days in Look, you're just going to have to be patient with me, you understand why? If I'm driving you crazy, you have to tell me. And if you just want to give me the pump and walk away, so I can see what you did, that's fine too. But we have to find a way that I can see what's going on without driving you bananas, and that you can feel good that I'm still trusting you, I still respect you, I still think that your decisions about your body are ultimately the most important. But I need to help you with control IQ. Because at 15, and everybody may be different. But my kid is not old enough to really go through this and troubleshoot. And he's not interested. I mean, he didn't even really want to watch the training. He wants me to tell him about it. And that's fine for us, because we've talked about it now and I feel a little bit better about it.
But and I'll share another embarrassing thing. I just said that, you know, the last seven days, boy, he's been in range to 80% of the time. Well, today he's kind of struggling as I'm recording this. I'm not exactly sure what's going on. But he got to school and he went over 200 He probably ate some thing, right? I mean, it's not it. You don't have to be a genius to figure this out. And then he went back down. And in my head, I'm like, should I text him? No. Should I find out? What's going? No, you should leave them alone, Stacey, which I did. But I'm also thinking, Oh, I really hope that we're in range. But in my head, I'm thinking, Oh, I really hope we're in range more, because I don't want that 80%. It's messed up. I mean, come on. Oh, this stuff is not easy. I think acknowledging that It's troublesome to think this way, is important. I think acknowledging that I'm still going to think this way, is important. I'm trying to work it through and change it. Thank you for being my therapy on the show this week. Maybe I'm yours as well. If you have similar thoughts. I'm not really sure how to get past it, other than to acknowledge it and talk it out and laugh at it a little bit. Do you have a better idea? Do you have a way that all of us who are thinking about these lines And graphs as ours, and I'm not talking about younger kids, it's so different when your kid is two, or four or seven, or even nine. But once they're in middle school, you know, this transition, to independence, their own care for them to think about it, to take ownership of it, to know that you trust and respect to them. Even if you're questioning, I trust and respect my husband doesn't mean I don't ask him questions, right? It's a difficult transition. But it's such an important one, because soon enough, he's going to be in college and independent, and he's going to be out on his own independent, if I'm lucky. So I do think it's worth discussing, even if it's a little embarrassing.
And I was at a JDRF conference this past week that I mentioned in Raleigh, and I brought this up, I was with three adults with type one. And I mentioned I was going to call myself out on the podcast this week because of my graph thinking about it as my numbers. And their reactions were really interesting. They didn't tell me I was a terrible person. They didn't tell me I was a helicopter mom. They just said yeah, it's Gotta be tough. It's got to be hard. But it's really important to know those are not your number. It's not your diabetes. I think something else that's important to keep in mind is, this is so new, right? These closed loop systems are so new, there really isn't even a good instruction manual for how to know what your pumps settings should be adjusted to 10 history, the great job with the training, I think endocrinology practices are doing a great job with helping people but let's face it, most of us are getting advice on how to adjust this stuff from Facebook, which is not the best place ever, because I'm seeing a lot of people had a lot of highs, we had a lot of lows, the advice there is not going to be comparable, right?
So I'm going to give myself some grace. I'm going to give myself some patience. And I'm going to hope that I get better at this, that I continue to see the humor in this that hopefully Benny continues to see some of the humor in this and that I can continue to watch my language. I don't mean keep it PG. I mean to watch my language so that I am not saying my, when it comes to graphs, or diabetes, or more importantly, maybe most importantly, about how Benny feels, right? Isn't that the most important thing? I can see that number, but it's really about how he feels, how he wants to react at 15 years old, it is well, to the time to let him do that. So I hope I can continue to work toward those goals. Well, now you know why I am the world's worst diabetes mom. I really hope that if you get a chance to check the book out, you let me know what you think about that as well. It is available as an audio copy and you can get that for free. There's lots of opportunities there. I will link up all this stuff on the episode homepage. There's also a transcript of every episode beginning this year, and that's very popular now. So I'm hoping to go back soon and transcribe more of the episodes. We have almost 300 of them now. Holy cow back next week with our full Interview episodes. In fact, next week more McCarthy is back, ask the de moms is back. And we're gonna be talking about a variety of things, answering your questions, including talking about driving, because Benny just got his promise. And yeah, we're trying to figure all of that out as well. Oh my gosh, this stuff never stops. So I will see you back here for that on Tuesday. And in the meantime, be kind to yourself.
Benny 16:27
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All rounds avenged.
Transcribed by https://otter.ai
Choosing your diabetes technology can be complicated. Wouldn’t it be nice if there was sort of a Consumer Reports for pumps and CGMs? We found out about Diabetes Wise from people who know it’s about more than the hardware.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Stacey talks with Dr. Korey Hood who lives with type 1 and is with Stanford University as well as Laurel Koester, with the Helmsley Charitable Trust. Together, these two groups created Diabetes Wise. Stacey, Korey & Laurel talk about how it works and why it’s needed.
Stacey spoke to Korey on a previous episode about diabetes gear and mental health. Find that episode homepage here.
Join the Diabetes Connections Facebook Group!
In Tell Me Something Good – the greatest game of Marco Polo every played.. and Stacey finds her diabetes doppleganger.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode transcription (it's a rough transcript, please excuse grammar, spelling & punctuation)
Stacey Simms 0:00
Diabetes Connections is brought to you by one drop treated for people with diabetes by people who have diabetes, and by dexcom, take control of your diabetes and live life to the fullest with dexcom.
Announcer 0:17
This is Diabetes Connections with Stacey Sims.
