Taking Control Of Your Diabetes® - The Podcast!

Hello everybody and welcome to this edition of the Taking Control of Your Diabetes podcast. I am one of your hosts, Dr. Jeremy Pettis, joined as always with my good friend and colleague Steve Edelman.
And if you're just tuning in, um, Steve and I are both endocrinologists. We work at University of California San Diego. We both have type 1 diabetes since we were 15. Steve just about 20 years after me. And we both work at Taking Control of Your Diabetes, which just celebrated on Friday our 30th anniversary of Steve basically creating this wonderful organization. So, we have a very special podcast today and a very special um guest. So, what you might not know is that our TCOYD office here in San Diego is maybe half a mile from Dexcom. So we literally, Steve and I and especially Steve, have been very close with uh Dexcom over the years. The evolution of not just Dexcom but you know sensors in general, how they've been made, the you know the accuracy, um the clinical use of them is something that we should talk about. This is such a cornerstone of all diabetes care now, but it didn't used to be that way. So we have who better of a guest than uh recently appointed CEO of Dexcom, Jake Leach. Uh so Jake, say hi. Tell us a little bit about yourself and then I thought we'd go through the history.
Of course. Yeah, it's a pleasure to be here with you guys and congrats on the 30-year milestone. That's really incredible. Um so yeah, uh excited to be here. Uh Jake Leach, um I've actually been a part of Dexcom for uh 21 years. Uh started as one of the initial engineers working on the sensing system and um has been part of just an incredible development of technology uh and patient impact, clinical data, all the things that um we've done over the years um has always kind of really been focused on the idea of the user experience, making sure users are getting the most out of the technology. But I just have to say the growth and the opportunity that CGM has to impact the world is just not something I think we contemplated when we first started. We were really just trying to solve this hard problem of putting a glucose sensor under the skin and accurately measuring glucose. Uh and that was just it was an exciting engineering project. But then as we learned more and the technology improved, we started to see this tremendous impact that CGM can have. Um starting with type 1 diabetes, but through the whole spectrum through pre-diabetes and beyond.
Yeah. Whoever would thought that it'd be now standard of care for people with type two on insulin and pretty soon it's going to be standard of care for all type twos no matter what they're on because you just mentioned the importance of the feedback you get from looking at it for people with pre-diabetes. But we were just talking before we started the podcast for the listeners and viewers that uh Dexcom started off as an implantable sensor and then quickly transitioned to the subcutaneous patch. And you were with Dexcom the whole way and you told me that you were with Medtronic for 8 years before that.
Correct. I was. Yeah, I was actually with MiniMed up in Los Angeles. Uh we were focused on insulin pumps and then we started building glucose sensors and so it was my first job out of college. I was uh working in the chemistry lab actually as an intern before I even graduated. Uh and I didn't really know a lot about diabetes. Um, but I just needed uh, you know, the best internship I could find and that was at MiniMed and then it turned into an engineering job after uh, I graduated. Uh, and then went into um, the engineering group working on sensors. Uh, and then this little company called Dexcom came around and they said, "Hey, we got this really cool technology. We're trying to implant glucose sensors continuously measuring glucose under the skin for 6 to 12 months." Uh, and I was really intrigued by it. Uh, and I went down to Dexcom here in San Diego where it was founded. Uh, and the company was about 5 years old at this point. Didn't have any products in the market, but was a really incredible engineering team. Uh, and really focused on uh, this idea of a continuous sensor. Uh I joined thinking I was going to be working on these implants and then we rapidly at the time pivoted to the um architecture with the sensor under the probe and the patch and making it more of a subcutaneous disposable sensor, uh which has basically been our architecture since uh the very first product that we launched.
What year was that when that was?
2004 when I joined. And Steve you said you were involved in those clinical trials which I actually didn't know, so that was a good story.
Yeah, they were in the cadaver lab and no one should ever donate their body to science and uh no, it was a great experience and I think it was a part of a learning curve for Dexcom. They realize that the body just gunks up anything and it turns out to be a win-win-win with the transcutaneous sensors and Dexcom's come such a long way and I think the G7 is such a major advance over the G5.
Well then tell us that history. So um implanted these devices didn't really work that great. You know you pivot to subcutaneous sensors. What was the first sensor on the market? When did that happen?
So uh fantastic question. 2006, uh March of 2006, we got approval for the STS 3-Day. And what that basically was is we taken all the learnings from the implant sensor which in general we had got about 70% of those implants to work reliably but then the other 30% uh we just we couldn't quite get them to accurately measure glucose for the long run and so we kind of said that's probably not going to work out as a product especially an implant. Uh also the other thing too is just the engineering time it would take to determine if a 12-month implant was going to work for 12 months.
It is 12 months.
