
Dexcom G7 gets FDA approval for 15-day wear. It’s in adults-only and should hit the market in the second half of this year. I’m talking to Chief Operating Officer Jake Leach about this newest advance for Dexcom, why they didn’t go for pediatric...
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This week on diabetes connections, Dexcom's G7 gets FDA approval for 15 day wear. This is in adults only and should hit the market in the second half of this year. I'm talking to Chief Operating Officer Jake Leach about this newest advance from Dexcom, why they didn't go for pediatric approval, their partnership with sleep ring company Aura, and what else is coming this year from Dexcom. I am also asking a lot of your questions. This podcast is not intended as medical advice. If you have those kinds of questions, please contact your healthcare provider. Welcome to another week of the show. I am always so glad to have you here. I'm your host Stacey Sims and we aim to educate and inspire about diabetes with a focus on people who use insulin. I am nursing a bit of a cold right now. We had some really nice travel recently to see family for the Passover holiday, but I did pick up a cold from my 4 year old. I think she's my great niece. She is my husband's nephew's daughter. So family tree people, you can let me know what she is for me. I can tell you that she and her seven month old brother are adorable, but I forgot how kids colds travel. I think as part of the cold that was going around, Benny had some diabetes excitement while we were away and as you'll hear me talk about with Jake Leach in the episode he he shared his Dexcom info with me for the first time in a while. Because of that excitement, we've got an episode with Benny coming up pretty soon if you're new around here. My son Benny was diagnosed right before he turned 2 back in 2006 and he comes on the show every once in a while to keep us updated. He's now 20 so things are a little different and as a matter of habit we we don't share and follow anymore and we haven't done that since he was a senior in high school. Everybody does this their own way and that leads me to Mom's Night Out. I want to give you a quick update. These are our events for moms of kids with diabetes and women with type 1. Two events coming up this fall. Minneapolis is in September, Phoenix is in October. The speakers have been announced. More information over at diabetes-connections.com and click on the Moms Night out tab. Early Bird special is going on for both events as is our Pay half now, pay half later. So lots of easy ways to attend. Please reach out to me if you have any issues or let me know where you'd like us to go next year. We're planning four more of these for 2026. Okay. My guest this week is Dexcom's chief operating officer, Jake Leach. We cover a lot of ground in this interview. I do want to say, and longtime listeners know the drill. Dexcom is a sponsor of this podcast. You're going to hear their ad in just a minute. And they also support Mom's Night out now. But they don't tell me what to ask or what to say outside of those commercials. I think it's really important to disclose all of this. My son has used a Dexcom since 2013. We love it. But I still want to ask all the questions and I think we do a good job of that. So please let me know either way. My conversation with Dexcom's Jake Leach right after this. When I think about our family's use of CGM and Dexcom, it's getting harder and harder to remember how we did things before. I mean, how did we manage when Benny needed something like ten finger sticks a day when he was a toddler, we thought it was amazing to switch to Dexcom CGM when it needed to be calibrated twice a day. Remember that. Now Dexcom G6 eliminates finger sticks for calibration and diabetes treatment decisions. We love the alerts and alarms and that we can change them both for him and for us. A lot has changed as Benny has grown from a toddler with type one to a college student. Dexcom share and Follow has let us help give him more and more independence. If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. Learn more go to diabetes-connections.com and click on the Dexcom logo. Jake, welcome back. Always great to talk to you. Really appreciate your updates. Thanks for being here.
B
Happy, happy to be here. It's a pleasure, Stacy.
A
As usual we have lots and lots of questions. Probably veering off the topic for which you are set to come on, but I know that doesn't faze you. Let's just jump in and start with the approval for 15 day wear for the Dexcom G7. Give me the highlights.
