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Digging deeper into recent news from and about Dexcom. Stacey talks to Chief Technology Officer Jake Leach about the news that competitor Abbott has received approval for it’s Libre 2 CGM. What does that mean for the marketplace? She also asks Jake about G6 sensor issues, data gathering and more.

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

Dexcom statement on data and privacy:

Patient safety is a top priority at Dexcom, and we design our products to be as safe and secure as possible, as the data that comes into our system from CGM devices is extremely important for patients and physicians in understanding and improving diabetes management. Dexcom works with government agencies, industry partners and security researchers to apply current best security practices for medical devices to help ensure the integrity and availability of our systems.

Our terms of data use are laid out for patients to consent or opt-out when they first set up a Dexcom account, so they know exactly how their data could be used and who will have access to it. In order for healthcare providers to access patient data, each patient must approve the sharing of their data to the healthcare provider through the CLARITY app. Another way patients can opt-out of sharing any of their data is by using the dedicated Dexcom receiver to view their glucose levels instead of a smart device.

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Episode Transcription:

Stacey Simms  0:00

Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.

 

Announcer  0:16

This is Diabetes Connections with Stacey Simms.

 

Stacey Simms  0:22

Welcome to a bonus episode of Diabetes Connections. So glad to have you along as always. A bit of an unusual situation this week in the very last episode, and hopefully you’ve heard it. I spoke to Dexcom CEO Kevin Sayer. we taped that episode before the ADA conference actually took place. You know, the time shifting nature of podcasting. we taped these interviews ahead of time and then a couple of days or a week later, generally, the interviews air. A a couple of days after taping that interview, the FDA approved Abbott’s Libre2 and this is a different CGM is able to continue transmit glucose data every minute. And users can now set the system to send alarms when their glucose is too high or too low. And previously, you had to scan the sensor in order to get any kind of glucose reads. So that is a big change, and frankly, more direct competition to Dexcom.

I have reached out to Abbott in the hopes of learning more and asking them any questions that you may have Dexcom though, immediately reached back out to me and asked if we wanted to talk more about CGM and how they stack up in the marketplace. Now, I am not going to pass up the opportunity to ask more of your questions. And that’s why we have sort of a Dexcom double feature this week.

My usual disclaimer Dexcom as you have heard, and longtime listeners know Dexcom is a sponsor of this show. That means they pay me to have a commercial in the show. That sponsorship gets them a commercial, it does not get them any kind of approval over content. And so what does that mean? It means I don’t send them all the questions. I have of time, we don’t plan out what we’re going to say. I hope you know, as you’ve listened that I don’t hold back on questions and criticism from them. But we do have that relationship. And it’s really important that you you know it right because we were doing news interviews here.

And this interview is with Dexcom CTO, Jake Leach. I will link up more information at the episode homepage. And as always, there is a transcript. So here is my interview with Dexcom’s chief technical officer.

Jake, thank you for jumping on and spending some time with me and my listeners. We always appreciate learning more about what’s going on at Dexcom. So thank you.

 

Jake Leach  2:36

It’s a pleasure to be here. Stacey. Thanks for having me.

 

Stacey Simms  2:38

Absolutely. So I just talked to Kevin Sayer. We did kind of a high level, you know what’s new, what’s next? How are things going? Talking about the G7? It he’s of changes that have happened to the G6 COVID delays, that sort of thing. My listeners had a bunch of questions as this is the backdrop of course of the Libre news that came out Abbott’s Libre 2 have got approval for use of the United States. The number one question that my listeners had was, can they talk about the price difference? I don’t know if that’s a CTO level question.

 

Jake Leach  3:11

Yeah, as much as you know, I’m involved in it. We basically, when we think about the cost of the product, the most important thing to be thinking about is making sure people have access to it. So insurance coverage, we feel really good about the fact that 98% of the private insurance companies do cover the product, as well as Medicare started covers it. And in states, many Medicaid systems do also cover the product as insurance. That’s where we focus our time is really on on that. And we very few of our customers actually pay cash for the product. The vast majority of everybody gets it through insurance coverage.

