There's new help for doctors who want to treat the person with diabetes and not feel overwhelmed with data. The people at DreaMed Diabetes are behind the brains of the Medtronic 780G system, but they're hoping to help thousands of people who may never use an insulin pump by making diabetes data a lot easier for doctors to use. This week, CEO and Founder Eran Atlas explains their Advisor Pro system to Stacey.
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Episode Transcription (beta transcription - computer only)
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke. hypopen, the first premix autoinjector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:23
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:28
This week, there is so much data when it comes to diabetes that even your doctor would like an easier way to interpret numbers and make dosing recommendations. A new first of its kind technology called DreaMed may help
Eran Atlas 0:43
with the use of your system. I can stop being a technician I can learn to being a mathematical or an engineer, I learned how to be a physician and I wanted to continue to go and practice medicine. I don't want to go and practice engineering.
Stacey Simms 0:55
That's DreaMed co founder and CEO Eran Atlas, talking about the reaction he's getting from people who use their system will explain what it's all about and how it could help
in Tell me something good. A big award for a doctor you all may know better as an amazing racer, and I learned the word soccerista.
innovations. Let's talk about women and diabetes tech design.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I'm so glad to have you along. I'm your host, Stacey Simms, we aim to educate and inspire about type 1 diabetes by sharing stories of connection, as well as stories of technology. And that's what I'm talking about this week.
And I went into this episode, I gotta tell you sort of thinking it would be one thing, because I know many of you are very familiar with the technology and these companies. DreaMed is behind the algorithm that's inside the Medtronic 780 G, which was just approved in the US. And we actually are talking to Medtronic and our very next episode about that many other things. But the agreement with Medtronic and DreaMed was it was done several years ago. And DreaMed while I'm sure very proud of that algorithm, they've moved forward, they moved on they want to talk about something else. It was very interesting for me to go through this interview, and I hope you enjoy it as well,
for more of the mundane, less technology and more basic, how much more basic can you get with diabetes and insulin? I'll give a quick update at the very end of the show. I had mentioned in a previous show, we had some insurance changes, a bunch of you wants to know how that was going. Hey, yay, insurance changes are always fun. So I will talk more in detail about that at the end of the show. But in terms of insulin, yeah, we're switching types. Don't you love that? We had been on novolog for many years. And then when Benny was I want to say about eight or nine. We switched insurance and they switched us to human log and we have been on that ever since he's 15 and I guess it's time to go back to no vlog. So I'll talk more about that at the end of the show. Luckily, we don't have any issues or haven't had so far I know a lot of people do. Fingers crossed. So yeah, insurance update and more at the end of the show. All right. Interview with the CEO of DreaMed in just a moment.
But first diabetes Connections is brought to you by One Drop. One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drops glucose meter looks nothing like a medical device you've seen this. It is sleek, compact, seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to One Drop to keep track of the big picture and easily see health trends. And with a One Drop subscription, you get unlimited test strips and lancets delivered right to your door. Every One Drop plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doctor visit your personal coach is always there to help go to Diabetes connections.com and click on the One Drop logo to learn more.
My guest this week is the co founder and CEO of DreaMed and is really company with the slogan we treat the data you treat the person Eran Atlas talked to me about everything from their partnership with Medtronic. As I said they develop the algorithm that's inside the newly approved 780 G to their newer technology. And this is all about helping doctors better interpret the data they're getting from CGM and pumps. He mentioned a brand new study on this, comparing their algorithm very favorably to outcomes from Yale and Barbara Davis diabetes centers. And I will link that up in the show notes at Diabetes connections.com. I learned a lot from this conversation. I really hope you enjoy it as well. Here's my talk with Eran Atlas of DreaMed.
Eran, thank you so much for joining me. I'm excited to learn more about this. Thanks for coming on.
Eran Atlas 4:49
Thank you very much for having me.
Stacey Simms 4:50
All right. Tell me just generally, what is DreaMed What does this mean for the diabetes community?
Eran Atlas 4:56
Well, you know, for a certain amount of years A lot of effort has been invested on, let's get more accurate glucose measurements, let's get more continuous glucose measurements, let's get those glucose measurements and insulin measurements being connected. And everybody told us that if we will have more data, more accurate data, more accessible data, all the problems about managing people with diabetes will be solved, right, because the patient will be more knowledgeable, the providers will be more knowledgeable, will have the tools to get into a better decision.
Now DreaMed started as a technology team within one of the biggest Institute's that treat people with diabetes, Type One Diabetes here in Israel. And what we saw there is that data is not all and and sometimes in order to make this analogy, these logic thinking between data and decisions, there is a lot of gap that you need to jump in order to make that move. You need to be experience, you need to know what is important, what's not important, and you need to be able to make the right decision in the right time for the right patient. So what dreamed is taking on is we would like to take the responsibility of allowing providers and patients to make better decisions about insulin dosing.
When we started in 2007, the Holy Grail was okay, let's try to develop these automated insulin delivery algorithm that will make these decisions in real time. And we managed to do a prototype and we published these results as were the first publication in New England Journal of Medicine. And finally, after didn't several clinical trials send people home, we were the first group in the world that sent people home with automated insulin delivery, we licensed that to Medtronic diabetes. But the cohort of people that are going to be using are currently being using automated insulin deliveries pretty small depend on the amount of people with diabetes type one type two that needs to make decisions about insulin. So what dreamed is now focusing is on developing those and commercializing those algorithms that will be able to take all the vast amount of data that's out there, and it can be accessible from cloud to cloud, mobile and everything. And how do we get into the most accurate, personalized decision about how much insulin a specific person with diabetes need to infuse? Not just in terms of real time, but more about looking on the treatment plan? How to optimize carb ratios? How to optimize basal treatment, how to optimize insulin sensitivity factor? What is the difference between a patient on an insulin pump to a patient that is using multiple daily injections based on only different kinds of types of injection regimen? That's what DreaMed right now to do. So we would like to make sure that we will treat the data. So a person with diabetes can continue to live in a provider can start dealing with the person that is in front of them and not just looking into the computer, making himself a technician with numbers and decide what to do.
Stacey Simms 8:04
you have heard the podcast. So you know, I'm easily overwhelmed by data and information. I listened to everything you said. And here and I'm trying and here's what I heard. We want to make life easier for you. There's too much information that comes your way even with accurate CGM. Even with automated insulin delivery, there's so much data and information that unless you are a numbers person, you know, you may not be able to crunch it yourself. And I know you, you mentioned already a lot more down the road. But if I could focus on that the automated insulin for just a moment and come back to some of the other things. Can you just tell me as I'm listening and please correct me if I'm wrong, Vinnie, my son is using control IQ with the algorithm that's inside the Tandem pump using partnering with Dexcom. Is this sort of that? Is that the first step that you're talking about when you talked about automated insulin? Is it the algorithm that controls the pump in the CGM together?
Eran Atlas 8:56
Correct. We started in 2007. Building such an algorithm at the time we called him the medical doctor, the MD logic artificial pancreas. And the idea of what is different between the algorithm that we developed back then and the one that you have right now in control IQ, is how do you make these real time decision about how much insulin to infuse and, and while control IQ, as you may know, is using MPC technique, a Model Predictive Control, and you have that model of Medtronic that uses a different kind of type of control. It's coming from the engineering world, we were strong in understanding how physician analyze data and what we did is we took a technology called fuzzy logic, and I thought you know what fuzzy logic is but I'm sure you have it in your washing machine, and you have it in trains in China and everything. And the idea behind fuzzy logic is that you know why the world is not one and zero black and why there has to be a mathematical way to make decisions based on gray areas. And it's pretty much the way that we're thinking as a person.
So, we took his the way that physicians analyze data, make a decision and automated using dispatches fuzzy logic. And we develop these automated insulin delivery algorithm. And we tested it and when he got the the ability to communicate with Medtronic pumps, and now, we have our some part of our algorithm is going is inside the Medtronic 780G that they announced that they got to see mark for that in June DC or in there, I'm sure that they're going after that the FDA, the main difference between what we did and what happened in control IQ and Medtronic 670 G, is the fact that we were the first that play with the changing automatically both the basal and bolus. And we have the ability to predict glucose into the future and dose insulin based on the predicted glucose. Some of the elements that we have, you have also in control IQ. And I noticed Ctrl Q is working pretty well. But one of the things that we had in that time is the understanding that there's a lot of sensitivities off the patient that these AI D algorithm will need to use. So for example, when you are using your control IQ, you still need to go through your meals, right? So you need to optimize your carb ratios. And some of the safety limits are still dependent upon the insulin sensitivity factor off the pump or the open loop basal rate of the pump. So the algorithm is like riding on that basal rate. So we had a similar methodology. And we developed these what we call today, the DreaMed Advisor. It's that algorithm that optimize the sensitivity factors. So I back into the time we have two pieces of our technology. We only licensed one of it to Medtronic. And we continue to develop the other one because we believe that the other one will have a much more larger number of people with diabetes.
Stacey Simms 12:01
So tell me about that other one, where will it be used? Or you're talking about people with type two or people who use insulin, any type?
Eran Atlas 12:08
So that's an interesting question. So we just we started with an algorithm that basically optimize open loop pump therapy, and we took data from CGM at the beginning. And history of pump delivery basically did an automated way what any physician is doing in the clinic right now. And we developed that technology we got we won a grant from Helmsley Charitable Trust back then in 2015. I out of 70 applicant applicants got $3.5 million to evaluate the performance of this algorithm versus doctors from Joslin Diabetes Center, the School of Medicine yell, Barbara Davis in Colorado University of Florida, within three sites in Europe, with the intention to show that if you are a physician, any kind of type of physician that uses all algorithm, you'll get into the same clinical outcome as if that patient data was analyzed by doctors from these leading academic diabetes centers. And yesterday, the results of the study were published in Nature medicine, showing that we are doing the same outcome. As expert Doc's. If you can think about it, 60% of the cohort, we type 1 diabetes, the adults one are being treated by primary cares where we can do to the to the glucose control of these patients, if we will equip those primary cares with a technology that helps them analyze data and get the same performance as special endocrinologist, what we can do to the touchpoint of changing the insulin treatment of a patient, if instead of the patient will need to wait 3, 4, 6, 8 months to see his endo will have some sort of virtual place that he can send the data and share the data with the algorithm the algorithm will make all the calculation and recommend how to change the insulin dosage or the insulin treatment plan of that patient. So that was the what we did so far. And when we approach FDA, we that FDA didn't know how to regulate such a device. Yeah, because there was no predicate to what we offer to FDA to do. So what we managed to do with a very strong partnership with the FDA team is to decide and we will regulate this device as a new product. So in 2018, we got FDA clearance based on 510 k de novo. So we are the first in the US system that regulated a product that an algorithm can take continuous glucose sensor data and make recommendations to our healthcare providers how to optimize insulin treatment for our patients.
Stacey Simms 14:44
So I'm trying to break it down because that does sound like such a useful tool. I'm an adult with type one, I'm seeing a general practitioner who may not know the nuances of treatment, they take my CGM data, they take my dosing data either I'm assuming either from a pump or from me They send it to your service, the care provider, the doctor then gets the data back and can give the patient advice based on your technology using the expertise and you know, from the algorithm. And that new study said that advice is comparable to Yale and Barbara Davis and all the places that you indicated. Did I get that right?
Unknown Speaker 15:21
Exactly.
Stacey Simms 15:28
Right back to Eran in just a moment. And he's going to be explaining their agreements with other diabetes groups like Glooko, like Tidepool, but first diabetes Connections is brought to you by Dexcom. And do you know about Dexcom clarity, it's their diabetes management software. And for a long time, I just thought it was something our endo used, you can use it on both a desktop or as an app on your phone. It's an easy way to keep track of the big picture. I try to check it about once a week, it really helps Benny and me dial back and see longer term trends, and help us not to overreact to what happened for just one day or even just one hour. The overlay reports help add context to Benny's glucose levels and patterns. You can even share the reports with your care team, which makes appointments a lot more productive. managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at Diabetes connections.com and click on the Dexcom logo. Now back to my interview with Eran Atlas
Eran Atlas 16:27
And the way that it has been flowing in so we sign a data partnership with gluco. With Dexcom, we take all we have our own platform, so the patient can download the data at home, he doesn't have to get physically to see the provider, which is super important, especially now when it COVID-19 is and then the data is coming to our system, all the provider needs to do is just push a button request the recommendation here we'll get that recommendation and nothing's going to get you know, blurred the things you know, please consider looking on. He will get exact numbers that the algorithm will tell them listen at 6am change the call ratio, that specific patient from one to 15 to one to 10 exact numbers.
Stacey Simms 17:11
All right, I have two questions. From a very practical point of view. I'm curious if you've run into a provider who says I can do this better? I don't need this. Sure. I don't know the difference between Lantus and Tresiba. I'm a general practitioner. But why do I need something like this? Have you run into resistance from providers? Or are they I could see the flip side, thank goodness for taking this off my hands because I don't have the time to learn all of this.
Eran Atlas 17:37
So there are two types of providers. So first of all, that the approval that we have right now the clearance that we have with FDA is just for type one people on insulin pump, we are pursuing the advance of the indication for use for the injection cohort and with the intention to submit it by the end of the year. But in the study that we did, and right now we are we already deployed the system in several clinics around the US. You know, we are in Stanford University, University of Florida, New York University, Texas Children's so that we are already people who have already more than 1000 people that use the technology. And so when we heard for them, these couple of things. So number one, it became they curious, they want to check, we want to make sure that we didn't make any false recommendations. And they're not agreeing 100% with anything that we are recommending. So we always allow them to edit. If there's anything that they would like to edit, they can edit it before they share it with a patient. But as time goes on, and they building their confidence with a system, they are relying on the system, and they're really feeling how they've helped them. So for example, Dr. Greg Forlenza from Barbara Davis said, you know, what would you use of your system, I can stop being a technician, I can learn to be a mathematical or an engineer, I learned how to be a physician. And I wanted to continue to go and practice medicine, I don't want to go and practice engineering. So this is one of the feedbacks. And I think that when we'll code to the mass numbers of providers, there will be different kind of providers, some of them will be resistance, but I think that one thing we'll see the clinical benefit and the response of their patients, I think that it will endorse that and it will build our confidence with it.
Stacey Simms 19:17
I love that that he doesn't want to be an engineer, he wants to be a physician. We should all be so lucky to have a doctor who wants to do that. My other question on this and I'm apologizing just throw things at you to mess up the system. But the first thing I thought of was somebody like my son who's a not an unbiased person, but he's a great kid. He is not a perfect diabetes person. Perfect example that I think would mess up your algorithm. This morning. He had I don't even know coffee, hot chocolate glass of juice. I don't know what he had. But he had something as he's going to virtual school to. He's he's right down the hall for me so I could go ask him, but I can see that his blood sugar has already gone up to 140 it'll drift back down thanks to control IQ. I don't know if he bolus for that drink. If or If people just after, what is the algorithm do when people aren't, quote, perfect diabetics, because you can adjust the carb ratio and the basal rate all you want, but most people with type one aren't automatons who are going to fit an algorithm?
Eran Atlas 20:14
Oh, that's an excellent question. I think that at the end, if you are creating something for the use of people, you have to understand that nobody's perfect. And you have to make sure that the recommendation that you are providing will be a right on the spot, because otherwise it will cause safety issues. So what we are doing, when we're taking the data, number one that we are doing, we are trying to split that data into events, and understand, okay, that's a meal event, that's a bonus event, that is events that usually debatable could make an influence because there's no BOCES a meal. Before afterwards, we also apply different kinds of techniques to automatically detect places where the patient ate, and the bowls for that, or didn't report the name use these calculator in order to calculate the amount of light and and then for each one of the events, we are trying to ask the algorithm is asking himself Okay, is it a issue of dosing problem? Or is it an issue of behavioral problem? Do we see the high glucose posted meal because the carb ratio is wrong, or because the patient just deliveries, bolus 1520 minutes after the meal, and there's no way that the glucose could be down? So we are from our experience, because we are so much integrated with doctors that understand data. And because you know, I'm here, ces 2007 is closing my 14th. year on February, we know so much about people with diabetes, how they behave. So we programmed the algorithm in that way. So the recommendation that we are delivering is on the spot. If we're saying that we don't have enough events that imply on changing and dozing will not issue that we can personalize even the behavioral messages and calculate what is the most important behavioral that will improve the timing range. And we're not issuing 20 types of behavioral messages. Learn to be have a message note, we're issuing no more than three. And we're very specific. So if we're seeing something that happened specifically on the breakfast of Benny world, tell him listen, Benny, please pay attention on breakfast, deliver the insulin, 10 minutes before the meal, because that's what's set what makes your entire day being hot. Or if we're seeing that when he has an iPhone, you just eat whatever he finds in the refrigerator. And we see it from from the dynamics, we're trying to teach him how to compensate for a high pole in a better way.
Stacey Simms 22:46
It's absolutely fascinating. I think that's tremendous that you're building in the behavior as well. And you can really account for it back to the automated systems. And forgive me, Eran, you used a term open loop rather than closed loop and pardon my ignorance, you explain what that is?
Eran Atlas 23:02
Sure. So open loop is what we call using pump therapy with CGM or with self management blood glucose meters without any ID system. So though some people call it sensor augmented pump therapy, some people say just a regular insulin pump therapy. Some people say it's open loop, there is no algorithm that closed the loop in real time and command in real time how much insulin to infuse on an insulin pump based on CGM data.
Stacey Simms 23:33
Okay, if we go back to the algorithm that is more closed loop and kind of looking ahead for what you're planning on that we've already talked about mealtime, boluses, and how challenging they are for people, whether it's estimating correctly or remembering to do them or doing them late. What's your plan for that? I know there were a few AI systems that are looking to try to do away with a manual mealtime bolus is that in the cards here.
Eran Atlas 23:56
So for us is not on the cards at a moment. I think that what we are trying to look is is beyond the AIP system. It is how to help those with type two on insulin, how to have those on injections because think about it a couple of years ago, nobody knew what's going on with people that still doing injections, right? None of them knew CGM you didn't know what's going on with injections because they didn't record that or they just cheating and when they sat in, in the reception area of the clinic, they to complete the paper and and try to make lottery on when they did at those doors. They're instantly now these days been available thanks to the hard work that Dexcom you know avid Medtronic is doing on the CGM space and companies like companion medical and others they're doing you're connected to and and we know other efforts of other companies. You know, no voice is doing that Louie's doing that. So all of a sudden the same problem that we had a couple of years ago when people on CGM and pumps for the type one persons and depression And the amount of data, we're not going to have it in a much, much broader population, you have about 12 million people that dose insulin in the US, but only 1 million of them are on pumps with type one. So the question is, what are you going to do with these 11 million people? And that's where our focus on that's number one, another focus that we are looking at is going into contextual data? And how can we know and combine the fact that we can know where you are from your personal life in terms of you know, if you are driving or you are walking, or you are going into a restaurant? And how to combine that information with the glucose data? And what predictive real time notification we can give you in order to improve that, and the glucose control?
Stacey Simms 25:49
Alright, wait, wait, you're gonna know where I'm driving? I'm walking to a restaurant. Wait a minute back up? Are you in my this is something in my phone? Are you using cell data?
Eran Atlas 25:58
That's easy. You know, when you're driving? Do you have a Bluetooth in the car? Yes. So the phone knows that you are connected to the Bluetooth of the car, right? Yes. So for example, if you will give the permission, our application will be have the knowledge that you are driving? Are you using navigation software?
Stacey Simms 26:17
Yes. Do you have to lift or no, I don't mean to interrupt your train of thought here. But for some reason, I just thought of the Pokemon Go app from a couple of years ago, because it knew when my kids were in the car and not walking, right. I mean, I know I sent you're probably laughing because I sound so ignorant with this stuff. But yeah, with our cell phones, I'm sure that everybody knows where we are at all times. It's
Eran Atlas 26:37
amazing. That's right. But I think again, so I'm not talking about you know, poking your privacy and everything. And it's have to be on a certain things that that the user will need to authorize, or the benefit of the user, but but potentially, many will learn driving, like they will go into any driving license, I'm sure that nobody wants a person with diabetes, that these glucose is going down or predicted to be down in next 30 minutes to start driving.
Stacey Simms 27:05
So would it give in your system, would it then give a reminder, um, you know, I'm walking into a restaurant time to bolus Is that what you're envisioning.
Eran Atlas 27:13
So again, your glucose is dropping in the next 30 minutes it please take something before you start to drive. Or we're seeing that you're going into a restaurant and you're using glucose is sky high, or going high and the high trend, please correct your glucose now before start eating, because then it will be much more difficult to correct your glucose. These are the types of things that you know are examples of how you take context and combine it together with glucose and insulin data.
Stacey Simms 27:41
It's so interesting to me, because I think, especially with the type two community who use insulin, it's a very different world than the type one community where most people well, I'm biased, because my podcast audience is so well educated. But people are thinking about it so much more often. I have lots of friends with type two, who dose insulin who don't really think about it, who don't really know, just because they're, as you said, they're seeing a general practitioner, they're not as educated. It's not a it's not a personality flaw. And I could see where this would be so helpful. Just these reminders with people with type two, have you already learned any nuances of how they want to use this kind of system? Is it different than people with type one?
Eran Atlas 28:22
So I think that within the type two population is very much dependent when there are on multiple daily injection therapy, or they're just doing basic only. So that's one big difference between type two and type one another big difference is Yeah, like you said, they're thinking about the condition differently. They are denying the fact they have a condition. I think that's much stronger than people with type one, especially teenagers with type one that you know, try to break the system and try to see what's going on. But it's still you need to find other ways to do that. And we're still studying eighth, what is the best way to deliver that to people that have type two diabetes. And that's why initially we're focusing on their providers, and try to better understand what people that are treating people with type one diabetes would like to see how we can help the providers provide a better treatment for them. That will be our first step, then when we will get these endorsement and understanding about the actual users will be much more comfortable to offer something that will go directly to the user because as you said it truly it's a different population. I remember
Stacey Simms 29:31
years ago, there was a big push and I know you were you were around. If you started in the mid 2000s, there was this big push to almost gamify type 1 diabetes, right with apps that kind of gave you rewards for checking or here's a game that would help kids learn or even adults. And it turns out that most people didn't want to think that much about it. They just wanted the system to take care of it like stop reminding me to log stop reminding me to dose handle it. Talk to me about how DreaMed will do that. Even though You are talking about reminders,
Eran Atlas 30:02
because I think that the difference between the reminders that are in the market, they used to be in the market. And what I'm trying to talk about is that those reminders were based on general timeframe. So for example, you know, you're logging into the app that you need to take your basal insulin between seven and 9am. And and now it doesn't matter if you are going just to go into deliver that it will be some sort of mechanism to just ping that, that reminder to you and will drive your crazy, right? I think that what dreamin is trying to do is a couple of things. Number one, we're not just giving them regular reminders, we're giving actionable reminders, so it will tell you to do something, because this is the right time for you to do these actions. And number two, we are trying to take off the burden of treating diabetes, you know, taking the burden off thinking about your glucose and thinking about what you need to do right now, for people that use a ID system. This is exactly what he gave them, you know, you know that there is something that looks on your glucose on a regular basis every five minutes, analyze the situation and provide your the actual dozy, but on people with with multiple daily injections are not using pumps. So there is the only way to make the insulin injected is to make some sort of a partnership with a user. So that's what we're trying to do. We're trying to create all the mechanisms that will bring this partnership between the person with diabetes on injections and the algorithms, we're trying to make sure that wherever we are issuing some sort of reminder, it will be an actionable one. And and hopefully it will be within a certain timeframe that the user is willing to accept such a reminder, because for example, if you're driving and then the system is shouting out, give insulin right now there's no way that you're going to give that insulin right because right now you're driving. But if we're able to capture the exact moment that you're open to get that reminder, and this international reminder, it's not a general one, I hope that people with diabetes will find it useful. And I think that's the thing that we are trying to learn together with the community. And to be are we personally diabetes at work for us, because at the end, it's a partnership between the person, the provider and the industry. And that's what we're trying to create. It's important for people to know that there are companies that are not in the US and might be a little bit small, but they are trying to make a difference for you. And I hope that together with what we're trying to do and what the community is trying to do, when we are partnership, we really, really be able to make that difference. Because the culture of dream ed is coming from a clinic. It's a company that the importance of making lives better is on our culture. Another thing in our countries, make sure that whatever we're issuing has a clinical benefit. We're just not not just want to have a cool product and just get more money. And I really, really optimistic about the impact that we can do on people with diabetes. And we're committed to do that
Stacey Simms 33:14
around before I let you go. Do you mind if I ask about the population with type one in Israel? Sure. I'm trying to think I know in Scandinavian countries, it's very high.
Eran Atlas 33:23
it's debatable, but it's between 30 to 50 k people in type 1 diabetes in Israel, this is it. But we don't have a lot of people with type 1 diabetes. If you're looking on the pieds all the peas are being treated by you know, academic centers, big hospital clinics, the clinic that I'm coming from, is pretty much treating a very large portion of this of the kids and adults are usually go in the same way either to a specialist, but the most of them are going into two primary cares. Where were very techie we were had a lot of a lot of people on CGM and insulin pump. We currently don't have control IQ and ease rail. It's not approved so and 670 G is not reimbursed so the majority of the cohort here in Israel are on regular pump and CGM.
Stacey Simms 34:11
This is well as I said, before we started taping, my son is planning a long trip to Israel next summer. So maybe knocking at your door if you're just some hand holding.
Eran Atlas 34:22
I will be happy to I will be happy. Don't worry. Yeah, I think I can vouch for that.
Stacey Simms 34:29
Everyone, thank you so much for joining me in explaining all this. I really appreciate it. I hope we can talk again soon.
Announcer 34:39
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 34:45
More information in the show notes Just go to Diabetes connections.com. And every show has show notes we call them I call it an episode homepage as well because not every podcast player supports the amount of stuff I put There, every episode this year has a transcript. Every episode ever has links. And so sometimes if you go to Apple podcasts or if you listen on, you know, Stitcher or Pandora, or wherever you listen, and we are everywhere, right now, they don't support the links. So if you're ever curious, or you can't get to something, just go to the homepage and find the episode, there's a very robust search, because we're up to 325 episodes. So I wanted to make it easy for you to find what you were looking for. But when you do that, you can find more information about DreaMed, and I linked up the study as well that he mentioned, comparing their algorithm to doctors at Yale, that sort of thing. You know, I'm curious, as you listen, what you think about something like this, I feel like this podcast audience is so involved in their numbers in a way that most people in diabetes land are not. I mean, let's face it, there's very few people who are interested in DIY stuff like this audiences. I mean, I know you guys, you're very technical, you're very involved, even if you're listening, saying, hey, that's not me, the very fact that you're listening to a podcast about diabetes puts you in a different educational plane, then, you know, 90 95%, let's say, of all people with all types of diabetes, which is not a knock on them, it's just the reality of diabetes and education. So I'm really curious to see how this can help. Because as he's saying, you have a general practitioner, who's treating people who's dosing insulin, right, they're given the prescriptions out. And an algorithm like this can make it so much more precise and safe for the people who are getting those recommendations from these doctors who, you know, might really want to do good, but do not have the experience of the education in at a chronology. So that's my stance on it. We'll see what happens I'd love to know what you think. All right, innovations coming up in just a moment. And I want to share this article I found about women in diabetes a device design, but first diabetes Connections is brought to you by a new sponsor this week. I am so excited to welcome g Volk hypo pen. You know, almost everyone who takes insulin has experienced a low blood sugar. And that can be scary. A very low blood sugar is really scary. And that's where evoke hypo pen comes in Jeeva is the first auto injector to treat very low blood sugar. evoke hypo pen is pre mixed and ready to go with no visible needle. That means it's easy to use, how easy is it, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes connections.com and click on the G Vogue logo. g Vogue shouldn't be used in patients with pheochromocytoma or insulinoma, visit Jeeva glucagon.com slash risk.
saw a great article that I wanted to pass along to you from the wonderful folks at diabetes mine. And the headline on this is where are the women in diabetes device design? And I'm not going to read the whole thing to you I will link it up. But the question here was all about our the shortcomings of diabetes technology a result of just the the functional design requirements the way it has to be made? Or could it be related to the fact that there aren't enough women in the medical technology design field, they did a whole survey about you know wearing this stuff, and you know where to attach it, how to put it, you know, dresses, things like that, which you know, at first, listen may sound kind of silly. But when you think about it, wearing the device, the comfort of wearing the device, the mental stress about wearing the device, these are so incredibly important, because people with diabetes men and women, as you know where this stuff 24 seven, I mean, you think about the difference between something that is clunky, that looks outdated, that, you know, just doesn't feel right in your hand. I mean, these things make a big difference in terms of how I hate to use the word compliant, right, but you know, how well we use them how much we use them how comfortable we are with them, in addition to focusing on the pump companies, and in particular Omni pod, very, very interesting take on women who work at Omnipod there, they also focus on women designed accessories for diabetes tech, because when you think about it, and they list all of these companies, you know, we've talked about a bunch of them in the past myabetic and funky pumpers spy belt tally gear pump peels, one of my book to clinic sponsors, thank you very much pump peels, these are all founded by women, because they saw the need and wanted to make life easier and better. So I'll link that up. I really thought it was a great look at a topic that we hadn't thought a lot about before. We focus a lot on what patients need to be involved people with diabetes who actually wear the gear need to be involved. But what about people who wear the gear differently and have different expectations and that by that I mean women. My daughter when she was in high school, wrote a whole paper on pocket equality and did hard research into why women's clothing doesn't have pockets and rarely has pockets that are big enough. I mean, my son puts his phone and his palm I don't know, you know, a lunchbox in his pocket, and he can fit everything in there. He doesn't think twice about it. But sometimes I think about where the heck would I put a pump, if I was wearing what I'm wearing today, right, I have any pockets. Really interesting discussion and hats off to diabetes mine for focusing on that innovations is also your chance to share hacks and tips and tricks that work for you, you know, just little things that make life better with diabetes. So you can post in the Facebook group, or you can email me, Stacey at Diabetes connections.com.
Didn't tell me something good this week, a big award for a familiar face around here. Most of you remember Dr. Nat Strand from The Amazing Race. She was the in the team of Nat and cat. And that was The Amazing Race 17, which I can't believe was 10 years ago. We talked to Dr. strand, earlier this year about working as a physician. And during this time of COVID. And how she was treating her patients. She treats patients with chronic pain and that sort of thing. And we're talking about her on tell me something good, because she is the inaugural winner of the Lisa Stern's legacy Diversity Award from the American Society of pain and neuroscience. So congratulations, Dr. strand. Of course, the ceremony was virtual, but you could follow her on Twitter and see the pictures and see what nice things people are saying about her and I will link up her Twitter account if you don't follow her already. Also, in Tell me something good. Something that popped up in my local group. Brian shared a post about his daughter Emerson about diabetes and soccer. And he said I could share it. And it's actually a story about her. It's a story by her. It is Emerson's sucker rista story playing with diabetes. And this is a column that Emerson wrote that is published on the girls soccer network, I would really urge you to read it especially if you have a child who is a high performing or wants to be a high performing or elite athlete. She talks about no days off. And how well you know I'm sure your mind went to diabetes. That was her mantra in terms of sports. And it has really helped her she says deal with soccer. And with diabetes. I'm not going to read her words here. I just think it's a great column I would urge you to read it I'll link it up on the episode homepage and I'm going to put it in the Diabetes Connections Facebook group as well. Well done Emerson really great to see the incredible hard work that it looks like you've been putting in and what a wonderful column as well. So thank you so much Brian for sharing that and for letting me talk about it a little bit here. If you have a Tell me something good story could be a birthday a diverse serie, you know, your child has published in a national print publication, you know, anything you want to focus on, that is good news in the diabetes community, please reach out and let me know, just tell me something good.
Tell me something annoying, could be the name of this segment, I just want to talk a little bit about our insurance changes, mostly to commiserate with with many who have gone through this. So as I said at the top of the show, our biggest change is now that they're going to switch insulin on us. You know, I talked to Benny about this, we are so fortunate to have a frankly, have a pretty good stockpile of insulin that we've built up. If you follow the show for a long time, you know that I've discussed his insulin needs went way up. And they have gone back down to almost pre puberty levels. But we never changed the prescription. So you know, I have unfortunately or fortunately, I don't know I have shared insulin in the Charlotte area with adults in need. We have some great local groups. And it is ridiculous that we need to do this, but we do share with each other. And I've been happy to help out on that. But we are basically out of pins. And I like to use pins as a backup. And Benny likes to have them for flexibility. You know, he'll take them sometimes. And if something's wonky with his pump, he knows he can get himself a shot, that sort of thing. But I hate the idea of changing insulins right everything's cookin right now everything's chugging along really well. I don't want to rock the boat. But I also don't want to pay $300 for a pen. So I'm going to be talking to our endocrinologist, Vinny has an appointment in two weeks, as I'm taping probably more like a week and a half as you listen. And we know we'll talk about it, then maybe have some samples, but most likely we will be switching and we did not have an issue when we switched in the past. So I have fingers crossed that it will be fine. It'll be fine. But that is annoying. And I know I don't feel like appealing and fighting if we don't need to. It's possible that novolog will work just as well for him. So let's at least find out and we'll go from there. The other issue was, of course, that we are now dealing with edgepark. And I will spare you all of the details. But I tried to do a workaround. And I'm laughing because I should know better by now. I tried to get the Dexcom prescription to stay at our pharmacy because man we've been filling it at the pharmacy for the last couple of years. And if you have already been able to do that, you know, it's like a dream. At least it is for us. It may take an extra day to get it but it's a day. It's not like they're mailing it out for you and it takes three weeks. It's been wonderful. And I just had on auto refill. And it's been great. But edgepark told me, we don't filter your pharmacy, you only can do it mail order. Well, I didn't want to wait. I didn't want to be cut short. So I let edgepark go ahead and fill the order. But then I did some detective work. And I kept calling and talking to people, because what else do I have to do, but be on the phone with these people? And I finally got someone at my insurance company to admit they would fill it at the pharmacy. But here's what she said. She said, Well, we don't like you to go to the pharmacy, because they don't often have it in stock. And I said, Come on, you know, that's not true. They can fill it in a day. They've been filling it for four years. And she said, Okay, well, you can you do a pharmacy benefit and, you know, blah, blah, blah. So I hung up the phone, and I will fill it at the pharmacy next time. I already have the order from edgepark through the mail. And I thought you know, that's just because my insurance company has a deal with edgepark. That's all that is. She's trying to discourage me from going to the pharmacy because that's their business. I get it. But how stupid is that? How outrageous is that? Oh, now you know why I saved it to the end of the show. I will keep you posted on our many adventures as this moves forward. Because Up next, I have to fill Benny's tandem pump supplies. And we've never been able to do that at the pharmacy. So I'm sure it'll be more adventures with edgepark my new pals. Ah, goodness gracious. All right. Thank you to my editor john Kenneth for audio editing solutions. Thank you. If you are still here, listening to me rant. I love you. Thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Benny 46:35
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All rounds avenged
Transcribed by https://otter.ai
What do you use to treat lows on the go? One of the newest options is a flexible necklace, filled with 15 grams of fast-acting glucose. The Thrive Glucose Gel Medical Alert Necklace is easy to take with you, rip off and open if you need it. The idea came to first responder Kris Maynard after his own severe low had to be treated by paramedics. His family had tried to use the "red box" emergency glucagon kit but missed a vital step.
More about Thrive Necklace from Glucose Revival
Kris also shares that one of his teen sons has been diagnosed with type 1 via TrialNet and explains how their family is coping with that knowledge.
Listen to our first episode with Kris when the necklace was a prototype in 2018
Check out Stacey's new book: The World's Worst Diabetes Mom!
New segment this week! Innovations – focusing on hacks and tips and tricks to make our lives easier.
And Tell Me Something Good!
Join the Diabetes Connections Facebook Group!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
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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 Real Good Foods, real food you feel good about eating and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:20
This is Diabetes Connections with Stacey Simms
Stacey Simms 0:26
this week, what do you use to treat those on the go? One of the newest options is inside a necklace. The idea came to first responder Kris Maynard, after his own low had to be treated by paramedics because his son didn't know how to mix up the glucagon correctly.