Stacey Simms 0:23
This week, choosing your diabetes technology can be complicated. Wouldn't it be nice if there was sort of a Consumer Reports for pump and CGMs? Enter DiabetesWise from people who know it's about more than the hardware,
Korey Hood 0:38
there's the physical side to wearing it, then there's this mental burden that is related to having to pay attention to it and to think about what's going on. And then there's also the social side that is the distractions and the potential workaround. So you have to come up with in these various settings, whether it's school work, family relationships,
Stacey Simms 0:56
that's Korey Hood, who lives with type one. He's part of the Team at Stanford who along with the healthy trust created DiabetesWise, we'll talk about what it is how it works and why it is needed. In Tell me something good, the greatest game of Marco Polo ever played, and I find my diabetes doppelganger. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I'm your host Stacey Simms. So glad to have you along. And I'm really excited about what we're talking about today. Because I don't know about you. But when we went to pick out our pump for Benny, and I'll tell the story during the interview, it was just overwhelming. And while our educator was fantastic, I really wish we'd had just something to kind of compare and contrast the different types of tech like now exists with DiabetesWise. So we'll get to that and the interview in just a couple of minutes.
But you know, I get so many great things emails and messages and I'm so terrible at reading reviews and sharing this stuff with you. You know, there's all sorts of techniques and strategies for getting people to share more reviews and email you more in blah blah blah. I'm just terrible at that. But I have to share this one with you. Because it was like getting a message, like a message in a bottle from a time machine. So here's what happened. Casey messaged me. “Hi, Stacey. I'm sure you get messages like this one all day every day, but I couldn't resist reaching out. I wanted to reach out and tell you how you impacted my world for the better. My son was diagnosed with type one on the 21st of November of 2019. We are soaking in all the new information, trying to get sleep keep up with our jobs, all while trying to keep our regular life intact. I came across your podcast and more specifically, the episode titled all about babies and toddlers with Type One Diabetes. I immediately thought finally a podcast discussing everything we have been dealing with lately. Plus, it's run by a type one mom – score! and Anyway, long story short, she writes, I listened to it and learned a lot.”
“But that's not why I'm messaging you. I am messaging you because my son's name is Benny. And he was diagnosed just six weeks before his second birthday. His sister is four. If that wasn't enough similarities for you, we are also from Charlotte. They live in Charleston. Now, I know this might not mean that much to you. But for me listening to your podcast, shifted my world, listening to your story somehow made me feel not so alone. All I can say is thank you. Thank you for telling your story and putting your life out there for the world to see.”
It took me a minute, I had to reread it to be honest with you. Because if you're not familiar with our story, my son, Benny, was diagnosed right before he turned two his older sister had just turned five. So it's a very similar story. I mean, they have used to live in Charlotte. It was just this feeling of kinship. Yep, I'm not sure I we're still talking. I'm kind of working out the emotions, because it is kind of like looking at a time machine. And I'm so grateful for the people that were there for us when Benny was diagnosed, and the blogs I read and the people that I talked to. So to be that for somebody else now is really remarkable. So Casey, thank you so much for reaching out. Definitely. Let's keep in touch, our Benny's. Maybe we'll meet at some point, how much fun would that be? I mean, we go to Charleston every summer. That's where we go to the beach. So I'm really hoping to follow up on this because man, those connections are really what it's all about. For me, it sounds really hokey, but if you've listened to the show for any length of time or met me, I think you'll say that that's the truth.
Alright, so DiabetesWise coming up in just a moment. But first, Diabetes Connections is brought to you by One Drop and it is so nice to find a diabetes product that not only does what you need, but also fits in perfectly with your life. One Drop is that it's the slickest looking at most modern meter My family has ever used. It's not just about the modern meter setup. You can also send your readings to the mobile app automatically and review your data anytime, instantly share blood glucose reports with your healthcare team. It also works with your Dexcom Fitbit or your Apple Watch. Not to mention they're awesome test strips subscription plans, pick as many test strips as you need and they'll deliver them to your door. One Drop diabetes care delivered, learn more, go to diabetes, connections dot com and click on the One Drop logo.
My guests this week are Korey hood PhD professor of pediatrics and of Psychiatry and Behavioral Sciences at the Stanford School of Medicine. We did a great episode a while back about the mental burden of wearing devices. With Korey It was really eye opening for me and I will link that up on the episode homepage. And we're also talking to Laura Kester T1D program officer at the Helmsley trust. I should note, we taped this interview a few weeks ago. So when they Talk about things added to the website. Some are already there. And starting this year, all of our episodes are transcribed on the homepage. Have you checked that out, you can go right to the episode homepage on diabetes, connections. com, scroll down just a little bit. And the whole episode transcript is there so you can read the episode, if you prefer. love to know if you're doing that. So let me know what you think. Here is my interview with Korey and Laurel. And I start out by asking Korey, what is DiabetesWise?
Korey Hood 6:30
Well, thanks again, Stacey for having us on. And we're always happy to talk about diabetes life. So this is a website that we collaboratively worked on. So I'm a psychologist and clinical researcher and one of the things that we've noticed in practice and and also in research is that people are not always aware of the different device options they have and I'm not always aware of the different technologies available to them for managing Diabetes. And so we wanted to create a resource that was unattached to device manufacturers to companies that hopefully is unbiased and and can be free and people can go there and compare different devices and understand a little bit about what other people who are using those devices have, you know, thoughts on it. And so, we've been doing some collaborative work with the Helmsley Charitable Trust for four or five years on understanding some of these device and psychological factors related to device use. And so we have support from them and have been working on this for much of the past year and a half.
Stacey Simms 7:45
Laurel, let me ask you, I remember years ago now, looking for the insulin pump for my son who was two at the time and it just seemed overwhelming what was out there. I had no idea how to make a decision. What would I find at DiabetesWise how would this have helped me?
Laurel Koester 8:03
Sure. So one thing I think is really critical about DiabetesWise and makes what makes it so different from what's out there is the use of personal stories from real people living with diabetes. So, you know, our ultimate goal at the trust is to help people be aware of all their technology options that are out there, and kind of get the inside story and real talk from other living with type one about their experiences, trying, maybe stopping, maybe trying, again, different types of technology. And we found through some market research that we've done is people really you know, they're kind of two groups of people. There's a group of people that you really trust their doctor above everyone else. Then there's other folks that really look to online information sources. Know, like a DiabetesWise, like beyond type one. But there was nothing really focused specifically on technology. And what is really great about DiabetesWise is that it has a short questionnaire at the beginning that basically serves as an algorithm to help see where people are when they come into the site, and then provide suggestions on what device is right for them through the use of the personal story.