Yeah. With these short-term sensors, we started doing these turnaround studies that were three days long. We could do a study, we could learn from it, and then we could start another study the next week. And so the rapid evolution of the technology really occurred when we changed the architecture to something that was much shorter duration. Uh and so that first product, yeah, this STS 3-Day was there was so many things in that product that it was just we had to figure out how to do it as fast as possible. We had this receiver device. Um funny note about these receivers. So this is before smartphones had Bluetooth. Before smartphones existed, we had the display device kind of looked like a finger stick meter that showed you your glucose. When we first started building those, we actually took Motorola pagers and we took the electronics out of them and we developed our own version of the circuitry that could read the readings from our sensory implant and put those inside these Motorola pagers because we didn't have an engineer that could design a new whole housing. And we're also we were a scrappy little startup trying to save money. So yeah, the original receivers that people used in some of the studies look like a pager. Um, and then we went into a new design sequence and we built this oval-shaped uh receiver. Some people called it the Tylenol just because it was reminiscent of a round Tylenol capsule. Uh, and so that product in 2006 we launched it and it worked well for some people and others it really um wasn't accurately measuring glucose. Um, I think the MARD on that product was about 26%. So that really means that it was within 26% of the reference on average. So it could really tell you if your glucose was changing, whether it was going up or down, but it was not accurate enough to make a lot of treatment decisions.
Did you use that sensor, Steve?
Yeah, I was on the short-term sensor, the 3-day, the little Tylenol pill, and I remember clearly that it may not have been as accurate as I would have wanted, but you have to remember where I was coming from. Pricking my finger 10 to 12 times a day. So, I just thought it was incredible that I could just put the sensor on and get a blood sugar every 5 minutes. And you know what? I did double check with a finger check cuz I was used to doing that. It worked pretty well, I would say, the majority of the time. And for me, it was the beginning of continuous glucose monitoring. It was amazing. So, yeah, you have to remember where people were coming from. Nowadays, people get diagnosed like last week and they're so freaking spoiled. You know, they get put on a CGM in 24 hours.
Well, you know, I was thinking my first experience was in 2010-ish and you with the 7 Plus, which um you know, was still kind of like the oval looking receiver. And how long did that sensor last?
So, it was a... So, we started with the STS 3-Day, which by the way stood for Short Term Sensor. That's what when the engineers get the name of the product, that's what we, that was our marketing. Uh and then we did a 7 which was basically extending the wear life to 7 days. Uh and then we did a 7 Plus which was taking a bunch of feedback from users on uh the performance of the product and also the user interface of the receiver. Uh and so we added some uh enhancements there. So 7 Plus was a really nice upgrade from 7 and it was at the time a 7-day sensor and no one had really done at that point in time these subcutaneous um type products like you know the infusion cannulas used for insulin pumps was one of the things that we looked at. No one had done anything more than three days and I remember just sitting around going, "Why don't let's try and make it last a week, you know a week seven days, you know, let's try it." And uh turns out it worked well.
Yeah, so I was telling the story before this that it was actually when I first met Steve and I was in my internal medicine residency and I was thinking I wanted to do cardiology mostly because I had massive student loans and you know endocrinologists don't make that much. And I met Steve and he said, "You know, you have type one," and we chatted for a while and he was like, "You know, are you on a CGM?" And I literally said, "You know, what is that?" And he about lost his mind and then told me all the stuff that was going on. And honestly, I had no idea that, you know, sensors were happening, updates and pumps were a little bit behind that. But I kind of went through my medical training feeling like type 1 diabetes was stagnant. You know, there wasn't much going on. It wasn't an exciting area. My care had not changed for a decade. At least yours had like multiple decades. So that was a big reason for me to actually go into endocrinology. Like there's actually stuff happening and stuff happening here in San Diego. And so I got on the 7 Plus, but I think it's also interesting that um to get it prescribed and to get it covered was just a nightmare. I mean, first of all, I had to go see um a physician who didn't know what it was. Um it was tough to get covered. They gave me this huge log book to fill out, you know, times that I had, you know, blood sugars less than 50 to kind of justify getting it. And I'm saying this because um that obviously has changed. Like when these sensors first came out, I think they were viewed as like they're kind of niche. They're like, you know, like you don't really need that information. And actually on the medical side, it was very much um "patients shouldn't have this information." Too much information. They're going to be looking at their glucose all the time. Oh my gosh, they're going to be adjusting their own insulin doses. Heaven forbid. Um and they're going to have car crashes and all these things. And we didn't know at the time how that would pan out. Of course, we know now that CGM helps people stay safe and less hypoglycemia and all these kinds of things. So, what was the company's or your feeling when these products first launched? I guess one from kind of the technical side and two from the headwind you were facing I suppose in diabetes care.
Yeah, it um I remember vividly the day that we um unveiled some internally in the company unveiled some clinical data that just basically when we saw it we were like "we got it" and it was a study where we blinded the sensors for uh a week. So people wore multiple sensors and the data was blinded so they didn't get to see it. They just knew they were wearing a continuous glucose monitor. They had no idea what the data was. Uh and then we unblinded it and started showing them real time glucose data and the dramatic increase in time in range and the reductions of the hypos and the hypoglycemic events in just the matter of a couple days when you turned on the real-time data. And these... we didn't give them any education. We, you know, this is early days, these things, you know, we just cobbling them together. But when they got the real-time feedback and started um obviously adjusting their therapies and the food and everything they were doing, having data they'd never had before, this real-time glucose data, we knew that we this was going to work.
