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.
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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
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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
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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!
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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!
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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.
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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!
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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!
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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!
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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!
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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