 

Stacey Simms  3:48

When I look at the Libre, and full disclosure here, my husband has type two diabetes and he uses the Libre and Benny my son has used the Dexcom since 2013. Now, wow, yeah, it’s funny to think about how much time has gone by. But one of the things I look at with the G7 coming and the you know, the bit that we know about it is that it will be much more like the Libre in terms of the sensor and transmitter in one. Can you speak to that in terms of the G7 in terms of size, insertion, that sort of thing?

 

Jake Leach  4:25

Yeah, so the G7 is, as you pointed out as an integrated sensor all in one, so it’s the wearable device that goes on the body includes both the sensor, the transmitter, as well as the electronics inside the wearable that are both monitoring the center and then taking that signal and sending it via Bluetooth to the different integrated display devices whether that’s a mobile phone, so a smartphone with an app on it, Android or iOS, or a insulin pump for automated insulin delivery systems. Other display devices, we have our receiver that is our proprietary handheld, some people really like that as their way to access the information. So our goal is to make it as interoperable as possible, which is one of the key important points about IC GM is that it’s interoperable device

 

Stacey Simms  5:16

you And with that, I always get hung up on it. Because when I heard about interoperability A few years ago, in my head, it seemed like, Okay, well, I could switch out my pump, or I could switch out my sensor, I could use a different brand with this thing and kind of mix and match. And of course, insurance for most of us is the biggest problem for getting different devices. But it doesn’t really work like that, does it? I mean, if a Dexcom g seven works with say, Omnipod five horizon, and with a T slim X to control IQ, people aren’t really going to be able to just switch out devices like that and use the same sensor, are they?

 

Jake Leach  5:51

Yeah, as usual, it’s more complicated as you look at it under the hood. But the key thing about the integration is that systems have to be designed To be able to be integrated. And so one of the big moves that we made when we transitioned between Gen four, and Gen five, and then subsequently Gen six, and as well as Gen seven, we moved to Bluetooth technology, which is a much more readily available technology within the display devices. So we moved to that. And when we did that, we designed an architecture that the intelligence of the system is all on the the wearable. So all the glucose calculations, all the information that you need is actually on the little transmitter device in G6, and will be in G seven as well. And so that is the device that can be accessed by multiple displays. If you think about it, you can use your mobile phone and the whole share feature that comes along with our mobile system, the remote monitoring feature, you can use that and at the same time, you can use a tandem controller to pump doing automated insulin delivery. And so the system is really designed to have that type of integration where you’ve got the right information in the right places and makes it interoperable. The systems have to be designed To be connected, for example, horizon five Omnipod five, the system that is in development by insolate is being designed to be integrated with both G6, that’s what they’re doing their studies with as well as G seven. So you have to do the design work and do the testing to ensure that it operates safely. But interoperability is a great thing. But it isn’t as simple as just pulling and pulling everything it has to be designed and tested.

 

Stacey Simms  7:22

Yeah, it was interesting. I in my head, I always had it as well, this, you know, I can mix and match, I can figure out what I want. But when I talk to technical people, they always kind of smile at that because they understand more of the intricacies, I think of what it takes within the technology to make that kind of stuff happen. Whereas as the user, I just want to hokey pokey it around and use what I want. But we’ll see as it goes down the road. Some other G7 basics that my listeners asked was, will the G7 have a shorter warm up and does it have a lower MARD? Is it more accurate than G6?

 

Jake Leach  7:55

Great questions. The warm up time is designed to be shorter than g6. And so we’re As we’re landing exactly how much shorter it’s going to be, but it’s definitely going to be a faster warmup. Also, the mard is the average difference between the sensor and the reference measurements that we measured the performance of the device and so on. That way, we want to ensure that we hit those iCGM standards. And so I think G7 definitely has the opportunity to perform better, but it definitely will meet those CGM standards, which are rigorous and important to ensure the product performs accurately throughout its life.

 

Stacey Simms  8:30

Can you give me a hint on the warm up? Is it going to be more an hour and 45 minutes or more?

 

Jake Leach  8:35

No, no, no, it’s gonna be It’ll be an hour or less.

 

Stacey Simms  8:40

You know, just had to double check on that.