B
Yeah, we're incredibly excited about FDA approval for that 15 day G7. So it takes the G7 10 day product, extends it out to 15 days. It still has the 12 hour grace period. So it's actually 15 and a half days. So we kept that feature so you get a full 15 plus the grace period. It is again raises the bar on accuracy and performance. We've taken everything We've learned like we've done with previous generations, where you learn a lot once you start manufacturing a lot of sensors and people start using them and you start to see field performance. You know, a lot of our algorithm that basically takes the sensor signals and turns it into glucose readings, a lot of it's based on, you know, pretty launch data. We do a lot of clinical studies to dial in the performance of the sensor. But once you start having millions of users using millions of sensors, you're able to dial that in even tighter. So that's what we did with the 15 days. We extended it 15 day, but also it made some accuracy improvements. So it's actually an 8% MRD. So it's the first and only sensor to ever show that in an ICGM level study, which is important in terms of the rigor that goes into a study of that size and the way the studies are done. So, yeah, very excited about it. We plan to launch it later this year. Right now, working through, making sure we have compatibility with all of our pump partners that they can start using that sensor. The goal right now is to have that compatibility across all the pump aid systems. At launch of 15 day. We are still dodo working through it with those partners to make sure and also working through coverage to make sure that when users are prescribed a 15 day product that they'll have the coverage there. So that's why we're kind of working through all those details before we actually do the launch, to ensure that it's a really smooth transition for folks.
A
Is the hardware the same? Is this the same G7 that people have used since its launch?
B
It's the same. In terms of the component, it is the same. You know, it's obviously the box is labeled 15 day, but also the firmware inside the transmitter. So the actual software that's embedded in there has the new algorithm in it and the extended wear time. So it is. While the physical hardware is the same, the internals are a little different.
A
Yeah, that's interesting because I would have thought that to continue the life of the sensor, you just kind of flip something on the software. But it is a change in that.
B
Transmitter in the firmware. Yeah, that's in there. It's the software that's in there. And also to implement the new algorithm, there's quite a bit of work that went into the new 15 day algorithm.
A
Any other changes to that algorithm that you can share with us that the user might notice?
B
No, it's basically, you know, I think one of the things about where Our performance is today. You know, someone says, hey, do you notice a difference between 8.2 and 8.0% mard? And I think what is important to note is as we improve that average relative difference. Right. That's what MRD stands for. What we're really doing is improving sensor kind of outlier type sensor performance. Right. Everyone has experienced at times a sensor it's like not quite tracking as well as we want. You know, there's a lot of different reasons for that. But as we improve the performance and accuracy, a lot of it is around tailoring in on those. Those sensors that have are less accurate to really bring the whole group up. So I think there will be folks will notice the differences particularly in those situations. And there's always room to keep improving. We know that there's still room in terms of sensor performance and reliability and extended life. All those things that we pioneered and been working on for over two decades. We're going to keep doing that for all of our users.
A
But no changes in terms of the watch direct to watch all those things.
B
Kind of take on. There are a lot of changes that we're going to continue to enhance and improve the feature sets of G7, but it'll go across both 15 day and 10 day.
A
You've already mentioned the pump partners. People are always concerned about interoperability. So when the longer Wear G7 is released, I know you can't give us times at exact. You already mentioned you're hoping to launch it with full operability. But is it possible that this will be okay with one pump but not another? People will know. People will get that understanding if we.
B
Run into that type of a situation. Right. Each, each pump partner has to do their own assessment of compatibility, just like we did when we went from G6 to G7. You know, in this case it's the high likelihood that there aren't any changes required on the pumps, but they have to really go through some work to mature that if there is a situation where we have compatibility with certain partners and not others, we'll make sure we're extremely clear about that upfront. And then the good news is even if we're in a situation like that, I think it would be for a very short amount of time just because maybe there's some update needs to be made to the pump. But the goal is to get all this ready so that we can launch to all users that want to upgrade.
A
Boy, I'm going to get in the weeds with this one. And this is probably a question more for the Pump companies like Tandem that use different sensors, the user can select the sensor. Is there going to be a situation where it's like, well, I'm going to either use the G6, the G7 10 day or the G7 15 or do.