Kris Maynard 0:44
Why am I not carrying this for something that we know that works, and as an EMT, for 100% of the calls that I've been on for low blood sugar 100% of the responses have always been glucagon is just too much and it expires,
Stacey Simms 1:00
we'll talk about Kris's solution, the thrive necklace, and his son recently was diagnosed with type one. He shares that story
new segment this week innovations, focusing on hacks, tips and tricks to make our lives easier and tell me something good. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am so glad to have you on. You know, we aim to educate and inspire about type 1 diabetes by sharing stories of connection. I am your host Stacey Simms. My son was diagnosed with type one right before he turned two back in 2006. My husband lives with type two diabetes. I don't have diabetes. I have a background in broadcasting and radio and TV news. And that's how you get the podcast.
Quick birthday shout out to my mom. If you are listening today. This goes live on September 1. It's My mom's birthday. And she had a great line recently that I wanted to share with you. I was talking about how amazed I was with control IQ. We traveled back and forth from New Orleans recently to drop my daughter off at college. And Benny came with us. We rented an RV. I told this whole story last week, but it was basically you know, 11-12 hours in the car there. Same thing on the way home. And if you've done a long trip of any kind, you probably know that you need to raise your basal rates. We have done lots and lots of car trips. My parents are in Florida, we're in North Carolina, they spent the summer in Delaware. So we're all over the place. Except, you know, in the times of COVID, where we haven't traveled at all this was our first trip. Gosh, since everything started since March, probably but we've always had to raise Benny's bazel rates at least 50% that may seem like a lot, but he's very active kid and you know, sitting still, we really needed to increase basal rates by quite a bit over the years.
And of course now with control IQ, we don't change them at all and it does all of the work for us. I was absolutely amazed. For the two days that we were on the road. I only grabbed a screenshot of our trip there. I didn't look on the way home. But he was 84% in range for that time with an average glucose of 139, which I will take hands down any day, which it would translate, I guess to a one see if like 6.4 or 6.5. I mean, it's only two days. But that's if you're if that's how you look at the numbers, that's what you would get. Now, of course, when we got to the hotel, he fell asleep and didn't have insulin and his pump. He wasn't in my room. He was in my husband's room, so I'll blame them for that. I wait a minute. I know that. Nope. We got two hotel rooms. So I stayed with my daughter. My husband stayed with Benny and it was kind of nice to just have it was two days that we stayed there and it was really nice just to have some time alone with my daughter. But yeah, that's that sounded weird about the separate hotel rooms.
So that 84% range didn't last for another 24 hours but it was pretty close. I mean control IQ once you put insulin in the pump control Q does some incredibly heavy lifting for us. I was telling my mom about this, he was texting her about how great it was going. And she said, quote, sh—y disease, great technology. And I said to her, you know, I'm gonna send that to Tandem, because I'm sure they'd want to use that slogan. Anyway, thanks, Mom and Happy birthday to you.
We have a lot to cover. This week, I've added a new segment called innovations which will be coming up after the interview.
So let's get to it. Diabetes Connections is brought to you by One Drop, and One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drops glucose meter looks nothing like a medical device. It's sleek, compact, and seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to one drug to keep track of the big picture and easily see health trends. And with a One Drop subscription you get unlimited test strips and lancets delivered right to your door. Every one drug plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doc Visit your personal coaches always there to help go to Diabetes connections.com and click on the One Drop logo.
I met Kris Maynard more than two years ago, it was July of 2018. We did an interview on the floor of the friends for life vendor area. I mean, you know what I mean? on the floor of the vendor area, that big open area, we were sitting at a table, but doing the interview various how I realized my microphones were not meant to be held. I will link back to that first interview, and you will hear a lot of that (microphone noise). That's why I bought microphones standards.
But Kris Maynard's product that he brought to friends for life in 2018 was the prototype for what's become the Thrive Glucose Gel Medical Alert Necklace. He was there to get feedback, see if there was a need for the product. Kris is a first responder who lives with type one. At that same conference. His family went through trial on that testing. One of his teenage sons was found to have the markers for T1D, we've got a lot to talk about with Kris Maynard. Kris, thanks for coming on with me. It's great to talk to you again. I can't believe it's been two years. How are you?
Kris Maynard 6:11
I'm doing good. It's I'm excited to be here.
Stacey Simms 6:14
So much has changed. And I want to talk about not only your product and your family, there's a significant change there as well. But you caught my attention recently, because it looked like you were on Mount St. Helens. Can you tell me a little bit about what you've been doing?
Kris Maynard 6:29
Yeah, well, it's something I've always wanted to do. I mean, it's really a way that I really wanted to be at a test or product. And I've learned over the last couple years, how much I love diabetics. I love being around other people that's living with the disease. So I wanted to be able to just challenge other diabetics to join us into making that hike. And I mean, it was something that physically was the hardest thing I've ever done in my life. But at the end of the day play it was so enjoyable. absolutely loved it. How long
Stacey Simms 7:01
was it?
Kris Maynard 7:02
round trip? It was a total of about nine to 10 hours.
Stacey Simms 7:06
Now pardon my ignorance, but when I think of Mount St. Helens I only think of I think like so many people. I think of it as a an active volcano.
Kris Maynard 7:15
Yeah, yeah. Okay, just make sure I'm not wrong. No, you're exactly right. 40 years ago is when it exploded here in Washington State. And we live about five hours away from it, and it just covered our city with ash. And so I was I don't remember five years old or so at the time. And I just remember wearing the masks really, of what we see being worn around today.
Stacey Simms 7:41
I'm a child of the 80s I remember it's one of the the significant news events of my childhood like when they say what do you remember when you were a kid? You know, that's one of them. So living around the area, and again, pardon my ignorance, but people are allowed to climb now and you can go up there, there's no restrictions,
Kris Maynard 7:56
correct. But you need permits to go there. We actually bought Tickets before co started because in April's when they start selling the permits, and those permits sell out within the first day or two. And so we got ours then to where they only allow 100 people to go up per day. And so it just happened to be that last week was our magical day.
Stacey Simms 8:22
And you had a look at the pictures. You had young people, you had diabetes educators, was almost everybody in the group, part of the diabetes community.
Kris Maynard 8:30
Yes, well, the most encouraging thing to me was two things is one person during the first mile was ready to call it a day. It was just too complicated in that first mile, and we'd kind of just gathered around and saw where she was struggling and she continued on was able to finish it, which was amazing in itself because when we look back, that first mile was 100 times easier than the rest and then 13 year old who's got type one. And I just physically think how hard and how exhausting it was for me. And to think that that 13 year old, was able to do it, because he had his struggles along the way as well. But for him to be able to enjoy that with his dad was just, I mean, encouraging and motivating. For the rest of us. It was amazing that he was able to finalize that exhaustive day.
Stacey Simms 9:29
Did anybody need the thrive necklace,
Kris Maynard 9:32
three people used it. In fact, the 13 year old ran out of supplies. That was the last thing that he had on the way back in about two and a half miles left, which was amazing because the cell service on that mountain was better there. And sometimes in the some houses or buildings that we go in and out. So he texts me saying, Hey, we just ran out of supplies. I'm worried for my son. Who just ran out of his food, his drinks and everything else. And so he said he just used the necklace. I don't know what his number was, but and then afterwards, he said it bounced back up to 157. But there was also other problems that he was also going through between the cramps running out of water. So it really wasn't about the necklace. It was being with other diabetics making that climb.
Stacey Simms 10:28
Well, yeah, and I guess that's a good point. It's a good place to run out of supplies. If you're surrounded by people who also have their own. I assume that they shared with him or he got down.
Kris Maynard 10:37
But I mean, by that time, we were separated, we were actually done. And so I we had to drive back to the finish line. And a friend of mine that was with me, I couldn't make the trek back because my legs were just cramped up and stiffened up and the buddy of mine who's in better shape, ran that last two miles to be able to get supplies. So, the buddy was amazing. He was the former firefighter. And another person was able to call 911, just in case, and then to see him walk that finish line to where you wouldn't have noticed that he was tired at all, or that his legs were stepped up at all. So yeah, I mean, it was fun to be able to embrace at the end and just cheer him on. And that's really beyond seeing him at the top of the mountain and then seeing him finish no one the struggles that he went through.
Stacey Simms 11:30
Alright, let's talk about the thrive medical alert necklace. Give me your elevator speech. What is this? Yeah,
Kris Maynard 11:37
well, it's funny because when I saw it a couple years ago, at the friends for life conference, really still at that point, it was just an idea. And we needed to figure out if it was something that was wanted or needed on the market that kind of helped formulate along with messaging that we're going through with other diabetics on now we need to make something out of it. And so learning that 80% of the diabetics Don't carry glucagon. And from the EMTs perspective 75% of the EMTs cannot administer glucagon can't give injections or can't give IVs. And so I look at it from the EMT side and from the diabetes side. So really the elevator pitch for us is we have the only wearable product to be able to help with the most common issue that diabetics face which is low blood sugar by using what EMTs use, being able to use it for any level of low blood sugar from a low to a severe state.
Stacey Simms 12:35
No, let me just clarify that because I've always confused when I hear that one of the EMTs do how do they treat low blood sugar if they come across someone who needs that kind of help?
Kris Maynard 12:44
Well, I'll take you from a time that I was unconscious camping with my kids is that they take the glucose gel, bring it and rub it on their finger and just massage it on the gums to become absorbed. And it was funny because that But it happened to me. I've administered it many times throughout my career, but I just never thought of carrying it myself because we always had glucagon. Well, that time that the ambulance was called for me, my son administered the glucagon for me called 911. What I thought that he knew was how to properly put it together. He didn't mix the two together. And so that was our failure on teaching him. But that's when I thought, why am I not carrying this for something that we know that works, and as an EMT, for 100% of the calls that I've been on for a low blood sugar 100% of the responses have always been glucagon is just too much and it expires. And so at that point, we're just thinking of a cheaper alternative that's really easier to find.
Stacey Simms 13:53
So what was the reaction when you went from idea to product because when I last talked to you, we're not shipping as He said this was something more of a concept. What was the reaction?
Right back to Kris. But first diabetes Connections is brought to you by Real Good Foods, introducing real good entree bowls, real ingredients, high protein, gluten free and low carb. So what are they're talking about here they mean Mongolian inspired beef, lemon chicken, lasagna, chicken. Real Good Foods is here to make delicious foods. We feel good about eating. And by adding these entrees, you can really see where they're going here. They want to make nutritious foods across every meal, snacks, even desserts, but they're delicious ice creams readily available at the local grocery store. We can get our products at the Harris Teeter, they have them at Walmart. Now not everything is in every store so you can find their guide. Just go to the website. You can even get a great coupon right now. And you can order online for everything that they've got. Find out more about Real Good Foods. Just go To Diabetes connections.com and click on the Real Good Foods logo. Now back to Kris and he is answering my question about the first reaction he got to the thrive necklace.
Kris Maynard 15:14
overwhelming. Because again, I was thinking and an idea that day worked for me. And that's really where it was going to go to until my endocrinologist came back and said, You ought to make that available to all diabetics because you don't know how many or who you can help. And so that's when we took it to friends for life after that, and then seeing the reactions of people touching it. There was fun to see, in really all of this. The most exciting thing for me is being able to meet diabetics because before I went to that conference, there was only one other diabetic at that point that I've ever met or known. And now since then, I've met thousands. Each one of them. I get excited to meet because I love hearing their stories. I love seeing what works for them. And I love being able to share how we can help them as well.
Stacey Simms 16:07
So tell me what the necklace actually is. Can you describe it because obviously, this is a podcast, we're not looking at it, although I will link up the website so people can see what it is,
Kris Maynard 16:15
yeah, thrive glucose aid. It's implemented as a medical alert necklace. And as it's pulled off, I mean, it's held on by magnetic connectors. So it can really I just say rip it off, and then it becomes uncapped, like a toothpaste container. And it's just squeezed out. And you can put the tube right onto the gums, if that's the state that the diabetic needs to be able to get the help. Or I can just take it off and put it in my mouth and really just squeeze it out myself to just get my blood sugar back up.
Stacey Simms 16:48
And when you say it's also medical alert, it's got the medallion on it. Tell me about that.
Kris Maynard 16:52
Well, I went through a two year process, we put the blue circle on it as the symbol of diabetes because I wanted people to be Got to recognize it knowing that this is for diabetics to be able to help diabetics. And I mean, it took me two years to be able to get permission to be able to use that from the International diabetes Federation to whereas on the backside, is where it says type one diabetes or diabetes, so that again, it signifies if an EMT or someone looks at it, if they don't recognize the blue circle, they can see that it is a person with diabetes.
Stacey Simms 17:26
I know you've heard this, so it's not criticism. But what do you say to people who tell you? Look, Kris, this is great, but I can just throw some Smarties in my pocket. Or, you know, I've got the icing with me, what do I need this for? I wouldn't argue with that at all.
Kris Maynard 17:43
Because I mean, when I learned that only 58% of diabetics carry something to treat with hypose that concerns me that concerns me that 80% of the people don't carry glucagon. So it's that 80% that I'm scared for and I want to To help if people can eat something, or drink something, that's what I want them to do. Matter of fact, if they're conscious enough to be able to take something else, we don't want them to use the necklace because there's more cost effective alternatives. Matter of fact, with me, I carry a, like a eight ounce juice really wherever I go to where I'm saving the necklace for my wife, kids or someone else to where if I can't administer it to myself, they know where to find something. They don't need to go look in a duffel bag, a drawer, a car, wherever it might be. They know where to find it, they can rip it off and now administer it to me. Is it refillable? It is and that was another process through our FDA attorney from the get go she said it cannot be bought. Why is the question
Stacey Simms 18:48
in the way I did you heard me like bracing. Can you kind of Yeah, because I remember it couldn't be at the time but
Kris Maynard 18:53
yeah, it took about six months to be able to figure out that on being able to have them Make it refillable, because from the get go when we initially started about, we wanted it to be refillable to be more cost effective for the diabetic. So that was hurtful news when our FDA attorney told us that it cannot be and then once we figured out how to make it refillable, then we got back on track with what our goal was.
Stacey Simms 19:22
So while back, you were making these available for healthcare providers, and now I see you're making them available for teachers. Yeah. Tell me about these campaigns. How did you decide to do this?
Kris Maynard 19:34
It's funny because you give me the chills when I hear that the health care workers as soon as COVID started, I'm all about the diabetic from the business side. I don't look at it, unfortunately, and I hate to admit that I don't look at it from the business side. I've never looked at coming into this business trying to make money from it. When COVID started, I wanted to be able to provide a way to all diabetic healthcare workers so that they have something And just because at the time and still today, we didn't want them to have to worry about a low blood sugar at a time that they're working their tail ends off on to helping us in our country trying to get it back to a normal state. And so I mean, we ended up giving about $70,000 worth of product during about a four month period. And now as schools are starting to begin now our goal is because the lack of school nurses and and the ones who can actually help administer anything, because ours is FDA a food product. Now, teachers, principals, friends, family, anybody can help with this. If it's needed. They don't need to wait for the EMTs fire trucks ambulance crews to arrive. Now they can help administer what's within our necklace knowing that that's what EMTs are going to use anyways.
Stacey Simms 20:57
Alright, so tell me the secret. How are you? able to afford all of this and how can we help?
Kris Maynard 21:03
I still have my firefighting job. And so time if you can afford me more time, I would love it. Fortunately, we did get some good press out there. And we are able to match really one per one on what we gave away versus what we're selling. And if I can continue that match in one for one, I will do this for the rest of my life, being able to get this out there until there's something else out there that can do better. And I know there's other products. In fact, one product I just picked up and I've been in deep discussion with with xirrus because I think their company that's offering one of the best solutions for low blood sugar, or a severe unconscious with their new GE Volk auto injector. I absolutely love that product. I brought that with me when I climbed Mount St. Helens just so I can have Security so other people can have that security as well. I don't look as a business that I'm trying to compete with anyone. I just want to be able to provide something for anyone that wants to wear a wearable or to have a product to where they feel more comfortable with. And I compare it to some people like apples, some people like peaches, some people like great. And that's what we are. We're one of those.
Stacey Simms 22:25
I love it. It's interesting when you're talking about xirrus and the G Volk hypo pen, you mentioned at the beginning of this, that your son didn't mix up the glucagon, the traditional that red emergency box right that glucagon correctly. And so many studies show that people do not do that correctly. I went to a training, it's probably four years ago now. And I'm, you know, I'm so well educated and every year I take out the old glucagon and mix it make sure I know what I'm doing. And the CDE laughed at me because he said I was holding it wrong. I had my thumb on the back of it. So I would have actually have pushed it too early, you have to throw it like oh, throw it you have to hold it like you're throwing a dart Do not throw your look. Yeah. So I was shocked that I would have been one of the many, many people who use it incorrectly. I kind of ask you, is your son okay about what happened? I mean, I know that you probably are fine. And you know, and you've got to reassure him, but after all this time is he is he's still upset about it.
Kris Maynard 23:23
Oh, he wasn't upset about it that next day. Oh, great. He knew and I knew that it was an educational thing that I neglected on, leading to him. But I mean, at the end of the day, nothing happened. I was able to after I got the glucose in my mouth, everything was fine. And so fortunately, he was able to move up and move on with his day, the next day. Wow,
Unknown Speaker 23:47
that's great, though. How's everybody doing? Now? You've got two sons. They're both just they're both off to college.
Kris Maynard 23:53
Yes, one just moved out this last few weeks and the other ones getting ready to move in about three weeks. And the scary part from my end is the one that's moving across the country is expected to be a type one within the next two years. And that's really something that motivates me encourages me to try to get heavily involved with the diabetes side. There's a lot of things that I don't think being done enough for diabetes, and I want to make sure that I understand the full spectrum so that I can get him the help he needs. Because really, when I was young into my firefighter career, I lost my job for two years because of a low blood sugar. I want to make sure that that doesn't happen to him. And that doesn't happen to any other diabetics.
Stacey Simms 24:41
When you say he's expected to become type one. I assume you've done trialnet correct. Wow. Tell me about that experience. Had you always taken the kids through or was it something you did that you tried newly Can you can you share a little bit about that?
Kris Maynard 24:57
Yeah, the friends for life conference really changed. Many things about me personally, and for the rest of my life, because that conference to me taught me so much. And that's where we were introduced to trial net. And that's where we brought our kids to get tested, including my wife, she got tested as well. And that's where we found out our son had to have the indicators that he's going to be a type one at that point was within the next five years.
Stacey Simms 25:24
Has he shown any signs? Is there anything that you have to do now? Or is it just something that you kind of monitor?
Kris Maynard 25:29
No, it's something we monitor, and he could have gone through some trial testing. But we left it up to him to decide if he wants to partake in that. So really, what I do is I'll take my decks and have him wear it for a few days so I can monitor him to see if his numbers are elevated at all. And fortunately, he's a good sport about it. He still doesn't like to get poked or prodded at but fortunately he's had me to figure out the ups and downs with a diabetes. So he's up for, I almost think that he's an expert in it just as much. But getting him to really, as I say, play my game so I can monitor him and see how he's doing. So the scary part for me is when he goes to college, because now we're apart from him. And so we've been in great discussions with the school nursing program, so that I mean, I'm asking them to test his blood sugar every time that he comes in for a doctor's appointment, so that they know and he knows where he's at.
Stacey Simms 26:35
Are you and your wife, glad that you went through trial net, knowing what you know now?
Kris Maynard 26:40
Yes, whether it's good news or bad news, I always like the truth. That just helps us to be able to prepare and educate him in the process, because I'd hate to find out in two years from now, without knowing that he's a type one thinking that we could have prepped him in some way and so He's really prepped now to become a type one at any point. I love the, of what trialnet is doing and what they offer.
Stacey Simms 27:07
Thanks so much for sharing that. I think people worry about doing trial net, you know, they're not sure what they're going to find out, but I would want to know, so what's next for you? You go on up any more volcanoes you coming up with any other products? Or are you just trying to get your kids off to college?
Kris Maynard 27:22
You know, going up that mountain, I said probably a good 20 times remind me never to do this again. Because of how hard it was. But now that I'm past it, I would love to go do another mountain climb. It's weird how the mind works and how forgetful it can be once you get past something. But at this point, I mean, the the group that we're with, they are more experienced than what I'm in on the mountain climbs. They want to start doing some annually. Whether we do that or not, I don't know at this point. The fun part of this journey too is that somewhere along the line Shark Tank, found us and reached out to us and interviewed me and said, Hey, would you like to be a part of the show? And thinking immediately, I would love to broadcast diabetes on a national stage. So, yes, and so they gave me one week to make a video. And that video that we made, we shared on social media and got tons of viewership tons more than what we normally do. The hard part that we've learned from that is that they said they would contact me by whatever date that it was, and we'd never heard back so we assume we didn't make it to the show. But again, what a fun experience to be able to go through trying to figure out how to put something together answering 50 questions, getting it done within one week and a video getting it back to them.
Stacey Simms 28:55
So you never know they may call and now you know for the next time too. had to do that even better. But we'll keep an eye out for you. Yeah, that sounds great. And I'd love to, is that video still online?
Kris Maynard 29:06
Yeah, we have it on our YouTube channel. I don't think it's on the website anymore.
Stacey Simms 29:12
I think Listen, it's a great experience, right? And you never know, they could call. But we'll leave that video up, you know, maybe somebody listening will see it be able to pass it along to the right people you never know.
Kris Maynard 29:23
Yeah. And again, it really I mean, two things is one I want to get diabetes on that national stage and to the blue circle. I've been in contact with the CEOs that beyond type one jdrf and the ADA on hoping that they will just put the blue circle around their emblem, I don't want them to lose their emblem, but really, each one of them has told me that they want to brand themselves and from that from the diabetes side. That's not comforting to me, because I know outside of the diabetes community, what I've learned is that the jdrf is really known as "the Walk" And the ADA is known as "the legal". And most people don't know what beyond type one is. And I think if the diabetes community got on the same page, how much efforts we can make, because the pink ribbon for breast cancer, I mean, it took them about 15 years to be able to build up that, but the funding for that from the government agencies skyrocketed. And so that's what my hope is with the blue circles to get the diabetes community whether it's type one or type two, because the power numbers coming together, and recognizing that blue circle is what's important to me. So that the fundings there so that I mean, if one out of every three in our world is going to eventually have diabetes, now's the time to come together so that it can get the funding that it needs. So that one out of three doesn't need to get diabetes.
Stacey Simms 30:51
I hear you. Well, Kris, thank you so much for jumping on and sharing your story and the update with us. I really appreciate it. It's great to talk to you again.
Kris Maynard 31:00
It's great talking to you, Stacey. I appreciate your time so much.
Announcer 31:08
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 31:14
And you could find out more about Kris and about the necklace. There's a couple of different kinds, mostly about sizes there. And there is a promo code, you can find that all at the episode homepage at Diabetes connections.com. Kris is generously giving my listeners 15% off using the promo code, blue circle, and that is all one word. And I really wish him the best. It's not easy to have both your kids going off to college, certainly in a year like this. And certainly at a time when the younger one you know, they're kind of waiting to see what happens in terms of diabetes, but I'm a huge fan of trial net. I really do think as he said, you know, you want to know and I have a lot more information on the website as well. If you want to search that up. We have a very robust search box if you're new to the show. This is Episode 320. And you can search by episode type. You can search by Subject keyword or by date, and we've done a couple of episodes on TrialNet that I would highly recommend.
Alright, my new segment Innovations coming up in just a moment. But first diabetes Connections is brought to you by Dexcom. And when Benny was very little, and in the bathtub or at the pool, a kid could have spent the whole summer in the pool. I always noticed his fingertips. I mean, you know exactly what I mean. They were poked so much, they were just full of little pinprick holes. You can really see when they got wet, although I don't know if people actually know this anymore. I mean, they were like little Franken fingers. But when when you have a little kid now, so many of you are already on Dexcom so quickly, I'm not sure if you've gone through this. This is fingertips basically look normal right now. We have been using Dexcom for almost seven years. With every new iteration we have done fewer and fewer finger sticks. The latest generation the G six eliminates finger sticks for calibrations and diabetes treatment decisions. Just thinking about doing the 10 finger sticks we did every day in the past makes me so glad that Dexcom has helped us come so far. It's an incredible tool. If your glucose alerts and readings for the G six do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Alright, let's talk about innovations. This is a new segment I'm starting because I have heard about so many fun things over the years that you are so smart to come up with. And I want to help spread the word. So let's start talking about your innovations. Now this segment will include everything from probably cool stuff coming down the pipeline that we hear from industry and tech companies and I really want it to include your innovations and that can be everything from the woman Gosh, I wish I remembered who this was years ago. She gave me the advice of if you're in a hotel and you have insulin in the fridge or if you're leaving your home and you have insulin in the fridge you want to bring on a trip. She leaves a shoe in the refrigerator the shoe she is going to wear in the morning So she does not forget. Now I use that but I put my car keys in the fridge. Because I'm not putting a shoe in my refrigerator. I'm not even putting my shoe in a hotel refrigerator. But I do put car keys in so that you don't forget, it really helps. You can't go anywhere without the keys. And when you get the keys, if you forget where you put them, hopefully you remember you put them in the fridge. There's the insulin. So that's the kind of stuff I'm thinking of for this segment. This week. Although I guess I just gave you one there.
I want to talk to you about happy Bob. Happy Bob is a new app. And it was created by a mom of a child with Type One Diabetes. Her son was diagnosed at age six. She lives in Finland, which by the way has the highest incidence of type 1 diabetes in the world. What is happy Bob, it is an app that connects to Apple Health kit, it streams CGM data. Now it gives you you know, stars that you can collect. And I think there's a bunch of apps out there that have tried to gamify diabetes, which really hasn't gone over that well because most people they just want to do less. They don't want collect points. Although that is a popular aspect of happy Bob, the big deal about it is that it gives you editorial for where you are. It'll say things like your blood sugar is 110. You are awesome. Or your blood sugar is 138. Your numbers today has been on fire. If I had a buddy, I'd be dancing right now. He was silly things like that. But the best part about happy Bob, in my opinion, is his alter ego snarky Bob snarky Bob enjoys making. I wouldn't say rude comments, but more sarcastic comments. And they're always changing. They're funny. It's just such a smart idea. Now I did mention that it links to Apple. I just found out that they are testing the Android app. So of course they are developing this. There's even a Facebook group I think or a Facebook page for sure. For happy Bob. So I will link all of that up in the show notes. I tried to get Benny to put it on his phone. But he as of this point is not interested although he did think that the snarky Bob It was pretty entertaining. kudos to them for doing this. I think it's fantastic. If you have an innovation like that, send me something I'll post in the Facebook group as well. You can always email me Stacey at Diabetes connections.com. I'm very interested to see what we come up with as a community. You've got some great fun hacks out there and some really useful stuff too. So let's help each other and spread the word.
All right, time for Tell me something good. And this one is really a nice one. We don't have any huge milestones. I don't have any marathons or 50 year diversities. These are all kind of a day in the life kind of things you'll understand what I mean. Caitlin says my tea Wendy got to have her first playdate with her best friend. Since lockdown began in March. They were so happy to see each other and only had to be reminded once to keep their masks on, which was pretty amazing to me. She writes since they are four and five years old. When we left she said it was her best date. Mike Joyce said the wild flowers on the Pacific Northwest trail are pretty great. And he sent a beautiful picture he posted in the Diabetes Connections Facebook group. Also Mike writes, I've walked a third of the trail to the Pacific Ocean from Glacier National Park. Mike keep the pictures coming. That said our six year old T1D jumped off a small Cliff into a mountain Cove this weekend. She has no fear of man, everybody's getting outside. I mean, that's one good thing. We're all spending more time outside and Shelley said the rain is finally filling up our new backyard lake. If you look closely in this picture, again in the Facebook group, you can see my four year old and his new favorite way to burn that glucose and this kid is splashing.
So if you have a Tell me something good. I think these are all great stories. Send it to me Stacy at Diabetes connections.com or post it in the group. Just something that makes you smile. I love sharing these stories. Before I let you go, I am working on a new episode. This will be out probably by the end of this week, and I'm a little nervous about it. So I really hope you give it a listen, I have a feeling. I've been working on this for a while that the philosophy of kid first diabetes second is really not working, actually never worked. So I'm going to be talking about that what I mean explaining it and dipping my toe into I think some pretty controversial borders. So I'm not asking you to agree with me. I mean, you haven't even heard it yet. I am asking you to give it a listen and let me know what you think that'll be out in just a couple of days. And then back to our regular you know, interview type episodes next week. big thank you to my editor John Bukenas from Audio Editing Solutions. A big thank you to you as you listen, I absolutely adore doing this every week. It is such a privilege to create the show for the diabetes community. Thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days for that bonus episode. Until then be kind to yourself.
Benny 39:07
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Why do you love your pump? We asked listeners to give us short reviews of the systems they use. This is sort of a companion piece to our last episode – when we went through how to choose a pump (click here to listen). That was more about process. We talked about how you can’t make a bad or wrong choice, and this episode really bears that out.
Spoiler – every pump has big fans.
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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, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Announcer 0:22
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:28
Welcome to a bonus episode of Diabetes Connections. We're going to talk about why we love the insulin pumps we use, or really you use. I asked listeners to give me short reviews of the systems they love. And I cannot thank you enough for sending these in. This is sort of a companion piece to our last episode, we went through in detail best practices of choosing a pump, right not which pump but that was really more about process. You know you really cannot make a wrong choice here. This episode really bears that out and might be a disappointment to some of you I'm sorry to say but spoiler alert here. Every pump has big fans.
I asked in our Diabetes Connections Facebook group who loves their systems, what do you love about it? Then I had one adult with type one and one parent of a child with type one to chime in on each pump system. So these are pump systems that are available in the United States. There are only three pump companies right now, Medtronic, Tandem and Insulet making pumps that are available in the United States. I decided no DIY for this because people who use DIY systems generally know enough and educate themselves enough about their options. And their options are different, right? So these are the commercially available pump systems and they're actually for all of them. the very latest, which I didn't expect and didn't ask for, but it turns out everybody who chimed in, is using the up to the minute latest system as we are recording here in the middle of July of 2020.
If it sounds like these folks are reading, they probably are. These aren't actors, as they say they're real people. They weren't actually interviews. I just asked them to send me the audio. I gave them a little bit of a prompt, and then said, just send me some short stuff. Some people are a little shorter. Some people are a little longer, but I think you're going to get the idea pretty quickly.
Let's start with Medtronic. And both of these folks are using the 670G system.
Shelby 2:30
Hello, I'm Shelby from Elizabeth City, North Carolina. My daughter Caroline was diagnosed with Type One Diabetes on Thanksgiving Day. 2017. And she's now 10 and a half years old and thriving with a Medtronic 670G insulin pump. We got this pump shortly after her diagnosis in January 2018. I love the automated feature that adjusts the basal rates either up or down based on how Her blood glucose is trending. The pump is waterproof, which is great, since we do a lot of swimming in the summer. And if we're going to have extra activity, we can tell the pump to set a temp target which helps keep her from going low. The CGMs the continuous glucose monitor that works with the pump does not have a share or follow feature at this time. But we found a do it yourself workaround called Nightscout, which in my opinion is superior to the typical share follow function on other CGMs systems. I'm definitely excited about the new upgrades that Medtronic is coming out with, but for right now we're very happy with the overall control that she has with her blood glucose with very little need for micromanaging on my part or her part. So that is my thoughts on the 670G
Phyllis 3:54
Hi, I'm Phyllis. I'm from the greater Boston area and Massachusetts. I've been living with diabetes for over 40 years and have been using the Medtronic Minimed 670G system for about three and a half years. Originally, I really was interested in the 670G because of auto mode. Although to be honest, I wasn't sure that the system could do better than I could with managing my diabetes. But I was pleasantly surprised. One of the areas that I was really looking forward to with some help is around exercise and the systems built in temp target of 150 really took the guesswork out of my workouts. So now three and a half years later, my time and range is generally about 85% with minimal effort when I put a little bit more time and pay attention to what I'm doing and eating that easily bumps up to 90% and that equals average A1C of about 6.2, 6.3 for the last three and a half years. I feel better about everything. I physically feel better and really excited about this system.
Stacey Simms 5:06
Next up is Tandem. And both of these listeners, just like with Medtronic are using the latest model. They're using a tslim X2 with Control IQ.
Chris Wilson 5:16
Hi, this is Chris from San Diego, California. I've had type one for almost 23 years and I've used a pump for five of those years. I use a Tandem tslim X2 with control IQ. I started with the original tslim upgraded to the X2 when it was released. And I've been through three major pump software updates in that time. The thing I like most about the pump is Control IQ, which is Tandem’s advanced hybrid closed loop software. I was initially drawn to the tslim by the touchscreen user interface and the rechargeable battery. The only thing I'd improve is the cartridge fill process which is a little complicated but gets easier with practice.
Beth 5:50
Hi, I'm Beth and I live near Denver, Colorado. Our six year old has had Type One Diabetes for three and a half years. She started on an insulin pump six weeks after diagnosis And has been on a Tandem tslim for approximately a year. She's been on Tandem tslim with Control IQ for seven months. We love that it communicates with her Dexcom CGM and gives her more or less insulin as needed. The exercise mode is great for bike riding and swim practice and the touchscreen is simple enough for her to operate herself. She loves that her blood sugar and trend arrows are visible directly on the pump. With Control IQ. My husband and I have had the most uninterrupted sleep since before our daughter's diagnosis. We couldn't be happier for this technology. This pump is the best choice for our family.
Stacey Simms 6:34
And finally, the people who are using the Omnipod dash system.
Lynette 6:39
Hi my name is Lynette and I live in the Atlanta area. My son was diagnosed with type one two years ago yesterday and we have been on a pump since October of last year. We started on Omnipod the biggest reason he chose Omnipod was because he did not want a tail as he said, or tubing. We went with the tubeless pump we love that it's waterproof we love that he can shower in it believe that he we can do smaller amounts than you can with pens because he tends to need smaller amounts than half units. We love just everything about it. To be really honest, our only major complaint is that it tends to come off on pool days and we've tried lots of different options for keeping it stuck and so far we haven't found something that works. But other than that we're super happy with our Omnipod dash system.
Sondra 7:30
Thanks. Hi, this is Sondra and I live in Tacoma, Washington. I was diagnosed with type one in 2006 when I was 57 years old. I did MDI for a year got the Dexcom in 2007 and still struggled with random overnight low lows in 2008. I started using the Insulet Omnipod. I chose tubeless as I had struggled with sleep since menopause, being able to have a very low basal rate overnight has helped me so much with my nighttime lows dialing in basal rate It says made managing my type one much simpler. I love being able to do watersports and not worry about being unplugged from basal insulin. I'm looking forward to the Omnipod five which will create a closed loop with my Dexcom six. I'm hoping the FDA approval for the Omnipod five and Tidepool Loop come soon.
Announcer 8:23
Your listening to Diabetes Connections with Stacey Simms.
Stacey Simms 8:29
Thank you so much for sending those in. Isn't it interesting that it's pretty easy to find people who love whatever system that they're using? I didn't have to hunt high and low I put an ask in the Facebook group and found a whole bunch of people. In fact, I had to cut off the comments. We had so many people who wanted to say how much they loved the system that they use!
Of course, there are personal factors and preferences that come into play. So just like we said in the previous episode, you got to see these systems you got to hold them in your hand. And I do think you need to know also as you listen and you we've assumed this but just in case, all six of those folks are using a system, not just a pump, so they're using a continuous glucose monitor.
In the case of Tandems tslim, they're using the Dexcom. Same thing with Insulet Omnipod, they're using the Dexcom. With the Medtronic 670G, they're using the Guardian sensor three, which is a Medtronic sensor. It's actually the only one with the same company. The other two are separate companies with working agreements.
You can use an insulin pump without a CGM. We did it for almost seven years. Between the ages of two and nine. My son Benny did not use a continuous glucose monitor but he did get an insulin pump six months into it, at age two and a half. He just used a pump and certainly you can use it that way as well. We now use, as you likely know, if you listen, we use the Tandem system we have the X2 with the Control IQ software. We've had that since January. Benny wears a Dexcom CGM and we love it. I think it's a fabulous system. There are aspects about it that he really enjoys and prefers that you know, friends of his don't feel the same way about.
I’ll lay it out here, I've said it before. What he likes about the tslim is that he doesn't have to have an external controller. There's no PDM for it as there is with the Omnipod. He likes that it's flatter on the body. And he absolutely loves the Control IQ software, which has not only lowered his A1C significantly, it's done it with less work from him and less nagging from me, although he still argues that I may like him too much. I mean, come on, man. But he's 15. I guess that's his job.