Stacey Simms 9:40
And we're like, I definitely want to talk more about the homestay trust and why it got involved here. I mean, so much for people with diabetes, but Korey, okay, so you've and I've talked before about the mental load people with diabetes carry when we carry when one of these devices is attached. Right and how we kind of don't think about that. I mean, it never occurred. occurred to me when he was two and a half we put the Animas 2020 on him, it never occurred to me to think well, What's this doing mentally to my child? You know, as a teen, it's kind of easier to see. But can you talk about that a little bit about how it's beyond? I mean, they all work really well. There's not a bad insulin pump out there.
Korey Hood 10:19
Yeah, absolutely. I think that, and what you just mentioned, I think is a great a great example of why we have to think about this at different stages. And, you know, for somebody who's, like your son diagnosed the two, and then the family is adjusting and I mean, the burden around the mental burden around diabetes management at that point, even devices are not as really on the parent and so the it's really just a physical side that's on the child, but as they develop and then you know, as you know, many of the people with diabetes using these devices are adults that there's a I think there's a couple different parts of Did that sit in the psychological impact and one of them that we noticed a lot, especially in the teen years, there is the social side. And so what kind of attention is drawn to the person based on wearing these devices and having alerts, alarms, having, you know, disruptions and various things that they're doing. And so I think that the there's the physical side to wearing it, then there's this mental burden that is, is related to having to pay attention to it and to think about what's going on. And then there's also the social side that is, you know, the distractions and the potential workaround, so you have to come up with in in these various settings, whether it's school work, family relationships. And so I think that there's a, there's a lot to think about, that we often I think, especially in the clinical care side, we forget that as soon as people leave the clinic, this is what they deal with.
Stacey Simms 11:56
Just this quiz, well this take me through which pumps beeps Am I going to actually listen to which CGM sensor alarm? Well I respond to I mean, I'm kind of joking. But you know, alarm fatigue and things like that. Are things that really happen. Are those kinds of things taken into account when you're trying to figure out what to choose?
Korey Hood 12:17
Oh, absolutely. I think that you know, one of the things that we wanted to do, and I think that this is best illustrated with our CGM comparison tool, which we did a lot of collaborative work with Laurel and her team to make sure that we got it right. And one of the things that we have there, you know, people can compare the sensors compare the different devices on whether or not it provides, you know, you have to do calibrations, you have to do finger six, but you also know the kind of alerts whether they're customizable or not. Because, I mean, as you know, as you just stated in all the user testing that we did, that is a big concern for People are these alarms and alerts and and what are the ways that we can at least notify people of them and what it's going to be like that also, in our, in our stories, people talk about that. And they talk about it being disruptive at different times and some of the little tricks that they found to actually help those situations. And so we try to, you know, it's just, you know, essentially just real talk about what it's like to use these different devices.
Stacey Simms 13:27
Also, Korey mentioned your team and some of the research that you did you had done. Can you talk about that a little bit?
Laurel Koester 13:33
Yes, absolutely. So I think just want to take a step back is, you know, we know the technology works, but how do we get more people to be aware of them, and not only aware, but to then use them and found them. And so we know that there are a lot of different factors that kind of play into the space around technology adoption, you know, there's a lot of barriers, but also facilitators out there. And so we really wanted to hone in on, you know, we know their system level barriers, like insurance coverage. So our idea was, let's go directly to people living with diabetes and, you know, just understand their awareness around different technologies. And some of the market research we did was specific to CGM, but we thought, hey, if there are the system level barriers, and we also know that, you know, maybe not all providers actually know about these diabetes technology, you know, especially if you're talking about primary care providers. And, you know, given the number of people living with Type One Diabetes, but also type two in the number of endocrinologist in the US there’s just not enough to meet demand. There are a lot of people that are seeing in the primary care sphere. primary care providers just, you know, don't have the bandwidth. So some of the market research we did was to, you know, we wanted to learn about information sources that people trusted. And the the two main points that I alluded to earlier was, there was a group of people that really trust a variety of information sources, ranging from their doctor to diabetes bloggers, to online community groups, and then there's another group that overwhelmingly trust their doctor. So for us, this told us that we need different approaches to raising awareness about diabetes technologies, one being through patient facing resources, like diabetes lives, but I think part of our larger vision is to also we understand now from this research that we also need to involve healthcare provider. Ultimately, the truck vision is to increase the use of diabetes technologies for people living with diabetes and others who are on intensive insulin therapy because it really is a an effective tool to help improve management.
Stacey Simms 16:22
Cory I'm curious as somebody who lives with type one, and I assume I shouldn't assume, but I was gonna say I assume who wears devices? Do you use a CGM or a pump?
Korey Hood 16:33
I do. Okay, yeah. So you probably too many of them.
Stacey Simms 16:36
Wait a minute. So tell us how many are you wearing at the moment?
Korey Hood 16:40
Oh, no, I'm just, I'm just exaggerating. I've tried I think everything that's on there.
Stacey Simms 16:45
That leads to my question, which is, do you mind sharing separate from DiabetesWise? How did you choose? And you can mention brand names if you want to, but I'm curious how you go about before there was a resources like resource like this. How you You went about choosing what devices you would at least try and then wound up with?
