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Diabetes Connections with Stacey Simms Type 1 Diabetes

The T1D news show you've been waiting for! Long-time broadcaster, blogger and diabetes mom Stacey Simms interviews prominent advocates, authors and speakers. Stacey asks hard questions of healthcare companies and tech developers and brings on "everyday' people living with type 1. Great for parents of T1D kids, adults with type 1 and anyone who loves a person with diabetes.
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Now displaying: Category: technology and tools
Jan 25, 2022

Take a deep dive into the future of Tandem Diabetes. In December, the company laid out an ambitious 5-year plan to update software, move to a smaller pump and ultimately a tubeless version. Company leaders say they want to think even bigger and we're talking to Chief Strategy Officer Elizabeth Gasser. We’ll go through the short term changes Tandem has in the pipeline like the tiny Mobi pump and talk about philosophy and more.

Tandem R&D Presentation (slides) 

Tandem R&D Presentation (replay) 

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 Below (or coming soon!)

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*DEXCOM*

 

Stacey Simms  0:00

Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 where Diabetes Connections are made.

This is Diabetes Connections with Stacey Simms.

This week, a deep dive into the future of Tandem diabetes. That company laid out an ambitious five-year plan to update software, move to a smaller pump and ultimately move to a tubeless version. company leaders say they want to think even bigger.

 

Elizabeth Gasser  0:37

we have thermostats that manage our home temperature for us. We have self-driving cars we have on demand consumption services that you know, help us get our groceries and plan our meals. Come on. We should demand that level of ease of use in what we're doing here as well.

 

Stacey Simms  0:54

That's Tandem Chief Strategy Officer Elizabeth Gasser. We’ll  go through the short term changes Tandem has in the pipeline like the tiny Mobi pump, she'll answer a bunch of your questions. We'll talk about the philosophy of the company moving forward, and more. 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 only so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. back in December Tandem made a big splash with their very first research and development presentation. If you haven't seen that, I highly recommend that it is rather long, but it's definitely worth checking out. I'll link that up in the show notes. And you can always find out more at diabetes connections.com. But in this R&D presentation, they laid out a very ambitious five-year plan for the company, which we're going to go through and talk about in detail today.

Quick date check for you This interview was taped on January 10 2022. And we're releasing it on January 25 2022. So as of right now, the FDA has not approved anything new for Tandem no Mobile bolus that is in front of the FDA, and we'll talk about that and so much more. There were a few questions I didn't have time to get to or that you sent in after the interview. So I sent those to Tandem and I will come back after the interview. I'll update you and answer what I can also after the interview, if you are a health care provider, a diabetes educator and endocrinologist if you work in those offices. And a very specific question for you. Please come back. I'll make it quick. But I need some information. And I know you will can help me. Okay.

My guest this week is Tandem Chief Strategy Officer Elizabeth Gasser she says Call me Liz. So I do. Her background isn't in diabetes, it is in strategy and corporate development, working at Qualcomm in their internet services division and at open wave systems, the world's leading Mobile browser provider at that time, and we talk about what it's like to come from that world to this one, I think it's really important to kind of get an idea for these individuals, you know who they are, who are making these decisions that affect so many of us. And of course, we go through that 10 to five year plan product by product.

 

Liz, welcome to Diabetes Connections. Thank you so much for joining me, we have a lot to talk about today. Thanks for being here.

 

Elizabeth Gasser  3:24

Oh, my pleasure. I'm excited to chat.

 

Stacey Simms  3:27

There are a lot of items that Tandem announced in December, there's a lot to go through there. But I wonder if we could start kind of by backing up a little bit I've heard that you Tandem is kind of talking about being less of a hardware company, right, the pump, which will always be there in some way, shape, or form. But thinking more about the software, can we step back a little bit from the products here and talk a little bit more about kind of the philosophy or the vision? Oh, happy

 

Elizabeth Gasser  3:53

to and if you've watched our R&D day, you'll you'll know that I do enjoy expanding on this particular topic. You know, as with any connected device, the minute you take a piece of hardware, and you give it a cellular connection or or a Wi Fi connection or a connection to the Internet, you've opened up the potential way to do an awful lot of creative things with both data but also with software, it really opens up the potential for continuous update functions and capability. And then also the ability to pull and push data back and forth from a device and and once you've done that, you you really crossed into that that world of the Internet of Things which requires you to be both an excellent hardware company, because you're managing the device, the functions of that device. It's touchpoints through connectivity, but it also requires you to be an excellent software company along the way. And if you look at the Tandem journey over the past five to seven years, you really do see the company's products moving down that pathway. Of course, the pump remains front and center for us it you know, the delivery of insulin is what we do. It's how we bring that therapy benefit to our users. But you also see a start to do things like the ability to update the pump software itself that unlocks new features and functionalities, including the algorithms which we can now continuously update, it allows us to update the different types of devices we integrate with, you'll see we've obviously moved from supporting Dexcom, G5, two, G6, and we're moving to G7. That's all done through software updates. And so it's really hard to be in this space and to be talking about connectivity and connected devices without also embracing the fact that you really are a software company and have to be incredibly good at it to deliver the value that you want to deliver to your customer base.

 

Stacey Simms  5:59

I do remember years ago, our first pump and I say our work has been he was to when he got it. So it was definitely it was a group effort. But it was the Animas pump. And then a few years or months who remembers after he got that there was an update, where you could bolus from the remote meter. But we had to wait until our insurance would cover until we were up for a new pump. We had to wait I think three and a half years before we could get that. And so when we switched over to Tandem, I think we had the pump for a month when we there was a software update. So it really has changed. And to your point it is it is really remarkable to see that. Let's talk about, as you mentioned, the R&D presentation and some of what's in development. And of course, the usual disclaimer, I am sure that a lot of what we're going to talk about here is in development, it is not FDA approved. So there are limitations, I'm sure about what you can and cannot speak about. And if you can't answer something we totally understand. But let's just jump on in and kind of go through a list here. My listeners are extremely interested in getting some kind of update on the bolus by phone, which is in the FDA hands. But I have to ask you about

 

Elizabeth Gasser  7:07

  1. I figured you would like the the world is obviously a very unpredictable place these days, not least when it comes to projecting FDA timelines. That said, we still feel very confident and we're planning on an early 2022 approval. So I can't say much more than watch this space. But we're still leaning into the timelines. We talked about it R&D Day and looking at getting this much requested feature to our user base as soon as we can.

 

Stacey Simms  7:39

Can you share with the rollout process may be? In other words, will it be a simple update to the T Connect app? Will there be some kind of required or prescription required online patient training?

 

Elizabeth Gasser  7:49

Yeah, happy to and this this kind of ties to the conversation we were just having about, you know, being a software company, right? The introduction of this feature will be straightforward software updates. And so what does that mean? In practical terms, that means updating the iOS or Android Android application to the newest version, which will have the Mobile bolus capability. And at the same time, making sure you do a pump software update so that both sides of that dialogue can happen. And as part of the pumps software update, which happens through the Tandem device updater. There will be some online training, music click through to make sure that they understand the capabilities that we're introducing. And many of our users will be familiar with how you do that.

 

Stacey Simms  8:33

Would there be a prescription needed for that kind of feature? A

 

Elizabeth Gasser  8:36

Mobile bonus? Yeah, no,

 

Stacey Simms  8:39

this may be a silly question. But can you share any details of what Mobile bolus actually means? In other words, I visioned this as Benny will take the his phone out and have full functionality controlling the pump from the phone. Is that accurate?

 

Elizabeth Gasser  8:53

Yes or no, in that the primary goal of Mobile bolus is to allow for the delivery of a bolus from the phone. So in that sense, you're absolutely right, it will become for most of the day, the app will be the vehicle through which you can interact with the pump the piece, it won't do his full control of the pump. Meaning when you need to go in and look at changing settings, for example, that's not going to be in the Mobile bolus release. That's something that you don't have to do all the time, and can reasonably be done by taking the pump out and using the user interface on the device. As we get to the movie launch. Obviously, that will not have a screen. And so those control features, what we call full control will migrate into the app as well, for the movie pump.

 

Stacey Simms  9:46

Of course, yes, that makes perfect sense. I'm not going to let myself get too far ahead because boy do I want to ask you about but to just stay on on Mobile bolus for one one or two more questions, but with Mobile bolus are there other There are features that will be on the phone, obviously, it

 

Elizabeth Gasser  10:03

will marry with the app that currently exists today, right. And so that that is predominantly today, a secondary display tool allows you to see all of the things that are going on with the pump allows you to see blood glucose readings allows you to see insulin on board allows you to see the insulin delivery that you've conducted through the day. And so all of those features will remain. And the focus here really is on augmenting it with the ability to deliver a bolus from the phone. And so that sort of feels like it downplays. No. But it's incredibly, it's an incredibly exciting augmentation, and one that we think is an incredibly important first step towards that for control. Because it is the hardest use case, we have to get that absolutely right.

 

Stacey Simms  10:49

Will that have share and follow? Is that something that you're working on for down the line? Or is that something that may come sooner? So really

 

Elizabeth Gasser  10:56

good question. And we do recognize that share follow is incredibly important to our users and their families. Were continuing to look at where explicit share and follow capabilities for on our roadmap and what the best path to implementing that is, in large part because there's a diversity of CGM follow options out there, including our own Sugarmate application, which which can be used for blood glucose monitoring in a follow capacity. And so we don't have roadmap dates to share at this point in time, just know that we're sensitive to figuring out what the best possible implementation is for our customers here. And we want to make sure we're getting as much experience as we can, in the meantime, really understanding how to do good follow. And as I say, we're getting some of that through the Sugarmate app that we're operating, which actually just went live with the Dexcom real time API, right. And so there's a little complexity to thinking through what the best implementation model is. We're working on it and watch this space.

 

Stacey Simms  12:00

Well, since you brought up Sugarmate, I have to ask with Sugarmate, which is if it's not clear, Tandem owns as you said, many people don't realize that is sugar beet, something that people could use, kind of as a bit of a workaround for a Tandem share and follow or Sugarmate only displays Dexcom data right now.

 

Elizabeth Gasser  12:18

So today, sugar is explicitly a CGM companion application. It displays data from the Dexcom CGM. Over time we're looking at what features need to be added to that to ensure it delivers the best value proposition to our users. Really interesting

 

Stacey Simms  12:33

stuff. All right, you segwayed beautifully into my question about Dexcom. How soon after Dexcom G7 is FDA approved, do anticipate it being available on the x two and again, is that a simple software update?

 

Right back to our conversation, but first Diabetes Connections is brought to you by Dexcom. just about to talk about there. And one of the most common questions I get is about helping children become more independent. You know, those transitional times are very tricky elementary school to middle school middle to high school you get but I'm talking about using the Dexcom has made a big difference. For us. It is not all about sharing follow. I mean, that is very helpful. But think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four to five finger sticks at school, or for a second grader to show their care team the number before Jim at one point, but he was up to 10 finger sticks a day and sometimes more and not having to do that makes his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at diabetes connections.com and click on the Dexcom logo. And now back to Liz I just asked about tandems planned integration of Dexcom G7 when it is approved and released.

 

Elizabeth Gasser  13:53

We are intending to implement Dexcom G7 With both pump models so that means X2 and that means Mobi, down the road, our current goal, and this remains our goal is to deliver that within a quarter of FDA approval of the G7. And in terms of how they gets rolled out. I mean, it's very consistent with the software conversation we were just having right. The beauty of the software model is you know, as that gets approved, and as the implementation is ready, we'll be making it available to customers through a simple software update.

 

Stacey Simms  14:26

Let's move on and talk about the December R&D presentation where this large plan, I think very ambitious and exciting was laid out for the next five years. And we've already mentioned a couple of the products. We're going to go through it in some more detail, but I am curious kind of, you know just what it was like that day and if you didn't see it or hear it, I can link up the video. I'm assuming that it's still up there. But I guess I'm asking this is what were you all talking about that day? There were so many people involved in the presentation, kind of doing handoffs and saying, here's the product, here's the software, here's the philosophy, it had to be a big deal. Tandem had to be a lot of relief when all the technology worked. And everybody got their presentations through with it. You were done.

 

Elizabeth Gasser  15:07

Oh, absolutely. I couldn't agree more with that sense of it was momentous. And certainly at the end of it, we're all pretty tired. But no, it was, it was exhilarating, too. And I think, you know, we spend a lot of time because of because we're in a regulated space, we spend a lot of time talking day to day about the here and now the stuff that's approved, the stuff that's in market, and the reality is a lot of what we shared R&D day we've been working on for a while now. And you know, some of it's been skunkworks. Some of it's been more formal programs, you know, you just ticking along. And it was really exciting to have a vehicle to share a lot of that thinking and a lot of that innovation that we get to see day in day out. But we don't always get to tell the world about because of the rules and regulations in our space.

 

Stacey Simms  15:59

Alright, let's talk about it as much as we can. You've mentioned Mobi several times, this had been referred to and I had been told this was not gonna be the name. So we didn't know that. But this had been formally referred to as T-Sport. Now, it is Tandem Mobi. Can you go through the features? Can you go through what this product is?

 

Elizabeth Gasser  16:19

Absolutely. Where to start? First at it. It's the world's smallest durable pump. So if you're familiar with with the X2, it's half the size, that's really small, durable, four year lifespan hardware. So that in and of itself is exciting. In terms of where we go with the software on top of Mobi, it's going to support Control IQ. So same great algorithm that's in market today, it will be deployed on on both pumps in the same way. And so we get to bring that algorithm across the entire portfolio when Mobi launches, it will be controlled by phone as we were talking about earlier. And that means full control at this point in time, obviously, because there's no screen on the device itself. So what does that mean? Everything you need to do to interact with the pump settings, whether it's bolusing, whether it's looking at your statistics throughout the day, that will come from the phone, it will be charged inductively, which that you know, not something you don't really focus on. But that's that's pretty cool. With we're getting used to wireless charging for all of our consumer electronics devices not having to hunt around for a cord to plug it in. That's what we're doing with with Mobi as well. It'll sit on a little charging station, very easy, very straightforward, less pieces to worry about on pump bolus button. And this one we think is a little differentiated. Certainly in the on body arena, I think it will be the only one only pump out there of this size that has the option to fall back to a button push on the pump just to make sure because obviously, when you are interacting with your pump solely through a phone, we need to build in some measure of failsafe fallback, right if you find himself without the phone, and needs to bolus. And then lastly, waterproof. We're going to support waterproof capabilities through IPX8, which I think is pretty competitive. So lots of stuff packed into a really, really tiny device.

 

Stacey Simms  18:25

I'm sorry, what is IPX? Eight mean?

 

Elizabeth Gasser  18:28

The best way to articulate it, it's really just the standards we comply with and IPX eight means fully waterproof, you'll be able to swim and shower with it.

 

Stacey Simms  18:36

One question about Mobi is I'm trying to visualize how it connects. My understanding is that it uses the standard pumping fusion set that like my son's Tslim currently uses, is that correct? It just sits closer to the body.

 

Elizabeth Gasser  18:51

That is correct. The Mobi pump will work with the Tandem portfolio of infusion sets. And with the Mobi pump launch, we will also be introducing a shorter infusion set that four or five inches long, that allows for greater diversity of wear options.

 

Stacey Simms  19:09

I'm so fascinated to see how this works because I'm a very visual person. So he could put it on like my son could put it on his arm and it kind of dangles off. Does it also stick to the body in a way? Or does it just kind of hang there on the tubing, the tiny tubing

 

Elizabeth Gasser  19:24

work, we're working on the accessories to allow for a diversity of wear options, whether the belt clips or sleeves or a body worn adhesive patch through which you can that you can pop the pump into. So there's a variety of places you can push

 

Stacey Simms  19:39

it interesting, alright. And like I said, I will link up so you can you can really dial down if you want to and see all of the features of everything we're going to talk about. But just for time limitations, we're not able to go through every single thing. Let's move on to the T slim x three that seemed to be next in the pipeline. What is that?

 

Elizabeth Gasser  19:55

x three. That's the next iteration for the T slim X To pump. And really the focus there is to continue really honing the capabilities of the T slim form factor, right. And so we recognize that over time t slim continues to play a role in the portfolio, many of our users will continue to want a pump with a built in user interface. And so really the x three programs emphasis is on further developing the processor capabilities of that device, looking at battery life, looking at durability, reliability, looking at wireless software update capabilities, really to make sure that the T slim x two kind of line has continued vibrancy as part of the portfolio over time. And we're making the appropriate investments to support the diversity of software and user interfaces that we want to bring to the portfolio at large. So

 

Stacey Simms  20:54

right now, it sounds like the changes you're talking about aren't something that, you know, I would look at the pump and say that is significantly different, right? Or that works completely did you've changed at all, it's making small improvements and things that the user, frankly, may not notice? Or will they're, you know, things will just run better, like you said battery life, that sort of thing. Are there significant changes that you could think of that would be coming to the pump itself?

 

Elizabeth Gasser  21:16

Oh, no, that's absolutely right. I think this one's a little fun for me, because I come from the consumer electronics space, originally and spent 20 years you know, working on phones. And as you think about the types of releases, you do with consumer electronics, year to year, a lot of them are under the hood, that it's really focused on making it connect better, giving it more horsepower, making the battery last longer. And those things aren't always visible on the surface to a user, but may manifest through the quality of the user experience they get from interacting with that device.

 

Stacey Simms  21:50

The next product is Mobi tubeless. We've talked about what Mobi is, I'm assuming this means know to tell me a little bit about Mobile tubeless. This is

 

Elizabeth Gasser  22:01

a certain creativity and the naming convention there isn't so

 

Stacey Simms  22:06

we shouldn't laugh. It's a very big deal. It's a very big deal.

 

Elizabeth Gasser  22:09

No, I say that affectionately. And look, it's back to the conversation we were having on kind of the Mobi, shorter infusion set and different Bodywear options, more ways to air Mobi, right, we recognize that not everyone ultimately wants a pump with a tube. And so we've been pushing ourselves to say, okay, how can we improve the wearability and the wear option, so that we're reaching the broadest possible base of customers here. And, and this one's kind of an example of the things that we've had in the hopper for a while that not everyone gets to see, we took a little trip in the Wayback Machine and dusted off some of our earliest thinking on movie here. And maybe a tubeless infusion site option has been in our minds for a while. And so we felt it was the right time to bring that idea back to look at how to make it a reality as we get closer to the official launch of Mobi. And so this sits in the roadmap for Mobi as additional ways to utilize and engage with the product. And hopefully, it will give users choices, right? Some days, I don't want to wear my pump on my body, I might want to have it in my pocket and connect via a standard infusion site. Other days, I may be a little more active and find a really need to have a have a tubeless wear option, we get rid of the tube, the goal for us is to satisfy all of those use cases.

 

Stacey Simms  23:34

And then the last one is the completely disposable patch pump that's in the pipeline. Is this a different form factor than Mobi? Is it a different design? Or is it similar?

 

Elizabeth Gasser  23:44

So this is a different program? I can absolutely share that. I can't say a whole lot. This is one we want to keep fairly tight under wraps for competitive reasons. But the emphasis there is is very much on miniaturization. Got it. Can we really push the design envelope here on form factor for the device?

 

Stacey Simms  24:06

You know, it's so interesting. We've been in this community as a family for 15 years. So now you're certainly not as long as many other people but in that time, we've seen and heard a lot of products, right? We've heard about new things coming. We've seen some really great advancements, we see things go away. This is a very ambitious portfolio that we're looking at and five years is it doesn't seem like a long time really certainly as I get older, it seems less than less. Seems everything's going more and more quickly. But a lot can happen in five years is the is the plan here that all of these products will exist together. As you said, you know, the movie tubeless you kind of made it sound like I might be able to take out my Tandem movie with the longer tube and then switch to the tubeless another day is the idea that all of these would exist side by side.

 

Elizabeth Gasser  24:50

That's a great question, Stacey. I think the best way to answer that is to really reflect on the fact that we do fundamentally believe the day Diabetes space and particularly insulin dependent diabetes is a far more segmented market than every industry analysis would lead us to believe. You know, we often talk about type one and type two, as if those are the only segmentations that are relevant, we do actually think there's various needs, that we should appropriately be segmenting around, including, where preference form factor and user and interface size. And so as we look at the portfolio, we're really looking at how we can satisfy the broadest array of user needs. That may mean there is on occasion, some overlap in functionality between different products that sit in the mix. But the goal is really to provide the right device for the right group at the right time. And so as we think about where we go from here, the roadmap as we have sketched it out, for the 22 to 27 period really is very much about a tube pump offering with a screen, that's Tslim X2, a smaller form factor, more discreet phone operated screen, this option in the form of Mobi and there, the goal really is to create as diverse an array of wear options as we can to satisfy the needs of different user groups and their day to day activities, and then pass that as you think about the idea of a passionate disposable patch that exists as a third category that overtime will, we'll have to see how these different offerings play out with the segments that they're serving, and they are likely to coexist.

 

Stacey Simms  26:39

So interesting. As we begin to kind of wrap this up, I did have a couple of questions from listeners I wanted to get to, and one of them was about control IQ, frankly, and any changes coming. In other words, we had heard a lot about changing the adjustable, changing the target rates lower than 160 and 180, that they are right now not the target rates. That's when the pump takes action, that kind of thing. And I remember hearing that there was something in front of the FDA, I don't know how much you can share. But can you talk to us about changes coming to control like you, yeah, happy to

 

Elizabeth Gasser  27:09

talk about the design goals. In terms of control IQ today, it's delivering great outcomes. And in its current instantiation, I think one of the things that's helpful to understand about algorithms is that they're all going to work in different ways. It's like chocolate chip cookie recipes. If you think about it, lots of people have them, but it's how you put the pieces together and in what order and it's the secret sauce that affects how it tastes. Similarly, with algorithms, a lot of it comes down to how you put it together. And it's not always practical to compare from one to another. The real test is, you know, are you getting users to where they need to be in terms of, you know, being able to achieve their time and range goals, for example. So I think it's worth wrapping your head around that idea upfront. Now, having said that, for the control IQ roadmap, our next development frontier really is very much around personalization, and usability. While we're not going to get into very specific, you know, roadmap feature intersections at this time, we're exploring quite a bit here. And Jordan alluded to this a little bit in our R&D Day discussion, part of personalization for us does include exploring lower target ranges, and personalized target ranges, and looking at what it would take to deliver on those capabilities.

 

Stacey Simms  28:32

Here's a real speculative question that I don't expect you to answer. I'm hearing in the DIY space, that more and more people are coming up with algorithms that don't need meal announcements, or don't even need meal boluses. Is that something that Tandem is working on for an algorithm? Or I guess the real personal question is, could you please Liz, help me because my son forgets to bolus for many meals. He's 17. He's very independent. But oh my gosh, when I see people working on things like that, I just feel like that would be life changing.

 

Elizabeth Gasser  29:05

Yeah, mail handling unannounced meals on lounge consumption. Yeah, it's the hardest thing to confirm it with the algorithm here. It is fair to say that as part of our ongoing roadmap explorations, we are looking at what it means to improve unannounced meal handling.

 

Stacey Simms  29:24

I'll take it. I'll take it. Thank you. Another question came up about new infusion sets. And you had mentioned this, you touched on this briefly, but we talked to folks at ConvaTec who make many of the infusion sets and they were talking about longer life improvements to the cannulas or those sorts of things coming to Tandem. Yeah, so we

 

Elizabeth Gasser  29:46

did talk a little bit about our goals here. During R&D day. You know, it is only one piece of the system but we do recognize infusion set issues can be a real pain point for customers and so we have programs IPs that are ongoing. Some of them are internal driven by us. Some of them are in conjunction with our partners working on a diversity of things. Some of it is extended wear time, which we know is important. But we're also looking at insertion, ease and usability there, we're looking at how to reduce infusion site failures, specifically around occlusions, obviously continuing to look at things like adhesives, reduction of material waste. And so this one, it's a pretty diverse view that we're taking. It's not all necessarily anchored solely in the idea of extended wear, I can't give you any specific breaking news in terms of you know, what we're coming up with and the products we'd like to bring to market. But this one we're paying serious attention to, we recognize that our customers want to see progression here.

 

Stacey Simms  30:57

Yeah, I have been amazed since day one of pumping, I feel like the infusion sets have, at least for us, and everybody is different. And everybody's skin is different. Everybody's insertion technique is different, which is part of the problem. But you know, I've just been amazed to me, that has always been the weakest link of pumping. And the idea that I'm using pretty much the exact same infusion set that I put on my son's body 15 years ago, just with all the advances that we've had to me, that's the one that needs much more attention. So I'm really, really glad to hear you're working on that. Alright, so this is not a question. But this was a thought that ran through many of the comments. Many people wanted to say, thank you for getting this is terrible. Thank you for getting control IQ through the FDA before COVID. Because oh my gosh, nothing has happened since like, this was approved, what December of 2019. And many people started getting it I think the earliest was January of 2020. And the diabetes community it feels like very little, although there have been there have been approvals. But it feels like everything is moving so slowly now. So I'm sure Tandem is happy about that. But I know the community as well. So I'm not sure if I can even ask you to answer. There's no question there. But thank you.

 

Elizabeth Gasser  32:05

Oh, I'm not sure there's any good answers there either. Stacey, I certainly applaud the the yeoman's work going on at the FDA to manage through this crisis. And certainly while it's frustrating to have extended approval cycles, and yes, in retrospect, a blessing that we secured approval prior to COVID. I can't do anything but feel respect, admiration and a little bit of sympathy for our friends at the FDA. Yeah. And

 

Stacey Simms  32:35

again, I don't know if you can answer something like this. Have you heard that they are they're kind of making their way through it just seems like there was such a log jam, I understandably so any feeling any word that they are kind of clearing the deck, so

 

Elizabeth Gasser  32:47

to speak? I don't think it's my place to comment on my workflow there. I

 

Unknown Speaker  32:50

tried. You can we do have good

 

Elizabeth Gasser  32:52

back and forth with the FDA, you communicate with them regularly. And so they continue to engage with the industry constructively, productively.

 

Stacey Simms  33:02

Alright, before I let you go, you don't live with diabetes, as you said at the very beginning, you know, you come from a software background and that sort of thing. But what is it like to come from that and work in in diabetes, where the work that you do I mean, here I am complaining about infusion sets, and, you know, change the bolus, from what you know, before it reaches 180? You know, we're talking about all of these little things add up to such quality of life issues for people, you know, what does it been like for you to work in this space?

 

Elizabeth Gasser  33:28

That's a great question. It's one that I think you're the first person to ask me to reflect on. You know, I think it is both sobering and invigorating, sobering because, you know, when you come from a world that's, you know, focusing on clicks and engagement and eyeballs, and consumption of media, you can get lost in the little things, and really stepping back and recognizing just the enormity of what type 1 diabetes is, and the burden it places on people's lives, day to day, and feeling like I can show up to work and even in a little way, help with that. That's sobering and profoundly rewarding. It's also invigorating, because, you know, coming from a consumer electronics environment, you see what's possible with the technology as it exists today, and many of those technologies have not yet come to medical devices in a very fulsome way. And so I certainly get out of bed day in day out wondering how we can help therapy benefit from all of the innovation that is going on, in the consumer electronics world, right. You know, we have thermostats that manage our home temperature for us. We have self driving cars we have on demand consumption services that you know, help us get our groceries and plan our meals. I don't mean to trivialize the differences that are involved in translate I think that to medical devices, but I also think as you look at that and say, Come on, we should demand that level of ease of use in what we're doing here as well. And so that that's profoundly motivating.

 

Stacey Simms  35:13

That's great. Well, thank you so much for sharing so much information for answering what you could answer. And I hope we talk again soon. My pleasure.

 

Elizabeth Gasser  35:21

Thank you, Stacey.

 

Stacey Simms  35:27

You're listening to Diabetes Connections with Stacey Simms

more information at diabetes connections.com, including the link to the research and development presentation. If you'd like to watch that or just listen to it, I will link that up over on the website along with the transcription. I really appreciate your patience with the transcriptions. I think we do a great job. But my transcription software doesn't speak diabetes, I try to teach it but it is a little unreliable. That way we go through and try to catch the big stuff. But if you do see anything egregious, or very confusing, please let me know. And I can pretty easily fix that.

I want to take a moment and address a couple of the questions that we ran out of time with Tandem or your questions came in late. I'm going to do that in just a moment. But first, I mentioned at the beginning of the show that I had a question for healthcare providers, I have a question for you, I have a favor to ask of you. You may have heard me talk about Club 1921. I mentioned it right at the beginning of the show, I'm only talking about if you're at the end of some of the podcast episodes, and in the Facebook group, we are in beta. It is my new project. It's all about events in the diabetes community nationwide, any type of diabetes anywhere in the United States.

I need your help, because it's very easy for me to find the big events, right friends for life, JDRF, even ADA stuff online. What I would like to add to the website, and what I think will be vital to its success are all of the events going on in your hospitals. Almost every hospital has a nutrition program for people with type two, an education program for gestational diabetes, things like that. They can be virtual, they can be in person, but I need to find those programs, I need to get into those hospitals, I need to reach the people who want to add those events. This is not a community calendar, where I hope a couple of groups post their events. And we all go from there. I want this to grow into a site where 1000s of people with diabetes, any type of diabetes, find their community find help find what's being offered. And I know that these hospitals want to connect with these folks. So if you could help me do that point me in the right directions to meet with the association's it doesn't have to be one on one with hospital systems, although that would be great, too. But whatever you think might be a help, I would really appreciate it, you can email me Stacey at diabetes connections.com, you can message me on social media, thank you so much, because this will only succeed if we reach out beyond the community that we are already talking to. So thanks.

Okay, let's get to the kind of leftover questions from Tandem, the most common one had to do with international rollout. And I unfortunately, I don't really have any good answers for you. I'll tell you what Tandem said I asked specifically about Australia, I had two people who emailed me asking about what is going on in Australia with the rollout of Control, IQ, nevermind all these other features. And they just said we do not have an update at this time. And then asking about other international markets. So let me read that response in full Tandem says we have launched in a large majority of the international markets, and we're near to medium term focuses on ensuring we work to make our technology broadly available to these customers. We don't have anything to disclose with regard to additional markets at this time. So I know not the answer you were hoping for. I will keep asking on this one. And I do apologize, we are a very US centric podcast because I am US centric. But I appreciate the reminder. And I will try to keep that focused and you know on my list of questions as we move forward with lots of different technology this year.

And then I had also asked them about changes to the current controller queue algorithm. I had asked during the interview if it could take action at a lower number than 160, which is where it jumps up to basil and 180 where it gives an auto bolus at 60% of the bolus rate that the person programs in and Liz did answer that question in the abstract, but I wish I had pushed on it. So I followed up because I thought I had heard that Tandem had already submitted a change on that to the FDA. They responded quote, as Liz mentioned in the interview, we are working on personalization features which include lower targets and thresholds. We've begun to engage the FDA and started our design work, but we're not currently providing any of the feature details and quote, I will add this editorial comment. Every pump company I talked to has started out saying we're going to have lower ranges, we're going to have tighter ranges, we're going to have customizable ranges and every time it hits the FDA that kind of starts to change set You know, Omnipod, if you'll go back and listen to the interviews from two or three years ago, they were going to submit with I think it was 80 to 100 as one of their ranges. And that didn't happen they've submitted with higher ranges, just like Tandem did. I think, again, this is my speculation, I think these will all gradually come down. But if you are looking now for tighter control with these hybrid closed loops, you might want to go the DIY route. Although if you keep your pump in sleep mode, you know you're sleeping beauties with Tandem it's trying to keep you at like one 12.5 The whole time you just have to remember to bolus which works beautifully for some people, and not at all for the person in my house.

 

Okay, before I let you go quick look ahead. Of course in the news is every Wednesday we do that live on Facebook, and YouTube and I added LinkedIn this week. My goodness, we're also live on Instagram a little bit later, still can't do all of that at once we're working on it. And then I turned that into an audio podcast episode that is released on Fridays, upcoming longer format shows we'll cover more technology including a new pump called Sigi. We've also got some really interesting community interviews. What is it like right now when you live with type one, but you also live with another autoimmune condition that makes it very difficult to get a COVID vaccine. And I'm going to be talking to some of the Joslin medalists who are this is a theme right living longer with type one and the issues that have cropped up for them that nobody really far, we would have to think about so I'm excited about that and so much more.

Thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon until then, be kind to yourself.

 

Benny  41:48

Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

 

 

Jan 11, 2022

This week, Dexcom CEO Kevin Sayer spoke to the JP Morgan Healthcare Conference about the G7 and beyond. We talk about information from that presentation and get to as many of your questions as time allows.

This interview took place on Tuesday Jan 11 and much of what we discussed isn't FDA approved.

Dexcom presentation info here

Club1921 info here 

Our usual disclaimer: Dexcom is a sponsor of this podcast, but they don’t dictate content and they don’t tell me what to ask their executives.

Recent Dexcom episodes:

CTO Jake Leach talks about Garmin, Dexcom One & more

CEO Kevin Sayer talks about G7, Direct to Watch, Adhesive and more

CEO Kevin Sayer talks about Dexcom in Hospital, G7, VA program and more

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

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Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
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Episode Transcription Below 

Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921. Where Diabetes Connections are made
This is Diabetes Connections with Stacey Simms.
Welcome to another week of the show. You know I'm always so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. And I'm talking with Dexcom CEO this week, it's Kevin Sayer, he is back to check in with us again. And in the interest of getting this episode out to you as soon as I could. It might sound a little different right here at the beginning. But Dexcom episodes are always so high interest that it really merits a quick turnaround. I didn't want to sit on this interview for a week. So here's the setup. Dexcom CEO Kevin Sayer gave a presentation to the JP Morgan healthcare conference, if you're listening as this episode goes live, that was just Monday of this week, January 10, the interview you're about to hear took place on Tuesday, January 11.
My usual disclaimer Dexcom is a sponsor of this podcast, but they don't dictate content and they don't tell me what to ask their executives. I asked the Diabetes Connections podcast Facebook group for questions. And Whoa, boy, did you have a lot as always not a surprise. And I really appreciate you sending those in, I got to as many as I could, while also trying to include what the folks at Dexcom had really asked me to bring up there are some topics that they wanted Kevin to make sure to address. And I think we do a pretty good job of trying to reach a balance here.
Kevin, welcome and Happy New Year,

Kevin Sayer 1:46
and Happy New Year to you.

Stacey Simms 1:48
Thank you. Well, this seems to have started out in pretty happy way on the headline, just from this week. Dexcom CEO touts unprecedented performance of G7 in clinical trial. This is after your talk at the annual JP Morgan healthcare conference. Tell me a little bit about that unprecedented performance data.

Kevin Sayer 2:08
I'm happy to. And I just have to qualify it by saying no, I can't send it to all your listeners at the end of the call yet. We're still waiting for approval in Europe. And we have filed this with the FDA, I'm going to take you back a little bit, we made a decision when we were going through the G7 development process that we wanted to answer that performed better than G6. And all of our scientists looked at us and they go oh, really, you're sure because this is really good. And so we spent a lot of time new algorithms and new manufacturing techniques, there's a lot of things in G7 that make it different. We also wanted to validate that performance with a study that was so large, nobody could refute it. So as you look at the data that I presented at the conference yesterday, over 300 patients 39,000 Match pairs all across since one ranges and on the I CGM standard side, but with the 5% 95% lower bound, and even the absolute points, you can see we are well within all of the iCGM standards, which are very technical and actually are a very good measure of how a sensor actually performs in reality. And they were very thoughtful in developing these standards to try and pick the centers that don't work to put you statistically in a bind to whereby if you really aren't performing in the low range or wherever, you're not going to get that iCGM designation. We're very comfortably there.
And the overall MARD in the study, Stacey is eight point, you know I it's in the low eight for adults and pediatrics. And if you start looking at the data, we gather the data sets in three periods, you know, days one and two, the middle days, four, or five and six, and the last days nine and 10. It's pretty low, I think it's below 10. In the first group a day, the first days, which are always a little bit higher, traditionally in our centers than the other days. But in those middle and end days, it's it's near seven, and strips for six. I mean, we have done something that I've been in this business for since 1994. I didn't think we'd ever do this when I started. As far as being this good. This is really, really good data. And we're going to continue to deliver the experience to our customers that they demand from us. So as you can as you think about an iCGM that's driving an automated insulin delivery system. And not only is the performance great, the user where it's 60% smaller, it's a 30 minute warm up. It's a new app. From our perspective, we've got a lot of the clarity data, your listeners will know about clarity. We've got a lot of your clarity data right on the app. There's new alarm configurations.

Stacey Simms 4:48
I'm gonna just jump in with a couple of quick clarifications before we go on. You mentioned a number of there that went by quickly I apologize when you talked about the 300 people in this trial 39,000 match what I missed that one

Kevin Sayer 5:00
matched pairs. That's where you compare the CGM value to the blood glucose value from the laboratory instrument. So the way our studies work is literally we draw blood samples from the individuals in the study at intervals, and then we actually match the CGM data to that laboratory blood instrument. So 39,000 points from these 300 people in this study were matched. Got it?

Stacey Simms 5:27
And you mentioned the MARD mean absolute relative difference. Most of you, as you listen are very familiar with this, the lower the better for CGM G6, I, my understanding was G6 was in the low nines. This is 8.1 for peds. 8.2 for adults, as I'm reading it, that's right. I know you can't tell me I'll ask you anyway, why? What made the difference here? Is it sighs is it algorithm? Do you have anything you can point to? Or is that a trade secret

Kevin Sayer 5:49
it's combination, I think the algorithm has been the most, the algorithm changes were really extensive here. And, you know, we always have manufacturing processes to get better, the way we build the G7 centers different in every step of the way. Literally, our G6 manufacturing processes go away and the G7 ones take over the summer, we're a little similar on the actual sensor wire itself, and that manufacturing, but everything else is different. We just think it it's smaller, it's a lot shorter than G6 was. And so it is it's going to be a completely different experience for everybody.