Study, is that what that was called? I remember seeing these slides, a bunch of them. But let me just say, Jake, that um that's one thing that drove me nuts with the Medtronic CGM, the 3-day blinded sensor. I was so adamantly against blinding data. And they said, "Well, you know, if a patient sees their number, they're going to change their behaviors and it's going to improve their numbers and we won't know what improved it." I said, "Well, there you go." And I remember debating Ian Blumer.
Well, and real quick, just for make sure people know, blinding means that people would wear these sensors, but they wouldn't see the numbers and they would have to take it to father or doctor to interpret, you know, and see their information and then tell them what to do. And that was kind of the initial use of this like as a way poke them in the eye so they can [see]. Um, and so there was a huge debate. We actually wrote several articles about it, blinded versus unblinded. And you know, our stance was always that blinding was like, you know, unethical even that like why not show people this information? But that was a huge debate. So sorry.
No, no, that's it. And I remember having to debate this issue. And there's there's one paper uh that's in the medical literature about the first recorded uh you know, passing away of a type one called "Dead-in-Bed Syndrome." That's where that happens. I don't want to get too morbid on the podcast here, but he was wearing a blinded CGM and sure enough they documented him going down and his body tried to fight back a little bit. Blood sugar came up a little bit and then he passed away. So I mean that's the the ultimate and if it was unblinding, if he saw the information, he would have been alerted to it and you know like that's just crazy.
Yeah. Well, anyway, it you know what, it's all part of the evolution. And you're right, Jeremy, people were writing, "Oh, it's way too much information for patients." And that actually occurred when finger stick uh Chemstrips came out from urine testing. They thought about blinding the meters, the little fingerstick devices. So I remember Jay Skyler, you know, kind of a big leader in diabetes for so many decades and he wrote a op-ed against that, you know, so it's just tough to change the way we do things in medicine.
It took it definitely took a while and I think I remember early days uh to Jeremy your point around access and how hard it was to get a CGM. I had a friend that uh had actually worked with me at Dexcom in some of the early days and he'd gone on to do some other medical technology projects and he was diagnosed with type one and he called me and he said, "Look, my doctor's not going to give me a Dexcom till I prove that I have hypoglycemic problems. So, I'm going to go and record a bunch of hypoglycemic data, but I would like to have a CGM. Can you just get me one for now until I get my insurance to pay for one?" And I was like, "Of course, I got him one." Uh, but just the fact that he had to go through this hoop of "I'm going to prove that I have hypoglycemia and have to document it" to be able to get the tool he needs. I mean, it was crazy.
That's exactly what I had to do. And of course, I made up a bunch of numbers, you know, like, "Well, yep, I was 50 yesterday and 45." I gave him different colored pens and crayons so it wouldn't look the same. I mean, on the flip side, like if you want me to have a severe hypoglycemic episode right now, I could, you know, like why should I have to force myself to to do that to get this therapy? But anyways, all right. So this was, you know, early days and a lot of work to be done. And honestly, Steve, I think like a big thanks to Steve. I would say outside of Dexcom employees, maybe nobody as important as Steve Edelman is like really being a voice for getting CGM going and kind of a advocate for that. And because um we're talking about it like it was these old crazy days, but it kind of was in the sense that like this was um a technology that was not quickly adopted and here we are just not being able to live without it now.
Yeah. Well, thank you for that. But, you know, having type one myself, I think I really could realize the importance of it probably more than someone that doesn't have diabetes. So, so then I don't know, maybe catch us up, Jake, between, let's say, 2010 and now there's all these iterations, you know, G4, G5, G6, um, more clever naming, by the way. So, um, anything um jump out at you like in that evolution that like we should highlight?
You know, funny thing about the G's, we actually called, uh, the first product G1 and G2 and G3. And so G4 was internally we called it that as an engineering team but finally um the marketing team then adopted the engineering speak with G4. And so G4 was a huge product for us because it was the first um CGM that had the accuracy and performance. It was still calibrated. You still had calibrations to it but it really met the needs of a much broader population than say what 7 Plus uh did just because of some of the fiddle factor and some of the usability and the reliability of the product. And funny enough, G4 started out as mainly a manufacturing project in terms of how do we make sensors, you know, in a little bit more scalable way in terms of the way we put membranes on the sensor wire. And uh it turned out that the better we got at making the sensors, the better the performance we got out of them. Uh and we made some changes to the materials. It was a big leap and really the fundamental material stack that we use uh even on the G7 today, a lot of its roots trace back to that original G4 uh development. And that that product again it's still before we have smartphone integration but uh that along with access and insurance coverage people were really starting to listen to you know um the Steve Edelmans of the world around the advocacy and how this product works and uh insurance companies started paying for it and so those two things really started broadening the adoption of CGM, the better technology and the access, and it's really just from there it's grown and grown. G5 was a big advancement around smartphones.
