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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: Page 1
Mar 10, 2020

Lilly Diabetes announced they were getting into the pump and pen business almost two years ago. How’s it going? We get an update from Marie Schiller, Vice President of Product Development for Connected Care and Insulins at Eli Lilly – Connected Care is what they’re calling this platform of pumps and pens – now to be integrated with Dexcom.

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

We’ll also have a bit of an update on some other pump companies’ plans for the near future.. bolus from your phone?!
In TMSG a big fish, a hula hoop winner and a chance meeting over a foot?

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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 Transcript:

 

Stacey Simms  0:00

Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Real Good Foods, real food, you feel good about eating, and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

 

Announcer  0:21

This is diabetes connections with Stacey Simms.

 

Stacey Simms  0:27

This week, Eli Lilly announced they were getting into the pump and pen business almost two years ago. How's it going? We get an update. And of course I asked about price and access.

 

Marie Schiller  0:38

Look, we're not here for the sake of having this innovation sit on a shelf somewhere, not why I'm here. It's not why others are here. And so it is really important for us to be laser focused on how people act. So

 

Stacey Simms  0:53

that's Marie Schiller, Vice President of Product Development for connected care and insulins at Lilly We'll also have a bit of an update on some other pump companies plans for the near future. Well, let's sing from your phone in Tell me something good a big fish, a hula hoop winner, and a chance meeting over a foot. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

 

Welcome to another week of the show. I am your host Stacey Simms, so glad to have you along for another week. As always, we aim to educate and inspire by sharing stories of connection. My son was diagnosed 13 years ago with Type One Diabetes. My husband lives with type two. I do not have diabetes, but I have a background in broadcasting. And that's how you get the podcast.

I'm excited to catch up with Lilly. I know a lot of people don't want to hear anything from them until they address the price of insulin. And I do understand that I want to be sensitive to that. And I definitely asked Marie all about that. Even though she has nothing to do with the price of insulin but she doesn't work at Lilly and this system. I can't be really separated from that, let's be honest. But I also think I have a responsibility to share what's going on in terms of diabetes technology, and Lilly plans to be a big player in this space. So that's what the interview is all about. We'll be talking about their system. We'll be talking about their partnership with Dexcom and other things as they move forward.

Before we get to that, I want to thank Kerri Sparling and the folks at children with diabetes. We replayed the interview that Kerri did with me this was on their YouTube channel and then last week in the kind of the mini episode although it wasn't really a mini we replayed the audio from that interview. It's always a little weird for me to be on the other side of the microphone, but it's always a lot of fun to I bring it up not to hammer on the interview again, if you wanted to see it or listen, you know, you know where to find it and I will link it up in this episode. But because they are doing a contest. The contest is open until March 20. And to enter you do have to email them so I will link that As well, it's over on the children with diabetes a website. But all of these links will be in the episode homepage. They're giving away a paperback of the world's worst diabetes mom and the audio version. So I'd love for you to go and enter and find out more on their websites.

Speaking of the book, I am having such a blast on the book tour that I'm doing this year. You know, we'll see how it goes. Obviously there are some health scares out there right now. And I'm not sure that all the events are going to stay as scheduled for right now. They're all on the books that's on the website as well. And if you're interested in the world's worst diabetes mom, that's an easy place to find out more but I have to share with you that I got a great note from a woman in Australia who listens to the show and you know, has read my book she bought it you can get it on Amazon really in so many countries now print on demand is absolutely amazing. And she got it in Australia and she reached out to me because her local group wants to do a bulk order. So we are doing that. And if you have a situation like that where you would like a little large number of books for your group. please reach out to me directly. You don't have to just buy it on Amazon for the full retail price. I am happy to work with you. My publisher has given me some ways to do this. That really makes sense. It's an amazing thing to think about people all over the world reading the world's worst diabetes mom. It didn't say America's worst diabetes mom. So I guess I have to stand by that now.

All right. We will have the interview with Marie Shiller from Lilly coming up in just a moment. But first let me tell you about Real Good Foods Diabetes Connections is brought to you by them. Have you tried their cauliflower crust Margarita pizza. They have a full size and a personal size as well. So yummy. It is low carb high protein real simple ingredients. And you know you gotta be careful because some cauliflower crust pizzas are made with corn starch. You know rice flowers, processed grains. And if you're looking for something that is 100% grain free and gluten free, this is what you're looking for. I love how Real Good Foods keeps creating Eating new products, they keep coming out with new yummy foods for us. It's the kind of thing where you as soon as you don't feel like cooking, sometimes you want the convenience. And when you go for convenience, you really don't want to sacrifice nutrition, right? I mean, you don't want to just pull out some junk food. I love Real Good Foods, it tastes terrific. And the people behind them are solid. They get involved in our community. They listen to what we have to say. It's really nice, find out more, go to diabetes, connections comm and click on the Real Good Foods logo.