Stacey Simms 6:28
So to go back to what you were talking about, before I jumped in there, you were starting to talk about alarms, is there something different for the alarm,

Kevin Sayer 6:35
the app is different. And so access to them, and, and just how you use them, if we try to get to be more consumer, thoughtful, as we configured the alarms, we'll see how everybody loves him. It'll be interesting. The alarms are one of the things we get the most comments on when we launch a product initially, we try and please everyone, but we never please everyone. And then you get you know, the agency at one time. I don't know if your call. I think one of our other discussions, we had to make the mute override not work on the low end. Boy, we got a lot of people mad at us about that one. So we've tried to comply with what our users want, and also comply with what the FDA has asked us to do. But I think users will find the alarm experience. Good as well. I like I think it's just gonna be a home run. Yeah, well, I

Stacey Simms 7:24
mean, my son would be happy if an alarm never made a noise again. And I know other people who put like it to alarm every time there's any movement. So I hear where you're coming from, can you give any insight into the G7 app in terms of what the differences that we may see as users? And I guess especially one of the questions I always get is about follow any changes of significance coming that you can share follows

Kevin Sayer 7:47
on a separate software track. And so the G7 system, the app is just we tried to get more data in the app itself, versus what we have with G6. So a lot of the clarity data, or at least summary query data is sitting there right in your app. And that will be i we think people will like that just to see how they're doing over time you got your time in range data for, you know, three 714, you know, a month, 90 days, see how you're doing time in range wise and the app is other than that it's relatively similar. The startup is different and you know, in the interface is going to be different. I think over time, what you'll see with us is that app is now going to get more sophisticated, we changed the entire software platform for G7 and started over again, and we developed a software platform, we can now really change and add on to a lot easier than we could in the past. And so we're hoping to have more frequent software releases.
But we've also learned that CGM is not like Battlestar Galactica game, a game where you want to get a new release every two weeks to fire everybody up. We can't do a release every two weeks, because people depend on this for their, you know, for their lives. And if you do too frequent releases, and you botch a release, you do some wrong, you remember what happened, if we ever make a mistake on the software, the data side, we can't do that. But we do want to add more features more quickly in this platform will enable us to do that. I think one of the things you'll see going forward on the software side, we really want to automate a lot of the tech support features.
We've added some, you know, you can get FAQs right from the app now with respect to your sensor, but there are other things we think we can do tech support wise in the app that will you know, reduce everybody's burden. Nobody likes making a phone call and nobody likes picking up the phone. And when we have a sensor fail, and we do have sensors fail, it just doesn't make any sense that you have to call us if we've got data on a phone, it'd be much easier. For example, if we could diagnose that failure right on the app and go through a very quick process to why but where you could get one. I can't give a timeframe when all those things are going to come but the platform is robust enough that over time, we can add features like that. One of the other nice things about G7, since it's fully disposable, you know, every sensor has its own unique serial number. Whereas with G6, that same transmitters used with three months’ worth of sensors. So it will be, it will be fun to be able to follow things like that and see how the sensors go through the channel where everybody gets attract things of that nature. So what we're really looking forward to the change in our business that G7 affords us.

Stacey Simms 10:28
As usual, I have listener questions, I'm going to try to not repeat because you've been really accessible in the last year, we've talked to a couple of folks from Dexcom, besides yourself. So as you listen, if I didn't get to your question, or if you have a question, good chance, we actually answered it in the last year, year and a half. But given let me ask you about compression lows, because that's one of the things we had talked about, about testing the G7. Any update on that in these trials, if you lay on it, you know, circulation slows, and you can get a false reading any better with the G7

Kevin Sayer 10:54
part of the clinical study is in the compression, because you're pretty much sitting in a chair with a needle in your arm drawing blood. So I'm sorry, we can't really test that we'll learn more about compression when it gets in the field. My hope is that it isn't as much but I can't promise that because I don't know, we're not enough people. I think there are ways over time where we can manage compression better, I'm not going to get into all the science on the phone, believe it or not, I do spend a lot of time with the engineers on this specific issue. Because I have it happened to me from time to time too. So I will call them up say Hey, can we do X, Y or Z? And I think there are some some answers, but I can't give them away because I don't want to give away the playbook. So let's let's just see what we can do overtime on that one.

Stacey Simms 11:42
Okay. All right. But you know, the next clinical trial just have them lean against the side of their bed.

Kevin Sayer 11:46
We will we'll have to do well. Diffic very scientific.

Stacey Simms 11:50
Another question came up, and I think I'm gonna knock wood. I think we've been very lucky on this. It's about new iOS launches from Apple. And I'll read the question and it'll tell you, briefly our experience. This person said Dexcom is part of the Apple Developer Network developers have access to new release such as iOS months before launch, why does Dexcom lag behind Apple iOS launches by months in terms of quote, approved use. And our experience, frankly, is that we have not had any issues Benny and I both have, we just got but as a 13. Plus, we both had very old phones. And we have a latest software and no glitches for us. But that's not everyone's experience, can you talk a little bit about that,

Kevin Sayer 12:30
we do get the iOS versions in advance, and we do our best to comply with them, I would I would tell you that it isn't as simple as it's made out to be. And the iOS version that's launched isn't always exactly what we've worked on as they as they make tweaks, not big ones. But you also test for everything that you know about the new iOS versions, and sometimes are things that you don't know, that are in there that come back and may affect the app later on, which is why we delay a little bit, we try and go through every bit of testing that you can imagine. And I'll be honest with your users, Apple's made iOS changes, because of us, we have called up and said, Look, you got to do XY and Z here we have a problem. And they're very good to work with, they've not been difficult at all, you know, when you think about iOS and Android operating system and all the things that they impact. And it's very hard not to impact somebody adversely when you do a new iOS launch.
And you know, the perfect example with us is the home you'd override journey that I brought up earlier. In the beginning, I believe the only app that can overcome the mute override within iOS is authorized manna in the beginning was Apple's alarm clock, but other people would go around it with their apps was a medical device, we can't do a go around, we have to make sure what we do is in compliance and known so they work with us very well to make sure we could do what the FDA wanted with respect to the mute button. And the same thing with Android on that, and that was a very difficult exercise. So if there's a delay, it's because we're taking time to see what might have been put into iOS that would change our app. And it just one more thing that will stop. new operating systems are often designed to minimize power usage to extend battery life. Oftentimes, minimizing power usage affects an app that has to be running continuously. And those are the types of battles that we fight are things that we have to make sure we test as a new iOS minimizes power usage. Just does that turn us off? Does it does that stop Dexcom? And we've had, we've discovered things of that nature where it could affect our app. So there you go. Long answers. All right.

Stacey Simms 14:44
No, no, that's great. And you mentioned you've asked iOS you've asked Apple to make changes. I assume the alarm was one any others that you can share.

Kevin Sayer 14:52
I know that nothing I could share. Nothing major that I like you said they're very cognizant of the Dexcom community there we are. You know, we're we're a very large part of the iOS, you know, we're pretty, it's pretty vocal group when it comes to iOS,

Stacey Simms 15:06
pretty vocal group period, the whole community. Alright, we say that with love. So another question came from my group, which was about Sugarmate. This is a, I would describe it as a third party app that uses the Dexcom information. And now the real time API to display and and act on data in its own way, my understanding is that Tandem owns Sugarmate, just from way of background here. And you know, Dexcom owns a little bit of Tandem. So there's a relationship there. Can you speak a little bit about data sources, but the bottom line question here was using Sugarmate and the situation to ask you, does Dexcom feel like they own the patient data? Or do the patients still own their data, even when going through the Dexcom web API's, we believe

Kevin Sayer 15:49
the patient's own their data, not us, let me rephrase that we believe the patient's control the use of their data, we are the stewards of that data sitting on our servers. And so we have a responsibility to maintain it and to keep it but where that data goes and where that data is used. We do believe, particularly if it's identified data, that the patient absolutely has complete control over that there's vector sugar made, it's interesting, it was not using API's before it was a like many and non authorized use of the data to display it in a different format that people quite candidly, mess, like better than looking at the Dexcom app. And that's fine. That's why we built the live API's, we made a server change to upgrade our server platform, again, more capacity, more safety, more redundancy. It's a project that's been going on for years. And we've come to the end of that project this year. And when doing so there were some technical issues with Sugarmate, they very quickly switched over to the live API's. And now this is an authorized use of the data based on platform and data pipes that we built. So we're willing to share the data with people when they want it. I think that's an attitude of Dexcom. That changed very much over the years, when we first started, we had a hard time with that concept. Because we worked so hard to invent this technology and gather this data, why would we share it with anybody and say, See, you remember the early days and Nightscout, they were mad at us, we were mad at that. Now, we're not mad at anybody anymore. I think it's important that the data sharing be structured and be used for good purposes. But you know, all in all, it's a, it's a good use of the data that we have, because these are still Dexcom customers. If you want to, you're still buying sensors and using them. It's not a bad thing.

Stacey Simms 17:35
Let me ask you a question about the sensors. And this came up in the fall. I've seen it less since but it's still out there. And I don't know if this is something you can answer. But it seems that we have not received this. But it seems that some customers are getting the G6 sensors, the inserters brand new in the original packaging, but a new label on it that says this product meets shelf-life extension requirements. I'm your people I reached out to them in the fall, they told me the stickers, oh, you know, it's all legit. There are updated expiration dates. But I'm curious why this is happening. And you know, what is the shelf life of the G6,

Kevin Sayer 18:10
I can tell you exactly what's going on, you do shelf-life testing for product as selling your product will last. And over the course of our product lifecycle, you trying to extend that shelf life through more testing to make sure the product still works for the same amount of time period, if you manufactured product with 12 months shelf life, and then extend that shelf life to 18 months. And it's still the same product and still same manufacturing process rather than unbox it, put it in a new box or throw it away, we put a sticker on the outside because it's same products been tested, it's been proven that it works for 18 months, that's not a problem. That doesn't mean that it's 18 months old, we never have inventory that sits around that long to my knowledge, but we do extend shelf lives, it's important for us to do that, with respect to the distribution channel, particularly as we go to the pharmacy, you know, in the drugstore and and our distributors, the longer they have, you know that they can keep product, the better. We don't want people throwing product away if they don't have to. So all that means is we've extended our testing and shown that the product still works for a longer period of time and wanted to to label the product accordingly. That's all

Stacey Simms 19:17
Yeah, I think because it came at a time when there is nervousness just in general not just in diabetes about supply chain and, you know, scarcity concerns. It just seemed unexpected, if that makes sense.

Kevin Sayer 19:30
Well I one of the reasons to extend life is in fact supply chain we don't have inventory issues with G6 you know G6 is a very very well running process right now and still, you know, the premier sensor on the market. In fact, we launched a G6 derivation product in Europe, these past three months called Dexcom. One a it's a cash pay product sold on the E commerce platform in four European countries say See now and it's a lower price and geographies. But we did a feature that we took away, share and follow. We're not connecting any devices. It's it's a simpler technology. And again, we have d six supply to be able to go and do things like that. And we are planning to have G7 capacity to do similar things. We are not shooting small on either front will have capacity on both sides. And, you know, listeners on a supply chain perspective, we have been extremely diligent with respect to components for our products. And right now we see things very good today. We my operations team has just been outstanding on this front. So knock on wood, no, no Dexcom problems today.

Stacey Simms 20:40
All right, two more questions for you. As always, we're going to run out of time. And as you're listening, I would refer you again, we did have a conversation about Dexcom. One in a previous show. So I will link that up. This one is more of I've asked this, you answered it, but I still continue to get questions to please ask you please make sure when GS seven comes out that Medicare is taken care of?

Kevin Sayer 21:00
Well, that is a great question. And I think we've learned from our mistakes in the past. So we will when we get G7 done, what we will do is we will file with CMS to get G7 reimbursement. That's a process that I've heard anecdotally takes three to six months. So if we can get it done in three months, we can't file with CMS until it's approved. But we'll file after approval, and then we'll go and it is our plans to have capacity for all of our US users. When we go it is not that Medicare delay for G6 was one of the most emotionally gut-wrenching things I've dealt with here, because you can't imagine how many emails I got. But we didn't have capacity, and we didn't have everything ready. We've learned from our mistakes. And we'll hopefully be ready to go to everybody. That's our plan right now.

Stacey Simms 21:49
That's great. Okay, and my last question is, and I hate doing this to you, but I'm doing it anyways, look into the chapter, we're gonna look, we're gonna come at it sideways, because I did have one listeners and ask him what's planned for the g8? And I said, Come on, let's let him get the G7. Oh, you know what? I'm happy? You can answer that. Let's go for it?

Kevin Sayer 22:07
Well, well, I'll give you two because we did lose some time in the beginning because my computer wasn't functioning properly. As we look to the future, we want performance to continue to be better. And then we ask ourselves, but we're getting to the point where as you get to an eight, Mar D, we're getting close to finger six, I don't know how much more of a gap there's going to be, as we look to the future, and even G7 derivatives, we want to go to a longer life, we want to go to 15 days rather than 10. We'll be running studies doing that over the next couple of years. We've got a couple of plans there. We're always looking to upgrade the electronics, and how much better electronics, you know, I know one of your bigger user complaints is connectivity and loss of data, how do we improve that experience for our customers to make that better over time? Because we can always be better. And phones change faster than medical devices? So what why do we put there, we're looking at ways how we can help the environment for future product launches again, and changes in the next platforms, G6 has a lot more materials than G7 does as far as just raw plastic. So how do we make an impact there? On the cost side, there's some form factor things that are pretty far out there that we look at that I won't go into that are really, really fun. We'll see if we had done that. And if they're feasible from a cost of manufacturing perspective, but again, we're now very much focused on customer preference, rather than can't we make this work well enough, you know, in my early days here, it's Can we can we just get this thing working well enough to whereby people can rely on it. Whereas now it's one of those features that are going to make it a more engaging experience. And the last one will be software and analytics and things like that, as I look out over time, do we end up with analytics to whereby we can offer our users a menu of choices on the software side to whereby they can get more if you want Dexcom when don't want to connect or talk to anybody? You can have that if you want something that literally literally analyzes every glucose measurement that you take and does something scientifically. How do you get there, I think there's a number of experiences we can develop over time for future product generations without changing the form factor. So I don't see any slowdown in investment on the r&d side. And on the product side, G6 is the best product out there now and G7 will just be better in every way. And then we just keep going from there.

Stacey Simms 24:27
And I appreciate you answering that. Thank you. So if you keep going from there, this is the sideways kind of question I wanted to ask. Okay, go ahead. Okay. A couple of days ago, Abbott announced the idea of what they're calling Lingo, which is bio wearables that will track not only glucose, but ketones and lactate and alcohol. And they say these are not medical devices. You know, this is for people who want to be you know, ultra-marathoners and things like that. We're already seeing sensors used in that way right now. Any plans to do something like this?

Kevin Sayer 24:56
You know what our electronics platform for G7 We could put any, if we could develop a sensor wire with membranes and analytes and such for to measure something else, it would fit right into G7. And we design G7. With that in mind, we have advanced technology work going on with the other analytes. But it's still an advanced technology phase, we have to answer a couple of questions. First, have we done all we're supposed to do on the glucose side? Before we run there, and we got a lot to do right now, Stacy, you've heard me talk on this call. And so we need to get done what we started, we need to get G7 launched, we need to scale it up and manufacture it in the 10s. And ultimately, hundreds of millions of products as we stand up a factory in Malaysia and get our Arizona facility built out even more. So we've got to get that work done. The second piece, I'm going to answer this in three pieces. The second piece is what is the commercial opportunity for each of those things. They did announce this line of sensors, but they're all individual sensors.
So I've worn a lactate sensor, I'll be completely honest with you from the lab and seeing what it does to my workouts and it's very cool, I can see which workout is better than another one. But I'm not ultra-marathoner, I probably wouldn't change my life. But it was very interesting to look at. There are other scientific uses of black data, particularly in a hospital setting. But what is the market for those, and so we're gonna kind of take an approach, we'll continue to develop the science and if Abbott wants to go develop a market, I am happy to follow this time rather than create it, like we've done with glucose. The third piece of this is there are a lot of biosensors out there. Now, you have your Apple Watch, and Apple is continuing to gather more and more data or ranks, whoop bands, Fitbits, they're advertised on television all the time, I would love to incorporate data from these other sensing technologies into into Dexcom. And vice versa, share our data with those people, particularly as you head down the health and wellness path. And let's get some other people's sensors into our platform. In all honesty, if Abbott's really good at sensing these other things, we'll take that data on our platform and analyze it to if they want to, I guarantee you, that probably isn't gonna, gonna happen. But we would, you know, let's be open about this. We're going to get our glucose work done to because we've not seen an opportunity that exceeds this.

Stacey Simms 27:13
Got it? Excellent. Well, thank you so much for answering that it really is so interesting to watch and to see if, as you say, if any of this really, really makes a difference commercially, if people do want to adopt it widely. You know, I think the jury's still out, so we shall follow.

Kevin Sayer 27:26
Hey, thanks for having me again.

Stacey Simms 27:27
Thank you so much. Have a great day.
You're listening to Diabetes Connections with Stacey Simms.
More information at the episode homepage, diabetes, Dash connections.com. I'll have the transcription up as soon as I can. But again, quick turnaround on this episode. Thank you so much, again, for sending in the questions. Obviously, I didn't get to all of them. And if you're not in the Facebook group, that's generally where I asked for questions for this kind of thing. It's Diabetes Connections of the group. I'll link it up in the show notes. As always, I know not everybody's on Facebook, please feel free to always email me if you email me now about Dexcom. I'll save those questions until the next time we talk to them. It's Stacey at diabetes connections.com. Again, it's in the show notes and it's on the website. But I get it not everybody is on Facebook these days.
To that point, at the very beginning of the show, in that little sponsor tease before things even begin, I mentioned club 1921. So let me tell you a little bit more might be an update for some of you. Maybe some of you are hearing about this for the very first time. Briefly, club 1921 is a website. It's a project I've been working on for a long time. And it is a place where anyone with any type of diabetes can find events anywhere in the United States. We are in beta right now. I invite you to go to the website club 1920 one.com. Until around, check it out. Let me know what you think we've immediately identified we went into beta, late last fall several things mostly about the signup that need to be fixed, those could be fixed by the time you log in, my guess is closer to the end of January. There's a little bit of confusion there. I'll explain in a moment. But other than that, it's pretty well set.
The idea here is that instead of a Google Calendar or something like that, this would be a website where you go, you sign up, you tell us what kind of events you're looking for, and then you never have to come back, we'll email you automatically. When events that meet your criteria are edit, very easy. So you pick your type of diabetes, you pick your location, you pick which type of events you want, you pick your age, I mean, you can just say I want everything in every category you can kind of go through, but whatever you pick, and you can change those if you want to come back and change your filters, but whatever you pick, we will email you when those events are added.
If you want to add events. There are two types of events you can add one we're very creatively calling events. This is your JDRF walk. This is your friends for life conference. This is your hospital education for people with type two. It's an event by an organization a was a staff an event where they expect lots of people or it's regularly scheduled, or there's a fee, that kind of thing. The other kind of events we're calling Hangouts. These are my favorite types of events. I love what we're calling Hangouts. This is your mom, coffee, your kid play date at a playground, you know, you're going out to a bar, post COVID, with your adult friends with type one, hang outs are not put on by an established organization. They're put on by people like you and me, we don't have a staff, we just want to meet people in our area. When you're adding those. That's where a lot of the confusion came up in the registration process. Because if you want to add events or Hangouts, you actually have to sign up in a different way.
So I'm going to talk more about that as the weeks go on. We're fixing that part of the website. But if you try to sign up and you see some confusion, it may be because you are trying to add an event or a Hangout. If you want to just sign up to learn about the events and Hangouts, it should be pretty simple. But if it's not, if you have any questions, any suggestions, please let me know. Email me Stacey at diabetes connections.com. Pretty soon you'll email me Stacey at Club 1920 one.com You're going to be hearing a lot more about this because I'm so excited about it. Yes, I know, we might not have a lot of events this year, that's fine. We're going to have events, eventually, in the diabetes space. Again, we're gonna have lots of events, and social media, Facebook, even things like Eventbrite are a terrible way to get the word out about them. And it shouldn't be work to find them, you should be able to just raise your hand and say, I want to know about this stuff. And it should automatically come to you. And that's what I'm hoping to do here.
Okay, back to our regular schedule with the podcast. We will have our Wednesday in the news that's live at 430. Eastern on Wednesday on YouTube and Facebook, and then 445 on Instagram. And then that turns into an audio podcast episode for Fridays. And hopefully next week, we're back to Tuesday and Friday. And we won't do any of this nonsense of pushing episodes around. But I do appreciate your patience. Again, I didn't want you to wait a week for this interview. All right, thank you as always to my editor, the very flexible and understanding John Bukenas from audio editing solutions. And thank you so much for listening. I'm Stacey Simms. I'll see you back here in just a couple of days until then, be kind to yourself. Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Dec 21, 2021

We're taking a quick look back at 2021 and a longer look ahead to 2022 and beyond. Stacey is joined by DiabetesMine Managing Editor Mike Hoskins for a fun talk about technology, trends and even few rumors in the diabetes community.

As always, please remember this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. We’d also add that Mike and Stacey are well-educated about what they're talking here but this isn’t inside information. Don’t set your investments or decide what products to buy from this episode.

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

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Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
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Get the App and listen to Diabetes Connections wherever you go!

Click here for iPhone      Click here for Android

Episode Transcription Coming Soon!

Dec 7, 2021

When we heard about a new seven day infusion set approved this past summer, we had a lot of questions! We've been told since the very first day of pumping to only use the inset for 3 days tops and to always rotate the site. How did they get seven days out of one of these without skin irritation and with good absorption? We asked the folks who make the inset to come on the show and explain.

Turns out, ConvaTec Infusion Care makes the insets for Medtronic, Tandem, Ypsomed, Dana RS and Roche pumps. So while I started off talking about the longer-wear version, the conversation you’ll hear includes everything from proper insertion technique, their challenges teaching users best practices, improvements they're making to the cannula and more. In this interview you will hear: John M Lindskog, President & COO, Matthias Heschel, Vice President, Research & Development and Intellectual Property Rights and Dr. Kerem Ozer, Director Infusion Care Clinical Development

Good article about using insets correctly and understanding the different types.

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here

-----

Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----

Get the App and listen to Diabetes Connections wherever you go!

Click here for iPhone      Click here for Android

Episode Transcription Below: 

Stacey Simms  0:00

Diabetes Connections is brought to you by Dario Health manage your blood glucose levels, increase your possibilities by Gvoke Hypopen, the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

This is Diabetes Connections with Stacey Simms.

This week, how much have you thought about the way your insulin pump connects to your body? Honestly, it's where a lot can go wrong. The people who make the insets know that they have come a long way. And they're trying to make it better.

 

Matthias Heschel  0:40

It's what some people call their Achilles heel in the arm therapy were very much aware of it. And our approach simply is instead of doing product design at the drawing board, to the product design in the field, really taking the patient at the core of our design process, really understanding behaviors, understanding what could go wrong, and then design the product accordingly.

 

Stacey Simms  1:05

That's Dr. Matthias Heschel, head of R&D for ConvaTec infusion care. He, the CEO and the Medical Director sat down with me to talk about longer were tips for users and what's next for this really important part of pumping.

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, you're always so glad to have you here. We aim to educate and inspire about diabetes with a focus on those who use insulin. I am really excited and happy to talk to the guys from ConvaTec. This week, you know, they were frank, they were really up for anything. And I have said for years that insets are the weak link in pumping. And they really opened my eyes to some of the issues and what we can do as users or you know, as parents of users to make things a little bit better. And of course, they're working on improvements as well.

But before we jump in a little bit of housekeeping, I want to talk about the rest of the year schedule for the podcast, I can't believe we're in well into December at this point. Right now the plan is to keep going with these longer format. The interview shows that air on Tuesdays, and we'll have that there shouldn't really be any interruption or any week skipped through the rest of the year and into January. I'll let you know if that changes. But that is the plan right now.

As for the newscast, I will probably not have a newscast on the 22nd of December. Again, I reserve the right to jump in and make a liar out of myself. There is breaking news sometimes late December is when the FDA makes a lot of decisions. So we could have some breaking news. But I would say right now, it looks like at least that one date will not have the live newscast on Wednesday on Facebook, Instagram and YouTube. And so then I will not be turning it into one because that would be a podcast on Christmas Eve and I don't think there's a lot of demand for you to listen on Christmas Eve but you tell me if there is I'm happy to serve and try to put all that together.

Another quick announcement and I'm actually going to talk more about this after the interview is that book number two is in the works. The second World's Worst diabetes mom, I signed on the dotted line to deliver that next year. So we have a timetable. We have a theme. I have lots of stuff. I'll tell you about that again after the interview, but man, I'm really excited about it.

Alright, a little bit more about our guests. ConvaTec infusion care makes insets for both of the tubed pumps available in the US they make for Tandem they make for Medtronic, they don't make Omni pods. They also make insets for Ypsomed and other tubed pumps abroad. But if you use a tubed pump in the US you use their products. In this interview you will hear John Lindskog The President and CEO, Dr. Matthias Heschel, the head of R&D, research and development and Dr. Kerem Ozer, the Medical Director, I worry a bit about three voices. I mean, really, it's for with mine, but we do I think we do make it clear. And there is always a transcript over at diabetes connections.com at the episode homepage, if you find it easier to you know some people follow along, reading as they listen. Some people prefer to read my transcription software. Let me tell you got a workout on this one. It doesn't speak diabetes very well to begin with. And as you can imagine, there was a lot of technical stuff but we did it we got it and it's there for you. But I think that these three were very frank and gave us a lot of information a national here. They have a question for us.

That's coming right up but first Diabetes Connections is brought to you by Dario health. Bottom line you need a plan of action with diabetes. And we've been lucky that Benny's endo has helped us with that and that he understands the plan has to change. As Benny gets older you want that kind of support. So take your diabetes management to the next level with Dario health. Their published studies demonstrate high impact results for active users like improved in range percentage within three months reduction of a one C within three months and a 58% decrease in occurrences of severe hypoglycemic events. Try Dario’s diabetes success plan and make a difference in your Diabetes management, go to my dario.com forward slash diabetes dash connections for more proven results and for information about the plan.

John, Matthias and Kerem, thank you so much for joining me. We have a lot to talk about. And I feel like I've ever been to the company at my disposal. Thank you so much for taking the time to do this.

 

John Lindskog  5:20

Thank you, Stacey. This is John and thanks for having this opportunity to talk with you. Maybe just a couple of words of ConvaTec infusion care. I'm the president and CEO of that part of ConvaTec. We are based out of Denmark and out of Mexico, we have one plant making a few sets in Denmark, and we have two plants almost side to side in Mexico, and also is fully dedicated to making few sets for subcutaneous infusion. Today with me, I have the Matthias and I Kerem and if you could just kind of introduce yourself briefly.

 

Matthias Heschel  5:58

Yeah, this is Matthias. I'm heading research and development at ConvaTec Infusion Care. I’ve been with the company for 10 years. Just happy to be here.

 

Dr. Kerem Ozer  6:07

Hi, everyone. I'm Kerem Moser and I'm the medical director for ConvaTec infusion care. I'm an endocrinologist by background. I've been with ConvaTec for about four months now. And prior to that I was in practice seeing endocrinology and diabetes patients for about 15 years, and very excited to be here.

 

Stacey Simms  6:28

Wonderful. Well, thank you all so much for joining me. We have a lot of questions, questions for my listeners questions that I have as a mom of a kid who has used insets since he was two years old. So let me jump in and ask about the newest infusion set as I see it, which is with Medtronic and Matthias. Let me ask you about this if I could. we're hearing really interesting things seven day up to seven day wear, which I believe rolled out in Europe first is now approved in the United States. How I don't want to ask you to give any trade secrets away. But how do you get it to last so long when we've been told for years that two to three days is the maximum for an infusion set?

 

Matthias Heschel  7:03

Yeah, actually, the answer is very simple. Stacey. Medtronic, they provided quite some details about the year back at the virtual conference. So Medtronic, they added a proprietary connector, which connects the tubing to the pump reservoir. And this connector stabilizes the instrument. On top of the canula, a new tubing, which contains the preservatives, contains the antimicrobial effect of the preservatives. And the last thing is that we added a new adhesive to keep the infusion set on the body for up to seven days. So basically three things. New connector, new tubing, containing preservatives and a new adhesive.

 

Stacey Simms  7:48

So it was kind of a partnership with Medtronic. It's not all on the inset itself.

 

Matthias Heschel  7:52

It's a partnership with Medtronic, and they in general, talking about new product development, future products. It's all at system level. So we cannot just develop a new infusion set. We need to take the reservoir into account we need to take algorithms into account so it's it's always a close partnership with pump manufacturers.

 

Stacey Simms  8:15

how have people received it? Or is it working well, is the adhesive doing okay, on people's skin?

 

Matthias Heschel  8:20

It seems so we have received some first indication Medtronic percent that results at the diabetes technology meeting here this week, actually. And that has shown that there are lower occurrence of hyperglycemic events. There are fewer occlusions. And I think the average wear time was seven days. So it seems that the patients that have come on to an extended wear infusion set are really happy and the infusion sets perform as designed.

 

Stacey Simms  8:57

Before I move on from this one more question for you Mateus if I could. I'm curious, are you working with other pump companies on longer where infusion sets? Or is this going to be a Medtronic exclusive for the foreseeable future?

 

Matthias Heschel  9:10

Well, extending the wear time of infusion sets, that's the unmet need, number one among all patients, so and that's in general interest from all pump manufacturers to have extended wear products in the portfolio. So yes, we're working on the portfolio of infusion sets.

 

Stacey Simms  9:30

Kerem, let me move over to you if I could for this question. As a parent of a child with type one. We were schooled early on the importance of rotating sites, right? You can't let an infusion set go in the same part of the body over and over again. But most kids and frankly most adults I've talked to who use these products do kind of have a favorite spot. The body. Can you talk a little bit about Yes, I guess there the importance of rotating, but something like a seven day wear or what's coming in the future. Is there a possibility that it could be a little less important? to move that around, or am I dreaming?

 

Dr. Kerem Ozer  10:02

That's a really good question, Stacey sort of looking forward, just taking a quick step back, just like you said, the importance of sort of proper rotation is something we always talk about in clinic yet in real life, we know that people have their favorite sites. And part of the idea of the rotation, of course, is to reduce scarring and is to reduce lipohypertrophy. I know your listeners will be very familiar with this. But of course, when we say lipohypertrophy, we're talking about sort of the hardening that bumpiness of the layer right under the skin, that subcutaneous area. And when I think about lipohypertrophy, there are several factors that increase that risk, you know, multiple daily injections, pumps, continuous glucose monitors, sometimes the type of insulin being used, and that really changes from person to person reusing pen, needles, all those factors, even higher insulin doses tend to cause more of a higher risk, higher diabetes, duration is a higher risk. Now, when I think about those factors, some of them are you can't change those like diabetes, duration. Some of those factors, you can change by rotating things, when you look at something like extended wear, I think one advantage is you are going to need to change it out less often. So you're technically changing it, you know, less often, it's probably best practice to still change the site and rotate the site. But one thing I think that's going to be even clearer, and I see this all the time, you know, when I talk with my patients, is, I think it's going to be important to realize subtle changes in the characteristics of that site, even before you start feeling hardening of the skin, even before one starts feeling that bumpiness if you notice that a site is starting to not respond as well, you know, you're feeling that you're needing more insulin, you're feeling that the dynamics are changing. That's I think, when it's going to be really key to make that site change.

 

Stacey Simms  12:21

Interesting. I have kind of said, it's a little bit flippant, but I've said since we started pumping, 14 and a half years ago that gosh, these insets are the weak link in pumping. And what I mean by that is they can fall off easier, they can get occluded, they only last a couple of days. John, maybe let me ask you, can you talk us through a little bit about how you're really trying to make these better? Because I feel like I can have the greatest algorithm in the world on my pump and if the darn thing is flapping on my kids off my kids stomach it's not gonna work

 

right back to our conversation. Yeah, he does answer that question. But first Diabetes Connections is brought to you by Gvoke Hypopen. You know low blood sugar feels horrible. You can get shaky and sweaty or even feel like you are going to pass out – there are lots of symptoms and they can be different for everyone. I’m so glad we have a different option to treat very low blood sugar: Gvoke HypoPen. It’s the first autoinjector to treat very low blood sugar. Gvoke HypoPen is premixed and ready to go, with no visible needle. Before Gvoke, people needed to go through a lot of steps to get glucagon treatments ready to be used. This made emergency situations even more challenging and stressful. This is so much better and I’m grateful we have it on hand! Find out more – go to diabetes dash connections dot com and click on the Gvoke logo. Gvoke shouldn’t be used in patients with pheochromocytoma or insulinoma – visit gvoke glucagon dot com slash risk.

Now back to John Lindskog answering my question about making the insets more foolproof.

 

John Lindskog  14:00

No, no, no, I totally understand what you're saying I will say and then maybe Matthias can chime in after this that, you know the products like insets, they go through a quite extensive and long development program before they actually come to the market and the products also available on basis on customer feedback. And since this is a medical device, it's very highly regulated in the US through the FDA requirements and Europe through CE and in many, many other countries through local legislation. So the level of rigor and preciseness that you have to do in this work is quite extensive for us to develop a product and mass make it into volumes, which we're talking about millions of units per year does require quite a bit of development work to go there. And there is a little bit of you know there's a lot of factors that play into to the to the development, particularly manufacturing of the infuser set, the quality has, of course, to be the highest possible within the requirements. And there's also, of course, a economical part of it, where you need the competitive cost in order to have these products on the market. So I mean, the process that you see today is actually a combination of all the the user input, and of course, also about, you know, the requirements from regulatory authorities. And, and you know, what can be made in very high scale, we, you know, and strive to improve the products along the way, however, even what may seem as being very small, and my new changes, does actually require a complete change process, which is very well documented, and in that sense, also kind of lengthy process. And I don't know Matthias. If you have any anything to add to that, yeah, quick

 

Matthias Heschel  15:56

Yeah, but I would like to add is that we have, we have about 1 million pump users worldwide. And as a create variability, it's both the interpatient variability and intra patient variability. So huge differences between patients and also huge differences between the use conditions during a day for the same patient. So what we are going after in our product design is really making as robust designs as as reasonably possible. And best example is, is the newest infusion set on the market, which is the base of the extended wear we talked about earlier, an infusion set we call Mio advance which virtually only has one user step. So you hit the bottom activation button and it produces the soft cannula, retracts the needle and detaches the serter all instantly. I mean, all the steps happening in a fraction of a second. And that means you're basically take the patient out of the equation, the patient cannot do any mistakes during the insertion process. And there we see a huge reduction in in failures on the market. So to your question, Stacey, I mean, we understand that the infusion set is the weakest link, it's what some people call the Achilles heel. In pump therapy, we are very much aware of it. And our approach simply is, instead of doing product design at the drawing board, to the product design, in the field, really taking the patient in the core of our design process, really understanding behaviors, understanding what could go wrong, and then design the product accordingly. And we have seen the first successes and they hope to see further successes.

 

Stacey Simms  17:40

You know, that's a great point about the very simple insertion of the Medtronic inset. Are there any plans to simplify more brands, because I'm thinking of the one we use for Tandem? And you know, by the time you open it, you peel off the sticky stuff, you, you cock it, you get it ready? You know, sometimes you're already set for error, because if the paper writes up the needle, you know, there's all sorts of different things that can happen if people either press too hard or do it at a weird angle. I know you know this, I don’t have to spell it out for you. But are there plans to simplify other insets in the way that you just described? Since you've seen how successful it is?

 

Matthias Heschel  18:16

yeah, plans to incremental improvements on existing infusion sets, based on the learnings we have from the field, among others, what we touched upon removing the paper liner from the adhesive, we can certainly redesign this to make it easier for the patient. And that's, that's definitely on our agenda.

 

Stacey Simms  18:37

I have a bunch of questions that I got from my listeners, they were really interested that we were talking so let me go ahead and grab those. The first one here was really interesting to me. This listener wants to know about the faster acting Fiasp insulin, which seems to have a little bit of difficulty in some pumps, I was wondering if you were looking into that for different faster acting insulins that the manufacturers are coming out with and if you're testing those and working on ways to improve that in the insets

 

Matthias Heschel  19:06

Yeah, maybe keep a close eye on the market. And every time a new insulin is approved for pumps, therapy, we add this onto our list and do all the necessary trucks stability testing, device stability testing, so you can put this onto our indication for the infusion sets and then it's up to the to the pump manufacturer to also indicate the pump for the new insulin and then the patient can use it. So and that also applies to Fiasp. So we have done all the necessary homework and we know that at least a couple of the pump manufacturers are considering to broaden their pump indication to also include the Fiasp

 

Dr. Kerem Ozer  19:47

And to that I may also add that we're also going to be looking at Lyumjev ultra rapid lispro insulin from Lilly, which as you know is also approved just recently for pump use. So That will also go through the same processes that Matthias mentioned, whether it's working on biocompatibility, looking at what the system does to the insulin, and its excipients and what the insulin is excipients do to the pump. And so that's in the works as well.