The thing I remember about a couple things about the G4. First of all, it was a cooler looking receiver. It was like a square kind of a rectangle one. Um, versus the oval, which was pretty big and bulky. I mean, you had to calibrate it. We forget now that that was a thing, you know, like so twice a day, you had to actually enter a blood sugar. And then, you know, everybody wanted it to go to the smartphone. Everybody wanted it to go to the kind of the cloud that didn't exist yet. So you could get this little dock for the G4 which was like the initial Share right that you could plug it into like you know this dock at night and you know or or I guess whenever you weren't using it but primarily at night and it could go to people to kind of follow your blood sugar. So I remember that being kind of a big deal.
It was the Share cradle and we uh we developed it and it was the first time that a class three medical device which is basically like the highest level of oversight uh at the FDA for medical devices. These are things like heart valves and brain implants are all in that class three at the time. CGM was also in that category because they were still trying to figure out exactly how to treat the technology. It was the first time that type of class had ever been connected to a smartphone and it was very purposeful for us. We knew we wanted to get to full display on a smartphone. You don't have to carry your receiver device. Just everything on the smartphone because we knew we could do the remote monitoring, the convenience, all the computing power. But we knew we couldn't get there in one step. So we went and we did the cradle, which was the idea was you can charge your receiver, but it also pulls the information out of the receiver and puts it on your phone so it can go to the cloud so then loved ones could follow you. Uh and uh that technology we really actually only sold I think there was about 1,800 of those cradles that we sold because we quickly built the cradle technology right into that cool new receiver and so you didn't need the cradle. But I funny story, I remember when we first were started doing um uh clinical studies with that receiver cradle one of the kids that was wearing it was in college and he said, "Hey I love this thing. My mom really likes it because every time I plug it in the data suddenly populates on her phone and she knows what time I got home."
Yeah, that's the thing with Share, right? You know, it goes both ways like you know, people can see your blood sugars and um but yeah, so to me the next big thing was then the G6 losing calibrations, but it seems like you wanted to talk about G5. What stands out there?
So G5 was uh um the first time we connected the CGM directly to a smartphone and it was your as we call it in engineering speak "primary display." So uh there was no other device and the big thing around that was you had to prove that you could reliably do the glucose alerts that alert users when their glucose is low or high, that you could really reliably do that on a smartphone and that was no small task. Uh and that so really was the big development of G5 was how do we ensure that the safety and effectiveness is in this product that is on really a platform that we don't totally control. Um iPhone at first and then Android quickly after that. And uh that I remember when we launched that product, we launched it globally all at the same time. Um actually September um 2015, we were at EASD and I got to stand on the stage like Steve Jobs and talk all about this new technology. Uh and uh it really was the beginning of the unlocking the power of what a smartphone can do for users that have their device connected to it. Um, and in the development of that product, we made a very conscious decision that's worked really well over time, which was the idea was the device on your body, the patch, the wearable, it is where all the intelligence is for glucose. And so what that allows you to do is it allows your your CGM on the Dexcom to connect to your smartphone to an insulin pump for automated insulin delivery because we also were doing insulin pump integrations at the time, starting to get towards closed loop. So we knew that was important, but people still wanted Share/Follow. And then ultimately it led to our ability to connect directly to the Apple Watch. So people have that extra convenience of uh just having the glucose on your watch and not having to have your phone with you. That was all really foundationally developed in the G5 days which was you know way before um you know the smartwatch.
Yeah. And I remember this too because this was back in the day. This was pre-COVID still. Um and TCOYD, you know, we would travel around the country and we would put on, you know, uh workshops, in-person conferences, a Saturday in Kansas City or, you know, different cities like we did one a month. And this was such a big issue. Again, something that we take for granted now, your CGM, of course, it goes to your phone. But people were like, "Why doesn't this like go to my phone?" People were mad about it. And you know, I remember thinking that yes, there did seem to be this discrepancy between like how quickly smartphones and things were moving and kind of how relatively slow it was to connect with it a lot because of these regulations and the clinical trials and things that were required. So I don't know that seems interesting to me then that must be something you struggle with as a company is like yes we can do this tomorrow but like we need to go through the proper steps and things like that.
Yeah. The... I remember even before people were getting angry they couldn't connect to their iPhone, we'd ask if you remember how many of you have a CGM? And out of maybe 200 type ones maybe 15%. And now you couldn't even see the hands of the type ones that don't have one, you folks on MDI they all have one in standard of care now. But what I remember too is the auto inserter answer my question you always do that you chime in with a second question yeah I had a question. Does technology kind of interface?
No, no, it's I thought that was a comment. Sorry. No, it actually um does you guys remember the Blackberries?
So, that was the smartphone before there was the iPhone, right? Uh and we actually had a project working on trying to integrate with one of those and the Bluetooth required so much battery power to communicate with the phone that we ended up with these wearables that were just too big. And so we really went and we talked to Apple, we talked to Samsung and and even Sony at the time was making Android phones. We were advocating for a lower power connection to the phones so that we could build a wearable that worked. And ultimately Apple was the first to adopt what's called Low Energy Bluetooth and that was the unlock for for connectivity to the smartphones because then you could do it at a low power and your battery could be small and the wearable could be small. But it was I mean I never envisioned that as you know someone who's involved in CGM development that I'd be going around to Samsung and Korea and going up to Cupertino to meet with Apple to try and convince them to do this. Uh and I think there were others doing it the same at the same time for other technologies or other industries and it was a big unlock for us is when Apple adopted that Low Energy Bluetooth.