 

My guest this week is Marie Schiller Vice President of Product Development for connected care and insolence at Lilly. Two years ago, I was part of a group of writers and reporters from the diabetes community invited to Cambridge, Massachusetts, to take a look at Lilly's entrance into the pump and pen market to give feedback on those plans and to hear from their partners. We did an episode back then and I'll link up what I and others wrote at the time. No pictures still of what they show. Very briefly that day, they showed us kind of the prototype, but it is a tiny pump. It's kind of like a fat little disc. It's much smaller than an omni pod pod. It's maybe about the size of the tee sport that tandem is coming out with. I'm actually going to talk more about that after this interview a pump update from tandem some news from Omni pod. We'll get to that after this interview, but I'll put up some photos of the T sport, but this is thinner than that the Lilly pump is just a small thin disc. It is tubed. So the idea is that you can stick it to your body or use longer tubing and put it in your pocket. We do talk about that. It'll fit in the palm of your hand very easily. Of course we do talk about the price of insulin, and what that means for access of anything coming from Philly. So here's my interview with Marie Schiller. Marie thanks for talking to me. I'm excited to catch up. It's been about almost two years since we've MIT in Cambridge, thanks for coming on the show.

 

Marie Schiller  7:02

Thanks for having me. I'm excited to be back.

 

Stacey Simms  7:05

All right, so give us the update. I know we're going to talk about the partnership with Dexcom and some other things that Lilly is working on. But when we last left this episode, the last time we talked at least in person, you over talking about the device that Lilly had been working on, can you give us an update on that

 

Marie Schiller  7:25

I can and maybe to be helpful Stacy just to remind the audience of what we've been working on. So Lilly has a personalized diabetes management system that is incorporating inform delivery devices, software and analytics. And obviously that will be combined with glucose data and other contextual information in order to hopefully to improve diabetes management. We have two parts of that system. So we obviously have a pen based platform where we'll be using our refill disposable insulin pen, with data coming in from glucose monitoring devices and be able to combine that with different elements of care in that platform. And then the pump based platform, which would be a hybrid closed loop system, integrating the the pump itself in with a continuous glucose monitoring and an algorithm as well. So that's the journey we started on. I think we were we had not just kicked off the program when we last talked a couple years ago, but it was certainly early in the development program. It's been a frankly, an awesome couple of years is advancing both of those areas we had started I know when we last talked, but with the development agreement with Dexcom, which we have continued to advance our relationship with Dexcom and now have entered into a global commercialization agreement with them. We continued our clinical trials with the pump based system we'll be talking about Some of the first clinical data will be shared this coming February at the the conference in Madrid at TCU. And on the connected pen side we have, so we secured a supplemental drug approval for the pen that will be compatible with the personalized diabetes management system. And we're in the midst of working with the FDA on the other components of the system that we will need to bring forward and launch the entirety of that integrated solution.

 

Stacey Simms  9:35

So there's a lot of moving parts, there are a lot of different things going on. You mentioned the clinical trials, and let's kind of take this step by step. I'm sure you can share the information ahead of the release. But what were you looking for this was for the pump system. Was this a safety trial? Was this an outcome trial? Can you share any information

 

Marie Schiller  9:55

for you know, I won't go into any details that we will be sharing at the conference, but As has been seen with other products going through on that hybrid closed loop system, we are focused on showing that the system is functioning accurately. So we are looking at that first stage looking at different you know, stress situations with the system making sure the system is responding as we would expect it to respond. And obviously as part of that is the safety of the system.

 

Stacey Simms  10:27

So, as we're talking about this system, what's so intriguing about it to me is that it is a pump, but it acts more like a pod. At least it did when I last saw it or I saw a mock up of it even so is it still that way it's very teeny tiny, but it it acts as a tube pump with a very small tube that goes into a traditional inset Is that still the hardware?