 

Jake Leach  8:42

Yeah, no games there. We’re just we’re still trying to dial in exactly what’s going to be to ensure we you know, the system has to be accurate. Second, it starts up but we do value short warmup time because we know how important it is when you know you’re without the sensor data for that warmup period. So you want to make sure it starts up as fast as possible.

 

Stacey Simms  8:59

Yeah, it’s interesting too. Because I’m probably an outlier but previous to we use the control IQ system with tandem previous to using that the two hour warmup really didn’t bother me too much. I mean, it was only two hours especially if you came from like we did seven years with no CGM. It’s really did not seem to be that big a deal. But now that we’re using this algorithm, and the pump relies on the Dexcom data, two hours just seems like way too long to be without it.

 

Jake Leach  9:27

I agree. Really interesting.

 

Stacey Simms  9:29

Speaking of wear time, we’ve been very fortunate. Again, as I said, we’ve used Dexcom for a long time we do not really have a lot of issues knock on wood with it. He’s of sensitivity which Kevin mentioned in his in our interview together, we went over that, but also with where time, but a lot of my listeners wanted me to ask if you are really checking into the people who can and there are many who can never seem to make it to 10 days on a sensor. Right who really was it whether it’s because they have a young  child or the body chemistry for whatever reason, it does seem to be an issue that many people can’t get the full life out of a sensor.

 

Jake Leach  10:07

Can you address that? I know you’re looking at it.

 

Jake Leach  10:09

Yeah, yeah, I’ve got, of course. So a couple things there. There’s quite a few things we’ve done over time. And we continue to research on this. There’s two aspects to sensor longevity. One of them is how long the sensor can remain accurate. And so within our device, we have algorithms that are checking the performance of the sensor at all times. And so there are times when we detect that that sensor signal is not accurate and not meeting the CGM standard. And so we we actually shut it off and that’s when you get on the display, you get the sensor failed signal. That’s basically we detected that that sensor is not working properly, and it’s not going to return to functioning based on the data that we’re seeing from it. As you mentioned, most people are able to get 10 days out of the sensor particularly now that we’ve made some changes with the adhesive as well. But there are some people who don’t and with those folks, we often spend some extra time with our tech support, and kind of walk through what their issues are. And there’s quite a few things that can be done to help sensors last longer. I mentioned the adhesive, we recently updated our adhesive, we’ve added an overlay. that’s optional, people can ask if you have access to the clear adhesive that goes over the top of the white one that comes with the product. And so we’re looking at lots of different ways.

Because what we found is everybody’s a little different in terms of what their needs are and what works for them. And so we’re trying to do is have as many options that we can to make the sensors stay on and heared. And it’s really that’s our philosophy around sensor longevity is if I really wanted to I could I could run a study and claim that G6 goes 15 days because I know the performance would meet that the problem is not all the centers would last that long. And so what we’re really after is making sure all the sensors, as many as we can get out to the labeled timeframe, not just some of them. And I think that’s one of the key differences that you’ll see over time between different CGM companies is we’re very focused on a high level liability, you’re never going to get 100%. You know, sensors will come off and they’ll get knocked off. It’s a challenge. But it’s one that we’re very focused on trying to ensure that we can have the highest flow reliability possible.

 

Stacey Simms  12:12

Let me just follow up on that, because sensor sticking is one thing, right? I mean, I know that that’s an issue in everybody’s skin is different. And you have the overlays now, and the adhesive does seem to be sticking better to many people. Butwhat about people who have no trouble getting the adhesive to stick in the wire to stay in, but get recurrent sensor failure? Are there any best practices for people who seem to get that over and over again,

 

Jake Leach  12:36

there are and it’s actually often comes down to, you know, sensor placement and you know, the sensors indicated for abdominal use. And so, we often instruct folks to try at different locations. We’ve also, if someone’s really having repeated challenges and where they’re getting those sensor failures, we do have specific capability with our tech support to work with that customer and look at their data and To help determine exactly what is going on, there’s a number of things to we tend to see, that happens when people are more dehydrated. So you know, kind of making sure they’re well hydrated and drinking water. But if someone’s having consistent problems all the time, then we really want them to reach out to us and talk to our tech support. And we can get someone who is experienced, but you know that those types of issues to talk to them and look at their data and help work through it.