I will say though, in all fairness and knowing what I know about the diabetes community and the technology that's out there, a lot of people feel very differently, right? There are a lot of people who prefer the flexibility of sticking an Omnipod anywhere they want on their body. They don't care about schlepping a PDM. They like that. It's waterproof. They like that they can remote bolus their kid. That's a big deal. We talked about that last week.
And for Medtronic, people, there's a lot of people who like that it's all in one (note: I mean that it’s all one company. There is no “all in one” CGM/Pump device). They like that. They don't have to go to different companies, and they like that their doctor may be more familiar with it.
Is there a downside to every system? Sure, I went through a couple of pros and cons there. But it does come down to personal preference, I am going to link up a lot more information about these systems and what's coming. Unless something really bonkers happens. And you know, the delays from COVID, or something really goes wrong. They're all on track to be controlled by phone, if not by the middle of next year, then in the next couple of years. And once that happens, and you get true remote bolusing for all of these systems, then it's really going to be personal preference. I mean, once that happens, it's going to be absolutely amazing. But you cannot buy today on promises of tomorrow.
You know that it is of course worth noting that podcast listeners are more educated and have more money than the population overall, not just in diabetes, not just for this show. That's really just podcasting. So it's not really a big surprise to me that we easily found six people using the latest and greatest. Of course, there is so much to talk about in the diabetes community when it comes to access and affordability and insurance and affording the insulin that needs to go into these pumps. So I don't gloss over that. We've talked about that many, many times before and will continue to do so. But this particular episode, I hope is helpful in seeing what people think about the technology that is out there right now. There really is no one answer.
I'm going to tell you one quick story before I let you go here. And I'm sorry, I apologize in advance to all of my rep friends, the reps for all of these companies are just like everybody else. There's wonderful ones, and there's people in it for the money. And you have to be careful about claims. And I'm not singling anybody out. I'm not singling any company out. This happens here, there and everywhere. But I was at a conference years ago, and I went over to one of the booths just to check out and see when I go to all the booths see what's going on. And the rep for this pump company said to me, if you switch to our pump, I guarantee your son's A1C will come down half a point I asked him about that. And he gave me some cockamamie answer. If I tell you more about it, you'll know the pump company. So I don't want to go into it. But I mean, it was really a stretch. But if I had been a newer diagnosed family, I think I would have been very much influenced by that. I asked him if he had any literature and studies to back up his claims, and he did not. But he said he would email me something, I gave him all of my information. Of course, I never heard from him again, the idea that switching technology can lower your a one c by a certain point, and that's why you should switch. That's a tough one. I just said that control IQ dropped my son's A1C significantly, right. But you know what? It's the whole story of him. It's not just that pump system. If we were new to pumping, if we didn't have the settings right, if he didn't know how to, you know, do certain things if he was going through a phase or something where he didn't want to do anything. If he wasn't having success with the CGM if he was getting a rash if it wasn't working For him, if it was falling off, if the pump wasn't comfortable, if it wasn't the pump he chose, and he didn't want to use it, there's a lot of things that can happen there.
Pumps are not a panacea. And anybody who tells you that they are.. I want to be careful what I say here. But let's just say they may not have your best interest at heart. So my good guy reps, and there are so many of them. And we have one who is amazing, and I love and is one of our heroes in the diabetes community. I'm sorry for that. But I think it's really important that people understand it's just like the endocrinologist who says, I'm only going to learn this system. So you can't have a separate pump, because I don't want to learn another system. Right, man, we got to fight for so much in this community.
I hope this helped. If you have any more reviews or questions about pumps jump into Diabetes Connections, the group will have an ongoing discussion there. And I kind of hope this helps you think a little bit more critically when you see these discussions in other Facebook groups, but let me know what you think. And I will link up in this episode a whole bunch of guides from different And organizations who've done really good work comparing the technology that's out there pro and con, and please go back and listen to the previous episode about how to choose a pump if you haven't already. thank you as always to my editor John Bukenas from audio editing solutions and thank you for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Benny 15:24
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
“What insulin pump should we get?” is a really common question. But it isn’t the right question, at least to start. We're turning that around into, “If I want a pump, how should I choose one?” After all, every pump out there has devoted fans, which tells you there isn't a bad or wrong choice. Stacey is joined by long-time diabetes advocate Melissa Lee and together they lay out what adults and parents of kids with type 1 need to think about.
This show discusses insulin pumps available in the US, but the ideas and conversation can be applied to any make and model pump on the market.
If you like this episode you might want to listen to this one as well: In "Why I Love My Insulin Pump" we hear from listeners who love the system they use. All three commercial systems available in the US are represented in that episode.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
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Pump Comparisons from Integrated Diabetes Services
Episode Transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:16
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:22
This week. What insulin pump should I get? You know what? That's not really the right question. You have to start with, if I want a pump, how should I choose one? After all, every pump out there has devoted fans
Melissa Lee 0:32
And what that means is that there's not a bad option. There are certainly options that might have a specific feature or style or might fit in with your lifestyle better, but there's not a bad option.
Stacey Simms 0:44
That's longtime diabetes advocate Melissa Lee, she's talked about this issue for years. And together we lay out what adults with type one and parents of kids with type one need to think about. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. Welcome to another week of Diabetes Connections. I'm so glad to have you along. I am your host, Stacey Simms. And if you are new to the show, because you heard about us or saw me at Friends for Life, the virtual conference that happened last week, I am thrilled to have you here. What a great conference that was, oh, my goodness, I hope you had a chance to participate. They had so many more people because instead of being you know, in person in July in Orlando, unfortunately, they had to go online like everything else this summer. But the plus side of that was that so many more people could participate and learn about Friends for Life and learn about this community that we've been so fortunate to be a part of for many years. Now. This isn't an episode about that. I won't talk too much about it. I hope you've followed along on social media. And please reach out if you'd like to learn more. I'm really looking forward of course, to getting back to in person appearances, but I think Friends for Life has really set the gold standard on how to do these events virtually. It was really well done.
I've wanted to do an episode about choosing an insulin pump for a while I did one way back when, and I can link it up in the comments, but you have to know if you go back to it that it's pretty dated, but it was going through all of the options at that time. And I've realized since then, that it's really not about which pump, right, it's about choosing the pump. But I know that you want to know more about the different kinds of pumps and which one people think is best. So I'm putting out a separate episode in just a few days with what I'm calling true believers, people who love the insulin pumps that they're using right now. And that episode will have a little bit more editorial to it. This week, though, I want to talk about process, you know, beyond tubes or no tubes. There is so much more to it than that. If you even want to switch to a pump at all, which you know, you don't have to do I hope this episode clears some things up and gives you tools that you can use going forward as you make these decisions.
Diabetes Connections is Brought to you by One Drop and getting diabetes supplies, you know, pumps, supplies, meter supplies, whatever you're looking at. It's a pain not only the ordering and the picking up but also the arguing with insurance over what they say you need and what you really need. Make it easy with One Drop. They offer personalized test strip plants. Plus you get a Bluetooth glucose meter test strips lancets and your very own certified diabetes coach. Subscribe today to get test strips for less than $20 a month delivered right to your door. No prescriptions or co pays required. One less thing to worry about. not that surprising when you learn that the founder of One Drop lives with type one they just get One Drop gorgeous gear supplies delivered to your door 24 seven access to your certified diabetes coach learn more go to Diabetes dash connections dot com and click on the One Drop logo.
My guest this week is always terrific to talk to in fact I just had her on the show a few weeks ago. Melissa Lee is a longtime blogger and patient advocate dogs goes with type 1 diabetes at age 10. She is known for her extensive knowledge of diabetes technology and her role as a leader in the diabetes online community. She was the former tech editor of a sweet life. And that's where I first saw our technology reviews. She also did it on her personal blog, sweetly voiced and she'll talk about that she led diabetes hands foundation as its executive director before serving as Big Foot biomedical’s Director of Community Relations. And right now she's leading clinical training content development at tide pool. So Melissa has worn a lot of hats and she is very careful as she speaks to let us know which hat she is wearing. But I saw Melissa do a technology presentation years ago and I thought Yes, we've got to have her on the show for this. Before we jump in. I gotta let you know. We do talk about insurance and your medical provider and stuff that may seem boring in the beginning here, but it really is important. I mean, who's gonna pay for this right? What's your provider going to talk to you about? These are things we have to really get into if you are here for tubes or no tubes skip ahead to about 20 minutes in when we do talk about, you know, active kids and active adults and tubes and pumps and the nitty-gritty of what you have to carry with you. But really don't skip those first 20 minutes. I really do think these are topics that maybe aren't talked about in those Facebook groups when we're talking about pumps, but they are so important. All right, here we go. Melissa, thank you for jumping on. I'm really looking forward to this conversation. I feel like I learned something every time I talk to you. Thanks for being here.
Melissa Lee 5:31
And I will thank you so much for the invitation and for touching on this topic that so many people have questions about.
Stacey Simms 5:37
One of the reasons I wanted to talk to you, in addition to knowing you've done this presentation is to know that you have used a lot of different pumps, like a dozen different kinds of pumps. Is that mostly to get the experience from how do you do that?
Melissa Lee 5:50
Oh, well, that's it's a very good story. So I got my first pump. I was 20 years old, it was the year 2000. And there were only one or two options on the market now. I went with the one that my doctor said, well, all my patients are on this one. And it was a Medtronic, I followed a very traditional pathway, I think that many of your listeners probably follow, which is I got a pump from a company, when they released a new version or a new software upgrade, I upgraded. And I went through that process three or four times. And I stayed on Medtronic pumps for nearly eight years. And they served me very well. But what I also didn't do during that time was, you know, I was in my 20s. First of all, I wasn't watching the market to see what else was developing. And I would start to hear in my late 20s Oh, you know, there's some other options. I was married to Well, you've had us both on the show, married to a technology guy who is an early adopter of many technologies and, and I really have to, I mean, in so many ways, I credit Kevin with a lot of things, but my husband Kevin said if you want to try something else, like your warranties up if you want to try something else, and you don't like it, that's okay, like let's see what else is out there. There, and suddenly I had this. First of all, I had a husband, who had more income than I've had as a single teacher, but he, you know, we had good insurance and I could say, Okay, my warranties, I'm just going to see what else there is.
Now the sidebar of that conversation is that through that I found Amy Tenderich’s really amazing piece about this is this open letter to Steve Jobs that she was written about the state of technology and that launched my entire entree into the online world of diabetes, which is a whole other story, right? You know, going and finding out Okay, so what else is out there? And so I looked at some pumps that were available at the time this would have been on 2008 I looked at the Cosmo and the Animas ping was just coming to market and so I looked at these options and I started to bravely try something new and with every time you try something new, there's this anxiety about like, Oh, God, am I gonna like this thing? You know, I've had eight years As Medtronic paradigm pump in my, under my belt, and that was what I knew was something else going to be good.
[And from there, I like once you make the jump once you get a little bit more bold in like, Well, okay, I didn't die. I liked. I like things about this experience that I like things about my first experience. So again, what else is out there? And then I began to, to write up reviews of these things for other users to read, like many of us do now that I was one of the first bloggers to be writing about some of these products like I was on my blog that is now sort of frozen in time, but like so many bloggers, I would write it about, this is what I liked about it. This is what my expectations were, this is what I didn't like about it. I would reach out to the sales reps into the company is to be like, Well, I have a question about this. And so then as I began to review, more of these pumps, fast forward, maybe four or five years, then pump companies were reaching out to me to be like Like, Hey, will you try our thing and tell us what you think of it? Would you like to do a two week trial of it? Would you like to wear it for 30 days? And, you know, I was never in a position like some folks, I was never a paid spokesperson for a pump. I was not someone who was given free pump supplies for using the product or anything. But I did get experiences with these devices. And yeah, I've worn something like a dozen pumps from six companies over the years.
Stacey Simms 9:26
My story, which is really Benny's story about picking his pump way back when it's similar to yours in that I went to our care team and said, I have a two-year-old, we'd like an insulin pump. How do we choose? You know, what do we even do and at this point in 2007, as we knew there were a few more choices back then, which is kind of sad to think about, but I let our educator kind of guide us in terms of and I said I really did say this give me the idiot-proof one that works the best, right? I just need the one that a dummy can use and clip onto a two-year-old and that will also work well for him. We went and looked and held and touched everything and decided on the Animus 2020, which then became the Animus Ping. And we went from there. But we really leaned on our educator. And I'm glad in a way that I didn't have the amount of, I guess we'll call it anecdotal support that there is right now. Because if bring this question to a Facebook group. Let's face it, you're gonna get a lot of bands for certain brands. So if the question then becomes not which pump do I use? Because we all have our personal biases, but how do I choose? You already mentioned you had a change of insurance? You had a better situation than you'd had before? Let's start there. Let's talk about insurance. Because not every insurer covers everything.
Melissa Lee 10:44
Yeah, absolutely. And it's such an important point. And it's one that we as patients and particularly if you're in patient advocacy, like I have been, it can make you angry, but at the same time, you said something important. Every pump has its fan base, as well as its detractors. And I would say by enlarge, the fan base is huge compared to the number of detractors for every single pump product on the market. And what that means is that there's not a bad option. There are certainly options that might have, you know, a specific feature or style or bike fit in with your lifestyle better, but there's not a bad option. And I firmly believe that what that helps with is the if your insurance does not cover your first choice, it's important to note that the price differential between paying out of pocket for these really high touch high tech and expensive technologies, it is probably worth it for most people to consider that if my insurance will support my use of my second or third choice. I will be in a better position to be successful on this than if I have to pay out of pocket. For my first choice, and if you have the wherewithal financially to support your use of your first choice, and it's not on insurance then by all means, get your prescription for it and proceed. But I think that the majority of people fall into, I'm going to need support from an insurance payer to pay to support my use of this product. And that is not just the product, but also the supplies going forward. You know, if you have a situation where you have your first choice pump is maybe only available through your medical benefit through the durable medical equipment benefit, and you have a terrible plan that has only you know, 50% or less coverage of your durable medical equipment, then you might consider the choice that you could get through your pharmacy benefit because maybe for you on your insurance plan, your pharmacy benefit will cover 100% or 90%. And so, as much as we as particularly in the US value this I want to be able to choose my therapy, there's a reality of the cost I think it's really important to be able to say my insurance covers this pump, and this pump. And so I'm going to choose my best option from those.
Stacey Simms 13:09
And I would jump in and say 100% agree with that, that is worth a phone call for you. I know it's a pain. I mean, we all hate dealing with the insurance companies, but it really is worth calling and double checking this yourself. We love our reps. We love our healthcare teams, but I had boy Benny’s been on an insulin pump for 13 years and there was one time when everybody assured me it was okay. And it was not and if I had called myself and gone through those hoops which think I would have realized so it's worth calling that to double check as much of a pain that it is
Melissa Lee 13:42
well you know, and you bring up an important point because you say call myself call who you know many of us start with calling our insurance company and then we find out that they don't even do the representative you may be talking to from your insurance company covers deals with a lot of therapies and benefits and you say insulin pump and they may be actually looking at the wrong thing, or they may have the wrong information. If you have identified I want a product from company A call Company A, because Company A actually has every single company Dexcom, Medtronic, Tandem, Insulet. They all have people that are dedicated to what's called verification of benefits. And as soon as you give some information to these companies in terms of, here's who I am, you don't even necessarily need the prescription before they verify this, you can be doing that in parallel, because of course, you will need a prescription for whatever you choose. But they can be looking at your insurance plan. And they have experts on the inside who are able to look this up and say, Oh, well, actually, you could get it but we're going to have to order it from this other company that's closer to you because you have a thing that says you have to order within 50 miles of your zip code or Oh, we can get it but we can actually get it through the pharmacy channel. And so they can actually they have experts who do this and they have a vested interest in getting you on their product. So they're going to work really hard to find that out
Stacey Simms 15:00
I think back to my experience, right starting that insulin pump with Benny and I needed my care team so much. I know everybody has peer groups now and online support. But I needed a device that my care team knew how to operate. And while sometimes that limits you, I do think it's really important. I guess we can talk about the flip side of that. But let's start by talking about that question of what does my healthcare team have experience with why that important to you?
Melissa Lee 15:27
Well, and I do want to talk about the flip side of that as well, because I've challenged it several times. But on the one hand, your clinicians office is probably already set up with a representative for that, for that product they use, they probably already have the software installed for that product they use, they probably already understand how to both read and analyze the data that comes off of those devices, how to change the settings, how to troubleshoot with you, as well as how to also seek their own reimbursement for it because the time that They spend evaluating the data is actually part of their fee schedule. So I do think it can be a benefit to you both in getting you on the device faster getting you on boarded to the device more smoothly, because they already have a process in place, and they have a comfort level of supporting you with it.
The flip side is, I remember when I was living in North Texas and I had this amazing endocrinologist who would just let me run out and try whatever I wanted, and she'd absorb the cost of like, whatever new software she was going to have to install, she would let me be a guinea pig. What that also meant is that if I had a bad experience on something that soured her for the rest of, you know, her patient base. If I had a good experience, without overprescribed, I felt a lot of responsibility there. But at the same time, she said she would go to conferences, and she'd be sitting at a table with nine other clinicians, and nine of them had only heard of one insulin pump brand. And so by that same token, you if you're out here As a patient or a caregiver, and you're doing your own research on what your options are, you may have done the right research to find the right thing for you, and your insurance will cover it. And you know, you want it and you bring it to your caretaker or to your clinician, who says, Ah, you know, sorry, I'm an all XYZ shop. And you actually may need to advocate for Will you let me try it? What are your concerns about it?
And, you know, we see that especially, and Stacy, you've done so many podcasts about the DIY movement and do it yourself. You know, there are certainly clinicians who haven't heard of those options. And you may actually find yourself having to make a case for why you can be trusted to try this thing that they don't have experience with. And there also may be the case where they say, Listen, I can't absorb the liability of that or I can't buy the new software that would go with that. I remember, I was the first person in my clinicians office to try the insulin pump from isanti back when they were are around and my doctor's office had to buy a whole new piece of hardware to get the data off of my device. Like that's an expense that I'm asking my clinicians office to absorb for one patient out of thousands. So yes, find out what your clinician has familiarity with. They may have also anecdotal, good stories and bad stories about like, Oh, well, I had great success when so and so got on that, but also, it's okay. If they haven't, there are ways to convince them to consider allowing you to try this.
Stacey Simms 18:32
I wonder, too. I mean, right now, there's only unless I'm wrong. There's only three commercially available insulin pumps in the United States. Right. So three brands, okay. That is correct. So there's only three brands and we still hear about endocrinologist, and I think it's mostly adult endos. But we still hear some pediatric just anecdotally, who are, I'm only this guy. I'm only going to look at that stuff. And it can be hard I think for a parent of a young child or a young adult. Who's not used to advocating for themselves to say you? Well, I want this other one. I'm curious Lissa, someone who has advocated very well for herself. What do you do in those cases? I mean, I know what I would say. We're pretty outspoken people.
Melissa Lee 19:13
We are and many, many books have been written about sort of the paternalism of the medical community and how it can feel like what the doctor says goes and I don't want to challenge that I don't feel comfortable. When I'm like, half-naked with a paper gown sitting on butcher paper, do I really feel like fighting right now with somebody in a lab coat with a stethoscope and like a kid but there may be an increase to ask of you, in order to prove yourself to this clinician about this and in terms of Do you have blood sugar logs to give them Do you have CGM data to give them Can they see the data they would need to know that they can prescribe this product that is new to them and they would get insights Back to know whether they made a good choice for you. Do you have the kind of relationship with them or like, Listen, I'll schedule an extra phone call with you, I will prove, you know, I have this great literature I could send you and I've known people to sort of print off white papers and drag them into a, you know, a clinical paper, really, from a research journal and be like, Look, look, it's a valid option for my situation. And the same holds true for if you know, especially for parents who might want off label use, like maybe your child is below the indicated age, or there's some reason why, you know, same holds true if you're a person with type one and you want to take a drug that's indicated only for type two and how do you make that case often there is an ask of you that is, am I going to be able to give my glucose data and my maintenance and management visibility to this clinician so that they will prescribe this in a way that doesn't reflect poorly on them. And if they can feel like okay, I will have the information I need on this. And I would also say it's important to note that it's actually likely a minority of people with type one who were treated in these facilities where they even prescribed these products, right. So let's say you're treated by a general practitioner, and maybe they've heard of an insulin pump before, but maybe they don't even know what the brands are. And so you're going to need to be able to put something in front of them that allows them to feel confident in prescribing,
Stacey Simms 21:30
I was going to definitely talk about documentation, because we've already mentioned Facebook groups, I would not recommend the Facebook group printout to bring to your endo, that's not going to do it. And you laugh, but I know I know, sometimes that's the end. It's sometimes the best information. I mean, sometimes it's the worst information, but sometimes it's really good. But what I would recommend is, you know, find that diabetes forecast article that talks about all the pumps that are available, find the, you know, the diabetes minds to find the different comparisons that are out there, and I'll link up A few In this episode, you have to stay current on it because things are changing. But articles like that documentation. research articles, as you mentioned can be really helpful because then they have some meat. It's not just me going in and saying I heard about this cool thing. I want it for my son because it has a blah, blah, blah. You know, now I'm really backed up.
Melissa Lee 22:17
There are a couple of resources to use. Yes, absolutely. Like the diabetes forecast, diabetes, mind diatribe like where they've written about these products. But there's also a really cool, fairly new website that some behavioral health researchers out of Stanford like Cory hood, and the Helmsley Charitable Trust in New York City put together it's called diabetes wise.org. And you can go in and sort of say like, what am I looking for? What are my options? What's out there? How do I choose and so some of this is actually on diabetes wise, and I think they've done a really nice job. I think they plan to do more with it, but I really like what they have so far. And then as well, you can go each of the websites for instance, we said in the US it's Medtronic Tandem and Insulet each of those websites has a provider version of the website for your healthcare provider where they could go and get information as well. And you could give them that URL.
Stacey Simms 23:11
So let's start talking a little bit more about, you know, we were at this esoteric level and then just kind of dial it in a little bit more. Because, you know, the questions that I see the most are, you know, what would you recommend for an active three year old? You don't like there's no, I mean, that makes me laugh all the time. Because I don't know any three year old who's not super active and running around. So I always want to say what's the best pump for a chilled out? Relax three year old. Let's talk about type of pump. I always think that somebody should really think about how they will wear an insulin pump. And I do think you don't know until you do it, what you might like or what you don't like. But I mean, let's just talk about tubing for a moment because I personally feel and I've never worn insulin pumps. So I am a parent. I am not a person with diabetes. I feel like this seems to be much more of an issue than it actually is for most people, and that there are pros and cons of both, that most people don't think about at all. I mean, my son, gosh, was two years old when he started a tube pump bonkers kid, you know, super active, did tons of activities, and I would say probably got his tubing caught, you know, once in a while, just as much as his friend with a pod got his pod knocked off the first month that he was wearing it. But to me the tubing, I don't know, there's other things to think about. There's, you know, where on the body, you're gonna wear it, how much real estate it takes up, you know, that's why you have to kind of look at this stuff. And also, I'm getting in the weeds here, Melissa, but when you have a pump without tubing, right now, with the commercial availability, you need a separate controller. So these are all things to think about.
Melissa Lee 24:47
Such an important point I don't think people have ever I'll say honestly, I don't think people have ever believed me that tube versus no tube doesn't really matter. And what I will say is that That's a yes and. And to some people, it very much matters. And you know what, even if that is only in their perception of it, I absolutely grant that that is an important perception. What I will say is that there are what I often describe as, so I started I was on a tubed pump for nine years, then I was on a tubeless pump for three years. And I was on a tubed pump for two years that I was on a tubeless a year and like, so I've done both, right. And, you know, I think the folks at Insulet are fantastic, but I remember early on this is more than 10 years ago and me going to them and be like, Well, why is your pump great? And they're like it's tubeless and I'm like what else and they like it has no tube. You know, give me I'm okay with the tube. So give me another value props and now of course they have fantastic value propositions and they market that much better, but, you know, no dig on them. But the fact of the matter is, is that we wear glasses, wedding rings, wristwatches, smartwatches, earrings, there are many things we have To our bodies, that the first time you wear them, you're like, Okay, I'm so aware of this thing that I'm wearing. And then over time you feel naked without it, right? You know, you look down, you're like, I just I knew something was off, I'm not wearing my ring, or I'm not wearing my watch today. And a tube on an insulin pump is very much like that. And there are athletes in every sport, wearing every brand of pump available today. And so I don't believe that how active you are, should necessarily dictate whether you go tubed or tubeless route. I think that it's more about your perception of tubing and there is a real negative connotation about what it means to sort of, quote be hooked up to something like and so for if you are someone who can't like who that is a mental hurdle for your body awareness or for thinking about your child than great, you have a tubeless option, but what I would not ever say is that Having a tube is somehow limiting. Because like you say, there's the other side of that coin of, you know, if I'm wearing my tube pump, and I don't have my controller nearby, do I have access to do all the things I want to do? Or you know, the same thing, like just having the tubeless option make me feel like I'm freer or like, I don't have something attached to me, or does having the tube option make me feel like it's a lower profile, and I can tuck the thing away in my pocket. It's like, for many people, it's more about what your personal comfort level is. There is definitely not a huge difference in lifestyle, between a tube and a tubeless. And I think you and I are really aligned with that.
Stacey Simms 27:43
I would also add, we've said tubing and if you are listening and you have used the word or heard the word wire, instead of tubing, I do think it's an important difference, because to me, it's not a wire and wires are something completely different. And I do think that that's a really Interesting. I don't know how that started. I don't know if somebody's way back when I thought it was a wire, but it's a tube. It's a very thin plastic tube that if you're my son, you can swing your pump from Please don't do that. Why do you do that? You know, or it's it's but it's very thin, it doesn't conduct electricity. It's not a wire. So I just kind of want to get that out.
Melissa Lee 28:20
That that makes me think one of my favorite comedians Chelsea Reiss talks about he has a joke about the bedroom and getting a cot and a ceiling fan and having it swinging around. It's hilarious. I'll just leave that considering I don't know how general your user or your listener,
Stacey Simms 28:36
I appreciate that. I appreciate that. But
Melissa Lee 28:38
Yeah, so you know, there are things to think about many people when I was 20. And so my endocrinologist in the late 90s started pushing me to get a pump and I want to say that very clearly. I was pressured to get a pump. And he would say, well, all my type ones are on a pump. And I would say, Well, what does that do for me like That's good for you. Why do I have to fall in line? And for me, I thought it for about two years. And then I was in college and I met a girl with an insulin pump. And I suddenly found that I had this series of questions that I never would have asked my older male endocrinologist in his role. They were questions like, Well, how do you sleep with it? And what do you do with it when you're naked? And when you go to the bathroom? Like, do you have to move the tube out of the way? Like, how does that work? And do you lay on it? And does it hurt your back and like all of these questions that I needed to ask someone else who actually lived with it? So that's where I think our groups online things like Facebook and Instagram, where you can actually see what people's lifestyles are? and answer the question, you know, and short answers for everybody is you just deal with it. Like you just move it out of the way if you lay on it and it's uncomfortable, you roll over, you know, you toss it in the bed next to you, you unplug for a bit like there's lots of answers to lots of those questions but for me, but the important part was, I was being pressured to use one If I needed to speak to someone who knew what it was like to actually use it, and that was the trigger for me as soon as I met her, and I saw what her life was like, I was like, Oh, I can do this, this is no problem.
Stacey Simms 30:11
And we're going to get to the answer of I don't want to use a pump. And that that's okay. Let's talk about that. I'm gonna make a note. We'll talk about that quote towards the end of this, but to kind of flip around the tubing question. One of the other questions I think people need to address in terms of like, how they live or how they plan to use a pump, what they think about a pump is thinking about the remote bolusing and the remote operation of the insulin pump. Because I gotta say, Man, I missed that animus Ping. Now my son is 15. So I don't do as much with him. I mean, I never quote bolus him anymore. I mean, he does everything himself with our support. But there is something to having a toddler and not having to go over to them and take the pump out of the belt or out of the pocket and being able to just dose from across the room. Now I know and we should also talk about this, we should talk about future technology and processes and what's to come. But I think it's a really important thing to consider. Can you do it and be just fine? Yeah, Benny had a regular old pump that we had to touch from ages two to almost six, because that very first pump we had for four years was the animus 2020, no remote. So we bolused him in his car seat, and you know, in bed and did all that stuff. But when he was six, when we did get the remote meter, it was very freeing. And I have to say, I really liked having that. I'm glad we can, again, it's coming for the different pumps in the future. So I'm glad about that. But I think we do have to focus on what's available now. I thought we solicited an adult, I think of something like that. I mean, in terms of taking the pump out or wanting to remote bolus,
Melissa Lee 31:45
Yeah, that's huge. You know, when I was working for Bigfoot biomedical, we were doing some market research in social media where we asked people like where do you wear your pump and a lot of people reported I wear it clipped to my underwear, I wear it inside my skirt and wear it in a bra. And it was a significant population wasn't majority, but there are plenty of people who prefer to keep a device tucked away whether for their own personal discretion and their job, or maybe safety, you know, maybe they're likely to get tubing or a pod knocked out. And so I think that there were a lot of women for instance, who preferred who really liked the Animus ping and struggled with the decision to move up to the Animas vibe because the loss of that remote bolusing One of the things that I think is, you mentioned future technologies, and with full disclosure, I currently work for tide pool and tide pool is working on a product and development that would allow you to remotely bolus from your phone like so I need to fully disclose that that is literally what I work on for my day job. That you know, I think several things have happened both the Animus product and then which was commercially available, and then In many of these DIY solutions, and then of course Insulet Omnipod with the PDM, the personal diabetes manager that allows you to, to bolus, we've seen that there is a market need per se, as was we'd say in marketing, like there's a hunger for people to want to bolus with more discretion. And, you know, for those who aren't comfortable, let's deliver a dose of insulin at once, with this feature. And so these things are coming, you know, tandem diabetes just released an app that in future iterations they plan to include some degree of remote control. Insulet is of course iterating on their devices that allow for this, and Medtronic has put forward pipeline goals that they plan to get there and so and there are many products and development and products outside the US that allow for that remote bolusing like outside the US diableloop has that as well.
importantly though, and you said it, we have to base our decisions on what is available now and one of the things that I say With love in my heart for every sales rep I've ever worked for is never trust a sales rep. To tell you how soon something is coming. I remember so many adequate so many cases where people have been promised the next gen of whatever it is they use for going on 5,6,7 years. Oh, it's coming next spring, it's coming next spring. And the thing is, unless they can show you where they already submitted it for FDA review, it is more than a year away, right? And so and even then it might sit with the FDA for additional review for a longer period. And so unless there's a launch date, choose from what's available now. You can we get locked into this idea of like God, if I make a decision, I'm making this for the next four or even five years because of the warranty. Yes, you are, but you can't base it, on hope and dreams. You have to say if I'm getting one today, these are my options. And I can guarantee you that if there's a new option a month from now there will be at Upgrade pathway for you. But there is, you know, in many of these, all three of the companies that have stuff available today in the US have trade in options. And it might be, you know, you might not get the full value of the products with your trading, but I don't believe that you're stuck forever with the thing you chose. And we worry so much about buyer's remorse. Like if I get this thing, and then the thing I really wanted comes out in two months, I'm gonna be so miserable, and there's a pathway to get you to where you want to go. I believe that.
Stacey Simms 35:29
Another question I think people need to think about is, again, my perspective is as a parent, but it's what do I carry on a daily basis? You know, if I'm on multiple daily injections, or I'm using a particular insulin pump, what do I already schlep around with me and am I willing to carry more or do I want to carry less and I see this not as a good parent who makes her child take full diabetes stock with him everywhere he goes, but as the terrible parent that I am, that lets him run out of the house just with His Dexcom His pump and some hopefully Smarties or Skittles in his pocket, he would not want to have to carry extra stuff with him. Now, if he goes for an overnight or if he's gone for longer, he's got to take pump supplies, he’s got to take a backup insulin pen, he's got a whole kit. But just in terms of heading out for a little while, or, you know, being the 15-year old that he is he can get away with carrying less with the technology that he has. If you've got a teenage girl who perhaps takes a purse everywhere she goes anyway, that might not be an issue. But I do think it's kind of important to acknowledge that real-world kind of stuff, Melissa, that's one of the questions I urge parents to think about.
Melissa Lee 36:35
I'm smiling so big Stacey, I'm gonna put two hats on okay with my first hat. I work for a medical device software company and I'm writing the instructions for use for a future product and development. And I must say that it's very important to note that anytime you leave your place of residence you should take glucagon glucose tabs, a full meter kit, a backup, backup cartridge or reservoir pod. Some syringes, some insulin, your mother's maiden name like, Yes, I was really you should be prepared. And you know, I love blogger Scott Johnson talks about the caveman who lived and he talks about like, people with diabetes. We are the evolution of the caveman who lived the caveman who came out of the cave in the morning and said what do I need to do today to not die and we're really good, especially parents of kids with type one are so good about planning for the all those eventualities. Now I'm going to take that hat way off and toss it under the bed where it can't hear me and say that the reality is you or your child will find a way to screw this up. No matter what. You give me a pump that has batteries, I'll run them into the ground, you give me a pump that has rechargeable battery, I will forget to recharge it. I will lose the cable you give me a pump that needs to be thrown away at the end of three days and I will let it expire and then go six hours before I remember to change it. So trust in your teenager or your child to mess this up, it's fine, it's going to happen. There's no foolproof way to prepare for all of those individualities. At the same time, like you said, I feel confident leaving the house wearing only my pump and CGM, like I am, which I can look at on my phone. I choose not to carry a meter and a land set and strips and additional insulin. But I mean, I'm sure Benny has stories like this as well, that you know, there have been cases where that bites me, right. And one of my you know, I do music video parodies and one of the ones I did was about being at the office and running out of insulin and not being able to eat lunch until I go home and take care of it like these things happen. And you can just like with diabetes today, you can choose to leave your supplies at home and absorb whatever risk comes along with that. But the nice thing is, is that Yeah, you can wear your pump and leave your home and It continues to just pump along, pump right along with insulin.
Stacey Simms 39:03
But you made a great point, it doesn't matter what brand of pump or type of pump you decide on, you are going to mess it up. And you're going to have situations where it gets a little hairy and nine times out of 10 you're gonna just MacGyver something and be fine, regardless of pump type.
Melissa Lee 39:19
Yeah, you know, for me, I had a situation, you know, I mentioned I was 20 when I started on an insulin pump. And just to give you an idea of what I understood about diabetes as a very bright top of my class, 20 year old I'm just gonna say I was it wasn't completely brain dead. I was brand new to a pump. And I actually, I had, you know, as a musician, I had several gigs booked one after the other at this church where I was going to be singing for the day, and I arrived at 7am and booked until one o'clock, and I looked down and my pumps out of insulin. And I think to myself with my 20 year old brain and my knowledge of diabetes, I thought it should be fine because I used to go hours Between injections. And what I didn't understand was the difference between how a pump delivers insulin and how my long acting insulin that I had taken at the time would have had this undercurrent of coverage for me. And so I get sicker and sicker as the day proceeds. And by about 12:15 I'm standing up in front of, you know, maybe 800 people, and I just collapsed. Just done. My blood sugar was super high, I was out of energy. I was dehydrated, just, I just decided to lay down behind the pipe organ and you just see my feet sticking out the end like I'm the Wicked Witch of the East under the house, right. And, um, you know, the organist pops up off the bench and start singing the Gloria to the congregation of Catholic parishioners and, well, you know, I learned an important lesson that day Stacy. That you know, the fact of the matter is, is that we are going to make mistakes, especially your kids and I am fortunate that I you know, I was not in DC I did not end up at the hospital, and they will learn these things as we go. And as those frontal cortexes start to develop, those things will actually be able to be applicable to how they manage their diabetes.
And I think some people and this is an important point to make about, if you're new to pumps, some people are really afraid. Like, what if it fails? Yeah, it's another device like sometimes my phone doesn't power up like I want to sometimes my household robots don't respond when I say their wake word or whatever. And like, yes, it is another device. And that is why in here and putting my industries hat on, that's why they take a long time to get to market because so many fail-safes are put in so many considerations are made about what the risks to the users are. And that's why you carry backup supplies and that's why you have a backup solutions but at the same time, pumps can provide a lot of benefits for being able to kind of tweak your own care. You know, one of the things I often say in these presentations that I Do on technology is, if you are a pumper, you're actually in the minority of people with diabetes. And even with type one, even insulin users, you're in the minority. And so if you choose not to do it, you're choosing the standard of care, the standard of care is that it's perfectly appropriate. I spent my first 10 years with type one on injections. And that's a perfectly fine way to choose to do it. A pump affords you different options. And for me at age 20, the thing that a pump did most for me, was allowed me to, like choose not to finish a meal or to have seconds or to order dessert after the fact or to graze at a buffet like for me, it was about like, it was just less hassle at meals, and that's how it sort of started. And I liked that and I didn't mind the body image perceptions that it might change. It was that was not an issue for me. But for others it really might be.