Yeah. I would just say yeah what like a cool you know progression of things and I don't know what sales and use looked like but it must be you know this kind of like steep curve of all these things coming together that the technology is getting better so it's more accurate people trust it sudden like eventually you don't have to use your meter anymore because it's accurate enough by the FDA you can actually use it to control like insulin pumps and things and you know as these uses become more and more and more and people kind of have adopted it insurance companies you cover it. All these things took time to come together. But again, now we are here um where it's just such a standard of care and Dexcom is you know been a huge leader in this. So let's jump forward to today's sensor and then you know want to talk about what's next, what's coming with um with Dexcom. So um we unfortunately had to jump over the G6 again for me that was huge getting rid of calibrations that was like just like monumental in terms of you know I don't poke my finger at all like ever. Anyways, I'll just say one quick thing, last thing about the development. The autoinserter was kind of a nice feature. You know, the the guillotine, the G6, you know, boom. And uh, of course, that's so much better with the G7. But, you know, that was nice cuz I had no problem with the G4 pushing that thing in, but some people did, you know. So, anyway, we did we we had a video that we used uh to as a motivational tool and really to help engineers understand what we were trying to do when we were developing the auto applicator. And it was a a video that was on YouTube of a mom chasing a little girl around holding an applicator trying to hold her down to get the sensor in. And she was, you know, crying and she's running around. Her mom's chasing her and I said, "This is the problem we're trying to solve, team."
Yeah. And the G4, the previous ones with that giant like syringe. I mean, it didn't look like fun. You know, you're like pushing this needle into you. So, yeah. Going to the applicator and it freed up where you could put it. I know you like to put it like all over your—
Yeah. Yeah. Yeah. I put them— He's got like 17 on right now. Favorite sensor spot. Um, all right. So, we get to um G7 and you know, I want to talk about obviously there's some there's there's many advantages to it, but there has been at least like anecdotally people having issues with it. And for me, I would say it's like one-third one-third like a third of my patients are like, you know, this is a superior product. I love it compared to the G6. It's a it's a huge positive. The other third in the middle are kind of like, you know, there's some bugs, there's some issues like but it's no big deal. And there is a third or so in my like opinion um that they're losing connectivity or there's accuracy issues and they just they can't wear it. So what what is this issue? Um how do you quantify it? What's Dexcom's kind of opinion approach and all that to it?
Yeah, it's super important because if you think about uh user experience and and um you know CGM is such an important part of managing diabetes for so many people uh that we are very focused on you know making enhancements every generation we've made the product more accurate more reliable uh but as we've seen larger and larger populations of users we we learn lots uh you know one of the things we we pride ourselves in is listening to users taking the feedback and you know as we've scaled G7 as you mentioned kind of like the large um volume of new people using CGM. Uh, you know, we've had certain struggles in trying to ensure we could build enough products. You know, towards the end of last year, beginning of this year, we had some supply shortages. Um, we had some deployment reliability problems that started kind of earlier this year with G7 that I think really amplified some of the frustrations out there. Uh, and we were very aware of it. We're working super hard to fix it. Uh, and at the scale we operate at, um, there were, you know, people were having those experiences and getting those sensors. And so we spent a lot of time focusing on how do we make this system as reliable as possible. Uh and so there there definitely have users have experienced some challenges. Um there's as you mentioned there's lots of users having fantastic experience. But our focus right now is making sure we know everything that people run into and that we're on top of resolving it. Um, and then the other thing too I think that we've also learned again this that's idea of continuous learning is when people call in when they have an issue um you know how our tech support talks to users and manages that and make sure that they have a great experience and if they need a replacement they get the replacement and they get in the time frame. And I think we've made some mistakes in the way that we rolled out some of the support policies around um how we replace sensors uh and I think with good intent we always had the positive intent but just the way it came across and we learned a ton from that. And so one of the things I want, you know, users to know is that we will replace any sensor that doesn't work for you. There's no limit. There's no cap on those. Uh and the um and if you need a sensor overnight, we're going to ship it overnight. You know, I think that's also been something where users um have had hard time accessing sensors. "It's my last sensor. I've got an AID system." We understand how critical it is if you need a replacement to get for us to get it to you. And so that's something that I'm ensuring our teams are doing everything necessary to ensure people can get the sensor replacements they need.
Jake, I was going to ask, is the problem fixed? Now, I know that when I spoke to Kevin Sayer, your predecessor, he you know, he the way he described it to me was that they, you know, you're producing a ton of these things. You you bring in parts from a lot of different companies and and at some point some of them were defective and a bunch of sensors got out into the world. And that's part of the problem. I'm sure you know it 10x but the bottom line is, is the problem fixed or will pe people still be experiencing connectivity issues stuff?