 

Stacey Simms  20:15

I meant to ask earlier, I had heard about something I don't know if this is the in-house name or something that you're using and research called Lantern technology. Could you explain what that is what you all are working on?

 

Matthias Heschel  20:27

I was hoping you would ask this question. Lantern is a pretty simple feature tries to mitigate the occlusions we sometimes see for soft cannula infusion sets, when the soft cannula is bent or kinked. And the Lantern features are actually pretty simple. So we provide the soft cannula with additional slits close to the tip of the cannula, and in case the soft cannula experiences any physical impact is spent or even kinked then those slits would open up and would allow to the inset to continue to flow. So it's basically a measure to mitigate the risk that a cannula on the infusion set can get occluded in the cannula.

 

Stacey Simms  21:15

That sounds really interesting. It sounds like didn't BD medical a few years ago have something that sounded it sounded at least to my ear similar that it had the different slits in the cannula? And it never came out? Is this similar technology.

 

Matthias Heschel  21:29

It's you could see it as it's different as a similar technology. It's though, quite quite different. I mean, they provided an additional exit hole, just one hole close to the tip of the cannula. And that actually weakened the cannula significantly, and the product was out on the market. They call it a smart flow technology. And the product was marketed by Medtronic as a process that was withdrawn from the market right after. And with our long term technology, putting a number of slits, we have really avoiding this issue that the cannula really occludes. Imagine if you just have one side hole and the cannula kinks or bends, and you would close up this hole. And in our case, having four or six slits, that would be always a couple of slits open and allow the Insulet to flow. So it's a different technology.

 

Stacey Simms  22:25

Yeah sure. And I don't know how much you can share which brands might get that? In other words, are you working with Medtronic on this? Or you're working with Tandem on this as somebody else? You know, in the should we be watching for this in a more proprietary form? Or will it just going to go in all of your insets?

 

Matthias Heschel  22:40

Right now we're in the process of implementing technology in our mainstream products, which are the inset two products, which are available to all pump manufacturers, and then we need to see pump manufacturers will pick up on this.

 

Stacey Simms  22:56

Got it. Kerem, let me ask you if I could, do you have any best practices for your patients when it comes to using the insets and infusion sets? Are there mistakes that are very common that people make, I'd love to kind of hear, you know, what you what you tell your own or in the past what you've told your own patients?

 

Dr. Kerem Ozer  23:13

Absolutely. The key things, especially if someone is very new to living with diabetes, as you know, there's there's a lot of anxiety there. Everything is new, a lot of new information is coming in, you know, at our clinic, what I always tried to do, what we always tried to do was sort of taking a deep breath, letting people know that there's a lot of resources, there's a lot of support, you know, at the risk of sort of repeating the cliche, it's not a sprint, it's a marathon, and really providing the resources, sort of focusing that more on to the infusion set side, I think one key thing is starting, especially if someone's new to pump therapy, sitting down with them going over the whole process, we had demo kits, sometimes I would demonstrate sets on myself even just to make sure that everyone's feeling comfortable, especially for our younger patients, having the parents there and really taking the time to walk them through the process of what an ideal insertion looks like. And I think doing it in real life really helps in person in real time. As opposed to watching a video which where everything looks so perfect, right? So we definitely emphasize that prioritize that. And then when we start thinking about using the sets, a lot of those things using the alcohol pad and cleaning the area, a lot of things that are repeated, easy to say hard to do every single time. But I think emphasizing the fact that the closer and closer we get to that ideal that the longer we can keep the site's healthy, the longer we can keep the process healthy is important. And as more technology comes in as continuous glucose monitoring gets integrated. As the pumps get smarter, I think there's always the importance of that of that person factor. And making sure that we're really addressing everyone as an individual and sort of seeing where they are and going and holding their hand and walking with them to where they need to be or where they want to be, is key. And then there is as you know, a lot of variation from person to person. And there's a lot of variation from day to day. And being aware of that repeating that message. And sometimes you wake up and you have a perfect day. And sometimes you wake up and there's a lot of obstacles and changes and bringing that message that, yes, diabetes is there. Yes, it brings challenges. But if we see it as part of a larger system, and if we address it as well as we can, as if we can stick with those guidelines, and recommendations. And if we keep open lines of communication between the patient and the family and the clinic, things tend to fall into place. And I'm very proud to say your many, many patients, of course, live decades and decades of healthy lives with diabetes. And I think that the key component there is keeping those lines of communication open and keeping that sort of positive attitude going.

 

Stacey Simms  26:38

Alright, let's get back to some of the questions that my listeners had. And I thought this was a really interesting one, she asked me when insets are designed is any consideration given to those of us who deal with limited hand strength, or older adults with smaller hands, or even using color tubing to increase the visibility of air bubbles or maybe using color in the cannula. So it'd be easier to see if it was correctly inserted. I've got to believe that you look at this and you do research it but Matthias, can I ask you to just hop in an answer that one?

 

Matthias Heschel  27:07

Sure. Well, every time when we design a new product, we put a lot of effort into the initial conceptual work. And that means that you propose certain designs, which we then show to the target population. And if the target indication of the product is smaller children or elderly people, those will be included in the assessment of the concept. So we really trying to already in the concept phase to design the product in the way that we can make sure that it can be used by the by the target population. And at the same time, we are compliant with standards. For example, when we have a product that requires activation to push a button, what's the strength of a point of finger for a for a small girl? so we were really trying to incorporate this in our product design.

 

Stacey Simms  28:05

Another question came in there used to be an infusion set by a different company called an Orbit. I don't recall this, but this sounds great. It rotated so the tubing was less likely to get caught. Any plans to bring that back or something similar.

 

Matthias Heschel  28:18

Well Orbit is owned by another company Ypsomed in Switzerland, and to our knowledge, the product is still on the market. So we don't have any insights in the in the details. But it's not it's not one of our products.

 

Stacey Simms  28:35

Got it? It's probably something that's not available in the US yet because we don't have Ypsomed here yet. But it's it's supposed to be coming. Okay, I have a very might be a silly question, but I will ask it anyway, this is a silly question. I get it from listeners all the time. One of the first times I remember getting our box of inserters we had the old one I always describe it looks like a little spaceship. I mean, I know you know exactly what I'm talking about for it was the Animas way back when and now we use Tandem, it came with these little plastic pieces, and no one ever told me what they were for. And as it turns out, then we realize this after my son's inset got filled with sand at the beach, and we could not reconnect. It turns out these little pieces are supposed to go in and protect the site and keep sand out. But I've heard a lot of different versions of what they are really supposed to do and when you are supposed to wear them. So my question is, when you put an inset on the body, it was explained to me like it's almost as though you've got like a vial of insulin with a little rubber on top. You can pierce it, but you can't get into it. In other words, you don't have to cover it every single time you take a shower or go in a pool because nothing is seeping through until you reconnect the needle. Is that the proper use of those inserters

 

John Lindskog  29:50

Yeah, this is uh, John maybe just a quick comment. So that that is that is true that at the at the time development there were some spare caps. And the idea here was that when you disconnect the tubing from the side, it's true that you know it sealed, the side doesn't seal because there are septums that closes the fluid pathway. However, the idea about providing these small inserts was that you could protect kind of the surface of the septum. With that kind of cover so that you wouldn't have any kind of larger particles being able to, to come in the way like the listener just described getting sand in it. So it was actually, you know, kind of a protection. However, it was not something which was necessary, it was kind of, you know, choice you could make to add that in, though. So that the reason behind that

 

Stacey Simms  30:48

perfect, there just seems to be a little bit of a misunderstanding in some parts of the community, what people think it keeps bacteria from getting, in other words, if you swim in a lake or something like that, you should pop it in. But it really is just to keep out particles like sand.

 

John Lindskog  31:01

Yeah, it's only for larger particles. And, you know, the site is perfectly sealed as it is. So it's it's more to kind of say, Okay, I want to make sure that that, you know, I don't have to clean it up afterwards, and so on. So that was the rationale behind that.

 

Stacey Simms  31:18

I have one or two more questions, kind of to wrap it up. Have I missed anything in particular that you guys wanted to make sure to bring up before I start wrapping up?

 

John Lindskog  31:26

Actually, there was just one question that I think that at least I had, I would be curious to know about, you know, in each box of the insets, there is an instructions for use, how you deploy, the infusion set.  What's out and, you know, that is in some countries made in a number of different languages and so on. And I guess I'm just curious about is that being read all the time, or is that you know, being kept in the place or simply just, you know, put it into the trash can. But what's kind of, because I have a I have an assumption. We have an assumption, what happens to these but but I was just curious to know, if you could share that with us.

 

Stacey Simms  32:07

I'm so excited that you asked that question, John, I think you know the answer, I can't imagine anyone is really reading the instructions, we all should. In fact, I'm going to take those instructions out and look through them. But it's one of those situations where my book that comes with each box is so thick and intimidating. As I'm telling you this, I'm thinking this is why I don't do it, maybe it's just I'll have to take a look at how long the actual instructions are. Maybe it's in several languages. And that's why it's so thick, but we're so used to and maybe we can blame the iPhone for this. We're so used to opening something up and being able to use it immediately and hoping right that it's very intuitive, that maybe that's why we don't read the instructions. So there's a lot of user error. And frankly, I know there's a lot of user error within sets. I've seen it in my house, I've been the user making the error. So I'll ask my listeners, I mean, I'd be happy to take a quick poll in the Diabetes Connections Facebook group, but I do recall taking a pump class, and we were there for two hours, I came home a couple of days later, I had to change the inset on my two year old I had forgotten everything I had learned. And at the time, this was 2007. I found one video, I mean, think about the days of YouTube back in 2007. And it was in French to show me how to change the inset. But I did that rather than look for the instructions. So John, what a great question. And I will get you more feedback from the community on that.

 

John Lindskog  33:29

Okay, thanks. Thanks a lot. Thanks. I will say though, that, you know, it is a regulatory requirement that we put those in a box. And we would, you know, like to move it into some kind of, you know, YouTube media or something like that. However, the regulatory requirements are that they should always be there. So we want to see if we can move that in the regulatory requirements. So we can, you know, save some printed matter, and, you know, reduce the waste and make it easier to access.

 

Stacey Simms  34:02

It's a great point. That is a great point. Before I let you go, here in the United States and I assume in many parts of the world, there's a lot of concerns about supply right now. Any issues, any concerns anything people should be thinking about for the next couple of months?

 

John Lindskog  34:16

No, I you know, and we have had some issues on supplies in the beginning of the when COVID-19 was at the highest and we have been putting in extra capacity for making progress and investing large sums of money into getting you know, capacity brought up and we should be out of those weeds by the end of this year. And we don't really see any, any issues going forward. But you know, it may take some time to get that all through the supply chain, but I can assure you that we're doing everything which is now a power to always have the capacity to supply the what the demand is.

 

Stacey Simms  34:57

Let me as we wrap this up, Kerem, let me ask you this. You are new to the company, or you are the newest person here, so the company, what excites you and you know, you've worked with patients for a long time, you've seen how important this part of the device and system is, what excites you about this technology going forward?

 

Dr. Kerem Ozer  35:15

This is a great question. And this is the reason I'm, I'm here, I'm in the company, I think it really goes back to that point about realizing how important looking at patients insights, their experiences, where they are, what they need, and bring that feedback into the company to help develop new technologies. And I would say, a direct corollary to why I'm so excited about my role here is this is really sort of being a medical person, a physician, and endocrinologist and industry, you really play a bridge role. You're constantly talking with the engineers with the business side, and you're keeping your ear open to your patients, your community and your colleagues. And sort of you're part of that feedback loop, bringing back ideas, presenting your products and saying this will work. This is a great idea, and sort of keeping that momentum going. And I'm very excited about that.

 

Stacey Simms  36:20

Excellent Matthias you are in r&d, you are the head of r&d, you're in the I wouldn't say the trenches so much. But you're really seeing realistically what's happening on the company every day. Anything you want to add to that. I mean, is there anything that you're really excited about that you'd like to listeners to leave listeners with? Yeah,

 

Matthias Heschel  36:37

I mean, what, what I always tell the engineers is, you guys, you are directly responsible for how patients or people in the state beat is, how they feel how they are able to manage their daily life. If we do a great job, those people can lean back once in a while and perhaps even forget about the disease, if it will not do a perfect job. They have a terrible day. So that's, that's really what people understand. And that's why at least how I see it. I mean, those people in the medical device industry typically work longer work harder, because they understand they understand the responsibility they have.

 

Stacey Simms  37:17

Well, thank you so much all of you for spending so much time with me for answering our questions for posing your own questions, which doesn't happen that often. And I'm really glad that you did that. We will get you some answers. Thanks so much, gentlemen.

 

You're listening to Diabetes Connections with Stacey Simms.

Lots more information at diabetes connections.com at the episode homepage, and I'll link to some of the studies they talked about that longer were the stuff that's in the works. And let me tell you, I went and got the book. I have it right here. Can you hear that? I'm wiggling it, I went and got the book that comes with the insets. And it's right there. Of course, at the top with the little horseshoe thingies that they explained. I hope they cleared up some stuff for you. The book is long, because as I said, it's in many other languages other than English, the directions are maybe two or three pages long. I think it's really just two pages. There's some pictures here. But the English instructions are one to three pages long. And then that's it.

So Benny and I actually sat down and read them. And he does it slightly differently. But what he does works, I mean, we are 15 years into diabetes. So that means we were 14 and a half years into pumping. So he's got it down. But if you're having trouble, I may start a thread in the Facebook group. Because there's some really easy tips and techniques to make sure that you you put these insets on correctly in follow the directions. That's your best bet. But as you know, the community can help too. So we'll we'll put that in there. And of course, I'm going to put a poll up about the and we put I may have already done that by the time the episode airs, because a pull up about have you ever read the directions? I was a little embarrassed. You heard me laughing when he asked, but I'm glad he did.

Alright, I've got some news coming up about next year. Oh my gosh. But first Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom, it was back in 2013. It was about this time here, the share and follow apps were not an option. They just hadn't come out with the technology yet. So trust me when I say using share and follow make a big difference. I think it's important though to talk to the person you're following or sharing with and get comfortable with how you want everyone to use the system. Even if you're following your young child. These are great conversations to have, you know what numbers will make you text, write how long you're going to wait to call that sort of thing. That way the whole system gives everyone real peace of mind. I'll tell you what I absolutely love about Dexcom share and that is helping Benny with any issues using the data from the whole day night. And not just one moment. Internet connectivity is required to access separate Dexcom follow up to learn more, go to diabetes connections.com and click on the Dexcom logo.

A couple of weeks ago I told you I would have some book news and I do I am so excited to announce that the world's worst diabetes mom, part two is going to be out next year, I just signed on with my publisher. We talked this week, actually this morning, as I'm taping this episode, and we laid it all out, because my goodness, with some of the publishing issues, probably hopefully not the shipping issues by next year. But a lot of what's going out of the publishing industry, I have to have everything done earlier than I did last time to have the book Ready by a certain time of year I wanted out for as you can imagine, I wanted for November of next year, because Diabetes Awareness Month is my best bet to get any kind of, I guess, mainstream media attention on diabetes, media attention. And that worked really well. In 2019. When I put out the first book, the name of the book is not part two. I'm not sure what we're going to call it yet.

But I will be sharing that with you all, I'm going to be sharing more of the process this time around, just as I think it'll be fun. And I'm going to be sharing things like cover options and title options in the Facebook group Diabetes Connections, the group. So if you'd like to help me the community was a huge help last time around in terms of how to word things. Because you know, when you're a parent of a child with type one, there are some differences that you want to be respectful about. There's some differences and ways of wording things that that just for clarity, right? A good example is are you a T one D parent, to me, that means a parent who lives with type one, right? So you have to It's little things like that you just have to be careful about and you will help me so much with that the first time around. So I will be asking the second time around, I have an idea for a title, I kind of know what the direction is going to be. I know what the title is going to be. I know what the focus is going to be on. We're going to be addressing a lot of the things that I have been asked about since the first one came out. So really excited, a little bit nervous. But man, I loved writing the first one. So I hope this will be as much fun to put together.

All right, thank you so much to my editor John Buchenas from Audio Editing Solutions. We will be back on Wednesday. We are now live on Facebook and YouTube at 430. Eastern time. And then around 445 I'm live on Instagram. A little bit different for those of you who live on Instagram a lot like evolve. I mean, what a pain. Right? But it's fun. I like doing it. It's only a pain because I share photos. And I'm not that adept. Really. I mean, Instagram is not a friendly platform for sharing photos live and reading a script. Let me just tell you say if you've got advice on that, and you know how to do it, well, let me know. Or you could just listen to the audio podcast that comes out every Friday for in the news. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon Until then be kind to yourself.

 

Benny  42:35

Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Nov 9, 2021

At this point in 2021, we thought there would be several new pieces of diabetes technology on the market. COVID delayed several FDA submissions and approvals so where do we stand? Stacey sits down with Kamil Armacki, AKA Nerdabetic, and Chris Wilson to talk tech. Both Kamil and Chris keep a close eye on everything from filings to clinical trials to investor calls and neither is affiliated with any diabetes company.

There is also video of this if you prefer to watch over on the YouTube channel.

Check out Stacey's book: The World's Worst Diabetes Mom!

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Episode transcription below

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Stacey Simms  0:00

Diabetes Connections is brought to you by Dario Health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar, and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.

This is Diabetes Connections with Stacey Simms.

This week, I wanted to try something a little different as we enter the end of 2021. And look ahead to next year, I thought it would be a good time to sort of take stock of diabetes Technology. Welcome to another week of Diabetes Connections. I'm your host, Stacey Simms. And we aim to educate and inspire about diabetes with a focus on people who use insulin. And while this community likes to say we are not waiting, frankly, there was a lot of stuff that we are waiting for right now, I asked a couple of friends who really have their finger on the pulse of this stuff to come on and share their thoughts. The only problem we really like to talk. So this is a longer episode than I expected. And frankly, it's not just that we'd like to talk there's just a lot of technology that we are waiting for. So to that end, I'm just going to jump right in, we'll do the quick add that we always do at the top and then we'll get to the panel. There is also video if you prefer to watch our conversation that's over on the YouTube channel. I'll link it up in the show notes but we are not showing any product. So it's really just about whether you prefer audio or video.

Alright, Diabetes Connections is brought to you by Dario health. And the bottom line is you need a plan of action with diabetes. We've been lucky that Benny’s endocrinologist has helped us with that and that he understands the plan has to change as Benny my son gets older, he wants that kind of support. So take your diabetes management to the next level with Dario health. Their published studies demonstrate high impact results for active users like improved in range percentage within three hypoglycemic events. Try Dario’s diabetes success plan and make a difference in your diabetes management. Go to my dario.com forward slash diabetes dash connections for more proven results and for information about the plan. And as always, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

All right, welcome. We're trying something new on Diabetes Connections. And that is the first of its kind kind of tech panel. And I am joined in this conversation by Chris Wilson and Kamil Armacki . And these are two guys that I'm gonna let them introduce themselves a little bit, but that I follow for technology news, as well as for some analysis. So thank you both for jumping on with me. You're not industry people. But let me ask you to kind of describe yourselves first, Chris, you are somebody that I always turn to for the insight and information about technology. But this is not what you do for a living?

 

Chris Wilson  3:00

No, not really. I sort of jumped into the online diabetes online community when I reached a point where I had access to insurance and could actually look at diabetes technology because it became affordable. And at that point sort of started jumping into a lot of the groups and online discussions tried to figure out what I was interested in for myself at the time. And then over time, I wound up being asked to join the admin team of a couple of the bigger Facebook groups getting involved on Twitter and other platforms. And so now i is part of that role. I sort of find and analyze listen to the investor calls that the companies do, you know, sort of keep an ear to the ground here what people's sales reps and endos are whispering about to to their patient populations and glean some information from that. I've also been a frequent participant in research, especially in clinical trials. I was in the clinical trial for the G6 that prove that acetaminophen didn't interfere with it. I was in the clinical trial for the Xeris Gvoke. I was in the clinical trial for the Ilet, which is still apparently ongoing. I've got a fair amount of experience for playing with stuff that isn't necessarily out yet. And sort of seeing things from a different perspective than just the end product that people see when they finally get a prescribe from their doctors.

 

Stacey Simms  4:23

That's great and comedic view or better known as Nerdabetic. On social media, many people probably recognize your Omnipod. Those are Omnipod pods lit up right behind you.

 

Kamil Armacki  4:34

That is absolutely right. That is 550 inch LED Omnipods. Most of them this is very DIY. Most of them actually placed with LED lights and painted and we saved them on a temporary wall kind of thing and we glued them off. So we had this is one of the proudest things I've ever done as Nerdabetic I also can't really take credit my dad that 95% I only paid a couple of walls, and I feel like I'm taking all the credit. So massive shout out to him.

 

Stacey Simms  5:07

I love it. I love it. And as Nerdabetic, you are known for interviewing CEOs getting all sorts of tech information out there. And we'll probably mentioned this at least once later on, you do a lot of both, you do some 3D printing, right to see what the items might look like. Yeah, so

 

Kamil Armacki 5:23

I've been running my YouTube channel for I think four years at this point, just when I started university, and I just graduated this summer. So it kind of it was over four years ago. So you just been trying out different things within within that channel. One of them was 3D printing. I'm absolutely fascinated by that technology. I don't own a 3D printer. But I think it is a very interesting way of giving an idea, a bit of a tangible feel to it. So for doing that, and all of those things they mentioned. And most recently, I had the honor of speaking to some pretty pretty important people in the industry to see what's been happening over there as well.

 

Stacey Simms  6:01

Cool. All right. And Kamil is in the UK, obviously, you sound like you're based in the UK, but you are there now, which means some of this discussion will include information from the US FDA, or at least we're gonna speculate about that same thing, European CE mark, but some differentiation of products there. But I just thought it'd be fun to talk to you guys. So all right, we've got it out there. And I'm a diabetes mom, I read stuff, I listen to stuff, I don't think quite as much as Chris, or Kamil, but that's my knowledge base. So just to be clear, nobody who works for the FDA, nobody who works for diabetes company, we are just observing and birth speculating, which I think would be some pretty fun and interesting conversation we'll see. So let's start by talking about what is in front of the FDA right now, because this year, and last year had seen some big delays due to COVID. So we're waiting. I mean, it's been a long time. Let's start with Omnipod 5. And that is, of course, still as we are speaking, I mean, who knows what will happen today or tomorrow, but it is still in front of the FDA. But what's interesting is when they submitted and Phil, I know you talked to their CEO recently I talked to her I believe right before they submitted, it was going to be very different from the other commercial hybrid close loops in that the range was going to be lower. In other words, your blood sugar range, initially, I believe, was supposed to be able to get below 100 As a set point, but now it's 110. And they do have all sorts of really interesting other features. What did Shacey Petrovic, the CEO of Omnipod share with you recently, when you talk to her anything changed, or anything that stood out to you?

 

Kamil Armacki 7:36

Yeah, so I've spoken to her a couple of weeks ago at this point. And the product that they've submitted to the FDA, for my understanding, has a target glucose, which goes as low as 110, and can be customized up to 150 milligrams per deciliter. In terms of the actual product, I think I'm very excited about Omnipod 5, because it will be the first product, the first pump, which actually talks directly to the Dexcom G6 continuous glucose monitor. So there'll be no need to carry a physical controller, which obviously, I think makes sense for a product like Omnipod because you know, you wear it on your body. And so it will connect directly in terms of actual updates to submission as of a couple of weeks ago, she said they still expect an A by the end of the year, with a limited release in the US. And during that interview, which was slightly kind of European focused. We talked about many things including Omnipod on the runway during Italy's Fashion Week in Milan. But she also mentioned that they are hoping to bring that technology to their to Europe to the UK, once they get their FDA approval.

 

Stacey Simms  8:48

When you said the first one or the only one do you mean in the UK? Because we've got Dexcom talking to Tandem, at least here in the States.

 

Kamil Armacki 8:55

First one where you don't need so where the pod talks wearable talks throughout behind okay. Yeah, I thought directly to the G 610.

 

Stacey Simms  9:05

Is control IQ approved in the

 

Kamil Armacki 9:06

UK stupid question. Yes, we have. So at the moment, we have control IQ and seven ATG which we will I'm sure mentioned Oh, yeah. Okay. I didn't come EPS actually. So we have three other countries across Europe. They have other systems like dialup as well, France, Germany, but we don't have that one here. Yeah. Hashtag Brexit.

 

Stacey Simms  9:28

I was gonna say show off, but then right. It's not in the UK. Lots of and there's other systems coming to that we may get to, Chris, anything that you have heard over the last year in terms of Omnipod? Five. I mean, I just feel like we're kind of waiting.

 

Chris Wilson  9:40

I mean, just from my view on the outside. I think that insolence estimates of hopefully getting it before the end of the year, probably right. I know that it did qualify as a breakthrough device. So it's supposed to have a faster review at the FDA, but we're still dealing with the COVID backlog with all kinds of stuff. For me, there's things that we probably expected six months ago, there's still pending. And I know there's always rumors circulating that this got approved, but it hasn't been released yet. And so half the time I'm going and checking the FDA database for what approvals were announced in the last week.

 

Kamil Armacki 10:16

Only Chris does this kind of stuff.

 

Stacey Simms  10:20

I did have an interesting question from a listener who was talking about Okay, so as we're taping, Dexcom g7 has not yet been submitted to the US FDA, it has been submitted in Europe. And her her thought was like, Oh, my gosh, if Omnipod has been sitting there all this time, and Dexcom hasn't even submitted, how much longer is it going to take? And my point to her was, it's not as though Omnipod and these other submissions are just sitting in a file cabinet. Right? I mean, they are actively being looked at. You're both nodding. Can you tell me a little bit about what we know I mean, these submissions again, they don't just land on a desk and then one day someone opens them and rubber stamps them.

Back to our conversation in just a moment, but first Diabetes Connections is brought to you by Gvoke Hypopen and you know, low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're going to pass out there are a lot of symptoms and they can be different for everyone. I am so glad we have a different option to treat very low blood sugar. Gvoke Hypopen is the first auto injector to treat very low blood sugar. Gvoke Hypopen is pre mixed and ready to go with no visible needle before Gvoke people needed to go through a lot of steps to get glucagon treatments ready to be used. And this made emergency situations even more challenging and stressful. This is so much better. And I'm grateful we have it on hand, find out more go to diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke glucagon.com/risk.

Now back to Chris answering my question about FDA submissions.

 

Kamil Armacki 12:00

Yeah, so for the pandemic, the main reason as to as to why we have a backlog is that regulators that used to regulate that were in charge of regulating medical devices like continuous glucose monitors, hybrid closed loop systems. And this is across actually Europe and US it's very similar, simply because of the pandemic, they were actually responsible for overseeing all of the medical queries related to the pandemic from, you know, vaccines emergency authorizations. So that's what we call when a product is used in a slightly different way to kind of simplify it. And so using a CGM and hospital was a good example of that we seen an emergency authorization of that, so they've kind of, you know, dos thinks took priority. So too, you know, that's where we have a backlog, but now they from my understanding, kind of back on on track, and, you know, four hands on that backlog, working their way through it.

 

Chris Wilson  12:57

There's just only so many people to do the work. And I mean, even when stuffs in development, there's always a lot of back and forth between the company that's developing it and the FDA, what are you going to require us to do, and so then they alter the product design sometimes to make it fit what the FDA wants, and that can even go into is as deep as the training modules. And the other information that gets given to patients when the product is prescribed, they're looking at all of that they're looking at human factors testing are people you know, able to follow the directions and use it the way that it's intended to be used, are they going to do something stupid and mess it up? They're looking at all of that. And then they're going through all of that data on all the different aspects of the devices and needing to decide, okay, is this safe enough to actually be effective? And there are different standards in Europe versus in the US? The FDA has much higher safety thresholds, whereas the European standard is basically does it do what it says it's going to do?

 

Kamil Armacki 13:58

And just to close up Omnipod 5, I think FDA has added it Chrissie would agree this is just my personal opinion. I think FDA has been pretty scared of going to full control. And the biggest today there isn't an insulin pump, which offers, you know, remote bolus capabilities. And that's part of Omnipod 5, you know, that's what they've submitted to them. So, you know, my speculation would be that if actually they didn't submit full control within that first submission, maybe we already you know, maybe it would be here already. You know, it is an area that FDA has been very cautious about. So I guess that's a significant factor contributing to to the to the backlog as well to the delight.

 

Stacey Simms  14:40

Well, and that brings us to our next item that's in front of the FDA. Thank you for setting that up. So Tandem has also submitted in the last year and is waiting for bolus by phone. You know, that's not the official name of it. But I agree with you. I think the FDA is really taking a very, very careful look at that bit of technology. And Tandem, you know, I believe, to your point, Chris, there has been some back and forth. You know, they don't issue press releases. Every time they asked for that, but it is happening, I think, to me, you know, as a mom of a kid who takes his phone everywhere, you know, this is something that I cannot wait for. I mean, bullets by phone just seems like such a basic capability in 2021. But of course, it's a medical device, and it's your phone. Chris, are you hearing anything? Or do you have any opinion on that?

 

Chris Wilson  15:29

I mean, at least as far as Tandem goes, I think there's less of a risk because you still actually have the physical pump that can be used to do something if for some reason, there's a problem with the phone. If you're relying exclusively on the phone, you've got to worry about what happens if it gets lost. What happens if they're dead batteries? What happens if you unlock it and hand it to your kid to play a game and the kid goes into your bolus app and accidentally gives you 15 or 20 units of bolus while they're chatting around? I mean, all of those things need to need to be taken into consideration and mitigated as much as possible.

 

Stacey Simms  16:01

I wonder Kamil, it's interesting to think about Omnipod because they've when I've talked to them, I've always asked like, why can't you put some buttons on the pod. And their point was, and I think this leads to Chris's point from the phone, their point has always been well, it's for safety with the pediatric patients, they don't want the kids touching the pod pressing buttons, this makes perfect sense. I was a parent of two small children, they're gonna touch everything. But it's kind of the flip side now on the phone, right. So it's an interesting look to see what you trade off in a way.

 

Kamil Armacki 16:31

So actually, to that point, in the UK, we do have an insulin pump from rush called accucheck. Solo. And on the high level, it's kind of like a nominal pot, where the pot like device that you put on your body and actually has two buttons on it. So you can actually bolus from the patch itself. And the way they've actually engineered it is that you need to press both buttons at the same time, ensure that you don't kind of you know, lean on the you know, you could very easily lean on a button and just press it, you know, other companies have gone down that route as an Omnipod. To use that I do use a monopod. So I use Dexcom and Omnipod in a DIY setting. And yeah, I love the simplicity of it. So yeah, massive, massive fan.

 

Stacey Simms  17:14

I think it's just all trade offs. Right. I mean, there's no perfect system, I don't think but people want to perfect. Exactly. Right. Exactly. Chris, what do you use? If you don't mind me asking?

 

Chris Wilson  17:25

I am on a Tandem with control IQ, although I don't use it exactly as designed. I've been working with better bullet strategies and playing with the modes that have put that it gets put in be an exercise or sleep that change some of the the targets that it's trying to hit to get it to behave a little bit more like I think it should.

 

Stacey Simms  17:47

So you're using Ctrl Q and Kamil, you're using

 

Kamil Armacki 17:50

loop? Yeah, that's right. Yeah. on any iPhone. Yeah.

 

Stacey Simms  17:53

All right. I don't want to move on from Tandem quite yet. But I want to talk about loop in a moment. So we've got bolus by phone in front of the FDA, which we also think could come approval could come by the end of the year, but Tandem moved their submission for TSport. Right. They were going to submit that in 2021. Chris, they are moving that to 2022. Right.

 

Chris Wilson  18:12

That was the last that I heard. Yes. To me.

 

Stacey Simms  18:16

I see you nodding.

 

Kamil Armacki 18:17

Yeah, I agree that that's what my understanding of the T sport is, I think they had some communication with FDA with the phone control, which obviously plays into T sports as well. Like the point Chris was making, you know, there's no display I don't think on the although, you know, it's a patch, you know, it's kind of moving into that kind of tubeless to pipe bridge mode kind of pump. So yeah, I'm pretty sure they've decided it's pushed back further.

 

Stacey Simms  18:48

And I should have set that up better if you're not familiar with a tee sport is a very tiny version of the T slim it is been to me it looks kind of like a beefed up cartridge and it sticks somehow to your body. There is still a tube and there is still an inset, but it kind of I don't know if it dangles off, or it sticks some I don't know. So they haven't they haven't released that I've asked a bunch of people when Lily a while ago was coming up with its own pump and it was supposed to be inset and sticky. I'm still trying to figure out how it supposed to stick to your body with an inset and they haven't really explained that. So maybe at some point, but clearly you made a 3D version of this yourself right? Didn't you like mock up a Teesport at one point and freak everybody out? Because we thought you had one?

 

Kamil Armacki 19:27

I did. So just on that entire idea in general, there's actually a pump in it's been kind of out here in Europe and has been taken off the market and I think it's coming back at some point called collider which uses a similar idea of where three colors bright colors. Yeah, so So that's kind of it's an interesting concept because you have an infusion set and like a sticky dye upon your body. And I think it that's what Tandem has gone off as well. But yeah, I did. It's very interesting how people often will look at especially on YouTube because it's a very visual form, they will look at a picture without watching the video. And yeah, a lot of people thought I had some insider info on the T spot, which was a very interesting experiment and a lot of comments about that go like, where did you get this? And I'm like, I didn't Freeview print hello, it's 2020.

 

Kamil Armacki 20:19

Be careful, be careful, hey,

 

Chris Wilson  20:21

I need to take some of the blame, actually, I think for potential delays on the other Teesport, I was involved in some of the Human Factors testing. And based on some of the questions that I got asked afterwards, I think I may have done some things that they weren't expecting it some stupid things or something that was not dissipated. So that may actually be the source of some of the

 

Stacey Simms  20:45

Alright, well, if you can't answer I understand what the heck could you have done? What

 

Chris Wilson  20:52

I think it was, it was just in case of directions weren't necessarily clear. Or I was expecting, you know, think about this, rather than actually do it. I obviously can't go into specifics. But needless to say, I clearly wasn't doing everything that they expected as part of the tasks in the testing. So who knows that may be part of the the reason that things got delayed, but hey, if it prevents somebody else from doing the stupid things that I did, and having a problem later on, then that's actually a good thing. And actually,

 

Kamil Armacki 21:24

I'm so glad that you did, Chris, because so many companies have tried this idea of you know, having a patch and in a short tube. So novo, they went out of business Kaleido also really struggling, we don't really know if they're gonna come back. And Tandem is now trying, they're kind of stab at it. No one has really made this idea work. So

 

Stacey Simms  21:43

yeah, it's a good point. But one thing I do like, again, I don't have diabetes, I don't wear the devices. But the idea I like is that with an inset, you do have a choice of how it connects angled or what the cannula length is, or steel, you know, with Omnipod, or you don't have as many options in terms of how it connects. Now, many people will say to counter that, well, you have many more options of where you can put it, you know, so it really just depends on how you wear it where you're comfortable with. But I think that's why they keep trying cumulus because there's that different kind of inset that people can use. So who knows? But I think that's a really good point.

 

Chris Wilson  22:18

Well, it's a great example of how your diabetes may vary. Yeah, no one solution is going to work for everyone. So that's why it's important that we have these options.

 

Stacey Simms  22:27

Alright, so let's talk about loop. One of the other submissions. This is such a laundry list in front of the FDA is tide pool loop. And that was submitted earlier in 2021. It's been very quiet, but it is it's hanging out there. Anybody here anything? Anybody know anything? Any comments?

 

Chris Wilson  22:45

I really haven't heard anything. I mean, it's so pure speculation. Obviously, this coming from the open source community is going to be subject to a lot probably more scrutiny than if it's coming from an established player. And I was not entirely clear on exactly what the trials for approval looked like. It sounded like some of the DIY data from DIY loot may have actually been used as part of the submission. So I would imagine that that's probably at least one of the things that may be taking a little bit extra time because I'm feeling the FDA is probably going to look a little bit more closely at that than they would if it was coming directly from Insulet. Or someone else.

 

Stacey Simms  23:28

That's a good point and was used I believe, that's what they told me earlier this year was a lot of that open source a lot of that DIY community data was put in so you wonder what then the FDA came back and asked for no, no, what we really need is or no, that is enough. I mean, we'll find out later, but it's very interesting stuff.

 

Kamil Armacki 23:46

And in some ways, it is a perfect storm, because it is using, you know, using that DIY technology, which is just absolutely amazing. I mean, the whole title team has been so tremendous in this project. So it's you know, taking that DIY, but then also the phone control point that we mentioned earlier, where it's an Omnipod. So actually, you know if your battery dies, I'm sure everybody's asking those questions. You know, if your iPhone dies, how is the child going to bolus? I'm sure that those are the questions that you know regulated system has to they need to have that usually answers for that. So I'm sure they face in similar scrutiny on the phone point just like Omnipod 5 does with eventually

 

Stacey Simms  24:26

this just occurred to me and again, I don't use the system so that's probably way to think about it, but these DIY systems that already use the phone can you use your watch to control them to Kamil, I wonder if that's something that's done? Yes.