Stacey Simms 42:57
I think a good reminder to about pumping is it's nothing surgically implanted. So if you change your mind, it is an expensive brick, you did use your insurance, you did go through a lot. But if you're six months or a year in and it's not what you want, and you prefer multiple daily injections, you can take it off, you can take a pump break, you can do what you've done, perhaps and tried different models, if you can figure out a way either way ensures we were able to switch once for medical necessity, we were able to talk to an endocrinologist and my son was using enormous amounts of insulin. I've talked about this, you know, just what he loves when I talked about puberty when he started into puberty, but he really did use a lot of insulin and the Animus didn't hold enough. And we were able to get coverage to switch to a different pump that held more so you're not always locked in but you're definitely not locked into not going back to shots. And I think that you know that just to make the point that it's okay and shot technology is improving every year. Absolutely. I think it's worth looking at to.
Melissa Lee 43:57
You bring up another important point like we and you said this early on with when you were in your buyers process your customer journey with Benny's first pump. Like, if you have not held that pump in your hand and pressed the buttons, then please do not buy that pump. There are representatives in your area that can meet with you from any of these companies, your CDE, your endocrinologist, somebody has a pump in a drawer somewhere. And you need to know what it's actually like to operate it. You know, for me, and this is a weird thing. And I've never met anybody else who felt this way. But for me, when I was first looking at the animus ping, there was something about the refresh rate of the screen that bothered my eyes. And like that's not something I would have known for their product literature. And I was just like, yeah, you know, it's I don't know, it's weird. I don't, there's something I didn't like about it.
Stacey Simms 44:43
Yeah, important.
Melissa Lee 44:44
But like if I had never pressed the buttons on it, I wouldn't have known. There are pumps that there are people who prefer a color screen or a lighted screen or a screen that's more visible in sunlight. You know, there's just so many things that until you've held the pump played with it. It's, it's like driving a car without a test drive. And this is a big commitment you're making. And I think it's perfectly appropriate to demand that you get that pump in your hand before you order it sight unseen.
Stacey Simms 45:12
We're getting long here, but I don't wanna let you go without asking. You had two points that I think really are wonderful. And that is the question to ask yourself, What do I love about technology you're currently using? and What don't you like about what you're using? Can you kind of touch on how to ask yourself those questions? Oh, absolutely. You know, a lot of people. And I think this is fair to assume when you see people out there, and maybe they're bloggers or influencers, or you've heard their name before something and you assume that they're out there, and they're being paid to promote the thing that they wear and I am not that and I have no problem with that. Like I believe companies should actually seek spokespeople who live their lives with the product and can speak to the experiences they're having. What I am, is a person who has used many of these products and I like to sort of break them apart and say these are the good things and these are the bad things and they all have good things or bad things about them. They've all nailed some features and failed some other ones. And so people approach me and they're like, what pump should I get? And they think I'm going to say you should get the pump I have. And I rarely say that and said, I say, Well, what are you looking for in a pump? What do you love about the thing you use now? And often like if you told me that what you loved about the product you're using now and it was the Animus ping and you're like, I love that I can bolus him when he's under the covers and I don't have to pull this pump out then I would say well then here are your options for that. Like there are DIY things where you can do that there's the Omnipod where you can do that and like those are the things you should go look at. And if you told me what you loved about it was what I really liked the security of a tubed pump because the way he's been able to use it and I like the color screen then I would say oh, you should definitely go look at tandem’s TSlim line because they have those things and so you know, depending on what you like about the thing that you use, look for that feature, specifically In your next thing because you're going to miss it terribly whatever that feature is that you love. And then the same thing. What do you hate about your current system? Like, are there too many lines on the screen? When you scroll through it? Do you hate all the confirmation screens that you have to go through? Do you hate the CGM that it pairs with? Like, what is it that you hate? Okay, we'll look for one of the pumps that actually resolves that and talk to people and find out whether that specific thing that you hate about it resolves it because if I go into a Facebook group, and ask 3000 people what pump should I get? Everybody's gonna say, you should get my pump and then a few people are gonna say, Oh, God, don't get the pump I got I hate it without thinking about what your individual situation is. And so I think it's more a case of we don't know what questions to ask ourselves. And so we just ask it broadly, and the questions are, what am I looking for? What am I looking to resolve? With what currently bugs me? You know, I had a friend reach out to me once and she said, you know, my child uses the Omnipod. And he's having lots of site infections with the canulas. So site changes, he was a very young child site changes have been horrible. And I was thinking about getting this other pump. And I said, Well, tell me about that more. And as she explained it, she was like, well, I thought if I got a pump that didn't have a hardcoded expiration at this 72 or 80-hour mark, that I could leave a site in for longer and go more days in between site changes so that it wasn't so anxiety-inducing for him. And I was like, okay, you just told me your child's having a lot of site infections, leaving a Canula in longer to go longer in between is actually not what you're looking for. Maybe you should stay on what you have. And it would be fine if she went the other direction, but it was what exactly are you trying to solve by changing?
Stacey Simms 48:53
Yeah, when we were looking for a pump, I knew what we were trying to do. Because Benny was fine with shots. I mean, the first two weeks, were called But after that he as long as we didn't stop him from playing or eating, he would like stick his leg out or close arm out. He didn't care at all. And he's ambidextrous, which we learned at this time. So he really didn't care. He was getting like eight shots a day we were on our endo had us on a routine where he could eat whatever he wants, and we just, you know, we bolused after and it was a routine that worked really well for us for six months. But I wanted an insulin pump because he was getting such teeny tiny doses that we were not even close. You cannot measure with your eye, a quarter unit of insulin in a syringe, at least I couldn't. And we were really struggling with big, you know, swings because of the dosing. And working with our endo, they recommended an insulin pump for the flexibility and precision. And that made sense to me. And boy, did it make a big change when we were able to really dial in a quarter of a unit of insulin as a dose for my little guy who's now almost six feet tall. But if you can't answer that question, right, why do you want to get an insulin pump if the answer is because everybody else has one, put it in a drawer, think about it later come back when you really have a need. And I'd also say, Melissa, and this especially for parents is if your child is old enough and old enough means different things to different people, they really have to help decide if not totally decide.
Melissa Lee 50:17
Absolutely, it just absolutely. And I would say, if your child is old enough to talk, they're old enough to have a say in this. And I have two children. So I know how early that starts to happen. But so my children don't have diabetes, and they do take medication for another condition. And the fact that they take medication like that is a constant conversation I have with them about the why and how do you feel about it? And the Do you feel like it's helping you and in these conversations that I think that we are, particularly as parents, we're so quick to want to solve things for our kids. We're like, oh, there's a technology out there and it's better than shots. So I'm gonna put this on them and Your children will do best on a therapy to which you have their buy-in. Like, if you really like that pump a has feature x and feature x is not important to them because feature y on this other pump is so much more like okay, that pump comes in pink and that's what I care about. Like Yeah, the pump that comes in pink, then honor that because again, they're all good options.
Stacey Simms 51:27
That's exactly that's a great point. It comes in pink,
Melissa Lee 51:31
But you know none of them do anymore to like now you have to get like a rubber skin right? Think about it Tandem 670 g like, there was a time you know, 10 years ago, every pump company had five or six colors that would come in and better believe I hate that. I can say that. You better believe that mattered to me. It's like oh, you know, I like purple but I don't like their purple.
Stacey Simms 51:53
But it's important because it is not just something that sort of this way it's important because think about how much stuff we do with our phones, right? We all decorate and put skins and screenshots and pop sockets. It's the same thing with an insulin pump. You know, some people don't care at all. But some people, if I were insulin pump, I would have different things for every day of the week. I mean, I get it. And my son used to care a lot more, we had different skins and he had pink and he had purple and camo. And now like I said, he just got makes me crazy just shoves in this pocket. So let's go from one, one kind of extreme, which is might, you know, pink to another. We mentioned earlier, don't buy anything, don't make decisions on future promises. But I do think it's important to listen to talk about the most recent stuff, and by the time this comes out, something else might have been improved, who knows. But the software, the inner workings of these pumps is changing. And thankfully, it's changing at a pace that we hadn't seen in the previous 10 years. And I think it makes it almost more difficult to figure out what to get right because somebody might really want a tubeless pump, but then they see that and I you know I am guilty of this too talking about how much I Love control IQ, which is only with the Tandem right now. And there's DIY stuff, which, you know, I'm very vocal about this. I love all the DIY people, but we have never used a DIY system. It's not something I'm comfortable with. So what's your advice for people who are just kind of intimidated or thinking about the different software systems now?
Melissa Lee 53:18
Sure. It's such an important question, I think. So it's only been and it's funny to those of us who are in the thick of this, especially myself, I've been in industry now for four years. It five years it's been a while there is this. We're in the very, very infancy stages of automation of insulin dosing. And so for years, this was a promise we were going to get there commercially. And now we have two systems commercially available. We have a third system, the one from Insulet, coming just out of clinical trials, so we can expect that we'll probably see it go to FDA in the near term. So there is this now it's not just get a pump. And a pump is a different way to take insulin, which that was my standard line for many, many years. It's just a different way to take insulin. It’s an electronic syringe. To now it's actually dosing you for you. It's actually it has some degree of intelligence, that is changing your doses, without your say, right. And so now it's like, well, now there's this whole, like, Is it a quality of life upgrade if I get this product? Or now what if I, I don't understand how to read like this algorithm? First of all, what does algorithm mean? And this one has an algorithm that does this, and this one has an algorithm that does this, and I don't know like, it could be green could be purple. I don't know how to, like, I don't know, I don't care, too, which I will say, as someone who has had to write extensive documents about these algorithms and such. I will quote my dear friend, Lane Despereaux, who says all these algorithms work. They're all the same. It's I mean, they're not, but they are. They all work. If it's coming to market, it's been deemed safe to use. And you have, there are tiny, tiny details where if you are the person who cares about those incremental details, you probably are the person who actually understands those incremental details like, you know, how will it drive me to a target glucose? And how do they do it differently from one another. And the fact of the matter is, they both do it. And so the goal of any of these systems is to try to keep you at a glucose level that's safe for you. And they do them differently. But they all do it. They're all fine. And if you are trying to get into the nitty gritty, you're going to hear people's success stories and you're going to hear people's horror stories, but they don't live your life. And there is no one out there who is the exact like copy of who you are with your situation and your child's situation, to know whether or not the experience they have is experience. You're going to have And to that end, you know, your, your doctor may have some information on these, do you really want to go through and read the clinical trial data? Would you understand it? If you did? And what would you actually extract from that that was important to you? And this is one of the things that I see in the sort of, you know, and I love my DIY brother in like, that's a cut my teeth in DIY in many ways, and but like if we're just going to slice up people's algorithms to try to decide which one's going to get you to a 6.5 instead of a 6.6. A1C, like, Is that what you care about? If that is what you care about? Go forth and slice, slice those algorithms read those white papers, that's fine. But what do you actually care about? And when you ask that of people, they're often going to tell you, I care about whether I can think about it less. Right. Okay, so what details about this system are going to tell you whether anything about that lesson or not. And it may be well, you know, my sister's kid has one and she really likes it. Okay, so great. Does your insurance cover it? Go forth? Yep. And that, if I'm trying to choose between a, like a Toyota rav4 and a Honda CRV, like I can get down into the nuts and bolts of the horsepower. And I'm gonna say a lot of words, I don't understand, you're gonna notice I'm maybe, like, what is the torque? I don't even know what torque is. But you know what I mean? Like right? If you're the type of person that cares about that, then great. Do you need to care about that for your insulin pump system? Or just really like the red one?
Stacey Simms 57:29
Like, there's also and there are a lot of people who will choose between those two vehicles on what's the safety rating and how close we live to the dealership? Yeah, right. You know, there's all sorts of different ways to choose these things, knowing that they all work really well. And then you're just talking I think a car is a great analogy.
Melissa Lee 57:45
It is, well you know, you either want that middle row seat or you want the extra cupholders. So which one is most important to you? sign the form and send it away and then don't freak out that you made the wrong decision because all decisions can be unmade. You can always go back to the thing you were doing before, you can always find a way out. And I say that even acknowledging the privilege that I have. And I do want to make that clear, like I have a privilege to be able to afford a different pump. If I, if I really wanted one and whined enough to my husband, he would be like, fine, fine. But the same thing is just like with a car. Okay, so you may have to drive it for a while. It's not the right thing. You can't Well, I can't say you can sell it because it's a prescription medical device. But you know, there are ways through this. And I think we get really caught up on whether or not we're making the right decision. And it may just be that there is not a wrong decision. And whatever you make is likely the right decision for you.
Stacey Simms 58:43
Melissa, thank you so much. We could definitely talk for another hour about this, but I think we've covered at least the first go-round as best we can. But I really appreciate you spending so much time with me. Thank you. It's
Melissa Lee 58:54
always lovely to talk to you, Stacy. And I hope that this can help people. At least take a breath And they'll still post but yeah, but should I get that and that's fine, that's fine. It's okay to ask.
Announcer 59:14
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 59:20
I'm so sad to know there aren't pink pumps anymore. I didn't even think about that. It was so important when Benny was little I mean he wanted the blue pump but then we got a bunch of skins and covers that he could change it to whatever he wanted to and Animus had great colors right that was part of their marketing all those that rainbow color scheme of different pumps. Oh my goodness, I guess it you know, you can bring out whatever you want. Any option of pump can be blown out. That's, that's not really what I was going for. Any option of pump on the market right now can be decorated any way you want. Please go ahead and share this episode. Yes, it was a long interview, but there is a transcript. And I do think this is a really important topic. That gets kind of skimmed over when people say, just this pump, or just that pump, or I love this one, or I hate that one, or should I even get a pump, and that bonus episode is coming with those true believers. Those super fans who do love the pumps that they use Diabetes Connections is brought to you by Dexcom. And it is hard to think of something that's changed our diabetes management as much as the Dexcom, share and follow apps. The amazing thing to me is how it helps us talk less about diabetes. It really is so wonderful. It's so great about sharing follow as a caregiver, a parent, a spouse, you know, a friend, whatever, you can help the person with diabetes manage in the way that works for your individual situation. Internet connectivity is required to access Dexcom follow a separate follow app is required. learn more, go to Diabetes connections.com and click on the Dexcom logo.
I mentioned Friends for Life at the beginning of the show, I need to let you know and I've put this in a Facebook group and elsewhere on social media but just so you know, I'm doing a special promo code for the world's worst diabetes mom for my book, if you order it from my website from Diabetes connections.com, use the promo code ffl2020. And you're going to see $4 off the cover price. This is a pretty big discount. I don't think I've done a discount like this. Since we launched the book last summer at Friends for Life. We did a pre-sale a couple of months before the book came out. And this is a big one. So it's $4 off promo code is f f l 2020. Of course, it's always available at Amazon and Barnes and Noble and target. There's an E-book and the paperback book and the audiobook. That's all over the place. But I wanted to make sure to let you know about the discount and the promo code for Friends for Life. All right, bonus episode coming in just a couple of days on those true believers in the pumps that they love and then back to our regular Tuesday drop if all goes well, I'm Stacey Simms. Until then be kind to yourself.
Benny 1:01:59
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged.
Tandem presented new studies at the recent ADA conference and got approval for some of the youngest people with diabetes to use their newest tech. Steph Habif is Tandem’s Senior Director of Behavioral Sciences. She shares what those studies found, gives us more information about Control IQ and touches on what products are up next for the company.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Listen to our previous episodes with Tandem Diabetes
In Tell Me Something Good, great news about college scholarships for students with type 1.
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Episode Transcript:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom , take control of your diabetes and live life to the fullest with Dexcom .
Announcer 0:16
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:22
This week, Tandem presented new studies at the recent ADA conference and got approval for some of the youngest people with diabetes to use their newest technology. But Tandem is also keeping a close eye on including many more people in future studies.
Steph Habif 0:37
It's a shared responsibility across many communities to figure out how to make it easier for different types of people to be included in this research.
Stacey Simms 0:48
That's Steph Habif, Tandem’s Senior Director of Behavioral Sciences. We'll talk more about what communities she means there and why Tandem wants to reach out more. And of course, we talked about Control IQ And what's next for Tandem? In Tell me something good great news about college scholarships for students with type one.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I am so glad to have you along. I am your host Stacey Simms. We aim to educate and inspire about diabetes by sharing stories of connection. This time of year we are sharing a lot of stories about technology and studies and that is because the American Diabetes Association Scientific Sessions conference has recently concluded so every year at this time, there's new information.
Sometimes it is also timed with FDA approvals like we saw last week with the Libre 2 and with Tandems approval that we're going to talk about for the Control IQ software to be used down to age six. It means a lot of information. It means some bonus episodes, it means some playing with the schedule. Because just trying to get this information out in podcast form can be a little bit more difficult. But you know, that's what I am here for what I love to do
If you're new, my son was diagnosed with Type One Diabetes right before he turned to my husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting and local radio and television news. And that's how you get this podcast. And just a quick note about my son Benny, I realized the other day, so we're 13 and a half years in with type one, which means we're coming up July 4 which his 13 year anniversary of wearing an insulin pump, which I cannot believe and I remember it like it was yesterday. So I'm going to maybe do an episode or talk about that in another episode, looking back on what's changed and you know how to pick an insulin pump and all that kind of stuff, but oh my gosh, oh, I can't believe he's 15.
Speaking of Benny, the world's worst diabetes mom is now available in more places. My publisher reached out to me. We are now sold online at Target and Barnes and Noble and pretty much expanding to every place You can buy a book online, I didn't realize this was a thing that we started on Amazon and now we are elsewhere, which shows that it's a good thing that I have these people to help me out. But it's also available in library form. And I'm still investigating this. So as you listen, if you get ebooks, that's the library form, it would have to be an E book, you know, Kindle or something like that. If you have a service that gets you library books, check it out, let me know where it is. Because I haven't been able to exactly track that down with COVID. I think there's some issues. I'm trying to get the hardcopy into libraries too. So that's something that you could really help me out with.
And I have to give a big shout out to Molly Cooper. Molly lives in the UK. She sent me a message that she really enjoyed the book. It was so nice of her to reach out like that. So of course, I asked her a little bit about it. You know, I have some UK readers, but I'm interested in the process. There's a different Amazon site for different countries. So I was just interested in how it all worked. And then she posted in one of the diabetes parenting Facebook groups that she belonged in, and oh my god. Molly, thank you so much. A bunch of people talked about the book. And it was such a nice thing for you to do.
So if you've read and enjoyed the world's worst diabetes Mom, I always ask please leave a review on Amazon that helps us so much when people are looking to see if they want to buy the book or get the book. But if you could also post in your Facebook group or on your timeline about it and tag me, but it would be so helpful to spread the word because let's face it, this isn't gonna show up in the New York Times Review of Books, right we have the community to spread the word and it may be immodest to say but I do think it's a book that can help people it's not just our story. There's a lot of advice in there and a lot of learning that I did over the years, I believe very much in it and I really appreciate those of you who are already spreading the word if you're ready and you don't like it forget you know me!
In just a moment I'm going to be talking to Tandem’s, Steph Habif about Control IQ, new studies and lots more. But first diabetes Connections is brought to you by a One Drop and getting diabetes supplies. It's a pain let's face it. Not only the ordering the people up the arguing with insurance over what they say you need and what you really need. Make it easy with One Drop. They have our personalized tester plans, plus you get a Bluetooth glucose meter test strips lancets and your very own certified diabetes coach. Subscribe today to get test strips for less than $20 a month delivered right to your door. No prescriptions no co pays required. One less thing to worry about. not that surprising when you learn the founder of One Drop lips with type one, they get it One Drop gorgeous gear supplies delivered to your door 24 seven access to your certified diabetes coach learn more go to Diabetes connections.com and click on the One Drop logo.
My guest this week is Steph Habif. She is the Senior Director of Behavioral Sciences at Tandem which means she really advocates for the people who use the technology. She presented some of the studies we're gonna be talking about at ADA and of course has presented elsewhere and a quick note if you are new to the show, we use The Tandem system. They're not a sponsor of the show, but I know I am biased toward Tandem. So I want to make that disclosure. First thing I just love the way it works. Look, it's not perfect nothing is but we have been using Tandem for three years now. We switched from Animas insulin pump in August of 2017, just as the Dexcom G 5 update was approved for for Tandem. So basically we got a pump and then we immediately updated the software. We have done two other updates the basal IQ last year and we went to Control IQ in late January pretty much just as it hit the market. I can't believe it has been six months already. So well. I don't think that influenced the actual questions I'm asking. It certainly influences how I feel about the system. So here is my interview with Tandems, Steph Habif.
Steph, thank you for joining me. I'm so excited to talk about Tandem and learn more. Thanks for being here.
Steph Habif 6:55
Thanks for having me. I've been a listener of yours for a while so it's a real pleasure. Thank you very much
Stacey Simms 7:02
this year's ADA very different may start by just asking you what that was like for you to to present and have to do everything virtually.
Steph Habif 7:08
Yeah, it was definitely, I think unique and interesting experience for a lot of us especially people who regularly attend the ADA each year. And I'm not gonna lie. My favorite part about the event is getting to see people and kind of have very energized Creative Conversations together in person, I think a lot of brainstorming and some of the best ideas, birth from, you know, getting together with kids from all over the world at meetings like that. So that part was kind of missing, obviously this year. But given what's happening in the world, I think it was put on fabulously well produced really, really nicely. The excitement leading up to the conference was there that was a part of my experience this year for sure, like every year, and then it all happens through email and chat and tech So my eyes hurt. At the end of the conference, I think my eyesight has taken a little bit of a hit in the past couple months, like a lot of other people. But there was some very exciting information that got presented.
Stacey Simms 8:12
Yeah, let's talk about some of that. We've talked about Control IQ in depth before its launch or right as it was launched. Tell us about some of the presentations here. I know one of them was Control IQ in the real world, the first 30 days. Tell me about that.
Steph Habif 8:29
Yeah, so that was a proud moment for me and my team, the scientific posters that we presented at this year's ADA. I think one of the people you have had on your podcast to talk about Control IQ is Molly Malloy and she's on my team here at Tandem, we get to work together. She was one of the researchers whose name was on these presentations at ADA and the first 30 days. That was really our first look under the hood, so to speak. So one of the things that my team here at Tandem is responsible for is post market surveillance and user experience research. Meaning once the FDA approves or clears a medical device, like the T slim X2 and people start using it in their everyday lives, the job of my team is to observe, measure, learn, how's that going for people? whether it has to do with their glycemic outcomes, like time and range, or quality of life, things like how's your sleep? Those are all the things that we're responsible for researching and studying. Now, what we did for a DEA was we didn't have very much time with Control IQ in the market before the ADA deadline presented itself.
So Control IQ came to the US market starting mid January, and we had to have all of our materials submitted to ADA by the second week of March, so not a lot of time. So like I said, sort of first look Under the hood, meaning we went into our databases into our T Connect web application, back end systems, and we use some research methodologies to kind of see how it was going for people. What sort of glycemic trends and outcomes were we seeing for the early adopters right out of the gate, and we specifically focused on folks who software updated. So I think Benny's a software updater - he was on Basal IQ leading up to Control IQ. And how old is Benny? Again? He's 15. So he was probably included in our analysis. Absolutely. So sorry, no. Yeah, so anybody who was age 14 or older and had at least 21 days of use on control, IQ technology, leading up to march 11, was included in this analysis. So
Stacey Simms 10:52
he was he was definitely in there. And you would have seen a great response. I don't mind telling you.
Steph Habif 10:56
Yeah, so this information that we presented at ADA Like I said, we didn't have that much time. So really data mining to look at glycemic outcomes. So it was a retrospective data analysis exercise, essentially, which is a very common thing to do when it's your first look at sort of what's happening in the real world. And we were really pleased to discover that overall real world users are experiencing an increase in time and range of 10%. Before updating to Control IQ. The folks in this study had a time in range of about 68%. And throughout their first 30 days on controlling IQ, they experienced an increase to get that overall time and range metric to 78%. And what's exciting about that is that 10% jump matches what we saw in our control, IQ clinical trial.
Stacey Simms 11:53
Did you have any data about ease of use? In other words, do people continuously use it? Did people have sensor issues? If you have have problems figuring out how to adjust anything I know it's it's tough to glean in such a short time. I'm just curious if you learned anything else.
Steph Habif 12:06
So for the purpose of what we presented at ADA, we kind of kept it really simple. Again, because we didn't have very much time we mined data we we worked with what was available to us. And so we really focused on things like changes in time and range hyperglycemia hypoglycemia, and we didn't for the purposes of what was presented at ADA, talk about quality of life, things like sleep improvement, but what we do know is that for the folks who were included in this analysis, overall, they experienced the percent of time in closed loop automation was 96%. And that's really exciting. Now for the Control IQ technology system. The only reason a user isn't in automation is if they lose connection with their CGM for 20 or more minutes, that's it. And then once CGM is reconnected automatically, you're back in that automation close loop. So that's really elegant and simple. And that came through in these metrics that we presented at ADA.
Stacey Simms 13:17
Yeah. So that's interesting. I mean, not to jump to a conclusion. But let me just make sure I'm hearing you right. So we can pretty much conclude if 96% of people using Control IQ, excuse me, if people using Control IQ stayed using it 96% of the time in automation. That means that their sensors were working that things were chugging along just as they should.
Steph Habif 13:35
Yes. And thank you for bringing that up. So we have some consensus guidelines on data integrity for this type of research. When you're doing real world research like this, the guideline is for the purposes of data integrity, to include CGM rates that are 70 to 75% or above. So what that means is in our analyses for the ADA we included people who had at least 75% CGM connectivity over that 60 day period. Now in the clinical trial for Control IQ, the investigators reported CGM connectivity in the high 90s. That was a way that we could sort of control for that variable given that we were doing a retrospective data analysis, if that makes sense.
Stacey Simms 14:27
Yeah, it does. Because it's really important. And you know, this people in the diabetes community, there's separate issues here, right? There's Control IQ. There's the Tandem pump, but there's the Dexcom sensors, which Listen, it's not a Dexcom interview here. But we've talked a lot on this podcast about people who just have trouble with the sensors, and sensor failures and things. So I'm glad to hear you clarify because I'll be honest, that 96% number didn't really sound real world to me, but it makes a lot more sense when you understand that it's already looking at people who have good sensor luck. I don't know what to call it. Good sensor usage or It lasts.
Unknown Speaker 15:01
Connectivity.
Stacey Simms 15:03
Yes, connectivity, that’s what I was looking for. Yeah, that makes a lot more sense. There was another study, if I'm reading this correctly about people with type one and type two, use the Control IQ. I didn't know anybody was type two was was really using it. Can you speak to that?
Steph Habif 15:16
Yeah, that's pretty cool. So it turns out we have a fairly present segment of our customer base that have insulin dependent type two diabetes. And so again, first look under the hood, we sort of sat there and we were curious, and we said, well, we have some people who are updating software updating to Control IQ who report that they have type two diabetes, I wonder if they're experiencing things differently than folks with Type One Diabetes. And it turns out that both people with type one and type two diabetes are experiencing significant improvements in time and range with use of Control IQ. So the second publication that we presented at ADA was looking at glycine outcomes type one versus type two. Now you've heard me say that folks with type one in our analyses experienced a nine or 10% increase in time and range as a result of their software update. And for folks with type two, that was a 6% increase in time and range. But here's the really cool part, the analysis that we did for looking at the difference between type one and type two, we required a minimum of 14 days of use leading up to the software update, and then 14 days of use after the software update, which is half the amount of time from our first analyses. And so what that means is by seeing that our folks with type one got to a 9% improvement in time arrange, it means that those improvements are happening really quickly, right after the software update.
Stacey Simms 16:46
That's really interesting. I want a little dig a little deeper into some of these studies. But I also want to kind of do some bullet points here. So let's talk about Control IQ okayed for young children, because I just happened. Yeah, can you speak to what those studies found? Was there anything different or anything parents of children down to the age of six now should be thinking about anything different?
Steph Habif 17:06
I don't really think so. We recently, just a couple days ago, got our FDA clearance for the pediatric indication for Control IQ for children's six year old Jr. Before then it was previously approved for ages 14 and older. We know investigators have been doing research and even younger populations. But right now we're only approved down to age six. And what the clinical trial that focused on ages six to 13 using Control IQ saw was the sensor timing range increase to 67% from 53%. compared to those in the control group, and overnight children using Control IQ technology in the same study state and range an average of 80% of the time, those glycaemic outcomes match what we're seeing in the real world with a slightly older group, and so it's looking very consistent. So far across the board,
Stacey Simms 18:02
one of the things I wanted to ask you about these studies and in Tandem isn't the only one who does this. It looks to me like a lot of the automated studies that I'm reading from Insulet, Medtronic and some of the other companies, was that 68% in range number that you mentioned, like the people who started when from 68 to 78, which is fantastic. But we know that so many people with diabetes have like 30%, time in range, right? They need this technology so badly. And I'm wondering, can you just speak to that in terms of I don't know why the studies, and I was glad to hear the kids study was 53% to 67%. That seems a little bit more realistic to me. I mean, God forbid you study teens. What, you know why? Why do you? Why do most of these studies take people who frankly, have relatively decent control, right, we're talking about the whole sphere of diabetes, that just people who have great technology, I would think you'd want somebody who's got an A1C of 10 and you can say, look, we knocked them down to six.
Steph Habif 18:55
That is a great question and you are speaking my language. I'm so thrilled To hear you ask that question. That was actually one of the biggest themes to emerge from this year's ADA. And it certainly isn't a new theme, but it was a very prominent theme this year. The call for more diversity in research studies diversity, whether it has to do with baseline A1C or baseline time and range where somebody lives. There was a really exciting study presented at the ADA by researchers in New York who looked at inner city urban teenagers onboarding to the T slim x two with Basal IQ. And that was very cool to see. And so you're absolutely right. It is on us as researchers, as scientists, as clinicians to figure out how to be more inclusive in this type of research. And that's certainly one of our goals here at Tandem.
Stacey Simms 19:49
It's interesting because I thought you were going to say, I don't know I thought it was going to be more on the medical side of it. So in other words, is it more of a question and I'm pardon my ignorance here because I wasn't really even sure what I was. Asking there. Is it just harder to find people to be in these studies? Or is it the study criteria that excludes people?
Steph Habif 20:07
So at Tandem, we try to have the most inclusive criteria that we possibly can for this year's ADA, again, because we had such a short amount of time, and we really only could take quote, unquote, the first look under the hood, we had to work with the data that was available. When you consider early adopters of any technology really, but certainly early adopters of Control IQ technology, like you said, a lot of those folks were already doing pretty well, especially because most of them were on T slim x two with basal IQ leading up to their Control IQ technology update. It's a loaded question, you know, why isn't there more diversity in this type of research? And there's no one simple answer to that question. I think it's a shared responsibility across many communities to figure out how to make it easier for them. Different types of people to be included in this research. So I think the medical community, the research community, the scientific community and the diabetes community sort of at large, we just need to be better about being more inclusive.
Stacey Simms 21:13
Well, and I think it's very easy. Once you set the parameter that you looked at people who are early adopters, we know who those early adopters were there us, there are people who listen to podcasts, there are people who are super educated, they went for the portal before the email came to them. So it's a it's a very self selected group of highly educated people. So I'm not being critical. I get it. It's just Gosh, like I said, I'd love to see what happens when you start people who have a very high A1C and don't have a lot of time and don't have a lot of perhaps access to get a technology like this and see what it can do. Because, you know, I'm such a cheerleader. Listen, my bias is showing, but my son has always been in very good health with diabetes. We've been very lucky. You probably know we don't share numbers, but we're on track to have probably his lowest A1C ever and he has never done less work. It's amazing. So I just hope everybody gets a technology like this.
Steph Habif 22:05
Yeah, you know, the psychologist and behavioral scientist in me is just thrilled to hear you say that. I mean, for somebody like me who has studied social science her entire career and has also worked in health technology and medical technology, my entire career, I like to say that my purpose professionally is to advocate for the humans using the machines. And so I want the science to be able to tell the most insightful stories, whether powerful stories like one you're experiencing with Benny, where he's having to do less and less work but experience better and better outcomes, or whether it has to do with, you know, somehow shining a light on underserved populations who could be the greatest beneficiaries of this type of technology, and how can we make that happen? So all of that, to me is very exciting.
Stacey Simms 22:56
It's gonna be fascinating for somebody with your background to work in this field, where the mental side of diabetes is just as important. The Human Factors on pumps. It's, we could talk all day.
Steph Habif 23:05
Absolutely, yeah. So the easiest way to think about it for in terms of what I do and my team's do here at Tandem is, as you know, the FDA requires very rigorous Human Factors testing in order to submit and receive clearance on a medical device. And so my teams do all of the usability and Human Factors testing prior to our FDA submissions. And then other parts of my teams are the psychologists and the social scientists responsible for doing all the work to understand how the machines are functioning and the everyday lives of everyday users. I feel very blessed to be able to do that for work.
Stacey Simms 23:39
So moving to, you know, heaven forbid, we left to let you rest on your laurels at all moving ahead to what may be next. We know that COVID-19 has delayed a lot of things, you know, in all medical fields, but can we ask about the T sport and the Tandem mobile app? Can you talk about where those are right now?
Steph Habif 23:57
Of course you can ask. So a lot of you know We have a new insulin pump system that we're working to bring to market next year, we typically refer to it as the T sport. That's our internal project name for it. That's what we've kind of affectionately been calling it while it's been in development. It's about half the size of the T slim x two. It's being designed to be controlled either entirely by a mobile app or by an independent controller. And you're right due to the current COVID-19 environment. We have had some delays in some of our human factors testing. Because the data is required for our regulatory filings. The target submission timing for the tee sport will be pushed out until protective government restrictions are lifted. And because I am the person that oversees our human factors team, let me just say that trying to plan and carry out to actors testing during a pandemic is one of the most unique challenges of my career. And I know for anybody out there who's attempted to plan anything right now it's been particularly difficult.
Unknown Speaker 25:04
Before we go on, do you believe the Tsport will have a different name when it launches?
Unknown Speaker 25:08
Oh,
Stacey Simms 25:10
I won't hold you to it. It's just the first time I've heard somebody say that. Like with Omnipod, you know, they said, Oh is Omnipod horizon? And they said, No, it's Omnipod five. Yeah. Sometimes we sometimes we find ourselves getting ahead, right. We're ahead of marketing. We're ahead of labeling we we follow these projects. So early that we kind of assigned we as a community assign names to things that don't even have a name yet, right?
Steph Habif
Yeah, I am not a betting woman. And so I would be afraid to put money down on what t sport is officially going to be called when it gets commercialized.
Stacey Simms
Alright, fair enough. Fair enough. We'll just know that that's the working title. And then the mobile app. I know there's some people beta testing the phone app, which is more of a observant app, you look at things you can't do anything really yet. Is that the same timeline as the tee sport, whatever that timeline turns out to be?
Steph Habif 25:58
No, the mobile app is happening on In a different timeline. So we're developing a mobile app platform that is the foundation of our digital health strategy. The first generation of the app had a beta launch in the first quarter of 2020. And it will be rolled out more broadly in the upcoming weeks. So the first generation of the app will include remote data uploads so that patients can send their hcps important pump data without an office visit. We know that right now we've kind of been forced into this telehealth world. So that's going to be a really critical part of the user experience. And future iterations of the app will include remote bolus capability due to COVID. For sure. We've had some delays in human factors testing on the remote bolus features. And again, because data is required for our regulatory filings, we have to work with that the best we possibly can.
Stacey Simms 26:48
I'm so excited about that. I mean, obviously, the idea of bolusing from the phone seemed like the holy grail for a long time, but that is exactly what you're saying. right that the idea here is that you would take out your phone, bolus using pump, you'd be able to control it from your phone.
That's right. I give you the impression. I want to talk to you much more about that.
Steph Habif 27:09
You know, it's, I will say, being a scientist who's in charge of doing all of the research makes me an interesting candidate for a podcast interview.
