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"Innovation All Stacked Up, Ready to Go" - Medtronic Diabetes Group President Sean Salmon

Diabetes Connections with Stacey Simms Type 1 Diabetes

Release Date: 10/06/2020

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It's been a busy fall already for Medtronic; they've acquired Companion Medical and the FDA approved their 770G pump. Stacey catches up with Diabetes Group President Sean Salmon to talk about that and much more. Find out the difference between the 770G and the upcoming 780G, their plans for longer-wear pump insets and when they might have a no-calibration sensor.

In Innovations this week, a new study showing the benefits of once a week basal insulin. It's called Insulin Icodec.

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

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Episode Transcription

Stacey Simms  0:00

Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes by Gvoke hypopen, the first remixed autoinjector for very low blood sugar, and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.

 

Announcer  0:21

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:27

This week, catching up with Medtronic, we're talking about the newly approved 770 G, looking ahead to the 780 G, their acquisition of In Pen and how they think they've cracked the code on longer where pump in sets,

 

Sean Salmon  0:42

the things that are in insulin to keep it from going bad. The preservatives, if you will, are behind a lot of that sort of site actions that you get. So we're able to take that stuff out and have just filtered Insulet. a queue will deliver to the site. That's really the magic behind getting the extension of use.

 

Stacey Simms  1:00

That's Sean Salmon. He heads up Medtronic diabetes group. In innovations this week, a once a week basal insulin, how would that even work?

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

Welcome to another week of the show. I am so glad to have you if you are new welcome. Glad you found us We aim to educate and inspire about type 1 diabetes by sharing stories of connection. My son was diagnosed right before he turned to back in 2006. And we have his high school sophomore 504 meeting this week. Yeah, it's virtual. His whole school is virtual. I've shared on the show before he is part of a very large school district in the Charlotte, North Carolina area. And the whole district has been virtual. younger kids are starting to go back to school in October. They're staggering it right now High School won't go back in person until January at least that's the plan.

So I'm really interested to see how they handle this 504 meeting. He's had one, you know, we've been diagnosed since he was two. So he's always had one. In our district. We have a separate DMMP a diabetes medical management plan that covers a lot of the basics that are maybe in your your child's 504, but I assume this will focus on testing. I don't know. I mean, he's home. So you know, he can go to the bathroom when he wants he can drink water when he wants. I'll share more about that though. Mostly, I think this is about keeping our place in the 504 for things like the ACT and the PSAT and all that testing and he is so thrilled, but it's going to be coming up.

Another thing I want to tell you about real quick is Hey, in September, we saw a big boost of sales of the audio book of the world's worst diabetes Mom, you know, this is my book, it's part memoir, part advice, stories, real life stories about raising a child with type 1 diabetes. And the audible version has been very popular. And I'm telling you September, I don't know maybe end of summer and everyone decided to get an audiobook, but audible loves when that happens. And now I have two free copies to give away, you do not need to have an audible account, you don't even need to really start one here, you're not going to be signing up for something you can't get out of you do need an Amazon account.

So if you want the copy, I'm not doing a fancy contest on social media, I probably should. But all you have to do email me Stacey at Diabetes connections.com put audio book in the subject line and I will give you the first two people who do so a free book will make it very simple there. If you're interested in perhaps the paperback or the ebook, you can head on over to Diabetes connections.com or it's on Amazon, whatever is easiest for you.

One more thing and it's an apology. Last week I apparently mixed up when I was talking about Medtronic 770 and 780 G. We do clarify that in the interview here with Sean Salmon. But to be clear, the 770 g was recently approved in the US. It is basically the same as the 670 g except for the addition of Bluetooth connectivity for data sharing and remote monitoring. And as you will hear, you'll be able to update the 770 G and future Medtronic pumps at home just like your phone. Alright, Sean Salmon. With that and a bunch more we go down a laundry list,

but first diabetes Connections is brought to you by One Drop, and I spoke to the people at One Drop, I was really impressed at how much they get diabetes. And it makes sense when you think about it. Their CEO, Jeff was diagnosed with type one as an adult. One Drop is for people with diabetes by people with diabetes, and the people at One Drop work relentlessly to remove all barriers between you and the care you need. Get 24 seven coaching support in your app and unlimited supplies deliver no prescriptions or insurance required. Their beautiful sleek meter fits in perfectly with the rest of your life. They'll also send you test strips with a strip plan that actually makes sense for how much you actually check One Drop diabetes care delivered. learn more, go to Diabetes connections.com and click on the One Drop logo.

My guest this week is Medtronic Executive Vice President and President for the diabetes group, Sean Salmon. And we spoke just as the deal for Medtronic to buy companion medical makers of the In Pen was closing. So that is a done deal. Now, In Pen is a smart insulin pen, you're probably familiar with it, it keeps track of dosing and recommended dosing, sort of like what you'd get with an insulin pump, you still have to inject, but the dosing can be automatic, the app will tell you exactly what to do. And keep track just like an insulin pump does as well. We talk about that. And a lot more here. Here's my talk with Sean Salmon.

