Hi everyone. Diabetes Connections has expanded into in-person events. There are two remaining for this fall. Mom's Night Out, our event for moms of children with diabetes and women with type 1, will be in Phoenix in October. And we've added a new event for the entire community, Club 1921. The next of those will be in Charlotte, North Carolina in November. We have four more cities set for Mom's Night Out for 2026, and we will be adding and expanding Club 1921 out of Charlotte. All of the Mom's Night Out information is at diabetes-connections.com. If you're interested in partnering with us on any of these, please reach out. Diabetes Connections is what it's all about.
This week on Diabetes Connections, catching up with Dexcom's Jake Leach. Our first interview with him since we found out he's going to be promoted to CEO. As always, a lot going on. We get the details on a recent recall for Dexcom software, the studies presented at EASD, a look at what's coming up for the rest of this year and into next. And of course, I ask your questions. 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 Diabetes Connections. I'm your host, Stacy Sims, and we aim to educate and inspire about diabetes with a focus on people who use insulin. If you're new around here, my son was diagnosed with type 1 just before he turned 2 back in 2006. He is now 20, almost 21, so we've been doing diabetes for a long time. And full disclosure, he has used a Dexcom since he was 9 years old. He started on the G4 pediatric platinum and he does use the Dexcom G7 these days. You're also going to hear a commercial for Dexcom. They are a longtime sponsor of the podcast, but we keep the interview separate. They don't tell me what to ask or what to say, and they don't listen back to the interview before it goes to you. Longtime listeners are very used to hearing these disclosures and disclaimers, but I do think it's really important, especially if you're new, and technology episodes like these bring out a lot of new listeners. I'm going to talk about this more in our in the news episode coming up on Friday, but I want to highlight this. It doesn't have anything, as far as I know, to do with Dexcom, but I think it's really important. And this is a letter that the Food and Drug Administration has sent out to drug advertisers. This happened about a week or two ago. And the letters went out to traditional pharmaceutical companies as well as to online companies. You may not realize that America is one of, I think, only two countries in the world that allows pharmaceutical advertising direct to consumers. And boy, were there a lot of people against it. I was a health reporter back in the '90s when they changed the rules and allowed companies to do this. I'm going to link up more information in the show notes so you can read up on it. I've already heard from some big diabetes companies that are taking a very close look at this. I think there's going to be a lot more to come. I just wanted to spotlight it here. Again, has nothing to do with Dexcom as far as I know, but I didn't want to wait until Friday to let you know that this is in the news if you hadn't seen it. Lord knows there is so much going on these days, but I think this is something that affects all of us as consumers and certainly it's a big diabetes industry story. Okay, I've talked to Jake Leach a couple of times for a few years now. As I mentioned, he was recently promoted to CEO. The current CEO Kevin Sayer will step down at the end of the year. I caught up with Jake at the EASD conference. That is the European Association for the Study of Diabetes. The conference happened last week in Vienna. And because of my travel and Jake's schedule, this recording took place on September 16th. We are airing it on September 23rd. My conversation with Jake Leach right after this.
Jake Leach, welcome back to Diabetes Connections. Always great to talk to you and get caught up on all things Dexcom. How are you doing as we are talking? You're in Europe.
I am. Yeah. Thanks, Stacy. It's a pleasure to be here. And yeah, I'm in Europe at the EASD conference, biggest diabetes conference in Europe. Since we last talked, big development for you. You have been named CEO to take effect in the new year. Congratulations. And let me just start by asking, you've been at Dexcom for more than 20 years. Any thoughts on changes, goals, stay the course? I'd love to hear what goes through your mind when someone says, 'Oh, you're going to be the new CEO in January.' What's your move?