Stacey Simms 27:20
All right. Well, I have so here's a question for you. And again, no answers a fair answer. I'm curious. When you you start doing things like that. The remote monitoring capability of the Dexcom , obviously, has been very, very popular. I'm curious if I wouldn't expect to bolus my son from my phone. Right? You wouldn't expect a caregiver to be able to do something like that. But what a caregiver be able to see more about the pump? Will there be more information available to people who want to, let's say follow, I don't know what kind of language we'll be using, like the pump battery, the insulin onboard, all of that kind of stuff. Will that be
Steph Habif 27:54
available? Yeah. So that's a great question. So follow capabilities through a mobile app. is certainly a part of our product roadmap, there are plans underway for that. I can't speak to when that would come to the market specifically, but it is being worked on.
Stacey Simms 28:11
Okay. And one more thing if you can't answer this is fine too. Would it be possible I'm just thinking out loud when my son was was younger and we did do everything for him? If like I could use you could designate like, this is the bolus phone, and it wouldn't necessarily be the phone that's with the kid.
Steph Habif 28:25
Great question. You know, cybersecurity is such a critical consideration in this land of remote anything. I can't tell you one way or the other, whether or not you as the parent would be able to use your smartphone to bolus you know from your son's pump. We'll have to wait and see what the FDA decides in the land of you know, security and safety and cybersecurity. For sure. Right now we're focusing on doing the necessary Human Factors testing for enabling the pump wearer to be able to use his or her smartphone
Stacey Simms 29:00
I'm trying to keep track of the timeline here. So forgive me for clinical trials underway for the T sport yet,
Steph Habif 29:06
right. So for the T sport project, we are not yet doing active clinical trials. But as many of you know, being a medical device company, we have a robust r&d department, and our engineers are experimenting on a regular basis.
Stacey Simms 29:22
Ooh, sounds intriguing. You should do all of your studies in Charlotte, North Carolina, you should include 15 year old boys. Yeah, let's move on. Do you know this isn't really your department, a bunch of my listeners had questions about insurance. And a lot of insurers were making noise a few years ago about only going with one pump company. And of course, the big one was United Health and Medtronic does tend to make any progress in that, you know, that deal. Right? So like
Steph Habif 29:53
what you said is true. It's not my department. So we don't provide individual payer updates, but we We believe having continued positive data on our technology, like what we presented at the ADA helps with all of our payer discussions.
Stacey Simms 30:08
So I would say to paraphrase that Tandem is not going to give up on working with as many insurance companies as possible.
Steph Habif 30:14
That is correct. We believe in doing whatever we can to create access for as many people in the world as possible.
Stacey Simms 30:21
another bit of news that came out right around ADA was FDA approval of Libre 2 and you all have had an agreement already with Abbott. I don't I don't know the parameters of the agreement. I don't think there's a lot of public the timeline or how it will work. Can you speak to anything about that about how sometime in the future I suppose the Libre will work with a Tandem pump?
Steph Habif 30:42
Yes, so Abbott and Tandem share a common goal to provide people with new ways to manage their diabetes that can integrate easily into their daily lives. The interoperability landscape is is very promising in Tandem is working with Abbott on an agreement to integrate a future generation of their glucose sensing technology with our insulin pumps. We haven't announced a timeline for the completion of the agreement, but we're working on it.
Stacey Simms 31:08
so dumb question because I always get confused with interoperability. Would this be a situation where I flip a switch on my pump and one week, I could use a Dexcom sensor and the next week, I could use a Libra sensor.
Steph Habif 31:17
I think for some people, that is what the vision is, like, I think we're all playing an active role right now in forming what this interoperable landscape could be. But conceptually, the idea is you could mix and match your technologies and they would be able to speak to one another. Now, that requires business agreements between the companies as well. So don't forget that part because that's an important part.
Stacey Simms 31:42
Yeah, yeah. Yeah, let's keep dreaming. Let's forget. So what are you studying? Now? Obviously, this isn't the end of the studies on Control IQ or Tandem products. Can you give us a glimpse into what what you're looking at in the next couple of months?
Steph Habif 31:55
Yeah, sure. Well, as you know, we currently offer the TCM x two with basal IQ technology and Control IQ technology. We had some pretty exciting research debut at the ADA on basal IQ in that we followed folks who on boarded to basal IQ during their first six months on basal IQ. And that was what we call a prospective study, meaning we were able to follow people in real time over the course of several months to see how it was going for them. The research we presented at ADA related to that specifically focused on self reported severe hypoglycemia episodes, and we were thrilled to tell the world that basal IQ is doing a phenomenal job of decreasing adverse events related to severe hypoglycemia. So basically, like he's seemingly doing a very good job at keeping users safe. And you know, safety is always at the top of our priority list.
So as we continue to see more people take on Control IQ technology if they choose to do that. We will Do these long term studies where we follow people if they opt in and want us to, we'll follow them while they onboard to and get to know and continue to use Control IQ technology so that we can learn from them. Again, not just the glycemic outcomes, things like time and range and hypoglycemia, but sleep quality, or other things like is it a hassle to use? Is it making your life better? One of the things that I'll never forget is a couple months after phase like q hit the market, I had the chance to briefly talk with a father who had a 16 year old daughter, and she had been on basal IQ for about six weeks. And he looked at me and he said, this is the most under promised, over delivered diabetes technology Our family has ever experienced. And I said wow, tell me more about that. And he said, We're finally sleeping. You know, we can sleep through the night. And you know, sleep is a precursor to everything for everybody. So we're going to be doing a lot more research on the sleep front to see how we can be better continue to improve sleep quality for people with diabetes. That's a very big topic of interest for us.
Stacey Simms 34:19
I'm curious to if you're looking at how people on board and adjust to Control IQ, because most people and again, we're biased because we think we're very well educated, right? When we were in Facebook groups, we talked to each other. Most people kind of went through the training, talk to their endo and then did all the troubleshooting themselves over the first two to three weeks. We're experiencing lows we didn't experience before so we decreased bezel or we increased ISF or whatever, whenever people had to adjust. Are you following like common practices to find out how to better teach? Okay, I'm sorry, we are
Steph Habif 34:51
we are and in fact, next week we're putting on a couple of webinars specifically for healthcare providers first because it's We've been hearing from them even before we launched into market when we started training healthcare providers on the control acute technology system. We have some best practices now to share now that it's been out there for a couple of months. And we've been able to connect some dots. We'll be putting on several webinars next week for health care providers, where we'll be talking about these best practices and tips and tricks. And we know that not just health care providers, but users and their family members want to be able to ask these questions, too. So I think Molly told me that maybe she'll be getting together with you again, Stacy for a future podcast.
Stacey Simms 35:36
Yes. So I'm going to be asking her all of these questions. As the webinar we can kind of see what the what the research shows people with right we're gonna be doing another episode in the near future about best practices. That's great.
Steph Habif 35:46
Yes. And so Molly's just such a great person to talk with about that. But for sure, I'll send you the information on the webinars next week. If you want to chime in and watch they'll be recorded as well. And we are starting to roll out all of that message. Now,
Stacey Simms 36:00
oh my gosh, that's wonderful. Because I gotta tell you, we laughed. We got ours so early, like I said, who waited for the email? Right? We just logged into the portal that my son's endocrinologist said, Hey, let me know what you've learned. Let me know how you adjust.
Steph Habif 36:15
Yeah, that's true. That's true for my family members as well. So one of my niece's has type one, and she's now I think, gosh, almost 12 that blows my mind 11 or 12. I can't believe it. And her dad reminds me on a regular basis that she teaches him, you know, about how to use the pump, and how to use the technology. And I've heard that from other families as well, like, well, we went to our endo appointment, and I'll say, How was it? Well, we taught her a lot, you know, we were able to teach her a lot.
Stacey Simms 36:47
It's so funny. Well, it's also new. It's it's amazing to realize that we're all kind of doing this together.
Steph Habif 36:52
The energy and enthusiasm for good that is in the diabetes community is so special and so unique.
And so I feel very lucky to be a part of it and to play some small role in trying to make it better for everybody.
Stacey Simms 37:07
I can't thank you enough for jumping on. As I said, I'm kind of a fan. So I don't think this was an unbiased interview. But your information is fantastic. And I thank you so much for jumping on and sharing some of it with us. Thank you so much stuff.
Steph Habif 37:19
Absolutely. And I look forward to continuing to listen to hear how other people you know, share their experiences and tell Benny to keep us informed.
Unknown Speaker 37:30
No doubt
Unknown Speaker 37:36
you're listening to diabetes connections with Stacey Simms.
Stacey Simms 37:42
More information at Diabetes connections.com. The episode homepage always has the transcript and other links that you may need. And I will link up our last episode with Tandem there as well which was all about the launch of Control IQ. And as Steph mentioned, we're going to be talking to Molly Malloy and Others from Tandem. I'm in discussions with them this they've already agreed. It's just a question of scheduling, about getting someone to talk about best practices and other questions. You had so many questions for Tandem, that are more mechanical about how Control IQ works, that we want to do a second interview and really dig into the nitty gritty right, how do I know whether I need to adjust Bazell? How do I know whether it's the carb ratio issue and a bunch of questions of what you'd like to see in the next iteration of Control IQ. So that is coming. Thank you for your patience.
But it's always interesting, right to get a high level view of what's going on in these companies, and to try to look at the timeline as best we can. So that was really interesting that the reminders Steph gave me about how we do kind of get ahead of the curve around here, you know, not just on this podcast, but those of us who are engaged enough to be in Facebook groups and be on conference calls and listen to the investor calls these companies make and feel like we are familiar with the language and the labeling before it's even submitted to the FDA. So I'm in interested to see if the name of the T sport does change. Frankly, I really like it. But hey, that's I'm not in their marketing department. So we'll see.
Okay, tell me something good coming up in just a moment. But first, do you know about Dexcom clarity, it is their diabetes management software. And for a long time, I really thought it was just something our endo used, right? It was something we went there and he looked at it, but you can use it on the desktop or as an app on your phone. And it is an easy way to keep track of the big picture. I check it about once a week. Well, to be honest with you, I check it more now ever since we flipped over to Control IQ. I really like to look at it because and I noticed a psychological, right because it gets better and better. But it really does help me and Benny dial back and sees longer term trends. And it does help me not overreact to what happened for just one day, or even just one hour. The overlay reports help context to Benny's glucose levels and patterns. And then you can share the reports with your care team which makes appointments a lot more productive and it was essential for a remote appointment that we have Back in March, it was amazing. managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at Diabetes connections.com and click on the Dexcom logo.
Tell me something good this week all about diabetes scholars, we talked about this, I try to let you know when it opens up. This is something that comes from Beyond Type 1 and they give more than 50 scholarships to students living with Type One Diabetes. So it's a combined $250,000. And these are for students who are in the high school class of 2020. entering their first year of college. This was a record number of scholarships for the organization. So a little bit about the kids 54 outstanding students representing 26 different states. They are advocates, student athletes, scientists, writers, actors, mathematicians, and leaders. Each of them of course lives with Type One, two beedis there is a list of the diabetes scholars class of 2020 that I will link up so you can peruse and see all these fantastic students who aren't going to change the world as they head off to college at a very uncertain time. Oh my goodness. And these are significant scholarships, they range from $1,000 for individuals to $5,000. If you have a student who is in high school, and you want to check this out, I will also link up how to enter they do not open again until January.
And I should mention that diabetes scholars was an independent organization for a long time. But when it kind of seemed like it for I don't know the reasons behind it, I hope I'm not privy to the inside information. But a couple of years ago, it seemed like they were going to go under and beyond type one scooped him up and put them under their umbrella. And now they are part of the big beyond type one family. And that's one of the really interesting things not to get off the subject here about beyond type one. You know, when they first started, a bunch of us who've been around for a while, kind of thought, Well, what is this fancy new social media feed going to do? Right? What is there Legacy going to be what kind of changes are they're going to make? And while I think that they have still differentiated themselves by appealing, perhaps more to young adults, and focusing a lot, I mean, their social media is amazing. They've also now really made a name for themselves by being an umbrella organization for smaller diabetes groups that it's really hard to survive with a low budget when you try to go yourself safe sitting as part of them. I think slipstream now is part of them. Lots and lots of be on type run lots of little organizations that make a big difference, but needed their help so I guess that's a Tell me something good as well for beyond type one.
If you haven't Tell me something good story. I'm in the process of gathering more I've been putting up the posts in the Facebook group and elsewhere. If you have some good news, I want to share it just let me know you can also email me Stacey at Diabetes connections.com and tell me something good.
I mentioned at the top of the show that we are going to be marking 13 years with an insult pump in July, really just late next week, July 4. Yeah, we were geniuses and decided to start it over Independence Day weekend, when we were not even at home. That's a story for another time that I have told that I tell in the book too. But we are also next week headed to the endocrinologist for the first time since January, we did not get an A1C when I had a telehealth appointment for Benny in March. So I'm really interested to see I mean, I know the drill from Dexcom . And while I don't share numbers, I think we are going to have one of if not the lowest A1C’s Benny's ever had thank you to Control IQ. But there's always more to talk about when we see the end, other than just the numbers. So I will keep you posted.
If there's anything that Benny wants me to share, or that we want to talk about, but I'm really looking forward to that appointment just because Gosh, we've never gone six months without seeing our endocrinologist and while I know a lot of people think it's a pain to go every three months i mean i think it's a pain to but I'd like checking in I love Dr. v. I always learned something we always ask about Questions, even though he except it was asks me questions now, which is really funny and I do enjoy. I think that when you have a kid who changes as much as my kid has over the years, just physically, you know, and everything else, it's really important, at least for me to have that kind of touchstone, so I am really looking forward to it. And I think Benny's grown an inch. He thinks he hasn't grown at all. Anyone. Let me measure him. I mean, how ridiculous so we'll get a bite, which is what I'm looking forward to as well.
Okay, we have so many great episodes on tap. I have all this technology stuff. I have some personal stories that I've been holding, always a mix around here about the technology, the news, the great stories from our community camp. Oh my gosh. So there's lots coming up. It's just a question of what comes next. If there's any breaking news, we'll do our very best, but please join Diabetes Connections, the group on Facebook, that is the best way to stay up to date as to what's coming and I often ask you all questions as well, which helps me figure out what episodes are really important to you. Thank you to my editor John Bukenas from audio editing solution. And as always, thank you for listening. I'm Stacey Simms. I'll see you back here next week until then be kind to yourself.
Unknown Speaker 45:12
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Digging deeper into recent news from and about Dexcom. Stacey talks to Chief Technology Officer Jake Leach about the news that competitor Abbott has received approval for it's Libre 2 CGM. What does that mean for the marketplace? She also asks Jake about G6 sensor issues, data gathering and more.
Check out Stacey's new book: The World's Worst Diabetes Mom!
Dexcom statement on data and privacy:
Patient safety is a top priority at Dexcom, and we design our products to be as safe and secure as possible, as the data that comes into our system from CGM devices is extremely important for patients and physicians in understanding and improving diabetes management. Dexcom works with government agencies, industry partners and security researchers to apply current best security practices for medical devices to help ensure the integrity and availability of our systems.
Our terms of data use are laid out for patients to consent or opt-out when they first set up a Dexcom account, so they know exactly how their data could be used and who will have access to it. In order for healthcare providers to access patient data, each patient must approve the sharing of their data to the healthcare provider through the CLARITY app. Another way patients can opt-out of sharing any of their data is by using the dedicated Dexcom receiver to view their glucose levels instead of a smart device.
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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 and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:16
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:22
Welcome to a bonus episode of Diabetes Connections. So glad to have you along as always. A bit of an unusual situation this week in the very last episode, and hopefully you've heard it. I spoke to Dexcom CEO Kevin Sayer. we taped that episode before the ADA conference actually took place. You know, the time shifting nature of podcasting. we taped these interviews ahead of time and then a couple of days or a week later, generally, the interviews air. A a couple of days after taping that interview, the FDA approved Abbott's Libre2 and this is a different CGM is able to continue transmit glucose data every minute. And users can now set the system to send alarms when their glucose is too high or too low. And previously, you had to scan the sensor in order to get any kind of glucose reads. So that is a big change, and frankly, more direct competition to Dexcom.
I have reached out to Abbott in the hopes of learning more and asking them any questions that you may have Dexcom though, immediately reached back out to me and asked if we wanted to talk more about CGM and how they stack up in the marketplace. Now, I am not going to pass up the opportunity to ask more of your questions. And that's why we have sort of a Dexcom double feature this week.
My usual disclaimer Dexcom as you have heard, and longtime listeners know Dexcom is a sponsor of this show. That means they pay me to have a commercial in the show. That sponsorship gets them a commercial, it does not get them any kind of approval over content. And so what does that mean? It means I don't send them all the questions. I have of time, we don't plan out what we're going to say. I hope you know, as you've listened that I don't hold back on questions and criticism from them. But we do have that relationship. And it's really important that you you know it right because we were doing news interviews here.
And this interview is with Dexcom CTO, Jake Leach. I will link up more information at the episode homepage. And as always, there is a transcript. So here is my interview with Dexcom’s chief technical officer.
Jake, thank you for jumping on and spending some time with me and my listeners. We always appreciate learning more about what's going on at Dexcom. So thank you.
Jake Leach 2:36
It's a pleasure to be here. Stacey. Thanks for having me.
Stacey Simms 2:38
Absolutely. So I just talked to Kevin Sayer. We did kind of a high level, you know what's new, what's next? How are things going? Talking about the G7? It he's of changes that have happened to the G6 COVID delays, that sort of thing. My listeners had a bunch of questions as this is the backdrop of course of the Libre news that came out Abbott's Libre 2 have got approval for use of the United States. The number one question that my listeners had was, can they talk about the price difference? I don't know if that's a CTO level question.
Jake Leach 3:11
Yeah, as much as you know, I'm involved in it. We basically, when we think about the cost of the product, the most important thing to be thinking about is making sure people have access to it. So insurance coverage, we feel really good about the fact that 98% of the private insurance companies do cover the product, as well as Medicare started covers it. And in states, many Medicaid systems do also cover the product as insurance. That's where we focus our time is really on on that. And we very few of our customers actually pay cash for the product. The vast majority of everybody gets it through insurance coverage.
Stacey Simms 3:48
When I look at the Libre, and full disclosure here, my husband has type two diabetes and he uses the Libre and Benny my son has used the Dexcom since 2013. Now, wow, yeah, it's funny to think about how much time has gone by. But one of the things I look at with the G7 coming and the you know, the bit that we know about it is that it will be much more like the Libre in terms of the sensor and transmitter in one. Can you speak to that in terms of the G7 in terms of size, insertion, that sort of thing?
Jake Leach 4:25
Yeah, so the G7 is, as you pointed out as an integrated sensor all in one, so it's the wearable device that goes on the body includes both the sensor, the transmitter, as well as the electronics inside the wearable that are both monitoring the center and then taking that signal and sending it via Bluetooth to the different integrated display devices whether that's a mobile phone, so a smartphone with an app on it, Android or iOS, or a insulin pump for automated insulin delivery systems. Other display devices, we have our receiver that is our proprietary handheld, some people really like that as their way to access the information. So our goal is to make it as interoperable as possible, which is one of the key important points about IC GM is that it's interoperable device
Stacey Simms 5:16
you And with that, I always get hung up on it. Because when I heard about interoperability A few years ago, in my head, it seemed like, Okay, well, I could switch out my pump, or I could switch out my sensor, I could use a different brand with this thing and kind of mix and match. And of course, insurance for most of us is the biggest problem for getting different devices. But it doesn't really work like that, does it? I mean, if a Dexcom g seven works with say, Omnipod five horizon, and with a T slim X to control IQ, people aren't really going to be able to just switch out devices like that and use the same sensor, are they?
Jake Leach 5:51
Yeah, as usual, it's more complicated as you look at it under the hood. But the key thing about the integration is that systems have to be designed To be able to be integrated. And so one of the big moves that we made when we transitioned between Gen four, and Gen five, and then subsequently Gen six, and as well as Gen seven, we moved to Bluetooth technology, which is a much more readily available technology within the display devices. So we moved to that. And when we did that, we designed an architecture that the intelligence of the system is all on the the wearable. So all the glucose calculations, all the information that you need is actually on the little transmitter device in G6, and will be in G seven as well. And so that is the device that can be accessed by multiple displays. If you think about it, you can use your mobile phone and the whole share feature that comes along with our mobile system, the remote monitoring feature, you can use that and at the same time, you can use a tandem controller to pump doing automated insulin delivery. And so the system is really designed to have that type of integration where you've got the right information in the right places and makes it interoperable. The systems have to be designed To be connected, for example, horizon five Omnipod five, the system that is in development by insolate is being designed to be integrated with both G6, that's what they're doing their studies with as well as G seven. So you have to do the design work and do the testing to ensure that it operates safely. But interoperability is a great thing. But it isn't as simple as just pulling and pulling everything it has to be designed and tested.
Stacey Simms 7:22
Yeah, it was interesting. I in my head, I always had it as well, this, you know, I can mix and match, I can figure out what I want. But when I talk to technical people, they always kind of smile at that because they understand more of the intricacies, I think of what it takes within the technology to make that kind of stuff happen. Whereas as the user, I just want to hokey pokey it around and use what I want. But we'll see as it goes down the road. Some other G7 basics that my listeners asked was, will the G7 have a shorter warm up and does it have a lower MARD? Is it more accurate than G6?
Jake Leach 7:55
Great questions. The warm up time is designed to be shorter than g6. And so we're As we're landing exactly how much shorter it's going to be, but it's definitely going to be a faster warmup. Also, the mard is the average difference between the sensor and the reference measurements that we measured the performance of the device and so on. That way, we want to ensure that we hit those iCGM standards. And so I think G7 definitely has the opportunity to perform better, but it definitely will meet those CGM standards, which are rigorous and important to ensure the product performs accurately throughout its life.
Stacey Simms 8:30
Can you give me a hint on the warm up? Is it going to be more an hour and 45 minutes or more?
Jake Leach 8:35
No, no, no, it's gonna be It'll be an hour or less.
Stacey Simms 8:40
You know, just had to double check on that.
Jake Leach 8:42
Yeah, no games there. We're just we're still trying to dial in exactly what's going to be to ensure we you know, the system has to be accurate. Second, it starts up but we do value short warmup time because we know how important it is when you know you're without the sensor data for that warmup period. So you want to make sure it starts up as fast as possible.
Stacey Simms 8:59
Yeah, it's interesting too. Because I'm probably an outlier but previous to we use the control IQ system with tandem previous to using that the two hour warmup really didn't bother me too much. I mean, it was only two hours especially if you came from like we did seven years with no CGM. It's really did not seem to be that big a deal. But now that we're using this algorithm, and the pump relies on the Dexcom data, two hours just seems like way too long to be without it.
Jake Leach 9:27
I agree. Really interesting.
Stacey Simms 9:29
Speaking of wear time, we've been very fortunate. Again, as I said, we've used Dexcom for a long time we do not really have a lot of issues knock on wood with it. He's of sensitivity which Kevin mentioned in his in our interview together, we went over that, but also with where time, but a lot of my listeners wanted me to ask if you are really checking into the people who can and there are many who can never seem to make it to 10 days on a sensor. Right who really was it whether it's because they have a young child or the body chemistry for whatever reason, it does seem to be an issue that many people can't get the full life out of a sensor.
Jake Leach 10:07
Can you address that? I know you're looking at it.
Jake Leach 10:09
Yeah, yeah, I've got, of course. So a couple things there. There's quite a few things we've done over time. And we continue to research on this. There's two aspects to sensor longevity. One of them is how long the sensor can remain accurate. And so within our device, we have algorithms that are checking the performance of the sensor at all times. And so there are times when we detect that that sensor signal is not accurate and not meeting the CGM standard. And so we we actually shut it off and that's when you get on the display, you get the sensor failed signal. That's basically we detected that that sensor is not working properly, and it's not going to return to functioning based on the data that we're seeing from it. As you mentioned, most people are able to get 10 days out of the sensor particularly now that we've made some changes with the adhesive as well. But there are some people who don't and with those folks, we often spend some extra time with our tech support, and kind of walk through what their issues are. And there's quite a few things that can be done to help sensors last longer. I mentioned the adhesive, we recently updated our adhesive, we've added an overlay. that's optional, people can ask if you have access to the clear adhesive that goes over the top of the white one that comes with the product. And so we're looking at lots of different ways.
Because what we found is everybody's a little different in terms of what their needs are and what works for them. And so we're trying to do is have as many options that we can to make the sensors stay on and heared. And it's really that's our philosophy around sensor longevity is if I really wanted to I could I could run a study and claim that G6 goes 15 days because I know the performance would meet that the problem is not all the centers would last that long. And so what we're really after is making sure all the sensors, as many as we can get out to the labeled timeframe, not just some of them. And I think that's one of the key differences that you'll see over time between different CGM companies is we're very focused on a high level liability, you're never going to get 100%. You know, sensors will come off and they'll get knocked off. It's a challenge. But it's one that we're very focused on trying to ensure that we can have the highest flow reliability possible.
Stacey Simms 12:12
Let me just follow up on that, because sensor sticking is one thing, right? I mean, I know that that's an issue in everybody's skin is different. And you have the overlays now, and the adhesive does seem to be sticking better to many people. Butwhat about people who have no trouble getting the adhesive to stick in the wire to stay in, but get recurrent sensor failure? Are there any best practices for people who seem to get that over and over again,
Jake Leach 12:36
there are and it's actually often comes down to, you know, sensor placement and you know, the sensors indicated for abdominal use. And so, we often instruct folks to try at different locations. We've also, if someone's really having repeated challenges and where they're getting those sensor failures, we do have specific capability with our tech support to work with that customer and look at their data and To help determine exactly what is going on, there's a number of things to we tend to see, that happens when people are more dehydrated. So you know, kind of making sure they're well hydrated and drinking water. But if someone's having consistent problems all the time, then we really want them to reach out to us and talk to our tech support. And we can get someone who is experienced, but you know that those types of issues to talk to them and look at their data and help work through it.
Stacey Simms 13:22
I don't mean to harp on it. But I've just, and I'm, I know, you may not be the right person to try to pin down on this, so forgive me, but I'm thinking like, Is it an insertion thing is it I mean, we've, anecdotally, the community has said, drink water, stick in the fattest place you possibly can maybe rock the sensor a little when you're inserting it so it doesn't go as deeply in like it's more shallow. I'm just curious with all the data that you will collect in these phone calls. If there's any, like I said, a best practice that would help or if it's just you know, you've got to talk to your local rep, maybe get an in person or zoom call lesson or talk to tech support, but you know, just a more concrete business advice, I think would be so helpful.
Jake Leach 14:01
Yeah, I think a lot of it does have to do with that insertion saying, like you said, you want to put it into a place where you've got good interstitial tissue. The other thing I've seen, too, is, um, you want to make sure that it's not at a place where you're going to compress the center a lot, you know, if it's under compression, you're not getting the same amount of perfusion there have glucose under the skin. And so that can also lead to issues. There is something recently that we've released in a product that has really solved a number of issues in that people were getting sensor failures during really high glucose excursions. We've sent some solved that problem with a new version of our transmitter that is now out in the market, almost everybody has that device. Now, it did make quite a dent in those we were detecting the algorithm was detecting that really high glucose as a potential issue. And over time, we've learned through looking at the data that that wasn't an actual issue until we were able to correct that in a recent version of the device. But yeah, it does come down to kind of working through sensor insertion and placement in Don't have data that validates, you know, some of those techniques that you mentioned that says it will work if you do these things. But we have heard from the community, and in our own times speaking with patients that it has been very helpful. And some of those concepts you just mentioned.
Stacey Simms 15:14
Jake, I'm sorry, can I ask you to clarify? It may have gone over my head. But when you were mentioning the newer transmitter that is out, can you just clarify what you meant by when it was reading very high blood glucose? And that was affecting the sensor? And then it sounded like you said, but that wasn't the case. Can you just clarify that?
Jake Leach 15:31
Yeah, sure. So what it was, was that during really high glucose excursions, the device was detecting a potential sensor failure where it wasn't the sensor failure. There's nothing wrong with the sensor. It was working. But you know, it's one of those things that once you once you get a product on the market, you learn more about it. And so we've made several iterations to the G6 even since it's been in the market for several years to improve it. And that is one of the cases that we saw patients running into, that we resolved with the newest version of the device is that it doesn't give The sensor error when when there was really high glucose excursion,
Jake Leach 16:03
and I'm just curious cuz it does sound like you've resolved it. What is really high glucose? Like over 400?
Jake Leach 16:10
Oh, well north of 4, 5, 6 hundred.
Stacey Simms
Oh my goodness,
Jake Leach 16:14
yeah, we're really, really high glucose.
Stacey Simms 16:16
So if somebody has a teenager who's like bumped up to 250 and getting sensor failure, that's not the issue.
Jake Leach 16:21
That's not the issue. No, no, no, not in not in those,
Stacey Simms 16:24
because everybody has a different idea of really high glucose. So Thanks for clarifying.
Jake Leach 16:27
Yeah, that's a good thing to clarify. Because, like you mentioned,
Stacey Simms 16:32
you know, another question that my listeners had was about data. And we've talked a little bit here about some of the data that you collect. And I don't know if it's different internationally, but to speak about the data.
Jake Leach 16:43
Yeah, sure. Of course, first of all, data privacy is very important, both just fundamentally and philosophically as well as to be in compliance with all the global regulation we're seeing in this area of data privacy. There's a lot of advancements in the laws and regulate Around consent, and users granting access to their data, because in the end, it's the users data. We're just a steward of it. And so we take it very seriously. And so in our processes and our controls, that's how we proceed. So the data that comes into our systems from the CGM devices are used for things like share. So we provide the share system, the remote monitoring, that connectivity is super important. The data is also through that same system made available to the clarity application for use by the patients or customers or their physician. And then we also have that data in a safe lockdown repository that can be used by our tech support agents. If users are having track challenges, like we talked about tech support agents can actually log in and work with that user on their specific data. But
Stacey Simms 17:48
hey, it's Stacey jumping in here. I need to insert myself into the interview with the episode here because we hADAn audio issue right there and it was completely my fault. So apologies. Dexcom is going gonna give you a full statement on data and privacy, and I will link it up in the show notes. So Jake can kind of continue his thought that way and give you the full statement. One thing he said that I thought was very interesting though was if you are concerned about privacy and want to opt out, you can just use the receiver all by itself. They don't collect any data that way. But then you can't use clarity or share the information online with caregivers or your health team. But if you want to opt out, that is one way to do it and still use the Dexcom system. I did follow up the data question with one about transmitting data and why it's limited to certain devices. If you use a tandem pump like we do, for example, the transmitter can send data to your phone and to the to the mix to pump but then not also to the receiver.
Jake Leach 18:52
Yeah, the ad goes down into the specific engineering of the device deep down inside the wearable, for example to the transmitter producer. There's a battery in there. Every connection to a display device takes a Bluetooth communication channel. And so today, which is six, we support two channels, one for mobile phone and one for a medical device such as the insulin pump, or the Dexcom. receiver, it can support to have those connections to the med devices, because we need one available for a phone. We are looking in the future to allow multiple different types of devices you can imagine watches and other things. And so that technology is we're working the architecture of that. But the key there is that circuitry has to be low enough power that it doesn't use up the battery. We specifically designed G6 to be reliable for that 90 day period for the mere life. And so we couldn't put that system you can't support more than those two connection.
Stacey Simms 19:45
Yeah, practically speaking for us. It's plenty. I was just curious about the thinking behind it. And is that going to be the same thing with the Omnipod five? horizon? I'm laughing because I have to figure out how to say that Omnipod five. will it be the same thing Work goes phone and PDM or something, or is that a different setup altogether?
Jake Leach 20:04
It's a little different. But it's it with the G6 integration, G6 will support the Omnipod five as well as a mobile app like a G6 app. So it does support that. And as we look into the future towards things like g seven and future versions of G7, we are looking at architectures that could support even more display devices, more than just two.
Stacey Simms 20:24
And I'll hope to talk to Insulet in the future to get the specifics. But as I'm asking you this question, that sounds a little ridiculous, because where would it show up on the pod? I guess it would show up on a PDF if you use that instead of a phone.
Jake Leach 20:34
Yeah, I think one way to look at it for all of these automated insulin delivery systems is you want good communication between the algorithm that is doing all of the calculations for how much influence to deliver, you want a good connection between that and the glucose signal and the pump that's doing the delivery. That's part of the system engineering of the of the product and part of G6 was designed specifically for interoperability with so that it can support use cases like that
Stacey Simms 20:59
you mentioned To watch, I did talk to Kevin about this. So I'm sorry to bring it up again. But my listeners are really waiting for that direct to watch component. Can you speak to that from your perspective?
Jake Leach 21:11
Yeah, sure. So, you know, it's a it's a feature that we've been working on in development for for quite a while. And as we've worked through it, well, it turns out, you know, on our side, as well as on the leaves, Apple Watches is one of the one of the examples other than a significant amount of engineering. I think that we all underestimated when we first started talking about that product in the way that it interacts with the G7, as well as the phone app. And so we've been working with Apple closely know, over the last couple of years, actually, when when they announced this feature, it was really kind of a prototype feature. We started working with them closely on it, making quite a few updates on both sides to support that type of a feature. And so while we don't have any dates, where we're going to launch it, it's important feature that we know, adds flexibility to users lives and so we will continue to work on it. But at this point in time, we don't have a specific comment.
Stacey Simms 21:57
Yeah, I'm curious um, before I let you go here, DiabetesMine, which is a really great news source, if as you listen, you're not familiar, I always read them. I think they're fantastic. They recently, earlier this year, put out an article, headline “39 potential new continuous glucose monitors for diabetes,” as some of these are never going to happen. A lot of these are, you know, non invasive wearables that, you know, look at a headline, and we may never see again, but some of these are going to happen. Jake, I know you all are watching the competition. You know, I know that, you know, Dexcom has enjoyed a long time here of not having a lot of competition, especially the United States. I'll give you the floor. Are you guys ready to take on these companies?
Jake Leach 22:39
Absolutely. I think the just notion that there's that many different companies and working in this space is kind of validating the concept that continuous glucose monitoring is the standard of care for diabetes management and so perfectly comfortable with Mark people working in this space and we continue to drive forward all of our efforts on advancing the technologies, whether it The performance of the sensor the longevity of the sensor, particularly the ease of use, and the integration of our CGM with other devices. And you know from what we've seen, it's a very large opportunity. There's a lot of people who could benefit from CGM, so we're comfortable not being the only player. And we actually going to welcome expansion of CGM space across the globe with other companies as well as tech from
Jake Leach 23:23
Well, thank you so much for jumping on. I feel like I got a double feature of Dexcom this week. So thank you for the info. It's always great to catch up.
Jake Leach 23:29
I appreciate it. Stacey. Thanks for having me.
Jake Leach 23:37
You're listening to diabetes connections
Jake Leach 23:39
with Stacey Sims.
Stacey Simms 23:43
More information in the show notes as always, the episode homepage and there is a transcript there there are important links. Same thing if you're listening in a podcast app, you should be able to get to the show notes. But you know some apps are weird and they don't post links and Apple podcasts which is the most common one. Used as kind of bad for that sort of thing. So I always put it on the episode homepage, which you can find at Diabetes connections.com.
And a little bit on that audio error if you're interested. I mean, here's some inside baseball. But here's basically what happened. Whenever I do a remote interview, and probably 90% of the interviews on this podcast are remote, right? We're not together, I do them generally through Skype. And my computer is set up so that it automatically records when a Skype call is placed. I have a backup recorder. For those of you who are technical and want to know it's an h5 zoom, and it's fabulous. But it's an external recorder that's plugged into the computer and has an SD card inside of it. So this call like a couple I've done recently, our zoom calls, my computer is not set up to automatically record and you know, everybody knows zoom by now if you're not the host, you don't have the power to record well 99% of the time, I asked the host to please record it on their end and then send it to me as a backup and I just roll the h5 zoom over here. forgot to ask them To hit record, there's always a PR person on these calls, you know, Jake doesn't have to worry about it, they'll take care of it. But I forgot to ask her to do that. So I'm rolling on my end, but they weren't rolling on there. And then and this has never happened before, the SD card was full. And it's a huge SD card. I don't know what the data is. I'm not going to pop it out. Now, look, but you know, I cleared out periodically, but probably only once every six months. And oh, my gosh, I completely forgot to do it. So it just clicked off and stopped recording. I share this with you. Because I mean, we're more than 300 episodes in right. We're close. You know me, I know some of you, but I thought you might appreciate it behind the scenes look at some of the nonsense that goes on here. I was able to stop the interview, ask them to start rolling and then restart. But we did lose that part, which I hate about the data. I have talked to Dexcom in the past about data.