Sean, thank you so much for joining me. There's a lot going on at Medtronic these days, I appreciate you spending some time with me and my listeners.

 

Sean Salmon  5:44

That's my pleasure. I appreciate the opportunity. Thanks, Stacey.

 

Stacey Simms  5:46

We're gonna go down pretty much a laundry list of technology and questions from listeners and things that they want to know. But let me start slow. And just ask you, how are you feeling about everything these days, we've got delays because of COVID. We've got, you know, a year like no other it's a cliche at this point. But you know, in your own words, how are things these days at Medtronic, and in terms of, you know, what you're looking at going forward?

 

Sean Salmon  6:09

Well, it's interesting, right? I think we're all living through some unprecedented times, just everywhere in the world right now. And it's certainly challenging. But at the same time across Medtronic, you know, I think we've got such a rich pipeline, and just about every single business, it's, it's exciting to see what you know, what the future is gonna bring, we get past some of these near term challenges. I've been here for 17 years, I can't remember a time where we had so much innovation all stacked up, ready to go

 

Stacey Simms  6:34

Well, let's jump in and talk about it. One of the first things I want to ask you about is the acquisition of companion medical. And this is the startup they've got the in pen. This is the I think my listeners are very familiar with it. And we've done episodes on it. So tell me a little bit about what the plan is, for companions in pen product with Medtronic, what are you gonna do with it?

 

Sean Salmon  6:59

Yeah, sure. Well, maybe I'll start out with, you know, why did we decide this was a good idea? And yes, I came into this role. Yeah, you whenever you start a new job, it's been about a year from now, the first thing you do is you formulate a strategy of how are you going to serve your patients in the market? And it's really, you know, strategy is really a question of, what are you providing for who, when you start asking those questions, it really narrows down what your focus should be in, and didn't take that long to sort of Peel apart? What is it that are people living with diabetes are seeking and how are they? How are they being treated today. And if you look around the world, it depends on the country you're in. But multiple daily injections is the most frequently chosen therapy, it's something that ranges between 60 and 90% of the treatments that are out there.

So you know, really the philosophy app is that for us to know, what are provided for whom we need to know, you know, where do people where are they on their journey? And where do they want to go. So, you know, injection in and of itself is a fine therapy. But there's just really variable outcomes that patients are being able to get from that. And a lot actually about just the, it's made difficult by the fact that you really don't always know how vigilant you are, how much insulin you've taken, how much you have on board. And it's very hard to keep track of all that. And what companion has done with the implant system, of course, is to track that insulin, so you know exactly how much is given at the right amount of time and have some estimation for carbohydrates, the ability to load that up. And then of course, the CGM data is there. So when you have those components, a lot of that difficult math calculation about how much insulin Do I need to take at a given time is made simpler. And we can extend that by adding a lot of what we have within our automated insulin delivery systems, algorithms, personalization of those algorithms into that experience with a pen.

So if you will, we're trying to close that open loop, or at least close it down some and what we do with automated insulin delivery systems as we have this track record, right, have you just recording CGM data over time, and knowing what the influent amount is, you can really get to an understanding of how individuals kind of respond to insulin, and more personalized, the amount of dosing that happens. So get an even tighter connection to how much insulin someone needs to take at a given point of time. Of course, on meal handling, that's the place, we're really pushing a lot of our technology, we have a very large and capable group that does data science and artificial intelligence. And all that really means is that we're able to take large data sets, and then put them into actionable insights that really simplify how people can get better control without having to do anything.

And one of the really interesting areas we're investing in right now is around meal handling. So we can with our technology have a really good sense of when you're going to eat. And we can confirm that some gesture control technologies that come from a wearable like a Fitbit, or an apple watch or something like that. That tell us can confirm that some is eating. So in that instance, you could, for example, remind people, there's been no bolus given that it's time to bolus. And if you miss just two boluses a week in a meal, that equates to about a half point increase on the A1C. So obviously, outcomes can be made better. But the important thing is that it's done in a sort of an invisible way or helpfully in the background way. We're not asking somebody to anymore, which I think is really the sort of driving principle behind what companion medical set out to do within pen spec, this least burdensome as possible? Well, we can add a lot of technology that isn't visible to the user, for the most part, but can really drive a better experience and better outcomes. So what we're trying to do with a closed loop we can bring to this open loops, I said, and that's really, I think how the two fit together can help it a lot of ways.

 

Stacey Simms  10:58

A couple of questions about You just said you. You mentioned the gesture technology. That's Klue, right. You all acquired Klue this year.

 

Sean Salmon  11:03

Yes, exactly.

 

Stacey Simms

Is that going to be part of a companion medical system?