It's a good question so and I'll I'll talk about the connectivity issues too um so uh when it comes to sensor deployment reliability we fixed it in the factories uh and so there are still very small and again we're talking about like small single-digit percentages of these problems but when it's more than it was before people feel it and it can be very frustrating, right? So we fixed it in the factory but then there are still sensors out there as we kind of move through the huge um volume of sensors um you know there's more more than um 4 million sensors are are used in a week right so we're talking about um you know we have over 3 million customers um and uh and growing and that doesn't even include the Stelo product which is also rapidly um expanding so we we're going we are getting through it very quickly um and you know CGM technology is not perfect and we know that uh every iteration of the technology we work to make it better. And so people uh can still have issues and the goal is to make sure if they do run into an issue that we've got the technology to replace it. But when it comes to those deployment issues, we're seeing it come down pretty dramatically. Our warranty um replacements are actually lower than they've been and they've been on this slow decline in the in terms of the number of sensors we have to replace basically because we've continued to improve the technology from where it started. Uh but there's still plenty of work for us to do uh to make this technology um further more reliable. We've got our 15-day product coming out soon which extends the wear life and so uh still lots to do uh when it comes to making making technology better.
Well, let's yeah, let's talk about kind of what's coming next and maybe starting with keeping with glucose for now. Um tell us, you know, about the 15-day and then what what's next? G8, you know, where is glucose sensing at Dexcom?
Yeah, it's uh incredibly exciting. Uh we've got our 15-day sensor which is the longest lasting CGM, the most accurate. It has a further enhancement on the the um performance of the the algorithm that's in the product. Uh and so we're launching that imminently here. Uh patients are going to start um we've already got some wearing it, but we'll have some more.
We're happy to beta test it for you.
Oh, anytime. I'm wearing one right now, actually.
Oh, good. Well, we always get frustrated when people without diabetes. We're glad you're wearing it, but then you know, like we have fellows that wear it and they're like, "Oh, I went up to 103." We're like, "Oh, you know, boohoo."
Yeah. Not only am I wearing it, but um I literally am using the receiver.
Oh wow. I I use the receiver myself.
Let me ask you, is it 15 and a half day or 15?
It's 15 and a half days. So it still has the grace period on it that allows you the convenience of changing your sensor when you um when it's convenient for you. Um so that it's uh 15 and a half days, the extended um performance. Um and then also there's a lot of software updates too that we're putting out. Uh so uh we're going to launch 15-day here shortly and then we're also going to shortly after that put out a a feature called Smart Basal. Uh because we have so many new users to CGM that are basal insulin users uh either initiating basal insulin or or someone who's trying to optimize their their daily dose of this long acting basal insulin.
This is mostly this is a type two type two population.
Yeah. And so that that is really around helping their physician and them titrate to a dose safely. You know, you don't want to experience hypoglycemia, but you want to get to that dose that really helps you keep those blood sugars lower. Uh and so that insulin algorithm technology is implemented in G7 uh as well as in the Clarity uh software.
What does that look like? They get a little ping. Hey, like you know consider increasing by one unit? Or how specific is it? Or does talk to your doctor? Like what does it do?
Yeah. So basically the physician uh enters in the order. So they kind of put in what's the starting dose that they want that patient to start at. What's the maximum dose allowed? And then how much do you want it to be able to increment uh per day and then uh basically puts that into Clarity and then that is sent to the user and it says it gives them a recommended dose for the first time and then you acknowledge that you took the dose. It has a reminder built in. The physicians really like this idea too where you could remind the user to take it.
That's cool. And then the CGM can help show the impact of of taking insulin versus not and then it just every day gives you a recommendation and get you the dose.
So needed. I mean, how many lectures have we given on, you know, like basal initiation, titration, and type two diabetes that we start at 10 units of Lantus, 10 units of Lantus or whatever it is, 6 months later, they come back, they're still on 10 units, and, you know, like it becomes—
Yeah. Maybe 12.
Yeah. Um, and there's you lose months, years sometimes of poor glycemic control without, you know, like really prompting people because people aren't used to um they're actually told not to adjust their medications most often. You know, "This is your dose of your blood pressure and your cholesterol medicine and under no circumstances are you to change this." But here we're saying with insulin, not only do you change it, but sometimes daily. And so it takes, you know, like some reminders and some comfort with those parameters for patients to take control of their diabetes.
Yeah. And you know, we we went to a UCSD faculty meeting today. One of the biggest issues is access. You know, patients can't get into clinic. And I think that's why this technology is even more important because they can't see their doctors, you know, every six months now. You know, maybe a quick note through the medical records, uh, you know, EMR at 3 months, but access has never been this bad. And I think post-COVID, there's lots of reasons for it. So, anything patients can do at home is perfect.
And it's motivating. I think, you know, with a um a patient that's taking an injection once a day, if it's not really, you know, helping them improve their glucose, uh, why, you know, why are they really going to want to do it? But if you show them with the CGM and the titration algorithm just how much better their glucose control is by taking the right amount of insulin, that's a real motivator to do it.
You're right. And we've been saying that forever, you know, with usually like finger sticks and now but with the CGM seeing it in real time. So, um, other things in the glucose area you wanted to talk about?
Yeah, we've we have our next-gen platform. Uh, so it's a new wearable. Uh, it's, uh, called G8. Uh, and, uh, it's smaller.
Could have guessed.