I will link up the specific interview where I talked to them about that. And I will link up the statement that they gave me after the fact I asked them to email me some information about that. But you know, hey, we're not perfect around here and we don't pretend to be the next Episode shouldn't be an interview with tandem. if things work out. We're still in the process of moving some things around with ADA and breaking news, we always like to do the best we can. So tandem should be up next, please join the Facebook group Diabetes Connections, the group to stay up to date. And that's the best way to get your questions into these interviews. When I have something like this, I always ask and you guys are amazing at getting me great questions and letting me know what you want to talk about. So I appreciate that very much. Thank you as always to my editor john Buchanan's from audio editing solutions. And thank you very much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself, even if your SD card is full.
Benny 26:45
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Dexcom is featured in a lot of headlines coming out of this year's just-completed ADA Scientific Sessions. Stacey talks to CEO Kevin Sayer about everything from how COVID has impacted the G7 timeline, what the G7 will actually feature, adhesive changes and more. She asks why Europe got approval for back of arm placement and when we might see that in the USA and, once again, we check in on direct to watch progress.
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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 and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Unknown Speaker 0:17
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:23
This week catching up with Dexcom at the ADA Scientific Sessions a time when a lot of new studies are presented. But this year COVID-19 means delays for expected tech, including Dexcom G7, which was moving ahead with trials.
Kevin Sayer 0:38
It was in full force in March it was gonna continue throughout the rest of the year that came to a grinding halt. We are in the process now of resuming and replanting that schedule.
Stacey Simms 0:50
Dexcom CEO Kevin Sayer goes more in depth about the G7 we also talk about adhesive changes, working with European pump manufacturers and what else Coming down the line and tell me something good a major league dream comes true. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I am so glad to have you along. I'm your host Stacey Simms and you need to educate and inspire about diabetes by sharing stories of connection. My son was diagnosed with type one right before he turned two. He is now 15. My husband lives with type two diabetes. I don't have any kind of diabetes. I have a background in broadcasting and local radio and television and that is how you get the show.
The American Diabetes Association Scientific Sessions is a conference where every year many studies many many studies are released and thousands of people gathered to hear what's new and to do some serious schmoozing Of course this year the entire conference was virtual, which is a terrific opportunity. You know maybe you're able to register and jump online. A lot of new media outlets offered their own platforms for you to kind of take part into the virtual conference. I've never been to a da. And while I don't plan on reading every study, you really can go online and see just about everything. I'm going to link up some of the major links, including the one right to the conference, and some of the abstracts. I think every abstract was on one of the pages I saw. So I will link up all of that information on the episode homepage. And I've already put a lot of it out on social media. And chances are good that as this episode airs the Tuesday after ADA that you may have read about a lot of these things you may have seen some of the studies, but I really like going in depth with the the newsmakers as we call them as I used to work in News Radio, but you know, the people who are putting out these studies, so this is the first of what I hope are many interviews over the next couple of weeks. I have confirmation from several of the pump manufacturers. I've reached out to some of the other tech people and people doing these studies and we'll have more information on And follow up on some of the information that came out.
A quick disclaimer. As always, I always like to make this clear. Dexcom is a sponsor of this show, you'll hear their commercial later on, but they don't have any editorial control. And that means they don't tell me what to say or what to ask when I have Kevin Sayer or anybody on from Dexcom. longtime listeners know the drill. But I just like to make that clear. I'll also add we just had Kevin on the show a few weeks back, it did a whole episode when they announced that they were going to have CGM access to hospitals because of COVID-19. And I asked our Facebook group if it was a little too much Dexcom. But overwhelmingly, they said no, give us as much information as you can. So we will get to Kevin in just a moment.
But first Diabetes Connections is brought to you by One Drop. You know, I spoke to the people at One Drop and I was really impressed at how much they get diabetes. It really makes sense because their CEO Jeff was diagnosed with type one as an adult. One Drop is for people with diabetes by people with diabetes, the people Let One Drop work relentlessly to remove all barriers between you and the care you need. Get 24 seven coaching support in your app and unlimited supplies delivered, no prescriptions or insurance required. Their beautiful sleek meter fits in perfectly with the rest of your life philosophies send you test strips with a plan that actually makes sense for how much you actually check. One Drop diabetes care delivered, learn more, go to Diabetes connections.com and click on the One Drop logo.
The ADA Scientific Sessions this year pretty different all virtual, but the information is still coming out. There's so much of it as always, and I was able to talk to Dexcom. now this interview happened Friday just as ADA began. And while we were able to talk about things that were going to be presented over the weekend, there's always a chance breaking news happens since the interview follow along on social media for more information if anything changed, of course we'd put it out that way. And I will link up more information in the show notes.
Quick bit of housekeeping, there are a couple of terms that we throw around here that I want to make sure to just to define really quickly and kind of loosely, most of you are familiar. MARD is a measurement for CGM, the lower the MARD, the better, the more accurate and we talked about that. We also mentioned iCGM. That is a new we're just about two years old classification from the FDA here in the United States, where an integrated continuous glucose monitoring system can include automated insulin dosing systems, you know, insulin pumps, it can integrate other devices like the Dexcom G6 does with the tandem pump, that sort of thing. It also classifies it as a new type of device in a different class for the FDA, which means different things for approval going forward. I will link up more information on that but when he says iCGM, that's what he's talking about. Here is my interview with Dexcom’s Kevin Sayer.
Kevin, thanks so much for talking to me. It hasn't been so long. Since we last spoke, but with the ADA once I get a roundup of everything that was happening, thanks for jumping on.
Kevin Sayer 6:06
Well, thanks for having me again, Stacey. It's always fun,
Stacey Simms 6:09
we have a lot to catch up on some things that we just talked about a few weeks ago. I'm going to start if I may, with something that may seem very mundane, but really caught my eye. And that is the approval in Europe, of placement on the upper back of the arm. We are a largely US based podcast, we do have large international listeners who are very interested in Dexcom. But can you talk a little bit about how that came to be? And as we have talked about before, many people here in the US were on the back of their arm, even though it's not FDA approved. So I guess the second part of that question is, are you submitting for approval here too?
Kevin Sayer 6:48
Well, I'll answer all those questions. And let's start with your You are correct. People have been wearing this thing on the back of their arm for a long time, even though legally and regulatory, I cannot encourage that on a podcast. The fact is when you go to, in particular to like a kid's diabetes meeting, that's where you see all the sensors. And so we've seen that a lot in Europe, we had done some studies and there was some evidence presented that was compelling enough to the authorities that we can get that arm indication. And so we filed that and we got it. Also combining that in Europe, we got a pregnancy indication as well. So we were in a really good position with with respect to C mark. With US regulations, we have that iCGM standard. And the evidence that we presented in Europe for approval isn't strong enough to meet those iCGM standards that we have with our G6 system. But we are working on putting together some evidence in the US that we think would work and will be good enough. So we will ultimately seek a G6 arm indication. I think the other thing to look forward to as far as that when we run our G7 pivotal study, we're going to run the study on In the back of the arm and on the abdomen and on for pediatric patients and on the upper medics as well. So we'll have three labeled sites there. And that will give our patients literally the optionality labor for label indications where the center and the in the most popular places.
Stacey Simms 8:17
It's interesting, when you have a chance, I understand why you wouldn't go back with the G6 and redo things like that, you know, I would imagine the cost alone would be prohibitive. But with the G7 in new systems, it must be interesting to hear from customers, not only things like arm placement, or I wonder if there are other things that you might test. In other words, I have always heard and I guess you can confirm I don't know if it's the case, that the reason that pumps and CGM should not be put through airport scanners is because it wasn't tested there. Is that the kind of thing that in the future we might see you You trying? You know, hey, let's test it with this condition. Let's test it under that condition. I mean, does that come into play?
Kevin Sayer 8:55
we do all of the testing required under federal regs. For those things, I mean, I've worn my CGM through scanner, never worn anything through the scanner through the suitcase, mind you better but I will tell you some of the things we do there is, you do have a very good question there. Because you do ask, do we listen and what are some of the things we try before we lock in on our product design and what do we test and some of the things we've we've talked through and thought about what G7 because we've been at this for quite a while we've had multiple size configurations. Before we locked in on what we did.
We've made it smaller, we've made it bigger. We've liked it on the size we like it on because that was the optimal configuration for the electronics and you get to a point sometimes when things are so small, you can almost lose dexterity or the ability to use it properly. We know people want a smaller less visible sensor. As we look going forward. We will continue to focus on that. we tried numerous adhesives with G7 in our research work, what sticks the most without causing problems, etc. We, we even experiment, not just from a customer standpoint or customer feedback standpoint, but from a scientific standpoint, what's the shortest we can make the sensor and still get the outcome and the accuracy that we want. So we've spent enough time on the G7 system, to whereby we've tested a number of things of that nature to figure out what the best configuration we can get is. And we balance that with getting the product approved, and again, through the iCGM standards. So there will always be when we launch a new product, there will always be some features that we leave on the table that we don't put in it that we would like to put in the next generation. But ultimately, we have to stop and say that this is good enough. It's my job to make them stop. I promise you, the guys have more great ideas than you could ever imagine. But that is a very important part of our process to really listen and test those things. As we go.
Unknown Speaker 11:00
Okay, so you mentioned you've brought up now the G7. So let's jump ahead. I do have some G6 questions, but let's jump ahead and look at that. Where are you on the G7? Did the has COVID delayed things? I know you hate to put dates out there..
Kevin Sayer 11:13
All right, and I won't put a final date out there. But COVID has delayed things on a couple of fronts. The major one is the clinical study any of your listeners and involved in one of our pivotal studies where our patients go into the clinic for you know, at least half a day, at least 12 hours to have blood drawn and tested in the lab instrument is glucose values are raised and lowered. All those types of activities have ceased due to the COVID situation and we had a very aggressive clinical trial schedule. Literally, it was in full force in March and was going to continue throughout the rest of the year that came to a grinding halt.
We are in the process now of resuming and re planning that schedule, but we still don't know all the dynamics of the schedule and the best example I can give you if you go to a large Diabetes Center They might have had four or five patients at the same time in the room being monitored, while the social distancing Are we going to have to? Are we going to be able to have four or five? And what protocols are the various centers going to be running with respect to those clinical trials? So we are really literally out there rescheduling the pivotal study for the G7 system. That is the biggest delay. The other thing we have experienced, and it's to a lesser extent, is just the effect of COVID-19 on all of the people involved in this process. You know, I was talking to somebody the other day, and they used to quote, it takes a village to raise a child it sure as heck takes a community to build a product. And we do depend on a number of other suppliers who encountered their own COVID difficulties, the easiest one that comes to mind which you summon the molds for the plastic or an 18 month lead time and the molding company was hit by COVID and literally shut their whole factory down for a month. And that's not the mold makers. That's not a problem that just does Just reality, we put all of the operational pieces of the schedule back together. We're comfortable with those timeframes.
Now we've got to get the pivotal study up and running and get it big enough. And I will go back to you know, I've talked about iCGM and the bar that the FDA has said, This isn't a study, we can go run with 80 patients and call it a day, there's going to be several hundred patients here. To the extent statistically we can come up with models to decrease the size of this study, we will, but we do analyze it, because the criteria are such and the one that they explained to me that rang the truest in the mid range of the good range of sensors, you know, timing range between 70 and 180. If we have 1000 data points, and if seven of those are off by 40 points, or 40%, the whole trials done, and our biggest source of error in the studies is not the sensor, and it's not because the centers aren't great because they are, there's just so many pieces of paper and so many things that have to happen. So we are really refining that process. Given the fact that we can't run studies now, we're very optimistic once we get them going, and we'll do well. We're going to run a study for Europe, in addition to that, and file that separately, so you'll hear more timeframes from us. But it's going to take longer than even a couple of months to have the perfect schedule laid out a timeframe is not coming for a while.
Stacey Simms 14:17
Can you share anything about the G7? In terms of what makes it different? And why move ahead with a new type of sensor?
Kevin Sayer 14:26
and I'll go back to my first statement to listening. The one feature our patients have all said they want a smaller, and that's pretty universal. When we embarked on this many years ago, we literally started with something the size of an m&m. Now the G7 is a little bigger than a nickel. It's not as small as an m&m, but it's still pretty small. And we wanted to do that. We wanted to eliminate some of the difficulties with respect to transmitters and pairing the whole G7 system is disposable. We also when we looked at G7, and when we started down this path We designed this from the very beginning to manufacturer in an automated manner. There will be humans manning the machines but these aren't going to be human lives. Everything else we've done we designed around the fact that we manually put everything together or have many manual processes now G6 is about to the point where that will be pretty much all automated or manual lines will go away but we wanted to build a product that we could build 10s if not hundreds of millions of in a repeatable manner and our previous generations or product, even G6 up until now I think G6 has now crossed the barrier where we can build lots of them but build g five system says you could have never got to the volumes we anticipate getting to as as technology continues to expand and explode and i and i think what we've created and our goal which he said is to give us a product configuration that anybody can wear and then it will have multi uses. It's as big a step forward from G6 is G6 was for G five.
Stacey Simms 15:56
When you say the whole system is disposable in the size of a nickel Retreat you want to avoid transmitter issues? Is it all in one is the transmitter and the sensor
Kevin Sayer 16:04
transmitter and sensor all built into one unit yes
Stacey Simms 16:07
I'm you know, having been with Dexcom for more than six years now and I think we started in the g4 Platinum I'm trying to visualize
Kevin Sayer 16:16
No, it's much smaller and much thinner and it literally if you wear a G7 you have no idea it’s on your body.
Stacey Simms 16:25
Really interesting and you anticipated having a similar more similar you know accuracy as the G6
Kevin Sayer 16:31
yes, yes, it has to meet the iCGM standards and and so we've we're designing it that way. We're designing the algorithm the pivotal studies along those lines. And right now what what is becoming very clear to us as we go through these statistics, while MARD is always important from an overall perspective, the iCGM standards are more important than than just the margin number is important that these things be reliable and offer the same experience every time. So we Certainly you have to have a good MARD to be approved on those iCGM standards, but the reliability of the sensors is every bit as important. We're focused on both.
Stacey Simms 17:09
Well, as we look forward to that, as you said, it'll be a while because of COVID and other delays. My listeners, as always have questions and one that has come up quite a bit. We'll go back here to the G6 and current manufacturing is a question about whether the adhesive had changed recently on the G6. As always with me, it's anecdotal. I don't have access to studies or thousands of people. But we've noticed within the Facebook group that I run for the podcast that more people are reporting, rashes and problems with the adhesive with the G6 than they had in months and years past and the question came up is has something changed?
Kevin Sayer 17:43
Yes, it has. There's a very fine balance. On the adhesive side. We warranty our product for 10 days. We say this as a 10 day sensor, and one of our most common occurrences of replacing a sensor as it falls off, in fact, the most common one so for years, we have studied adhesives and wanted to make an adhesive change that would give patients a better experience and have that sensor last the entire 10 days. And so we did change the adhesive out to something that was more sticky on the one and we are very happy to report that we are seeing a great reduction in the number of sensors that fall off people. So we are delivering on end to the experience. On the other side of that we have seen an increase in allergic reaction to that new adhesive. We have some data on our website. And we have done some clinically based work for those patients to give them some options to whereby the adhesive will not have that same effect that there's some mitigate mitigations that you can make to do that. So if you contact us, again, I believe it's on our website or also you can contact our tech support. There are some clinically based solutions that we can offer.
Stacey Simms 18:46
All right, so I will refer people to the website and we'll keep helping each other but I think people wanted to make sure and just get confirmation that something had changed.
Kevin Sayer 18:53
Well we did change it we did
Stacey Simms 18:54
Dexcom offers the free over patch when people request it you know to help it be more simple. Has that changed at all? Or that seems to be the same?
Kevin Sayer 19:02
I believe, yeah, the over patches are the same.
Stacey Simms 19:04
Okay, I feel like this is almost like when I used to ask you about Android, but it popped up in my timeline that three years ago, the Apple Watch product came out and it was a huge press release from Apple about this is gonna change your health, this is going to change you know, everything. And in that article was, of course, and you'll be able to see your blood glucose from your Dexcom. They also would hope to get on your watch on your watch.
Kevin Sayer 19:27
We're always supported it. We're not direct to watch it yet. That project has has proved to be extremely difficult. The architecture of a watch is different than the architecture of the of the mobile phone. And in the middle of that I believe there have been changes made to the watch architecture as well. We as we've looked at and prioritized our projects and our resources and we look at software things we need to work on. While that project is still on our list, getting more reliability went to patients each and every day has been above that. And this taken some precedent to it, we will eventually get there.
But there's also some interesting issues with the watch that we didn't even contemplate when that release came out. And I'll give you the perfect example. You've got to charge your watch every day. How do you get that alert on your wrist? When your watches charging, and things of that nature, there is a different experience, and different safety features are going to be required to be implemented over time. We're working through it and thinking about it. We aren't ready and in all fairness, as we've looked at resources, if we're picking for example, between G7 and the watch, look, I love to watch you use I use all these tech gadgets all the time, and I put different ones on, we will eventually get there is a lot more complex than we envisioned when we started down the path. Probably the most loyal Apple Watch, customers are Dexcom patients. If you're an apple watch on an Apple phone and use an apple watch those patients use the Dexcom app on that watch a lot. Even through the phone. The watch experience has been a very good experience for our patients who use it
Unknown Speaker 21:00
What about other watches like Fitbit or devices like that
Kevin Sayer 21:03
we display on the samsung watches or some of the Android platforms now we've had discussions with Fitbit. Fitbit just got acquired. And I think they're regrouping and figuring out where they go. I think it'd be wonderful to offer our patients solutions along those lines, it becomes a question of do you get the whole device safety experience on that display? And how do we label it and what do we do? But these are the things we're looking at and pursuing?
Stacey Simms 21:27
Another question I got from a listener was all about can Kevin talk about other Dexcom partnerships with newer pumps, at least new to the US like, Ypsodmed if I'm saying it correctly, and other you know, European and worldwide, pump companies, is there anything new to talk about with those partners?
Kevin Sayer 21:45
You know what? We just signed an arrangement with Ypsomed to work with them, their pump will pair with our sensor. It'll be in Europe first. They will bring it to the United States at some point in time. They have also signed an agreement to license, our type zero technology, the algorithm that we have that has been involved in numerous studies around the world and is the basis for control IQ as well. So they will use that algorithm and it will continue to work with our sensor. I don't know all their US plans, I won't speak on their behalf. So we'll see where that ends up.
We do have research relationships with a number of entities getting to commercialization, we'll just have to see these partnerships. You know, I would tell you that the 10 of joint product offering is doing extremely well we get great feedback. The Insulet study has started back up. I look forward to the day when all these things are on the market. Stacey, giving patients the choice to have these automated systems will be a wonderful thing for patients and they've been very patient waiting for us and for our partners to get them out. I think when the day comes it will be fabulous but we cannot pair with every single. It is kind of a hard balance. pairing with every single pump is a lot of work to support in house but we want To be interoperable, that we want to get products out, we really want to get solutions out there. And we're happy with the partners that we have. In the US, I think initiatives like the loop initiative where they're gonna develop an algorithm that could work on a number of pumps and number systems might be a very good option for Dexcom to pair with others because the pairing is done by them in the app, not necessarily by work by us. So over time, the interoperability strategies one will continue to challenge and we are prepared to work with anybody that can enhance patient's lives and help our business
Stacey Simms 23:32
it just a clarification question you mentioned Dexcom owns the type zero algorithm, which is the brains let's say of control IQ really are the basis of it if it's used in another pump, if it's in the Ypsomed pump, is it the same exact bit of software? Or do they are there changes or
Kevin Sayer 23:50
tweaks? No, I'm I know that Tandem has made changes to the app and how it works, but the fundamental math and the algorithm will more than likely be the same. I can't speak Exactly. To what Tandem’s done, but I'm pretty confident it'll be a similar experience from an accuracy and from a patient perspective is the way it works. And then we're working with our type zero team to develop other algorithms, and advanced versions of what they've learned in the past. We are free to license to others as well.
Stacey Simms 24:15
It'll be interesting to see how that evolves. And when we talk about interoperability, I actually have a little bit of trouble with that, because in my head, and I've described it like this before, it seems like it should be more like Mr. Potato Head, right? Like I have the base, and then I get to put the ears on that I want the eyes on that I want the feet or whatever. But it's not exactly that easy, right? It wouldn't be a question of like, grab a Medtronic pump, but I get to slap a Dexcom sensor on or you know, buy or anything like that, right? It's not No,
Kevin Sayer 24:42
no, it's not that simple at all. And in all fairness, I think Dexcom has done a better job and design our product to be interoperable better than anybody else. And I can give you a very simple example. I tried to close this many years ago. Our transmitters designed to talk to multiple devices at this Same time to more than one. And that took a lot of time and a lot of engineering and a lot of dollars. And so I raised the question, why are we talking to multiple things? Let's just talk to one. They all kind of like I should know. Well, now think about things. Now you can talk to your tandem pumpers. You can also talk to a phone app at the same time. What a wonderful feature for our patients. And what a wonderful feature as our software changes or gets an advanced feature, that maybe our pump partners or a pen partner or somebody else doesn't have be able to talk to both is a wonderful opportunity for our patients if they want to use both apps. And I think over time, particularly as we look at refining your software experience, it seems to be more important.
Stacey Simms 25:41
Last listener question was about compression lows. I don't know if what they're really called. But anecdotally you sleep on the place for the Dexcom is the circulation slows or for whatever reason you get a fake low. I'm sure you're all aware of this. are you addressing it you think it will be cleared up with the G7
Kevin Sayer 25:59
I don't know. It'll be completely cleared up for G7, I would hope it decreases because, and I can only speak from a theoretical perspective, the sensor is smaller and the transmitter is less bulky. So there might be less pressure pressed on it. But compression has existed in all sensors forever. I have asked the team to look at other ways to deal with the compression issue and come up with some ideas. And they have some very good ones. It wouldn't be in the first version of G7. But I we've got a couple of thoughts that I won't share, because they're very proprietary. I think we have some good answers for compression over time. The question becomes, though, Stacey, and this gets back to the patient experience. And since your listeners are familiar with us, if it's compression low, do we still alert you and wake you up and tell you to roll over? Or do we guess what your glucose value should be and just keep going? What is much safer is to alert you and wake you up and say you're having a compression error roll over? It's not a real low. But do you all want to be woke up for with that type of error or would you rather is Wait for a half an hour and say I was just compressions con, these are the kind of things we shouldn't talk about, and contemplate within the engineering group, which is why these guys want to work here. It's really interesting.
Stacey Simms 27:10
Hey, there's so much information that is coming out at ADA that we haven't even touched on. And I you know, as you listen, I will link up a lot of the information. There's the G6 two year anniversary study. There’s a lot of information about the hybrid closed loop partnerships that's coming out. I'm curious, the launch of the G6 Pro. Honestly, I'm not sure that too many listeners of this podcast would use a product like that, whether it's blinded or they just get it temporarily from their their provider. But talk to us a little bit about that. Who is that for? What was the demand like for that?
Kevin Sayer 27:42
Well, the demand on that has been huge. And the demand starts in the physician offices. And literally, if you think about Dexcom, our pro product right now is a g4. It's not even G5 and our physicians have never had the opportunity to be able to say to a patient, let me Let you have a CGM experience similar to what you would have if you're one. So for your audience in particular for patients who would like to know what CGM is like the physician can output a unit on it. This is exactly the G6 system. The G6 Pro is a transmitter to sensor in a single box. Patient wears it and it's disposed of at the end of the sensor where period, the reason you have the blinded app physicians have asked for it. We think for patients unblinded is obviously the way to go because they can learn what to do with their own management. But the fact is, for a physician, there's a baseline check as to, hey, how's my treatment working? Or how's this treatment working in a type two non insulin taking patient in particular, you can put that sensor on blinded for a 10 day period and get a readout and go, wow, this is working.
the audience is very much from an educational and therapeutic perspective. In the professional environment. We have priced it in a manner to whereby the physicians can really acquire this at a reasonable cost. It will also be you know, at As you look at what's happened with COVID, as well, taking newly diagnosed patient and telemedicine, you can put a patient on this professional system. And if the patient uses the date alive, the physician can use the data live. As we've gone through the the virus situation, the the learnings we've had from our physicians about how CGM actually works. It's been really interesting. I mean, I get phone calls, do you know I can watch my patients from home I didn't know you could watch your patients from home and clarity, we reduce the three hour time lag, we've got near real time. And that's helpful. So you know, in this new age, where you have telemedicine and all the information that physicians need to get, we think G6 pro fits in very nicely and we want patients to be able to have that experience and learn what index comm is like rather than than other things and learn the information they can get ultimately for us as timing range becomes the measure. Now let's take it a step further. If you're a physician and your key measure Simon range Your patient doesn't wear a sensor, you can just put a blinded Dexcom on him, send him home for 10 days and come back, download it, you can read it. And you know what that patient assignment ranges. It has a number of great uses for us and will be a platform for growth going forward, we think is going to be very, very, very important.
Stacey Simms 30:16
I didn't realize it hadn't been updated since g4 that makes a lot of sense. No. And then before I have to go one more quick question. Last time we talked, we talked about CGM in hospitals. I know how long but how is that program going? What is the feedback? And can you talk about how widespread it's been
Kevin Sayer 30:33
able to come? We've had interest from many, many well over 100 hospitals close to 150. And we're in quite a few of them. The interest has been great. It has taken more time for us to do this than we would have thought when we started. when everything started happening very quickly. We were getting requests from hospitals and people didn't quite know what CGM was but read about it that we literally thought 10% of our production might be going to the hospital and it hasn't been that great of a demand. We've learned the intricacies of hospital operations with respect to it and GE, we're sending you free phones fuse the sensor and you guys don't want to use them because you don't know if they're HIPAA safe. We've had to learn all these steps along the way. But where are we got it, and where it's up and running? Well, the results have been everything we'd hoped for the sensors performing the way we want it to it's accurate. We haven't seen major problems due to drug interference, which was a concern that has been an FDA concern over time, the ability of the healthcare providers to monitor from in the hallway, a finger stick administered by a healthcare professional, somebody timed it for many other days, about 15 minutes because you got to gown up, put on gloves, go stick the finger, okay, if you're doing a finger stick an hour, you're saving 15 minutes of nurse time every hour. For every patient, they don't have to stick the finger on. There's been a huge reduction in PPE.
The patients are getting off the insulin drip faster because their diabetes can under control more rapidly. are leaving the ICU faster. They're going home healthier, all the outcomes. We hope for happening, the speed of which the uptake has been slower than we would like, but it is still going on and people are still expressing interest. And I, I think based on the places where it has been, I don't think anybody's going to let it leave. Particularly while we sit and anticipate what could possibly happen in the fall, we are going to gather data. And when we can gather data and get enough data to whereby there's a meaningful submission, or at least a discussion, we'll take that and we'll discuss it with the FDA and decide what next steps would be to get the labeling and to get a hospital usage approved. I think the products always belong there. I went through an experience personally with my mom many years ago, she had a heart valve replaced and it took them longer to get and she had type two diabetes. It took them longer to get her glucose under control than it did to get her heart valve and all the other pieces of her recovery then it was fascinating. I mean, they kept coming in adjusting insulin dosage, taking it up taking it down. And I kept saying I have something we could put on her to make It's easier, and no, no. So I do think it belongs here. It's a great use for the product.
Stacey Simms 33:06
That's really interesting. Well, Kevin, thank you so much for taking some time to talk to me about this. A lot of things happening at once. And I always appreciate your time. And when you start the G7 trials, I know that we all go through the official channels, but you know, call me We'll get my son and
Kevin Sayer 33:24
hey, we appreciate I always love to come on on your show. We always have a great discussion, and I'm happy to deal with any questions that come up. You know, I don't hide.
Stacey Simms 33:33
Yeah, I appreciate that very much.
Unknown Speaker 33:40
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 33:46
For information at Diabetes connections.com. As always, at the episode homepage, we do have a transcript as well if you prefer to share it that way if that's helpful for people that you know, easier to read it than to listen and just to be crystal clear, if it wasn't paying 100% choking. At the end of that interview, I could no more get into a clinical trial by talking to Kevin Sayer than I could, I don't know, get Benny a better wrestling birth by going to the NBS Linux department of his high school. I mean, I don't know about you, but that's not how it works for me. And we joke all the time being Penny never been able to get him in a clinical trial. We keep trying, I'm signed up all over the place. Maybe the word is out on what a pain in the butt I am. But I would love to get him in one of those. So we'll keep trying, but interesting information there. And I will link it all up at the episode homepage. Tell me something good in just a moment. Let's talk about baseball. But first diabetes Connections is brought to you by Dexcom. And you know, when we started using basal IQ a couple of years ago, that's the Dexcom G 610. to pump software program. I was so happy with it. And then with control IQ. It's just amazing. less work. better results with diabetes with a teenager. I mean, Benny always liked seeing his face GM numbers on the pump, right? We got that pretty much right away with tandem. But honestly, it was just more of a cool feature he really took us pump out to just look at it. There's some secret sauce, though, in first basal IQ and now control IQ, right? That just really is incredibly helpful. His range time and range has increased significantly, his agency has come down significantly, you know, I don't talk about specific numbers. Holy cow. Of course individual results may vary. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Intel Tell me something good this week. This is a cool story that just because it's a cool story on its own, but I was alerted to this because in one of the Facebook groups I'm in, a mom posted a picture and this picture had to be at least 10 years old, maybe 1215 years old, of her son on a baseball team with another little boy both kids with type one and the other little boy was just dropped By the Milwaukee Brewers, Garrett Mitchell was selected 20th overall in last week's draft. Now, there's a lot of information here about baseball, I don't know. But I like this sentence, many heads a left handed hitter projected as going into the top 10. So the early take is the Brewers got a gym who dropped further than expected. And then they go in about like, well, his power numbers, and there are questions about this. But Wow, I'll link up one of the articles where Garrett Mitchell is quoted, and he really did talk about it. He said, You know, a lot of these teams, it did come down to diabetes, what teams want to deal with that, you know, what teams are comfortable with that? And he says, personally, I don't really see this challenge. You know, there are a lot of people who questioned him, but he says, I know how my body works. I know what I need to do. And he has been dealing with it since he was a young child. And I think it was really interesting that the story I'm reading this from isn't from a diabetes publication. It's not a profile on jdrf. There's lots of those and I hope we hear much more about Garrett Mitchell, but this is just a regular sport. story where the diabetes stuff comes way, way, way down in the article, so congratulations to him. Thank you for those of you who alerted me to this on Twitter, which is always great if you see something good like this, please tag me let me know. And of course we are efforting an interview with Garrett Mitchell because why not? I would love to talk to him. If you have Tell me something good story. If your child is starting to play sports, and I mean, forget about hitting a home run, you know if they just get through the game, and you don't run on the field. I'm kidding, but I'm not kidding. The parents know what I'm talking about. Right? If you have a Tell me something good story big or small. Let me know this is my favorite part of the show. Every week. I love sharing your stories. You could email me Stacey at Diabetes connections.com or just tag me on social media and tell me something good. Before I let you go more Ada stuff is coming. I am excited to have interviews on tap with a lot of other technology companies and we'll be sharing those in the weeks to come. There's a lot of stuff to unpack here. I also want to let you know and this is kind of selfish and I hate that these are all the same time every year but I guess this is a word season so I want to give you a heads up that the we go health and the independent podcast awards are coming up in a thankfully it's not a vote everyday situation I hate when people do that just just awful that they asked you to get your listeners to vote every single day What a pain in the ass for I'm not gonna win anything with that attitude. But I have been nominated for a we go health award on the voting for that, which is basically just please go ahead and like me on the wiegel Health site will open up in July. And I will be putting that out on social media, the independent podcast awards. We've been very lucky where some wood that I can knock. We have been named a top 10 Health podcast. That's a nationwide independent podcast award every year since the podcast launched and I love keeping that streak going. So I will be asking for your help there as well. Again, it's just a vote once please. And there's lots and lots of podcasts to vote for. Same with legal health. There's lots of categories to vote for. So if you know somebody else in the diabetes community or there's a podcast Guess that you like you'll be able to nominate and vote for them there. So more to come on that just thank you very much. I hate asking but that's the only way to do it. All right, thank you to my editor jump, you can start audio editing solutions. Thank you very much for listening. And Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Unknown Speaker 39:25
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Melissa and Kevin Lee played an important role in what we know now as NightScout and the DIY movement. Their interest was initially sparked because they wanted to have children. Melissa lives with type 1 and Kevin has an engineering background. They jumped in with many other "hackers" to create what we know now as Nightscout and other DIY systems. By the way, the Lee's children are now ten and eight!
Check out Stacey's new book: The World's Worst Diabetes Mom!
In Tell Me Something Good, wedding bells for a T1D couple – which spark some fun stories from others in the community.. and an update on a change my son made after our last episode.
Join the Diabetes Connections Facebook Group!
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
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Find all of the "We Are Not Waiting" episodes of the podcast here
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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 Real Good Foods, real food you feel good about eating and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:19
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:25
This week, Melissa and Kevin Lee played an important role in what we now know is Nightscout and the DIY movement. It's kind of hard to remember but those early days very different. Melissa remembers what it was like the first time Kevin for husband followed her numbers and acknowledged what a hard day she'd had.
Melissa Lee 0:45
And I didn't realize I just looked at him and he said, this is how every day is, isn't it? And like I still get chills thinking about it. They say it was the first time that anybody outside of me or another person with diabetes looked at I said I see you. This is hard.
Stacey Simms 1:02
Melissa and Kevin were interested initially in the DIY movement because they wanted to have children. Their kids are now 10 and eight. We have a lot to talk about.
And tell me something good wedding bells for a couple who live with type one. And that sparked some fun stories from others in the community. plus an update on a change my son made after our last episode.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of Diabetes Connections. I'm so glad to have you here. I'm your host Stacey Simms we educate and inspire about type 1 diabetes by sharing stories of connection. And this is a story of connection. Melissa and Kevin have so many wonderful anecdotes to share about finding the DIY community about those early exciting days about the projects they worked on. And we talked about what it's like as a married couple to go from not sharing any information. about diabetes to being some of the first people to be able to see CGM information, you know, how does that change your relationship? How do you talk about it? And we'll get to that in just a couple of minutes. It was great to talk to them.
I wanted to bring you up to speed first, though, on something that I mentioned. Well, Benny mentioned it when I spoke to him last week. So Benny is my son, if you're new, he was diagnosed right before he turned two. He is now 15 and a half. And we talked last week about changing a bit of our routine, he has been taking a long acting insulin called Tresiba for almost two years along with using an insulin pump. It's a method called untethered, I'm not going to rehash the whole thing. I've talked about it many times. But if you are new, that will link up more information in the show notes and you can go back to listen to last week or previous episodes with Benny about why we did that. bottom line he was using so much insulin because of puberty and maybe some other issues genetics who knows that it was very, very helpful to add an additional basal source that took the pressure off the pump inset, but Over the last month, his insulin use has gone way down. And that is because of three factors. He's probably coming out of puberty, he has lost a lot of weight. And we are using the control IQ system, which we noticed right away meant we were doing far fewer big corrections and we just used it so much less insulin on it.
So during the show that the last endocrinology appointment, Dr. V, had said it was fine to go off the Tresiba, no problem, do it when you want if you want, and Benny said that he did want to do that. So as I'm taping this, it's probably about eight days since we made this switch. It takes about two to three days everybody's a little different to get Tresiba out of your system. It works a little differently than some other long acting so it takes longer to get out of your system. We did have a rocky three days but we were used to that we knew that was coming and just as I had hoped control IQ the software system with the tandem pump and the Dexcom just has worked even better than it did before and I don't talk about specific numbers with my son. That's not how we Roll, but just to give you some perspective has been about 70% in range, you know, it goes up, it goes down very happy with that number. He has been 80% in range, I think 82% in range for the last seven days as an average and two days where he was like 98% in range. It's crazy. So I don't think that'll continue because that's how diabetes works. Right? Don't you find sometimes it like lulls you, when you make a switch, it always starts out great, and like a week or two later floor like the rug just pulled out from under you. So we'll see.