 

Kamil Armacki 24:39

It's it's just like with Dexcom you still need your phone. So phones like the the house the home of the of the whole system, you can remotely you know, bolus and enter carbohydrates and Al's meals etc. Using your Apple Watch. Bought a phone is still required to actually do all of the calculations the brain behind all of it on Omnipod, five doc, this all happened on the pod both title loop that's all happening on the phone just like with a DIY system. Oh, yeah, that's a really good point. So you really need that to to make this system work. And there are all of those you know, your phone die in, you know, someone's stealing your phone cases that you know, I'm sure FDA is wants answers for

 

Stacey Simms  25:22

it to be clear, because a lot a lot of information there. I think this is a good point Omnipod 5, as you said, controlled by the pod. So you lose your phone, it keeps on trucking, it's going to deliver basil, the loop will continue a tide pool loop and loop DIY, whatever it's called right now is all controlled by the phone. So if your phone dies, the system won't continue.

 

Kamil Armacki 25:40

Well, so by design, it will always deliver background insulin in the way that it's intended. I mean, my phone dies, sometimes you know, it's live, right? I'm a 23 year old. Me because it is difficult to keep it charged in the pub. So you know it does happen. So and those are kind of a real world cases that you know, I'm sure FDA is also asking about. So with the DIY system, and I would assume with Title loop as well. But that is just my speculation. When your phone dies with the DIY system, it automatically goes to the default background rates for you kind of bolus because you need your phone to do that. And I would assume it would be relatively similar of tide pool loop, because I don't think there would be making a separate backup device like Omnipod just doing with Omnipod 5. Okay,

 

Stacey Simms  26:31

thanks. Alright, last item that is in front of the FDA, I think is the Medtronic 780, which is already available in Europe.

 

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Now back to Kamil answering my question about whether the Medtronic 780 is available in Europe?

 

Kamil Armacki 27:34

That's right. Okay. So 780 G has been here for it's been approved last summer. So kind of just as COVID was kind of a couple of months in, and it's been rolled out across various countries in Europe. I think we got it in the UK earlier this year. Well, I think the 770 G's, the newest version that you guys have in the US. So the 700 pumps, they all have Bluetooth built in. So you can have your pump alarms, all of that on your phone, no control. But you can view everything by the 780s, kind of the newest pump in that line, which has a new brain new algorithm. In my view, it is completely different. Because actually, it's not really made by Medtronic. It's made by an Israeli company called Dream met.

 

Stacey Simms  28:23

So that's free. That's right. The algorithm is from Dream Med, I've interviewed them, I forgot to actually

 

Kamil Armacki 28:28

said that in one of my videos, and Medtronic wasn't really happy with me. So

 

Stacey Simms  28:32

I feel like we have it's ours. Now. It's been,

 

Kamil Armacki 28:35

they officially said something like it's built by a dream met with Medtronic engineers. So you know, it is a partnership. And that's apparently true. You know, I have no reason to deny that. So I'm sure they work together on it. But you know, the the foundation of seven ATG is actually completely different. It's not like they took 670 and added a couple of capabilities. You know, it's a great we design I mean, on the outside, it looks the same, but actually the the actual brain inside is completely different. And I guess one of the one of the key things that we mentioned is actually the ability to have your glucose set as low as 100. You know, people have diabetes across Europe, they've they've been really kind of enjoying that. And it has automatic corrections as well. So a lot of people listening to this might not be as techie as we are. So just in simple terms, it kind of matches control IQ, I would kind of say in terms of the feature set, maybe slightly better, because you can reduce your target to 100, which I know a lot of people have been asking about. I don't know if you agree, Chris, without saying it's kind of at the same level as control like you

 

Chris Wilson  29:37

from a tech perspective. Yeah, they both the the key difference or the key feature there is the automated correction boluses, which is what differentiates what they call an advanced hybrid closed loop from just a standard hybrid closed loop, which is what the 670 and 770 were, it's nice to see more high tech options coming to the market from more players. says it gives people more options.

 

Stacey Simms  30:01

That's interesting, though about any kind of criticism for mentioning dream, Ed, because I mean, control IQ was developed by type zero technology, right? Wasn't it like a University of Virginia thing that then Tandem bought? Yeah, well,

 

Chris Wilson  30:14

it got bought by Dexcom Dexcom, bought type zero and then license the tech to Tandem. So

 

Stacey Simms  30:22

interesting times. And we should also mention that all the Medtronic systems use their sensors. This is not yet a mix and match world, I believe the Medtronic sensors, and I keep hearing that they're much better, but still need to be calibrated. So even the latest version No, your shake your head, Kamil tell Oh, that's right. We're waiting for that approval in the US.

 

Kamil Armacki 30:42

Well, so. So guardian for has been approved in three guardians. And so that's the no calibration version. And it's I know, like one person who's using it. So it's not I think they slowly roll in and out. They haven't really started shipping it yet. But it's basically what we all know, as guardian free just with with no calibrations. As far as I'm understanding the accuracy is not improved. It's kind of the same, if not slightly worse, from a margin perspective with Guardian four, compared to Guardian three. And yeah, I think it's in the FDA backlog as well. I'm gonna go ahead and

 

Stacey Simms  31:21

just double check that on my end only because it'll be good to know the actual mark from their studies and things like that. So we'll pop that into the show notes. But I think you're exactly right, because I was just doing the time. It'll be interesting to see what the time shift is, in terms of episodes being released, because we were just doing our game show. Wait, wait, don't poke me for friends for life. And I actually I can't believe I forgot I asked this question about Guardian four. Because the codename for it or at least the in house name for it was Zeus. So we had been talking about Zeus for Medtronic for a long time, no calibrations I know this is the I get in the weeds of the trivia and then I forget what I know. So thanks for correcting me. Alright, and then Alright, let's talk about Dexcom. Because Dexcom g7, as we're taping g7 has not been submitted to the US FDA, but it has been submitted for European approval. Kamil, you had Dexcom CEO on your show, wearing and showing off the device. I was so jealous when I saw that I'm gonna yell at Kevin Sayer. Next time I talked to him. But yeah, tell us what that was like and what you thought of it when you saw it.

 

Kamil Armacki 32:27

You know, I've been the massive Dexcom advocate, I pay for my own decks because I'm not an ambassador, I just genuinely it's been a life changing product for me. And yeah, it's been it's been an honor speaking to him. So you've spoken to him a couple of weeks after they announced that they submitted for the for the European European approval. I mean, it looks tiny, as I'm sure you've seen, if you've seen the video, I'm incredibly excited to see kind of how that one develops, and from literally a couple of days. So they kind of in the investors call, like Chris was saying, I also sometimes tune into those, and they confirmed that the expecting to get that approved in Europe by the end of the year.

 

Stacey Simms  33:07

It's interesting. And Chris, maybe you could speak to this, for people who might not be that familiar, the Dexcom technology, while it is very different from the G6, the speed at which it might get approval, Europe is one thing, right us is another this is not like an insulin pump, we don't expect it at least to take quite as long as insulin pumps are different systems because it's not putting insulin into your body, right? It's just measuring,

 

Chris Wilson  33:28

but it is being used to calculate doses of a high risk medication, which is insulin, there's definitely still some concern as far as how accurate it is. And if it's off it, how off? Is it? Is it going to cause a problem? But I'm really excited with the clinical data that they presented. I think it was at EASD Earlier this year, showing that the g7 the marred the that measure of accuracy that they use is actually now under 8%. With the g7 which I mean we're getting into how much more accurate can we reasonably get just because there's so much variation in human body that I mean, you can take six fingerprints from six different fingers and get six different answers from his standard meter. The fact that we're really dialing in the accuracy is as tight as we can and actually ever since is almost in the same boat with their new Wow, what any product they had. I think two versions I recall, but that's coming as well. And the the 180 day version as long as we're talking CGM. Yeah, there is no absolute answer for anything. This is actually I was in a study last Thursday, where they were seeing how long I could go without insulin. But as part of it, they're they're monitoring it with a y si, which is this reference grade laboratory meter that they actually do a blood draw and they centrifuge it down. And then they measured the glucose level in the plasma without any of the blood cells in it. And that device in the lab was actually not putting out the correct numbers, there was some sort of hiccup, they had to restart it to get it to come up. But my Dexcom was matching, and then they compared it to multiple Ultra accurate fingerstick meters and set to figure out what was going on. But, you know, nothing's perfect. This was, you know, elaborate reference glucometer. That's the most accurate one that you can get. And they don't even make them anymore.

 

Stacey Simms  35:23

I will never forget, when Betty was little like poking the same finger, you said six different fingers, who put the same finger three times in a row because it was confusing or something. And it was always three different numbers. It's crazy.

 

Chris Wilson  35:33

I just think it's important that people keep in mind that you know, nothing is ever going to be perfect. whatever device you're wearing, however, you're measuring your stuff, there's always going to be variation, it's never going to be exactly the same number every time on every device

 

Stacey Simms  35:46

you mentioned ever since that's the CGM that goes under your skin. And then the transmitter goes on top. And Kamil, you are you've got a little bit are you using the libre as well like to test it out? Or did you? What did you show us earlier,

 

Kamil Armacki 36:00

I am trying the free celebrate free, which is like the newest version. It's not available in the UK, I should make it very clear. But someone bought it for me in Germany. And they imported it over to the UK is actually it's actually been a very interesting over here. Because obviously it's it's not available in the UK. So I had to enter freestyling briefly, there was no physical receipt, but you need to get an app. So only use your phone, you can only use your phone, there's no physical reader, there's no physical device, which I don't know how that's going to work with, you know, children going to school and you know, having to carry phones, but anyway, but it's not available in the British App Store. So I had to create a German Apple ID. And everything on my phone is German. So I gem Apple Music, German podcasts, everything is in German, it's still English. But other than that I have been enjoying my German lifestyle over the last I've had it for four days now. So it's been it's been fun.

 

Stacey Simms  37:03

What are the different features like what's I'm not as familiar with the Libre system. So what is new with the three,

 

Kamil Armacki 37:08

it's much smaller, it's much smaller compared to the first two. And on a high level, it works exactly like you would expect a CGM to work like Dexcom web, no scan and it just always shows the value and the glucose your trends alarms ever found on your phone. So they kind of made it work in exactly the same way as at the center of Dexcom. But most importantly for me, they keep them the same price. And I think that's very important for a lot of people have diabetes here in Europe because I mean, Libra has been a giant success in the UK for example, just because actually, because of its price point it is accessible to the National Health Service. So it is you know reimbursed to you know, vast majority pretty much every single person of type one who wants it to get can get it. And libre two is the same price point is libre one and now libre free. In Germany, when they did launch, it's also the same price. So they keeping it the same, which is which is very reassuring

 

Stacey Simms  38:08

process, we'll see what happens in the US. But that is very reassuring for our friends in Europe. I went device I meant to ask about and didn't but I don't think it's been submitted. And that is beta bionics and the iLet. And Chris, you kind of alluded to this much earlier in our talk, because you were I believe in one of those trials,

 

Chris Wilson  38:25

I was at least told that I was patient number one at the trial site that I was at.

 

Stacey Simms  38:33

But we don't think we don't know for sure they have not submitted down or have they?

 

Chris Wilson  38:38

Well, I keep hearing parents and other patients still people diabetes, still saying, you know, I just finished my time in the primary phase of the trial for the eyelids, or now my kid is going into the extension phase, things like that. So if the trial is ongoing, clearly, I don't think they've they've submitted yet. It's definitely more hands off. I won't lie my time and range did go down a little bit when I was on it.

 

Stacey Simms  39:03

But your your time and range we should specify is extremely high.

 

Chris Wilson  39:06

Right? My 90 day average right now is 94% a week going into the current trial, the arm of the trial that I just finished was actually 97.

 

Stacey Simms  39:20

So it's all relative, but otherwise. Yeah. But it's a good point in that, you know, the eyelid is much more hands off, as you mentioned,

 

Chris Wilson  39:32

right? It's you know, no correction boluses there's not even mechanism to do it. All you can really do is tell it when you're eating and give it a rough guesstimate as to the meal size. So I would imagine especially for people who want to be more hands off with their diabetes and have good control because of the control wasn't bad by any stretch of the imagination, that it'll be a very good option for a lot of people once it does get approved. And this is the Insulet only version. We've still got The version with insulin and glucagon having both a gas and a brake will definitely make it easier to drive the car going forward in the next version. So we're looking forward to, to them starting the trials on that as well.

 

Stacey Simms  40:13

Yeah, it is all relative. I mean, I just think about my son, you know, he misses a couple of meal boluses a week for sure. And I think he would happily trade off control, you know, to just have that kind of stuff be taken care of. It's so interesting to see how I mean, I'm, I'm, I know, we're gonna get somebody questions as Chris gets so much time and range, what is he doing with control IQ? So that'll be another episode tips and tricks from Chris to or maybe the maybe the tips and tricks, Kamil is just spent a lot of your time in diabetes trials? Yeah. I mean, I kidding. I know. That's not it. But

 

Kamil Armacki 40:48

well, you're my time and ranges, but it's knowing me about? Very, very happy with it. I like to say that my time and happiness, though is 98. If not 100%?

 

Kamil Armacki 41:00

Go? And that's what matters. Yeah, right.

 

Stacey Simms  41:04

Absolutely.

 

Chris Wilson  41:05

I mean, that we joke about doable, do a lot of trials. And it helps. But there is definitely some truth to that. I mean, I get to talk to and interact with some of the top endocrinologist in the world, right? Sometimes, you know, on a weekly basis. So I'm going into the clinic to have an injection of something that they're testing out or to check in and let them download the data from the device that I'm testing in half the time we're chatting while they're doing other stuff. And you know, discussing the theories that underlie a lot of this stuff. And it definitely deepens your understanding, if you want to really understand diabetes, more and more like an endocrinologist does that say, it's a great way to gain some experience?

 

Stacey Simms  41:49

Let's talk a little bit. We've talked about what's happening and what we're waiting for. So let's talk a little bit about what we're excited for. And not just the products that we mentioned. But if there's anything else that's on your mind, I'm curious what you guys who live with diabetes, you use these devices, you follow this tech? Chris, what are you looking forward to? And I mean, it could be something that we talked about, or something that's like maybe 10 years from now,

 

Chris Wilson  42:10

I think probably the thing that that's most interesting, I mean, to a certain extent, the tech we even if it's not there yet, we know where it's going. Yeah, where it's sort of the end point is the point is you were a sensor, you were a pump, and it does everything for you, and you don't need to worry about it. But beyond that, I think one of the things that I'm most excited about is seeing the medications that were originally designed for type twos being used in more type ones. Yeah, since most type ones do have some insulin resistance, it's actually you know, a known thing that happens, it's partly just due to the fact that normally, insulin gets made on in the middle and spreads out to the edges, and we're infusing it from the edges and having it go into the middle of the circulation. But things like I know, Stacy, you've mentioned in the past the SDLT, two drugs that help us her pee out the excess sugar from your blood, those have shown really great improvements in kidney health, cardiovascular outcomes, and making those safer for type ones, since it can cause an issue with going into DKA even though your blood sugar's stay relatively normal. That was actually the the test that I was last Thursday was checking a new drug that as an add on to help reduce the chance of that happening if you're a type one on one of these medications, but there's lots of different classes of medications that are coming out things that not only enhance the function of insulin, but potentially block some of the functions of glucagon to help improve things since they've documented that. A lot of type ones the the sort of regulation and counter regulation in insulin, the insulin glucagon axis, I guess, it does happen with a fair amount of frequency in people with type one. So that may be something moving forward. And actually, it's not even necessarily just diabetes. They're testing this medication that they were trying to lay on me as an enhancement for cancer immunotherapy. Wow. In North Carolina, I somebody was asking me about something. And so I went on the clinical trials website, it was digging into what said he's looking at this drug and found a study that they were looking at it to see if it'll enhance the ability of some immunotherapies for breast cancer. So I mean, a lot of this stuff may even have ripple effects outside of diabetes.

 

Stacey Simms  44:33

That's really amazing. All right. That's a great point. I love that. All right. You know, you don't have to go outside of technology. I mean, that is still technology gets medication, but can we what are you looking forward to? Are you looking at down the line? I'm

 

Kamil Armacki 44:46

going to keep this one very, very simple. I'm just looking forward to seeing more access to all of this. I feel like in terms of getting incredible technology. I feel like we could summarize all of this all of today's talking Massive tech, right? We have incredible continuous glucose monitors even better on the market. And even better versions of them are common over the next year or so with g7, libre free etc. Same with pumps, that technology so sadly, isn't really accessible to so many people. And this applies to so many regions, so many countries in the UK, we now have an a trial of 1000 people with diabetes trial in closed loop technology to hopefully have our national proof that it does work is self restraint and actually seeing all of this because, you know, it's like every single country wants their own proof even though you know, there are so many trials from all over the world proven that yes, actually, it does help people. But you know, it is a very bureaucratic process. So I'm just looking forward to actually see in 1000s, if not millions of people have access to CGM. And then if they choose to hypertrophic therapy.

 

Stacey Simms  45:55

That's wonderful. All right. Before I let you go, this last question, it's not really a great follow up to our discussion about access. But this is one that it just honestly, it drives me bananas, and I want to get your opinion on and that is this every other day, I feel like someone is asking me when the Apple Watch is going to monitor blood glucose with non invasively. Right, that I know, right? You're gonna get the watch, it's gonna read your blood glucose and then move on. And I get these questions all the time by people outside the diabetes community, frankly, who read about it or hear about it. What's your take? I mean, I know what's coming. I hope it's coming. I don't want to I feel like I'm the hope killer. I go on these threads. And I'm like, unless you see a clinical trial, right. It's not going to happen. But I feel like it is coming it will be useful to some people sometime, right?

 

Chris Wilson  46:44

I think, absolutely. I think there's a couple of companies that are pretty far along. In the process of actually doing non invasive glucose monitoring. I think you had an episode recently, where you mentioned one where they look at the eye, yeah, within the eye, which is cool. I've heard of a couple of different texts that are technologies that are being introduced, using either heat at low levels infrared, to potentially sense it, or radio signals, believe there's a company in Israel that's working on that as well. Yeah, they're probably not good enough to necessarily dose insulin from yet, but they're getting there and the tech keeps getting smaller and more portable and stuff, I think there's a company in Germany that's got the tabletop scale right now, where you can just basically put a finger into on the sensor and it will give you an estimate of your blood sugar in there hoping to scale that down to being a portable device that will be non invasive, and then eventually a wearable device that will be non invasive. So it's, it's definitely coming, but the stuff takes time, there's so figuring out serve a lot of the ways that the various sensing technologies interact with the body and figuring out exactly how best to estimate your blood sugar from the readings that they get back. So it's coming. I've seen presentations with actually impressive accuracy, especially considering that it's non invasive, but I don't see it any time at least probably not in the next couple of years, but especially integrated into a consumer device like an Apple Watch.

 

Kamil Armacki 48:13

I completely agree with Chris I think especially as someone living with diabetes we tend to look at this from a you know, kind of a medical point of view but if this ever were to happen, it's really a health companion and I think that entire trend have actually seen a lot of what I would consider mainstream technology companies you know, Apple Samsung, you know, those kinds of players becoming more involved in health is a good thing because I think you know, we've heard of so many stories of you know, people using you know, Apple watches and you know being alerted that actually your heart rate is too low or too high and actually you know, if you deploy that kind of capability on you know, a population scale you know, with with millions of people using Apple Watches, it really drives you know, big changes and cold drives colossal impact on you know, general population you know, how we live our lives for if ever does happen I mean, we hear about this all the time and literally this year I think it was six or seven days after Apple Watch Series seven came out there was already a rumor saying the Apple Watch Series eight Yes. Well habit and I saw on Twitter and I just went I just did this emoji six days, six days the longest amount of time we can have without any rumors about Apple Watch.

 

Stacey Simms  49:39

It just shows you how much money is in it

 

Kamil Armacki 49:43

It’s click bait, interesting topic because you know it is the next frontier that you know everyone is trying to tackle. Yeah, so I understand the excitement bore and sometimes I'm probably causing it because I have talked about as well. In my in my printer diabetic days, I I was excited about it. I've been excited about as Nerdabetic, and we can't not be excited.

 

Stacey Simms  50:05

Well, even this episode, someone could clip out what Chris said it's coming.

 

Kamil Armacki 50:09

Yeah. But we do need to be realistic about it that even when it comes in, you know, 1015 years, it probably won't really have any tangible impact on any buyer lives.

 

Chris Wilson  50:21

Maintaining being realistic, that's a very good point. Because it reminds me of the vertex announcement a couple of weeks ago, with the the first patient of their trial, got infusion of stem cell derived Ilet cells, and is, you know, 90% reduction in insulin use. And everybody went nuts over that. And I wound up posting a big, long thread on Twitter explaining that really like this isn't the hard part yet. It's great that they're this far, it's awesome that people are pursuing different avenues, I hope they succeed. But this isn't going to be something that people are going to have in the next couple of years to just go in and get your eyelid infusion. And then you don't need to worry about measuring your blood glucose or worrying your pump or taking injections anymore.

 

Stacey Simms  51:10

I heard a great point on that, which was if they've sent a press release, it's quite different than if they've submitted a for publication in a clinical journal. It was a little bit, I'll say a little meaner than that. I think the quote was something like, you know, if it's a press release, they're looking for money, if it's a journal they're looking for, you know, approval. There's some truth to that, though. And I think that that's a good thing for us to keep in mind as we stay very hopeful is a very hopeful crowd. And as we stay realistic, as well, I think we've run the gamut. There's always so much more to talk about. So I hope you'll come back on when these things maybe we hear more, they start to get approved, or we just talk about different things. But this was great. Thank you both so much for jumping on.

 

Chris Wilson  51:50

It's always fun to talk to you, Stacey.

 

Stacey Simms  51:51

Oh, thank you, thank you. It's always great to get caught up on this stuff and kind of speculate and talk about it. So thanks so much. I appreciate you guys both being here. And we will put lots of links in the show notes and everywhere else we can find them so that people can find you on social and follow your musings and your thoughts, but I really appreciate it. We'll talk to you soon.

 

You're listening to Diabetes Connections with Stacey Simms. Lots of information there. I'm going to link up a couple of articles some things we referenced at diabetes connections.com. At the homepage for this episode, there is a transcription as well as always, what do you think? I mean, I know it was long, and there were a lot of things to get through. But I'd like to do that on a more regular basis, maybe with some different people in the community. Love to hear feedback from you what questions you have, what topics you'd like us to tackle. But man, those guys, really they know the ins and outs of all of this, they really keep their finger on the pulse. So we'll follow up. We'll do more on that. This was taped, as I said the very first week of November 2021. So in a couple of days between now and when the episode comes out, maybe something else was approved. If it happened, we will follow up on it here.

All right, thank you, as always to my editor John Bukenas from audio editing solutions. We've got in the News Live every Wednesday now 4:30pm Eastern Time, on YouTube and on Facebook Live on both channels, and then we turn it around into an audio podcast episode that airs Fridays. So I hope to see you back here for that until then be kind to yourself.

Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Oct 26, 2021

With Dexcom announcing a big new agreement with Garmin this month, it seemed like a good time to check in on a few issues. Stacey talks with Dexcom’s Chief Technology Officer Jake Leach about Garmin, the upcoming Dexcom G7 and Dexcom One. She asks your questions on everything from G7 features to watch compatibility to the future and possible non invasive monitoring.

Just a reminder - the Dexcom G7 has not yet been submitted to the US FDA and is not available for use as of this episode's release.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Previous episodes with Jake Leach: https://diabetes-connections.com/?s=leach

Previous episodes with CEO Kevin Sayer: https://diabetes-connections.com/?s=sayer

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

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Episode transcription below:

 

Stacey Simms  0:00

Diabetes Connections is brought to you by Dario Health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

 

Announcer  0:20

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:26

This week Dexcom announced a big new agreement with Garmin this month seemed like a good time to check in on a few issues, including what happens to the watches and insulin pump systems that work with G6, when Dexcom G7 it's the market.

 

Jake Leach  0:41

We're already working with Tandem and Insulet. On integrating G7 with their products have already seen prototypes up and running, they're moving as quickly as possible.

 

Stacey Simms  0:49

That's Chief Technology Officer Jake leach who reminds us that the G7 has not yet been submitted to the US FDA. He answers lots of questions on everything from G7 features to watch compatibility to the future and possible non invasive monitoring. 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 are we so glad to have you here I am the host Stacey Simms, and we aim to educate and inspire about diabetes with a focus on people who use insulin. You know, my son Benny was diagnosed with type one right before he turned to my husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting. And that is how you get the podcast. And when I saw the news about Garmin, and Dexcom. I knew you'd have some questions. And I thought this would be a good chance to talk about some of the more technical issues that we're all thinking about around Dexcom. These days.

I should note that since I did this interview with CTO Jake Leach on October 19. And that's exactly one week before this episode is being released that Dexcom released some new features for its follow app. I did cover that in my in the news segment. That was this past week, you'd find the link in the show notes. And as I see it for that news that release in the update, the big news there is that now there is a widget or quick glance on the followers home screen, it depends on your device, you know, Apple or Android, there's no tech support, right from the follow up, and a way to check the status of the servers as well. And I think that last one should really be an opt in push notification. If the servers are down, you should tell me right, I shouldn't have to wonder are the servers down and then go look, but that is the update for now. And again that came out after this interview. So I will have to ask those questions next time.

And the usual disclaimer Dexcom, as you've already heard, is a sponsor of the show, but they only pay for the commercial you will hear later on not for any of the content you hear outside of the ad. I love having them as a sponsor, because I love that Vinnie uses the product. I mean, we've used Dexcom since he was nine years old. But that doesn't mean I don't have questions for them. And I do give them credit for coming on and answering them. Not everybody does that. I should also add that this interview is a video interview, we recorded the zoom on screen stuff. You can see that at our YouTube channel. I'll link that up in the show notes if you would rather watch and there always will be a transcript these days in the show notes so lots of options for however it suits you best. I'm here to serve let me know if there's a better way for me to get this show to you. But right now we've got video audio and transcript. Alright Jake leach in just a moment.

But first Diabetes Connections is brought to you by Dario health and you know one of the things that makes diabetes management difficult for us that really annoys me and Benny, it's not really the big picture stuff. It's all the little tasks that add up. Are you sick of running out of strips do you need some direction or encouragement going forward with your diabetes management? Would visibility into your trends help you on your wellness journey? The Dario diabetes success plan offers all of that in more you don't the wavelength the pharmacy you're not searching online for answers. You don’t have to wonder about how you're doing with your blood sugar levels, find out more, go to my dario.com forward slash diabetes dash connections.

Jake leach Chief Technology Officer for Dexcom thanks so much for joining me. How are you doing?

 

Jake Leach  4:22

I'm doing great, Stacey. It's a pleasure to be here.

 

Stacey Simms  4:24

We really appreciate it. And we are doing this on video as well as audio recording as well. So if we refer to seeing things, I don't think we're sharing screens or showing product. But of course we'll let everybody know if there's anything that you need to watch or share photos of. But let me just jump in and start with the latest news which was all about Garmin. Can you share a little bit about the partnership with Garmin? What this means what people can see what's different?

 

Jake Leach  4:49

Yeah, certainly so I'm really excited to launch the partnership with Garmin. So last week we released functionality on the Dexcom side and Garmin released their products, the ability to have real time CGM readings displayed on a whole multitude of Garmin devices by computers, and a whole host of their watches. So they've got a lot of different types of watches for, you know, athletics and different things. And so you can now get real time CGM displayed on that on that watch. So they're the first partner to take advantage of some new technology that we got FDA approved earlier in the year, which is our real time cloud API. So that's a a way for companies like Garmin to develop a product that can connect up to users data through the Dexcom, secure cloud and have real time data, we've had the capability to do that with retrospective data that three hour delayed, many partners are taking advantage of that. But we just got the real time system approved. And so Garmins, the first launch with it.

 

Stacey Simms  5:50

Let me back up for just a second for those who may use these devices, but aren't as technologically focused. What is an API? When you got approval for that earlier in the summer for real time API? What does that what does that mean? Yeah, so

 

Jake Leach  6:03

it's a API is an application programming interface. And so what it really means is, it's a way for software applications, like a mobile app on your phone, to connect via the Internet to our cloud with very secure authentication, and pull your CGM data in real time from from our cloud. And so it's basically a toolkit that we provide to developers of software to be able to link their application to the Dexcom application, and really on the user side, to take advantage of that feature, you basically enter in your Dexcom credentials, your Dexcom username and password. And that is how we securely authenticate. And that's how you're basically giving access to say, for example, Garmin, to pull the data and put it down onto your devices. What other

 

Stacey Simms  6:51

apps or companies are in the pipeline for this. Can you share in addition to Garmin? I think I had seen Livongo Are there others?

 

Jake Leach  6:58

Yeah, so Livongo so Tela doc would purchase the Lubanga technology, they've got a system. They're also in the pipeline for pulling in real time CGM data into their application. And so they're all about remote care. And so trying to connect people with physicians through, you know, technology, and so having real time CGM readings in that type of environment is a really nice use case for them. And so and for the for the customers. And so that's, that's where they're headed with it. And we've got kind of a bunch more partners that are in discussions in development that we haven't announced yet. But we're really see this, the cloud API's are interfaces as a way to expand the ecosystem around a Dexcom CGM. So we really like to provide our users with choice. So how do you want your data displayed? Where do you want it? And so if you want to right place, right time for myself, have a Garmin bike computer so I can see CGM readings right on my handlebars, I don't have to, you know, look down on a watch or even thought phones, it's really convenient. That's what we're about is providing an opportunity for others to amplify the value of CGM.

 

Stacey Simms  8:06

This was a question that I got from the listener. What happens to the data? Is that a decision up to a company like Garmin, or is that part of your agreement, you know, where everybody's always worried about data privacy? And with good reason?

 

Jake Leach  8:19

Yeah, data privacy is super important area when when you're handling customer information. And so the way that it works is, when you're using our applications at the beginning, when you sign up, there's some consents, you're basically saying this is what can be done with my data. And the way we design our systems is, for example, with the connection to the Garmin devices, the only way they can access your data is if you type in your credentials into there, it's like it's almost like typing your username and password into the web to be able to access your bank account. It's the same thing, you're granting access to your data. And each company has their own consents around data. And so we all are required by regulatory agencies to stay compliant with all the different rules to Dexcom. We take it very seriously, and are very transparent about what happens with the data that's in we keep it in all of our consent forms that you click into as you as you work through the app.

 

Stacey Simms  9:13

But to be clear to use the API or to get the Dexcom numbers on your garmin, you said earlier, you have to enter your credentials,

 

Jake Leach  9:19

you have to you have to enter your Dexcom username and password. And that's how we know that it's okay for us to share that information with Garmins system because you are the one who authorized it.

 

Stacey Simms  9:30

Right. But that's also how you were going to use it. You just said you have to enter your name and password for them to use the information. So they just have to read individually like okay, Garmin or Livongo or whomever. Yes. Your individual terms of services.

 

Jake Leach  9:42

Yeah, for each each application that that you want to use you it's important to read the what they do with the data and how to use it.

 

Stacey Simms  9:49

That's really interesting. And Has anything changed with Dexcom? It's been a long time since we've talked about how you all use the data. My understanding is that it was blinded, you know, you're not turning around over to health insurers and saying yeah, done on this day this or are you?

 

Jake Leach  10:03

No, no, not at all, we basically use the information to track our product performance. So we look at products there. So it's de identified, we don't know whose product it was, we just can tell how products are performing in the field. That's a really important aspect. But we also use it to improve our products. So we when we see the issues that are occurring with the use of the product, we use it to improve it. So that's, that's our main focus. And the most important thing we do with it is provided to users where, where and when they need it. So you know, follow remote monitoring that the reason we built our data infrastructure was to provide users with features like follow and the clarity app and so forth.

 

Stacey Simms  10:36

Do those features work on other systems? Can I use Garmin to share or follow?

 

Jake Leach  10:41

Not today? So right now, it's, it's basically intended for the the person who's wearing the CGM. It's your personal CGM credentials that you type in to link the Carmen account. And so for today, it's specific around the user.

 

Stacey Simms  10:57

I assume that means you're working on for tomorrow.

 

Jake Leach  10:59

There's lots of Yeah, lots.

 

Stacey Simms  11:02

Which leads us of course to Well, I don't have to worry about that right now. Because you can't use any of this without the phone and the Phone is how we could share it follow. So it's not really an issue yet. Jake, talk to me about direct to watch to any of these watches. Yeah, where do we stand? I know G6. It's not going to happen. Where are we with G7?

Right back to Jake answering my question, you knew I was gonna bring that up. But first Diabetes Connections is brought to you by Gvoke Hypopen. And when you have diabetes and use insulin, low blood sugar can happen when you don't expect it. That's why most of us carry fast acting sugar and in the case of very low blood sugar, why we carry emergency glucagon, there's a new option called Gvoke Hypopen the first auto injector to treat very low blood sugar Gvoke Hypopen is pre mixed and ready to go with no visible needle. In usability studies. 99% of people were able to give Gvoke correctly find out more go to diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com/risk now back to Dexcom’s jake leach answering my question about direct to watch

 

Jake Leach  12:19

That's a great question and a really exciting technology. So direct to watch is where through Bluetooth, the CGM wearable communicates directly to a display device like a watch. So today, G6 communicates to the phone and to insulin pumps in our receiver are the displays. With G7, what we've done is we've re architected the Bluetooth interface to be able to also in addition to communicating with an insulin pump or a receiver and your mobile phone, it can also communicate with a wearable device like a Apple Watch, in particular, but other watches have those capabilities, with G7, reducing the capability within the hardware to have the direct communication director watch. And then in a subsequent release, soon after the launch to commercial launches of G7, we'll have a release where we bring the director watch functionality to the customers, there's the Bluetooth aspect, which is really important, you got to make sure it doesn't impact battery life and other things. But there's also the aspect of when it is direct to watch, it becomes your primary display. And so being able to reliably receive alerts on the watch was something that initially in the architecture wasn't possible. But as Apple's come out with multiple versions of the OS for the watch, they've introduced capability for us, so that we can ensure you get your alerts when you're wearing the watch. And so that was a really important aspect for us. And it's also for the FDA to ensure that if that's your main display, you've walked away from your phone, you have no other device to alert you that it's going to be reliable. And so that's exciting progress of last couple years with Apple making sure that can happen. You know,

 

Stacey Simms  13:56

we're all excited for Direct to watch. Obviously, it's a feature that many people are really clamoring for. But you guys promised it first with the G five in 2017. Do you all kind of regret putting the cart before the horse that way? Because my next follow up question is why should we believe you now?

 

Jake Leach  14:15

Yeah, you know, it Stacy's a good question. So we are hand was kind of forced because Apple actually announced it before we did. So they basically said we're opening up this capability on the watch to have the direct Bluetooth connectivity. And of course, we were excited to have someone like Apple talking about CGM on that kind of a stage. But then as we got into the details of actually making it work, we, you know, continually ran into another technical challenge after another technical challenge, and I totally agree. I wish it would have been two years later that they talked about at the keynote, but I'm comfortable that we've gotten past those types of issues. And so and it is built into G7. So we've got working systems and so it will introduce it rather quickly with G7

 

Stacey Simms  14:56

and to confirm G7 has been submitted for the CE mark Because the approval in Europe, but has not yet, as you and I are speaking today has not yet been submitted for FDA approval in the US.

 

Jake Leach  15:06

Yeah, we're just we're just finishing up our submission, we get some validations that we're running on some of the new manufacturing lines to make sure we can build enough of these for all the customers, we want to focus to move over to G7 as quick as possible. And so we'll we'll submit you seven to the FDA before the end of this year,

 

Stacey Simms  15:22

just kind of building off what you mentioned about Apple and making these announcements or, you know, sometimes Apple lets news get out there. Because they I don't know if they seem to enjoy it. I'm speculating. I don't have any insight track at Apple. But I wanted to ask you, I don't know if you can say anything about this. For the last year, every time I talk to somebody who's not getting the diabetes community, but they're on a technology podcast, or they're, they're hearing things about non invasive blood glucose monitoring, right, the Apple, Apple series seven or some watch this year, we're supposed to have this incredible, non invasive glucose monitoring was gonna put Dexcom and libre out of business, it was gonna be amazing. Of course, it didn't happen. But a bunch of companies are working on this. And Apple seems to be really happy to say maybe, or we're working on it, too, is Dexcom listening to these things. I mean, obviously, they're not here yet. They they are going to come. I'm curious if this is all you kind of happy to let that lay out their speculation. Or if you guys are thinking about anything like this in the future,

 

Jake Leach  16:17

we pay a lot of attention to non invasive technologies. We have a an investment component of our company that looks at you know, early stage startups. We also have many partnership discussions around CGM technologies. And so when it comes to non invasive, I think we'd all love to have non invasive sensors that are accurate and reliable. You know, for many, many years since I've been working on CGM, and many years before that, there has been attempts to make a non invasive technologies work. The challenge, though, is it's just sensing glucose in the human body with a non invasive technology is not been proven feasible. It's just there's a lot of different attempts and technologies have tried, and we pay close attention. Because if if something started to show promise, we become very interested in it. And basically making a Dexcom product that uses it, we just haven't seen anything that is accurate and reliable enough for what our customers need. That's to say, there could be a use case where a non invasive sensor doesn't have to be as accurate and reliable as what what Dexcom does. And so maybe there's a product there. But we're very focused on ensuring that the accurate, the numbers that we show, the glucose readings that we present to users are highly accurate, highly reliable, that you can trust them. And so when it comes to non invasive, we just haven't seen a technology that can do that. But I know that there's lots of folks out there working on it. And we're, we stay very close to the community.