Going to guess, right? So creative.
We're keep keeping with the theme. Uh so it is and it is our eighth generation of sensor wearable technology and so much packed into it from a technology perspective. Very excited about um the new enhancements to uh basically glucose sensing. So we're we're shooting for again another huge improvement in accuracy, reliability, and performance. A lot of it's the um some of the the checks that we've built into the the hardware and its ability to check the sensors. Uh the size of the wearable is incredibly small. Uh and then we're also packing in some alternate uh analyte sensing, so not just glucose. And so we're working on a couple of different ones. Obviously ketones high in the list, uh but even things like lactate and potassium.
Oh, interesting. And so and there's there's a there's a whole host of analytes that since we've already got this amazing wearable on your body sensing glucose continuously, why not amplify the value by adding some other markers in there? Uh, and so that's that was one of our questions. That's amazing.
Yeah, it's it's I think it's really going to help us um as Dexcom really um further our impact um you know within diabetes but also in some of the other chronic diseases that are um so um you know synonymous with diabetes things like liver disease, um kidney disease, um you know even even heart disease. There's there's a lot we can do by better managing glucose and then also helping folks with some of those other markers.
And then G8 will have a better camera too, I'm guessing. It's a joke, Steve. Um, so, um, when do you think that might be like targeted?
It'll be a couple years. Yeah, we we're, um, you know, if you kind of look at our our technology iterations per generation, it's about every between 3 to 5 years, we come out with a new full new platform. And for us, what that really requires is not only the development of new technology, but also in manufacturing and how we make sensors. We do these large investments in wholesale changing of our um production facilities and everything to be able to make these new products. Uh and uh it's it's the exciting part about what we do is is bringing new technology that really furthers the impact uh that Dexcom has on people's lives.
And and how do you think I'm curious because as we add these analytes, do you imagine these would be separate products or like do you always have the CGM but you then you could choose well I also want potassium and ketones or it's all there and you can turn them off or on like how's that going to work?
I think the way that we see it now is it's it's pretty much be glucose plus. So you have a glucose and there's very few situations where having that glucose reading wouldn't be helpful, right? So it's kind of like at take the glucose reading. That's why I call it multi-analyte. Um, and then you add in some of the other other sensors. I I do think though, just like CGM has done, once you start building the technology and people start using it, you start learning about all kinds of other applications for it. And I think we're still in the early days of sensing glucose continuously for people who don't have diabetes. And there's so many learnings coming from that. Uh, and I think there's um still much more to come as we look at these other analytes. And even ketones, you know, there's a diabetes use case there that's important, but there's also a lot of use cases outside of diabetes for ketone monitoring.
Sure. You know, Jake, one thing you should just mention briefly about is people don't know about this new software update, the Smart Food Logging feature, cuz I didn't even know about it. I haven't played around with it, but tell us what it is and how could it help.
Sure. So, both in our Stelo product, which is our over-the-counter product, and our G7 product, we actually launched this in G7 first. Uh so in the mobile app update uh when you go to add your meal so not very many people would actually some people start out logging a lot of stuff but then over time they kind of um lose uh interest in it. But if you go into that menu now to log a meal there's a button for um the smart photo meal logging and you literally can take a picture of what you're about to eat and it uses AI technology to analyze the meal and then it will prepopulate it into your uh history log what it is you ate. And it's really detailed and and I've done all kinds of fun experiments with it. Uh testing what it can recognize and it does a pretty good job.
And it gives you like a carb count too or it doesn't. Did you know that?
I didn't know it.
Yeah, we we kind of launched it in stealth mode. It was a it was a new feature and and really one of the important aspects of the progression of the feature is for it to start giving you macros like carbs. Today, what it does is it gives you the good description, records it, and then also pairs up your glucose excursion. That's cool. That you you experience from the meal, whether it's a good one or a bad one or, you know, a big big excursion or not. It pairs it up with a meal and saves it. It also puts it into Clarity so that if your physician's working with you on a treatment plan and kind of says, "Hey, what happened, you know, last Tuesday?" or this, you're not going to remember what the hell did you eat?
Yeah. You're going to look at a glucose graph that's kind of like, okay, I don't really know. But now they have a full description of the meal. And so there is um there's that and there's also the ability to to log the insulin.
And I'm thinking on the research side, which I do a lot of, that that's always been a big bugaboo for us, like how do we capture what people are eating and like this sounds like a a great just, you know, step, take a picture, and like you can start pairing it with the CGM information. So, as you're saying this, you know, I I want to ask you kind of like pie in the sky, next 5-10 years because so much is happening right now. We can take pictures and analyze food like AI with all the all the data that exists with CGM, ketone levels, uh insulin pumps getting you know they're accurate enough to deliver insulin, like what do you see is maybe one or two of the the big things that you're hoping for in the next 5-10 years?