B
You know, I don't anticipate, I don't anticipate that because I think it's just a G6 or G7 because the G7 again, yeah, like you said. Stacy Little in the weeds, the communication protocols between the devices, between the sensor and the pump, they describe the connectivity and what they are. So the G7 will say, hey, I'm a 10 day or I'm a 15 day. So the pump will know. So I don't anticipate that. You're going to have to select that. But again, that is something the pump companies have to really ensure is the case. But that's would be the way I'd anticipate.
A
We love to get in the weeds, you know that we. There's nothing, there's nothing too granular for this, These folks and this audience and.
B
Me, you know, it's fun. You know, I'm an engineer by training and I did a lot of engineering on CGM systems in the early days and so I love getting in the weeds. It's fun.
A
Will people need a new prescription for this?
B
You know, that's a really good question and we are working through that detail. I think there's some situations where we're pretty clear it's not required. A new, new prescription is not. But then there's others where it's, it's a possibility. So we're working through those. That's another example of important detail that we want to make sure it's clear that they need, need the new prescription.
A
When I read the press release that you all sent out, there was a. As there often is, there's a little asterisk at the bottom and it talked about. I'm going to just read it here and ask you to clarify and tell us a little bit more about this. It says when using the product per package labeling, approximately 26% of sensors may not last for the full 15 days. Let's talk about that. How long did they last? You know, before I go on and ask you more questions about it, let's just kind of set the bar there.
B
Yeah, it's a really good question, I think. And that is a. One of the things that we've been working with our teams and also with the FDA on is making sure it's really clear how long sensors what the expectation should be for a user. Right. One of the things is that is that statement is specifically around the sensors that lasted all the way to the very last day. But we all know that sensors don't always last. Sometimes a lot of time it's a patch related, you know, it gets knocked off or something happens there. Sometimes it's the sensor probes no longer accurately sensing and so we detect that and say you need to replace your sensor. So there's a number of reasons why a sensor doesn't survive. It's our goal to ensure as many as possible make it in the clinical report that'll get released as we start doing the labeling for the product. It'll specifically show the days the sensors throughout the clinical study. That's what that data is based on. There are sensors that last, you know, all the way up to 14 and a half and that would be one that would be counted as a sensor that didn't last 15 days even though it went all the way up to 14. So it is a spectrum and the performance is quite good in most sensors all the way out to 15 days in terms of survival. But there are some that come off. And so just like any sensor, if that does happen to a user we're all about ensuring that they get the sensors they need. So a very robust program. You know, when we know going from a 10 day sensor to 15 day sensor, there's more chances that things, something could happen there. So we fully are prepared for that. I think it's a delighter for people to be able to use the sensor 15 days. But if something does happen in that 15 days where they need a new one, I want to make sure they can get that.
A
As you can imagine, this was the number one comment and question I got when I shared the announcement on social media. Many people concerned less with Dexcom, replacing more with insurance companies taking advantage of this to say oh you only need two a month now we're only going to cover that. When you talk about trying to get the coverage for this and talking to insurers, what are you thinking? Are you asking these companies to say well it's 15 days, two a month or are you saying well 26% of them aren't going to 15 days so let's stay with three a month for now. Is that something you talk to them about?
B
So based on labeled is an important conversation that we continue to have even with the 10 day products because we know that there's, you know, some doctors will Prescribe More than two, three sensors a month, even on the 10 day. And so that is an important aspect. I think our goal is, whether it's through working with the insurance companies or working through our sensor replacement program, the goal is to ensure our users always have the sensors they need. And part of that is working with the insurance companies to make sure there's coverage there. It's also one of the reasons why this isn't an adult only product. We haven't moved down to Peet's yet because we do know that in PEDs particularly, sometimes the adhesive performance, it's not as good because the kids are sometimes harder on their adhesives than the adults. And so that's what we've seen in clinical studies. And so we're launching this one as an adult only product just for that exact reason. We want to make sure that PEDs performance is where it needs to be before we launch. It is a focus of ours and part of it is, like you said, a discussion with the insurance companies and all the different payers because there's so many different ones. And then also having a very robust sensor care program for users because we want to make sure they got the sensors they need.