 

Stacey Simms  17:40

Yeah, one of the examples I gave a guy who doesn't he does an Apple technology podcast, and he was like, you know, what, what do you think? And I said, Well, here's an example. He would a scale, and you have no idea if it's accurate. But you know, that once you step on it that that number probably is is stable, then you know, okay, I gained 10 pounds, I lost 10 pounds. But I have no idea if that beginning number makes any sense at all, you might be able to use that if you are a pre diabetic, or if you're worried about blood glucose, but you could never dose insulin using it because you have no idea where you're starting. So I think that's I mean, my lay person speculation. I think that's where that technology is now and to that point, but other people outside the diabetes community are looking to one of the more interesting stories, I think, in the last year or two has been use of CGM and flash glucose monitoring for people without diabetes at all, for athletes, for people who are super excited and interested in seeing what their body's doing. So we have companies like levels and super sapient. And you know, that kind of thing using the Liebreich. I'm curious of a couple of parts of this question. If you think you want to answer it is Dexcom. Considering any of those partnerships with the G7, which is much more simple, right? fewer parts and that kind of thing.

 

Jake Leach  18:46

Yeah, that's a great point, Stacey. So yes, G7 is a lot simpler. It was designed to be to take the CGM experience to the next level. And part of that is just the ease of use the product deployment the simplicity, someone who's never seen a CGM before, we want to be able to walk up approach G7 And just use it. There's a lot of opportunity we feel for glucose sensing outside of diabetes. Today CGM are indicated for use in diabetes, but in the future, with 30% of the adult population in the US having pre diabetes, meaning the glucose levels are elevated, but not to the point where they've been diagnosed with diabetes. There's just so much opportunity to help people understand their blood sugar and how it impacts lifestyle choices impact their blood sugar. In the immediate feedback you get from a CGM is just a there's nothing else like it. And so I think, you know, pre diabetes and even as you mentioned, kind of in athletics. There's a lot of research going on right now in endurance athletes, and in weight loss around using CGM readings for those different aspects. So I think there's a lot opportunity we're today we're focused on diabetes, both type one and type two and really getting technology to people around the globe. That can benefit from it. That's where our focus is. But we very much have programs where we look at, okay, where else could we use CGM? It's such a powerful tool, you could think in the hospital, there's so much opportunity around around glucose. Alright, so I'm

 

Stacey Simms  20:13

gonna give you my idea that I've given to the levels people, and they liked it, but then they dropped off the face of the earth. So I'll be contacting them again. Here's my idea. If somebody wants to pay for a CGM, and they don't have diabetes, but they're like paying out of pocket because they like their sleep tracker, and they like this and they like that, or some big companies gonna buy it and give it away for weight loss or whatever. You know, the the shoe company toms, where you buy a pair of shoes and they give one away. People are in the diabetes community are scrimping and saving and doing everything they can to get a CGM. Maybe we could do a program like that. Where if you don't quote unquote medically need a CGM. Your purchase could also help purchase one for an underserved clinic that serves people with diabetes.

 

Jake Leach  20:54

Getting CGM to those folks that didn't need them, particularly underserved areas, clinics. It's so important. I like the idea. It's a that's if there was a cache component that then provided the CGM to those that are less fortunate. I think that's, I like the idea. Next month is National Diabetes Awareness Month. And one of the things we're focused on for the month of November is how can we bring broader access to CGM? It's something we've been working on, you know, since we had our first commercial product, and there's still, you know, many people in the United States benefit, you know, 99% of in private insurance covers the product. You know, a lot of our customers don't pay anything, they have no copay. But you know, that's not the case for everybody. And so there's, there's definitely areas that we need to we are focusing on some of our non profit partners on bringing that type of greater access to CGM, because it's such a powerful tool and helping you live a more normal life.

 

Stacey Simms  21:50

In the couple of minutes that we have left. I had a couple more questions, mostly about G7. But you mentioned your hospital use. And last year, I remember talking to CEO Kevin Sayer about Dex comes new hospital program, which I believe launched during COVID. Do you have any kind of update on that or how it's been going?

 

Jake Leach  22:06

Yeah, so it was a authorization that we got from the FDA to raise special case during COVID, to be able to use G6 in the hospital. And so we had quite a few hospitals contact us early on in COVID, saying, Hey, we've got these patients, many of them have diabetes, they're on steroids. They're in the hospital, and we're trying to manage their glucose. And we're having a hard time because their standard of care in hospitals is either labs or finger sticks. And so we got this authorization with the FDA, we ship the product, many hospitals acquired it, and they were using it pretty successfully. What we'd say about G6 is really designed for personal use your mobile phone or a little receiver device, designed integrated with a hospital patient monitoring system or anything like that. You could imagine in the future that that could be a real strong benefit for CGM, the hospital, you can imagine you put it on, you know, anybody who has glucose control issues comes in the door. And then you basically can help ensure where resources need to be directed based on you know, glucose risk. I've always been passionate about CGM at a hospital. It's one of the early projects I worked on here. Dexcom. And I think it there's a lot of promise, particularly as we've improved the technology. So there's still hospitals today using G 600 of the authorization. And we're interested in designing a product for that market specifically, instead of right now. It's kind of under emergency years. But we think there's there's a great need there. That CGM could could help in basically glucose control in the hospital.

 

Stacey Simms  23:28

That's interesting, too. Of course, my mind being a mom went to camp as well. Right? If you could have a bunch of people I envision like a screen or you know, hospital monitoring that kind of thing. You wonder if you could do something at camp where there's 100 kids, you know, instead of having their individual phones or receivers at camp, it would be somewhere Central?

 

Jake Leach  23:46

Well, you know, what, between with the with the real time API, there are folks that are thinking about a camp monitoring system that can basically be deployed on campuses right now with follow. It's great for a family, but it's not really designed to, to follow a whole camp full of campers. But with the real time API, there's opportunities for others to develop an application that could be used like that. So yeah, there you go.

 

Stacey Simms  24:08

All right, a couple of G7 questions. The one I got mostly from listeners was how soon and I know, timelines can be tricky. But how soon will devices that use the G6? Will they be able to integrate the G7 Insulin pumps, that sort of thing? Sure. It's only Tandem right now. But you know, Omnipod, soon that that kind of thing?

 

Jake Leach  24:26

Yeah, I mean, that's coming. So I'll start with the digital partners like Garmin and others, that is going to be seamless, because the infrastructure that G6 utilizes to move data to through the API's is the same with G7. So that'll be seamless. When you talk about insulin pumps, so those are the ones that are directly connected to our transmitters that are taking the glucose readings for automated insulin delivery. So those systems were already working with Tandem and Insulet. On integrating G7 with their products have already seen prototypes up and running so they're moving as quickly as possible. So once We have G7 approved, then they can go in and go through their regulatory cycle to get G7 approved for us with their AI D algorithms. Really the timing is dictated mainly by those partners and the FDA, but we're doing everything we can to support them to ensure this as quick as possible.

 

Stacey Simms  25:17

Take I should have asked at the beginning, I'm so sorry, do you live with type one I've completely forgotten.

 

Jake Leach  25:21

I don't I made a reference to where I wear them all the time. Because, as you know, kind of leading the r&d team here, I love to experience the products and understand what our users what their experience is. And I just love learning about my glucose readings in the different activities I do. So I don't have type one. But I just I use the products all the time.

 

Stacey Simms  25:42

So to that end, have you worn the G7? And I guess I'd love to know a little bit more about ease of use. It looks like it's, it just looks like it's so simple.

 

Jake Leach  25:51

It is. Yeah. So I've participated in a couple of clinical trials where we use G7, it is really simple. One of the most exciting things though, I have to say is that when you put it on, it has this 30 minute warmup. So the two hours that we've all been used to for so many years, by the time you put the device on and you have it paired your phone, it's there's like 24 minutes left before you're getting CGM. So it's like it's it. That part is just one of the things that you it sounds awesome. But then when you actually experience it, it's pretty amazing. But yeah, the ease of use is great, because it's the applicator is simple. It's a push button like G sex where you just press the button and it deploys. But there's other steps where you're not having to remove adhesive liners, the packaging is very, very small. So we really focused on low environmental footprint. And so it's really straightforward. But probably the most the really significant simplification the application process is because the transmitter and the sensor all one component and sterilized and saying altogether, there's no pieces, there's no assembly required, you basically take the device and apply it and then it's up and running. There's no transmitted a snap in or two pieces to assemble before you you do the insertion.

 

Stacey Simms  26:59

I think I know the answer to this. But I wanted to ask anyway, was it when you applied for the CE mark? And I assume this would be the same for the FDA? Are there alternate locations? In other words, can we use it on our arms?

 

Jake Leach  27:11

And yeah, that is that is a great question. Yeah, our focus with one of our phones with G7 and the revised form factor, the new new smaller form factor and sensor probe was arm were so yeah, arm wears is really important part of the G7 product.

 

Stacey Simms  27:26

I got a question about Dexcom. One, which seems to be a less expensive product with fewer features that's available in Europe. Is that what Dexcom? One is?

 

Jake Leach  27:34

Yeah, so there's a product that we recently launched in Europe in European countries. That is it's called Dexcom. One. And what it is, is it's it's a product that's designed for a broad segment of diabetes, type one, type two, it's a lower price point. It has a reduced feature set from G6. But what it's really about is simplicity. And so in you know it's a available through E commerce solutions. So it's really easy to acquire the product and start using it. It's really to get into certain markets where we either weren't didn't have access to certain customers. And so it's really designed for get generating access for large groups of people that didn't have access to CGM before.

 

Stacey Simms  28:20

What does e commerce solution mean? No doctor

 

Jake Leach  28:23

there. So outside the United States CGM isn't no prescription required for many, many countries. So the US is one of the countries that does require prescriptions, other some other countries do too. But there's a large group outside the US that don't, but it's really around, you can basically go to the website, and you can purchase it over a website. So really kind of nice solution around think Amazon, right. You're going you're clicking on add the sensors and you're purchasing it. It's a exciting new product for us that we are happy to continue developing.

 

Stacey Simms  28:53

I think it might come to the US don't know. Yeah, that's

 

Jake Leach  28:56

good. Good question. Don't don't know. I mean, I think right now we see CGM coverage is so great access is great for CGM in the US it can always be better and extend your focus on that. But it's really for countries where there wasn't access,

 

Stacey Simms  29:08

I would think tough to since we do need a prescription differently. Yeah, Jake, you have been with Dexcom, almost 20 years, 18 years now. And a lot has changed. When you're looking back. And looking forward here at Dexcom. I don't really expect you to come up with some words of wisdom off the top of your head. But it's got to be pretty interesting to see the changes that the technology has brought to the diabetes community and how I don't know it just seems from where I sit and you're probably a couple of years ahead. It seems that the last five years have just been lightspeed. It has

 

Jake Leach  29:39

been things are speeding up in terms of our ability to bring products to market and there's a lot of things one is the development of technology. The other component is working with your groups like the FDA on you know, how do we get products to the customers as fast as possible and that that's been a big part of it right moving cheese six to class to becoming an IC GM that That was a huge part of our ability to get the technology out quickly and also scale it. I think there's a lot of aspects that has been faster. And you know, when I started Dexcom, we had this goal of designing a CGM that was reliable didn't require finger sticks that could make treatment decisions. All that and we were 100% focused on that. And as we got closer and closer, and now we have that which you six and also what you seven, then the opportunity that that product can provide, you start to really understand how impactful CGM can be around the world. And that's what I'm excited about now is I'm still excited about the technology always will be and we still have lots to do on making it better, more reliable and more integrated. But just how much CGM can do around around the globe. There's just so many things. It's beyond diabetes to so very excited about the future.

 

Stacey Simms  30:47

Many thanks, as always, and we'll talk soon, I am sure but I mean, I could never get to say it enough. I can't imagine doing the teenage years with my son without Dexcom. You guys, I know you did it just for me. You did it just in time. Appreciate it very much. He is doing amazing. And I can't he would not be sticking his fingers 10 times a day. So thank you.

 

Jake Leach  31:05

That's great to hear. Thanks, Stacy.

 

Announcer  31:12

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  31:18

As always more information at diabetes connections.com. And yeah, but that last bit there, I can say nice things. I mean, I really do feel that way. And I can still ask not so nice questions. Like if you're new, quite often, I will open up a thread in our Facebook group. It's Diabetes Connections of the group to gather questions for our guests. And I did that here with Dexcom, there's usually quite a lot of questions, I do have to apologize, I missed a big one. Because of the timing of the interview, I promise I will circle back around next time I talk to Dexcom. And that is all about the updates for iOS and for new phones, and how you know, sometimes Dexcom is behind the updates. What I mean by that is that they lag behind the updates. So you can go to the Dexcom website, I'll put a link up for this for Dexcom products that are compatible in terms of which iOS and that kind of thing. And they are behind. And Dexcom will always say they've said very publicly that they are working hard to catch up. But I guess the question that a few people really wanted to know was why, you know, why do they lag behind? What can be done about that? So they know, but I think it would be a good question to ask. So Sarah and others. I appreciate you sending that question. And I apologize that I didn't get to it this time around.

And I'll tell you, you know, it's not something we've experienced, but I think it has to do and I'm speculating here more with the phone with the the newness and the the model of the phone sometimes then for the updates, especially if you don't have your updates on automatic. So I guess I'm kind of saying the same thing. But what I mean by that is Vinny, and I have very old phones. I have an eight. I'm not even sure he has the eight. We are terrible parents and I don't care about my phone, I would still have a Blackberry if that were possible. So I can't commiserate. I'm so embarrassed to even tell you that I can commiserate with the updates, because it's just not something that we have done. Benny, definitely if he were here, trust me. It's like his number. I would say it's his number one complaint that it's really high up on the list of complaints to the parenting department in our house. And yes, Hanukkah is coming. His birthday is coming. There will be some new phones around here. I'm doing an upgrade. I'm sure both of us have cracked phones. Were the worst. Oh, my goodness.

All right. Well, more to come in just a moment. But first Diabetes Connections is brought to you by Dexcom. And this is the ad I was talking about earlier in the interest of full disclosure. But you know, one of the most common questions I get is about helping kids become more independent. I get asked this all the time at conferences for virtual chats in my local group. These transitional times are tricky. And we've gone through this preschool to elementary elementary to middle middle to high school. I can't speak high school to college yet, but you using the Dexcom really makes a big difference. For us. It's not all about sharing follow, although that's very, very helpful. Just think about how much easier it is for a middle schooler to look at their Dexcom rather than do four to five finger sticks at school, or for a second grader to just show their care teams a number. Here's where I am right before Jim. At one point, Ben, he was up to 10 finger sticks a day, he didn't have Dexcom until the end of fourth grade not having to do that made his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at diabetes connections.com and click on the Dexcom logo.

I don't know about you, but I am getting a ton of email already about Diabetes Awareness Month and that is November this time of year I usually get I'd say 120 emails that are not snake oil, right one in 20 emails that maybe make sense for something we want to talk about on the show here that I would share on social media and I'm just inundated with nonsense. So I hope you are not as well. But I gotta say Diabetes Awareness Month this year. I've been pulling in My local group and talking about what to do because usually I highlight a lot of people and stories and I'll I'll still do that, I think, but I got to tell you people are, um, you know, this, we're all stressed out. And while it's a wonderful thing to educate, I always think Diabetes Awareness Month is not for the diabetes community, right? We are plenty aware of diabetes, this is a chance to educate other people. And that's why I like sharing those pictures and stories on my page, because the families then can share that with their people. And it's about educating people who don't have diabetes. But gosh, I don't know this year, I'm going to be just concentrating on putting out the best shows that I can

I do you have a new project I mentioned last week that we're going to be talking about in the Facebook group. By the time this airs, I will have the webinars scheduled in the Facebook group. So very excited about that. Please check it out. But what are you doing for Diabetes Awareness Month? If you've got something you'd like me to amplify, please let me know. You can email me Stacey at diabetes connections.com. Or you can direct message me on the social media outlet of your choice. We are at YouTube, Facebook, Twitter and Instagram. That's where Diabetes Connections lives. I'm on Tik Tok, or Snapchat or Pinterest. Oh my gosh. All right. Well, that will do it for this week. Thanks as always to my editor John Bukenas from audio editing solutions.

Thank you so much for listening. I will be back on Wednesday. live within the news. Live on Facebook and now on YouTube as well. Until then, be kind to yourself.

Benny:

Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged

Aug 31, 2021

How much do you really know about the only inhalable insulin? This week, Stacey interviews the CEO of MannKind, makers of Afrezza. Mike Castagna talks about how Afrezza works, misconceptions about the product, the worldwide market, pediatric studies and lots more.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

More about Afrezza

Tim Street's blog Diabettech 

Check out Stacey's book: The World's Worst Diabetes Mom!

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Episode transcription below:

Stacey Simms  0:00

Diabetes Connections is brought to you by Dario health manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar and by Dexcom take control of your diabetes and live life to the fullest with Dexcom This is Diabetes Connections with Stacey Simms. This week all about Afrezza How much do you really know about the inhalable Insulet. I had a great conversation with the people who make it

 

Mike Castagna  0:34

For me, it's about using the right product to meet your needs to get you in control. And if you're doing well, great, we're going to avoid the long term complications. But if you're not doing your health, and you gotta really try to find the best set of tools, they're gonna make you successful and fit your lifestyle.

 

Stacey Simms  0:47

That's mankind CEO Mike Castagna. We talked about how Afrezza works misconceptions the worldwide market pediatric studies and lots more. 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. We so glad to have you here we aim to educate and inspire about diabetes with a focus on people who use insulin. And this week, we're talking about the use of the only inhalable insulin, my son was diagnosed with type one right before he turned two, he is 16. My husband has type two diabetes, I don't have diabetes at all. But I have a background in broadcasting. And that is how you get the podcast, I have to say that personally, my family is very interested in Afrezza Benny really would like to try this seat. Of course, as I mentioned in that tease up there, they're looking at pediatrics, he is still under 18. So it's not proof for his age group. But we're watching it really closely. And I have a lot of friends. A lot of bloggers and people in the diabetes community have talked about this for years. And some things have changed. So I wanted to have them on the show and find out more. So a little bit of background for you. If you are brand new to all this, Afrezza was approved in the United States in 2014. And the company that makes it is mankind. For a while it was sold by Santa Fe, but then mankind took it back. It's one of those things where sometimes the business side seems to have gotten more attention than the product itself. So what is Afrezza it is a powder, it comes in cartridges, and you suck it in you inhale it with a special inhaler device. To me, it looks more like a whistle than a traditional inhaler like an asthma inhaler. It's not like a big tube. I'll link up some photos in the show notes. I'll also link up the Afrezza website so you can learn more and see their information.

And my guest this week is Dr. Mike Castagna, the CEO of mankind now he has a Doctorate of pharmacy, he worked as a pharmacist behind the counter for CVS at the start of his career. But then he went back to school and he got an MBA from the Wharton School of Business. He's fun to talk to he doesn't mince words, and he truly believes in this product, I do have to tell you that Mike mentions monomeric insulin a couple of times, I'm going to come back after the interview and explain more about that give you a better definition. All you really need to know is that it's faster than how liquid insulin is made. And all of that in just a moment.

But first Diabetes Connections is brought to you by Daario. And over the years I find we manage diabetes better when we're thinking less about all the stuff of diabetes tasks. That's why I love partnering with people who take the load off on things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends with suggestions on how to succeed, get the diabetes management plan that works with you and for you, Daria is published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash Diabetes Connections.

Mike, thanks for joining me, I'm really excited to catch up. And look, I'm stuttering because I can't believe this is the first time we're talking to you. But thanks for coming on. Oh, thank you, Rodney. I'm super excited before we jump in and start talking about Afrezza Can you give us some perspective kind of dial back because mankind is not. It's not a name that came out of nowhere? There's really important history. Can you kind of talk about that a little bit first?

 

Mike Castagna  4:14

Sure. Mankind comes from our founder named after Al Mann and Al Mann was a true innovator. He started I think 17 companies and everything from the cochlear implant to the pacemaker to insulin pumps that many of us know today as Medtronic used to be called mini med. And Al Mann built the insulin pumps over the 80s and 90s and was very successful and sold that company to Medtronic. And then he took literally $1 billion of his own money and invested in mankind. And he had put this company together through three companies he owned the technology to make Afrezza was really a combination of companies and the reason he was so dedicated as he saw in the pump market, which we now see today on CGM was that the variability in mealtime control was so high and the fluctuations you see that the influence takes about an hour and a half to kick in. And it's hard to get real time control if you can't get a faster acting insulin. And so he set out to make a real time acting insulin, so phrases and hailed as monomeric. And that was really what the magic was in our technology making a dry powder was was free dryness, if you heard of dippin dots ice cream, we have basically large dipping machines in our factory, but we free dry the particles to make a freezer and under stabilize the monomeric form. So when you're inhaling, you're inhaling influenza, as soon as it's in your blood is active, or when you inject it has to hold hexamer and has to break down there were about 45 minutes. And that's how you can make it stabilize an injectable form. But it has to break down and then it starts working. And that's why there's always this lag effect between we see injectable and foam in and help us is very different products were categorized with real time rapid acting, but the name mankind comes from elmen and the guy who probably 60% of people on pumps have their own pumps that he created. So amazing gentlemen, huge contributions to diabetes and millions of people were alive today because of his work and his generosity and roven to take that forward here and kids and frozen inhaled insulin.

 

Stacey Simms  6:06

I mean, never look at dippin dots the same again.

 

Mike Castagna  6:10

I see a large factory of they don't like it, you know, we can always make different types of things don't go well.

 

Stacey Simms  6:15

I love it. Let me ask you to go into a little bit more detail about how someone who uses Afrezza would actually use it. Can you talk a little bit about like a daily routine?

 

Mike Castagna  6:25

Yeah, I mean, I know, you know, well, you're in this disease. I mean, people sometimes graze all day, and they just kind of ride their sugars and take a little bit some along the way or many boluses. And some people you know, eat once or twice a day, or some people, you know, carb restricted and everyone has a different way. And I think that you know, the big thing difference was for the patients that I see is, it's in the moment, meaning you don't have to time your meal and your insulin, when you're going to take it and where you're going to be. As soon as your food arrives. You take your first dose.

 

Stacey Simms  6:50

Most people I know who use Afrezza take a long acting insulin with it. Is that pretty standard for people with type one?

 

Mike Castagna  6:57

Yeah, I'll take one year, right? Yeah, you need a basal insulin of some sort, you know, and, and a meal time was held, we do have some patients on pumps where they will use their punches for their basil, for example, and use a phrase for real time corrections. So you know, the average patient is very different. We have some patients that are type twos, you know not not on any basil, you'll need to be on basil for if you're type two. But if you're type one, you need to basil, long acting insulin, and you need your meal time. And we know the biggest problem in this country is still mealtime control is the number one thing people with diabetes struggle with. And it's a big reason why, you know, six, or seven or eight, you know, eight out of 10 people basically are not a goal on insulin because of the mealtime control. So it's a daily challenge for everybody.

 

Stacey Simms  7:39

Can you talk a little bit about how Afrezza is kind of measured out? Because when we think of mealtime, insulin, everything's a carb ratios. And especially as I mentioned, if you're on an insulin pump, you're you're putting in the carbs that you eat. So how does that work?

 

Mike Castagna  7:51

Yeah, it's funny, I get into many debates with people because, you know, I'm a pharmacist by training, but I'm not the smartest guy. But I couldn't do all the work people do every day to influence sensitivity ratios and carb counting and timing. And all I can tell you is everyone's masks off by 50%, one direction or another. And so we have this false pretense that we're that accurate. And dosing are influenced by down to the half a unit or one unit. And the reality is your angle of injection can decrease, you know, change your absorption by 25%, your site of injection can change absorption, your your stress level can change your impact with your insulin, there's so many things that go into your daily dosing of insulin, that, you know, being that precise, down to the unit is not as accurate as we all think. And I think that's that's one of the misnomers of, you know, the timing is what you really struggle with when you're using injectable insulin, and you just don't know what's going to happen. You know, when people I guess doctors often you know, you don't have to carb count with Afrezza . And they give me funny looks. And the reality is, you know, we've never done a study where you're carb counting to get your dose of insulin, that's, you know, so becomes a four 812 dose linear all the way up to 48 units, it's additive, and you just got to be close enough. And so it's about a two to one ratio, you know, there's no direct pulmonary equivalent to injectable insulin, unfortunately, but, you know, people are taking five units of injectable insulin per meal, they're gonna need about eight units of Afrezza and maybe even 12. And you're gonna figure that out, it's your first meal or two what what the right dose is for you. But you just got to be close enough. And that's a big misunderstanding for people of how accurate the dose has to be. This is the sixth dose cartridge is a big problem. I know plenty of type one patients who take for a 1224 meal, especially they haven't Chinese food or sushi, they just they dose a lot. So I think that's something people have been comfortable, so dramatically different than anything they've ever been trained or taught in their history of living with diabetes.

 

Stacey Simms  9:36

I would assume that a prescription for Afrezza comes with a doctor's visit where someone whether it's someone who works for Afrezza, or the endocrinologist talks to you about how to do this dosing. You said you figure it out, but I've got to assume that you're not just sending people home with this inhalable and say, just test it, I mean, right somebody, you're at a ratio

 

Mike Castagna  9:59

and I think That's the key thing is, you know, having patients understand because it's odorless and tasteless. So you inhale, and you're like, what did I get it? And I'm like, yeah, if you inhaled, and I have the second, it's in your blood, it's in your lungs, it's breath activated. So you can't really, of course, you can try to mess up something. But we have something called Blue Hill, where we can show proper inhalation technique in the office on an iPhone app or an Android. And so you know, we hope that patients are being trained either by our trainers or the doctors offices, and will propagation technique looks like that's number one. And then number two is the right dosing. And as you know, individualized dosing is important and fun. And, again, that's why I say we take a lot of the math out because it's either gonna be a four or an eight, and all of a sudden, you're like, Oh my god, I'm gonna take an eight units, it's a lot it's really not when you're taking inhalation units versus injectable units and that's what people got to get comfortable with if their first or second dose so they really do figure out this meal did this or pizza is going to take longer so pick another dose and now our people do figure it out pretty much within the first week. And then there's one thing actually I want to mention because I often forget this is because injectable insulin is such a long tail it's in your body for four to six hours before it's out and that feeds into your basal rate your long acting and so when people switch over presence pretty much out of your body in a net roughly an hour and a half. Sometimes people need to adjust their basil and that's something to watch out for if you do switch to Afrezza enter you're struggling with with some of the basil rates. Some patients you know I hear people anecdotally you know, we don't want to study their the bump up their basil 10 15% on Lantus. And I've heard patients on to see that because it does have that long tail of down there in front sometimes on the basil. So there are the other metrics patients have to watch out for when they are switching to the product. It's not just the uptime, it's also something that basil where you look at

 

Stacey Simms  11:38

I have a question and I i apologize because it's a it's a bit ridiculous. I'm gonna ask it anyway.

Right back to the interview in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And our endo always told us that if you use insulin, you need to have emergency glucagon on hand as well. Low blood sugars are one thing we're usually able to treat those with fast acting glucose tabs or juice. But a very low blood sugar can be very frightening. Which is why I'm so glad there's a different option for emergency glucagon, it's Gvoke Hypopen. Gvoke Hypopen is pre mixed and ready to go with no visible needle, you pull off the red cap, push the yellow end onto bare skin and hold it for five seconds. That's it, find out more go to Diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com slash risk. Now back to my interview with Mike, where I will ask that ridiculous question.

 

You had mentioned it's tasteless, odorless, I recall hearing and I'll have to fact check this. But I recall hearing that years ago dandruff shampoo, they had to add like that tingly feeling because people didn't think it was working like it's totally fake. But people just didn't believe it was a medicated shampoo because it didn't have an unpleasant sensation. Have you thought or talked at all about adding like a flavor or a feeling to so people really know that they got it? Or is that just really bananas?

 

Mike Castagna  13:12

If somebody might company come and talk to you ahead of time? There's somebody internally who wants us to look at like cherry flavor Afrezza especially as they go into pediatrics? And the answer is, look, there's blueberry Metformin because the metformin smells awful and tastes awful, probably. So you know, those things are possible. We've never done them. And to my knowledge in this industry with dry powders, it is a question that came up recently. Is that should we be thinking about the cherry flavor Afrezza or some other flavor? And I think the answer is TBD. We I don't know what the date is on inhaling the food coloring dye or whatever. Yeah. But that's some of the stuff we have to justify that it's safe and effective. And along with FDA would want us to test but they come up recently and another internal discussion. And since you're asking, I think we'll look at it, even if maybe there's a way to even show a placebo, that's a cherry flavor or something right a one time dose to see what it's like. So I don't know. But now, but people like I said, it's sometimes you get a call, like you know, when you take a phrase of one out of four people will get a cough initially. And generally there were the first four weeks that cough goes away 97% of the people. So I always tell people, you're having a cough, like as long as not interrupting your life, it should slowly get to your first refill. And it should be mostly resolved by that your body's getting used to putting a powder in your lungs. But that's uh, you know, when people ask, what's the difference between injectable and inhaled in terms of safety, you know, you're putting a drug powder in for the first time in your body and your body could choose that. And the number one thing that's different, were injectable insulin. You know, you have other other things. You're dealing with injection sites and pump sites and scar tissue and things like that.

 

Stacey Simms  14:48

Does the body actually acclimate to the powder or is it just a question of someone gets better and used to the inhalation sensation?

 

Mike Castagna  14:55

You know, it's it's a good question. I don't know if I have a black and white answer here. bodies give. Yeah, my guess is the body's getting used to putting a dry powder in and just exit and you get used to like weed. You can drink a glass of water before and after and help you minimize it. But it's generally like that's what it feels like it's not a productive call frightening, there's not a call to happens 10 minutes later, it usually happens. We have to inhale.

 

Stacey Simms  15:17

You mentioned BlueHale , can you tell us a little bit more about what that is?

 

Mike Castagna  15:21

Yeah, so BlueHale  is to two different things. The first one that we're looking at is with the patient training device. So we can show you whether you had a good emulation or not a good emulation and show you that technique. The second version, actually, you can detect with those you put in the cartridge and hilar. So it has a proprietary software there that we can see what cartridge you put in for the adapter. And it'll tell you on your app, if you took a for a 12 or 16, how much you took in that session. And then we hooked integrate that with the CGM data. So now you can show those response curves on CGM one day and eventually I want to get into AI and predictive analytics. But we're not there yet. But we think that's the magic of what people really want, which is one that I use the thing when you live with diabetes, you just must remember and be that perfect to know exactly what those you did with them. You took it, what meal you were and then I simulated being a patient for a week. And I realized I could remember if I took a four and eight, I take a six or 620 is that 30 minutes or one hour like it was it was amazing. When you just think about life and people are human. They're there. They're human. So they're not keeping track. And they're not that accurate. They're just estimating. And that's when I talked about the dosing of insulin, like we're always estimating everything, we're estimating the time our food is going to come and how long it's going to work. You know, what the carbs are? How much am I gonna eat or drink? Like, it's all accurate? It's all off. None of it's that accurate. That to me is the thing I realized when I was thinking of doing one of those a disease, you don't you think they're perfect. They're not. They're human beings. And that's when I see one out of five doses of injectable insulin are intentionally missed. And the predominant one that's missed is actually lunchtime, which makes sense to wear out in a social environment. They don't want to inject. And by the time they get back, they forget it's probably too late. Or you're already high.

 

Stacey Simms  17:00

What do you mean by intentionally Miss? You mean? Like they people just forget?

 

Mike Castagna  17:03

No, no, they intentionally knew they should take a dose of insulin, but they're in a lunch conversation, or they forgot their insulin in the office. Or they'll have their CGM receiver on the bike, or they essentially don't they miss one of the five doses. So if you're missing 20% of your doses, it's really hard to get in control. And there's all kinds of reasons, but that's intentional omission versus unintentional. Which is I forgotten.

 

Stacey Simms  17:23

I'm curious what the sources on that that's, I mean, I don't doubt it. I'm just curious.

 

Mike Castagna  17:27

Yeah, I couldn't find it. follow up on that. I have your email, I'll look for it. Yeah, no, because I didn't believe it. And then there was a study done with one of the pens coming out that has digital connectivity. And I looked at it and I looked at the data and like, wait, if a person needs three times a day, seven days a week, that's at least 1721 doses, right? And I think the average person is taking like 1212 shots a week. And I'm like, Well, that doesn't make sense. But you realize, you know, again, we're human, people aren't always as compliant as we want, or they don't eat three times a day perfectly are the two big meals, you know, everyone does something different. So having insulin that meets your needs, and your lifestyle, I think is really important in the world. And you know, look, we like our products, obviously, we're here, we love the Afrezza. But But I also just for me, it's about using the right product that meets your needs to get you in control. And if you're doing well, great, you're gonna avoid the long term complications. But if you're not, you own your health, and you got to really try to find the best set of tools that are going to make you successful and fit your lifestyle. And, you know, obviously, we're not doing well when 80% of people on insulin on a boat. I mean, that's that, to me is the number one thing, I look at this country and say, well, despite all the adoption of pumps, and technology and CGM, we still have not made a meaningful difference in percent of people to go. And that's frustrating.

 

Stacey Simms  18:35

Way back in the beginning of this interview, we talked about Chinese food and pizza. And I'm just curious, you know, these are things that are hard to dos for, because they they kind of they come later, you know, what most people listening are very familiar with, and I think probably have their own system for dosing, whether it's an extended bolus or injecting more than once. How would you do something like that on a Friday? Is it a question of you would take what you think when you're eating, and then again, in a bit later, like, how do you account for those high fat foods?

 

Mike Castagna  19:02

Yeah, you know, I'm going to pick on Anthony Hightower, who I know you interviewed before. So I actually met Anthony on a bed over social media. And he had showed me your servers where he ate pizza. So I'll pick on him because I want the public discussion here, sir. He pizza and his sugars are basically flat over the two, three hours post meal. And I said, I'm like, shocked. He's like, this is something people cannot do naturally on the history of injectable insulin, they they always struggle. And when you eat pizza, you're going to struggle not just for hours, but potentially for the next day because just throws everything off. I think in his case, right? I've watched him he took a big dose up front, you know, let's say he's gonna take 12 units of injectable he took 24 units of Afrezza. And then he washed her wasn't an hour, and then an hour she was above where he started. He took another dose, maybe took a four and he has to tap it off. And then an hour later, just thought was too high or not right. But you can always keep your sugars in that kind of control. That's one of the studies we did back in 2018, called this test study was showing that you could do as soon as one hour with no more hyper risk. And that was a big concern of people, how can I do that one hour, well, pretty much hit its peak effect in one hour. So if your servers are still moving in the wrong direction, you can correct them at that point. And so that's where someone on pizza or Chinese food, like, yeah, it's a high dose up front and may manage it through the whole system. Or they may see an hour or two later, they're still high and to take another dose, that they can bring it down at some point.

 

Stacey Simms  20:20

Alright, let's talk about the big questions that people generally have. And that the one I hear the most is, Is it safe? Right? Is it? Is it okay to inhale this stuff into my lungs? Can you talk about the studies that you've done?

 

Mike Castagna  20:32

Yeah, I think if we were able to make inhaled insulin 100 years ago, we'd be scratching our heads those who would inject themselves three times a day. So I think it's just an unfortunate matter of 100 years of difference. But we studied a phrase that probably over 3000 patients 70, some trials $3 billion over 20 years, like, that's how much money time and energy is going into prove the safety and effectiveness of this product. And you know, and I tell people like you know, there is no data to say that it's not safe. We have all the rodent studies, all the CT scans that along looking for fibrosis looking for pulmonary issues, we found nothing. So it doesn't sit in the lung. There's an old product called exubera on the market years ago. And exubera was a sugar based manatal formulation which got absorbed over time into your lungs in a friend this case, the it's got water and human influence. So when we ask about what ingredients are you worried about the human influence, human influence, it's the whole AI base, but it's human influence characteristic, and water is purified. So we know that safe and the other only other carrier in our products SDK p which is a excluded product that is not metabolized in the body, it's just 100% extruded. So you know, there's three ingredients in our product. One is human insulin, one is water, and one is tkp. And SDK p comes out of the system. So I don't I don't think the body is afraid of human insulin. And what are so I think, you know, I always struggle with this topic. Because, you know, what happened is there was some lung cancer cases and Newser, were they there was a couple of our data. But you know, in the seven years since FDA approval, we've seen no safety signals come up in the postmarketing. We have almost 10,000 patients on the presidency. I know people in the drug for 1012 years. And so, you know, we don't see anything that gives us concern. And we're going into kids now, who would have to take the drug for 40 5060 years. So I think it's hard to prove something that you've never seen. But safety comes with time. And I think the good news is product has been approved by the FDA for seven years now. And we've not seeing any safety signals in our database, which we look every year, our rems program ended early by the FDA and and we've continued to show good data and all the studies we've done, we've not seen anything new come up in our anywhere safety issues. So if you're, you know, the populations, I would say if you have COPD, and asthma, this is not the right drug for you.

 

Stacey Simms  22:41

So a dumb question, though. If you have diabetes, and you smoke, can you get an Afrezza? prescription?

 

Mike Castagna  22:48

We would say you should not? Yes, we have a warning for that.

 

Stacey Simms  22:52

Well, I just wanted to be clear that there was an actual warning, it wasn't just a please don't because it's bad for

 

Mike Castagna  22:57

warning. Don't

 

Stacey Simms  23:00

tell me about the study with kids. Because I've got one, I've got a 16 year old who was quite interested in this product.