Yeah, one of the ones that uh we're pushing and driving and and really looking forward to is just the continued access to CGM technology. You know there's over 600 million people in the world that have diabetes. Very few of them actually have access to CGM technology. Uh, and so that ability for people to use the technology, for us to continue to improve it, lower the cost over time, like all those things that allow the global population to really manage their diabetes and take care of it, um, is is really one of the things that keeps me, it drives me, it drives the company. Um, driving that access and the way that we do that is both through advocacy and doing producing the clinical uh, data that proves the value of the CGM, which we've done a lot of that. We still have more to do. Um, but it's also on the innovation side. As I've looked at the history of CGM and all the innovations we've done, each one of those innovations has unlocked more use of the CGM uh through either users demanding that the the having the technology or uh payers, those making the decision on how CGM is covered recognizing even more value in the product. And so as the products have gotten easier to use and there's more value in them uh and and again a lower cost uh you know CGM the price of CGM if you look at over the last 5 years has come down dramatically. Uh and we're always focused on the lowest out-of-pocket cost for our users because that's the most important thing for for someone who's actually using the CGM is for them to get access to it at a low cost. So that's one thing I'm really looking for is just global access. Better access here in the US, better access around the globe. The other thing too is um continuing to expand the applicability of our CGM technology along with the other other analytes. I see a day where Dexcom is a company that helps you on a health journey uh in and some of the most common challenges. A lot of it is around nutrition, glucose control, ensuring activity levels. There's all these things we can do to help someone make a slightly healthier habit. We're not talking about like completely changing everything you do, but if you can help reiterate a healthy habit for somebody that helps them, you know, live live longer, have a better life. I mean, that's really one rewarding and something I think it's truly possible uh with with CGM technology and and wearable technology in general, combining it with AI technology on the software side.
Yeah. And you mentioned this earlier, but so many other conditions that are associated with diabetes are silent, you know, heart, kidney, and liver disease. And if there could be some analytes that can, you know, have someone's red light go off and then they speak to their doctor, you could address these issues long before they get serious. So, I mean, that that is that is amazing to me.
Yeah. You know, I'm just thinking that, you know, as we've talked about this evolution, you know, it started to kind of with proving that this actually mattered for this individual patient, that it helped them control their blood sugars or whatever it might be. But you know with all the advances like all the opportunity there is on these population levels now of helping people not just with their diabetes their blood sugars but their overall health and Steve said we just had this faculty meeting today at UCSD. Um, and a big conversation was we don't have enough people like even in in San Diego, UCSD to see the patients that we need to be that need to be seen and that through things like Dexcom and having this data, we can change the entire way that we operate in medicine from, "Okay, Jake, you need to come see me every 3 months for your diabetes and you might be completely fine," but what about all these people that are out there that aren't coming to see me? Well, we now are getting to the point where we can access our patients and look through them and see their CGM data and reach out proactively to the people that actually need help. Um, their time in range is below where we want it or whatever it might be or something gets triggered that there's a complication. Um that that is an entire way differently way of operating uh with with health and this has largely been driven driven through data and diabetes is leading the charge in this because it is so data driven and there's companies like Dexcom that have been working on this for such a long time and I think have had a a significant runway compared to what other wearables are getting to now that you know diabetes is is really kind of the poster child for this I think.
Yeah. I I really see it as um a technology that empowers both the user and the physician to really drive a better outcome for everybody. Uh and I think it's it's very scalable. Uh it's uh you know CGM saves the health system money in the first year because if you eliminate extra utilization in healthcare like emergency rooms um and extra doctor visits to help I mean there's just so much um that resonates with CGM for everybody um including even the payers, right? And so we're um want to continue that message, make sure people understand it. Um, but it is it's an empowering technology and like I said, the day that we saw the impact that it could have when you turned on the the real-time display, we were like, "This is a really powerful technology."
That's the whole concept of Taking Control of Your Diabetes, you know.
It exactly is, you know, it really is.
When my CGM's, you know, warming up for god forbid for 20 minutes, I'm like, "What the hell am I doing?" Like, I don't know my blood sugar.
Do you remember when it was two hours?
I love how you can overlap them.
Yeah. Oh, that is that is that to me is a great little advance, you know? So that's right. Gosh, Jake, we can talk all day.
Yeah. Well, I was just going to say thank you so much and this has been a fun kind of trip down memory, you know, lane for the evolution of care and diabetes, but personally for me and Steve, too, like, you know, what care has been like for us and um it's so great having you so close by and we've known you for so long now and some exciting stuff coming. And that's the other kind of final thing is it used to be every five years that it's just like the rapid pace of these improvements that really kind of are meaningful to people is um is really impactful. So thank you so much for being here. We'd love to do this again at some point, you know, some interval. Um but comments nine.
No, I I just say uh Jake, thanks so much. I mean to me the listeners and viewers are going to be like our experience, you know, we have a greater appreciation what it takes to develop technology like this. You, you know, stealing from something from Motorola, never telling them all the way to all the way to the Blackberry and and forward. No, and I think people with diabetes, type one and type two, so appreciate this technology, but it it wasn't easy.
Yeah. No, there's and there's still so much more to do and I really appreciate being on with you guys and I really appreciate everything you guys do to to advocate for the technology and advocate for patients.
Yeah. All right. Well, thanks everybody for listening. Make sure to like, subscribe, follow, share, all those fun social media things. Send us comments, too. And we will see you or you will hear us on the next one."