I want to get to Melissa and Kevin. But at the end of the show, I'm going to talk a little bit more about some changes we've made recently, in addition to Tresiba, we have changed how we use sleep mode. So stay tuned at the very end. I'm going to talk about that. But I know not everybody uses control IQ. So standby
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My guests this week are part of the history of the diabetes DIY movement. longtime listeners know that I am fascinated by the we are not Waiting crowd. And I can't say enough about what they have done for our community. In fact, I'm actually trying to put together an oral history. And we've talked to a lot of people since 2015. When I started the show about this movement. The big problem is a lot of these wonderful engineering and tech types are a little spotlight adverse. You know who you are, but I'll get there. I did reach out to Kevin and Melissa, because, you know, I've talked to Melissa a few times about pregnancy and type one and other issues. I think that the show we did as a panel with other guests about pregnancy in type one and Steel Magnolias is frankly, one of the top 10 episodes, not because of me, but the guests are so amazing. And that night gets so much praise on that episode, people, you know, women pass it around. I'll link that up in the show notes.
But you know, I hadn't heard Melissa and Kevin's story, and their names always come up when we hear about the early days of the DIY builders. So our talk today is about much more than the technology it's also about marriage and kids and diabetes and sharing data. You know how that affects your life. Quick note, Kevin now works for Big Foot biomedical and Melissa works for tide pool. If those names don't mean anything to you, if you don't know what those are, or you know what they do, might be a little bit of a confusing interview. There's some presumed knowledge here, I will put some links in the show notes, you may want to go back and listen to previous episodes about the we're not waiting movement or just check out the links. Also, it is really hard to get people to acknowledge the difference they've made. These are all very modest people. God loves them, but I do try. So here's my interview with Kevin and Melissa Lee,
Melissa and Kevin, I am so excited to talk to you two together. Thanks for making time to do this. I know how busy you both are.
Melissa Lee 7:43
Thank you for having us on. This is a fun thing to get to do.
Stacey Simms 7:47
I don't know if Kevin's gonna think it's that fun. We'll see. And I say that because in the small way that I know you you don't seem like you're quite as conversational and chatty is as we Melissa, well, we'll see how it goes. Kevin, thanks for joining us and putting up with me already.
Melissa Lee 8:04
Well, you know, he actually is until you stick a microphone in front of his face. Oh, okay. You know, beyond that, yeah.
Stacey Simms 8:12
Well, let's start when when you guys started, and Melissa, I will ask you first How did you meet?
Melissa Lee 8:17
Oh, this is a story I love to tell. And Kevin's gonna already be like, why did I agree to do this? So this was like 2006 and I spent a couple of years doing internet dating. And you know, I'm very extroverted and and like a go getter. And I had just been on, like, 40 bad days, basically, on the internet. Basically, I was broke from spending money on lots of different dating sites, and I found a free one. But during that one, it turns out that this guy was on it because one, it was free. And two, he liked their matching algorithm that tells you a little bit about why you needed so we met online and then What a year and a half later, we were married. Wow. So yeah, we were married in late 2007. At the time, I was a music teacher. And Kevin, how would you describe what you did in the world?
Kevin:
I was working at Burlington, Northern Santa Fe, just deploying web applications as a contractor to IBM. And then in our early years, you worked for capital, one bank doing infrastructure architecture, and then later for American Airlines doing their instructor architecture. So we like to say, you know, we've been in finance he's been in travel is been in transport. He's been in lots of different fields doing that same thing that I just said infrastructure architecture, which I will not explain.
Stacey Simms 9:44
So, Kevin, when did you go from checking out the algorithm of the dating app, to noticing that perhaps the diabetes technology that your girlfriend and fiancé and wife was using, when did you notice that it really could be done better. And then you could do it
Kevin Lee 10:02
became a little bit later. And it first I kind of just let her her do her own thing. She managed it. She managed it well. And then as we started to progress, and we both wanted kids,
Melissa Lee 10:16
yes, we got back from the honeymoon and I had babies on the brain and two of my bridesmaids were pregnant. And then I have this whole, you know, in our pregnancy podcasts that we did together, I had babies on the brain, but I had this diabetes hanging over me. And I think that that was a huge motivator for both of us. So like mid 2008, my insulin pump was out of warranty.
Kevin Lee
And so that's that's whenever I really started to encourage her and I started getting involved and saying, hey, let's let's go experiment. Let's find what's what's right. Let's look at what else what other options exist and didn't find too many other options but no, we I did switch I switched insulin pump brands and we started talking about this new thing that was going to be coming to market called the CGM.
Melissa Lee
So I got my first CGM within the next year. And Kevin immediately started trying to figure out how it works. So this was the freestyle navigator. And this was like 2009. I think I was maybe already pregnant or about to be pregnant. And Kevin was trying to hack this device.
Stacey Simms 11:25
So what does that mean? When you said you started to figure it out? What did you do?
Kevin Lee 11:29
Well, it bugged me that the acceptable solution was the we had this little device that had a range of measured in the 10s of feet. That was it. And I had a commute. At the time, I was working at American Airlines and my commute was 45 miles one day daily, and she was pregnant, and I just wanted some sort of assurance that she was safe and there was no way to get that and I just wanted to be able to You know, it was obvious that this center was sending the data that I wanted on the available through an internet connection. How do I get that? Ultimately, that effort was unsuccessful. And that's when we started going to friends for life. And there, that's where we saw I guess Ed Damiano’s connected solution where there's remote monitoring, and we saw the Dexcom. And that's whenever I thought, hey, if that's an option, and so we started looking into the Dexcom and switched over.
Stacey Simms 12:39
I'm gonna jump in because I'm a little confused. When you said you said Damiano’s connected set up, I thought that he was showing off what is now called the iLet and the new the bio hormonal insulin pump. What was the Dexcom component to that that you hadn't seen before?
Kevin Lee 12:54
So it was just a simple remote monitoring, you know, he needed to be able to as part His research to be able to remotely monitor the patients that were well,
Melissa Lee 13:05
specifically, he had an early version of the bionic pancreas had a Dexcom that was cabled to a phone. Oh, and so if you look back at like, 2012 And so like he I remember Kevin holding the setup in his hand and looking at it and being like, you know, this is fascinating. Like, I have an idea.
Stacey Simms 13:30
Because at the time and I'll find a picture of it, but it was cable to a phone. And there were at least two insects from the pump. So you had to have the the CGM inset and then you had to have two pumping sets and then the phone cable for the bionic pancreas at that time. Am I thinking of the right picture?
Kevin Lee 13:45
No, I really should
see all of that.
Melissa Lee 13:49
You know, like we're so old at this point.
Like, like eight years ago now I wasn't realizing because how have my children are but this You know, I want to say that this was even before we'd have to go back and back with them.
Kevin Lee 14:05
Yeah. And that was just the moment that hey, okay, this is another alternative. And we were, we were actually looking to switch at the time because I think that's when the note and I switched.
Melissa Lee 14:17
Okay, we had to switch because navigator went off the market in 2011. So this is right around the time, we just switch to that.
Unknown Speaker 14:24
So what did you do with the Dexcom ,
Kevin Lee 14:26
whenever we noticed that there was a little port that was also used for, for charging and for data, I connected to it and started reverse engineering it sending data and seeing what we got back and trying to get that data off. It was first connected to my little Mac MacBook Pro. And I just had a goal over Thanksgiving to be able to get that data out of the CGM. And it took three or four days and I was able to get basic data out of the system. In premiere, it was just as simple as uploading it, and then visualizing it.
Stacey Simms 15:06
So for perspective, and I want to be careful here because I know there were a lot of people working on a lot of different things. I'll be honest with you. I'm not looking for who was first or when did that happen? Exactly. But just for perspective, is this basically the same thing that we then saw, like john Costik, put up on Twitter when he said he got it like on the laptop? Or, like, what would we have seen if we had been sitting in your house that day?
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Now back to Kevin answering my question about what does it look like when he figured out how to reverse engineering the free the Dexcom data.
Kevin Lee 16:30
Absolutely that we would you would have seen a little text flying by saying this is the the glucose number. Yeah, on the on the computer. It wouldn't have been very exciting to most. And from there, Melissa tweeted out saying hey, we have the data available from our Mac and I guess that's where Joyce Lee picked up on it and wanted some more information.
Stacey Simms 16:55
All right. So Melissa, take it from there.
Melissa Lee 16:56
Yeah, you know, Joyce has been a real champion as those early days. Why date and so I remember her reaching out to me and saying this is this is really interesting. I want to know more. And in this was the same year that Dana and Scott were bringing their thing to life with what was then DIY APS. This is around the same time, same era in history that, that john Costik was doing his great stuff and with Lane Desborough and the early days of Nightscout, so all of these things were happening in these little pockets, and we were just another little pocket at the time. One of the things that concerned us was whether we were doing something that was going to be shut down really quickly, like there's something that you find knowingly or unknowingly, it's kind of like when you agree to the terms on iTunes.
So when you use these devices, there's something called an EULA and End User License Agreement. And these eu la say, you're not going to reverse engineer this product. And so we were a little cautious about what we wanted to diseminate in terms of like your take this and run with it, but that culture was still developing. And so at the end of that year was the big d-data event at the diabetes mine summit, where there were a few really key DIY influencers sort of in the room. This is where Lane first coined the we are not waiting and, and the next day I was at that summit, and I was hearing Howard Look speak about what had happened at the d-data summit the day before. And I was like, Oh, my God, Kevin has to plug into this. So we want to help this initiative. Like we want to be a part of this. We have so much to offer we this whole remote monitoring setup that he had built for me. And at the time, like by then I think one of the biggest things we have done is Kevin has developed do you want to talk about glass.
Kevin Lee 18:51
Yeah, it was just a another way to visualize the data. So Google Glass, I don't know if you remember that. It was a kind of a connection eyeglass. Yeah, in some ways, it was ahead of its time in other ways. It was just a really interesting idea. I got a pair, and I was able to have it alert me when she crossed the simple threshold. And I was able to see historically three hours or 12 hours or whatever it was without having to pull up a web page. It was just kind of always there and on available for me if and when I needed it. So it was just kind of an ambient thing in the background that I didn't feel like a I had to worry about.
Stacey Simms 19:38
Interesting. Kevin, I'm curious in those early days, so if I could just jump in. You know, you you don't have type one. You care very much about someone with type one and you're doing this because you care about her and want to make sure she's safe. When you started meeting other people who were doing the same thing. What was that like for you? I know it's chancy to ask an engineer about how they feel but it had to have been nice to get kinship with these other people who basically spoke your language and also understood the importance behind what was going on.
Kevin Lee 20:07
Yeah, so that was actually really kind of interesting whenever we first started sharing that we wanted to share it just with a small group of people. And I think it was Manny Hernandez that introduced me directly to Wayne and Howard and a few other Brian Maslisch.
Melissa Lee 20:28
yeah, so I like to tell the story that I chased Howard Look down in the hallway after that, and was like, you have to connect with my husband. And then that didn't seem to work. So that's when Manny was like Manny Hernandez, who was the founder of Diabetes Hands Foundation. He is a good friend of ours and he was like, No, I have to connect you to these guys.
Kevin Lee 21:15
And so there's this pivotal email thread from January of 2014, where we started exchanging The well, here's the project that I've done and Lane says, Well, here's a project that that we've been working on and we call it Nightscout. And so we, we kind of exchange notes. And then it was a little bit later that Lane, well, maybe not lane. Exactly. But that's when the the whole CGM in the cloud and the Nightscout. Early foundations started to show up on on Facebook.
I think that's whenever another engineer had published the code on GitHub, and started to set appears. Here's how you set it up. Well, there weren't many in my situation, you know, one of the engineers was a parent. And I think we actually made a really great mix. And I think that that's part of what made the successful so one of the engineers working on the project was A father of a type one I represented the spouse and some of the other engineers were personally affected by by type one, and definitely added a different level increase the camaraderie between us. Those are early days we were were on the phone almost nightly. As soon as I get off my my day job, I'd go home and work on the evening job of trying to get the next set of features out or to fix some new fixes. I love to describe this day because throughout 2014 he would walk in the door and he was already on the phone with the other devs from night out. And if I walked in the room where he was working on the computer, I would be like, Hey, Kevin, and then I'd be like, hey, Ross Hey Jason, because I assumed that they were on the phone. Hey, Ben.
Melissa Lee 22:56
Like it was staying up all night long. They didn't sleep. They did this all day long. Kevin talk a little bit about the pieces you brought in tonight that from our system that we created, and then we like I, I have two producing diabetes data. I'm not gonna, I'm not gonna claim a lot of that. But I was just plugged into it. If people are familiar today with Nightscout, which many listeners may be like, what piece did they hold in their hands? That was yours.
Kevin Lee 23:26
So the the piece that I was so connected with was the what we refer to as the uploader. It was just a piece of extracted the data from the CGM and then uploaded it to the Nightscout website. The early days. I don't know if you remember it was the little 3d printed case with a phone that you got that happened to have a data plan and a wire connected to the the CGM. Right whenever Nightscout first came out, I was I was hesitant to start I mean, this was like the first few months I was hesitant to contribute. I wanted to see What I could do, but as it started to pick up be there, it was obvious that the pace of development that I was doing on my own was not going to equal what the rest of the community could be doing. But then he and I had these other features, which I'll go into in a moment here that I felt the community could benefit from.
So we started having early conversations with Ben and others. How do we fold in functionality that I had into the current uploader, that functionality was essentially the early ability to follow on a native phone app, it was decreasing the size of the packet and uploading more so using less data. It was an Android watch, being able to get the latest data on an Android watch. It was used in camping mode. I don't know if you're familiar with that. But the early days of knights count we had the pebbles that We're kind of Bluetooth connected smartwatch, that use the little EEG displays. Those required you to be connected to the internet. And one of the devs Jason Calabrese had said, I'm going camping next week. And I'm not going to have internet connectivity. And I sure wish that that I could. So I thought about it for a minute. And were able to quickly reconfigure it the existing code to be able to get that data on the watch without an internet connection. So
Stacey Simms 25:32
camping mode literally came from a camping trip. Yes.
Kevin Lee 25:37
Jason Calibrese’s says camping trip.
Melissa Lee 25:40
So well, and then the code that became xdrip which like thousands of people use today.
Kevin Lee 25:46
So that's, that's a great thing about open source community, whatever ideas reverberating off of each other and become more pronounced and it essentially becomes the sum is greater than the whole.
Unknown Speaker 25:59
Let me ask about xdrip, though, was it originally called Dexdrip? was that one of the first times Dexcom got involved and said No thank you, or did I miss remember that,
Melissa Lee 26:10
that was all part of Emma Black’s history. Emma took the code that Kevin and created and, and created built on top of that to create Dexdrip. And Dexcom did say you can't use our name and became accept yeah that you're remembering correctly. It was a very friendly discussion. And so it was renamed to xdrip.
But you bring up an important point about how industry was reacting to all of us in late 2014. The team at Medtronic actually invited many of the community members who were working on that into sort of the belly of the beast, and to come in and talk to them about the why and the challenges and the what could industry do and and What are we not hearing and just sort of like a meeting of the minds. But what was so cool about this is this is the first time that many of us had met one another in person. So here, people have been working on this for a year or two. And now suddenly, it's a table with Dana Lewis and Scott Lybrand with john Costik with Ben west with me with Kevin, with Jason Calabrese, like we're sitting around a table for the first time and talking with industry as this United Community. So it felt a little less, to me, at least as someone who's been really involved in fostering community, right? It felt to me like there's the start of something here. And that was a really exciting meeting. We like to joke that nothing came of it. I was gonna ask about that. But to me like that was exciting. It was this energy of like, we all came to the table and said like, these are the needs of the community. This is why we need remote monitoring. And this is what we're gonna do next. And you can either help us or understand we'll do it anyway. And so that was that we are not waiting spirit.
Stacey Simms 28:08
Well, and that was a very pivotal time. And, Melissa, let me just continue with that thought if I could, it was such a pivotal time, because you all could have said, we are not going to continue without you. Right? We need this. But it seemed to me and again, it's hard to for me, you know, it's funny that it's so long ago now. But it's only four. It's like, it's only five or six years ago, really? The seeds of that community. And you can see it just in the Facebook group with CGM in the cloud and everything else. There's 10s of thousands of people now who are part of this community. You know, did you saw the seeds if it Then did you ever imagine it was gonna get as big as it is now?
Unknown Speaker 28:48
Is it crazy to say yeah?
Kevin Lee 28:54
to directly answer the question. Yes. And that's where we were actually Faced with a another really tough decision of how do we continue to solve these problems? And we started to see the scalability problem that what we viewed as a scalability problem within the community. How do we continue to support it? And how do we deliver this safely to masses? It was a choice that we had to make of if we're doing the industry and we, we try to do it this way. I don't know there, there isn't really one right or wrong way to do it, but it was just a another way. And we believe that by joining the industry that we could deliver something simple, easy, and we could make it scalable and supportable for the masses.
Melissa Lee 29:44
I think those things like those meetings with Medtronic or, or Dexcom, early on. I mean, I remember sitting in Kevin Sayers office at Dexcom and I was there for a completely other reason. I was there on behalf of Diabetes Hands Foundation said and I just like went off about night prayer. But those conversations gave us a really like I want to recognize my privilege in that to be able to be in a position to go sit with leadership at these big diabetes device companies. But let us see that there was a way to bring the change we were doing outside. I don't want to use the word infiltrate because that sounds
to infuse what industry was trying to do with community perspective and patient perspective and and the change that we knew was possible. And that resulted in both of us for huge career changes.
Stacey Simms 30:43
And we will get to that for sure. Because it's fascinating when you mentioned and you know, we're doing a lot of name dropping here. And if you're if you're new to this and you've listened this far, I promise. I will be putting a lot of notes on the episode homepage and you can go back and listen to other episodes, but there's a lot of names that have Gone By. And a lot of names that you mentioned are people who either founded or were instrumental in the founding of newer independent companies that came out of at least as I see it, this DIY wave that happened in the mid 2010, that you all are talking about. And now you both, you know, you work with these companies and for these companies, but I want to continue this the scalability, as you mentioned, because it's remarkable that even as all those companies, I mean, Big Foot tide pool, you know, even as these companies came out of this, you're still servicing all these, and I'll call us lay people. I mean, I, you know, most of the people who were early adopters of Nightscout or things like that seem to have some kind of engineering background or something that helps software makes sense. But then the floodgates opened, and it was just easy for people or easier than it seemed for people to do that. Kevin, was there a point that you kind of remember looking at this and thinking, you don't have to be an engineer.
Kevin Lee 31:59
That's actually part of the reason why I continue to contribute with Nightscout and in the early days, we decided we were going to go ahead and launch on the Play Store. So we set up an account. And you know, instead of having to go out download the source code, compile it, we distributed it is via the channel that users were used to receiving their their app from. Another thing that we introduced was the barcode scanning. So what we found out was set up of the app was a little more complex than it needed to be. And so we introduced the the concept of barcode scanning to set that up,
Melissa Lee 32:42
which now exists in the commercial like every time you start a new transmitter on a Dexcom system today, you scan a barcode on the side of the box. Kevin did that. I remember, I'm not claiming but next time did not develop that on their own. I am just claiming Hey, we.. yes.
Unknown Speaker 32:59
out Yeah.
Stacey Simms 33:02
Yeah, that's wild. I did. Yeah, I was thinking about that. Because now that's, of course, that's how we do it. And Melissa, I know I'm kind of jumping around here, but I have so many questions. I wanted to ask you earlier. What was it like for you? At this time? You said, Well, I just provided the data. I mean, what was it like for you during this time other than, you know, just popping in and saying, Hey, honey, how were the phone calls going? It had just been exciting and a little nerve racking for you. What was it like,
Melissa Lee 33:30
by my count, and again, Not that it matters? I think I was the first spouse to be followed.
Sounds creepy, doesn't it? I was the first CGM stocks 4000. Now, um, but one of the things, it did a few things for me, and I'll never forget one day I was in the kitchen and I've got babies and toddler and lay like it had just been a day right when you're a young mom, and you've got Little ones and it has just been a day and Kevin walks in and he said, and you've had a really hard day and I just looked at him like, Are you an idiot? Yes.
And I was like, What are you talking about? And he was like your numbers. Oh, and I just looked at him and I didn't realize I just looked at him and he said, this is how every day is, isn't it? And like I still get chills thinking about it Stacey I like it was the first time that anybody outside of me or another person with diabetes looked at me and said, I see you this is hard. And I didn't even know like I probably said yes, you idiot I've had a hard day
Unknown Speaker 34:46
I doubt it.
Kevin Lee 34:48
I had worked on some some code to make Nightscout available via personal assistance. Think the Alexa and Google Home and, and other things. And while I was experimenting and testing it, it became very clear that I was not allowed to ask what what those values were.
Melissa Lee 35:14
He was like, it’ll will be so handy. And if you're in the middle of cooking and you've got like, you know, stuff on your hands, you can just ask it. But like, what you don't do is you know, your wife snaps at you. And you say, Alexa, what's her blood sugar right now? Like, that is not what you do. So now the story I was going to tell Oh, Stacey, you're gonna love this one. So this is like early 2015. And I am the Interim Executive of a nonprofit and I'm representing patients at this endocrinologist a meeting, and I'm alone in a hotel, and I had been out with all these endocrinologists and we've had tacos at a bar and I have no idea what my glucose was, but I had calibrated my CGM with probably tacos all over my hands. I go to bed. Well, this poor man, I'm in Nashville. He's in Dallas. This poor man is getting
Kevin Lee 36:09
the blood sugar was reading his 39. Yes, for those who don't know, is the world. The CGM can read anything below that he registered
Melissa Lee 36:19
as low. I have my phone on silent because I've been out with all these professionals. So he had called me 18 times. It didn't go through Sunday night disturb so far in two hours reading, like a 39. So hotel security burst into my room. Mrs. Lee, Mrs. Lee, are you okay? Do we need to call an ambulance, this string of expletives that came out of my mouth? I will not repeat on this good family show. But I was so mad and you know, I'm calling him and I'm like, I'm like 130 right now. Fine. by that same token, I have lots of like really lovely stories where You know, I'm alone in a hotel in New Jersey, and he wakes me up in the middle of the night to say, you know, wake up and eat something, honey. So, yes, there is a good story, but I must prefer the story where he had security break into my room. Oh, my God over over what nights? That was it.
So, you know, but to your question, we really were on the very bleeding edge of understanding things that you actually already deal with, with your son today and that people deal with today in terms of how will we actually establish boundaries on how much of my data you get to react to and for all the times that it is a benefit? Where are the times where it's like, no, I actually have to cut you off. We're now like seven years into him following my data. And so in some ways, I think we both see where people will get to when following data is the norm you know, should it ever scale by Live in terms of now, he doesn't look at my data all the time. Now he knows when to respond when it weren't so good. But it made me feel understood. It also made me feel a lot safer to know that just have somebody else watching my own back. I'll be celebrating 30 years with type one this year and celebrating is, you know, you've been
away there. But like to know that like somebody else is just there to pick up a little bit of slack you have for someone like where you are, it can be hard because I know when teams don't always appreciate or show their appreciation in the same way. But there is an appreciation for the fact that that you're there to pick up a little bit of slack just as much as there is resentment and issues with boundaries. And in times when they really need to just shut your assets off. And so I feel like we're just a little bit further down that road in some ways, you know, we'll let you know when we have it all figured out. But Exactly.
And what's right for us as a couple is not necessarily going to be right. For every couple, you know, there are couples that really feel like, no, my data is mine. And I don't trust you not to react to it in a way that's going to make diabetes any harder for me. And I think that that's what we 100% have, that I'm very fortunate to have is that I trust Kevin, to react to my data, the way that I'm comfortable with him reacting to my data.
Stacey Simms 39:33
So both of you, through this process wound up not only having two kids, but you made big job changes. And you now both work in the diabetes sphere. And I hope you don't mind I'd really like to talk about that a little bit. Because I mean, you mentioned the beginning. Listen, you're a music teacher. And you're right, your background, your music professional. You are Bigfoot for a couple years and now you are a tight pool and you're basically I'm going to get a But you're helping tide pool so that they can better train people and kind of explain to healthcare professionals and the public to kind of I look at that as translating, is that sort of what you're doing there?
Melissa Lee 40:12
Yes or no. So for instance, I know your family has just started with a new piece of diabetes technology. There were certain training modules that were there to support you. There's certain learning materials that were provided to your child's doctor so that they understood what they were prescribing. There's a user guide that comes with the stuff that you use in your family today, if you're buying things from companies off the shelf, and what the DIY community when we're talking about scalability, and how important that is to each of us having a knee accessibility, scalability availability like these important, how do we bring this to people in a way that they will actually be able to access tide pool announced about a year ago that they were going to take one of the DIY, automated insulin dosing systems and actually bring it through FDA review. Part of that is it has to have the kind of onboarding and support materials that your insulin pump he buys a medical pump and has today. So I am leading the development of all of those materials for both the clinics and the doctors, as well as for the end user to learn the system.
Stacey Simms 41:30
And Kevin, you're still a big foot. So you're a principal engineer there. What excites you about what you're doing there? Is it again about the accessibility because I know you know, Bigfoot is not yet to market but people are very excited about it.
Kevin Lee 41:41
Yeah. Accessibility is one of the large parts and reliability going through the DIY stuff. It's happening at an incredible pace change is happening there and things break things don't always go the way that you intended. There has to be balance there somewhere? Well, you have to have services. I mean, look at what happened recently with server outages and different companies, you have to be prepared for how am I going to support this time, I'm going to keep it running, you know, whatever the it is, it's that the reliability, we're all we're all human, that's humans behind the scenes, making the the changes and improvements that we rely on. So how do we do that safely and effectively as possible to minimize the impact and continue to increase the value to the user?
Stacey Simms 42:37
This might be a very dumb question. But Kevin, let me ask you, Melissa mentioned the the new software that we're using, and she's talking about control IQ from tandem, which is the software that we've got now. And there are other commercial quote solutions. There's other commercial systems coming out when you look back at all the stuff that the DIY community did, and is continuing to do. Do you feel like you guys really, really pushed it along? I mean, I gotta tell you and I know nothing. And I never even used Nightscout and people laugh at me. But I think we would never be close to where we are commercially. Does that add up to you?
Kevin Lee 43:12
Yeah, it adds up. It's not for everyone. You know, it is bleeding edge, the community, in a lot of ways drives industry.
Stacey Simms 43:21
You I'm not asking you to say specifically without this wouldn't have that. But it just seems to me that we would have gotten there eventually. But I don't know that the people behind Knight Scott and so much of the other things you've mentioned, really either got into industry and help push things along or helps with the FDA. You know, is it as kind of an outsider on this. Can you speak to whether that's true?
Kevin Lee 43:44
Yeah, absolutely. I think that it had you I mean, that's the nature of competition. There was an unmet need in the community and the unmet need was was fulfilled.
Melissa Lee 43:55
Well, what I would say is industry needs to see that something viability as an idea and so, I firmly believe that many of these things were floating around in companies as potential developments in the pipeline. What the community did with our DIY efforts is say, we are so desperate to this thing, we will just build it ourselves if you can't deliver. And so I think it helps prioritize like I've seen almost every company in the industry actually skip over other things that were in their pipeline to get to these things and reprioritize their own product roadmap to try to deliver. And I don't think it's, I it's not in a Oh, we better get this or the community is going to do it themselves way. It's a, okay, this is a real need, and we should, we should focus our resources on this. A lot of ways it's a playground for industry to concepts, live and die much more quickly in the DIY community than they do and it allows you to to iterate faster and find out what does and doesn't work, open source communities have existed outside of diabetes, obviously, it's a and throughout the last few decades, we've seen what happens in the open source world actually drive change in the industries to which they're associated. And so I think there are analogies to this in terms of like, what happens in the software industry, with personal computing with consumer electronics, so I don't, I don't find it at all odd or ridiculous to say that the DIY community and diabetes has actually resulted in change within industry. I mean, if only if, like you pointed out so many of those names, but we, you know, we're dropping them because we want to see people recognized for their extraordinary contributions, right. But all of those people, many of them have gone on to found companies, invent new things, join other companies. What's your Modeling about open source communities, regardless of field or genre or whatever is that you see that you see new people roll in with new ideas and lay new work on the foundations of code that were left behind and innovate and continue to innovate. And so we will see the DIY community around forever, they will continue to innovate. And we will also see many of those innovators move on into the industries in which they're working. This is a personal choice that they have to make them they'll go through the same decisions that we did. And not everybody. Well, I mean, Dana lewis is not associated with the company. We're not saying that that's an inevitability, right? But it's pretty common. You have to be pretty geeky probably to know of other open source communities. And I'm, you know, Kevin is way more well versed to speak about that, but in the way of fan
Stacey Simms 46:56
before I let you go, this all started because you wanted have kids, right? This this is the timeline that you set out from your weight the beginning here, and your kids now they're both in grade school, your daughter's 10, your son is eight. I'm curious, do they know their part in this story? Because it's not an exaggeration to say, and I'll say for you, it's not an exaggeration to say that you wanting to have kids sparked action in Kevin, that, frankly, has helped thousands of people. I know you didn't do it alone. I know. I know. I know. But your kids know the part that they played
Melissa Lee 47:31
to a degree like they know that we help people with diabetes. And they take that really seriously. As a matter of fact, when I was changing roles from my role at Bigfoot to my role at tide pool, my daughter's first question was like, but you'll still be helping people with diabetes, like will Bigfoot still be able to help people with diabetes like yes, it's all it's all good. We're all good. We're all still helping people with diabetes
and they've grown up with these things in the sense that we love to tell the story of when our son was about three years old and he would hear the Nightscout song that would was basically the alert that would play. And he knew that when I was low, there was a bag of sour ball candy on the top shelf of the pantry that came down. So he would hear that sound that Nightscout song and that song was sour balls to him and he was “sour balls sour balls!” he was all in or maybe like two I mean, he was little It was too and so like it became the sour balls song, right? You know, the other day he heard the Nightscout will song play and he said mom who undid that song and I posted something to Facebook. Well basically lane desborough and better that song or found it. I wrote something about like I just set my son down. I said, let me tell you the story of our people and how we came to the valley of silicon you know, which is of course not the way I said it to an eight year old but as you know amusing myself But essentially, you know, there is some of these folks that they literally do talk about uncle lane and Uncle Manny and Uncle Ben and like my daughter thinks she has a lot of uncles. But, you know, so they know that we've helped a great many people. And as they as they get older, and we can sort of expound on that, then I think, well, let's be honest, they won't care.
For a while, right? teenagers will be like we shut up about, oh, they'll care.
Unknown Speaker 49:30
They just want to know they care.
Melissa Lee 49:34
Someday, they'll appreciate it, and a different way, but that's what they know. Now,
Stacey Simms 49:40
Kevin, you also said this was about your commute, making sure Melissa was safe. Knowing that Melissa is a very strong and independent woman. Do you feel like she's safe? Did that check that box for you all this hard work?
Kevin Lee 49:53
Yeah, absolutely. This is kind of something that she went into earlier, but I really view the monitor. That I've done and the work that I've done is really just augmenting and trying to simplify and make her life easier. We first started dating, I actually told her that you will never find somebody work harder at being lazy than than me. And, you know, that was just the testament of I wanted to automate all the things that are just repetitive and predictable and easily managed to try to get that out of the way. And that comes from the background of operations and managing online sites. Being able to automate those those aspects have helped me feel like it's more safe. And then you know, other times like with with monitoring, it's great to be able to just see that you know, she's about to go out for a walk and then I happened to look over at Nightscout see how much insulin she has on board and where she is and say, you might want to run a temp basal. So it's just there. To try to augment and help her navigate it. And so yeah, it does give me a sense that she's safer because of this.
Melissa
Yeah, that's right. I got really mad at him the other day, he was right. I was like, whatever. And I left the house and I went massively low. I was walking the kids to school. I was like, Yeah, well, fine. So you know, there's that two parents completely unfamiliar to you. And
Stacey Simms 51:21
it sounds more like my marriage actually diabetes or not. That's just a component of marriage. Yeah, she was right again. Oh, oh, well, you know, thank you so much for spending so much time with me. I love your story. I just think that there are just amazing people that I hate have diabetes. But I'm glad if you had to that you've done so much for so many others who have it as well. And I really appreciate you spending some time to tell us these things from years ago now because they're really are important as we move forward. So thanks for being with me.
Melissa Lee 51:56
Thank you so much for being interested in the story and for help. Others here are cranky, Stan.
Unknown Speaker 52:08
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 52:14
Much More information at Diabetes connections.com you can always click on the episode page and find out more transcript is there as well. I just adore them. I know the interview went longer than usual, but I couldn't help myself. And as I said in Episode 300, when I looked back on 300 episodes, Melissa really helped change my place in the diabetes community by inviting me to speak at master lab in 2015. That really did change how I felt about where I want it to be helped me find and focus my voice. I really can't overstate that enough. So thanks Melissa, for doing that.
And again, lots of information went by very quickly let them name dropping there in a good way. And I promise I will keep on the Nightscout crew. I may ask some of you as you listen to lean on your friends, I'm not going to mention any names here. But people that I have reached out to, and they're the usual suspects. If you search, we are not waiting, or Nightscout on the website, you'll see some big omissions. So I'll talk more about that on social media, we'll get them as a community. Maybe it's just me, you know, who's fascinated by this. But I do think it's a very important part of our history that we need to document because in a few more years, many of the solutions that people like Kevin were working on are going to be all commercial and all FDA approved. And isn't that wonderful, but I don't want to forget what happened. And I think it'll be great to look back.
Okay, enough about that. I got Tell me something good coming up in just a moment. And then stay tuned. Later, I'm going to tell you another change we made to how we use control IQ with Benny, but first diabetes Connections is brought to you by Dexcom. And it is really hard to think of something that has changed our diabetes management as much as the Dexcom share and follow apps. I mean, what really amazed me we started it when Benny was about nine years old, the decks calm and we got shareable. little less than two years later, and the most immediate change was how it helped us talk less about diabetes. And boy did that come just in time for us because that's the wonderful thing about share and follow as a caregiver, parent, spouse, whatever, you can help the person with diabetes managed in the way that works for your individual situation, and going into those tween and teen years. It sounds counterintuitive, but being able to talk about diabetes less what's your number? Did you check what's your number? You know, so helpful. Internet connectivity is required to access Dexcom follow separate follow app required learn more, go to Diabetes connections.com and click on the Dexcom logo.
I am cheating a little bit this week for Tell me something good because while I usually read you listener submissions, I saw this on beyond type ones Facebook page, and I just had to share they did a whole post about people with type one getting married and they wanted Hear the wedding stories. So they started out with a a big Congrats, by the way to Kelsey, her husband Derek, and this adorable picture of them. They're both low at their wedding and they're sipping some juice boxes. And Kelsey is part of the beyond type one Leadership Council. So congratulations to you both. It's a really adorable picture. I'm gonna link up the whole Facebook thread because people share stories like you know, I had my pump tucked into my bra and I didn't think I needed during the wedding or I was a bridesmaid and I had it there and I had to reach in, um, you know, other people who went low trying on wedding dresses. I mean, I remember this. So this person writes, I went low in David's bridal trying on wedding dresses. It's a lot more physical than you think getting in and out of dresses and slips, hot lights and just emotions. My mom had to run across the street and grab a Snickers. I was standing in the doorway of the fitting room and inhaling a Snickers, praying I didn't get any on the clothes, which just added an extra level of stress. I remember a Polish ties into the employee helping me and he was like I don't even worry about it. And he stayed with me to make sure I was okay. Another woman writes my mom came up to me right before we were set to walk into the reception. She told me she had hidden a juice under our sweetheart table in case I went low. I've been diabetic 30 years and my mom still carry snacks for me in her purse. Sure enough, right after dinner, I ended up needing it. And the last one here, being excited, nervous and unable to sit still. I did a long and intense bike ride prior to my evening wedding. Luckily we had a chocolate fountain at our reception and I spent a large chunk of the night at or near it, and this goes on and on. So what a wonderful thread congratulations to everybody who is talking about their weddings and their their wonderful stories of support. And the humor that's on display here is amazing. So I will link that up. You can go and read there's there's dozens of comments.
If you've got a story like this Hey, that's what Tell me something good is for send me your your stories, your milestones, your diversities, your good stuff, you know anything from the healthcare heroes in our community. With cute who put his first inset in to a person celebrating 70 years with type one I post on social media just look for those threads. Or you can always email me Stacey at Diabetes connections.com.