Korey Hood 17:05
Yeah, I think it's a great question. And I think it's something that
there's there's probably a few themes about how everybody arrives at this place about devices. And I'll tell you mine, but I think that it's there are not that many different routes to people getting on devices. And so for me, I mean, I it was fairly straightforward. This is when you know, back in, this was 10 years plus now when the first CGM came out on the market, and my insurance would pay for it, that was what made me kind of intrigued about it. You know, I heard a I was I've been working in the diabetes space, so I knew that it was coming and and so I wanted to try it because I could, but if I had to pay for that out of pocket, I probably wouldn't have paid for it. I probably wouldn't have done it at that time. So it was it was accessible to me, which was, you know, an important part. And then also, you know, I was
I liked the idea of something that gave me a continuous, you know, feed of what was going on with my glucose because I knew from finger sticks and we still know most people are still using finger sticks that there's you miss a lot of the peaks and valleys with those kind of intermittent glucose readings and so for me that was appealing because then I could maybe catch a low I could. And so I just for the management purpose, I think that I was really drawn to it from the pump side. You know, I've been, you know, you've mentioned the Animas earlier and, and I that was my first pump and I use it for a long time and I still have it in my you know, diabetes Museum of devices at home. But I I, for that it was it was just because of provider said you should try this. I didn't know really a lot about it. You know, I was 1819 years ago and I thought you know, I'll try this and and so I think what I can tell you though now I currently use the Omnipod with the Dexcom g six within the loop system. And so my movement to the occupied was was just because it was working with that system and I was I wanted to give it a try to have to blitz and, and for me and my lifestyle and my you know, when I do physical activity, it's just so much better and so so they do have too long of an answer to your question, but I think it's evolved over time about why I've used devices and I've been drawn to ones more recently that are smaller that don't have to be in and that that make it a little bit easier to do the things I like to do you know, outside of work and family.
Stacey Simms 19:59
Our experience was, was not exactly similar and choosing an insulin pump in that we were given a lot of choices. And at the time, back in 2006, there were actually more pumps on the market, which is kind of sad to think about. And we chose the Animas 2020. Because I felt like of all of the devices that I was shown, it kind of seemed the easiest. I said to my educator, I really said, I need devices, including pump insets. And everything else. I need the the Venn diagram of idiot proof, and does really good does what it's supposed to do with diabetes, because I really was so overwhelmed. And that's what we wound up with. And as Benny got older, and you know, every four years you're changing and making decisions. We stayed with a two pump. We now use the tandem. One of the reasons we stayed with it is because my son is very responsible, great kid does well loses everything. And we felt the Omnipod PDM would be gone in about 30 seconds, but I'm curious. So when you go through the quiz Your pump and sensor and that kind of thing. What kind of questions are you asking? I mean, I should have taken the quiz before I talked to you, sorry. But I'm wondering like, do you want everything attached to your body? So you don't lose it? If that's one of your questions, or if that's, and I'm laughing, but you know, you understand I'm saying that's one of the No, absolutely, yeah, form factor or your lifestyle factor?
Korey Hood 21:22
Absolutely. And I think you raised a really good point about that. The systems that that work well, and are easy to use, have been designed with the person in mind. They've been designed to be, you know, to have the form factor, like you mentioned, but the user experience is something that is positive. And I don't think that all of them are designed and created equally, in that in that sphere. And so I think that, this really great examples of that, and I would say that the tandem is one of those that has You know, and using use an interface that especially for anybody who's been diagnosed in the last few years, you know, that's that's what they're used to in terms of touchscreen. And so with that said, it's a good question about the quiz and one of the things that we did just quickly give you a little bit of history of it. So, in our we did a lot of work serving over 1500 adults with type one 700 adolescents, 700 parents of kids with with type one, to really understand what are the main questions that we need to ask people so that we can put them on the right path toward, you know, an experience where they become more aware about devices and then also maybe matches better to what their lifestyle is. And so we were able to take hundreds of questions and and derive a quiz that have five questions in it. And a part of those questions is about the level of distress and burden that they perceive about that. BTS because we found that that's a really critical factor in making sure that people get the right kind of information about using devices. But we also ask them what their priorities are, what are their concerns? And what are their main ones. And although we don't specifically phrase it, the way that you mentioned, it is that we, we get it, we get at a number of different priorities that people have. And then that starts them on this path. And then because of the way that it's framed, and as Laurel said, around the algorithm, that it will then take people to, based on their responses that will take them to individual stories of others who have those same concerns or same priorities. But then when it one of the parts that's not live on the website, yet, is a device readiness tour device Finder. And so in there, you can drill down a lot more deeply about what your priorities are, and so For example, if someone really wants it to be discreet, if someone wants it really ease of use ease of use as one of the ones that we have in there as a priority, if someone really wants to avoid fingerstick there's all of this that you can tailor the advice or the recommendations that you're going to get based on what your priorities are. So that's great for people who have some idea of what it is, but it's also great for people who are just trying to get a sense of I'm not even sure what my priority is. I'm not even sure what I want out of this so you can learn about it as well in the process.
Stacey Simms 24:34
Alright, so I'm looking at the website, and I know that as you said, more is coming. But it does say there's stuff about pump and smart pump. There were only three pumps in the US as far as I know right now. Which ones are the smart pumps? to dump I'm sorry.
Korey Hood 24:50
Right? Exactly. I there was something funny there that I couldn't quite come up with but I do agree with you that it what we found and said this is Why is it so important to ask people and involve them in in user testing and development? One of the things we found were that people really wanted to distinguish between something you just put on your body that administers insulin that doesn't make doesn't have any kind of alteration or it doesn't change what it's doing based on anything else. And so, you program a pump and they're, they're, you know, they're sophisticated for, say, 1995. They haven't evolved a lot. But they, they still do a great job and are reliable and precise. With what's what we wanted to distinguish is this idea that a pumpkin do something like low low glucose suspend or can be part of a larger closed loop system. And so the smart pump idea really came from what we heard from people and although it's not a, you know, an FDA category of devices, we really heard from people that they wanted to that distinguish between kind of the traditional way that you would pump versus something that has the capability to be within a closed system or to have low glucose suspend. So that was really the distinction there.
Stacey Simms 26:11
Got it. So in other words, if you use an Omnipod on its own, that's a pump. But if you use an Omnipod as part of the non FDA approved loop with a Riley link, now you have a smart pump.
Unknown Speaker 26:26
Exactly. Okay.