 

Marie Schiller  10:47

It is so we what we like to call it is that is a hybrid system meeting on the days that you want to carry it and put it in your pocket or wherever is your choice of carrying it. You could use a standard length infusion set or a long infusion set, whatever your preference, but on days that you wanted to wear it, and adhere it to your body, you could do that. And so it would still work with a standard catheter infusion set, but you would obviously be using a shorter tube in that instance, if you choose to wear it on those days.

 

Stacey Simms  11:24

You know, it's funny, Marie, I've I didn't ask this when I first saw it two years ago, and I keep thinking about it, because now tandem has a I don't know where they are in their development stage. They have the T sport which sounds very similar that they're hoping to come out with. How do you actually were these tubes, tiny tubes, pumps, the hybrid pumps on the body? Did they just kind of dangle from the tube? Do you stick them to your skin? Does it work?

 

Marie Schiller  11:47

Yeah, I can't comment on tandem. It's a great question though. Stacey, you know, obviously with our so there's an adhesive component where you are wearing the pump. It's not obviously on the infusion set right? But ours is where you would be adhering to the pump itself.

 

Stacey Simms  12:04

And my frustration was I thought you're gonna say I can't tell you anything. But that's great. There's like a sticky on the pump and it sticks to your skin. does it stick to the body? Like a? Is it like a Dexcom? sticky? Or is it like the ever since which is more like what I call a color forms? Remember those color forms? You could take them on and off and on and off? Is it more like that? Or is it once it's stuck to your skin? Then you kinda have to pry it off.

 

Marie Schiller  12:34

Yeah, I may, at this point, just pull back a little bit because I think I may be going down. I may be going down the rabbit hole as if I'm trying. I feel like I'm going to be playing a game of charades as I try to walk you through how the system works. And it may be more confusing than helpful. So yeah, as I mentioned that you have the ability to wear it and there's an adhesive system and we'll leave it at that.

 

Stacey Simms  12:59

All right. But it's very interesting. So then my next question is, do you know if Lilly is going to be developing new infusion sets? And I asked this because I've shared for years and years, and I'm not the only one, that I really think that the traditional infusion sets are the weak link of any pump. They're just not great. And I'm always hoping that somebody is going to come up with a better one. Any chance, this is part of your plan?

 

Marie Schiller  13:24

as we've talked about, look, we are looking at all components of the system. Right. And so we are starting with our core system, we're looking at all aspects of the system. I would say, you know, it's hard for me to say yes or no, on that side. I think we're looking at the need in the marketplace. Right. I think on that infusion set side. I'd be curious to sort of hear your experience with that. I think in in some of the research we've seen, it's different sort of aspects where people would say they'd like improvement. Clearly. Extended wear is something that we're hearing a lot I know jdrf and others Groups are focused on that. But what areas are high on your list

 

Stacey Simms  14:03

that they work better, that that you can push more insulin through them that they don't get kinked and they don't get occluded. And they don't need to know that they're, they're not as damaging to the skin that they're not as painful that I feel I could go on and on. But truly, I really think they're the weak link of pumping and you know that they even what was the one from BD for a while like it had a better flow, it didn't just float the bottom of the canula even to be able to rotate it there was one you used to be able to spin you know, that would go with that would turn you know, there's there's so much so sure, I'll be in a focus group anytime or recall me.

 

Marie Schiller  14:38

I'm taking furious notes here to make sure I get all of this feedback because this is exactly what we need to hear, you know, and exactly what we're excited about. I think we just continue to feel that there are so much room for improvement on these systems. Albeit we've made a ton of progress today. But these are all of the nuances right then each of us I deal with every day and why, you know, the more innovation the better and space where we can continue to look at all of these elements and make progress.

 

Stacey Simms  15:09

So let's talk about the pen system too, because that's very useful and very fascinating. The pen is, as you had already said, It is not just an insulin pen, it is part of a connected system. Can you talk a little bit about what that means? We've mentioned Dexcom. already. I assume you use your phone. You can see where you've been it recommends dosing, that kind of thing.

 

Right back to my talk with Marie but first One Drop is diabetes management for the 21st century. One Drop was designed by people with diabetes for people with diabetes. One Drops glucose meter looks nothing like a medical device. It is sleek, compact, and seamlessly integrates with the award winning One Drop mobile app, sync all your other health apps to One Drop to keep track of the big picture and easily see health trends. And with a One Drop subscription you get unlimited test strips. lancets delivered right to your door. Every One Drop plan also includes access to your own certified diabetes coach have questions but don't feel like waiting for your next doctor visit your personal coach is always there to help go to diabetes connections calm and click on the One Drop logo to learn more. Now back to Marie answering my question on what a connected system means and whether the pins help keep track of dosing

 

as we expect.