 

Stacey Simms  13:22

I don’t mean to harp on it. But I’ve just, and I’m, I know, you may not be the right person to try to pin down on this, so forgive me, but I’m thinking like, Is it an insertion thing is it I mean, we’ve, anecdotally, the community has said, drink water, stick in the fattest place you possibly can maybe rock the sensor a little when you’re inserting it so it doesn’t go as deeply in like it’s more shallow. I’m just curious with all the data that you will collect in these phone calls. If there’s any, like I said, a best practice that would help or if it’s just you know, you’ve got to talk to your local rep, maybe get an in person or zoom call lesson or talk to tech support, but you know, just a more concrete business advice, I think would be so helpful.

 

Jake Leach  14:01

Yeah, I think a lot of it does have to do with that insertion saying, like you said, you want to put it into a place where you’ve got good interstitial tissue. The other thing I’ve seen, too, is, um, you want to make sure that it’s not at a place where you’re going to compress the center a lot, you know, if it’s under compression, you’re not getting the same amount of perfusion there have glucose under the skin. And so that can also lead to issues. There is something recently that we’ve released in a product that has really solved a number of issues in that people were getting sensor failures during really high glucose excursions. We’ve sent some solved that problem with a new version of our transmitter that is now out in the market, almost everybody has that device. Now, it did make quite a dent in those we were detecting the algorithm was detecting that really high glucose as a potential issue. And over time, we’ve learned through looking at the data that that wasn’t an actual issue until we were able to correct that in a recent version of the device. But yeah, it does come down to kind of working through sensor insertion and placement in Don’t have data that validates, you know, some of those techniques that you mentioned that says it will work if you do these things. But we have heard from the community, and in our own times speaking with patients that it has been very helpful. And some of those concepts you just mentioned.

 

Stacey Simms  15:14

Jake, I’m sorry, can I ask you to clarify? It may have gone over my head. But when you were mentioning the newer transmitter that is out, can you just clarify what you meant by when it was reading very high blood glucose? And that was affecting the sensor? And then it sounded like you said, but that wasn’t the case. Can you just clarify that?

 

Jake Leach  15:31

Yeah, sure. So what it was, was that during really high glucose excursions, the device was detecting a potential sensor failure where it wasn’t the sensor failure. There’s nothing wrong with the sensor. It was working. But you know, it’s one of those things that once you once you get a product on the market, you learn more about it. And so we’ve made several iterations to the G6 even since it’s been in the market for several years to improve it. And that is one of the cases that we saw patients running into, that we resolved with the newest version of the device is that it doesn’t give The sensor error when when there was really high glucose excursion,

 

Jake Leach  16:03

and I’m just curious cuz it does sound like you’ve resolved it. What is really high glucose? Like over 400?

 

Jake Leach  16:10

Oh, well north of 4, 5, 6 hundred.

 

Stacey Simms

Oh my goodness,

 

Jake Leach  16:14

yeah, we’re really, really high glucose.

 

Stacey Simms  16:16

So if somebody has a teenager who’s like bumped up to 250 and getting sensor failure, that’s not the issue.

 

Jake Leach  16:21

That’s not the issue. No, no, no, not in not in those,

 

Stacey Simms  16:24

because everybody has a different idea of really high glucose. So Thanks for clarifying.

 

Jake Leach  16:27

Yeah, that’s a good thing to clarify. Because, like you mentioned,

 

Stacey Simms  16:32

you know, another question that my listeners had was about data. And we’ve talked a little bit here about some of the data that you collect. And I don’t know if it’s different internationally, but to speak about the data.