 

Sean Salmon

Yes. So the idea is, we're going to have that for any means of insulin delivery, right. So it's the ability to detect that somebody is in the process of eating. And the absence of any kind of bolus is a great opportunity to say here, let me give you a helpful tip here and remind you to bowls, whether you're pushing a button on your pump, or you're, you're reminding yourself to bolus we can drive some improvement there. And it was evaluated in a recent study that we did. It's a small study. But we showed that we could fact drop a one suit by a fairly sizable amount just by bolus reminder. Now, ultimately, I think we can use Klue and that technology in a way that can actually automate the delivery of bolus so nobody has to do anything within a sort of closed loop system. But you know, that's, that's some more work than where, or whatever to do it. Absolutely. It's

 

Stacey Simms  11:53

you heard me laugh, because, you know, just by bolus reminder, parents around the world have children with Type One Diabetes would argue with you that a simple bolus reminder in the form of a parent does not make that much of a difference. Yeah. But I hear you, I

 

Sean Salmon  12:07

think it Yeah, I mean, the difference here is the bolus reminders, and just it's time to bolus what we can do. Knowing the history of how much insulin is on board. Get a quick estimation is the medium small, large amount of carbohydrates being consumed, we can tell you how much to bolus not just that you need the bolts, right? which we think is a helpful insight.

 

Stacey Simms  12:28

When you talk about Klue. It also makes me laugh as you listen. As I talked about Klue, we did an episode with them in the past if you'd like to learn more, and Sean , I laugh because every time I talk about Klue I do the gesture of eating food. I don't you can't see me but every time I mentioned it, I think that's because that's how it was explained to me when they first demonstrated it. It's a really interesting technology. But that'll be in not just pens, you're planning on using that in pumps as well.

 

Sean Salmon  12:53

Yeah, so you know, Klue actually runs on on a wearable. And then it talks to the algorithm that's either you know, on your phone for your pen, or can be the algorithm that's driving the automated insulin delivery system. So think of it like a sensor, and the sensor gives input so that the algorithm knows what's happening. And it lends itself to any means of insulin delivery.

 

Stacey Simms  13:15

One of the big concerns and you know this when a large company buys or acquires a small company or product the big concern is that you know, it'll be shelved or there will be big changes to make it more proprietary. The in pen is now used with Dexcom and the ever since implantable CGM. Can you reassure people who are using it right now that you're not going to change that I assume it'll be used with a with a Medtronic sensor, but will you continue with the sensors that it is integrated with right now?

 

All right, right back to Sean answering that question. But first diabetes Connections is brought to you by Gvoke hypo pen, and almost everyone who takes insulin has experienced a low blood sugar and that can be scary. A very low blood sugar is really scary. That's where Gvoke hypo pen comes in. It's the first auto injector to treat very low blood sugar Gvokek Hypo pen is pre mixed and ready to go with no visible needle. That means it's easy to use in usability studies 99% of people were able to give Gvoke correctly. I'm so glad to have something new. Find out more go to Diabetes connections.com and click on the G voke logo. gvoke should not be used in patients with pheochromocytoma or insulinoma visit gvoke glucagon comm slash risk.

Now back to Sean , talking about Medtronic plans to continue in Pen with its current partners.

 

Sean Salmon  14:44

Yes, we have no plans to take away anybody's sensors from them. But we're not entirely in control of that. So if if sensionics and Dexcom plan to maintain that access and then we're game we want to make sure that people have the support they need

 

Stacey Simms  15:00

When you say you’re not in control of it, you’re talking about what Dexcom and Eversense would do,  you're not talking about something on your side.

 

Sean Salmon  15:07

No. So the way all this works is you have to have, depending on what platform of phone you're dealing with, you have to have a thing called an API, which is basically a hook of software into the algorithm. So somebody on Sony decides they don't want to have that access to the longer they can turn it off. But we're not going to turn it off. We don't have control over that. So our belief is that, you know, if we're meeting patients where they are, and they're on a Sensionics device, we should maintain that access for those patients. Of course, we want to open up access to our own CGM. So we have a lot coming in the pipeline for CGM, which is pretty exciting. But no, I understand the sentiment that when you a large company buy something that they want to shelf it This isn't like big oil buying biofuel. Right now we're, we think we're gonna bring a lot better experienced to patients by combining the best of what companion has developed an impact with what we're endeavoring to do with things like Klue and neutrino and a lot of other personalization algorithms that be used in the closed loop side.

 

Stacey Simms  16:08

So let's talk about sensors. Let's just pivot right to that first, though, before we let this whole thing go within any timeline and integration with the guide. assume it's with the Guardian, CGM.

 

Sean Salmon  16:17

Yes, so initially, we'll have Guardian, but there's no we have three or four, five actually different generations of sensors coming and it's going to be compatible with everything we develop going forward as well.