Yeah. No, thanks for that, Stacy. Very excited. As you mentioned, been at Dexcom a long time. And Kevin, our current CEO who's transitioning into our executive chairman, he and I have worked together for many years. We actually worked together at MiniMed before we worked at Dexcom. So we see a lot of things the same. So there's a lot of things that I will do or keep running the same as we've always done. Things like focusing on customers, patient first mentality, innovation-driven. So there's a lot that will remain the same. I think moving forward, there's just so much opportunity for CGM to make a difference around the globe. Dexcom has been focused in many different areas, but one of the areas I'd like us to spend more time on is looking at how our technology can make a benefit around the globe, more people in general. We've focused kind of on that higher end of the category, like the high-risk category, which is a super important part of our customer base, but there's a lot of people with type 2 that are just starting to get coverage for CGM, and we want to be there to help meet their needs when the time comes.
And a lot more to come, I am sure, in the next weeks and months as you take that role. But let's talk about what's happening at EASD. The announcement that I saw this morning was about smart basal. Can you talk to me a little bit about what that is and what that means?
Yeah, it's an exciting new feature that we've been working on for a little while. It's under review by the FDA and for a CE mark. And what it is, it's an algorithm-led technology that is built into G7 or will be built into G7 when we launch it. And it's designed to help both a healthcare provider and an individual with type 2 who's just either starting basal insulin or maybe they've been on basal insulin for a while and not really meeting their goals. The point of the algorithm is it uses CGM data as well as some of the input from the healthcare provider to really optimize a basal insulin dose. The standard of care today with basal insulin titration is there's a lot of back and forth between the physician and the patient trying to get to the right dose. They usually start based on the individual's weight and then they kind of incrementally increase the dose. This is a system that automatically analyzes what the dose should be for that individual to meet their fasting glucose target, and it just adjusts. And the clinical study we ran, most of the subjects got to their optimum basal dose within 30 days. So that's much faster than what typically happens out there, even when someone has a CGM, because they're using a more manual based titration to get to that correct basal dose.
So does that assume that the person is talking to their healthcare provider this whole time to help with the titration? Is the CGM giving them feedback that the person can kind of use on their own? I mean, you know, I come from the type 1 world where we're always making our own adjustments. Don't tell our doctors even though they know.
Yes. This one basically the physician orders, puts in a treatment plan into their Clarity system and then sends it to the user. It shows up in the user's mobile app, and then it's a guided therapy adjustment that happens every day. It recommends a new dose until it gets to the optimum dose for that particular individual. And so this is long acting insulin, one shot per day, trying to basically minimize hypoglycemia while ensuring they don't go hypoglycemic. So it is an automated process that the patient does give their own dose. But the physician can check in on it at any time and how things are going, but they don't have to. The system basically operates until you get to that optimal dose.
Yeah, that's great. I wasn't thinking, you know, it's hard to adjust, Jake, as you can imagine for somebody like me who doesn't even see their kid's CGM anymore. I'm trying to figure out how would that work? Of course, you just look at the phone.
Any use case for type 1 for this perhaps in the future? It doesn't sound like you've submitted for approval for that.
No, it's really this one's focused on for type 2 basal users. But we also at the conference talked about our new trend adjusted bolus calculator. The idea on that isn't new, that's been used quite frequently in insulin pumps. But if you look towards multiple daily injection users that are manually injecting, we wanted to build that technology right into the G7 app to make it simple to use. And so also as we see more and more smart pen integration, we believe this is a feature that could really benefit users that are using smart pens versus automated insulin delivery to really get to the best control they can. And one highlight is that as we've also started to bring in the meal detection and the meal logging that we just put into G7, you can kind of see how those all start to bridge together to become a pretty complete package when it comes to analyzing a meal, recommending a bolus, and then helping ensure that they get to their glycemic target.
Yeah, I want to talk more about that if we have time a little bit later. But I also want to ask you about pregnancy and type 1. Really interesting study looked at exercise before and after eating. And it looked like exercising before made more of a difference, which is not what we usually think for people with diabetes, right?