 

Marie Schiller  16:28

It does so as we mentioned, it's based on the the quick pen platform is is a core component of it. So if you look at the quick pen platform that we offer in forums and we have our current basic lar influence and humor log both in the half unit one unit and two units, and then we have our ultra rapid insulin that's under review today. So as in and I don't know what's your son ever on 10 before you move to pump,

 

Stacey Simms  16:58

he was actually uncertain Because the dosing was so teeny tiny, and they didn't even have half units, but he was on quarter units. But we have since we use pens a lot, because it's a backup for him. If he gets to fly and feels like his infusion set isn't working, he'll take a shot. And he is also a little unusual in that we use. We use a long acting shot with the pump. So he does use a pen every day.

 

Marie Schiller  17:25

Okay, well, then you're familiar with it. And I can share with you that I was a pumper for years. And now I'm back to two shots, as we all sort of go through those journeys, but what I was going to describe is when you're taking those informs, especially as you know, you're taking the long acting in the short acting. There are just some basic elements that we still don't have today, right? You're running out the door, you're trying to get your son to school or I'm trying to get to work that I did I just take that shot or not again, remember right and just some of the most the simplest aspects of being able to be like up there. If I took that dose, right, and being able to have that check in place, but there are, you know, as you move down that level of sophistication, most people on informer fire some level of glucose testing, whether that is blood glucose monitoring, or as we're doing with the continuous glucose monitors. So the idea is, is that you would have the informed data from the pen, you would have your glucose data, whether that's blood glucose or CGM data, and you would take that in integrate them into this diabetes management system that depending on what you want, is how you would interact with that system. So some would have a preference of saying, you know, when I'm doing okay, or my regimen maybe easier, I don't need as much variation. So, for me, it's a place that I can capture that data and not have to go to different places to get that data for others having some different elements of support in that system. will be beneficial, right? If you think about things on the Faisal influence side for people with type two diabetes faisel, type tration as you get started on the insulin, or maybe after I'm on insulin for a couple years, how do I make sure I'm optimizing? Right? You can go through sort of that journey and see all of these different places where how we can do better than we're doing today. And I'm honing in on the glucose data and the informed data. So we all know I sometimes say life gets in the way right exercise and food you know, all those things that are pretty standard, but for a lot of us can make the road pretty bumpy as we're out there. So you know, over time being able to get the system smarter and smarter with that exercise data and then learning system. So, you know, we all talk about the algorithms that are out today are very much rule based systems right if my glucose is going up by default Like take this action and then be informed is delivered in the future. It may be well for Marie, her level is going up at x rate. And that's, that's not good for Marie versus for Stacey, that might be okay. Because I've trended back and looked at that data and say, you know, we're going to predict that she won't get to an elevated level as an example. Right. So if you start thinking about the personalization of these algorithms over time, it will not be day one, as we all know, it's going to take a lot more research and beta for us to be able to continue to get to that ideal state.

 

Stacey Simms  20:41

So I'm trying to read between the lines. So the plan sounds like it is to launch with a more let's call it a more static algorithm. Like we just started using control IQ from tandem which is a hybrid closed loop software system. It is a great system for us so far, but it doesn't learn anything. It's probably If This Then That, but it doesn't learn my size. Okay, it's not personalized. So I assuming you're kind of saying that Lilly will launch in a similar way, but the idea would be to eventually get to a learning algorithm.

 

Marie Schiller  21:11

Yes, I think that's a fair statement.

 

Stacey Simms  21:14

All right. So let's talk about the announcement that you're gonna be working with Dexcom. Just if you could spend a minute talking about what that means. It's not exclusive as I read the release that y'all sent over. So it sounds pretty interesting. Let's start with what it means first to work with Dexcom are they making? Sometimes there's, I hear special transmitters for certain things, certain software for certain things. Is this a Lilly Dexcom? Original?