Unknown Speaker 26:27
Let me ask you. We talked
Stacey Simms 26:29
about this at the very beginning that one of the things that makes DiabetesWise unique and very, very helpful is that it is not put out by a company with a stake in what device people
Unknown Speaker 26:41
choose. The
Stacey Simms 26:44
Helmsley charitable trust I think many people are familiar with is so much of what it has done for diabetes research and funding and grants. And we've talked to some folks from the homestay family on the show in the past. What was the purpose here? You know why did Helmsley want to get into involved, it seems really obvious, because you're helping people. But I just wanted to ask you about the involvement here.
Laurel Koester 27:08
Yeah, absolutely. Well, I think they see the point that you raised about the the fact that we are an independent entity really speaks to kind of the trust factor not only in you know, what Helmsley because we don't have a financial stake in this. But we're also partnering with some of the leading diabetes researchers in the field at Stanford University. So we really want to ensure that that we're supporting information that is unbranded and unbiased and that people can trust. And I think, again, to underscore that this website is really informed by People living with diabetes is their voices. And, you know, for example, one of the tools that Korey mentioned of this device readiness tool, some of the research that's going into that is, you know, from a sample of people with diabetes, so when people see, you know, different priorities and, you know, writing, as you know, kind of just a sneak peek into some of the features that are going to be coming out, those are actually based on input from people living with diabetes, who are using diabetes was for the first time so it's a really unfiltered real deal.
Stacey Simms 28:44
Cory, what's your hope for this? Do you do you hope that like a CDE would say, hey, let's sit down together go through the quiz on DiabetesWise, or is it a question of people just kind of seeking a little bit more, or even people. What I find fantastic about this is that you have empty I'm on here as well, you're not assuming everybody wants an insulin pump, some curious what your hope is going forward?
Korey Hood 29:07
It's a great question. And I think that the ultimately what we want to do is we want to be able to match the device with the person and their lifestyle and their interests and their priorities. And, and I think one way to do that is that we traditionally don't do a lot of in clinical care is to spend more time objectively figuring out what's what's going to be the best fit, because clinics are busy, providers are busy, it's hard to get that dialed down really closely. And so my goal really is to get the right one for the person and so it's not a one size fits all approach. And if people are using multiple daily injections, and using a meter, you know, I could argue most of the time that you know, add a CGM add dilib re add something that will give you a little bit more glucose information to dial it in. So there's Maybe a little bit of room, but if you don't want to move, and you are really happy with it, then maybe there's some other some areas of distress related to diabetes that we've learned about in this process that we can help you with. And so, you know, I, it's, it's really intended to be a resource that can match and fit with anybody's interested in what they want to do around devices. But also, you know, at a minimum, you know, it educates the person about it, it also can be a resource that like you said, CDs could use one of the things that we found really helpful is we went to a D over the summer and in August and Houston and one of the things that we learned and, and talk a lot about with CDs was, you know, how this could be a helpful tool for them. And so that's another thing that's in process is making sure that we have something that is that can be used by them in a in a helpful way so that they can also get people on the right devices. I mean, I think that everybody If you get the right device on somebody, and they use it effectively, everybody, when there's less time and involved in on the clinical side, they're better outcomes. The person's happier. I think that there's just so many reasons that we want to do this. And then the other vision for this is that we keep it completely free, that we keep it disconnected from are not connected, not tethered to any kind of device manufacturers, we need them, they have to be part of this. And they're doing great work. But we don't want to be as Laurel said, we're not you know, we don't want to be biased or branded in any way we want it to be free and an objective tool for people to use.
Stacey Simms 31:43
I'm curious, what do you mean by you need them for this?
Korey Hood 31:48
Well, I mean, I think that we don't necessarily, we don't necessarily need them for DiabetesWise, although, I mean, you could argue that, you know, we wouldn't have DiabetesWise if we didn't have devices, but that's Maybe getting a little
Stacey Simms 32:02
device.
Korey Hood 32:04
Right, exactly. But But I think what I think I'm just noting that we need for I think the person with diabetes, to have the best chance of the best outcomes we need device companies who are pushing the edge and who, who are, you know, are the competition is a healthy competition. And so I think it's good that they all exist and that they do the work. We just don't want them. We don't want people with diabetes to feel like they have to go to a certain device. And so that's why we we created this so that they could have a more
you know, unbiased view of what's available.
Stacey Simms 32:47
I just didn't want to make sure I just wanted to make sure I didn't misunderstand there that you didn't need them. In other words to give permission to recommend or that they had to somehow sign off on DiabetesWise.
Korey Hood 32:58
Right, right. Okay. There we go. We, you know, if if we want to, we want to work with them on this and make sure that we have accurate information. But ultimately, this is driven by us and our team and our collaborations. And so if there's something on there, that isn't that they don't like then or a story that someone bashes their device, and it's still going to be on the website. But it's also that we we appreciate that they've done a lot of work to bring us to this place where we can actually have these discussions and we can actually have options.
Stacey Simms 33:35
Yeah, it's interesting. I mean, I mentioned when Benny was diagnosed, there were more pumps on the market. And while there are fewer now at least the technology is improving. Before I let you go, Cory, could you speak just for a moment about where it's been for you? And you know, where you are looking for to go in the next couple of years?
Korey Hood 33:54
Yeah, you know, I think that I mean, I've been it's a little bit of background I've been using For over, I think two and a half years now and, and I've found a great deal of benefit from it mainly on glucose control, but also in on the mental side and having longer chunks of time throughout the day where I don't think about diabetes, which is really nice. So I, for me, I've been really happy with the progression, it's not perfect, and there are still pieces, you know, multiple pieces you have to wear, we still have to, you know, stab ourselves with sharp pieces of metal. So there are a lot of these things that aren't going to go away and I don't think are going to go away anytime soon. But I do think that the ability to put something on and to not pay much attention to it for a few days is we're close to that. And I think that that's what is really appealing. For me and I think for others that we talked to is that if we do Just continue to decrease the amount of time that people have to think about it, and they feel safe, and feel like it's reliable. And that's really what we're aiming for. And I really do think that that's where we're moving in the next few years.
