B (4:42)

Did you hear the pod drop?

A (4:44)

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.

B (4:52)

I am, yeah. Thanks Stacey. It's a pleasure to be here. And yeah, I'm in Europe at the EASD conference, biggest diabetes conference in Europe.

A (5:02)

Since we last talked. A 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, 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, you know, what's your move?

B (5:27)

Yeah, no, thank. Thanks for that, Stacey. Very excited. As you mentioned, benetexcom a long time. And you know 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, you know, focusing on customers, patient first mentality, innovation driven. So there's a lot 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 that I'd like to spend more time on is looking at how our technology can make a benefit around the globe. More people in general, we've been focused kind of on that higher end of the category, like the high risk category, which is 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.

A (6:35)

And a lot more to come I am sure in the next weeks and months on 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 Basil, can you talk to me a little bit about what that is, what that means?

B (6:48)

Yeah, it's a exciting new feature that we've been working on for a little while. It's under review by the FDA and for a C mark. And what it is 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 a individual 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, 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. In, you know, the clinical study we ran, most of the subjects got to their optimum basal dose within 30 days. So that's much, much faster than what typically happens out there, even when someone has a cgm because they're using kind of more manual based titration to get to that correct basal dose.

A (8:09)

So does that assume that this 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 one world where we're always, we're making our own adjustments. Don't tell our doctors, even though they know.

B (8:25)

Yes, this, this one's basically the physician orders, basically puts in a, a treatment plan into their clarity system and then sends it to the user and 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 hyperglycemia while ensuring they don't go hypoglycemic. So it is a 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.

A (9:09)

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 kids CGM anymore, trying to figure out like, how would that work? Of course, you just look at the phone.

B (9:17)

Yeah, exactly.

A (9:19)

Any use case for type one for this perhaps in the future. Doesn't sound like you've submitted for approval for that.

B (9:25)

No, it's really, this one's focused on for type 2 basal users, but we also at the Conference talked about our new. It's a basically trend adjusted Volus 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, you know, 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, 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, the meal level logging that we do for, 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.

A (10:24)

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. One really interesting study looked at exercise before and after eating, and it looked like before exercising before made more of a difference, which is not what we usually think for people with diabetes. Right?

B (10:41)

Yeah, I think it was basically just the importance. That study had some very interesting kind of 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. You know, the babies were lower gestational weight or they weren't, 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 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 and pregnancy.

A (11:19)

Something else that came across my newsfeed 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?

B (11:34)

Sure. Basically, anytime we detect a bug in our software, we do an analysis, you know, kind of hazard analysis. Okay, what's the risk of this particular bug? And 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. And 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 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 is actually stopped, the sensor stopped, and the app is no longer receiving glucose information. So that could be, as you could imagine, that could be a dangerous situation where you're not getting alerts even though you think you are, so 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. It's the way I characterize it. It's a little bit like a device, older hardware device regulation applied to software. The software, it's fixed and updated before it even gets notified and filed. But it is. We have to follow kind of the regulatory rules. And so that's. That's how it works. And so there's been, you know, over time, we. We've had a number of these where we find something. We say, hey, we need to upgrade all of our users, because we found this issue. And so that was basically. That happened in August of this year. We've already updated everybody to the newer version that doesn't have that issue. But yeah, that did just get posted.

A (13:19)

Yeah. So. And if someone's listening and they're not sure, they just need to check that their software's up to date.

B (13:24)

Yeah. And I believe we've actually, we forced the upgrade, so you can't be running an older version. So you got it. No one should be concerned.

A (13:32)

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, you know, like compounded pharmacies that are sending crazy ads for Ozempic and things like that, like Hims and hers and that kind of stuff. 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 in, you know, I've been a health reporter since the 90s and I don't, 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, it's very interesting to me.

B (14:20)

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. With cgm, the only real side effect is better glucose. So. So no. But anyway, the. We. I'm 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 basically we've often tried to make sure that the awareness around CGM is there. And as the 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, that is why we do so much direct to consumer.