A
Yeah, I was going to ask you about PEDs. Certainly you have so much data now. You know, your reference at the beginning of this interview, the millions of people using millions of sensors. Anecdotally, we've always heard and you know, my son is 20 now, but he's used a Dexcom since he was 9. It does seem like sensors may not last as long as in kids. And some of that is, as you said, they're tough on it, they're sweaty, they're gross, they're jumping around, they're playing sports, they're knocking tables. At least my son, you know, he's crazy. But there's also anecdotal discussion about, well, leaner people don't seem to be able to keep these things going as well. Do you have any evidence of that or any anecdotal data about that? Because some kids are so lean, it's hard. You know, you put it in their tush. It's really the only place you can put it.
B
Did you hear the pod drop?
A
Did you know all the sounds used to make that song come from a site change with the Omnipod 5 automated insulin delivery system? Pretty cool, huh? With Omnipod 5 pump site changes are simple. The pod lasts up to three days, 72 hours. And to change it, you just fill up the pod with insulin, place it on your body, tap a few buttons in the Omnipod 5 app and you're ready to go. There's no tubing to prime like with traditional insulin pumps, and it's virtually pain free, so you never have to see or handle the insertion needle. Want to try Omnipod 5 for yourself? Request a free Omnipod 5 starter kit today by visiting omnipod.com diabetesconnections. Terms and conditions apply. Eligibility may vary.
B
Yeah, you know, we've looked at that quite a bit actually. We looked across bmi, we looked across sensor placements, and I don't have any concrete quantitative data on it. But we do hear that, you know, if someone's lean, they do sometimes want to really find a place where there is some subcutaneous tissue, like you said, in the upper buttocks for the kids. That's why we have that indication and we continue to keep that because, I mean, frankly, it would be easier if we just don't run clinical studies in the upper buttocks. But we do because we know that some kids need to be able to wear sensors there. We don't have that specifically. The kids are pretty hard on their sensors sometimes and they are so important to them. Right. So it's a big deal.
A
What about pregnancy? What about the indication here for that for the 15 day?
B
Yeah, yeah. It's basically because it's adult only. The FDA is comfortable. Particularly when we went to the armwear that was one of the big components of accessing pregnancy indication. G7 was the first ICGM to have that indication for being allowed in pregnancy. And it was all about, you know, the performance of the sensor in that wear location was important.
A
Is the adhesive the same for the 15 day as to the 10 day?
B
It's the same as the most recent G7 adhesive. We made that change in G7. Midway through the launch of G7, we started updating that adhesive to one that worked better. And we're actually, still, we have a couple programs going internally where we're working on some that enhance it even further. It's one of those things. It's, it's an ever, you know, adhesives research. It's an ever evolving science where you're balancing this concept of the breathability of the adhesive and how well it sticks, but also that it doesn't irritate. And we really study irritation closely because it's a very small cohort of people who have irritation to adhesive, medical adhesives. But you really gotta make sure that when you introduce a new patch to a population of millions of users that you're not introducing an issue. And so we have to study adhesives even stronger now than we did in the past because the user base is so large and there's so many people that depend on this technology that while, you know, we're increasing adhesion, we don't want to be increasing irritation. So we've got a few that are in studies right now looking at it. And if we find one that works better than the current one, we certainly are going to cut that in across the whole base.
A
Do you have a number of people who like, off the top of your head, how many people are using Dexcom?
B
It's more than two and a half million every day. That's the active user base. It's. It's more than that. It continues to grow, obviously every quarter.
A
Is this rollout for the 15 day in every place internationally where the G7 already is, is it United States only to start or different countries over time?
B
It's going to be across the globe. The US is one of the first to launch it, but it will. Our intent is to bring 15 day across the whole portfolio. Right. So we've got Stello is already there. That's been working really well. We do intend to bring it to the Dexcom one products over time. As we look internationally, Pediatrics use Dexcom one plus. So that's an important part of our factoring in how we're going to do it. But we do intend to bring it across the whole portfolio.