 

Marie Schiller  21:39

no meaning we are basing it off of the transmitter that Dexcom has. So we will be compatible with the G six and we'll continue to work with Dexcom in our development arrangement as they continue to iterate and we continue to iterate to make sure we've got access to each other's latest technologies right because the last thing any of us want to do in these collaborations is to be behind in generation integration, right? I mean, that's what was happening and some of the first generation systems, right, you got people still on, I think it was what g4, and they'd want to be moving to the G six, and there was no way to do those updates, or the G five. So we've established our development, work with them and ability to make sure that we can continue to be running in parallel, as each of our platforms evolve over time. So it will be based on their latest transmitter based on our latest pump in our latest pen, and be able to integrate the the CGM data from Dexcom system into the diabetes management system, where some of the functionality that I talked about before could be available.

 

Stacey Simms  22:53

So I'm always trying to read between the lines You'll have to forgive me but when I see a press release that says non exclusive, I'm always thinking, you know I don't know of too many, or any pump systems. Gosh, it's so funny to say that Marie, because there's really only a couple in the US. But I don't know if I hear we hear a lot about interoperability, but it isn't here. Yeah. So my question, I guess, is when I see now exclusive, I'm thinking, Okay, are you do you have an eye to working with other CGM companies? And is that practical in the short term? When we all know FDA approvals, things like that, you really kind of have to stick with one system, at least so far, to get it through?

 

Marie Schiller  23:29

Yeah, you know, it's an interesting way you sort of posed the question, I think, let me say big picture and then sort of dive down to where we are right now. You know, at the end of the day, we believe having access to sort of the latest and greatest technologies is really important, right. I mentioned even with dex comm that we want to be on the same innovation curve that they're on. So people using our system can have access to that. It's really important that all of us, keep pushing For this innovation, right, and the way that you do that is to make sure that I have the ability to integrate other technologies into my system. And I think both of us hold that premise that keeping as a non exclusive allows both of our team to be able to, you know, have access, or have our users of our system have access, I should say to the latest and greatest technology. We have started our program with the XCOM and are really excited about the progress. But we think it's important to make sure that we will have the opportunity to bring different technologies in for different users, even on the systems available today. Right. There are differences in the system, and people are choosing different platforms because of that. Sure.

 

Stacey Simms  24:51

Yeah, it's really interesting. I mean, I keep hearing about interoperability, which I know is going to come someday but my interpretation of that which is I always call it the Mr. Potato Head. system is not the realistic system. So I try to temper my expectations but why not? Come on? I want to mix and match as much as possible. Why not?

 

Marie Schiller  25:10

I don't know. Did you like playing Mr. Potato? I was never a huge fan.

 

Stacey Simms  25:16

It's a it's an easier thing to explain, right? Why can't I use the lead Ray? With the tandem pump? Why can't I use a Dexcom with a barefoot pen? Why can't right i mean if it works better for me and my skin and my kid and my like, why can't I and I, I get it. But at the same time, I really hope that someday we're working towards that, hey, look, it could be worse for you. They could make us play operation or perfection or something terrible like that.

 

Marie Schiller  25:39

Those are worse. Yeah. But you know it, baby. I think there are a lot of people were having that sort of turnkey solution is, you know, where it's all comes in on and I just understand it and it's all designed to work together. They prefer that and other people would would like that choice, right. So I think we're gonna probably see both of those emerge over time. And the FDA to be fair, has opened the door to that event, right? I mean, they're trying hard to separate the approval of each of the components. We saw that with the ACE ban. We've seen that with IC GM, and now with AI controller that can pass. So, you know, I think, at least from the FDA perspective, they've worked hard to try to enable some of that.

 

Stacey Simms  26:25

I agree. Alright, so from interpretability. Let's talk about the proprietary aspect of this. Because I think when a company like Lilly, that makes insulin gets involved with the hardware in which the insulin goes, a lot of questions come up, and you mentioned the quick pen. So can you just confirm again and correct me if I'm wrong? Will other insolence be able to be used in either of these systems pen or pump?

 

Marie Schiller  26:52

Yes. So on the pen side, the system is being built around our quick pen platform. So it will be a system that work with really insulin on the pump side of the equation. In addition, we'll have a first generation that will be a patient built component, but over time, that may shift as well. So on the life cycle plan for that pump, we're looking at the ability to have Lilly insulin in that system, as well.

 

Stacey Simms  27:27

Okay, so to be clear, and not say, not putting a judgement on this, but just to be clear with the idea is that this would be a proprietary pump, that Lilly would make the pump and Lilly would want its own insulin. We've been human lock used in the pump.

 

Marie Schiller  27:38

Yeah, I think the system is being designed around Lilly's insulin.