A (15:09)

Yeah.

B (15:09)

And now with Stella, we've also been advertising that product as well. And sure people know that's available and it's over the counter.

A (15:16)

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?

B (15:36)

Yeah. If you've noticed, we've made a number of updates to follow in the last six 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.

A (15:50)

Jake, I have not noticed because I was kicked off the Follow app when my son was a senior in high school. Mutual decision. So let me ask you about those changes and let me also ask if you haven't yet done this, one of the things that I thought would be a good upgrade was you have the website now that you can see if there are any issues with servers. Right. Sometimes the server is not working in your area and people do not know. And honestly, you know, people don't know to go to that website. Any consideration of some kind of push notification?

B (16:19)

So we've, we do actually have push notifications built in to follow. We have the ability if it's a major outage. Actually, frankly a lot of this came out of some of the learnings from some of the challenges we've had many years ago with the system was when we had a major outage. The one time we did it was hard for us to notify users of that. We had things like our Facebook page and other. But coming out of that, one of the big learnings was we need to make sure we can notify people. So if we have a large outage that extends for a period of time, we can send everybody that notification. Generally our track record over the last couple of years is been the things are solved extremely quickly. On Follow, we haven't had any major downtime, but if we did we would send that notification. But I think the point around, even if it's a temporary issue, we could potentially build that into the notification system. Have you ever done we've only kind of been ready to hit the trigger on those, but with some sort of a major outage. But knock on wood, hopefully that doesn't occur.

A (17:13)

Have you ever sent out a system.

B (17:15)

Wide push notification for Follow we not system wide, but we have sent out push notifications. I'll give you some examples of for users that need to upgrade their apps and when we're doing a forced upgrade, there's a point in time where your old one's not going to work. So we have done quite a few of the notifications to users around that. We also basically started sending notifications to users when we recognize that, say they're having a trouble pairing their device. We actually can detect that and then send a notification that says here's some tips on how to, how to, you know, make your phone work better. So we're going to keep doing more of that because it really helps users in the moment they get the right information at the right time. So part of the user experience journey that we want to keep making the journey enhanced and better. That's part of it.

A (17:58)

Okay, so when I ever whenever I ask my listeners about questions for you in the past, we've got a lot of direct to watch, a lot of Omnipod, a lot of when is this stuff going to work together? You know, a lot of adhesive questions in the past. But Jake, this time around, almost all of the comments were please tell him that we are not really satisfied with G7 issues and I want to read you one and I always tell my listeners this and you know, Benny's been using this product for a long time. We don't have these issues. So like follow. It's not front of mind for me, but I'm going to read you this one that comes from Jeffrey, who I've known for a long time and he said, I have another one with G7 issues. I get it. Products fail, but I had seven failures in the last 90 days and the customer experience for trying to get a replacement is absolutely wild. I've started keeping the end of the box with the lot number on it. Since it's now required, I should be able to make three taps in the app to report a sensor issue and request a replacement. Or even better, a sensor failure should call home to Dexcom, let them know I had a failure and ship out a replacement. What's the response here? I'm sure you're aware of these issues. You keep track of sensor failures on your end.

B (19:02)

Yeah, I think that sounds like a large number. I'd be interested to find out what type of failure he's having. I would be surprised if they're all the same type of issue. But one thing though, to his Jeffrey's point there around the, you know, replacement experience, it's something we've been focused on because we've heard that from a number of users. And you know, one of the things we did was we. We started implementing some new policies around sensor replacements and it was really trying to manage some of the issues. We were seeing where folks were requesting sensors that either they. They weren't customers, there was. There was a little bit of fraud going on. So we're trying to resolve some of that and I think what it has caused is some. Some impacts within the community in terms of messaging that we need to make sure is correct. So we've been focused on that training our team. The other thing too is his point around you should be able to request it in the app. There is the page where you can request a sensor replacement in the app, but we've been working on making that easier to use. One of the things about it is if the information for your account isn't entered exactly correctly, it can basically not go through. And so we get. We want to improve that experience because I agree that it should be very. If a sensor fails, that's on us. It should be very simple for someone to get their replacement. And so it's a priority for me and for the team here to make sure we improve that experience for users.