A
You know, I have a whole bunch of other questions that listeners have asked me to bring to you, but I did want to kind of stop and just ask you about in the United States, the uncertainty around tariffs and maybe supply chains. I know it's difficult. As we're taping, tariffs seem to change weekly, daily. Not really sure, but there are some concerns. Can you speak to that, reassuring people that you are on it? I'm not even sure what to ask, Jake.
B
Well, I'd say yeah, we're certainly on it. We're certainly evaluating things as they unfold. We have a global supply chain. We have multiple factories. We don't anticipate this impacting our ability to provide products to people. I mean, that's our number one goal is to ensure sensors are available. You know, we'll work through whatever comes, you know, like just like everybody else is working through it, but we'll see. But you know, when it comes to sensor supply, which I think is what most users are most interested in, that shouldn't be an issue.
A
I also wanted to ask you about something that I had in one of our in the News episodes a couple of weeks ago and that is the FDA warning letter about what the FDA said were unauthorized changes to its glucose sensors. And let me just tell a little bit more for our listeners who may not be up to date on this. The article, this is from Medtech Dive says Dexcom pushed back on claims in an FDA warning letter that the company made unauthorized changes to its glucose sensors. I will link this up, but Jake, can you talk a little bit more about what happened here?
B
Yeah, sure. So, you know, we as a medical device company go through all kinds of audits from different regulatory agencies. They come in, they look, look through things. We do our own internal audits because we're always wanting to improve ourselves. And so the basically the FDA came in to a number of our sites, did inspections and basically had some observations of things that they recommended that we enhance or improve or change. And so we worked really collaborative with them on that. And so basically the warning letter is a response to those saying, hey, these are some things, these are the concerns, observations that we want you guys to look at. And so working on them, working closely with the fda, you know, we feel comfortable that, you know, we resolve all the concerns and we're always working to be better and continue to enhance things. It's not impacting our ability to supply sensors. It's not impacting our ability to get products approved. You saw the 15 day approval. It's really just a collaborative working with the FDA on things that they think we need to improve. And as we look at it, we see, yeah, we'll fix those issues. But again, it's not impacting our ability to provide products or the performance of those products.
A
Yeah, it's hard to believe that the FDA would have a serious concern and then approve the 15 day product. But if I could just follow up and ask about. They were talking about a change Dexcom made to a component used in the resistance layer of its sensors. Is that resolved?
B
It's basically there's a material that we introduced there. It was, you know, second source supplier and you know, they had concerns about the introduction of that. And so we've actually worked working through, we're still working through it with them on terms of how, how we validate it and how, you know, it's basically a second source but it's basically we're comfortable where we're at right now, comfortable supply. But we do have some things to work through in terms of what, you know, what they want to see to validate that material. Got it.
A
Okay, back to some listener questions about the G7 and the G7 15 day. I may not ask this question correctly. You'll probably know exactly what I'm talking about. And I think this is more of a question for Insulet about the OmniPod 5 Dexcom G7 and the OmniPod iPhone app. And the question was, can Dexcom basically nudge Insulet to get everything working on the same page because the G7 works with the system but not with the iPhone app?
B
Yeah, I think that certainly Insulet and Dexcom are certainly aware of wanting to continue to ensure there's compatibility across all of those. I don't have the specifics on timing for that, but I know it's a focus for basically all the markets, US and global, ensuring that there's iPhone compatibility with G7 and the Insulet system. When we put out a release, we ensure that it's available on both Android and iOS. That wasn't always the case. Right. In the early days we often launched an iOS functionality before we could get out on Android. Big part of what we did with G7 was complete re architecture of the software that allows us to do it not across iOS and Android, but across globally. So when we launch a new feature, as long as it's regulatory approved in all of the different geographies, we launch it across the globe. That is very different than what G6 and others experienced throughout the past number of years. So it's something that we're focused on with partners. We're always working with them to ensure our technologies are as linked up as possible in terms of timing. Right. I think with G7 we saw a bit of a time gap between compatibility with some of the aid systems and we've been working closely with our partners for when we come out with our next generation hardware that there's compatibility at launch or as close to launch as possible. We don't have these extended periods of time where users can't upgrade to the latest Dexcom technology because of their aid connectivity. So it's something that's very top of mind for us as we develop new technologies.