 

Mike Castagna  23:06

Yeah, no, I just found out Unfortunately, the dagga three year old cousin in the family have just come down with type one. And she will, she'll be four and our studies gonna go down to four years old to 17 years old, when we launch it. So I'm excited, we had to do a study to show that the pharmacokinetics and dynamics of inhaled insulin are similar in kids as it as adults. And so once that study was complete, we we wrote a protocol down to the FDA and said, We'd like to go into the next phase, and now run a larger study head to head against the standard of care. And the FDA has pretty much signed off on that protocol at this point. And we have contracted with a third party to now run that trial. And we'll be having our investigator meeting here in next month. And so hopefully, we'll see our first patient in the four to 17 year old range, probably here in September, October time frame. So super excited, long time to get here took too long from my perspective, but can't wait to help kids. But our founder Outman invested, he became very wealthy when he sold the insulin pump company. And he took $1 billion of his own money and made Afrezza inhaled insulin because he felt the problem with the injectable subcutaneous delivered insulin was it just took too long to work. And you know, somebody has an hour lag effects from food. That's real timing, it's always hard to catch those two even. And so he really wanted to make an inhaled insulin that really mimic a physiologic insulin that you see in the body. And he felt the only way you could get there was through a dry powder, lung delivered instantaneous insulin, you can also get there through an implantable pump. But that didn't work out when they tried that back in the 90s. I recall. So people got infections and things like that. So that would that didn't work. So they really were going to get a in my mind that physiologic inform that's gonna be monomeric stabilized is probably going to happen only through the inhaled route. So we have we have to get comfortable with this from overall efficacy and safety. Otherwise, you're not going to really ever get this control that people are looking for real time.

 

Stacey Simms  24:55

No man, he lived long enough to see Afrezza approved, didn't he?

 

Mike Castagna  24:59

He's All approved. And unfortunately, I'm here because he died on my daughter's birthday. So I was debating whether to come to mankind or not. And I'm very superstitious, the Al Mann pick the day he died. And he died February 25 2016. And then they made decision to join and help save the company and save a frozen kick on the market. Because I think, you know, I saw all these wonderful patients stories online. And I said, these patients like Anthony Hightower is one of them, what they did something that no one else did, they did something we never did in our clinical trials. And so I got to talk to them. And I realized we just didn't dose it properly. So you go back to the development of the product, a lot of the challenges were under dosing because everybody's trying to compare one to one to injectable insulin, and therefore one of underdosing patients, and therefore, they got equal outcomes didn't do any worse than injectable insulin per se. But could they have gotten better outcomes if we dosed improperly? Right? And I think that's, that's the state of we're now trying to generate to show that the kids buddy now be head to head, or if he knows him properly, what happens? Right, and that's we're really focused on right now.

 

Stacey Simms  26:01

Is there anything that you wanted to talk about that I haven't answered?

 

Mike Castagna  26:04

No. I mean, we're only available in the US, we're in the process of going to Europe. So I don't know if you have any. Yeah, we do. Though, so I know, we have patients on a name patient basis in Germany, and UK and Italy. So you know, their governments are actually important a president and pay for it. We're in the middle of filing for Australia. We were approved in Brazil, and we're going to India so so you'll see this more and more around the world. You have listeners in those markets. There's not gonna happen this year. And hopefully, the next year or the following year in some of these markets, we'll be looking at bringing it to more patients in those markets.

 

Stacey Simms  26:37

Well, and just got a big approval here in the United States for Medicare patients. Right.

 

Mike Castagna  26:42

Yeah. So that one, I, you know, we get a lot of questions on that one. And so you know, this market CGM patients were told you need to be injecting yourself, I think four times a day, we couldn't get your CGM. So then doctors were not getting patients Afrezza. And so we were able to ask CMS to change that, and they did to the year but rather haven't done they're not done. And so here we are a year later that that policy is now being updated. I want to thank CMS and all that you're helped make that happen. And I think it helps in people in CGN, because I understand that removes some of the other requirements to get CGM, even an injectable these patients so little mankind was the one who started that process. And then we're able to help a lot more people. So it's great. And we're trying to get Medicare $30 a month insulin. So we have Medicare listeners. And you know, we're trying to make sure we help get patients access that are on Medicare. I think that's important.

 

Stacey Simms  27:33

That doesn't stack up in terms of cost in the United States.

 

Mike Castagna  27:36

Yeah, I mean, you know, fortunately, the billion dollar debacle in this country is drug pricing, as we all know, and as a pharmacist, I know firsthand when people go through an LMS they're on how many co pays are on. And so we really have tried hard to make sure that no patients pay no more than $15. So we have copay card programs, we actually have a free drug programs, they really can't afford it, we'll give it to you for free. If you're going through the prior authorization process, we give it to you for free while you're going through that. So we all want payers and reimbursement to be the excuse of why a patient can't get access to our product, we think that people will do well on our product, we're willing to take that bet that they'll see good results. And if they see good results, the payers will usually pay for it. And it says you may or may not know that there's a monopoly in diabetes between two insulin players, and three payers, who are all working together to make sure there's no competition. You know, that's unfortunate, but they pay to make sure that patients have a difficult time getting Afrezza . And that's always one of my frustrations of competition or diseases. You know, 400 years, we've seen the precise the dispensing from 20 hours a while 95 and let's say miles, hundreds of dollars. You know, for me on the payer side, we want to make sure patients we try to bring it down to about $15 on commercial and Medicare, you know, they generally pay comparable to what they would and some Medicare plans a little bit higher I can you know, that's a hit or miss when you when you go to submit for reimbursement, but we try to do everything we can to make sure people will have access to our product

 

Stacey Simms  28:57

$15 for $15 for commercial patients, no, no, but what is it? What is it for? What do you get for $15? Is it a month? Is it a

 

Mike Castagna  29:05

my week? Yeah, whatever, whatever. You gave two boxes, three boxes, whatever is on that prescription for that month,

 

Stacey Simms  29:10

for the month. Okay, I didn't mean to interrupt you.

 

Mike Castagna  29:12

I don't think I know, I was gonna say I forgot we actually have a cash pay program. And people are paying cash for their insulin. And we do see several 1000 people a month paying cash for injectable insulin, we have influenced savings comm where it's $99 a month for frezza. And you know, can you a bigger box or more doses, you might pay 199 but we tried to make the cash price, you know, roughly $100 a month. If we if you had no insurance, for example.

 

Stacey Simms  29:37

I'm not sure you can answer this question. But I will ask it anyway, is the biggest challenge for you all the failure of exubera? Is it just people not knowing what this is? You know, as you move forward, you know, what is the big challenge to get more people to adopt us?

 

Mike Castagna  29:51

I mean, for me, the biggest challenge are the doctors. We created a program we basically gave it for free to patients for two years for 15 bucks. Like no no priority. Nothing, we just charge you $15. And that didn't change a lot of doctors from jumping on board. And doctors just don't know our data. And so they think this product doesn't have a lot of data behind it. And they don't know our data, they don't know. Like when I would ask a doctor, how fast from the time you inject your bolus, your pump to the time you look on a CGM, that your institute sugars are coming down, and I get in these endocrinologist, I'll get five minutes and mediate and 20 minutes an hour, the answers, I need 90 minutes, 220 minutes, that's the answer. And so they don't even know the pharmacokinetics and pharmacodynamics differences between injectable insulin inhaled, and then you have doctors, right, you know, calling some of these ultra acting drugs faster, we'll look at the package inserts, they're no faster than their old products. And there's a lot of misperceptions out there some of these newer launches of old tracking insulin, and to me they're, they're really not that much different than the predecessor and look at the data, you know, there's not a faster, there's not dramatically faster onset or offset or, you know, a one c lowering or weight gains on very much the same. So, no, I think it's just a matter of doctors trying to really understand the data.

 

Stacey Simms  31:02

Before I let you go, are there any plans in the future to change anything about the way it looks? or different colors? I mean, I know it sounds kind of silly, when you're just trying to get people to adopt the new technology, but from a user standpoint, and look, I know, you've heard all the jokes of my friends who use this will make you can't comment on designers. They don't say anything, they'll make comments like, you know, taking a hit or whatever, right? I mean, it's it's inhaling, it's this little thing that you're, you're inhaling, it looks a certain way. I'm curious if the cosmetics of it are anything that are on your radar, or needs to be improved even?

 

Mike Castagna  31:36

No, I mean, I think when you spend, you know, $3,000,000,000.20 years doing a new drug development or taking 100 year old product and reinventing it, you had to get that right in terms of device design and airflow dynamics and consistency. And those. And I think all that's really important because, you know, misperception that oh, my God, it's going to be less can be more variable than injectable insulin. And the data just doesn't support that statement. And so for us, we have one of the world's most unique installation platforms across the entire pharmaceutical industry, we deliver more power to the lung, the most technologies out there. So that's why you can get consistency, those two those, and you don't have a lot of variabilities, because our technology and our device is called a low velocity inhaler. And what that means is there's a resistor that helps slow the powders as they're coming out of the inhaler. So they get deep into the lungs. And that's why you get that nice absorption curves that we see. And we're most inhalers or high gloss inhalers. So it's just enough sucking air as hard as you can, and hoping you get you know, 20 30% of lung drug into your lungs, and mostly stuck in your teeth to device in the back of your throat. That's most dry powder inhaler technologies out there today. And so that's something unique to us and our technology and our device, they all work really well together, you couldn't just take our powder and put into another inhaler, and or just as well would not work. So yeah, we're pretty happy with the device I we are going to other diseases. So you know, we're we're going down to the FDA with our partner for an approval in October for pulmonary hypertension patients. And we have several other orphan lung areas we're going into to help more patients with lung disorders. So you know, I think that's important, like our, our technology, our inhaler, our platform is gonna be used in more and more patients over the next decade than just diabetes.

 

Stacey Simms  33:13

Well, that's what I was gonna ask is, if it works, so well, you know, will you partner with other medications? That's great to hear.

 

Mike Castagna  33:18

Yeah, you know, we're really busy, we probably have about 10 to 12 formulations of products working on this year and five marone products in the pipeline. And so it's it's a really good time of mankind, we're super excited to be here. And it was a turnaround, the company struggled for many, many years. And we're on our way to success. And I think, firstly, you'll be you'll be hearing more about it. So I know it's been a long time. And maybe you didn't talk to us yet. But hopefully you'll talk to us more and more as we continue to generate new data and more more patients start using it.

 

Stacey Simms  33:45

I'd love to, I'd love to, especially with the kids programs. And like I said, I've got a 16 year old who is very curious about this. And, you know, once once safe and effective. Once we get all that safety stuff in here. It's mom says, you know, I'll definitely I know, I would like to check it out. So I really appreciate you coming on and spending so much time with me and my listeners and explaining all this and we'll definitely talk again. Thanks, Mike.

 

You're listening to Diabetes Connections with Stacey Simms.

More information at Diabetes connections.com. Always on the episode homepage. I also have a transcription as well, sometimes those podcast players don't display the show notes and the links. So if you have any trouble, just go back to Diabetes connections.com. And I just want to say that I did reach out to have Mike or somebody from Afrezza on the show. And you heard him say, you know, it's been a while, um, you know, it just took a while to connect to the right person. Let's just say that, and I will have them back on because lots of good stuff is happening. As you heard.

I want to take a second and kind of explain Monomeric insulin and, you know, I'll be honest with you. The scientific points here are really not my strong suit. I'm a communications major, right. So I did what I always do, and I am People who know a lot more than I do to help me explain it. I went to the Facebook group Diabetes Connections as a group. And you know, I said, How do you explain monomeric insulin I know it's faster. And Tim Street, who is just wonderful and runs the diabettech.com page that's like diabetes tech diabetic, and I'll link that up as well. He provided this explanation, which really brought it home for me, and boy, I hope I'm pronouncing everything correctly.

So Tim wrote, insulin naturally links its chains together to form stable molecules. Typically it connects two together and then links three of those two chains together. Additionally, to create six This is highly stable and described as hexameric. In order to use these chains, you have to break the molecules apart to single chains, which are monomers. Typically fast acting insulins are stored as dimers, two monomers connected, which are easier to split, then hexamers. by storing the insulin as a single chain, a monomer, the body doesn't have to break the chains to instantly use the insulin molecule it receives. And that is why Afreeza wraps the monomeric form in the capsules, to make it ultra fast.

Thank you, Tim, that actually made a lot of sense. I gotta tell you, we have the smartest people and the kindest people in this Facebook group. If you're not there yet, and you want to join, come on in, I highly recommend it. You don't have to be a Tim Street. You don't have to be able to explain these concepts. You do have to be nice. And you do have to not post a lot of drama. I'm very tough on my diabetes groups. I run two of them. They're very nice and friendly places for a reason. But Tim, seriously, thank you so much. That was a great explanation. And I really appreciate it.

Diabetes Connections is brought to you by Dexcom. If you're a veteran, the Dexcom g six continuous glucose monitoring system is now available at VA pharmacies in the United States. Qualified veterans with type one and type two diabetes may be covered. Picking up your Dexcom supplies at the pharmacy may save you a lot of time to connect with your doctor for more info Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. It's all@dexcom.com backslash veterans, and all the information is always at Diabetes connections.com.

Before I let you go, just a quick note about back to school, I have never done less. I packed up a bag for Benny to bring to the nurse. He brings his daily supplies with him every day in his backpack. But of course, like most people, our nurse has backup supplies for him. So I put those together. He brought them in along with our plan or orders, you know from our endo. And that was it. I haven't set foot in the building. I'm not sure when I will go in or if I will go in probably when you forget something or they run out there. But I've never done less work. You know, I did a lot of work over the years to go to school and meet with people and he's got it. So not much to report. It feels very strange. All right.

Please join me this Wednesday when we have our in the news live on Facebook every Wednesday at 430 and then we turn that into a podcast episode. I love doing that. It's been a lot of fun. I hope you're enjoying it. Give me your news tips. If you've got any from this week, just email me Stacey at Diabetes connections.com thanks as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here in a couple of days until then be kind to yourself.

 

Benny  38:27

Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

Aug 3, 2021

Anticipation just keeps growing for the new Omnipod system, still waiting for FDA approval. This week, we talk to Dr. Trang Ly, Senior Vice President & Medical Director at Insulet Corporation. We’ll get an in-depth run through of the features of Omnipod 5 with Horizon, what makes it different from the other hybrid closed loops already on the market, and many other questions you all had.

Our previous interview with Insulet CEO Shacey Petrovic 

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Check out Stacey's book: The World's Worst Diabetes Mom!

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Episode Transcription Below

Stacey Simms  0:00

Diabetes Connections is brought to you by Dario health manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

 

Announcer  0:21

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:26

This week anticipation growing for the new Omnipod 5 system still waiting for FDA approval. Many of the people behind it have waited a long time to knowing the promise of closed loop systems for people with diabetes and their families.

 

Dr. Trang Ly  0:42

I still remember the very first time the very first patient that I put the system on and, and I was watching that insulin being delivered. And I remember just like hugging the participants, Mom, because we just both knew how incredible this was going to be if, if this could reach masses of people.

 

Stacey Simms  1:04

That's Dr. Trang Ly, Senior Vice President and medical director at insulin Corporation, we'll get an in depth run through of the features of Omnipod 5 with horizon. What makes it different from the other hybrid closed loops already on the market and many other questions you all sent in.

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. You know I'm always so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. As you listen to this particular episode couple of things to keep in mind, Omnipod 5 with Horizon the full name of the system we are talking about today is not out yet it is not commercially available as of this taping. This episode is live on August 3 2021. The FDA is still mulling it over. If you are looking for even more information and some of the history of this, it may be worth going back to our first episode about this system that was almost exactly two years ago with the company CEO Shacey Petrovic. And I will link that interview up in the show notes at Diabetes connections.com

COVID, really through this submission for a loop with the delays. And I didn't mean upon there with the word loop. But I know there has been frustration in the community. And there's frustration with an Insulet as well. But it really is close. Now, if you are not familiar and I know we have a lot of new listeners who've joined the show more recently. I know some of you have been hearing about this for years. But bear with me for just a moment as I explain it very quickly. You've got your Omnipod pod. That's the thing that holds and infuses the insulin, it's an all in one. It sits on the body, there's no buttons, there's no display, there's nothing to read, you've got your separate handheld controller, the thing with the display on it and the buttons are the touchscreen of how you actually control the pod when it comes to giving insulin for meals or for correction doses, that sort of thing. And for Omnipod five with horizon, you also have the Dexcom G6, the continuous glucose monitor, the pod and the CGM work together to give less or give more insulin to try to keep you in range. Now that is very, very simple. But Dr. Ly will explain it in much better detail. And I will also link up more information as always in the show notes. If you haven't ever seen what this looks like if you're curious, we'll link you up to all of the information.

Dr. Trang Ly, my guest is the Senior Vice President and medical director at Insulet. Corporation, she leads their Omnipod five automated insulin delivery system clinical program before her time at Insulet. Dr. Ly was a pediatric endocrinologist in Australia. And toward the end of the interview, we talk about how personally knowing families that will benefit from this system and systems like it, you know what that is like for her.

So my interview with Dr. Ly in just a moment, but first Diabetes Connections is brought to you buy Daario health and over the years, I finally managed diabetes better when we're thinking less about all the stuff of diabetes tasks, and that's why I love partnering with people who take the load off on things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends with suggestions on how to succeed get the diabetes management plan that works with you and for you, Dario is published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash diabetes dash connections.

Dr. Ly, thank you so much for spending some time with me. My listeners are very excited to get all the information that they can about this. So thanks for being with me today.

 

Dr. Trang Ly  4:58

Yeah, great to be program. Thanks, Stacey

 

Stacey Simms  5:01

you got it. Let's start with an overview. I know that most people listening are probably very familiar with what we think Omnipod 5 with horizon will be. But can you start by just giving us an update and taking us through what is in front of the FDA for approval as you and I are speaking today?

 

Dr. Trang Ly  5:17

Yeah, so happy to do so the Omnipod five system that you're referring to is Omnipod, or Insulet, first automated insulin delivery system. So this system, he has previously known as horizon or the Omnipod, five algorithm on the pod itself. And it talks directly with the ICGM, which is the Dexcom G6 sensor, and also has a separate controller device as well to be able to remotely deliver boluses and stop and start automated mode, the system that some kind of FDA just requires you to wear a pod and a CGM to stay in automated delivery, because the algorithm is on the pod itself. And I think that is the key feature of the Omnipod five system,

 

Stacey Simms  6:14

a lot to break down there. And we'll get to each of the components. But let's start there with the kind of the brains of the operation being on the pod. What does that mean, in a practical sense when someone is wearing the system that they don't have to worry about it stopping that sort of thing?

 

Dr. Trang Ly  6:27

Yeah. So the The key difference between previous products is that with our current Omnipod dash and earlier versions of Omnipod, the pod delivers the basil programs and the bolus delivery that the user has initiated. And so insulin is not under automated delivery. But in our future system with Omnipod. Five watch the pod does is that takes the CGM value which you wear on body and so that value directly communicate with the pod itself. And then the system and the algorithm on the pod takes that CGM value and determines how much insulin you need every five minutes. If you're running high, and you need a little bit more influence, the pod will automatically increase insulin delivery. And if you're at your target or dropping low, it will augment insulin delivery, so it might suspend or it might reduce the insulin that you need. That is the key difference between the product that is available today. And the future with Omnipod. Five,

 

Stacey Simms  7:38

you would still use the PDM or the phone and we'll get to that to give yourself a meal bolus or a correction bolus.

 

Dr. Trang Ly  7:47

That's right. For those instances where you're about to have a meal. Or if you're running high for whatever reason, like you underestimated carbs earlier, and you want to give a manual bolus, you can do that any time. And you would do that by using the controller device or PDM, to enter in your carbs, and use our bolus calculator to deliver that insulin. So all of those features are very similar to the current production on the pod dash, which again, is very similar to our earlier version. So that's on the pod.

 

Stacey Simms  8:24

Let's talk about the algorithm a little bit. I know there's a lot that's proprietary here. But I'm curious, we've seen over the last couple of years, Medtronic come out with a you know, an automated device. Tandem has control IQ, I believe my listeners are pretty familiar with the workings of those, what would be the biggest differences between how those systems work and how Omnipod 5 with horizon will work.

 

Dr. Trang Ly  8:49

I'm very familiar with those algorithms. Because I, you know, in my previous life, I worked very quickly with those systems as they were being developed. And so I say, you know, having been in this role for the last five years and been running the clinical trials. For them, I can tell you that the main difference I'd say would be that our algorithm, you can set the target glucose for whatever time of day. And the range we have is between 110 to 150, in 10 milligram per deciliter increments. And you might have a family where you want to go overnight, you want to run out and 20 because you feel more comfortable at 120 overnight, and then but during the day you want to run at 110 you can set up a profile so that the algorithm augments insulin delivery to your preferred target glucose level. And, you know, we we knew when we were coming to market that we were not going we certainly weren't the first and not the second product market. So we knew that we had to deliver a level of personalization for our users. So we really listened to what people wanted. And people do want that level of personalization and customization. And so we implemented that design feature into our clinical trial to demonstrate that our system performs very safely across those different target glucose level. Until our clinical studies which show we'll get into Dude, what was tested across a very wide range of patients, for initially, we did a beam study, which was for patients aged six to 70 years of age. And then most recently, just a couple weeks ago, we were reported on our preschool age participants who were between two to six years of age, and they see I'm sure you'll appreciate that they're young. glucose control is just very variable, very unpredictable. And, you know, I think strength of our algorithm is that it works very well, even if you, you know, Miss or skip a bolus, occasionally, you know, that algorithm is going to kick in, it's going to deliver, you know, a decent amount of insulin to get you back in range, it's going to happen immediately, but it's calling to do its best to keep you in the range as much as possible. And similar, I'd say to the other systems, especially, I'd say more second generation systems is that we are getting, you know, excellent timing range, especially in the overnight period.

 

Stacey Simms  11:32

It was I laughed a little when you said preschool, as you know, My son was diagnosed before he was two. And whenever I see studies with little kids that work so well, it's so exciting, because you know, that age group, they can't even tell you when they're feeling weird. They can't stomach my son couldn't even pronounce the word diabetes. So it's a different age group altogether. So I was thrilled to see those results.

 

Dr. Trang Ly  11:53

I know, well, I have two kids under five right now, and they don't have diabetes. And I have no idea how much they're going to ace or whether or not you know how much activity they're going to do. And I just can't even fathom how challenging it would be to have a child with diabetes. And are they low? Or are they or as I just grumpy? asleep,

 

Stacey Simms  12:18

I didn't have enough. Oh, my goodness, I should have said this towards the beginning. And I know, I know Dr. Like that, you know, this, we use control IQ. We're very happy with the Tandem, but we're not rooting for any system here. I think that the and I say we I mean me, I it's so exciting to see all of these systems beginning to come to market beginning to really have an impact to have differences in their algorithms so that people can pick and choose exactly what they want. And we're just at the beginning of it. So I am so excited to see the study's going so well, I have a couple of questions about what you've already mentioned, on that target of 110 to 150, just to be crystal clear about it, you're talking about not just putting the pump into say using Tandem, for example, exercise mode or sleep mode, you're seeing in you know, my weekday profile, for example, I know my son plays basketball every day from three to seven so we're going to create a profile that changes his blood glucose target for that period of time, perhaps starting you know, before he plays a little bit and then extending after and that's an actual profile in the pump that you then could change. Okay, perfect. All right, that's really interesting. Is there an Is there a and I hate to use Tandem is word sorry, is there an exercise mode or a sleep mode? Or is it just the user sets it as they want?

 

Right back to Dr. Ly answering that question. But first Diabetes Connections is brought to you by tchibo hypo pin and you know, low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're gonna pass out there are a lot of symptoms and they can be different for everyone. I'm so glad we have a different option to treat very low blood sugar Jeeva hypo pen, it's the first auto injector to treat very low blood sugar chivo Kibo pen is premixed and are ready to go with no visible needle before Jeeva people needed to go through a lot of steps to get glucagon treatments ready to be used. This made emergency situations even more challenging and stressful. This is so much better. I'm grateful we have it on hand find out more go to Diabetes connections.com and click on the G book logo g book shouldn't be used in patients with pheochromocytoma or insulinoma visit Jeeva glucagon comm slash risk. Now back to Dr. Ly. Going into more detail about how the Omnipod 5with horizon system works.

 

Dr. Trang Ly  14:36

Separate but yes, what you describe is exactly how our product works or during the day. It might be that you want your son to run out 110 through the day but maybe between the hours of three and seven you'd run at 140 that is an option. And you can set that up pre programmed so that he doesn't have to remember to do that every day or you can run in what we call a hyper protect mode, which is work similarly to like attempt days or that you you'll be familiar with. So that's more of an ad hoc, oh, I feel like exercising for the next two hours, I'm going to set my program in hyper protect mode. And hyper protect, what the system does is it adjusts your target glucose to 150. And it actually gives you less insulin than your basal insulin. So you're running essentially with less insulin on board than you would normally would during that period. And so we we did a lot of studies to kind of land on that design. And we feel that he does a good job of preventing hyperglycemia for, for people without problems asked afterwards. So it has worked well, because it doesn't, you know, sometimes, when you're preparing for exercise, you might take a snack, and that drives your blood glucose up. And then if you have a really robust algorithm that might kick in and give you a fair amount of insulin. So that's what we were trying to avoid with our design was that not just that the setpoint is elevated, but also that the system can't give too much insulin during that time. So that's sort of our equivalent exercise mode. We don't have anything called sleep mode. But as I said, our set point of 110, you know, once were created will be the lowest available in the United States.

 

Stacey Simms  16:30

One of the things I've learned recently, and I I feel like I haven't seen this reported very widely, is that, unlike Tandem control IQ, the Omnipod system, the Omnipod, five with horizon, learns the user it changes, it has a little bit of I guess I call it artificial intelligence. Is that correct? And can you walk me through what I'm saying? What I mean by that? Yeah.

 

Dr. Trang Ly  16:56

Yes, yeah, I think I think you're I'm getting to a really key difference between our, our system and others. So with, with our system, when we, when we were developing it, we wanted to reduce the work that comes with diabetes, as well. And so you know, a lot of the work that comes with that is adjusting those or rate adjusting, you know, all the settings and things like that. And so our system, initially, when you, when you have it out of the box, it does rely on your basal rate to start off, automated insulin delivery. But over time, the system learns through the turtle Gary informed that is delivered by the system. So the system knows about this, and can rely on this information, because it's reliable come through the system to augment insulin delivery. So you might have a small child who only has 10 units of insulin per day. Now system is not going to give too much insulin, based upon the fact that it knows that in the last few days, it's never given more than 10 units a day. And so the safety constraints are personalized for that user. And on the opposite end of the spectrum, know, we have users that use 100 units a day. And in that case, the algorithm knows that it can give a lot more insulin, and this person will tolerate it quite fine. Because you know, when you have insulin is unlikely to make much difference for this person who takes 100 units a day. And so as it accrues that information over time, the algorithm does adapt the ability to know how much insulin it delivers based on that information. So what it means is that, in order to get the results we got, you know, you're not having to tweak basil rates on an hourly basis. Sometimes I've seen, you know, people have different basil rates every hour. And what we're really striving to do here at Insulet is create products that reduce burden for people. And that includes including, you know, optimizing settings, so that people can get, you know, so that everybody can get good glucose control and, and not have to rely on perhaps educators and clinicians at the academic centers who are familiar with these devices to really get those good results.

 

Stacey Simms  19:38

So I'm just trying to understand the the automatic adjustment that you're talking about there based on the total daily insulin. So if after a few weeks of using Omnipod five with Horizon, a person should expect to not adjust basil rates should like what should they be seeing because if like let's say as someone has six different basil, right When they start on the system, what what's happening? Right? What's going on? Are they Is it like the other systems where it's adjusting every five minutes, it's giving you boluses. If needed you How is the smartness of the of the pump working there?

 

Dr. Trang Ly  20:12

Yes, if you had six different rates running for 24 hours, initially, the algorithm would take that information and would have bent in front of every every five minutes based upon the inputs that were provided to the system, as well as how your CGM is tracking how much insulin on board, you have all of those things. So at all times, the system makes a influence decision every five minutes. So that occurs, as soon as you put the system into automated mode. That happens all the time. And when people ask me about order corrections, I say, yes, this system automates and make some adjustments every five minutes to drive you towards your target glucose. So corrections are incorporated within the system, we don't consider any difference between basil modulation and what was modulation of insulin is insulin. So every five minutes, you're getting a essentially order correction if you need it. But that works very similarly to, you know, the systems that are currently on the market. And over time, the those six basil programs that you have really not utilized in the system at all beyond that first part. And so if you are running high for whatever reason, and you know, you you tweak other things, but not your basal rate. And so I'd say in in that way, you know, our system is more similar to the Medtronic system. And in that way that the basil rates do not directly inform automated insulin delivery. But things that are still under your control at all times is influence coverage, share your correction factor, target glucose, correct above all those settings that have always been within on the pod, and also very similar across many bolus calculators all stay the same. So you're always going to be sort of always going to be directly in control of all those fat. And so if you're running high, it might might be that you need more corrections over time before your system adjusts to that higher insulin requirement. But

 

Stacey Simms  22:34

you're in control, oh, wait, target number, but only only down to 110? That's right. Gosh, I have so many questions with the automated systems. I think you mentioned this, but I'm not sure. What about insulin duration, is that something that the user can change? Or is that something that is set,

 

Dr. Trang Ly  22:50

so there, so the Dow system, the user can change that, and how it manifests itself is that it will inform the duration of insulin action for all those manual boluses that you deliver. So if you're someone who's very sensitive to insulin, and it hangs around for a really long time in your body, and you have a six hour early insulin action, then you can program that until you know your bolus of insulin that you deliver at 6am in the morning, that's going to take till midday before it disappears from the system, as it knows that all of those will still be accounted in the same way with the duration of insulin action that you provide to the system. In terms of the automated insulin delivery, we have the intellects, proprietary duration of insulin delivery, that is the input to the insulin model from which we deliver that insulin that is consistent, and is just one value. And it's the same value and the algorithm that's been tested across the board from in all of our clinical trials. So that does not change, and is within the algorithm that dictates that five minutes away insulin delivery.

 

Stacey Simms  24:11

To me, that was one of the big surprises of using an automated system. We have, you know, My son is 16. And we started using an automated system when he was what 14. So you're in the middle of those fabulous teenage years, and he's using tons and tons of insulin. And it seemed to me that we needed an insulin duration of like two to three hours. And when they switched it on Tandem. It's it's five, I really fought on that thinking this is going to be a disaster, and it was fine. It worked really well. So it's one of those interesting things once you get an automated system and realize this is my opinion, once you realize how much work you were doing to try to stay in range. It's kind of nice to let that system take over once you trust it. And I would assume that that's what you found in these studies. I mean, you mentioned that people spent more time in range, but let me give you the floor. Take a minute or two to talk about. I've seen the study You know, you've been kind of putting them out with different age groups over the last couple of weeks and months, take a moment to brag about the studies.

 

Dr. Trang Ly  25:08

Yeah, we're so grateful to the diabetes community who really gave this product life through our clinical studies. So I'm just deeply grateful for every patient and family who took part in it. Because without them, you know, be a product, but it wouldn't be Omnipod. Five. And so it was really a ton of work that we I feel like has been many years in the making. Yeah, we've worked really hard on this algorithm to get it pretty much as good as it could be. And, you know, back in 2019, as we were preparing to do these clinical studies, I really wasn't sure about how our results would stack up. But I have to say that I'm completely blown away by how well our algorithm has performed. So in the talk first about our six to 70 year old age group. So the first lot of results that came out came out in March of this year, we had essentially two groups. So we had the children, which were six to 14 years of age, and then the 14 to 17 years of age, which is the adolescent and adult group. So I was just covered the adult group there. So we saw and time in range improvement to 74% in the adult Group, a once the reduction down to 6.8%. And then very minimal hyperglycemia. If you look at our hypo compared to other published data out there, it's the lowest hypo, which we measured by time under 70, compared to all the other groups. And in terms of the children, there's six to 13.9 years of age group, we got to a timing range of 68%. And this was equivalent to 3.7 hours per day improvement. So really remarkable improvement in timing range. And in terms of a one see improvement, we got that down from 7.7%, down to 6.99%. So really remarkable reduction in a one C. And what's super, super exciting is that just recently at Ada to see or wishes a couple of weeks ago, we showed that in the extension faces after the main three month pivotal study, everyone could continue using it if they chose to. And we saw a further reduction in a one C, which is just incredible. So in both the adults and children, we saw a continued decline in a one C. So just really super exciting to see that, you know, our product continues to be helpful for these patients with diabetes.

 

Stacey Simms  28:05

Let's talk a little bit about the the setup of the system. You know, when in the very beginning of the interview, I asked you to kind of describe it. And it's Omnipod Dexcom, G6, and then a controller of some kind. Let's talk about the controller. Last I had heard this was going to be the PDM. If needed, the more traditional I guess you'd call it but you'll expLyn it to me or an Android phone. Tell me about the controller in the short term. And then we can talk about what you're planning.

 

Dr. Trang Ly  28:32

Yeah, that's right. So we will have the controller device. So we have an Insulet provided controller, which our were choosing to use that word over PDM. Because not everyone knows what a PDM is that yes, that controller device, we will always ship with our product. And so you will be able to use that in a locked down device which can only communicate with pods and can't really do much else with it. And but users will have the option to download an app from their from selected android phone to also have that same experience. So it's the exact same app that would be that would exist on the controller. And you would be able to essentially control your parts and replace that controller with the Android app.

 

Stacey Simms  29:25

I should have said the PDM stands for what personal diabetes manager. That's right. Okay. So that's an antiquated term now, though, so we'll put that aside. But to be clear, so if I have the right Android phone, you're seeing this is not a lockdown Android phone, I can get this the app and I can use my personal phone to control my Omnipod five with horizon system.

 

Dr. Trang Ly  29:47

Yes, that's right. That's what's currently in front of FDA right now.

 

Stacey Simms  29:51

Do you know and again, if it's up to them, or you can say I know we're limited sometimes what models or is there a list somewhere?

 

Dr. Trang Ly  29:57

Yeah, we haven't. I don't think We have indicators or phone models that will be available at any time. But we'll do that soon after launch will list those out that they will be as the first offering selected Android phones.

 

Stacey Simms  30:14

And I would assume the plan is to eventually go to all types of phones, including apple. That's right. My question for Omnipod is always what I'm about to ask you. But phone control makes it a little bit obsolete. And that is why no button on the pod why not even like a one dose one unit or something on the pod?

 

Dr. Trang Ly  30:34

I've been asking this, since I've had the podcast. Yeah, I think he just originated with the original design. And I think perhaps, because it really started originally with the idea of children using our device, and having that separate controller to track all the information. I think just at that time, because it was primarily a product for children, we wanted to make sure that infant delivery was always, you know, very intentional, and not unintentional. And so would always to have that remote control potential and and not have any, you know, button on the pod, which could lead to accidental or insulin deliveries, unintended,

 

Stacey Simms  31:21

or just a couple of laundry list type questions. Dexcom has already announced that they're going to seek FDA approval for the g7. Soon, I would assume that Omnipod will eventually, you know, work with the g7, which should users should be concerned at all about that kind of compatibility?

 

Dr. Trang Ly  31:38

Yeah, I think eventually, you can expect that, you know, systems that are integrated with G6 Today, we'll be working towards g seven in future. You know, I think the whole idea of interoperability reach was beheaded by the FDA really enables companies to work faster to integrate with future versions of systems. So you know, we we want to be at the leading edge of that innovation. And I think that will come with time. We I don't think we've announced any times or dates regarding that. But it is something that, you know, we fully intend to support.

 

Stacey Simms  32:17

And this may be another business type question. But everyone who's using Omnipod right now, what's the plan for current customers? We're getting ahead of ourselves, I know the system's not approved. But can people using arrow so dash expect to kind of be seamlessly switched over to Omnipod? Five with horizon?

 

Dr. Trang Ly  32:35

Yeah, I don't think we have released all the information regarding how we're going to transition our current customers. Yes, I don't think that that is publicly available yet. But we, you know, one thing we do strongly believe in is supporting our current customers. And what we have said is that Omnipod five will be available via the pharmacy channel at price parity kadesh. And so what that means that if you are already receiving cash today that you're going to be in a very good position to have coverage for Omnipod. fi. And but we haven't detailed the information regarding you know, how we're specifically transitioning every single patient at this, at this point,

 

Stacey Simms  33:25

separately from the pod. tide pool loop is also in front of the FDA, as you and I are speaking, I'm not even quite sure really what to ask you about this doctor, like because I know it's coming from tide pool. But can you share anything about the relationship from Omnipod to Tandem? And how the loop project is going? It's kind of a it's a different animal kind of out there. But I don't want to leave without asking you about it.

 

Dr. Trang Ly  33:51

Yeah, you just said Omnipod to Tandem, but I'm

 

Stacey Simms  33:54

so sorry. Yes.