Before I let you go, I had promised to share the other change we made to control IQ. In addition to eliminating the long acting basal that we had used, you know, untethered for almost two years, we decided recently to completely turn off sleep mode. I know a lot of you enjoy sleep mode 24 seven, as we said back in our episode, gosh, in late December, when control IQ was approved in the studies, they called you folks sleeping beauties, because you enjoy that 24 seven sleep mode. But I found that since school has ended, and we're trying to figure out what to do with Benny for the summer, there is nothing really that's keeping him on a regular sleep schedule, and it's gotten to the point where he is now so nocturnal, and I'm hearing this about a lot of my friends with teenagers. Maybe I sound like a tear. Parents go to bed at like four or five, six o'clock in the morning. I walked into his room at eight o'clock in the morning the other day, I wanted to ask him a question. I was like, I gotta wake him up and he was awake can come to sleep yet. You know, it boggles my mind. It's all topsy turvy. And we'll get back into a routine at some point, but I'm not really willing to make a big fuss about it. He's key is keeping busy overnight. I guess his friends are up, I don't know.
But anyway, the point is, he's eating it really weird hours. And when he was in sleep mode, we noticed that it wasn't helping as much right because it doesn't bolus you in sleep mode. It only adjusts Faisal. So if you under bolus for his you know, Pad Thai at two in the morning, it wasn't helping out and true story. I asked him about that. Like, what's this line? And what happened overnight here, were you sleeping He's like, No, I was in the kitchen eating leftover Thai food.
So we decided that his numbers during the the quote, day when he was sleeping, we're hovering right around 90, maybe a 110. I mean, it was very in range, right? No need to mess with that. So I didn't think we needed to add sleep mode. And I did want to predict when he would actually be sleeping. So we just turned it off. And that has made a big difference too.
So I guess the bottom line is figure out what works for you for your individual situation, the weirdo wacko situation, if it's us, but you know, use this technology to benefit you, whatever way that is, if it's sleep mode right now, 24 seven, if it's no sleep mode, it's exercise mood all the time. And it'll be so fascinating to see. And this ties back into the DIY movement, right? It'll be great to see the flexibility that we will get in the next couple of years because, you know, Medtronic had a tie a higher target range, because they were first with the hybrid closed loop. tandem has a lower one Omni pod, we'll have a more flexible target, you can set your own target when they come out with horizon and of course, tandem and everybody else is going to be moving to that direction as well. And it just keeps getting better.
But it gets better because people like Melissa and Kevin Lee pushed and pushed and without these folks, and there's so many of them, of course, right who said we can do it better, we would not be where we are. I truly believe that technology companies would be five or six years behind and if you're new To the show new to the community and you're excited about, you know, control IQ or horizon or whatever you're using. Or maybe you're using, you know, loop off label with Omni pod, I would urge you to go back and check out our earlier episodes from 2015 and 2016. And learn about the really early days of the community, obviously, by 2015. We're talking about things that happened in the early 2000s. You know, I don't want you to misunderstand that. That happened in 2015. But you know what I mean,
okay, obligatory book commercial. And if you've listened this long, you maybe you own a copy of the world's worst diabetes mom, if you own it and love it, do me a favor post about it. The best way to word of mouth about the podcast and the book is always if you could tell a friend post in a diabetes group post on your own Facebook page, you know, I love this book. It's on Amazon, highly recommend it. If you've read it, and you don't like it. Forget that, you know, you know, just recycle the book. It's thanks as always, to my editor, john Buchanan's from audio editing solutions. And thank you so much for listening. I'm Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Unknown Speaker 1:01:09
Diabetes Connections is a production of Stacey Simms media.
Unknown Speaker 1:01:13
All rights reserved. All wrongs avenged
We started the show in Summer of 2015. This week, Stacey takes a look back at what was happening in diabetes technology at that time. Tandem had just announced you'd be able to upgrade without getting a new pump, Dexcom gave up on the Share cradle an Bigfoot & Beyond Type 1 were just coming on the scene.
Check out Stacey's new book: The World's Worst Diabetes Mom!
In Tell Me Something Good, we share your stories! What was happening with your diabetes in 2015?
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Lilly Diabetes announced they were getting into the pump and pen business almost two years ago. How’s it going? We get an update from Marie Schiller, Vice President of Product Development for Connected Care and Insulins at Eli Lilly – Connected Care is what they’re calling this platform of pumps and pens – now to be integrated with Dexcom.
Check out Stacey's new book: The World's Worst Diabetes Mom!
We’ll also have a bit of an update on some other pump companies’ plans for the near future.. bolus from your phone?!
In TMSG a big fish, a hula hoop winner and a chance meeting over a foot?
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Episode Transcript:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Real Good Foods, real food, you feel good about eating, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Announcer 0:21
This is diabetes connections with Stacey Simms.
Stacey Simms 0:27
This week, Eli Lilly announced they were getting into the pump and pen business almost two years ago. How's it going? We get an update. And of course I asked about price and access.
Marie Schiller 0:38
Look, we're not here for the sake of having this innovation sit on a shelf somewhere, not why I'm here. It's not why others are here. And so it is really important for us to be laser focused on how people act. So
Stacey Simms 0:53
that's Marie Schiller, Vice President of Product Development for connected care and insulins at Lilly We'll also have a bit of an update on some other pump companies plans for the near future. Well, let's sing from your phone in Tell me something good a big fish, a hula hoop winner, and a chance meeting over a foot. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Welcome to another week of the show. I am your host Stacey Simms, so glad to have you along for another week. As always, we aim to educate and inspire by sharing stories of connection. My son was diagnosed 13 years ago with Type One Diabetes. My husband lives with type two. I do not have diabetes, but I have a background in broadcasting. And that's how you get the podcast.
I'm excited to catch up with Lilly. I know a lot of people don't want to hear anything from them until they address the price of insulin. And I do understand that I want to be sensitive to that. And I definitely asked Marie all about that. Even though she has nothing to do with the price of insulin but she doesn't work at Lilly and this system. I can't be really separated from that, let's be honest. But I also think I have a responsibility to share what's going on in terms of diabetes technology, and Lilly plans to be a big player in this space. So that's what the interview is all about. We'll be talking about their system. We'll be talking about their partnership with Dexcom and other things as they move forward.
Before we get to that, I want to thank Kerri Sparling and the folks at children with diabetes. We replayed the interview that Kerri did with me this was on their YouTube channel and then last week in the kind of the mini episode although it wasn't really a mini we replayed the audio from that interview. It's always a little weird for me to be on the other side of the microphone, but it's always a lot of fun to I bring it up not to hammer on the interview again, if you wanted to see it or listen, you know, you know where to find it and I will link it up in this episode. But because they are doing a contest. The contest is open until March 20. And to enter you do have to email them so I will link that As well, it's over on the children with diabetes a website. But all of these links will be in the episode homepage. They're giving away a paperback of the world's worst diabetes mom and the audio version. So I'd love for you to go and enter and find out more on their websites.
Speaking of the book, I am having such a blast on the book tour that I'm doing this year. You know, we'll see how it goes. Obviously there are some health scares out there right now. And I'm not sure that all the events are going to stay as scheduled for right now. They're all on the books that's on the website as well. And if you're interested in the world's worst diabetes mom, that's an easy place to find out more but I have to share with you that I got a great note from a woman in Australia who listens to the show and you know, has read my book she bought it you can get it on Amazon really in so many countries now print on demand is absolutely amazing. And she got it in Australia and she reached out to me because her local group wants to do a bulk order. So we are doing that. And if you have a situation like that where you would like a little large number of books for your group. please reach out to me directly. You don't have to just buy it on Amazon for the full retail price. I am happy to work with you. My publisher has given me some ways to do this. That really makes sense. It's an amazing thing to think about people all over the world reading the world's worst diabetes mom. It didn't say America's worst diabetes mom. So I guess I have to stand by that now.
All right. We will have the interview with Marie Shiller from Lilly coming up in just a moment. But first let me tell you about Real Good Foods Diabetes Connections is brought to you by them. Have you tried their cauliflower crust Margarita pizza. They have a full size and a personal size as well. So yummy. It is low carb high protein real simple ingredients. And you know you gotta be careful because some cauliflower crust pizzas are made with corn starch. You know rice flowers, processed grains. And if you're looking for something that is 100% grain free and gluten free, this is what you're looking for. I love how Real Good Foods keeps creating Eating new products, they keep coming out with new yummy foods for us. It's the kind of thing where you as soon as you don't feel like cooking, sometimes you want the convenience. And when you go for convenience, you really don't want to sacrifice nutrition, right? I mean, you don't want to just pull out some junk food. I love Real Good Foods, it tastes terrific. And the people behind them are solid. They get involved in our community. They listen to what we have to say. It's really nice, find out more, go to diabetes, connections comm and click on the Real Good Foods logo.
My guest this week is Marie Schiller Vice President of Product Development for connected care and insolence at Lilly. Two years ago, I was part of a group of writers and reporters from the diabetes community invited to Cambridge, Massachusetts, to take a look at Lilly's entrance into the pump and pen market to give feedback on those plans and to hear from their partners. We did an episode back then and I'll link up what I and others wrote at the time. No pictures still of what they show. Very briefly that day, they showed us kind of the prototype, but it is a tiny pump. It's kind of like a fat little disc. It's much smaller than an omni pod pod. It's maybe about the size of the tee sport that tandem is coming out with. I'm actually going to talk more about that after this interview a pump update from tandem some news from Omni pod. We'll get to that after this interview, but I'll put up some photos of the T sport, but this is thinner than that the Lilly pump is just a small thin disc. It is tubed. So the idea is that you can stick it to your body or use longer tubing and put it in your pocket. We do talk about that. It'll fit in the palm of your hand very easily. Of course we do talk about the price of insulin, and what that means for access of anything coming from Philly. So here's my interview with Marie Schiller. Marie thanks for talking to me. I'm excited to catch up. It's been about almost two years since we've MIT in Cambridge, thanks for coming on the show.
Marie Schiller 7:02
Thanks for having me. I'm excited to be back.
Stacey Simms 7:05
All right, so give us the update. I know we're going to talk about the partnership with Dexcom and some other things that Lilly is working on. But when we last left this episode, the last time we talked at least in person, you over talking about the device that Lilly had been working on, can you give us an update on that
Marie Schiller 7:25
I can and maybe to be helpful Stacy just to remind the audience of what we've been working on. So Lilly has a personalized diabetes management system that is incorporating inform delivery devices, software and analytics. And obviously that will be combined with glucose data and other contextual information in order to hopefully to improve diabetes management. We have two parts of that system. So we obviously have a pen based platform where we'll be using our refill disposable insulin pen, with data coming in from glucose monitoring devices and be able to combine that with different elements of care in that platform. And then the pump based platform, which would be a hybrid closed loop system, integrating the the pump itself in with a continuous glucose monitoring and an algorithm as well. So that's the journey we started on. I think we were we had not just kicked off the program when we last talked a couple years ago, but it was certainly early in the development program. It's been a frankly, an awesome couple of years is advancing both of those areas we had started I know when we last talked, but with the development agreement with Dexcom, which we have continued to advance our relationship with Dexcom and now have entered into a global commercialization agreement with them. We continued our clinical trials with the pump based system we'll be talking about Some of the first clinical data will be shared this coming February at the the conference in Madrid at TCU. And on the connected pen side we have, so we secured a supplemental drug approval for the pen that will be compatible with the personalized diabetes management system. And we're in the midst of working with the FDA on the other components of the system that we will need to bring forward and launch the entirety of that integrated solution.
Stacey Simms 9:35
So there's a lot of moving parts, there are a lot of different things going on. You mentioned the clinical trials, and let's kind of take this step by step. I'm sure you can share the information ahead of the release. But what were you looking for this was for the pump system. Was this a safety trial? Was this an outcome trial? Can you share any information
Marie Schiller 9:55
for you know, I won't go into any details that we will be sharing at the conference, but As has been seen with other products going through on that hybrid closed loop system, we are focused on showing that the system is functioning accurately. So we are looking at that first stage looking at different you know, stress situations with the system making sure the system is responding as we would expect it to respond. And obviously as part of that is the safety of the system.
Stacey Simms 10:27
So, as we're talking about this system, what's so intriguing about it to me is that it is a pump, but it acts more like a pod. At least it did when I last saw it or I saw a mock up of it even so is it still that way it's very teeny tiny, but it it acts as a tube pump with a very small tube that goes into a traditional inset Is that still the hardware?
Marie Schiller 10:47
It is so we what we like to call it is that is a hybrid system meeting on the days that you want to carry it and put it in your pocket or wherever is your choice of carrying it. You could use a standard length infusion set or a long infusion set, whatever your preference, but on days that you wanted to wear it, and adhere it to your body, you could do that. And so it would still work with a standard catheter infusion set, but you would obviously be using a shorter tube in that instance, if you choose to wear it on those days.
Stacey Simms 11:24
You know, it's funny, Marie, I've I didn't ask this when I first saw it two years ago, and I keep thinking about it, because now tandem has a I don't know where they are in their development stage. They have the T sport which sounds very similar that they're hoping to come out with. How do you actually were these tubes, tiny tubes, pumps, the hybrid pumps on the body? Did they just kind of dangle from the tube? Do you stick them to your skin? Does it work?
Marie Schiller 11:47
Yeah, I can't comment on tandem. It's a great question though. Stacey, you know, obviously with our so there's an adhesive component where you are wearing the pump. It's not obviously on the infusion set right? But ours is where you would be adhering to the pump itself.
Stacey Simms 12:04
And my frustration was I thought you're gonna say I can't tell you anything. But that's great. There's like a sticky on the pump and it sticks to your skin. does it stick to the body? Like a? Is it like a Dexcom? sticky? Or is it like the ever since which is more like what I call a color forms? Remember those color forms? You could take them on and off and on and off? Is it more like that? Or is it once it's stuck to your skin? Then you kinda have to pry it off.
Marie Schiller 12:34
Yeah, I may, at this point, just pull back a little bit because I think I may be going down. I may be going down the rabbit hole as if I'm trying. I feel like I'm going to be playing a game of charades as I try to walk you through how the system works. And it may be more confusing than helpful. So yeah, as I mentioned that you have the ability to wear it and there's an adhesive system and we'll leave it at that.
Stacey Simms 12:59
All right. But it's very interesting. So then my next question is, do you know if Lilly is going to be developing new infusion sets? And I asked this because I've shared for years and years, and I'm not the only one, that I really think that the traditional infusion sets are the weak link of any pump. They're just not great. And I'm always hoping that somebody is going to come up with a better one. Any chance, this is part of your plan?
Marie Schiller 13:24
as we've talked about, look, we are looking at all components of the system. Right. And so we are starting with our core system, we're looking at all aspects of the system. I would say, you know, it's hard for me to say yes or no, on that side. I think we're looking at the need in the marketplace. Right. I think on that infusion set side. I'd be curious to sort of hear your experience with that. I think in in some of the research we've seen, it's different sort of aspects where people would say they'd like improvement. Clearly. Extended wear is something that we're hearing a lot I know jdrf and others Groups are focused on that. But what areas are high on your list
Stacey Simms 14:03
that they work better, that that you can push more insulin through them that they don't get kinked and they don't get occluded. And they don't need to know that they're, they're not as damaging to the skin that they're not as painful that I feel I could go on and on. But truly, I really think they're the weak link of pumping and you know that they even what was the one from BD for a while like it had a better flow, it didn't just float the bottom of the canula even to be able to rotate it there was one you used to be able to spin you know, that would go with that would turn you know, there's there's so much so sure, I'll be in a focus group anytime or recall me.
Marie Schiller 14:38
I'm taking furious notes here to make sure I get all of this feedback because this is exactly what we need to hear, you know, and exactly what we're excited about. I think we just continue to feel that there are so much room for improvement on these systems. Albeit we've made a ton of progress today. But these are all of the nuances right then each of us I deal with every day and why, you know, the more innovation the better and space where we can continue to look at all of these elements and make progress.
Stacey Simms 15:09
So let's talk about the pen system too, because that's very useful and very fascinating. The pen is, as you had already said, It is not just an insulin pen, it is part of a connected system. Can you talk a little bit about what that means? We've mentioned Dexcom. already. I assume you use your phone. You can see where you've been it recommends dosing, that kind of thing.
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as we expect.
Marie Schiller 16:28
It does so as we mentioned, it's based on the the quick pen platform is is a core component of it. So if you look at the quick pen platform that we offer in forums and we have our current basic lar influence and humor log both in the half unit one unit and two units, and then we have our ultra rapid insulin that's under review today. So as in and I don't know what's your son ever on 10 before you move to pump,
Stacey Simms 16:58
he was actually uncertain Because the dosing was so teeny tiny, and they didn't even have half units, but he was on quarter units. But we have since we use pens a lot, because it's a backup for him. If he gets to fly and feels like his infusion set isn't working, he'll take a shot. And he is also a little unusual in that we use. We use a long acting shot with the pump. So he does use a pen every day.
Marie Schiller 17:25
Okay, well, then you're familiar with it. And I can share with you that I was a pumper for years. And now I'm back to two shots, as we all sort of go through those journeys, but what I was going to describe is when you're taking those informs, especially as you know, you're taking the long acting in the short acting. There are just some basic elements that we still don't have today, right? You're running out the door, you're trying to get your son to school or I'm trying to get to work that I did I just take that shot or not again, remember right and just some of the most the simplest aspects of being able to be like up there. If I took that dose, right, and being able to have that check in place, but there are, you know, as you move down that level of sophistication, most people on informer fire some level of glucose testing, whether that is blood glucose monitoring, or as we're doing with the continuous glucose monitors. So the idea is, is that you would have the informed data from the pen, you would have your glucose data, whether that's blood glucose or CGM data, and you would take that in integrate them into this diabetes management system that depending on what you want, is how you would interact with that system. So some would have a preference of saying, you know, when I'm doing okay, or my regimen maybe easier, I don't need as much variation. So, for me, it's a place that I can capture that data and not have to go to different places to get that data for others having some different elements of support in that system. will be beneficial, right? If you think about things on the Faisal influence side for people with type two diabetes faisel, type tration as you get started on the insulin, or maybe after I'm on insulin for a couple years, how do I make sure I'm optimizing? Right? You can go through sort of that journey and see all of these different places where how we can do better than we're doing today. And I'm honing in on the glucose data and the informed data. So we all know I sometimes say life gets in the way right exercise and food you know, all those things that are pretty standard, but for a lot of us can make the road pretty bumpy as we're out there. So you know, over time being able to get the system smarter and smarter with that exercise data and then learning system. So, you know, we all talk about the algorithms that are out today are very much rule based systems right if my glucose is going up by default Like take this action and then be informed is delivered in the future. It may be well for Marie, her level is going up at x rate. And that's, that's not good for Marie versus for Stacey, that might be okay. Because I've trended back and looked at that data and say, you know, we're going to predict that she won't get to an elevated level as an example. Right. So if you start thinking about the personalization of these algorithms over time, it will not be day one, as we all know, it's going to take a lot more research and beta for us to be able to continue to get to that ideal state.
Stacey Simms 20:41
So I'm trying to read between the lines. So the plan sounds like it is to launch with a more let's call it a more static algorithm. Like we just started using control IQ from tandem which is a hybrid closed loop software system. It is a great system for us so far, but it doesn't learn anything. It's probably If This Then That, but it doesn't learn my size. Okay, it's not personalized. So I assuming you're kind of saying that Lilly will launch in a similar way, but the idea would be to eventually get to a learning algorithm.
Marie Schiller 21:11
Yes, I think that's a fair statement.
Stacey Simms 21:14
All right. So let's talk about the announcement that you're gonna be working with Dexcom. Just if you could spend a minute talking about what that means. It's not exclusive as I read the release that y'all sent over. So it sounds pretty interesting. Let's start with what it means first to work with Dexcom are they making? Sometimes there's, I hear special transmitters for certain things, certain software for certain things. Is this a Lilly Dexcom? Original?
Marie Schiller 21:39
no meaning we are basing it off of the transmitter that Dexcom has. So we will be compatible with the G six and we'll continue to work with Dexcom in our development arrangement as they continue to iterate and we continue to iterate to make sure we've got access to each other's latest technologies right because the last thing any of us want to do in these collaborations is to be behind in generation integration, right? I mean, that's what was happening and some of the first generation systems, right, you got people still on, I think it was what g4, and they'd want to be moving to the G six, and there was no way to do those updates, or the G five. So we've established our development, work with them and ability to make sure that we can continue to be running in parallel, as each of our platforms evolve over time. So it will be based on their latest transmitter based on our latest pump in our latest pen, and be able to integrate the the CGM data from Dexcom system into the diabetes management system, where some of the functionality that I talked about before could be available.
Stacey Simms 22:53
So I'm always trying to read between the lines You'll have to forgive me but when I see a press release that says non exclusive, I'm always thinking, you know I don't know of too many, or any pump systems. Gosh, it's so funny to say that Marie, because there's really only a couple in the US. But I don't know if I hear we hear a lot about interoperability, but it isn't here. Yeah. So my question, I guess, is when I see now exclusive, I'm thinking, Okay, are you do you have an eye to working with other CGM companies? And is that practical in the short term? When we all know FDA approvals, things like that, you really kind of have to stick with one system, at least so far, to get it through?
Marie Schiller 23:29
Yeah, you know, it's an interesting way you sort of posed the question, I think, let me say big picture and then sort of dive down to where we are right now. You know, at the end of the day, we believe having access to sort of the latest and greatest technologies is really important, right. I mentioned even with dex comm that we want to be on the same innovation curve that they're on. So people using our system can have access to that. It's really important that all of us, keep pushing For this innovation, right, and the way that you do that is to make sure that I have the ability to integrate other technologies into my system. And I think both of us hold that premise that keeping as a non exclusive allows both of our team to be able to, you know, have access, or have our users of our system have access, I should say to the latest and greatest technology. We have started our program with the XCOM and are really excited about the progress. But we think it's important to make sure that we will have the opportunity to bring different technologies in for different users, even on the systems available today. Right. There are differences in the system, and people are choosing different platforms because of that. Sure.
Stacey Simms 24:51
Yeah, it's really interesting. I mean, I keep hearing about interoperability, which I know is going to come someday but my interpretation of that which is I always call it the Mr. Potato Head. system is not the realistic system. So I try to temper my expectations but why not? Come on? I want to mix and match as much as possible. Why not?
Marie Schiller 25:10
I don't know. Did you like playing Mr. Potato? I was never a huge fan.
Stacey Simms 25:16
It's a it's an easier thing to explain, right? Why can't I use the lead Ray? With the tandem pump? Why can't I use a Dexcom with a barefoot pen? Why can't right i mean if it works better for me and my skin and my kid and my like, why can't I and I, I get it. But at the same time, I really hope that someday we're working towards that, hey, look, it could be worse for you. They could make us play operation or perfection or something terrible like that.
Marie Schiller 25:39
Those are worse. Yeah. But you know it, baby. I think there are a lot of people were having that sort of turnkey solution is, you know, where it's all comes in on and I just understand it and it's all designed to work together. They prefer that and other people would would like that choice, right. So I think we're gonna probably see both of those emerge over time. And the FDA to be fair, has opened the door to that event, right? I mean, they're trying hard to separate the approval of each of the components. We saw that with the ACE ban. We've seen that with IC GM, and now with AI controller that can pass. So, you know, I think, at least from the FDA perspective, they've worked hard to try to enable some of that.
Stacey Simms 26:25
I agree. Alright, so from interpretability. Let's talk about the proprietary aspect of this. Because I think when a company like Lilly, that makes insulin gets involved with the hardware in which the insulin goes, a lot of questions come up, and you mentioned the quick pen. So can you just confirm again and correct me if I'm wrong? Will other insolence be able to be used in either of these systems pen or pump?
Marie Schiller 26:52
Yes. So on the pen side, the system is being built around our quick pen platform. So it will be a system that work with really insulin on the pump side of the equation. In addition, we'll have a first generation that will be a patient built component, but over time, that may shift as well. So on the life cycle plan for that pump, we're looking at the ability to have Lilly insulin in that system, as well.
Stacey Simms 27:27
Okay, so to be clear, and not say, not putting a judgement on this, but just to be clear with the idea is that this would be a proprietary pump, that Lilly would make the pump and Lilly would want its own insulin. We've been human lock used in the pump.
Marie Schiller 27:38
Yeah, I think the system is being designed around Lilly's insulin.
Stacey Simms 27:43
Alright. So you know, we've Marie, we've known each other for a while now and I know you know, this question is coming, but I think it has to be asked in a day and age where people are so angry about the pricing of insulin. Why should we get excited about systems like this when people are worried about But affording the stuff that goes in the hardware, let alone affording the hardware, whatever it is, and how great it is. There's a lot of concerns about cost. I know it's not your department, but I can't have you on and not ask about it. Can you comment on that?
Marie Schiller 28:14
And no and not and I appreciate you asking it. And you have no need for a while as well. So I appreciate the service candid question. Look, you know, and I've said this before, and I'll say it again, you know, we are committed to be able to let people with diabetes, access our medicines, and in the future, disconnected diabetes system that will include sort of the pen based system and the pump and other components. I know you'll be frustrated at this next part of it. But I can't fit here in sort of the position I'm in and where we all want this platform to be any, you know, give you any speculation of the details of how that will happen, or how that reimbursement will be in the marketplace. It just wouldn't be fair to you or your user's to speculate on that, except to say that we are 100% committed to making sure that that access is available. Look, we're not here for the sake of having this innovation sit on a shelf somewhere, not why I'm here. It's not why others are here. And so it is really important for us to be laser focused on how people access the system.
Stacey Simms 29:24
And I mentioned in the introduction, but you live with Type One Diabetes, I definitely have another question for you. But it just occurred to me, are you allowed to even say this, have you tried this system? Like, are you in the trial? Can you trial your own? unprepared?
Marie Schiller 29:38
I sure how to answer that. I have no, I'm not in the trial, but I can give you that answer. So I am not in the clinical trials that have occurred today.
Stacey Simms 29:50
I'll tell you as a person who doesn't have diabetes, obviously, you know, it's just something that I always wonder about when I talk to researchers or clinicians or I know there's there's obviously rules for clinical trials. But you've got to think, alright, I want to try this on myself. I know a lot of people have done that. Okay. So the real question I wanted to ask
Marie Schiller 30:05
is okay, I can't wait. I can't wait. That's why there's no, we're pushing hard to justice available. I, I'm waiting, like out there to make sure that I get this.
Stacey Simms 30:18
Alright, so I've got a difficult question. So my real question about living with type one is difficult is it right now to work at Lilly, when people are so angry, and a lot of that is directed? We've seen protests separately headquarters, you know, and again, it's not you, you're not in the price department. Even if there is one. This is not something I know you can control. But is it difficult and frustrating for you to see the problem, frankly, with insulin pricing at all of the insulin companies?
Marie Schiller 30:46
And the answer to that they see and I think we may have talked about this, either the last time on the phone or when I saw you it's like how do you not feel the pain in you know from people, right? I mean, this dishes, dish issues difficult issues people are dealing with. So of course, you know, what I would say is is that worse from, you know, being here? You know, I look at what we're trying to do. And And And again, I'm not the person to sort of comment on this, but it's a priority for Lilly. And I'm really proud that Lilly has made it a priority to make sure that access is there.
Stacey Simms 31:25
Going back to two devices that we've been talking about. I always hate to ask about timelines, but I always have to ask about timelines. Can you give us a goal timeline here? Is there any indication of when it might be submitted to the pen or the pumping, which will kind of go in first?
Marie Schiller 31:42
Yes. So let's talk about the pen first. So as I mentioned, and you can see on the FDA site the supplemental approval for the pen has gone through. We are working with the agency on the other components of the systems. We are not giving an update right now. on the timeline for that system, but we expect to be giving updates over the next couple of months on the pump. As I mentioned, we'll be sharing the first clinical data and our signaling that we're still over the next couple of years hoping to get that system to market
Stacey Simms 32:16
where we thank you so much for joining me. I know it's a difficult conversation to have when you've got, you know, a lot of things about to come out and then other things that I'm asking that aren't really your department. But I appreciate your frankness. Before I let you go as a person who lives with type one, what is it like to work in the diabetes sphere? I mean, I think part of me would be kind of tired, like my whole day is diabetes. My whole life has diabetes, but it's got to be exciting as well. What's
Marie Schiller 32:41
it like? It's an interesting question. For me. I just don't know any different facing effects? The answer is, I don't know my kids would probably answer the same way. I don't know what I would do with myself if I wasn't doing this all day. My weekends are spent so much in the diabetes space as well. It's just something that that is it's just a part of me, right? so much a part of all of us who are living in this space. And I'm impressed every day by all of the people working so hard to make these advancements. And it's amazing, right? As you've seen, we're actually getting some of these solutions out and reading about the improvements that are there. And I'm excited and want to keep staying focused on doing what I can to get these products out and having my team man. I mean, everybody here is just so passionate about what we're trying to do to make these advancements. So it's, um, I know it's a it's like one of those questions someone would ask what would you do if you worked with your spouse? You know? I don't wanna say I love my diabetes so much because I'm not sure I'd answer that way. Am I cursed my diabetes maybe as much as I do other things in life, but it's data reason that probably keeps That's all motivated if we know how much better we can make life.
Stacey Simms 34:03
Well, thank you so much for spending some time with me. I really appreciate and I hope we get a snapshot of the devices soon enough, Marie thanks again.
Announcer 34:15
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 34:21
Of course, more information at diabetes connections.com. I always link up a lot more info at the episode homepage and a transcript. I'll be interested to see how this episode is received. As I mentioned at the start of the show, there are some people who do not want to hear anything from Lilly, if it's not about lowering the price of insulin. And I respect that I hear that I know that there's a lot of anger in our community and a lot of frustration at all the insulin makers and you know, I do share a lot of that, but I would be curious to think if we should not be following the other technology advances that are coming out of these companies, because I'll be honest with you, I said this two years ago, I think Lilly is seeing the writing on the wall. That the price of insulin is going to be mandated to come down in the next few years. And they are, they don't wanna lose money. They want to find other ways to continue to be competitive. And I certainly don't think that insulin will be free. But I do think that going into the pen and pump business is a move on their part with an eye on the price of insulin coming down. Look, I'm not an economist. I'm baby way off base. But that is something that makes sense to me.
up next Tell me something good. And then a little bit later on. I want to talk about some other pump companies and news that came out recently, diabetes Connections is brought to you by Dexcom. Do you know about Dexcom clarity, it is their diabetes management software. And for a long time, I just thought it was something or endo used. You can use it though both on the desktop or as an app on your phone. It's an easy way to keep track of the big picture. I check it about once a week. It really helps spinny and me dial back and see longer term trends and helps us not overreact to what happened for just one day or just whenever Our the overlay reports help with context of Benny's glucose levels and patterns. You can even share the reports with your care team, which makes appointments a lot more productive for managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at diabetes connections dot com and click on the Dexcom logo.
I love the Tell me something good stories this week. Honestly, I love them every week, but I got a bunch that are so fun to share. And one that frankly is pretty important. Alright, so first, Candace says my son was just diagnosed January 23. This year with a hospital stay. By February 13. He was dancing away and winning a hula hoop contest at his first school dance since diagnosis. He's 11 and he was so proud of his accomplishment winning the contest. And we as parents were so happy that his diagnosis wasn't holding him back. That is so cool. I didn't Kansas for a picture shockingly, an 11 year old did not want pictures of him hula hooping to be displayed. I'm actually not sure if she had any, but we respect that we hear it. I just think it's fantastic that he did it and that he's doing so well. This soon after diagnosis way to go Candace!
Alison said this is a tiny thing. But today my child was type one went to get her foot x rayed her shirt, rode up and showed her Dexcom and the text said, Hey, do you have diabetes? I do too. Then she pulled out her pump. It was super cool. Allison says her child was diagnosed in early December. I think that's great. Is there anything better than that diabetes in the wild citing, right? You know, you're with people who get it. It's just so great.
And then this one you may have seen on social media. I posted a picture of Isabella with her fish, not her pet fish a fish she caught. Isabella is nine years old and she loves fishing with her dad and boy she beaming in this photo with a fish that's like as big as she is. Her mother, Heather says she was diagnosed with type one at age four. Again, she's nine. Heather says, I will tell you this little girl is amazing. Her dad got diagnosed with lupus almost four years ago. He is on dialysis. We are on a kidney transplant list. I'm currently trying to be his donor. And a lot goes into that. This is her and her daddy's favorite thing to do. They live life to the fullest, and nothing stops them. Heather, thank you so much for sharing this story for letting us share the picture of Isabella, you guys are carrying a heavy load right now. And I'm so glad to hear that you're finding enjoyment in things like this. It's kind of trite. As I'm hearing these words, leave my mouth. I mean, there's really not much to say when you're in a situation like that. But I'm happy to share your story. And I hope you keep us posted. Let us know what's going on. And definitely send more fish pictures. I would love to see that I really would even if we don't share them. You can definitely send them our way are posted the Facebook group.
Our final Tell me something good is a little bit of a different story. It's more of an news story. But this is really important. And I think very good news. Beyond type one announced that they are collaborating with the National Association of School nurses to raise awareness of the warning signs of type one diabetes. So this is a new collaboration that means that 10s of thousands of school nurses around the country are going to get these awareness materials from beyond type one, if you haven't seen these we did in North Carolina push a few years ago. And they're just simple and straightforward. And they tell you the signs, and they talk about what to look for. I don't think those of us in the community had any idea what DK a was what it looked like, how deadly it could be, you know, before we our children were diagnosed, right? How would you know? So this education campaign is absolutely going to save lives. Huge thanks to be on type one. And a big thanks to the Helmsley Charitable Trust which is funding it. I will keep you posted. I will put up links in the show notes on how you can get involved because you know ordinary people state to state are getting involved. We sit around my dining room table here outside of Charlotte, North Carolina and stuffing envelopes and sent them out really can make a difference. Tell me something good happens every week around here. Give me your stories post in the Facebook group, email me Stacey at diabetes dash connections dot com. I would really love to hear from you. We got to get the good news out in our community. Tell me something good.
All right. We're getting a little long here. But I wanted to bring you some news from the other pump companies. I know I don't usually do a news update this far down in the show, but because I put the coronavirus episode out a little early. There was some news I was going to put into that episode that has gotten pushed here. Let me get right to it. We had an earnings call from tandem. And the really interesting bits from that were that the T sport hybrid patch pump is now expected later this year, possibly probably early 2021. The CEO of tandem says they plan to file with the FDA for t sport approval. This summer with a new mobile app, which means you'll be able to bolus from your smartphone. So apparently, they're going to submit this in two different ways two different filings. One would be a separate handheld device, right like a dummy phone or a dummy controller of some kind that you'd bolus from. I'm dummy and that it doesn't do anything else but control the pump. But the other filing would be remote bulleting by the smartphone app. And apparently the CEO said they will not launch t sport until both have been okayed by the FDA. So you would have the option of using your phone or of using the singular let's call it singular controller rather than the dummy controller. So that's really exciting. I'm gonna post some pictures diabetes mine posted this update and posted some pictures of the tee sport. It is a little patch pump that can be worn on the body or it has a tube so it can be put in your pocket again. I don't know how it sticks to the body. Did you hear me talking to Maria about that? Is it reusable? Like ever since or is it like a dexcom to rip it off or a pumping set. So we'll find out more about these things as they go forward. But that was some really interesting news from tandem.
The other bit of news comes from Insulet. They are in the middle of clinical trials for horizon, they had hoped to be filing for that approval. This summer horizon is the hybrid closed loop for the Omni pod. They did have a software issue. That means they are pausing the pivotal study, and it's going to delay things, not really sure how long, of course, they're really hoping that it won't be too long, you know, maybe a month or so. But they are now pushing the anticipated launch of horizon to early 2021. And I know there's a lot of disappointment because people really want this system. I will say to you that tandem had a similar issue with their software during the last pivotal trial for control IQ. It was very quickly fixed. I don't think it affected the timeline that much. Maybe it was just a month, but it still hit its goal of the end of the year. So hopefully Omni pod insolate can get back on this and get back to their timeline but I will link to More information on that, because I know these things just cannot come to market soon enough.
tank you for staying with me. This was a long bit after the interview and I appreciate it, but I wanted to get some information out there. I really appreciate you listening. There's a lot going on right now. All right, I'm gonna stop right here and thank my editor John Bukenas from audio editing solutions. If you have an audio project, I highly recommend john, you know, if he puts up with me, and my rambling that he can do wonders for you. All kidding aside, john is great. I love working with him. He never asked me to say anything in the show. But he really is such a strong part of what makes this podcast successful. And boy, is he nice to me and doesn't leave in all of my papers. So thank you, john. And thank you so much for listening. I'm Stacey Simms. I will see you back here next week.
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