A
Let me ask you about the Follow app. I was privileged to be put back on Follow. I do not follow Benny anymore, but he had an Infusion set issue and had gone very high and he said I'm just concerned I'm going to crash. Can you just watch me overnight? So I got to look at it for the first time in a while. Are there any changes coming to Follow. Because it does not seem to my eye that it's changed a lot in the last couple of years.
B
Yeah, it hasn't from the observable changes by the user in terms of what the UI looks like. There hasn't been as many changes there. There's been a lot of changes in terms of the background getting it up to the same type of ability to roll out releases across the globe like we do with G6 or with G7. But there is a whole host of updates coming this year to follow. We're basically doing quite an overhaul to the UI and the functionality and really focusing on making sure that we continue to differentiate ourselves there and ensure that people have, you know, the best experience possible with a follow up as a follower. So yeah, lots coming this year across actually the whole portfolio, Stello, G7 and follow and Clarity. And we're actually putting the. One of the neat updates that's coming is we're putting all of the Clarity functionality into the G7 app. And so while we have the card in there today where you get some of the overall statistics, obviously as you know, more Clarity functionality there in Clarity. So the Clarity app is basically being folded into the G7 app.
A
Nice. Can you give us any of a sneak peek on the Follow changes that are coming? Any hints?
B
There's a whole bunch and they're at different sequences and I don't want to misspeak. So we'll leave it at Stay tuned. We'll leave it as Stay tuned.
A
All right. All right. And then we've talked about this kind of high level for years. Any updates on measuring ketones or other, you know, other things that you can measure?
B
Yeah, it's definitely in our pipeline of technology projects and product development as we look at measuring alternate analytes on the subcutaneous probe that we've got, um, we've also started to do. You know, I was working with Aura on the integration of other physiologic signals like body temperature, heart rate, pulse oximetry. There's, there's a lot of things that are inside that platform that are basically non invasive measurements. So we're looking at integrating those. We are actually in the process of integrating those into our, our mobile app and our cloud infrastructure. So we've got that, we've got other analytes under the skin that we're looking, looking at. And so yeah, I think you'll just see a continuous stream of innovation there around how do we continue to move towards a system that is even more helpful in helping people make the Choices they need. Whether they're treating diabetes with insulin or they're looking at diet or they're looking at other medications like GLP1s, whatever. It's really about helping people guide them on that journey, ensure they're being as successful as possible and they're meeting the goals. A big part of this is improvement and showing that improvement.
A
You mentioned Aura and as you listen, this is a ring that measures sleep and who knows what'll come 10 years down the road. I don't want to get too much in the weeds in terms of possibly sleep glucose measurements, the same thing. But this is not a ring that measures glucose. What you're talking about is integrating the sleep information and displaying it within Dexcom, kind of making it. Yeah, okay.
B
I mean, we do that today with Stelo. We're importing sleep and activity data already and using that within the insights report around, which is basically weekly provide the insights to users around, you know, what they can do to further reach their goal. And a big part of that glucose control is, you know, sleep has an impact on it. We're also in the, you know, studying it too. The more we, more data we get, the more we're going to learn about those connections. But that's just the tip of the iceberg when it comes to what these platforms are capable of. So got a really innovative group over with Aura and a very innovative group here at Texcom working together to come up with some really exciting integrated product components.
A
Very cool. So before I let you go, I know one of the questions I'm going to get is, okay, Great, this new G7 is going to come out later this year, you know, discontinuing the G6, the older G7. I know there's, it's not approved for PEDs, so PEDs will have to stay on the 10 day G7 for a while.