 

Jake Leach  16:43

Yeah, sure. Of course, first of all, data privacy is very important, both just fundamentally and philosophically as well as to be in compliance with all the global regulation we’re seeing in this area of data privacy. There’s a lot of advancements in the laws and regulate Around consent, and users granting access to their data, because in the end, it’s the users data. We’re just a steward of it. And so we take it very seriously. And so in our processes and our controls, that’s how we proceed. So the data that comes into our systems from the CGM devices are used for things like share. So we provide the share system, the remote monitoring, that connectivity is super important. The data is also through that same system made available to the clarity application for use by the patients or customers or their physician. And then we also have that data in a safe lockdown repository that can be used by our tech support agents. If users are having track challenges, like we talked about tech support agents can actually log in and work with that user on their specific data. But

 

Stacey Simms  17:48

hey, it’s Stacey jumping in here. I need to insert myself into the interview with the episode here because we hADAn audio issue right there and it was completely my fault. So apologies. Dexcom is going gonna give you a full statement on data and privacy, and I will link it up in the show notes. So Jake can kind of continue his thought that way and give you the full statement. One thing he said that I thought was very interesting though was if you are concerned about privacy and want to opt out, you can just use the receiver all by itself. They don’t collect any data that way. But then you can’t use clarity or share the information online with caregivers or your health team. But if you want to opt out, that is one way to do it and still use the Dexcom system. I did follow up the data question with one about transmitting data and why it’s limited to certain devices. If you use a tandem pump like we do, for example, the transmitter can send data to your phone and to the to the mix to pump but then not also to the receiver.

 

Jake Leach  18:52

Yeah, the ad goes down into the specific engineering of the device deep down inside the wearable, for example to the transmitter producer. There’s a battery in there. Every connection to a display device takes a Bluetooth communication channel. And so today, which is six, we support two channels, one for mobile phone and one for a medical device such as the insulin pump, or the Dexcom. receiver, it can support to have those connections to the med devices, because we need one available for a phone. We are looking in the future to allow multiple different types of devices you can imagine watches and other things. And so that technology is we’re working the architecture of that. But the key there is that circuitry has to be low enough power that it doesn’t use up the battery. We specifically designed G6 to be reliable for that 90 day period for the mere life. And so we couldn’t put that system you can’t support more than those two connection.

 

Stacey Simms  19:45

Yeah, practically speaking for us. It’s plenty. I was just curious about the thinking behind it. And is that going to be the same thing with the Omnipod five? horizon? I’m laughing because I have to figure out how to say that Omnipod five. will it be the same thing Work goes phone and PDM or something, or is that a different setup altogether?

 

Jake Leach  20:04

It’s a little different. But it’s it with the G6 integration, G6 will support the Omnipod five as well as a mobile app like a G6 app. So it does support that. And as we look into the future towards things like g seven and future versions of G7, we are looking at architectures that could support even more display devices, more than just two.

 

Stacey Simms  20:24

And I’ll hope to talk to Insulet in the future to get the specifics. But as I’m asking you this question, that sounds a little ridiculous, because where would it show up on the pod? I guess it would show up on a PDF if you use that instead of a phone.

 

Jake Leach  20:34

Yeah, I think one way to look at it for all of these automated insulin delivery systems is you want good communication between the algorithm that is doing all of the calculations for how much influence to deliver, you want a good connection between that and the glucose signal and the pump that’s doing the delivery. That’s part of the system engineering of the of the product and part of G6 was designed specifically for interoperability with so that it can support use cases like that

 

Stacey Simms  20:59

you mentioned To watch, I did talk to Kevin about this. So I’m sorry to bring it up again. But my listeners are really waiting for that direct to watch component. Can you speak to that from your perspective?

 

Jake Leach  21:11

Yeah, sure. So, you know, it’s a it’s a feature that we’ve been working on in development for for quite a while. And as we’ve worked through it, well, it turns out, you know, on our side, as well as on the leaves, Apple Watches is one of the one of the examples other than a significant amount of engineering. I think that we all underestimated when we first started talking about that product in the way that it interacts with the G7, as well as the phone app. And so we’ve been working with Apple closely know, over the last couple of years, actually, when when they announced this feature, it was really kind of a prototype feature. We started working with them closely on it, making quite a few updates on both sides to support that type of a feature. And so while we don’t have any dates, where we’re going to launch it, it’s important feature that we know, adds flexibility to users lives and so we will continue to work on it. But at this point in time, we don’t have a specific comment.