 

Stacey Simms  16:30

Let's talk about Guardian Connect. This is the standalone CGM doesn't need to be paired with an insulin pump. Tell me a little bit about the reception of that, what the plan is for it. And you know, Who is it for?

 

Sean Salmon  16:41

Yes, so I think a standalone Guardian has been sort of an on ramp to be able to use an integrated CGM with our pump. But frankly, I think the experience that we've provided with that needs a lot of improvement. That's what we're endeavoring to fix with the pipeline. And there's two parts to that one is finger sticks, you know, to, to calibrate or to confirm before dosing as required finger sticks, and that's something that we are trying to remove in the next generation. And the other one is on just the, the ease of putting it on. And it takes a lot of overtaken steps to insert, and generates a lot of trash in the process. So all of that's problematic. And we're, we're moving to an integrated platform where the sensor, and the transmitter all in one, easy to apply three step, just press it on your body kind of approach. And in the interim, reducing or eliminating the need for finger sticks. That's what the near term pipelines about and then longer term, we can take the size of that down even further, we're already taking about 50% of the volume down from one move to next, we can get a lot smaller than that we have some really interesting technology that uses something called a wafer fabrication, which just means you can make very small electronics in a very highly repeatable way. So you take a lot of variation out.

And then of course, you know, making sure that we're continuously improving the reliability and the wear life of these devices. There's a lot of technologies we have aimed at to to ensure that that happens. And simple things like we spend a lot of time money and effort developing patches is going to stay there, you know, the adhesive that won't interfere with the skin, but will stay there through very difficult conditions. And it took a lot of engineering, we actually did a lot of work in the fields in South Florida, just you know, high humid, very hot heat to make sure that we would have this he's up just right. So there's a lot going on in the CGM side of things. That's pretty intriguing.

 

Stacey Simms  18:40

I'm curious, and this is a very specific question. These future generations, any plan to go straight from a CGM sensor to a watch, that's something that just seems to be very difficult, you know, no phone involved in between? Nothing like that.

 

Sean Salmon  18:55

Yeah, no, it is difficult. And it's difficult for a lot of reasons, including power management of how that that Bluetooth connection is different than one to a phone. So I think as as watches evolve, and maybe that technology changes and the ability to kind of talk a lot of this on the kind of wearable side of things. It's not entirely just what can you do with your CGM, your algorithm said some, it is more complicated than you'd think, you know, hopping from phone to watch that takes the processing power and the connectivity that's already there. But think of it like a highway, right? There's like so many lanes have a highway that you can drive a car on. And if the watch is already tethered to one, one connection by Bluetooth to your phone, you've got fewer lanes available, other connections. So that's really, you know, it's I don't get too technical about it. But that's really the the near term challenge. But you know, I think there's strong interest in this. And as the wearables progress, I think we'll have the opportunity to to do things like that. But right now, it's just complicated.

 

Stacey Simms  19:56

All right, let's talk 770 g This was approved by the FDA in August, and it's down to kids as young as two, my understanding was for the approval. Now I'm this is gonna pardon my take on this. And this is for all of the pump companies. I wish you guys would call your pumps, something that told us more about it. I don't know if it's a medical device thing, and I have this problem with Omnipod and Tandem and everybody else. But you know, it's all numbers. So tell us a little bit about what's different from the 770 g to the 670. And then to the 780. Like, right, what's different about this pump?

 

Sean Salmon  20:33

Yeah, so the the biggest difference other than age education, which does, you know, it's still indicated for people over the age. I think there was some confusion at first said it's just for kids, and it's not Oh, kids. Yeah, so I, you know, I think that the biggest difference is really the inclusion of Bluetooth connectivity with this with this device. And that does a number of things. So first and foremost, it allows a person or a parent or caregiver to see the CGM pump date on a film. So we we've been lagging in that competency. Now that's available.

It also allows the carelink system which is our management system glucose to automatically update so that you can do things like telehealth visits, right. Or if somebody's going to the doctor's office, rather than that, that kind of interruption to the workflow where the pump has to be connected and then downloaded, that really slows down that visit for for the person that's, you know, at the visit, it slows down the workflow for the health care providers. So the ability to take that connection and automatically upload it at your convenience without having to do anything, is what that connectivity brings to us as well. And then finally, it goes all the way to we can when software becomes available, make upgrades. Or if you have to patch something knows you know how to get out of your phone, where they'll have a new version to patch up something, you can just push that over the air. So we have that capability to upgrade future algorithms without having to connect anywhere.

 

Stacey Simms  21:59

So just to be clear, this is like what we do with the Tandem X2, you plug it into the computer, you get the latest download, it changes the software in the pump, and then you're off and running. Same thing, plug it in,

 

Sean Salmon  22:09

that was what one big difference, we'll plug into the computer, it goes over the air, just like you can update your unit up to your phone over the air today. If you changing your operating system, it's the same idea. You can do this without having to have a computer or having to plug cable in,

 

Stacey Simms  22:24

do you need a doctor's prescription for changes? Or is that a change by change? I would assume there might be?