Yeah. I think it was basically just the importance. That study had some very interesting exercise activity as well as outcome data on using CGM during pregnancy and just ensuring that glucose is under control so that you have a proper weight. The babies were lower gestational weight, they weren't overweight, which we often see in gestational diabetes. The high weight of the baby tends to indicate that they were using a lot of that insulin so that the mother was insulin resistant. So yeah, it's definitely something that we're focused on expanding and bringing more awareness to the benefits of CGM in pregnancy.
Something else that came across my news feed recently was a correction or a recall that Dexcom had issued for G7 apps and One apps. This was about unexpected sensor failure. Can you talk a little bit about that?
Sure. Basically, anytime we detect a bug in our software, we do an analysis, a hazard analysis, to determine the risk of this particular bug. Most of the bugs are small and we fix them quickly. This particular one results in the app shutting off and then not potentially alerting a user. The chances of this happening are very small. But if a sensor failed in a certain way, that older version of the G7 app could just move into a sensor failed state and it wouldn't tell the user that the sensor failed. It would have it indicated on the screen, but it wouldn't alert them audibly. So they may still think that they're getting their alerts and alarms, but instead the app has actually stopped. The sensor stopped and the app is no longer receiving glucose information. So that could be a dangerous situation where you're not getting alerts even though you think you are, say you're sleeping. So in that situation, we fixed the bug very quickly and rolled out a new version. But we did require users to upgrade because of the potential, although very small, there was a potential risk there. Anytime we do something like that where we force the upgrade, it generally falls into the category of a field action which then is considered a recall. The way I characterize it, it's a little bit like a device regulation applied to software. Software is fixed and updated before it even gets notified and filed. But we have to follow the regulatory rules. And so that's how it works. Over time, we've had a number of these where we find something and say, 'Hey, we need to upgrade all of our users because we found this issue.' That basically happened in August of this year. We've already updated everybody to the newer version that doesn't have that issue, but it did just get posted.
Yeah. So if someone's listening and they're not sure, they just need to check that their software is up to date.
Yeah. And I believe we've actually forced the upgrade, so you can't be running an older version. No one should be concerned.
Got it. Before we get to my listener questions, I had another one for you, and I haven't seen this get too much play yet. Maybe by the time this episode comes out, it will have, but the FDA sent a letter recently advising on direct to consumer advertising. I don't know if Dexcom was one of the companies that got a letter. It was about a hundred letters and most of this seemed to be focused on compounded companies that are sending crazy ads for GLP-1s and things like that. But you all do a lot of advertising direct to consumers. Is this going to be an issue? Have you seen this FDA letter? Is this something on your radar at all? Because it does seem to be, I've been a health reporter since the 90s and I don't see a lot of chatter about direct to consumer advertising since they made it legal in the late 90s. It's just very interesting to me.
Yeah. I think one of the unique differences here is when it comes to drugs, pharmaceuticals that have side effects, there's a lot of rules around how that gets advertised, right? And what the potential side effects could be. With CGM, the only real side effect is better glucose. So no. But anyway, we are aware of that letter, but I don't think it necessarily applies to us. But we do do a lot of direct to consumer advertising because we've often tried to make sure that the awareness around CGM is there. And as this category of CGM continues to grow and more people have insurance coverage for CGM, we want to make sure people are aware that the technology exists and they should ask their doctor about it if they haven't already been recommended a CGM. So that is why we do so much direct to consumer. And now with Stelo, we've also been advertising that product as well to ensure people know that it's available and it's over the counter.
Excellent. All right, listener questions for you. Karen has a question that is near and dear to my heart. Been asking about the Follow app for a very long time. Interesting. Can the Follow app have alert profiles? Every day I'm having to change my alarm setting twice. It would be easier on parents to have one less thing to do. I will fold that into an overall question. Any changes coming for the Follow app?
Yeah, if you've noticed, we've made a number of updates to Follow in the last 6 months and we have quite a few more coming. Profiles is definitely one on the short list of things to do because we know that having those types of profiles can add convenience for folks.