Stacey Simms 35:12
Laura, let me give you kind of the last word here, you know, what are your hopes for DiabetesWise and how it helps people
Laurel Koester 35:19
just positing said, That's quite a big question. You know, I hope. I think from the homepage standpoint, we want to make the information about diabetes devices and technology is available to everyone living with diabetes, you know, no matter where they live in the US, you know, um, you know, a lot of times just information isn't accessible for people and we want to make sure it's a trusted source of information. And you know, if someone lives in rural America, for example, and they don't have access to support CT groups or an endocrinologist that they can still connect with people like them to learn about the different technologies and devices and experiences of people that are navigating there. They're the same disease.
Stacey Simms 36:18
I'm thrilled that this is available. I really wish it was around when we were choosing our devices, because it was a little bit like throwing darts at a dartboard. Luckily it worked out. Okay. But Korey and Laurel, thank you so much for joining me. I really appreciate your time.
Unknown Speaker 36:38
You're listening to Diabetes Connections with Stacey Sims.
Stacey Simms 36:44
More info about DiabetesWise on the episode homepage and of course, the link is there to go ahead and take the quiz and tool around on their site and see what you think. Up next. What Marco Polo has to do with type one that's in our Tell me something good, but first Diabetes Connections is brought to you by Dexcom. It's hard to think of something that's changed our diabetes management as much as the Dexcom, share and follow apps. The amazing thing to me is how it's helped us talk less about diabetes. That is the wonderful thing about share and follow. As a caregiver, a parent a spouse, you can help the person with diabetes manage in the way that works for your individual situation. Internet connectivity is required to access Dexcom follow separate follow up is required. You can learn more just go to diabetes, connections dot com and click on the Dexcom logo.
It is time for Tell me something good. And this one made me smile when I read it. Oh my goodness. So Rachel shared a story: “We were at Target today and my son's low alert on Dexcom went off and we heard in the distance, ‘T1 I hear you – Marco’ my boy lit up. ‘Yes, you do T1 – Polo!’ and another kid pops up out of breath. And the two of them just chat for a few minutes about Legos or with with everything in common. I melted.”
So how about that? I mean, we've heard some Dexcom alerts or seen somebody checking their blood sugar. And of course, I want to run over. And how are you and what are you doing here? But I don't I try to contain myself. But every once in a while, I'll say something. But I can honestly say it has never occurred to me to yell Marco, and hope to hear back a Polo. Dexcom alert. So kudos to these kids. And Rachel, thanks for letting us know about it. any follow up? You have we would love to find out. I mean, I can see her son doing this again, and maybe they became friends. I don't know. But I thought it was a really cute story. And if you try it, and it works, let me know.
I think the closest we ever came was interestingly enough at a hotel pool speaking of Marco Polo, this years ago, we took a road trip to Chicago. That's a story in and of itself. We took an RV from Charlotte to Chicago. And we did six states and five days to go see Syracuse play in the NCAA Tournament. Anyway, long story short, we did not bring the RV actually into Chicago, it would have been very expensive to do that. So rather than you know, pay a lot and find a place to park it, we parked our RV at my husband's friend's funeral home in Skokie, outside of the city, but that's not what I wanted to tell you about. Um, so we're at the hotel pool. And we look over and there's a little girl with the Dexcom and Omnipod on the backs of her arms. And of course, Benny at that age, was willing to go say hi, be social. So he did and we struck up a whole conversation and they were so nice. It was a lot of fun. Sometimes those diabetes spottings in the wild, really give you more than you'd expect. There. Just something so rewarding and so affirming about knowing you're not the only one, I think as much for parents as for the kids, and someday I'll tell you more about our crazy road trips, we're on a quest as a family to try to hit all 50 states and the kids were so excited about this when they were younger, I think we're on 27 or 28, I'd have to check. And I think I'm the only one who's still excited about trying to do it has to be all four of us together, you have to have feet on the ground, airports do not count. And so feet on the ground, you can't drive through either you have to actually get out and stop and take a picture. You need picture evidence. You don't have to have all four faces in the photo because sometimes people are grumpy and don't want to take pictures. But we need all four of us. So we have one or two pictures where everybody's holding up a cup of coffee or hot chocolate. That one was like at 6am in Ohio on that road trip. I have another one in Las Vegas where we're all holding up gelato, and you can't see our faces. So I'm hoping this summer not to get completely off track to go to New England with the kids because we've got a lot estates a hit up there. Anyway, if you have a Tell me something good story can be a road trip or anything of the kind, whatever works for you. You can send it to me Stacy at Diabetes Connections. com or post it in the Facebook group Diabetes Connections to the group or send it to me on social media, it'll find its way to me, just tell me something good.
Keeping that busy schedule, which I'm actually having so much fun with. I'm going to Raleigh, North Carolina for the JDRF type one nation summit this weekend, doing not only the world's worst diabetes mom presentation, but also my favorite one about making connections in real life Diabetes Connections. I have been doing this talk since before the podcast came about. That's where the podcast got its name. And I'm also talking about social media. So I'm really excited to meet some new people right here in my state. And then in two weeks, I'll be in Maine, for an event in South Portland, Maine dizzy calendar as I head out on the world's worst diabetes. Mom book tour. And if you've got an event later in the year, things are still pretty busy. Definitely through April. But after that, it slows down to about one event a month right now. So if you've got a jdrf summit, if you've got another event, especially in the fall, please let me know. So we can plan for it. I would love to come and meet you. I can do those presentations. We can do a live podcast, we can just hang out and talk. It's always fun to meet new people. And I do love making those in real life connections.
All right, coming up later this week, another mini episode, where I'm taking on what I think is a pretty controversial topic. In fact, when I posted about this on my personal page recently, I was shocked at the response I got. I'm going to be talking about why I think it really is a bad idea to post pictures of your child in the hospital. Yeah, I know a lot of people do this, but it's just not good. So I'll be talking about that coming up on Thursday. In the meantime, thank you as always to my editor john ducatis. audio editing solutions. Thank you so much for listening. I'm Stacey Simms and I'll see you back here on Thursday.