 

Sean Salmon  22:30

Yeah, it depends on the change. So if you're talking about, you know, a security patch, you don't need a prescription for that, if you're talking about moving to the next algorithm, like the difference from 770 to 780 is really an algorithm change. It's the same hardware platform that would require a prescription.

 

Stacey Simms  22:45

So let's talk about the 780 which is the I assume this is the next thing in the pipeline and following the numbers.

 

Sean Salmon  22:52

Yes, so we we have released the adult data for the 780G, which at is about the algorithm now at the American Diabetes Association began this year virtually. And really, there's a couple of differences here. What this device does now is it takes the Ability Beyond just basal insulin, but also to bolus where you can the situation where there's rising glucose, the algorithm can bolus every five minutes to control. Somebody maybe missed a meal bolus, so they miscalculated how many carbs they ate, for example, and blood sugar still rising, we can predict where it's going to go both correct it without stacking up insulin. So what all that means is we can drive better time and range when there's there's missed boluses or miss calculations on carb counting. That's one big difference.

The other big difference is the target that you set these two, so you can set a target, as you may know, on the 670 G, the target you can set is 120, we can still set a 120 target on this algorithm. But we can also set that target of 100. And the clinical results that we showed, were clear that you could take the target lower without increasing the risk of hypoglycemia. In fact, it was so numerically lower rate of hypoglycemia. So this, this algorithm, I think really gives a lot more freedom. And that's, I think the biggest thing that we were looking for all these are great, you know, time and range, we've been leading that the industry and being able to provide the best time and range, but the user experience got a lot better. And a lot of it had to do with alerts and alarms and all the things that we did. And I think To put it simply, there was a belief as the first hybrid closer algorithm out there, that whenever something goes awry, that you should kick somebody out of what was called auto mode and have them go confirm something with like a finger stick.

Because I think the belief at the time was that you know, you can't trust his algorithms take care of somebody, and a person is better off better able to manage their diabetes than a machine. And I think that was probably a fallacy. As it turns out the algorithm that what we change here is we just aren't kicking people out. We are waking people up in the middle of night do things the algorithm pretty good at smoothing things out without causing any new troubles prevention. So a lot of that, I think out of abundance of caution safety alerts, kicking people out asking for fingerstick calibrations was unnecessary. And we're seeing a big reduction in all of that and very high satisfaction among the people in a clinical trial. And we've launched it in a limited way in Europe so far, and feedback has been really tremendous. This is a very big improvement of what we had been offering a couple

 

Stacey Simms  25:25

of just questions for clarity, Sean , the you're talking about the algorithm in the 780? Right, the 770?

 

Sean Salmon  25:32

Yes, that? No, that's 770 is basically the 670 algorithm. The big difference is really that indication of age, as well as the the ability to upgrade

 

Stacey Simms  25:44

software. If you want a pump right now that you can then upgrade when the new 780 algorithm is available. It's got to be the 770 you can't upgrade. Yes,

 

Sean Salmon  25:54

yes, you're correct. Okay.

 

Stacey Simms  25:56

Um, to that end, just again, just to clarify, are there other ranges you can set? Is it totally customizable down to 100? Or is it 120, or 100.

 

Sean Salmon  26:06

So you can choose, you can choose either target, but you can adjust other settings like the part ratio like insulin sensitivity factor. So there's some customization that can get there. And we ran, I think, three clinical trials. And we're currently doing what we call a continued access study in the US where we're trying to optimize those settings, to make sure that we can get the very best experience for people with the pump. And I think what we've learned is there's a lot of these other settings that we can give more help to the endocrinologists to be able to set those but right now, those settings are, are the endocrinologist job to go fix, we can give them suggestions. But the user themselves can't make those adjustments as easily.

 

Stacey Simms  26:46

Wait, I'm confused. The endo can make some changes, but the users can't.

 

Sean Salmon  26:50

Yeah, so there's certain things again, it's about making sure that people are safe, where we could recommend changes, or the algorithms can change things along the way. But there are certain settings like these carb ratios and everything else that need to be dialed in. Yeah, but

 

Stacey Simms  27:03

the user can do that. Right. I don't have to bring the pump to my endocrinologist and say, I Well,

 

Sean Salmon  27:07

they can, but they should they should make sure that you're talking to

 

Stacey Simms  27:11

Got it, yes, no, no with it with the guidance of an endocrinologist, but you're not going to make me get a prescription to change my carb ratio.