 

Stacey Simms  27:43

Alright. So you know, we've Marie, we've known each other for a while now and I know you know, this question is coming, but I think it has to be asked in a day and age where people are so angry about the pricing of insulin. Why should we get excited about systems like this when people are worried about But affording the stuff that goes in the hardware, let alone affording the hardware, whatever it is, and how great it is. There's a lot of concerns about cost. I know it's not your department, but I can't have you on and not ask about it. Can you comment on that?

 

Marie Schiller  28:14

And no and not and I appreciate you asking it. And you have no need for a while as well. So I appreciate the service candid question. Look, you know, and I've said this before, and I'll say it again, you know, we are committed to be able to let people with diabetes, access our medicines, and in the future, disconnected diabetes system that will include sort of the pen based system and the pump and other components. I know you'll be frustrated at this next part of it. But I can't fit here in sort of the position I'm in and where we all want this platform to be any, you know, give you any speculation of the details of how that will happen, or how that reimbursement will be in the marketplace. It just wouldn't be fair to you or your user's to speculate on that, except to say that we are 100% committed to making sure that that access is available. Look, we're not here for the sake of having this innovation sit on a shelf somewhere, not why I'm here. It's not why others are here. And so it is really important for us to be laser focused on how people access the system.

 

Stacey Simms  29:24

And I mentioned in the introduction, but you live with Type One Diabetes, I definitely have another question for you. But it just occurred to me, are you allowed to even say this, have you tried this system? Like, are you in the trial? Can you trial your own? unprepared?

 

Marie Schiller  29:38

I sure how to answer that. I have no, I'm not in the trial, but I can give you that answer. So I am not in the clinical trials that have occurred today.

 

Stacey Simms  29:50

I'll tell you as a person who doesn't have diabetes, obviously, you know, it's just something that I always wonder about when I talk to researchers or clinicians or I know there's there's obviously rules for clinical trials. But you've got to think, alright, I want to try this on myself. I know a lot of people have done that. Okay. So the real question I wanted to ask

 

Marie Schiller  30:05

is okay, I can't wait. I can't wait. That's why there's no, we're pushing hard to justice available. I, I'm waiting, like out there to make sure that I get this.

 

Stacey Simms  30:18

Alright, so I've got a difficult question. So my real question about living with type one is difficult is it right now to work at Lilly, when people are so angry, and a lot of that is directed? We've seen protests separately headquarters, you know, and again, it's not you, you're not in the price department. Even if there is one. This is not something I know you can control. But is it difficult and frustrating for you to see the problem, frankly, with insulin pricing at all of the insulin companies?

 

Marie Schiller  30:46

And the answer to that they see and I think we may have talked about this, either the last time on the phone or when I saw you it's like how do you not feel the pain in you know from people, right? I mean, this dishes, dish issues difficult issues people are dealing with. So of course, you know, what I would say is is that worse from, you know, being here? You know, I look at what we're trying to do. And And And again, I'm not the person to sort of comment on this, but it's a priority for Lilly. And I'm really proud that Lilly has made it a priority to make sure that access is there.

 

Stacey Simms  31:25

Going back to two devices that we've been talking about. I always hate to ask about timelines, but I always have to ask about timelines. Can you give us a goal timeline here? Is there any indication of when it might be submitted to the pen or the pumping, which will kind of go in first?

 

Marie Schiller  31:42

Yes. So let's talk about the pen first. So as I mentioned, and you can see on the FDA site the supplemental approval for the pen has gone through. We are working with the agency on the other components of the systems. We are not giving an update right now. on the timeline for that system, but we expect to be giving updates over the next couple of months on the pump. As I mentioned, we'll be sharing the first clinical data and our signaling that we're still over the next couple of years hoping to get that system to market

 

Stacey Simms  32:16

where we thank you so much for joining me. I know it's a difficult conversation to have when you've got, you know, a lot of things about to come out and then other things that I'm asking that aren't really your department. But I appreciate your frankness. Before I let you go as a person who lives with type one, what is it like to work in the diabetes sphere? I mean, I think part of me would be kind of tired, like my whole day is diabetes. My whole life has diabetes, but it's got to be exciting as well. What's

 