 

Stacey Simms  21:57

Yeah, I’m curious um, before I let you go here, DiabetesMine, which is a really great news source, if as you listen, you’re not familiar, I always read them. I think they’re fantastic. They recently, earlier this year, put out an article, headline “39 potential new continuous glucose monitors for diabetes,” as some of these are never going to happen. A lot of these are, you know, non invasive wearables that, you know, look at a headline, and we may never see again, but some of these are going to happen. Jake, I know you all are watching the competition. You know, I know that, you know, Dexcom has enjoyed a long time here of not having a lot of competition, especially the United States. I’ll give you the floor. Are you guys ready to take on these companies?

 

Jake Leach  22:39

Absolutely. I think the just notion that there’s that many different companies and working in this space is kind of validating the concept that continuous glucose monitoring is the standard of care for diabetes management and so perfectly comfortable with Mark people working in this space and we continue to drive forward all of our efforts on advancing the technologies, whether it The performance of the sensor the longevity of the sensor, particularly the ease of use, and the integration of our CGM with other devices. And you know from what we’ve seen, it’s a very large opportunity. There’s a lot of people who could benefit from CGM, so we’re comfortable not being the only player. And we actually going to welcome expansion of CGM space across the globe with other companies as well as tech from

 

Jake Leach  23:23

Well, thank you so much for jumping on. I feel like I got a double feature of Dexcom this week. So thank you for the info. It’s always great to catch up.

 

Jake Leach  23:29

I appreciate it. Stacey. Thanks for having me.

 

Jake Leach  23:37

You’re listening to diabetes connections

 

Jake Leach  23:39

with Stacey Sims.

 

Stacey Simms  23:43

More information in the show notes as always, the episode homepage and there is a transcript there there are important links. Same thing if you’re listening in a podcast app, you should be able to get to the show notes. But you know some apps are weird and they don’t post links and Apple podcasts which is the most common one. Used as kind of bad for that sort of thing. So I always put it on the episode homepage, which you can find at Diabetes connections.com.

And a little bit on that audio error if you’re interested. I mean, here’s some inside baseball. But here’s basically what happened. Whenever I do a remote interview, and probably 90% of the interviews on this podcast are remote, right? We’re not together, I do them generally through Skype. And my computer is set up so that it automatically records when a Skype call is placed. I have a backup recorder. For those of you who are technical and want to know it’s an h5 zoom, and it’s fabulous. But it’s an external recorder that’s plugged into the computer and has an SD card inside of it. So this call like a couple I’ve done recently, our zoom calls, my computer is not set up to automatically record and you know, everybody knows zoom by now if you’re not the host, you don’t have the power to record well 99% of the time, I asked the host to please record it on their end and then send it to me as a backup and I just roll the h5 zoom over here. forgot to ask them To hit record, there’s always a PR person on these calls, you know, Jake doesn’t have to worry about it, they’ll take care of it. But I forgot to ask her to do that. So I’m rolling on my end, but they weren’t rolling on there. And then and this has never happened before, the SD card was full. And it’s a huge SD card. I don’t know what the data is. I’m not going to pop it out. Now, look, but you know, I cleared out periodically, but probably only once every six months. And oh, my gosh, I completely forgot to do it. So it just clicked off and stopped recording. I share this with you. Because I mean, we’re more than 300 episodes in right. We’re close. You know me, I know some of you, but I thought you might appreciate it behind the scenes look at some of the nonsense that goes on here. I was able to stop the interview, ask them to start rolling and then restart. But we did lose that part, which I hate about the data. I have talked to Dexcom in the past about data.

I will link up the specific interview where I talked to them about that. And I will link up the statement that they gave me after the fact I asked them to email me some information about that. But you know, hey, we’re not perfect around here and we don’t pretend to be the next Episode shouldn’t be an interview with tandem. if things work out. We’re still in the process of moving some things around with ADA and breaking news, we always like to do the best we can. So tandem should be up next, please join the Facebook group Diabetes Connections, the group to stay up to date. And that’s the best way to get your questions into these interviews. When I have something like this, I always ask and you guys are amazing at getting me great questions and letting me know what you want to talk about. So I appreciate that very much. Thank you as always to my editor john Buchanan’s from audio editing solutions. And thank you very much for listening. I’m Stacey Simms. I’ll see you back here next week. Until then, be kind to yourself, even if your SD card is full.

Benny 26:45

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

 

Transcribed by https://otter.ai

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