 

Sean Salmon  27:17

No, no, no, I think it's just that we can really fine tune the system. But rather than experimenting on yourself, I think we can give some help to know what are the optimal settings for you. And that's know something we call personalized closed loop is, we could do that automatically in the background without anybody talking to anybody. That's one of our future pipeline projects, we can also tell you from the history of your glucose and insulin data, how you can get a little bit better precision for somebody. And I think that's what we're trying to do on the carelink side of things. Here's the ability to really dial this in the right way. I think that for some endocrinologist, that's not going to be helpful, right? They're very, very good at this to do it all the time. And then there's others who don't really have large type one populations. And they could use a little bit of light called the teachers edition of the textbook, to help them make sure that they're doing the best for patients.

 

Stacey Simms  28:08

I think that sounds wonderful. I just think, you know, this podcast audience is a little bit different, or I shouldn't, it's a lot different. This is an incredibly well educated audience that is going to get a pump like this, and mess around with it themselves at home and see how much they can change it. In fact, as you know, part of this audience is going to physically try to probably break into the pump and see what they can do with it. So I know you can comment on that you don't have to comment on it. But that's why my hackles went up when you said the endocrinologist can, but I get what you're saying for the vast majority of people with diabetes, the endocrinologist or even their general practitioner, which is different story altogether, is really going to be the guiding hand here. Just another question you mentioned with the 780. The change from, you know waking people up kicking out of auto mode, fewer calibrations, is that really in the works in terms of fewer or no calibrations or that's a hope for a future sensor?

 

Sean Salmon  28:58

No, that's absolutely in the works for the sensors. So we we have a product in that's complete as clinical trial and other ones very close to doing that. That eliminates or vastly reduces fingerstick calibrations? And then yeah, so it depends on the regulatory claims that we make on that specific device. And then we have two others in the pipeline that absolutely eliminate finger sticks altogether. Now, that doesn't mean that you know, if you get a reading, it doesn't make sense to you that you shouldn't go confirm it, the glucose, the blood glucose, then calibrate No, no perfect sensor. But yeah, our algorithm itself that goes into 770 cuts down by about half the number of requests for finger sticks with the same sensor. And then when we change the sensor, we can, we can largely eliminate that unless there's something that needs to be confirmed, because the reading doesn't make sense.

 

Stacey Simms  29:53

So is the hope that the 780G would launch with, I hate to compare it to Dexcom but let's just go ahead and do that. Cuz that's what we're all talking about here anyway, obviously, most people who use a Dexcom understand that it's not infallible, you do have to double check, sometimes, you know, you'll get a sensor error when it doesn't understand what the you know what it's getting the information that it's taking in, it'll stop working, that kind of thing. So is the hope to launch the 780G system with a sensor that's comparable to what I just described.

 

Sean Salmon  30:20

So it's gonna depend on where you are in the world. But the 780 is going to be compatible with past and future sensors. So you know that they may be on different timelines. And we really try to think about this like it's a system to so we've got the pump, we've got the algorithm, we've got that sensor. And the other thing we have is the tubing set and reservoir. And there's another innovation we're bringing that allows you to extend the use of that on label of that tubing set from the typical two to three days. At the seven days. We call that the extended wear infusion said that's also known as clinical trial. And the goal is to have that also compatible then 780G algorithm. So the algorithm that's on that pump, which can have all that connectivity Vantage can work with this current and future pipeline of sensors, and be upgradeable on the infusion set is all sort of in a suite of what we're trying to bring together.

 

Stacey Simms  31:14

Well, Boy, am I glad you brought that up. Because I have said for years, and my son has been using an insulin pump for I don't know, 13 years now that the inset is the weak link of pumping. And I know, you know, a couple years ago, we were all excited about the BD flow was supposed to be this the latest and greatest, it didn't work out so well. So that went away. Can you tell us a little bit about what you found? When I hear longer? Where insets? I think, Oh, my gosh, you know, we've all been warned about infection and scarring and don't use the same site for that long. What are you finding?

 

Sean Salmon  31:47

No, it's a really good question. And you know, what is it that's so magical about it? How do you get to extend it? And without getting too much detail to the simple answer is that things that are in insulin to keep it from going bad, the preservatives, if you will, are behind a lot of that sort of site reactions that you get. So we're able to take that stuff out and have just filtered insulin if you will deliver to the site. And that's really the magic behind getting extension of abuse. And you know, we did a study where we, we measured this and about 80% of the study participants were able to get seven days your body is going to react a little differently being who you are. You see that with CGM, right? Some people can wear those things for two weeks, and other people can't. Because their body's more aggressive at attacking that foreign body response, just by comparison, for three days, which was our control arm 70% of people got to three days, right? So we've got a higher proportion of people able to make it seven days, we think it's largely due to getting out those preservatives that are the insulin to keep it fresh.