 

Dr. Trang Ly  33:58

Yes, yeah. Well, that is title program. So it's best that you speak to Howard about that. But it is a program that we support. And and we certainly, you know, believe in interoperability and supporting points for our users. And yes, you're right. I believe the last update is that it is currently under review with FDA wouldn't use the dash parts, or does it use it with Omnipod? Five. So it's, it's not it's not going to be backwards compatible with dash pod

 

Stacey Simms  34:35

guidance. My next question was, so if Omnipod five with horizon is approved, Omnipod is manufacturing the same pods for both systems. That's right. I know you know, I'm not sure we're supposed to talk about it. But I know you know, because you've spoken to the loopers groups and you speak to people all the time that there's a bunch of people using the older pods, the arrows, pods, I believe for a nod FDA approved system, they're looping with the separate from title loop, they're looping with those pods is only going to keep making those pods once this new system is approved,

 

Dr. Trang Ly  35:10

we haven't said exactly when we will stop making those pods. But I think the community should expect which and I know that they already do that at some point in time in the near future, we would need to stop making those pods. And that's for a variety of reasons. But as you will know, Stacy, and many of your audience will know, you know, that is much older technology. And you know, we prioritize innovation that is going to work well and be safe for our users. You know, that's partly why we moved to dash to integrate Bluetooth technology. And then which has enabled us with Omnipod, five to talk via Bluetooth to CGM. So that type of safe integration is really important to us in our future offerings of product. And so at some point in time, that will, we will need to start making that and also, you know, that is with all the technology, all the components, and etc. So, once that happens, though, we will let the community know with sufficient time so that people can prepare for alternative methods of therapy. And hopefully that will be Omnipod. Five,

 

Stacey Simms  36:25

you've been so generous with your time, I just have a couple of more questions. I really appreciate it. One of the questions that was asked in the podcast Facebook group was when approved, how will the training for this go? In other words, with control IQ, I sat down, I took a course I took a quiz. And once I passed it, my doctor had written a prescription. And we got the downloadable, you know, into the pump. And we were off and running did not meet with a diabetes educator or an endocrinologist to learn how to use control IQ. What will the system be for teaching people and getting Omnipod? Five to them?

 

Dr. Trang Ly  36:58

Yeah, so for people who are already using Omnipod dash, you can expect that the experience will be similar to what you just described for control IQ. So you will not have to meet someone in person in order for you to start that system up. So it will be similar in a training quiz, number of steps. But you can do it all self directed and be often running on Omnipod. Five, or you can choose to speak to someone or meet in person with an educator if you wanted more information about for instance, how the algorithm works or whatever question you had on your mind. But for brand new users who've never used a pump before, then it will there will always be in person training, or virtual training. You know, there's some things that you we still feel that is necessary to cover, you know, basics of pump therapy that will require meeting with their certified trainer to go through. But yes, we're current on the Pog dashes as you can expect the transition to be fairly seamless.

 

Stacey Simms  38:08

Another question that came up was about insurance coverage, but particularly Medicare. Can you speak to that? Yeah. So

 

Dr. Trang Ly  38:15

currently, we have Medicare coverage under Part D, which allows for pharmacy coverage of the pod. So we do have that. And they only came in recently in the last I'd say three years or so. So once that came through CMS, we worked with many plans to get Omnipod covered under that peptides for Medicare. So one of the things that, you know, we're working on well, FDA clearances, is still under review, we are working on making sure that we get as many people covered as possible. When Lord, they come. So yeah, it's a major priority for us to make sure that our patients get covered for this product.

 

Stacey Simms  39:06

You referred back a couple times to your days as a pediatric endocrinologist. How exciting is this for you? You know, the people that use this product, you know, the people that use other automated pumps. Can you speak a little bit just from your personal side about the excitement because you know, this is going to help people?

 

Dr. Trang Ly  39:25

Yeah, it's just incredibly exciting. And maybe not everyone knows about this. But yes, Stacy, as you mentioned, I am a pediatric endocrinologist. And it's actually about 10 years ago now, but I did my very first study in automated insulin delivery and that was back in Perth in Western Australia. And in that study, we use a Medtronic pump add to Medtronic sensors and a blackberry phone and the algorithm was on a blackberry phone and it was I haven't mentioned this to many people. But those those sensors were, you know, were challenging at times to deliver insulin from. But it was such important studies, in terms of proof of concept to show that, you know, we could augment insulin delivery and, and making that decision every five minutes gets you in better glucose control. And it was really extraordinary. And I still remember the very first time, the very first patient that I put the system on, and, you know, and I was watching that insulin being delivered. And I remember just like hugging the participants, Mom, because, you know, we just both knew how incredible this was going to be if, if this could reach masses of people, it's always been for me, something that will be realized. And, you know, it has been through really great products like control IQ. And you know, soon Omnipod five will be out with a great algorithm. And because we just know that this type of technology is what is going to allow parents to sleep at night and let people be comfortable with their diabetes and be more confident about it so that they can focus their brains on other life decisions and not be so consumed by their diabetes. And so it is really incredible for me to be able to see the results of our algorithm just works so well in such a huge population of patients, even in just in clinical trials today. And I just know that there's going to be incredible impact from this product in future when we launched.

 

Stacey Simms  41:47

Well, thank you so much for coming on and sharing so much information. We're all excited to see what happens next. And I hope that you are you know, other folks or Insulet will come on and share more information, you know, fingers crossed as the rollout happens. So thanks so much for joining me.

 

Dr. Trang Ly  42:02

Thank you so much. So happy to be on.

 

Announcer  42:09

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  42:15

Lots more information at Diabetes connections.com. I know the one question everybody asks that we cannot answer is when will this be available, it will be available when the FDA approves it. And you know, that could come any minute it could come in a few months, you know, we are not privy to that information. But once it is available, it will take a little while to roll out. So Omnipod I'm sure we'll make a lot more information available as we move forward. We'll talk to them again. And we will answer as many questions as possible. Also got a lot of questions about insurers, that's going to depend as well, quite often, insurers will not initially cover new products. I know Omnipod is talking with everybody. But it may take a little bit of time. So we'll circle back on all of that it is difficult to pick and choose the listener questions that I asked but I really try to focus on what I know the person that I'm talking to can answer and I thought Dr. Ly was was really fabulous and spoke to me frankly, for longer than I expected. So I really appreciate her sharing so much information with us. And I hope you found that helpful.

All right. Diabetes Connections is brought to you by Dexcom. And I do want to talk for a moment about control IQ. You heard me mention that several times during the interview. That is the Dexcom G6 Tandem pump software integration. When it comes to Benny's numbers, you know, I hardly expect perfection I want I'm happy I'm healthy. I have to say control IQ has exceeded my expectations, Vinny is able to do less checking and bolusing and is spending more time in range. His last couple of Awan C's were his lowest ever and this isn't a teenager, the time when I was really prepared for him to be struggling. His sleep is better to with basil adjustments possible every five minutes, the system is working hard to keep them in range. And that means we hear far fewer Dexcom alerts, which means everybody's sleeping better. I'm really so grateful for this. Of course individual results may vary. To learn more, go to Diabetes connections.com and click on the Dexcom logo.

Before I let you go, we're actually traveling this week. So the interview with Benny about Israel is coming up and thank you so much for all of the questions that you have sent in. There was a Facebook group posted Diabetes Connections of the group. If you want to chime in and ask me some questions to ask my son who recently got home from one month overseas. He is 16 and he was with a camp group but it was not a diabetes camp. He's home safe and I've done some debriefing with him. It was really interesting. And Gosh, teenage boys. So interesting. I can't wait to share some of his stuff with you. And some things I'm not sure I will share. No I mean we're pretty much an open book but he right he doesn't really handle diabetes exactly the same as I would but home safe and sound and really did very, very well. reminder that on Wednesdays I do in the news live On Facebook on Diabetes Connections, the Facebook page, and that becomes a podcast episode on Fridays I, as I said, I'm traveling, so hopefully technically all will go well, we shall see. But that in the news episode has become a lot of fun, frankly, and people really enjoy that still short, so I'll put that out as well.

And then in the weeks to come, I have some great interviews for you. We have interviews about sports and being very active. I have an interview with the folks that have Afrezza that I'm really excited to bring to you. It's been a while since we spoke to them. And of course, that interview with Benny, so lots to come. thank you as always to my editor John Bukenas from audio editing solutions. I thank you so much for listening. I'm Stacey Simms. I'll see you back here in just a couple of days until then, be kind to yourself.

 

Benny  45:46

Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

Jul 6, 2021

What do we know about the upcoming Dexcom G7? Find out in this conversation with company CEO Kevin Sayer. As usual we have a long list of questions from you covering everything from adhesives to watches to more. Sayer shares details about how they’re preparing for the G7 rollout (it has not yet been submitted to the FDA), as well as issues with Medicare, integration with their current pump partners and when arms will become an approved wear site for US customers.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Dexcom G7 "sizzle reel"

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Check out Stacey's book: The World's Worst Diabetes Mom!

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Episode Transcription below

Stacey Simms 0:00
Diabetes Connections is brought to you by Dario Health: manage your blood glucose levels, increase your possibilities, by Gvoke HypoPen: the first premixed autoinjector for very low blood sugar, and by Dexcom: help make knowledge your superpower with the Dexcom G6 continuous glucose monitoring system.

Announcer 0:23
This is Diabetes Connections with Stacey Simms.

Stacey Simms 0:29
This week, a Dexcom update from the company's CEO. As usual, we have a long list of questions from you, covering everything from adhesives to watches to more about the upcoming G7.

Kevin Sayer 0:41
And the goal is to simplify CGM for everybody across the board. What I often say is everything you love about G6, you'll love more about G7. The size is so small, you don't really recognize it's on your body. It's really a great profile, a little bigger than a nickel.

Stacey Simms 0:56
CEO Kevin Sayer will also share details about how they're preparing for the G7 rollout once it's approved, as well as details about Medicare and use but their pump partners. This podcast is not intended as medical advice. If you have those kinds of questions, contact your health care provider. Welcome to another week of the show, always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. I'm your host, Stacey Simms, my son Benny was diagnosed back in 2006, just before he turned two. He is now 16 and a half. My husband lives with Type 2 Diabetes. I do not have diabetes, but I have a background in broadcasting. And that is how you get the podcast. My usual disclaimer, whenever we have them on, Dexcom is a sponsor of this show, you will hear their commercial later on. It's because we love the products. But when we have people from Dexcom on as guests to give you information, they don't tell me what to ask or what to say outside of that commercial. And I just want to take a minute to say, I very much appreciate Kevin Sayer and others from Dexcom being so accessible over the years, you know, they don't always answer my questions, but at least they come on and address them and listen to them. There are a lot of companies that are very reluctant to even do that, who won't come on the show. And that's really unfortunate because you, as you listen, and you know the diabetes community overall, I'm very much entitled to speak to these people and to these companies. So I will keep pushing nicely, but I'll keep pushing, I promise.

Quick heads up, there will likely be no longer format episode like this one next week. I'm still gonna do the "In the News" episodes that I have added live on Facebook and then turning them into podcast episodes. But I am, as you listen, if you're listening as this episode is going live, I'm at Friends for Life. I'm at that conference. They're having it again. I'm so excited. It's the first diabetes conference I have attended since February, no, since the first week of March of 2020. I went to a JDRF conference in Wilmington, just as COVID was beginning, it was very weird. If you did anything, any kind of public event in March of 2020, you remember that. But I'm back, they're back, I'm at Friends for Life. And I really don't want to rush out an episode. But if anything exciting or you know, breaking news happens or I'm able to record something and put it out, I will. But just a heads up, likely no episode next week.

Alright, and this week, not much of an introduction needed. Kevin Sayer is the CEO of Dexcom. And this interview focuses on some of what came out of the recent ADA scientific sessions and ATTD conferences. But mostly I share your concerns and your questions. We've covered a lot of these issues before, I don't ask a lot of follow up about things that, in my opinion, you can easily Google up. As usual, I had limited time with Sayer, who was doing back-to-back interviews. So if you have a specific question or if things went by very quickly, definitely jump into the Facebook group. You can comment on the post with this episode. We have some amazing members who will answer your questions, who will show you where to find the information. It's likely a previous episode, but we have people in clinical trials, we have people who were in on a lot of the investor calls. They listen, they take notes, they're fantastic. So if you haven't joined Diabetes Connections the group on Facebook, I highly recommend it.

My interview with Kevin Sayer here in just a moment. But first, Diabetes Connections is brought to you by Gvoke HypoPen and you know low blood sugar feels horrible. You can get shaky or sweaty or even feel like you're gonna pass out. There are lots of symptoms and they can be different for everyone. I am so glad we have a different option to treat very low blood sugar. Gvoke HypoPen, it's the first auto-injector to treat very low blood sugar. Gvoke HypoPen is pre-mixed, it's ready to go with no visible needle. Before Gvoke, people needed to go through a lot of steps to get glucagon treatments ready to be used. And this made emergency situations even more challenging and stressful. This is so much better and I'm grateful we have it on hand. Find out more, go to Diabetes-connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit gvokeglucagon.com/risk.

Kevin, thank you so much for jumping on with me. Another busy time for you, as so many presentations, lots of studies, lots of news, lots of upcoming and anticipated news. So I appreciate you spending some time with me and my listeners.

Kevin Sayer 5:11
Oh, thank you for having me. It's always fun.

Stacey Simms 5:13
Let's set the table a little bit here. We are following up on the ATTD conference and you are in the midst. Dexcom, as we're speaking of ADA, this is all still virtual though, right?

Kevin Sayer 5:25
It's all still virtual, yeah. I was looking, was hopeful earlier this year it might be in person, but not yet, probably not till next year.

Stacey Simms 5:33
Well, as we look through the news that is coming out of both of these conferences, I could just start out by saying it's kind of, I'm not sure victory lap is the right phrase here. But it does seem that almost every study is basically, Kevin. CGM works, it's good, it helps, we get better outcomes from it. So let me just give you a moment to talk about some of that. Because there were so many, we can't really touch on all those studies.

Kevin Sayer 5:58
There are so many studies, and it's good for a number of different groups as well. You've got all the automated insulin delivery studies, and other than Medtronic's product, all these other studies are powered by Dexcom. You've got stuff in the UK, France, Insulet Tandem in the US, there's a lot of good news on the automated insulin delivery system front. And all these works are powered by Dexcom G6 right now, you've got studies that we presented at ATTD ast week, or that were presented by physicians that we're very well aware of. The mobile study, which was for patients with Type Two Diabetes who are on basal insulin only. You know, when you start a study like that, it's kind of a risk, because you ask yourself the question, "What happens if it doesn't work?" Well, it works. And what we learned is these patients, even though they're not making a decision every four or five, six hours, for eating, they are making decisions about what they eat, and what they do and how they exercise when they can see data. And they can see the effects of what goes on in their lives. And their time in range goes up significantly, if they can see what their time and range is, you know, they've been operating in the dark, and people would argue that they don't need it all the time, like I do. And so that study, we think is just really good and will be the basis, hopefully someday for getting CGM coverage for that group of patients. And so we'll push on that one. There was another study we had last week, or at ATTD. Early in the month, published in Belgium, where a coalition of diabetes gurus I guess, over there's the best I'd call them, it's really all the leaders in the Belgian diabetes community, took a bunch of intermittent CGM users and put them on Dexcom G6 for an extended period of time. And then we looked to see what happened. And what we saw is on real time CGM, the patients are better in every category, every single category, time in range, hyper(glycemia), hypo(glycemia), you name it, they did better. So we really did validate the Dexcom equation over competitors with that study. And we think it's very important and they realize real time CGM, it is important, it is important for data (to) be accessible. And the alerts are something that you can use. There are other studies being presented by other people in the Type Two, Arena-Kiser's got a study where they show patients do well on, Doulas got several studies, they're across the board. And the evidence is building for these other markets. But it starts at the beginning, obviously with automated insulin delivery and, and we work our way down. But we've had information presented across the board showing the utility of Dexcom. And if you've been to this study, this meeting 10 years ago, like I was when I first started here, my literally, my first month was my first Dexcom ADA, nobody even knew who we were. And those who did said yeah, the product's not real great. So times have changed pretty dramatically.

Stacey Simms 8:41
Do you remember what that first study that was presented at ADA or ATTD? Which one it was that you were there for 10 years ago? I'm curious of that.

Kevin Sayer 8:50
Back in the day?

Stacey Simms 8:50
Yeah.

Kevin Sayer 8:51
First study, we didn't even present studies. Back then, we, I will tell you the most important study we did, we did a study in where we first got ADA recognition, we did a study with our G4 system against a competitor in Europe. And we got a bunch of recognition there. And then the next study that really got us a lot of recognition in ADA meeting was our DIaMonD study where we show the people on multiple daily injections. If they went to CGM, they would get much better results. What it was hard for me to learn is you don't say I want to do a study like this and get it done in a week. It takes a couple of years to accumulate all the proper data, process it, develop all the subsets and everything. And so my patience has been has been level set with respect to studies like this. And there's multiple studies going on in the field that will be presented over the next several years.

Stacey Simms 9:44
All right. Well, that's a really good segue to moving ahead, because, as you know, my listeners are very interested in this technology. And the slide that probably got the most attention in our groups was one that was presented at ATTD about introducing the Dexcom G7, showing all of the features of this. So let me, I'm not going to go through all of them, obviously. And you and I've talked about this many times before, but faster warm up. It's smaller, simple application, all in one. This is all still part of the plan, as we had talked about before.

Kevin Sayer 10:19
Oh, yes.

Stacey Simms 10:19
Okay.

Kevin Sayer 10:20
Yeah. And, you know, we started working on the G7 before G6 was even in clinical trials. The G7 is a project we've envisioned for a long time, Verily, actually it was Google Health before then, Verily was a partner with us in designing this product, and we (were) working out for quite some time. And the goal is to simplify CGM for everybody across the board, what I often say is everything you love about G6, you'll love more about G7, the size is so small, you don't really recognize that it's on your body. It's really a great profile, a little bigger than a nickel. We're running this study with arm and abdomen indications. And while patients wear them wherever they want, we're going to show you that it can be worn wherever you want. And I think that's a big deal, that we go ahead and do the work to do that. The faster warmup is kind of mind-blowing when you put a G7 up and then you look after you pair it. And then you look and see you only got 25 minutes left, it's like, oh, wow, I don't have to do the two hour countdown. You know the accuracy and performance that Jake presented at ATTD shows that we're not, we're not ever going to go easier on the performance side and say good enough, we always push ourselves to offer something that will keep people safe and confident with what they have. The app is completely new, we'll build things into the app over time, like automated, the frequently asked questions feature we have now but we're just gonna keep making it better. Some of the features of our Clarity system will ultimately be in the app. So you'll get more information. When you go to it and look at it out of the get go. You know, we'll get it approved. It'll be a while before our partners have integrated their systems. But we're working with Insulet and Tandem already on G7 integration, it'll be able to talk to multiple devices at the same time. Its manufacturing cost ultimately will be less expensive. It's been designed for an automated process. And we've got fully automated lines up and running to assemble the G7 sensors. We have, in fairness, have automated G6 lines up and running now too, but we've got special transmitter lines and center lines and those kinds of things. It is going to be, a really, the most advanced CGM ever.

Stacey Simms 12:25
Well, you've touched on a couple of listener questions already in that testing alternate sites, including arms, integration with the systems that are already using G6, so I don't want to spend a lot of time going in depth on things that you've mentioned. But in the slide it said direct to watch capability.

Right back to Kevin clarifying what was meant in that slide. But first, Diabetes Connections is brought to you by Dario Health and bottom line, you need a plan of action with diabetes. We've been lucky that Benny's endo has helped us with that and that he understands the plan has to change as Benny he gets older, you want that kind of support so take your diabetes management to the next level with Dario. Their published studies demonstrate high impact results for active users like improved in-range percentage within three months, reduction of A1C within three months and a 58% decrease in occurrences of severe hyperglycemic events. Try Dario's diabetes success plan and make a difference in your diabetes management. Go to https://mydario.com/diabetes-connections for more proven results and for information about the plan. Now back to Kevin Sayer, answering my question about what the company means when it says the Dexcom G7 has direct to watch capability.

Kevin Sayer 13:44
Capability. Yeah, it won't go there first pass. But we had to have different electronics and a different radio set to go direct to watch than what we have in G6. And it's easier to get us to change than it is to get Apple changed or to change their watch. And so as we were doing the G7 system, we did contemplate that. So it is configured to do so, I do not believe it's in the first release. But it will be not long after that. We'll have a direct to watch capability. And we know people really want that, the watch presents interesting problems. And we can all sit and say we want that. But you have to charge your watch every day or at least every 36 hours. Where are you getting your alerts if you're direct to watch and it's on the charger? And you're in different parts of your house? There's complexities to the watch that go far beyond just direct to connect. And particularly with the FDA who've used the alerts in the alarms and the connectivity is so important that we had to make sure we do it right. So we'll work on that and get it wired appropriately. But I look, I know what something I would want If I were a user. So we continue to push for it.

Stacey Simms 14:44
Just to follow up on that. When you say it won't be in the first iteration of it but you know, it'll be, it's capable, it'll come, that it kind of implies that you figured out what to do with the alerts and alarms when someone hangs it up to charge.

Kevin Sayer 14:56
I don't know what they have figured out. I just know they're addressing it all. I have to plead the fifth, I just, as I've asked that question, they said, "Well, here's a problem. How are you going to deal with that?" I said, "Well, you guys don't have to tell me." They'll come up with the right answer, Stacey.

Stacey Simms 15:09
Alright, so, I'm sure they will, but to say direct to watch capability, there's a little parentheses that says when we figure it out,

Kevin Sayer 15:15
Oh, I know we're working on it, but...

Stacey Simms 15:17
Okay.

Kevin Sayer 15:18
But Stacey, we couldn't even go direct to watch before with the electronics. We couldn't go direct to watch with a G6 transmitter, the G7 electronics stack and configuration is such that it can go direct to the watch, we could not with G6.

Stacey Simms 15:32
Okay. Many more questions. My listeners are very, of course, interested in the adhesive changes. Is the G6 to G7 change, I know you're addressing this, I know you're testing it, we've got emails from people who are in different trials for adhesive and reactions and things like that. And I have lots of questions, people say it's getting better, other people say it's getting worse. Anecdotally, it's very difficult, obviously, for me to know. Talk to me a little bit about those changes and how it's improving.

Kevin Sayer 15:58
Well, we've tested numerous adhesives before we landed on the adhesive we selected for G7. One of the reasons we kept the product life down to 10 days is to make sure we have enough adhesive to get to that 10 days. We'll be putting the overpatch in every box. So if somebody wants an overpatch, they don't have to call us. So everybody should be thrilled with that one. And it's quite easy to use, we're hopeful that there's no allergy with G7. Somebody's always gonna have a reaction, that's just physiology, but we're working with new tapes for G6 already, where it will hopefully have something. The things that cause a lot of the allergic reaction in G6 we've eliminated from the G7 manufacturing process. So we're hopeful that a lot of this stuff goes away on its own, we'll monitor it very quickly. But we've already got four or five other G7 adhesives in test in addition to the ones that we're going to launch with, to make sure we can create better options in the future if we need to. So, you know, stay tuned on that one, we are comfortable. As I sit here, we will not have the same level of reaction that we would have at G6 when we change it. But yeah, we won't know till we're out there.

Stacey Simms 17:09
Yeah. And you mentioned the 10-day wear and part of that being for adhesive. But my understanding is that the idea is for 14-day wear for Dexcom G7.

Kevin Sayer 17:19
Eventually.

Stacey Simms 17:20
Eventually.

Kevin Sayer 17:21
Eventually, not again, not first pass. We'll get it approved with 10-day data, very important to us is that we provide our customers with the experience they paid for and they signed up for. And we've looked at competitors' reliability data, how many make it out to 14 days, or how many make it to seven days if they only have seven, and we look at, it's one of the key management indicators, we monitor how many of our sensors are making it out to 10 days, and we've set a pretty high bar for how we want our system to work. And while we could have launched a longer lasting product, we wouldn't have hit the percentages with the configuration that we have. And so we said, OK, 10 days is enough. Our patient base is fine with 10 days as long as we deliver on the 10 days that we promise. And we'll get into longer live trials literally as soon as we're done with these and hopefully move it over. Because that does cost us a lot less and give us more pricing flexibility over time for the various groups. But for now we'll go 10 days, mainly, so we have more reliability. That's the biggest reason.

Stacey Simms 18:22
I have a few more G7 questions, but they're about pricing and accessibility.

Kevin Sayer 18:26
Well, I, you know what I can, I can't answer most of them...

Stacey Simms 18:28
Okay.

Kevin Sayer 18:29
...because we can't really go address pricing until it's approved.

Stacey Simms 18:32
Right.

Kevin Sayer 18:33
And we have as we put our G6 contracts together over the past couple of years, done so in anticipation of a G7 product to whereby, for example, for Medicare, it's a fixed charge per month. And for many of our insurance contracts, it's resembling more that type of business arrangement, we're hopeful that we can transition to G7 very quickly. But we will have to go to all your payers and get G7 covered before they'll pay for it. We're hopeful that'll be a quick process. But in the meantime, G6 is a great product and people will be able to use it. I can't give you a timeframe as to how long that'll take, we'll have to go to CMS, we'll have to go to all the Medicaid groups as well. What we're trying to avoid, and let me repeat what I don't want to deal with, is one of the things I dealt with with the G6 for a long time, we didn't have enough inventory of production capacity to get it to every group. So the Medicare population was stuck with G5 for quite some time. Those emails were not good. We want to make sure it's equal access when we can get it in the channel for everybody. And we're trying to build that type of capacity.

Stacey Simms 19:34
A couple of "what-if?" questions, just kind of looking down the road. JDRF recently announced that they are looking for and this is the very beginning. So as you listen or as you're watching, this is not in the works yet, this is a call for research, that they are looking for a CGM that could also measure ketones, and I haven't seen any companies step up yet publicly to say yes, we're working on that, we'd like to be part of that. Is that anything that Dexcom is thinking of doing?

Kevin Sayer 20:02
We've explored this for quite some time long before the JDRF initiative. And the question I keep asking, is continuous ketone measurement important? We know that for the pediatric world, that if you measure ketones continuously, you might predict dangerous DKA moment before it happens. But at what cost to the system? And is there a cost benefit associated with this? So we're setting all those things. We're in the learning phases, we think we have a platform that can do that. But we've got to decide do you sacrifice glucose accuracy? If you throw a ketone sensor on there? There's a lot of answers we don't have yet. But we're in the early phases. And we've talked with JDRF and others about it, is there a better way to measure ketones that might be easier and less expensive? I don't know. We've looked at several other analytes to go with our system over time. And I think in the future, that'll be something but that's not coming from us for at least three years, if not longer.

Stacey Simms 20:56
Got it. You've looked at other...

Kevin Sayer 20:58
Analytes

Stacey Simms 20:59
Analytes, tell me about what else has been looked at just for, you know.

Kevin Sayer 21:03
Well, I won't go into all of them. I certainly look at lactate from a stress level. And for physical fitness, for example, there are a lot of athletes who'd like us to produce a lactate sensor to whereby they can measure the progress of their physical fitness. There's also a use for lactate in the hospital environment with we think with respect to predicting sepsis over time, but those are you know, that's one of them. And we've looked at a few others and failed, I won't go into all those.

Stacey Simms 21:31
That's okay.

Kevin Sayer 21:31
We've looked at some that may be promising. What we find from time to time is yeah, what we'd love to measure but we can't is insulin on our wire. If there are any way we could measure insulin in addition to glucose, wouldn't that be awesome? We know exactly how much insulin you have on board. And we know exactly well, we, we've not been successful at that one. That would require different technology than what we have. So we look at all of them. And over time, we think we'll have some good stuff there. But not for a while.

Stacey Simms 22:00
Um, you know, you mentioned hospitalizations. And last year we talked about the CGM program in hospitals. Forgive me I, there were so many studies at ADA and ATTD, I don't know if this was presented. But let me ask a general, how is it going? Are hospitals adopting and adapting to using a CGM?

Kevin Sayer 22:16
They are adopting and adapting is harder than adopting.

Stacey Simms 22:19
Yeah.

Kevin Sayer 22:20
Because, you know, this is a device that was designed for your listeners. And for you. It wasn't a device that was designed to be used in a hospital room. With all of the cybersecurity and connectivity issues of a hospital, where do we send the information? How do we get it there? And so we've got to solve the workflow issue to make this meaningful in the hospital environment over time. What we have learned is our technology is more than good enough to go there. And that the places particularly where you have an endocrinologist very heavily involved in treating the diabetes patients in the hospital rather than a cardiologist or somebody else, when there's an endocrinologist involved, we can go very quickly, they can learn. Some of the hospitals would take an approach, let's put this on everybody. Others would only take an approach, let's put this on severe cases. So there have been different protocols used. But by and large, the response to CGM in the hospital has been very, very good. And we think it is a great market for us over time, we've got to work on the proper configuration for workflow. I mean, one of the best examples, how do you get the data to the medical record? Because everything in the hospital goes to the medical record. How do we make that seamless? We haven't figured that out yet. And that'd be important for all of our users even outside the hospital. Imagine how much easier would be to go to your doctor and have your Dexcom data already sitting in the medical record when you get there. We're not there yet. But we're having a lot of good discussions on that front.

Stacey Simms 23:41
Got it. One of the topics that's been kind of in the community recently, and I don't think it's so much Dexcom. But I want to ask you, anyway, is this issue of and you mentioned, athletes who want to measure certain things, of people without diabetes, using Flash glucose monitoring, or continuous glucose monitoring. I'm curious is that a market that Dexcom is looking to pursue? I mean, the G7 is smaller, it's lighter. And you know that I'm asking this because we've talked many times before. People who use insulin are very much afraid of not being able to afford, being left behind if many, many, many people who may not use it in the same way, start adopting these products.

Kevin Sayer 24:19
Let me address that in a couple of steps. Let's talk about the use case first. There are people, a lot of people using Dexcom, who do not have diabetes, as a health and wellness tool. And there are a number of apps that are being developed that require glucose information to level set your nutrition. Now, possibly Type Two diabetes or prediabetes, but there are groups and some groups with some very interesting ideas as to how to change your diet based on glucose data to make you healthier. We were used many years ago on The Biggest Loser with every patient that came in the door and one of the production people, I don't remember which one, might have even been the physician, came to me and said, "You need to get out of the diabetes business. You can make a lot more money in weight loss." Well, we're not getting out of the diabetes business, that's where we are and where we stay. One of the things we've contemplated with G7 is the fact that we're going to go to more people. And we're going to go to more people than just the Type One population. We plan on having capacity to build over 200 million sensors, before the end of 2023. 200 million sensors is gonna be more than enough for the intensive insulin using community. And as far as cost, well cost comes down if we can sell that much in volume. Now,

Stacey Simms 25:29
Well, hello...

Kevin Sayer 25:29
I would also argue...

Stacey Simms 25:30
You're in the American healthcare system, Kevin. You know this is not a market-based device, we don't...

Kevin Sayer 25:36
I'm aware, I'm aware of that.

Stacey Simms 25:38
I'll let you finish, I'm sorry.

Kevin Sayer 25:39
Let me keep going. At the end of the day, as you look at what somebody pays for taking care of themselves with delivering insulin and powering the insulin pump, that's a very complex task that requires a lot of customer service and support. If somebody is only losing weight, that's a different problem we're trying to solve, or if somebody is trying to titrate a Type Two drug, that's a different problem. I think we can find a way to make everybody happy. I don't think we're gonna disappoint anybody. And we planned this company and built this company to make sure that we have capacity to do all this, it's, you know. It's, one would look at me, I mean, we're gonna spend over a billion dollars on these factories over the next two, three years here. This is not a simple endeavor, it is a large investment. And this technology first goes to the community that we serve, now worldwide. We have to expand worldwide, but get it to the group in the US as well. After that, we'll go the other places, but we're going to have more than enough capacity to do that. In fact, one might question if I'm insane, or we're insane to create so much capacity and the 200 million, quite candidly, the wave design, the G7 lines, if we need to sample at a factory, we can do it very quickly. So this is a, this is a long term play for us. We believe this technology be beneficial to a number of people. And so if we can get, if we can get all these sensors out there and all these uses, I think it'll benefit your audience more than it'll detract from.

Stacey Simms 27:00
I know we're going to run out of time. I've got two more questions. You've mentioned,

Kevin Sayer 27:03
You got them, I'll give you time for two questions. Let's finish.

Stacey Simms 27:06
Okay, alright.

Kevin Sayer 27:07
Finish the way you want.

Stacey Simms 27:09
You mentioned already, lots of different apps are being developed, not all diabetes. You know, a couple years ago, Dexcom announced the availability of the API, you know, developers can get data through third party apps. I'm curious, is there anything going on maybe behind the scenes? Or are you doing anything further to kind of foster more innovation in the early stage, like the development of other companies? Or is that a thing of the past?

Kevin Sayer 27:31
No, I'll give you two things that we're doing. Number one, we have a live API use where you can have a live display of the data. That's on file with the agency right now, it'll eventually get approved. So you'll be able to run the Dexcom app, data'll go to the cloud, comes straight down to another one. I think that is a very good use of the technology and it shows our willingness to work with others. So that is a good use. One of the other things we have coming, then we'll see where it goes. Our intended use case in the beginning was with major healthcare systems. But we have another app that we've shown pictures of, it's an app inside an app. So let's say for example, you go to Scripts here in San Diego, I'll pick Scripts, and Scripts has their own healthcare app. And they also want to be the center of your diabetes care, particularly for Type Two diabetes, and they might have you wearing a sensor for something other than isulin delivery. We've developed an app that can reside inside another app, to whereby you can have your Scripts experience, but you can touch an icon and you go to a Dexcom experience. And it, it's an app that resides inside the app and for security, we're able to keep others out. That app inside the app concept is nothing we've done to commit to others, to give them an opportunity to use Dexcom technology in a different way. And yet preserving create their own experiences. We're very cognizant of the fact that we can't solve every problem, and there might be better experiences. And we can create. Okay, got time for one more.

Stacey Simms 28:54
All right, last question. And it's more of a request. But the question is when you, and this is from a couple of listeners, when you start rolling out the G7, any consideration for including and this may be an insurance question too, one extra sensor a year? So three in a month.

Kevin Sayer 29:10
What a wonderful question. And let me tell you something, we spend an inordinate amount of time analyzing sensor failure and returns and those types of things. We have run models that say if we give everybody, if we just gave everybody x more sensors a year, we could avoid all the phone calls and all of the issues and all that stuff. We analyze this warranty policy all the time. And I think what you'll see with G7, we'll have better tools. My hope someday just for your users, I would love to just diagnose this in the app in general, to whereby if your sensor fails, we know when we say your sensor failed, tap on this icon to get a new one. The flip side of that is we have a business to run and we can't do all free centers. So if it comes to the time, if you buy 12 months for the sensors, and pay for 12 months for the sensors, let's make sure you get 12 months worth of use. And if that means we ship you a free one because one failed, that's fine. But we're still, you know, we found one patient in another country, I won't say which one, they got 48 free sensors and purchased all of three, because they spent all this time. Those are the far exceptions from the rule, people will just want care. And so we are doing everything we can to come up with better policies to make it easier for you. Because quite honestly, those phone calls cost us way more money and they cause you guys frustration, we are going to make this better over time. That's a promise I can make. And let's talk about it in a future conversation and I'll tell you some of the things we've done.

Stacey Simms 30:35
All right, we'll hold up for a baker's dozen one of these days. But Kevin, thank you so much. You're always very accessible...

Kevin Sayer 30:41
Thank you.

Stacey Simms 30:41
...and I really do appreciate your time.

Announcer 30:48
You're listening to Diabetes Connections with Stacey Simms.

Stacey Simms 30:54
Lots of more information at Diabetes-connections.com. If you haven't seen it yet, a while back Dexcom sent me what they call a sizzle reel of their G7, what it looks like. So I'll put that video in the show notes as well. We have a YouTube channel. I don't put a lot of extra stuff there. But things like that Dexcom video, and the "In the News," you can watch it if you'd prefer, I always put that on YouTube. And all these episodes are there as well, although they're mostly just the audio, but a lot of people listen, watch, they listen that way on YouTube. So that'll be linked up in the show notes. And I realized I haven't mentioned it on the show yet. But you know, this time of year getting your Dexcom or getting any gear to stick can be difficult, lots of wet and sweat in the summer. And I've created a guide, seven top tips to get your diabetes gear to stick in the hot summer. Over the years, we've tried so many things. Benny has had a pump since he was two. He's had a Dexcom since he was nine. So a lot of, you know, trial and error. And this guide is available, absolutely free. So I will put a link in the show notes. If you get the newsletter, you may have already seen it. But just in case you don't. And the show notes are always at Diabetes-connections.com. Every episode has its own homepage with a transcription, started that in 2020 and we are working our way back. If you're listening on a podcast app, there are shownotes there, but in case you have problems with links or whatever, you can always go to the episode homepage.

And as I mentioned, Diabetes Connections is brought to you by Dexcom. It is hard to remember what things were like before we started using the Dexcom. I just said Benny was nine, right? But he had diabetes for seven years before we started using it. And I guess I haven't really forgotten what that was like. But it's just so different now. When he was a toddler, we were doing something like 10 finger sticks a day. And even when he got older, we still did at least six to eight every day, more when he wasn't feeling well or when something was off. But with each iteration of Dexcom, we have done fewer and fewer sticks. The latest generation the Dexcom G6 eliminates finger sticks for calibration and diabetes treatment decisions. Just thinking about Benny's little worn out fingertips makes me so glad that Dexcom has helped us come so far. It's an incredible tool. And Benny's fingertips are healthy and smooth, which I never thought would happen when he was in preschool. If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. Learn more, go to Diabetes-connections.com and click on the Dexcom logo.