B
Yeah. And G6, at some point we will discontinue G6. Right. The volume that we produce of G6 goes down every month because as people switch over to G7, a lot of that here on the tail end has been driven by automated insulin delivery compatibility, making sure those sensors are compatible. And so at some point we will. We don't have any date now, you know, picked where we said we're going to discontinue G6. There's a lot of people who are still enjoying using their G6. So at some point in time we will discontinue G6. We'll make sure it's very clear to users when that's happening. We'll give everybody plenty of notice, but it will happen at some point as we continue to move the technology forward.
A
Great. All right, lots and lots of stuff going on. What are you looking forward to? What stuff gets you jumping out of bed in the morning to do this?
B
You know, it's funny, Stacey, you know what gets me out of bed every morning is when I look at our active user base across the globe and seeing so many more people using cgm. I mean, it's just, it's, it's unbelievable how the technology has become so much more accessible. And that being said, there's still so much to do in terms of getting the technology to all the people that can benefit from it. And that kind of spans the spectrum of the product technology and continue to make it easier to use, continuing to lower the cost of the technology. Right. We've, over time, over the last five years, the cost of CGM has substantially reduced to the payers, to users. Our focus always lowest out of pocket costs possible. A big part of that is as you reduce your cost of goods, you can do things like that. So that's going to be a continual stream of innovation around reducing costs without compromising on quality or performance, you know, which we would never do. And the other thing though is it's around access, right? It's, it's advocating in the United States we have great access for people on insulin. We're getting, we're starting to see quite a bit of access coming for people that are not on insulin but have diabetes. And then we have our over the counter product with stelo that services the cash pay market out of pocket at the lowest cost ever for cgm. That's what gets me excited is just seeing this, this technology continue to be used by more and more people and, and the outcomes. When I, when I see some of the health systems in the US that use CGM and the vast majority of, you know, at this point in time, they're multiple daily injection users for either type 1, type 2. You can actually see A1C reductions in the population because they're starting to use this technology. And you know, there's other things that drive it. But CGM in my opinion has been the most impactful in driving down A1Cs and also increased time and range. Right. We're starting to use that as opposed to A1C time and range. And now we're talking about time and tight range, which is not something you could never talk about, time and tight range without cgm. So I think we're, we're making progress still. Still much, much to do out there though.
A
Well I appreciate you spending so much time with me Jake. Thank you so much. We will check back in with you soon I am sure. But thanks for spending some time with me.
B
Yeah, thanks Stacy as always.
A
More information about about the G7 and many of the other items we talked about. You can look back at in the news episodes for more information about the FDA question that I asked there. And please let me know if there's anything I missed that you'd like to know going forward. I try to collect all these questions and we ask them in the Diabetes Connections Facebook group and I do hold them until I'm able to talk to these companies. So please let me know what questions you might have for Dexcom or any other companies that are in the diabetes sphere. Couple of quiet weeks coming up in terms of travel and speaking, but we've got a very jam packed summer and fall so I will take it while I can get it again. Please head over to diabetes-connections.com, click on the Moms Night out page to learn more about our fall events and take a look back at the pictures and the reports from our previous events. And you can also go to the website and click on Community. See where we are heading later this year and and I also list all the talks that I do if you'd like me to come and join you virtually or if you want to put my name in for a breakthrough T1D summit. I'm always happy to bring the message of not perfect but safe and happy to summits, to zoom webinars and to just general meetups. I love in person stuff. I just really think there's no substitute for it. Thanks as always to my editor John Buchenis from Audio Editing Solutions. Thank you so much for listening. Hi, I'm Stacey Sims. I'll see you back here soon. Until then, be kind to yourself. Diabetes Connections is a production of Stacy Sims Media. All rights reserved. All wrongs avenged.