 

Stacey Simms  32:50

That's fascinating. It's simple as a filter. I've always thought that yeah,

 

Sean Salmon  32:54

it's not it's no, it's also your insulin is a very sensitive molecule too sensitive to temperatures, you know, and it's also sensitive to you know, how it's contained in the reservoir. So our rigid reservoir system doesn't like mechanically damage the molecule either. So that's, you know, an advantage that we've always had with our reservoir design, then you add to this, the ability to filter out the preservatives, and you get this extension to where so you can preserve a lot of insulin, use a little more judiciously, and of course produced it. You know, the difficulty of having to change your set every day. Maybe it's a fusion set Sunday, you change it once a week, and maybe same time of changing your your sensor as well. Who knows?

 

Stacey Simms  33:34

Well, I think that would be pretty amazing to have a longer wear inset. That works. Because a lot of people have trouble as you said, getting to three days. Yes. One of the big questions that came up in with my listeners when I told them I was talking to you, and we've covered most of them. But one of the big questions came up was Medicare, in terms of this technology is great. Will it be covered? Can you speak to that at all?

 

Sean Salmon  33:53

Which which part of Medicare you asked about? Are you asking about the Well, let's talk Yeah, more of a?

 

Stacey Simms  33:59

Well, I think the real question is everything. But let's talk about the the system. As you mentioned, you talked about it as a system, the 780 will the system be covered? Or will it be piecemeal?

 

Sean Salmon  34:09

Yeah. So the rules of Medicare are really around the designation of the sensor, can you make a claim of what's called non adjunctive, meaning that you know, you don't you don't have to confirm the CGM ruling before you dose insulin. So when you're 64 years old, and your pre medic quick care and you're on like a 670 g system today, your commercial insurance pays for the sensors, the tubing sets, the reservoirs, of course, did initial investment in the pump. When you turn 65 and you move to Medicare, you no longer can get the Guardian sensor paid for because we don't have that designation. For Non exempt. They've even though it's clearly driving the pump all day long every day. So we have to get that labeled claim for the sensors for everything to be covered. And that's what we're trying to do right now with the Guardian sensors and of course, the future pipelines. themselves. But like I think it's a, there's a couple different efforts on that. But it is a little bit of an idiosyncratic thing that that exists in Medicare itself, just the way the payment law works. And we're trying to get that changed,

 

Stacey Simms  35:14

has COVID, delayed studies, submissions, things like that for you, while

 

Sean Salmon  35:19

at the branch of the Food and Drug Administration that regulates diabetes face is also involved in a lot of things COVID related, including like the in vitro diagnostic testing, and that sort of stuff. So yes, I'd say on the medical reviewer side, in particular, there's been just a difficulty for them to service all the kind of pre market or new devices that are coming through while doing this difficult work of making sure that all the COVID tests and things related to that are done. So yeah, there's been something that has been a little bit challenging. And of course, in the clinical trial environment, we actually had a couple of trials going on during COVID. And some of them have gone pretty well. Honestly, I think people are stuck at home and not willing to participate the trial. It's not been like that. In other parts of Medtronic, we've got a lot of the hospital based studies have been very difficult and highly impacted by understandably, people's fear of going to a hospital for for anything right now is pretty high. So I'd say it's been a mix. Like we've had really good collaborative conversations with FDA making sure that we streamline and make it as simple as possible as we submit new dossiers. But there is really a constraint at that medical reviewer level that's been, you know, difficult for the entire industry.

 

Stacey Simms  36:35

You've been so generous with your time. I really appreciate it. I just have one more question for you here. And that's about tide pool, about a year ago, maybe more now, Medtronic and tide pool announced that they'd be working together on a, you know, a future interoperable, closed loop. And it would be a separate system from the seven at any update on that.

 

Sean Salmon  36:55

Yeah, we're worth continuing to work with tidepool. There's a joint steering committee that we participate in. Our goal here is to create a Ace designated pump that runs the tide pool algorithm. But yeah, that collaboration is ongoing. We're working well with them. But I don't really have an update on that.

 

Stacey Simms  37:13

Well, Sean , I really appreciate it. There's so much going on. Do you know to talk about and thanks for keeping us straight with the numbers and everything else. I hope you come back on and you know, continue to explain all of these developments. But I really appreciate it. Sean , thank you so much for spending so much time with me for sure.

 

Unknown Speaker  37:28

Thank you, Stacey.

 

Announcer  37:35

You're listening to Diabetes Connections with Stacey Simms.

 

Stacey Simms  37:41

We talked about a lot of stuff there. There is a lot more information as always over at Diabetes connections.com. You can learn more on the episode homepage about everything that Sean talked about. I'll link up some stuff to Medtronic into some other studies. I said a couple of weeks ago, there's something about September, October. It's like all summer long. Yeah, we have the ADA and we have the different conferences. But then every year at this time, I feel like oh, it's kind of slow, nothing's happening. And then I get all the tech companies in the fall. So I'm excited to continue to bring you as much information as I can. I have more interviews coming up. We just talked to Dexcom. I'll also be talking to Abbott. I'd love to get Omni pod that folks from Insulet back on here. So we'll we'll see what we can do. But in the weeks to come. definitely let me know if there's particular technology you want to hear more about. I love talking to these companies. It's always fun to get a kind of a peek under the hood. And I like hearing the voices and the stories of the people who are in charge of this stuff. I appreciate them coming on not everybody does you know that but it's great when they can answer your questions. And I love doing that. So let me know if you want to hear from and let me know what you want to know.