Unknown Speaker 43:12
Diabetes Connections is a production of Stacey Sims media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Using a shot of long-acting insulin along with an insulin pump sounds like a weird idea. But Stacey found when her son's insulin needs went way up around age 11, that it worked incredibly well for them. She explains the method of untethered, which is also sometimes called POLI (Pumping On Long-Acting Insulin), what led them to believe it would work, and why you don't always need to use a ton of insulin to benefit from it.
------
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
-----
Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode transcription (rough transcript, please excuse any grammar, spelling, punctuation errors)
Stacey Simms 0:00
This episode of Diabetes Connections is brought to you by the World's Worst Diabetes Mom, Real life stories of parenting a child with Type One Diabetes available as a paperback eBook and audio book. Learn more at diabetes connections.com
Announcer 0:21
this is diabetes connections with Stacey Simms.
Stacey Simms 0:27
Welcome to an episode of diabetes connections. I'm your host, Stacey Simms, and this is one of the new episodes I've added for this year. Where in addition to the weekly interview shows that are longer. I have started doing these shorter mini episodes where it's just me talking about one topic, hope you're enjoying them. It's been really fun to get the reactions and hear what people want to hear more about. So if you're brand new, just real quick. My son was diagnosed right before he turned two back in 2006 he is now 15 and a freshman in high school taller than me, and recently got his permit to drive like North Carolina. And our young, young permitted drivers are graduated licensing. But that's not what we're talking about today. Just to give you context on how old he is, and you know where we've been, he was diagnosed 13 years ago.
couple of episodes back. I mentioned Tresiba. I was actually talking about a Tell me something good segment on the show, which we do every week. Um, a family was sharing their last night of Lantus because their daughter was going out of pump, and Lantus really burns. So I was talking about Tresiba, which is another newer, long acting insulin as an alternative. And I had a couple of people asked me about that, one through email and a couple online. Don't you use Tresiba, they said, as an untethered method for Benny, and I thought this would be a really good chance to answer that question and talk a little bit more about what's called untethered or POLI. They both kind of mean the same thing. They're a little bit different, but we'll go through them.
I will start out by saying, once again, I am not a medical professional. All of the information I'm giving you here is through my personal experience as a parent of a child with Type One Diabetes. I am not a healthcare provider, please call your endo or your care team to follow up and ask them any questions especially about a topic like this one. But this is the kind of topic I love sharing about because the only reason we tried untethered, which changed my son's life and has just been amazing. Over the last. It's been more than a year now. We started in September of 2018. So the only reason we started it is because another diabetes mom reached out and said, Hey, have you thought about trying this? So Cheryl, thank you very much. I'm just trying to pass along the information here.
So what are we talking about? Well untethered means making use of an insulin pump. pump and taking long acting insulin at the same time, a lot of people use untethered to mean that they only use the pump for boluses. So in other words, all of the basal would be coming from the long acting shot. That's why another term has cropped up which is POLI pumping while on long acting insulin. And that is supposed to mean where you do something a little bit more flexible 50% of Basal from the pump 50% from the long acting, and all of the boluses from the insulin pump, and that's actually what we do, but I still call it untethered. So for the purposes of this podcast untethered is going to refer to any use of an insulin pump with long acting insulin, whether you're doing 20%, long acting 100%, long acting Basal, that sort of thing, just for conversational purposes. I think untethered is an easier way to go. I have been criticized online For calling it untethered, because I guess technically it's not correct, but you know me that has never stopped me before.
Alright, so why would you use it? Right? What this is my question, why would you go through all of the bother that is an insulin pump, right? inserting the inset every three days wearing the pump itself, you know if you've got little kids wearing it in the pouch, or if you've got the Omnipod schlepping the PDM around, you know, why would you do all that and then add a shot of long acting? Well, in my case, I couldn't imagine it until Benny became a teenager because what happened was his insulin needs went up so quickly and went up to numbers I never thought we would see. I didn't know people could take that much insulin and be ok.
And in our case, and this is a layperson opinion, but I stand by it. I think the insets get overloaded. You know when your basal rate is 40 50, 60 or more units a day. Those insets just They don't seem to be able to keep up. We had so many leaks. We had so many issues. And we tried everything. We rotated sites. We tried a longer needle. We tried every two days every one and a half days. But you know, I turned around the insulin would be like leaking down this kid's stomach. And we knew that it just wasn't working. Something wasn't going right. Plus, he has the Tandem tslim X2 which holds 300 units, we had switched from Animas which held 200. I mean, no pump holds exactly about that. It says it was always a little bit less because you have to prime it and blah, blah, blah, if you use a pump, you understand. But with that 300 units, he was still changing out his cartridge so much more often than before. And I knew that something had to give.
And then Cheryl reached out online and said, Hey, I really think you might want to try this. It really might help. So we talked to our endo about it. He recommended Tresiba which was also what Cheryl had recommended which is a newer long acting. And I always laugh because when I talk about Tresiba, I feel like I'm talking about whiskey Right, it's smooth. There's no burn. It's steady. It just doesn't sound like you're talking about insulin. But all those things are true. And it just lasts longer in the body than Lantus or Levimr. And that works really well. For some people, it doesn't work as well. For others. Of course, your diabetes may vary as always. But what's nice about Tresiba is once you hit the steady state, once you've been taking it for three to five days, there's a little bit more flexibility in when you have to take it. In other words, if you take Lantus every day at seven o'clock at night, you really have to take it at seven o'clock at night. There's there's not a lot of wiggle room with it. But of course, it's always better to take it at the same time. But with Tresiba you can miss that dose. We have missed the dose by several hours. And it really has been okay. It just works a little differently in the body and I'll link up more information as to why it's a different makeup. It really does work differently in the body and it's been amazing for us.