As I mentioned at the top of the show, I am at Friends for Life right now as you're listening. If you're listening as this goes live, on the day that it goes out there, I'm traveling to Friends for Life, and I'll be here for the week. If you're not familiar, this is the largest family diabetes conference in the country. It takes place every July in beautiful Orlando, it's so hot, but it's a great time, it's on the Disney World property. I don't usually go to the parks if my kids aren't coming. They're not coming with me this year, so I doubt I will be going into a Disney park. But it's a fabulous conference. And I just want to let you know, I'm doing a new presentation. I'm working up some new stuff. I'm very excited about it. And this one is called "Reframe your Diabetes Parent Brain." And I gotta tell you, I am really sick and tired of seeing people berate themselves and talk about mom fail and tell themselves how terrible they are as parents. So this is going to be a session where we talk about the mistakes we've made. But then I want to help people reframe them so that they see what they've learned. You know, my whole philosophy is you mess up and you learn. And that's what this is all about. So I'm really excited to try it out. Will it go over well? I don't know. You know, I think so many diabetes parents are so wrapped up in perfect now that they feel like if they go above 120 or 150 that they failed their children. So, gosh, I feel really passionate about it. And we're going to try that. And then for the fall, I've been getting a lot of questions about sending kids to camp, and I've gotten more and more of these over the years. You know, how do I send my Type One kid to regular sleepaway camp. So I'm working on a presentation about that because fall, August, September, is when a lot of people sign their kids up for next summer. So as you listen, if you're affiliated with a group that does meetups or zoom calls, or in-person conferences, let me know. I would love to speak to you and start these dialogues and help you really help your kids thrive with Type One. We're not done. We're far from done, right? Benny's 16. But you know, he's a confident and happy kid. So knock wood. Where's all my wood to knock? I say all the superstitious stuff, right? I mean, I don't kid, you know how superstitious I am. But I really hope that I can help other parents. You know, the idea here is that you don't worry. The idea here is that you do it anyway.

All right. Thank you so much for joining me. Thank you, as always to my editor, John Bukenas from Audio Editing Solutions. I will see you back here in a couple days for the "In the News" episode, but again, no long format episode, the following week. Alright, I'm Stacey Simms. Until then, be kind to yourself.

Benny 35:49
Diabetes Connections is a production of Stacey Simms Media. All rights reserved, all wrongs avenged.

 

Jun 15, 2021

We are very excited to catch up with the folks from Beta Bionics! Their fully automated bionic pancreas is called the iLet. They are getting closer to submitting to the US FDA and were able to give us an update on some of the most anticipated features.

Kate Farnsworth is a consultant for Beta Bionics currently acting as Digital Marketing and Communications Manager. She walks us through what makes the iLet a very different insulin pump, including: a system that only needs the user's weight (no basal rates or carb ratios), software that will learn from the user and make adjustments, how the system charges, waterproof status and much more. All dependent on FDA approval.

Kate's daughter was diagnosed at age 8 and we first spoke in July of 2015 about Nightscout. 

Past episode with Beta Bionics:

Ed Damiano in April 2016

Ed Damiano in May 2017

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

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Episode Transcription below

 

Stacey Simms  0:00

Diabetes Connections is brought to you by Dario health manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

This is Diabetes Connections with Stacey Simms.

This week, catching up with Beta Bionics . Their fully automated bionic pancreas, called the iLet has some new features not available in existing devices. And that's helped to ease the burden of diabetes in new ways.

Kate Farnsworth  0:33

Working for companies like Beta Bionics  give us the opportunity to reach a much wider group of people and really gives us the opportunity because we are a public benefit company to try and engage those people that aren't being engaged currently with the tools that are available.

 

Stacey Simms  1:02

That's Kate Farnsworth a well known name from the DIY community. Now with Beta Bionics . She'll give us the latest news on the iLet’s development and share some personal stories of her family's journey with type one.

Also this week, a big anniversary for the show, as well as for some of our listeners. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Welcome to another week of the show, always so glad to have you on, we aim to educate and inspire about diabetes with a focus on people who use insulin, guys, it has been six years of Diabetes Connections this month, work six years I started in June of 2015. It kind of snuck up on me to be honest with you. I had started the show in May of 2015, actually, but it was just audio that I put on my blog. We didn't get accepted into Apple podcasts and all the rest until June. So that's where I'm marking it from. I had been working on it for months and months. And I kind of wish I had started earlier. But hey, I'm thrilled with how it's gone. Almost 400 episodes now, so many of you wonderful listeners who I hear from all the time. Thank you so much for sticking with me. And if you could just do me a favor, the best thing you could do, I'm not doing much to celebrate this anniversary, I'm not doing a big thing on social or anything like that. But if you could do me a favor, just share the show, share this episode, share whatever episode you like, or just share a link to Diabetes connections.com on your social media, you can put it on your own timeline. Better yet share it in the diabetes Facebook group. It really does help get the word out. You can leave a review that's always fun, but sharing the show itself or telling somebody about showing them even to this day, how to listen to a podcast really goes a long way. So will we be here for another six years? I don't know, man. I hope so. I'm not slowing down. I'm really excited about where we're going. And I love talking to people like my guest this week.

Alright, let's get into it. My guest is Kate Farnsworth. She's a consultant for Beta Bionics currently acting as Digital Marketing and Communications Manager. Many of you know Kate from the DIY community. Her daughter was diagnosed at age eight, and we actually first spoke she was on the podcast in July of 2015. Just after we got started, we talk then about Nightscout she helped so many people get watchfaces set up back in the day among so many other things that she did. Now she helps run the Facebook loop to group with 10s of 1000s of members. Now the iLet, as many of you know has been one of the most heavily watched and anticipated devices in the diabetes space. First human testing was done in 2008. At Damiano the company founder has kept everybody up to speed over the years he has been very public showing the progress in presentations at conferences, and he's been on the show a couple of times himself, I will pick up those older episodes. for newer listeners. The iLet is meant to be a dual chambered pump. That means it will hold and infuse insulin and glucagon to help achieve better time in range.

Just so we're all clear. Putting glucagon into your body isn't like eating sugar or infusing quick acting sugar like glucose or dextrose. Very simply put, injecting glucagon or infusing glucagon stimulates the liver to convert its stored glycogen into glucose which it can then release into the body. The eyelid is being designed with two cartridges and two infusion sets one each for the insulin and glucagon. But the plan right now is to move forward with just the insulin so just one chamber like a quote regular insulin pump for now. I know that was a lot but after Kate and I finished the interview, we realized that a quick description like that and some information about glucagon because I still explain it I still have a lot of people who are newer in the community who don't quite understand. So I really hope that that helped.

Okay, a lot more in just a moment but first diabetes These connections is brought to you by Dario health. And we first noticed Dario a couple of years ago at a conference, and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed, you'll get a glucometer that fits in your pocket unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it. And personalized reports based on your activity. Find out more, go to my dario.com forward slash Diabetes Connections.

Kate, thanks, thank you so much for joining me, Boy, am I excited to talk to you.

 

I'm so happy to be here. Before we jump in, my listeners know that I promised this year that in 2021, I was gonna be very heavy on technology. There's so much in front of the FDA, there's so much going into pivotal trials and heading to the FDA that I thought it would be so easy to do all of these interviews. But I realized as we got further along that the very timing of all of this makes it very difficult for the companies to actually come on and share a lot of information because you are limited in what you can say and understandably so. So before we even get started. I know you have a disclaimer that you're probably going to bring out a couple of times during the interview. But why don't you go ahead and say that now.

 

Kate Farnsworth  6:21

Thanks, Stacey. So the iLet bionic pancreas is an investigational device and it's limited by federal or United States law to investigational use is not available for sale

 

Stacey Simms  6:34

as we go forward. And as you listen, I should also let you know that I've given Kate the opportunity as I did when I talked to Howard look from tide pool or you know anybody else who is in this phase of their device or technology, the opportunity to kind of let me know when I've crossed the line. So I may ask a question that you can't answer, Kate. But um, I think we all we kind of understand where we are. So I appreciate that. All right. Having said that, give us the lay of the land, if you can, where is the iLet? In terms of development, let's go high level as far as we can right now.

 

Kate Farnsworth  7:07

Okay, so Beta Bionics  is the company behind the iLet. And we're really different company because we're a certified B Corporation and the public benefit corporation. And that means our company is measured by an independent resource based on how our company's operations and business model impacts our workers, our community, our environment and our customers from our supply chain and input materials to our charitable giving an employee benefits. B Corp certification proves our business meet the highest standards of verified performance. For Beta Bionics . That means the people with diabetes and their loved ones have a seat at the table in our decision making. In that context that we're working to bring the commercial version of the iLet to market. There is currently a pivotal clinical trial testing the eyelid and people living with type 1 diabetes ages six enough. This trial is large and involves 17 different clinical trials sites across the United States. results from this clinical trial will potentially support our application to the FDA for regulatory clearance of the insulin configuration of the device in that population. Once the FDA application is filed, FDA review of 510 k market applications typically take about six months, which includes 90 days of FDA review time and time for response to questions that may come up during the review.

 

Stacey Simms  8:39

My understanding is that the iLet is a device it's we're talking about an insulin pump here. And I guess what I would call an artificial pancreas or hybrid closed loop system, where it communicates with a CGM to help you stay in a certain range. But the island has always been talked about as needing minimal input. In other words, last time I talked to Ed he was talking about you put your weight in. And that's really the only information it needs from the user to get started. Is all of that still the case? Is that what's in these pivotal trials?

 

Kate Farnsworth  9:09

Yeah, so that was designed to be initialized by weight alone. It doesn't require users to set curry shows or basal rates for instance, insulin sensitivity factors, the system uses your weight as a starting point and then learns quickly what your unique responses are based on CGM values that receives every five minutes. So with that in mind, we hope that once the FDA clears it, the iLet can be an automated insulin delivery device that requires very few inputs from healthcare providers and people with diabetes or caregivers. For us this solution isn't just about the feature is it's about the benefit that it could potentially give people reduced cognitive and emotional burden. You might recall Adam Brown has talked about the 42 factors that impact blood glucose at Ada conference and in his book bright spots and landmine, those of us in the community can definitely relate based on our own experiences. There are a number of diverse factors that pay people with diabetes on a whim, combine that juggling act with up to 180 diabetes related decisions that people with diabetes or their caregivers make each day. And we really do have a cognitive and emotional workload that those living without diabetes don't face. So our hope is that the iLet is cleared may reduce that burden, since it's offering a solution to type 1 diabetes management without the same numerical input as traditional employment therapy.

 

Stacey Simms  10:43

Can you speak to the idea of just entering weight and like announcing meals, I mean, I think for those of us my son's used an insulin pump since he was two. So we're coming up on, we're coming up on almost 15 years of using an insulin pump. And the idea of interacting with it less is a little bit mind boggling. You're a mom of a person with type one, you have a child with Type One Diabetes, can you just speak to that idea? You've already talked about the burden being lifted a little bit, but is it difficult for people to kind of wrap their brains around and the reaction of when it does work as well as

 

Kate Farnsworth  11:16

we assume I can't speak about the clinical trial right now or the results that we're getting. But what I can tell you as a mom of a child with diabetes, is that the cognitive and emotional burden that she feels just having to constantly worry about her diabetes is immense. And I think that we even as parents don't fully understand, you know, how much our kids have to think about diabetes, how much it impacts every moment of every day, and interacting with friends or going out or making decisions on whether or not they're going to sleep over at a friend's. And if there was a device that could potentially relieve some of that burden to me, you know, that's huge, that would be amazing for my daughter. So with the eyelid, when you're entering a meal, you would select whether the meal is the usual amount of carbs for you more or less, it's designed not to require you to count the actual number of cartons over time, the system's designed to learn what that means to you personally. So for my daughter, for example, might have a totally different usual meal than your son. So the system is designed to learn and adapt to each individual user. While there's, you know, that's the practical application. There are other considerations for wide the eyelid has been designed that way. There are 1000s of Americans who don't have access to an endocrinologist, we want him to engage them, we want to meet them where they are and help them get closer to their diabetes goals. I feel passionately about improving the lives of people living with diabetes and easing the burden they live with every day. And research has documented racial and ethnic disparities in diabetes treatments and outcomes. Technology uptake, for example, is much higher for white youth than black or Hispanic youth. As a public benefit corporation. Our goal is to get our solutions to as many people as possible. So we're actively exploring how we can reach the underserved populations and hope to be able to provide all people with diabetes, the same level of care,

 

Stacey Simms  13:33

I want to make a note and come back to that because there's been such a wonderful, I don't know how to say it, I want to make a note and come back to that. Because years ago, we talked about the DIY community, how it was reaching so few people, it was such a great benefit, but really not for a lot of people. And so many of you are passionate and wanted to bring this commercial product out. And now it's being done. So I'm gonna I want to follow up on that in just a little bit if I could, but let's continue to kind of talk about where we are, thank you. But the idea of no carb counting, to me, would be such a relief, because one of the shocking things that happened in my brain was within the first year of Benny being diagnosed, I think he was too he wasn't eating as much food as he does now at 16. But we realized that carb counting was so inexact and such guesswork, because you could try to be as exact as possible at home. But then you would go to a restaurant, and you really had no idea. And as you listen, my husband owned and operated a restaurant for many years. So you can tell somebody, this dish has this many carbs in it. But first of all, restaurants put so much more butter and fat, and seasonings and things in your food because that's what makes it taste so delicious at the restaurant, which affects how it breaks down in your body. But also, one person can make it to the next day even at a fast food restaurant, it's not going to be exactly the same. So what was the thinking behind it? Is it really just to make it easier on people or did the researchers and the founders here also kind of think that carb counting really isn't that exact

 

Right back to Kate answering that question, but first Diabetes Connections is brought to you by Gvoke Hypopen and you know low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're gonna pass out. There are lots of symptoms and they can't be different for everyone. I'm so glad we have a different option to treat very low blood sugar Gvoke Hypopen. It's the first auto injector to treat very low blood sugar. Gvoke Hypopen is pre mixed and ready to go with no visible needle before Gvoke people needed to go through a lot of steps to get glucagon treatments ready to be used. This made emergency situations even more challenging and stressful. This is so much better. I am grateful we have it on hand, find out more go to Diabetes connections.com and click on the Gvoke logo. gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com slash risk. Now back to Kate answering my question about the inexact science of counting carbs.

 

Kate Farnsworth  16:03

Yeah, carb counting is not very accurate. People are notoriously bad at carb counting, my daughter might be looking at her meal and see 15 carbs, another person with diabetes might count those curves completely differently, it's really helpful to be able to look at your plate and say, you know, this is usual for me, or this is more for me, this breakfast is way more than I would typically eat. So I'm gonna let the system know about that. Rather than counting the exact numbers in that restaurant meal.

 

Stacey Simms  16:43

I could talk about that for an hour. That to me is so revolutionary Benny the other day, we got these big cookies, which is you know, a real tree. We don't eat a ton of junk food, but we don't eat super low carb either. But there were these giant chocolate chip cookies. And he was higher than usual later. And I just asked him, I'm like, Hey, I'm just curious, because I don't look at everything he eats or talked about every bolus anymore. So what did you think those cookies were? And he said, Oh, I think it was I think I put in 35. I was like, dude, those were like, 65. Easy, right? And he was what I did. He's had diabetes for 14 years. Right? It doesn't mean he's a bad person. He just didn't. He just took a guess.

 

Kate Farnsworth  17:19

Yeah, exactly. Exactly. We have the same with my daughter. I don't manage her diabetes, you know, as actively as I used to when she was little, but occasionally I'll ask her, you know, how many carbs Did you think were in that, and then we'll compare it to the package. One really big example that we have, we have those flat pretzels, and they're in a big container. And she'll just pour herself a bowl. And, you know, she guesses on how many carbs are in that bowl. But one time we actually put it on the scale and calculated and she was 45 carbs consistently, because she had been doing this for some time. And I know the same thing happens with cereal, for example, once we move past that carrying a scale with us phase, our eyeballs are the judges and they're not very good. So yeah,

 

Stacey Simms  18:10

I think some people listening might be saying, Well, why don't you carry scales with you anymore? What kind of parents are you, but I got to say I'm not into adding any more diabetes burden, then we need to so I'm thrilled with letting technology replaced my brain on this, you know, control IQ has done a wonderful job for us and really helping and you know, what you're talking about is only going to help as well. So the big question with the iLet has always been about the dual chambered pump. This was a pump that years ago was talked about and I know you're still working toward a dual chambered pump with insulin and with glucagon in it, but my understanding is that what we're talking about today, what the pivotal trials are all about is insulin only. Can you talk a little bit, just kind of give the listeners an update on what we're talking about in terms of the one chambered pump and what you're working toward, with the dual chamber pump.

 

Kate Farnsworth  19:00

So the iLet’s designed with two chambers, one for an insulin cartridge and the other for our glucagon cartridge. Her initial device after an FDA clearance will have the insulin chamber available to users while the glucagon chamber will not be usable. Once the dual hormone configuration has been also cleared through the FDA through a subsequent 510 k application. The glucagon chamber will also be made available to users. Our hope is that it would be the same device just the second chamber would then become available.

 

Stacey Simms  19:34

I understand you may not be able to answer this. But if and when it becomes dual chamber pump. The hardware as you say would be the same. Is it just a question of software updates or is that looking too far in the future?

 

Kate Farnsworth  19:47

It is my understanding that it will be a software update. But we definitely are getting ahead of ourselves there. We have to go through the whole FDA and 510 k application for that company.

 

Stacey Simms  20:00

Got it. Okay. I'll be I'll tread lightly on Be careful on that. Of course, a couple of weeks ago, I talked to the folks at ziggo log, which I'm still not sure I'm saying correctly, which is the glucagon that I believe you all are working with.

 

Unknown Speaker  20:19

Is that still the case?

 

Kate Farnsworth  20:20

Yes. Yes. So we are working with Zealand to provide the glucagon that will be used in the clinical trial for the by hormonal device. And they recently got approval for adaptive glucagon for the treatment of severe hypoglycemia. And they're marketing it under the brand name Tagalog. I hope I am saying that.

 

Unknown Speaker  20:42

I think we're good.

 

Stacey Simms  20:43

I guess my only question on that, because I know it's a separate company. But it was so many years that we were waiting not just for the eyelid, but we were waiting for that shelf stable glucagon, so we didn't have to emergencies or for low treatment, reconstitute or kind of open that red box or that orange emergency box. So it was a big relief in many ways when the different types of shelf stable glue gun were approved. I mean, there's three options. Now, I know you can't speak in detail about a lot of this. But I got a question from a listener about how this would work. And the question wasn't so much about the mechanisms or the software. I know that's proprietary. But the question was, you know, it's always risky to use glucagon too much, right? It's also why we don't want to have too many lows in a row that your liver has to help out with because you can deplete the glucagon supply. And I'm curious, this listener wants to know, is there any danger of depleting the body's own sources if you're always giving it from an external glucagon, injection or infusion?

 

Kate Farnsworth  21:49

So we're deeply aware of the risks of severe hypoglycemia until we know more from a pivotal trial, it would be best at that question to an MD with expertise in glucagon storage and depletion. But what I can tell you is that we're partnering with seeland to provide the glucagon that will be used in the clinical trial for our bio hormonal device. As you know, they recently got approval for his ecolog. And we plan to use that same shelf stable ready to use quizzes on with the island in our bio hormonal pivotal trials. It's really important to note though, that the amount of glucagon that will be dispensed in the iLet will be substantially lower than the amount dispensed in the cycle of injection or prefilled pen. That's because the ladders for severe or hypo rescue and the amount the iLet would dispense is intended to be hypoglycemia prevention. So that iLet is designed to micro dose very small amounts of glucagon as needed based on the person with diabetes CGM readings and the speed of their glucose decline. So it's really important for people to know that they wouldn't be getting a rescue dose of glucagon in that scenario. Of course, the use of Desa glucagon with the iLet will need additional FDA approval for Depo glucagon. And the iLet will also need FDA clearance for dispensing deathly glucagon.

 

Stacey Simms  23:12

I mentioned earlier that the system and you mentioned this as well, is working with a CGM. And my understanding is that this is Dexcom g six.

 

Kate Farnsworth  23:21

That's correct. The eyelid is designed to work with the Dexcom CGM, but we're open to working with other CGM manufacturers in the future. Because we understand that choice is really important to people living with diabetes.

 

Stacey Simms  23:36

That's great. Dexcom g seven is moving forward. I assume that as that moves forward, this iLet will move forward with it.

 

Kate Farnsworth  23:45

I would think that's a fairly safe assumption. Okay, good answer. Can you tell me

 

Stacey Simms  23:50

any details? Again? I feel like I'm fishing here. But can I can you tell me any details about the pump itself? You know, we've got Omni pod, which has the remote PDM that is used with it. We have Tandem, which has buttons on the pump, and they're hoping to get bolus by phone pretty soon. Is the eyelid buttons on the pump? Is it a phone control? Anything you can tell me about that?

 

Kate Farnsworth  24:13

Yeah, so everything currently is designed to be done from the iLet itself. It has a touchscreen interface. And the infusion says at launch will be similar to the inside. So people are familiar with john caustic and our team are working on some of the potential mobile solutions for the iLet’s. And we hope to have more information about those as we get closer to launch.

 

Stacey Simms  24:38

I know that you have had a lot of input from the community because I've seen the the posts that you will have put out there asking for help from the community in terms of I guess what is called human factors and things like that. Can you share a little bit about anything that you've learned just anecdotally about what people like and don't like about using an insulin pump, or what you could any kind of feedback that you got along The way that might be of interest.

 

Kate Farnsworth  25:01

Unfortunately, I can't share that information. I'm sorry. Yeah, I can talk a little bit about the fact that we have a lot of preclinical data that's available on our website. So if anybody is interested in looking at bat, it's Beta Bionics  calm, and I can't comment on the results of our pivotal trial as it's still in progress. We do hope to have those results later this year and look forward to sharing them. Our goal backed by appropriate research, and continuously advancing technology is to create a solution that people with diabetes don't have to spend so much time micromanaging decisions that impact their condition, and that they can spend more time focusing on other things in their lives.

 

Stacey Simms  25:51

This is another question from a listener. And this is about changing the reservoirs out and I this would be when it is dual chambered. So do you have to change them together? Or can you change out the one that is empty? And I'll add to that, again, knowing I don't know if you can answer that, you know, right now, we are all told to change out an insulin cartridge within three days, do you have to change the glucagon in a period of time as well.

 

Kate Farnsworth  26:16

So as designed the insulin cartridge use that the iLet can be changed actually independently of the infusion set. So you can change your insulin cartridge, but not your infusion set. And we intend to have prefilled cartridges and user filled cartridges available if FDA clear, as for the glucagon, that's one of the things we hope to uncover during the by hormonal pivotal trial is the duration that people can leave the Deathly the carton cartridge in the device, and how often it needs to be changed.

 

Stacey Simms  26:52

You I didn't ask about infusion sets, and I'm not a big fan of any of them on the market. I think that's the weak link of pumping. I'm not alone in that assessment. Two questions there. So when it is dual chamber, do you anticipate two infusion lines and two infusion sets? I assume you're not mixing these two together? Right?

 

Kate Farnsworth  27:13

Yes, we anticipate using two inpatients.

 

Stacey Simms  27:16

And then the other question is, can you share what you're using is? Is there a new one coming from Beta Bionics  or are you planning to use one that's already on the market?

 

Kate Farnsworth  27:24

For our pivotal trials, we're using ones that are very similar to in test that are currently available for no medical. And that is what we plan to use that launch.

 

Stacey Simms  27:38

Couple other just kind of life style questions, I guess about the pump? How is it charged? Is it a battery is it is an external? How do you charge the pump.

 

Kate Farnsworth  27:48

So the iLets designed for inductive charging like modern mobile phones, so no cords or cables are required to charge it. The batteries designed to typically last about five days on a single charge and a full charge takes about two hours.

 

Stacey Simms  28:04

So wait, I think that went by too quickly for my brain. Okay, you mean like lay it on a charger? You don't plug it in? Correct? Do I have to get a special charger? Or can you use anything? Like you said a cell phone charger? I mean, no, I don't use one of those, which is why you're hear me stammering around I'm thinking like, do I get one on Amazon? Do you buy that this is easy. These are easily available for regular people.

 

Kate Farnsworth  28:25

Our hope is to ship you a charger with the device, but that it would also work with another charger of similar design that you might have around your house. Okay,

 

Stacey Simms  28:38

and is I'm probably said it's so old fashioned to everybody listening. But you know, what are you gonna do? And talk a little bit about the pump? Is it waterproof? Can it get wet? It is designed to be waterproof. Yes. So wait, now I have to ask. So like I can you can swim with it. It's not just waterproof to a certain amount.

 

Kate Farnsworth  28:57

So you remember those animals bubbling water displays that they used to have when they had their pumps floating in the water. So their devices were certified the same level that the iLet, we hope that the iLet will be certified to as well.

 

Stacey Simms  29:15

Very cool. Anybody have those old animist displays? You guys could grab those. I think I was at a display once they had fish swimming in the water once.

 

Kate Farnsworth  29:22

Yeah, exactly. I that's how it was explained to me by one of our engineers was the old venomous, complex the same way and they had the bubbler with the fish in it.

 

Stacey Simms  29:34

I think I have a photo because you know, I used to work with animals. And I'm pretty sure I spoke at an event where they had these centerpieces at a table and it was a fish tank and the pumps were ended. I'll have to search that up. And that's great. Let me ask you. I'm sure that my listeners will have many more questions about the eyelet. And hopefully we can speak again we'll get more information as it moves forward. But you and I have known each other for a long time in the community as fellow diabetes parents. Do you mind As a couple of questions about how you're doing and your daughter was diagnosed when she was what, eight, nine years old?

 

Kate Farnsworth  30:05

That's a incident. He was diagnosed when she was eight. And she just turned 18. Wow, she is now an adult. Oh, my

 

Stacey Simms  30:13

gosh, how is she doing? I mean, we've already talked about her a little bit, but it sounds like me, you have backed off quite a bit of the diabetes parenting, although we never really back

 

Kate Farnsworth  30:24

off. Yeah, so she's doing great. She's finishing high school, and she has been accepted to university in September, and she will be living in residence. So we are preparing for her moving out of the house in late August. Wow. Oh, my goodness.

 

Stacey Simms  30:42

I'm curious. Now, I don't want to get too far off the topic here. But I'm curious, did you all as a family do anything special in terms of college prep, I have a plan in mind. I don't know if I'll do it where like Benny's, second half of his senior year of high school, I really just want to leave him alone, completely, like, stop following him, you

 

Kate Farnsworth  31:01

know, be here if he really needs me. But I don't know, did you do anything like that. So we have been slowly transitioning and backing off as sort of naturally as the year has progressed. So she takes care of all of her diabetes management side changes all of those things without being reminded by me, which is fantastic. I have started transitioning to her ordering supplies. So I've taught her how to, you know, it's just a login to a website, and you click what you need. And they check our insurance is not very complicated. But I have walked her through how to do that, so that she has a bit more comfort with it, we are really worried about overnight, because she currently does not wake up for low blood sugars. So we've been sort of thinking through how we can do that. And over the summer, we will be backing off that and having her finding ways to get her to wake up to her low blood sugar alarms and try and manage those overnight. Because that is my biggest concern about her moving away.

 

Stacey Simms  32:11

When you and I first spoke, it was the summer of 2015 was the first year of this podcast. And we were talking about nightscout I can probably dig up the pictures, I had this giant setup that I slept to friends for life that I don't use on the road anymore. When we're back on the road, I'm really excited to see people again, but we talked at the time about the nightscout project and about your help to so many people in designing the Pebble watch face, you know helping people set that up. I'm curious as you look back, I mean, a lot of people from the Do It Yourself community, you already mentioned john kostik, and many others are now working in the commercial space to bring we mentioned this towards the beginning to bring what was better technology, better care. That was really only a very, very small percentage of people to the larger community. Could you speak to that for a minute, it's amazing to me to see how far everything has come.

 

Kate Farnsworth  33:09

I started out with a real passion for helping people living with diabetes and trying to get you know all of the technology to them. And the problem is that we reach a certain wall with the people that we can reach online, we're sort of in this echo chamber of the same people all the time. And what we've discovered is that technology uptake is much higher in certain populations. You know, I recently did a study and we're finding that people who are Caucasian or higher income are much more likely to be using these tools than the people of color and their counterparts. So working for companies like Beta Bionics  give us the opportunity to reach a much wider group of people and really gives us the opportunity because we are a public benefit company to try and engage those people that aren't being engaged currently with the tools that are available.

 

Stacey Simms  34:13

When you look back at your time in the DIY community. You know what stands out to you. It was such a buzzy busy time between 2013 and 2016, or even 2017. But as commercial offerings have, frankly, gotten better, you know, I know a lot of people still use the DIY stuff, but it seems like there was an energy and there was a really, you know, a time not too long ago were folks like you were I gotta imagine your phone was buzzing all the time with people asking for help. You know, what was

 

Kate Farnsworth  34:45

all that? Like? Yeah, it was a crazy time. And, you know, to a certain extent, those communities are still really active. The Loop community, which I run has 27,000 people in it, you know, so there's still A lot of activity surrounding these things. But I think as the commercial solutions come around, we're able to provide solutions for so many more people that that sort of aggressive need dies down from a little bit from the DIY community, because a greater number of people without maybe the same technical expertise are able to find solutions with the commercial offering. So I always said, I would keep doing that volunteer job until a commercial offering was able to put me out of business. because ideally, you know, I hope that commercial solutions like that iLet will be able to serve the diabetes community, so that we don't have to look to DIY solutions anymore.

 

Stacey Simms  35:49

I always hate asking this question, because I know there's probably not going to be an answer at the end of it. But what is the hoped for timeline here? Can you tell us anything about the submission or or things like that?

 

Kate Farnsworth  36:08

I love the silence. That's okay. I have to ask. Yeah. So as I said, once the clinical trial is completed, then we will submit for FDA regulatory clearance of the insulin only configuration. Once the FDA application is filed, there will be an FDA review of the 510 k market applications, those typically take six months. And then we will have a launch date. Once that has all been completed. This

 

Stacey Simms  36:38

might be an odd question. But as we start to wrap it up here, when we go to conferences, like friends for life over the last several years, and Ed Damiano speaks about the the product and the process and everything. Anything that has to do with Beta Bionics  and the iLet is so closely watched, it has just become, I guess the way to say this, you guys have a lot of fans out there in the community. I mean, it might be a small portion of the entire diabetes world. But this is a really passionate group of people kind of waiting for this. Do you as you talk to each other? Like, do you feel the pressure of that? Is that exciting to you? I just would imagine and I can't answer this for you. But going to work, there must be amazing every day to know that people are so excited about the product

 

Kate Farnsworth  37:25

is absolutely amazing. We definitely feel the community spirit and presence and pressure to deliver you know, every day, we talked about the fact that, you know, we want to help the people living with diabetes who have been waiting for us. And we don't want to make them wait any longer than they have to. And you know, the process has taken longer than we hoped it would. So we're definitely committed to the people with diabetes that we're trying to help. And we have the most passionate team working on this, everybody is so committed. And we have so many people who are touched by type 1 diabetes, either living with Type One Diabetes, or parents of children with Type One Diabetes, or children of parents with Type One Diabetes. You know, we're part of the community. We really feel passionately about this. So we cannot wait to have this device ready for those people.

 

Stacey Simms  38:27

Okay, thank you so much for joining me and for being patient with my questions. I know as I said, you're limited in what you can say. But I cannot tell you how much I appreciate Beta Bionics  making you accessible and coming in to share this. So and thanks for all your hard work. I cannot wait to learn more. I know you can't wait to tell us more. So thanks so much for being here.

 

Kate Farnsworth  38:46

Thank you so much for having me. I'm really grateful for this opportunity. And I look forward to talking to you again in the future.

 

Unknown Speaker  38:58

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  39:04

More information at Diabetes connections.com. Or, of course in the show notes. You can always go to the homepage though, to get the full notes and the transcription of every episode. And there's a lot there. as Kate alluded to, there are some other studies, there's some more information, and it's all at Beta Bionics . So I will link that up in addition to the interviews we've done in the past with Ed Damiano, and I'm gonna link up the first interview I did with Kate back in 2015. Because looking back, that made me laugh and this has nothing to do with Beta Bionics  or the pumper or technology or it's my technology. So I use very light technology.

This is just a little bit of inside baseball now on the podcast when I travel and I'm going to be traveling again to conventions this year, which is so exciting. I have a small kind of a studio in your pocket. It's a zoom h5 recorder and I use a couple of ATR 2100s if you're into that kind of microphone technology. Light stuff. I don't even need to plug it into a computer. The h5 is its own little studio. But when I interviewed Kate and I interviewed a bunch of people at that first friend for life that I went to as a podcaster, I brought my Yeti. The Yeti microphone is a brick. It's not that great a microphone actually that don't get me started. But it's a brick. And it's so, so heavy. And I brought like a mini studio, I had this paneling setup. Oh my gosh, I had so many things to check when I got on the airplane. And then I was schlepping it around the hotel at friends for life, which is not the most compact hotel. It's a lot of walking. So I'll see if I can dig up some pictures. But Kate was very patient with me as was everybody I talked to that day. Just funny how things do change over six years.

All right, we've got some Tell me something good coming up with some fantastic anniversaries, not about the podcast, some listeners who are celebrating very long time diversities and are doing great. But first Diabetes Connections is brought to you by Dexcom. And one of the most common questions I get is how to help kids become more independent. You know, those transitional times are pretty tricky. elementary to middle middle to high school. You know what I mean? Using the Dexcom makes a big difference for us. It's not all about share and follow that's helpful. Think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four to five finger sticks at school or for a second grader to just show their care team their number before Jim at one point Benny was up to 10 finger sticks a day and not having to do that makes his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to keep your kids more independence. Find out more at Diabetes connections.com and click on the Dexcom logo.

 

And tell me something good this week big time big diversities. Terry Lopes is celebrating 50 years of type 1 diabetes. She was diagnosed at the age of nine. And she made a really nice Facebook post where she talks about being grateful to the people in her life who helped her and looked out for her early on parents, siblings, friends, teachers, camp counselors, nurses, doctors, she says and thankful for those who still look out for me and for the technology that helps me have better control and live much more freely. And also makes it so that no one needs to be told they may only live to the age of 40 when diagnosed as a young child. Terry, thank you so much for sharing this. She also posted that her dad turned 90 recently as well. So Happy Birthday to him, my goodness. But it really is hard to imagine. And I know I'm so grateful to know many people who have lived with type one for 40,50, even 60,70 years. I mean, it's amazing that you know, I don't know them personally, but we've been connected online. And they were all told as children as children, that they would not live a long and healthy life. Our kids are not told that anymore. And I'm so grateful for that. Terry, I'm thrilled that you're in the group and thank you so much for sharing that.

Yerachamil Altman shared a different kind of diaverary, he posted that he has been using an insulin pump for 40 years. 4-0! he has got to be one of the first people to use an insulin pump. And we've had him on the show. I know he helped design insulin pumps. I mean, my goodness, what a life. And he always posts we're so thankful for this the old technology. So if you're in the Facebook group, Diabetes Connections, the group I'll make sure to repost this. But I mean, the first insulin pump was basically like a syringe taped to what looks like a big pager, and it just stabbed you with the needle and gave you the Insulet I don't know it just it doesn't look like something that would work. It looks like something Benny would have slapped together from spear diabetes parts when he was in second grade. God bless the people who use this and tested everything and made it so like I just said so that our kids and adults diagnosed today can live long and healthy lives. 40 years with an insulin pump, you're off a meal. Thank you for sharing that. And you know, I love sharing the good news. If you've got something Tell me about it. Stacey at Diabetes connections.com or post in the Facebook group. I love to hear it.

Before I let you go quick reminder about in the news, my new feature every Wednesday 4:30pm Eastern live on Facebook. I hope you can join me for that I'm working on some different texts. And to see if I can make it look a little bit more TV newsy. That's been really fun. I got a green screen and oh my gosh, I started out in television. And then I went to radio and then I went to podcasting. And now it's like back in TV reporting. It's bonkers. But I'm also as you know, if you're a regular podcast listener, and putting out those in the news episodes every Friday as well so if you miss it live, or you just want to hear the audio, I definitely want you to have options and like doing this a lot. It's been really fun. I'm trying to keep them short. So if you like it or you don't you've got any constructive criticism, any kind of criticism I can take but come on be nice. Please, please please let me know. I also announced on social media that I have taken a new position I am working with the fabulous folks at she podcasts. I'm Selling sponsorships for she podcasts live, which is coming up in October of this year. I'm going to do friends for life in New York in the beginning of October, and then I'm going to shoot podcasts live in the middle of October in Scottsdale, Arizona. It's going to be a busy month. I also have a big birthday in that month. So we're going to be we're looking forward to October, it's going to be great. But if you are at all involved in podcasting, and you're a woman, please check out she podcasts, I'll put a link if you are interested in reaching 1000s of women who podcast You don't have to be a technology company. But if you want to reach women who are movers and shakers, let me know because I can hook you up. That's my new gig. I'm still gonna be doing the podcast of course, and all my other projects. This is perfect because I get to meet some new people and do some fun stuff. But I don't have to give up anything but maybe some sleep. I don't know. I'm gonna get this done.

Alright, thank you, as always to my editor John Bukeas from audio editing solutions. Thank you so much for listening six years. Oh my gosh. I'm Stacey Simms. I'll see you back here in just a couple of days. Until then, be kind to yourself.

 

Benny  46:10

Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged

 

Transcribed by https://otter.ai

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