A (20:21)

Got it. Okay. So Chris wanted to know, and I'll tell you, Jake, I don't. I'm not following this one entirely, but you May, he says in explaining the issue with G7 sensors sometimes not starting when they are inserted and people using a magnet to get the sensors to start. You, he says, went on a different podcast and talked about the issue is the sensor not passing its internal startup checks. But when the magnet was used to have the sensor try again, it is passing on the second try and starting the sensor. Chris says that doesn't make any sense to me. A diagnostic failure should result in the sensor declaring itself failed and the magnet shouldn't do anything. What is that about?

B (20:58)

He's going deep on the engineering. Basically that check is. It's a battery voltage check to determine whether battery voltage is good and then it starts up. And so this one, what happens is when it first gets deployed, that battery voltage is just barely below where we want it and it doesn't start up. And so when you do the magnet swipe a second time, it does a second check and starts up. It's not an issue with the quality of the product, it's just that particular battery didn't pass that check. And so that's what explains it. It's not a kind of measurement accuracy, anything like that.

A (21:30)

Wow. Okay. You know we have a very great.

B (21:32)

You know, I was very impressed with the community who figured that out how to, how to do that. We didn't actually even know about it. We knew that that unit failed for a battery check, but then when they swipe it again, it tended to, tended to work.

A (21:44)

This you, they, they can do anything. They are unbelievably resourceful. The 15 day sensor, where are we in that? And then there was also a concern about replacements and insurance companies, you know, only giving people obviously a 15 day sensor. You're going to get fewer sensors for the year. So people are really concerned about their allotment failures and trying to replace those. So a couple of questions there. Sorry.

B (22:08)

Yeah, no problem. So 15 day, we're on the verge of launch. We've got, we're starting to use it in our community of warriors so that they can get access to it and basically start generating excitement around the launch and some the media assets and things we want to use. So it's kind of like the limited launch within that community and then we'll bring it out to the broad community here shortly. So it's. Yeah, it's it. We're basically building inventories, getting ready for launch. These, these days when Dexcom launches a new product, it's not like it used to be. We have to have a really significant amount of this product. In inventory to be able to launch because we don't want anybody to run into a shortage. We want that, that changeover to be extremely smooth for, for users and for their healthcare providers. So that's, that's important. On the other side for insurance companies, I think for sensors, it's really around. If you have an issue, we need to be able to replace your sensor. And that's going to happen. A 15 day sensor, the vast majority will last 15 days, but you may have a few that don't. And so we want to be able to replace that. So we've also been working with our team to make sure that they understand on the 15 day sensors as well as the 10 days that that replacement experience when a sensor doesn't last needs to be perfect for a user. And I think just in general in sensor technology, I get asked this question all the time around sensor survival and we strive to develop the technology to the point where it'll last as long. You know, all sensors last 15 days. But we all know things happen in life. Sensor adhesive starts to come off, sometimes the sensor probe stops detecting glucose accurately and we say, okay, it's no longer good. We want to need to switch it out. So that, that's part of I think CGM technology in general. And so our goal then is when sensors don't last, the experience for replacements needs to be best possible. And so we're going to continue to work on that.

A (23:46)

Any plans for G7 or Dexcom CGMs that are meant for people who dose insulin to ever go over the counter like Stello?

B (23:54)

It's a good question. If you actually outside of the United states there are RCGMs, G7, Dexcom One Plus. They are available over the counter without prescription. But in the US it is a prescription device. It's really focused on because insurance coverage is there for folks. That's the important part. And there's insulin involved. So there is a prescription at this point in time we haven't, haven't really looked into that in terms of expanding it, but it could be something the possibility.

