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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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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

 

 

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