Marie Schiller  32:41

it like? It's an interesting question. For me. I just don't know any different facing effects? The answer is, I don't know my kids would probably answer the same way. I don't know what I would do with myself if I wasn't doing this all day. My weekends are spent so much in the diabetes space as well. It's just something that that is it's just a part of me, right? so much a part of all of us who are living in this space. And I'm impressed every day by all of the people working so hard to make these advancements. And it's amazing, right? As you've seen, we're actually getting some of these solutions out and reading about the improvements that are there. And I'm excited and want to keep staying focused on doing what I can to get these products out and having my team man. I mean, everybody here is just so passionate about what we're trying to do to make these advancements. So it's, um, I know it's a it's like one of those questions someone would ask what would you do if you worked with your spouse? You know? I don't wanna say I love my diabetes so much because I'm not sure I'd answer that way. Am I cursed my diabetes maybe as much as I do other things in life, but it's data reason that probably keeps That's all motivated if we know how much better we can make life.

 

Stacey Simms  34:03

Well, thank you so much for spending some time with me. I really appreciate and I hope we get a snapshot of the devices soon enough, Marie thanks again.

 

Announcer  34:15

You're listening to diabetes connections with Stacey Simms.

 

Stacey Simms  34:21

Of course, more information at diabetes connections.com. I always link up a lot more info at the episode homepage and a transcript. I'll be interested to see how this episode is received. As I mentioned at the start of the show, there are some people who do not want to hear anything from Lilly, if it's not about lowering the price of insulin. And I respect that I hear that I know that there's a lot of anger in our community and a lot of frustration at all the insulin makers and you know, I do share a lot of that, but I would be curious to think if we should not be following the other technology advances that are coming out of these companies, because I'll be honest with you, I said this two years ago, I think Lilly is seeing the writing on the wall. That the price of insulin is going to be mandated to come down in the next few years. And they are, they don't wanna lose money. They want to find other ways to continue to be competitive. And I certainly don't think that insulin will be free. But I do think that going into the pen and pump business is a move on their part with an eye on the price of insulin coming down. Look, I'm not an economist. I'm baby way off base. But that is something that makes sense to me.

up next Tell me something good. And then a little bit later on. I want to talk about some other pump companies and news that came out recently, diabetes Connections is brought to you by Dexcom. Do you know about Dexcom clarity, it is their diabetes management software. And for a long time, I just thought it was something or endo used. You can use it though both on the desktop or as an app on your phone. It's an easy way to keep track of the big picture. I check it about once a week. It really helps spinny and me dial back and see longer term trends and helps us not overreact to what happened for just one day or just whenever Our the overlay reports help with context of Benny's glucose levels and patterns. You can even share the reports with your care team, which makes appointments a lot more productive for managing diabetes is not easy, but I feel like we have one of the very best CGM systems working for us Find out more at diabetes connections dot com and click on the Dexcom logo.

 

I love the Tell me something good stories this week. Honestly, I love them every week, but I got a bunch that are so fun to share. And one that frankly is pretty important. Alright, so first, Candace says my son was just diagnosed January 23. This year with a hospital stay. By February 13. He was dancing away and winning a hula hoop contest at his first school dance since diagnosis. He's 11 and he was so proud of his accomplishment winning the contest. And we as parents were so happy that his diagnosis wasn't holding him back. That is so cool. I didn't Kansas for a picture shockingly, an 11 year old did not want pictures of him hula hooping to be displayed. I'm actually not sure if she had any, but we respect that we hear it. I just think it's fantastic that he did it and that he's doing so well. This soon after diagnosis way to go Candace!

Alison said this is a tiny thing. But today my child was type one went to get her foot x rayed her shirt, rode up and showed her Dexcom and the text said, Hey, do you have diabetes? I do too. Then she pulled out her pump. It was super cool. Allison says her child was diagnosed in early December. I think that's great. Is there anything better than that diabetes in the wild citing, right? You know, you're with people who get it. It's just so great.

And then this one you may have seen on social media. I posted a picture of Isabella with her fish, not her pet fish a fish she caught. Isabella is nine years old and she loves fishing with her dad and boy she beaming in this photo with a fish that's like as big as she is. Her mother, Heather says she was diagnosed with type one at age four. Again, she's nine. Heather says, I will tell you this little girl is amazing. Her dad got diagnosed with lupus almost four years ago. He is on dialysis. We are on a kidney transplant list. I'm currently trying to be his donor. And a lot goes into that. This is her and her daddy's favorite thing to do. They live life to the fullest, and nothing stops them. Heather, thank you so much for sharing this story for letting us share the picture of Isabella, you guys are carrying a heavy load right now. And I'm so glad to hear that you're finding enjoyment in things like this. It's kind of trite. As I'm hearing these words, leave my mouth. I mean, there's really not much to say when you're in a situation like that. But I'm happy to share your story. And I hope you keep us posted. Let us know what's going on. And definitely send more fish pictures. I would love to see that I really would even if we don't share them. You can definitely send them our way are posted the Facebook group.