Date: April 22, 2025
Host: Stacey Simms
Guest: Jake Leach, Chief Operating Officer, Dexcom
This episode dives into the FDA’s approval of Dexcom’s G7 continuous glucose monitor (CGM) for 15-day wear (adults only). Stacey Simms interviews Jake Leach, exploring the technical, clinical, and user-experience aspects of this update. They cover why pediatric approval wasn't pursued, changes in device algorithms and adhesive, future plans for Dexcom products, insurance and sensor replacement concerns, collaborations with Aura sleep ring, and questions sourced directly from the diabetes community.
What’s new:
“It takes the G7 10-day product, extends it out to 15 days. It still has the 12-hour grace period... raises the bar on accuracy and performance.”
— Jake Leach [04:23]
Technical Details:
“...to continue the life of the sensor, you just kind of flip something on the software. But it is a change in that transmitter in the firmware.”
— Stacey Simms [06:27]
“It’s the software that’s in there... quite a bit of work that went into the new 15-day algorithm.”
— Jake Leach [06:34]
Sensor Longevity:
“Approximately 26% of sensors may not last for the full 15 days... there are sensors that last all the way up to 14 and a half and that would be one that would be counted as a sensor that didn’t last 15 days even though it went all the way up to 14.”
— Jake Leach [10:51]
Replacement Policy:
“Our goal is to ensure our users always have the sensors they need.”
— Jake Leach [13:01]
Pump Compatibility:
“The goal is to get all this ready so that we can launch to all users that want to upgrade.”
— Jake Leach [08:23]
Prescriptions:
“There’s some situations where we’re pretty clear it’s not required... but then there’s others where it’s a possibility.”
— Jake Leach [10:02]
“We haven’t moved down to Peet’s yet because we do know that in PEDs... sometimes the adhesive performance, it’s not as good, because the kids are sometimes harder on their adhesives than the adults.”
— Jake Leach [13:01]
The new 15-day G7 uses Dexcom’s updated adhesive, optimized for wear and skin comfort.
Research ongoing for even better adhesives with a focus on balancing stickiness, breathability, and minimizing irritation.
"We’re still working on some that enhance it even further... balancing the breathability of the adhesive and how well it sticks, but also that it doesn’t irritate.”
— Jake Leach [16:46]
Scale:
International Availability:
"The US is one of the first to launch it, but our intent is to bring 15-day across the whole portfolio."
— Jake Leach [18:14]
“It's not impacting our ability to supply sensors. It's not impacting our ability to get products approved. You saw the 15-day approval.”
— Jake Leach [19:59]
"There is a whole host of updates coming this year to Follow... putting all of the Clarity functionality into the G7 app."
— Jake Leach [24:01]
“We're importing sleep and activity data already and using that within the insights report... But that’s just the tip of the iceberg when it comes to what these platforms are capable of.”
— Jake Leach [26:56]
“...continuing to lower the cost of the technology... access... advocating in the United States, but also globally.”
— Jake Leach [28:38]
“CGM in my opinion has been the most impactful in driving down A1Cs and also increased time in range.”
— Jake Leach [30:38]
On advancing accuracy and user experience:
“As we improve the performance and accuracy, a lot of it is around tailoring in on those sensors that have been less accurate to really bring the whole group up.”
— Jake Leach [06:50]
On insurance and replacement worries:
“Our goal is to ensure our users always have the sensors they need. And part of that is working with the insurance companies to make sure there’s coverage there.”
— Jake Leach [13:01]
On collaborating with pump partners:
“The goal is to get all this ready so that we can launch to all users that want to upgrade.”
— Jake Leach [08:23]
On pursuing pediatric approval:
“We want to make sure that PEDs performance is where it needs to be before we launch.”
— Jake Leach [13:01]
On the mission of CGM:
"What gets me out of bed every morning is when I look at our active user base ... seeing so many more people using CGM ... there's still so much to do."
— Jake Leach [28:38]
For more updates, information on the 15-day G7, or upcoming Dexcom events, visit diabetes-connections.com. Got questions? Join their Facebook group or reach out for future listener Q&As!