All right innovations in just a moment with that once a week basal insulin that's being tested. We'll we'll talk about that. But first diabetes Connections is brought to you by Dexcom. And when you have a toddler diagnosed with type one, you hear rumblings for a long time about the teen years when it hit us full force a little early. I was so glad we had Dexcom you know Benny's insulin needs. I've shared this. They started going way up around age 11. And when I say way up, I know some of you parents out there with little ones think maybe we increased by point two or something like that, because I remember those days Benny's first basal rate was 0.025. That's how much basically got an hour. But by the time between ages 10 and 12, his basal rates doubled. And between 12 and 13, they doubled again. So along with the hormone swings, I really can't imagine managing diabetes during this crazy time. Without the Dexcom continuous glucose monitoring system. We can react more quickly to highs and lows. see trends adjust insulin doses with advice from our endocrinologist. I know using the Dexcom g six has helped improve Benny's A1C and overall health. And by the way, he's almost 16 and those insulin needs have already started going down. This is wild. If your glucose alerts and readings from the G six do not match symptoms or expectations. Use a blood glucose meter To make diabetes treatment decisions to learn more, just go to Diabetes connections.com and click on the Dexcom logo.

 

Innovations this week, a once weekly, basal insulin. This is something that was announced earlier this summer. I don't know about you, but it's snuck by me It was announced at the ADA Scientific Sessions, Novo Nordisk announced that a once weekly insulin Icodec had performed as well as Lantus in a 26 week trial. Now, this particular study was done with people with type two diabetes. But before you dismiss it, there has already been a trial of people with type one diabetes, and novo expects to submit and get this and hopefully FDA approved for people with type one and type two diabetes, I couldn't find a lot of information about the previous trial with type one, there is another one that completed over the summer, hopefully, they'll release the information on that maybe some of you who are more savvy in the ways of clinical trials can dig it up the

Can you imagine once a week basal insulin, I mean, obviously, the benefits of that would be incredible. And also thinking about it for people who like to go untethered using basal insulin from an injection along with an insulin pump, which is something we did for two years. And even with control iq and you know, more advanced hybrid closed loops. Just talking to Medtronic about there's, I know a few people who like to use untethered with it, who find that there's just something about getting that always constant, steady, basal insulin smooths everything out. And certainly when you get into the enormous elephant doses that Benny was taking for a while, it helped tremendously to take that load off of the pump. I mean, between his weight loss and you come in at a puberty and I know he loves when I talk about this stuff, his insulin needs have come down incredibly, and certainly to the point where we didn't need to stay on untethered, but I think it's fantastic, it's a great option to have and once a week, basal insulin makes that a lot better. So I will keep you posted if I find out more about the type one trial, but is called insulin Icadec.

If you have something for innovations, please let me know this can be a hack that you thought up a tip or trick something with technology or new influence. You can always email me Stacey at Diabetes connections.com.

I mentioned Benny's 504 Review earlier in the show. And that happens later this week. He's also got an endo appointment this week. lots going on. I don't think the endo appointments going to be too exciting, hopefully. But you know, we do check in every quarter. And I think to mix it up, my husband is going to take him this time. Slade rarely goes to the endo usually because he's working in busy and and it's been on me for the last couple of years, which I love to do. I really like catching up with our endocrinologist who's become a friend. But I think I'll let the boys go. And gosh, you know, another reason not to go. I'm looking at making sure my door is closed. So Benny can't hear me. You know, the kid has this permit, and he's gonna be getting his driver's license if he passes in January. And I know Slade will let him drive to Charlotte, which is like a 40 minute drive. So he can do that. I don't need that stress of sitting in the front seat and putting the mom's seat belt right throwing my arm out, which I cannot believe I do. But I've done it with both of my kids. Oh, I remember my mother doing that clear as day. I don't even know if they're doing driving tests here. They haven't been. I know plenty of kids who got their licenses this year, because of COVID. They're not actually giving them a driving test. They're just saying, oh, did you do your hours? Alright, here's your license. And it's a graduated system here in North Carolina. So they can't get their afternoons they can't drive at night until they take an actual driving test. I don't mind goodness. All right. So let's keep you posted and updated on next week. We'll see how much he lets me share.

Thank you so much to my editor John Bukenas from audio editing solutions. Thank you so much for listening. Don't forget if you want the free audio book, email me Stacey at Diabetes connections.com subject line audio book, and the first two will get that promo code. Thanks so much for listening. I'll see you back here next week. Until then, be kind to yourself.

 

Benny  44:03

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