A (24:21)

Yeah. And then one of the questions I got in the group was from a pharmacist who assists her 90 year old patient with her G7 insertion because of her hand strength or lack thereof. And I'm talking to more and more people about aging with type one is hand strength. I mean my God, that's remarkable at age 90, right, to be using the technology and hopefully for many more years. And any consideration for things like that as you move forward to Next iterations.

B (24:47)

Yeah, it is. It's actually we have design specs around the force it takes to both open the product as well as to pull it. And so we take a look at those, make sure that they're applicable for everybody. But we've. That was very conscious around the applicator design and the packaging design.

A (25:02)

Excellent. Just one more question about the G7. I mean, I don't know if you can share this, Jake, but there is this suspicion, and I'll just call it that among the community, that the G7 doesn't, quote, work as well as the G6. In my group, I got a lot of people said, I don't want to change. I'm going to keep the G6 as long as I possibly can. You keep track of these things. Is there any demonstrable difference in terms of sensor failure, connectivity, things like that?

B (25:25)

Overall, there's not. I think certainly when it comes to accuracy and reliability, there isn't, isn't a difference. We don't see that. I have seen users that have used G6, they've had occasional issue with the G6 sensor. They moved to a G7, and then if they do have an issue early on, often it's kind of equated to the G7. But what I will say is that in some of the connectivity to closed loop systems, the G7 has a different level of connectivity. It's designed to connect to three devices. G6 only connected to two. So there are some differences there. And one of the things we found is as we worked with our insulin pump partners, there's improvements that they've been making and we've made on our side too, to improve the reliability of the Bluetooth connection. Because that's something that, you know, we saw after, after the launch of G7. And we've made several enhancements as our partners have too. And I think there are still some coming on the insulin pump side to improve connectivity. That's the, that's the one I hear the most in terms of the different, one of the differences.

A (26:20)

All right, and then my last question, Jake, I asked you about CEO that happens in January. What's your first move? Are you cleaning out Kevin's stuff? Moving all the pictures? Are you taking? Are you. Is there something in the back of your mind that you really want to get done?

B (26:33)

You know, I'm planning to meet with a lot of our teams around the world. I already do that. But there'll be a new emphasis on that, making sure I get out and see all of our teams and learn everything I can about the different markets you operate in all around the world because healthcare is different in many different countries. And it's really important for us to have, you know, strong knowledge about how things actually happen on the ground and not, you know, just look at it all from a US Perspective.

A (26:58)

Well, congrats again and thanks for coming on the show as often as you do. I hope that continues. I really appreciate Dexcom's responsiveness and openness, even when the, you know, the questions aren't exactly what I'm sure you'd like to hear, but they are honest and I appreciate your response. Jake, as always, thanks for joining me.

B (27:13)

Yeah, it was a pleasure to be here. Thanks, Stacy, as always. And yeah, we'll keep doing this.

A (27:22)

More information in the show notes I will link everything up. Every episode has its own homepage over@diabetes-connections.com and the questions I ask from listeners come from our Facebook group, Diabetes Connections the Group. But you can always reach out, let me know your concerns, what you'd like me to ask next time, or for any of the tech companies. My email is stacyiabetes-connections.com and before we go, Shanah Tobah A Happy New Year on this first day of Rosh Hashanah, the beginning of the high holy days for the Jewish community. Thank you to my editor, John Buchenis from Audio Editing Solutions, and thank you so much for listening. 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. Diabetes doesn't always have to interrupt your day. Dexcom G7, a continuous glucose monitoring system, sends your glucose numbers to your phone or receiver. Know where you are and where you're headed without finger sticks and without interruptions. Dexcom G7 is the most accurate CGM and it's covered by Medicare. Learn more go to diabetes-connections.com and and click on the Dexcom logo. Finger sticks required. If symptoms or expectations do not match readings. See User Guide for instructions. Data on file must meet coverage criteria. For full prescribing information on risks and benefits, visit dexcom.com.