Our final Tell me something good is a little bit of a different story. It's more of an news story. But this is really important. And I think very good news. Beyond type one announced that they are collaborating with the National Association of School nurses to raise awareness of the warning signs of type one diabetes. So this is a new collaboration that means that 10s of thousands of school nurses around the country are going to get these awareness materials from beyond type one, if you haven't seen these we did in North Carolina push a few years ago. And they're just simple and straightforward. And they tell you the signs, and they talk about what to look for. I don't think those of us in the community had any idea what DK a was what it looked like, how deadly it could be, you know, before we our children were diagnosed, right? How would you know? So this education campaign is absolutely going to save lives. Huge thanks to be on type one. And a big thanks to the Helmsley Charitable Trust which is funding it. I will keep you posted. I will put up links in the show notes on how you can get involved because you know ordinary people state to state are getting involved. We sit around my dining room table here outside of Charlotte, North Carolina and stuffing envelopes and sent them out really can make a difference. Tell me something good happens every week around here. Give me your stories post in the Facebook group, email me Stacey at diabetes dash connections dot com. I would really love to hear from you. We got to get the good news out in our community. Tell me something good.

 

All right. We're getting a little long here. But I wanted to bring you some news from the other pump companies. I know I don't usually do a news update this far down in the show, but because I put the coronavirus episode out a little early. There was some news I was going to put into that episode that has gotten pushed here. Let me get right to it. We had an earnings call from tandem. And the really interesting bits from that were that the T sport hybrid patch pump is now expected later this year, possibly probably early 2021. The CEO of tandem says they plan to file with the FDA for t sport approval. This summer with a new mobile app, which means you'll be able to bolus from your smartphone. So apparently, they're going to submit this in two different ways two different filings. One would be a separate handheld device, right like a dummy phone or a dummy controller of some kind that you'd bolus from. I'm dummy and that it doesn't do anything else but control the pump. But the other filing would be remote bulleting by the smartphone app. And apparently the CEO said they will not launch t sport until both have been okayed by the FDA. So you would have the option of using your phone or of using the singular let's call it singular controller rather than the dummy controller. So that's really exciting. I'm gonna post some pictures diabetes mine posted this update and posted some pictures of the tee sport. It is a little patch pump that can be worn on the body or it has a tube so it can be put in your pocket again. I don't know how it sticks to the body. Did you hear me talking to Maria about that? Is it reusable? Like ever since or is it like a dexcom to rip it off or a pumping set. So we'll find out more about these things as they go forward. But that was some really interesting news from tandem.

The other bit of news comes from Insulet. They are in the middle of clinical trials for horizon, they had hoped to be filing for that approval. This summer horizon is the hybrid closed loop for the Omni pod. They did have a software issue. That means they are pausing the pivotal study, and it's going to delay things, not really sure how long, of course, they're really hoping that it won't be too long, you know, maybe a month or so. But they are now pushing the anticipated launch of horizon to early 2021. And I know there's a lot of disappointment because people really want this system. I will say to you that tandem had a similar issue with their software during the last pivotal trial for control IQ. It was very quickly fixed. I don't think it affected the timeline that much. Maybe it was just a month, but it still hit its goal of the end of the year. So hopefully Omni pod insolate can get back on this and get back to their timeline but I will link to More information on that, because I know these things just cannot come to market soon enough.

tank you for staying with me. This was a long bit after the interview and I appreciate it, but I wanted to get some information out there. I really appreciate you listening. There's a lot going on right now. All right, I'm gonna stop right here and thank my editor John Bukenas from audio editing solutions. If you have an audio project, I highly recommend john, you know, if he puts up with me, and my rambling that he can do wonders for you. All kidding aside, john is great. I love working with him. He never asked me to say anything in the show. But he really is such a strong part of what makes this podcast successful. And boy, is he nice to me and doesn't leave in all of my papers. So thank you, john. And thank you so much for listening. I'm Stacey Simms. I will see you back here next week.

 

Benny  43:55

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

 

Transcribed by https://otter.ai

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