So we worked with our endo and CDE to figure out the dosing, because we had to change it gradually over time to get to I believe we started out with 30% basal from Tresiba 70% from the pump, and we gradually moved it up. And now he's 50-50. It really took about three months to find the right dosing because we were hitting moving target, right, we went from 30 to 40 to 50%. And we were changing things all the time. But we saw changes right away. I mean, it was incredible. Once those basal rates in the pump came down, it seemed to work so much more efficiently. I really do believe it was the insets, but even if your insetts are working great, and your basal rate is like 20 a day, you know, if it's different and you're not a teenager, why would you want to try this?
Well, interestingly, the first people I ever heard of doing untethered, were adults. And the reason that they shared with me was, they just had a little bit of trouble, especially at first trusting the insulin pump. You know, think about it. If you've taking shots, your whole life with diabetes. And suddenly you're on an insulin pump. But you know, it's been 10 years or 20 years, it may be difficult to trust it, not just the technology, but you don't see the insulin going in, like you do with shots. So both adults said that they started with untethered, because it was kind of an emotional thing. They wanted to make sure that everything was working, they wanted to kind of ease into the pump. And then one person did that for a couple of months and one person stayed on it. And I have another friend who has really bad anxiety and she found herself worrying. Are my insets working? Do I have a bad cannula, is something's gonna go wrong while I'm sleeping. And her endocrinologist prescribed, untethered to help her with that anxiety and to help her feel better and to know that the insulin is indeed going in. And that's made a huge difference for her too. So there are a lot of reasons why you consider something like this.
But I think the most important thing is to know what's out there to know that this is something that you can do. You don't have to do it forever. You don't have to do it at all. But if you want to try it out, you talk to your endo. And you can do it for a couple of weeks, couple of months. Keep it or not, if it doesn't work for you, nothing ventured, nothing gained. And if it works, it could work amazingly well. Benny hit puberty and oh my gosh, I'm sorry, I don't wanna get too personal on him. But I do want to share this. He hit it like a rocket ship. I mean, it just happened so quickly. It was and he was younger than most kids. And his insulin needs went way up, his numbers went way up, because we really didn't understand what was going on. You know, we were doing everything we felt we were supposed to be doing. I was helping him at the time. So I know it wasn't a question of not bolusing. But whatever we did, you know, once you get high, it's so hard to come back down and that was happening all the time. And in my head I'm thinking, you know, is he eating when I don't know about it, is he not taking insulin, you know what's going on, and it was the basal rates, they just needed to be increased. And once we added Tresiba, and took the load off those insets, his A1C, all his numbers, his time in range, everything went back to pre puberty, even though his insulin needs have gone up, and his teenage hormones are obviously still there.
So he's 15. We just had an endo visit and things are finally beginning it looks like to come back down in terms of insulin use. So I don't know how long will stay on untethered and control IQ coming out is, you know, possibly going to change things for us. But he has said he wants to stay on untethered for at least a month into control IQ, and our endo and our CDE supports that and of course, I do too, so we shall see what happens. But if you're a parent of a teenager, and you're freaking out, because their numbers have started to get really high, and you think, oh, they sneaking food, are they not bolusing, but you know, that doesn't feel right. You just don't think that's really the case of what's happening with your kid and I don't want to talk about sneaking food that's those two words should not be used together. So let's just say eating food without bolusing. That's a different topic for another time for sure. But you You're not sure what's going on with your kid. Do not assume the worst is all I'm saying, do some basal testing, talk to your endo about basal needs. Because if like me, your kid was diagnosed at two. And the first basal rates you ever saw on a pump were 0.025 when they suddenly shoot above needing three full units every hour, it's easy to think this can't be happening. This isn't possible. But it is. And this is just one way to kind of help ease the pressure off the pump. If that's not working the way you and your endo think it should be. It's an alternative to think about that really, really helped us.
It is no fun to take a shot every day. I give Benny so much credit. Although now he rolls his eyes at me. I can't even say like, I'm so proud of you. And he's like, Mom, you're so lame. But you know what I mean, right? It's not me taking the shot. It's not you if you're a parent. So we really have to get our kids on board with this. I'm not above incentives. Try this for a month. You know, here's 25 bucks for Amazon, or whatever works in your family. But I think it's important to at least ask these questions rather than live day in and day out wondering, what are we doing wrong? Feeling like a failure. teen years are tough enough. And I know, you know, using Tresiba isn't gonna solve everything. But I talked to so many parents who just don't realize how high the insulin needs can get. I mean, look, a basal rate of four units an hour. sounds crazy, but it's not that uncommon, using 80 to 100 units a day of basal insulin. It sounds bananas. But for some people, that's what they need. And people who don't have diabetes, their pancreas is are just pushing this insulin out as teens. You have no idea how much insulin your kids’ friends without diabetes is making them his body. They need what they need. So talk to your care team about it. Talk to your kid about it. And if nobody thinks it's a good idea, just remember, I am the world's worst diabetes mom.
Oh, I will would be remiss before I go to not say, while I have sung the praises of Tresiba, like everything else in diabetes land, you're often at the mercy of your insurance company. We were very lucky to find that this was covered. But it is not always it is a much newer, long acting, so you may have to fight for it. definitely make sure your endo is willing to go to bat and help you appeal if need be. If this is something that you really feel strongly about, and they do, too. You don't have to use Tresiba as the long acting to go untethered, it's just what has worked for us, but unfortunately, it is so new that a lot of insurance companies do not cover it yet.
Alright, we are doing these minisodes every Thursday, and every Tuesday, we have our regular length interview shows where I talked to newsmakers, athletes, artists, celebrities, authors, speakers, and everyday people just living with Type One Diabetes. Learn more at diabetes connections.com. You'll also find the episode homepage and links to a lot of what I spoke about here, including studies about untethered and a lot more information so head on over to the website, please be sure to join the Facebook group diabetes connections group. I'm Stacey Simms, and I'll see you back here next week. Until then, be kind to yourself.
Benny 14:19
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai