Dexcom is featured in a lot of headlines coming out of this year's just-completed ADA Scientific Sessions. Stacey talks to CEO Kevin Sayer about everything from how COVID has impacted the G7 timeline, what the G7 will actually feature, adhesive changes and more. She asks why Europe got approval for back of arm placement and when we might see that in the USA and, once again, we check in on direct to watch progress.
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Episode transcription:
Stacey Simms 0:00
Diabetes Connections is brought to you by One Drop created for people with diabetes by people who have diabetes and by Dexcom take control of your diabetes and live life to the fullest with Dexcom.
Unknown Speaker 0:17
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:23
This week catching up with Dexcom at the ADA Scientific Sessions a time when a lot of new studies are presented. But this year COVID-19 means delays for expected tech, including Dexcom G7, which was moving ahead with trials.
Kevin Sayer 0:38
It was in full force in March it was gonna continue throughout the rest of the year that came to a grinding halt. We are in the process now of resuming and replanting that schedule.
Stacey Simms 0:50
Dexcom CEO Kevin Sayer goes more in depth about the G7 we also talk about adhesive changes, working with European pump manufacturers and what else Coming down the line and tell me something good a major league dream comes true. 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 am so glad to have you along. I'm your host Stacey Simms and you need to educate and inspire about diabetes by sharing stories of connection. My son was diagnosed with type one right before he turned two. He is now 15. My husband lives with type two diabetes. I don't have any kind of diabetes. I have a background in broadcasting and local radio and television and that is how you get the show.
The American Diabetes Association Scientific Sessions is a conference where every year many studies many many studies are released and thousands of people gathered to hear what's new and to do some serious schmoozing Of course this year the entire conference was virtual, which is a terrific opportunity. You know maybe you're able to register and jump online. A lot of new media outlets offered their own platforms for you to kind of take part into the virtual conference. I've never been to a da. And while I don't plan on reading every study, you really can go online and see just about everything. I'm going to link up some of the major links, including the one right to the conference, and some of the abstracts. I think every abstract was on one of the pages I saw. So I will link up all of that information on the episode homepage. And I've already put a lot of it out on social media. And chances are good that as this episode airs the Tuesday after ADA that you may have read about a lot of these things you may have seen some of the studies, but I really like going in depth with the the newsmakers as we call them as I used to work in News Radio, but you know, the people who are putting out these studies, so this is the first of what I hope are many interviews over the next couple of weeks. I have confirmation from several of the pump manufacturers. I've reached out to some of the other tech people and people doing these studies and we'll have more information on And follow up on some of the information that came out.
A quick disclaimer. As always, I always like to make this clear. Dexcom is a sponsor of this show, you'll hear their commercial later on, but they don't have any editorial control. And that means they don't tell me what to say or what to ask when I have Kevin Sayer or anybody on from Dexcom. longtime listeners know the drill. But I just like to make that clear. I'll also add we just had Kevin on the show a few weeks back, it did a whole episode when they announced that they were going to have CGM access to hospitals because of COVID-19. And I asked our Facebook group if it was a little too much Dexcom. But overwhelmingly, they said no, give us as much information as you can. So we will get to Kevin in just a moment.
But first Diabetes Connections is brought to you by One Drop. You know, I spoke to the people at One Drop and I was really impressed at how much they get diabetes. It really makes sense because their CEO Jeff was diagnosed with type one as an adult. One Drop is for people with diabetes by people with diabetes, the people Let One Drop work relentlessly to remove all barriers between you and the care you need. Get 24 seven coaching support in your app and unlimited supplies delivered, no prescriptions or insurance required. Their beautiful sleek meter fits in perfectly with the rest of your life philosophies send you test strips with a plan that actually makes sense for how much you actually check. One Drop diabetes care delivered, learn more, go to Diabetes connections.com and click on the One Drop logo.
The ADA Scientific Sessions this year pretty different all virtual, but the information is still coming out. There's so much of it as always, and I was able to talk to Dexcom. now this interview happened Friday just as ADA began. And while we were able to talk about things that were going to be presented over the weekend, there's always a chance breaking news happens since the interview follow along on social media for more information if anything changed, of course we'd put it out that way. And I will link up more information in the show notes.
Quick bit of housekeeping, there are a couple of terms that we throw around here that I want to make sure to just to define really quickly and kind of loosely, most of you are familiar. MARD is a measurement for CGM, the lower the MARD, the better, the more accurate and we talked about that. We also mentioned iCGM. That is a new we're just about two years old classification from the FDA here in the United States, where an integrated continuous glucose monitoring system can include automated insulin dosing systems, you know, insulin pumps, it can integrate other devices like the Dexcom G6 does with the tandem pump, that sort of thing. It also classifies it as a new type of device in a different class for the FDA, which means different things for approval going forward. I will link up more information on that but when he says iCGM, that's what he's talking about. Here is my interview with Dexcom’s Kevin Sayer.
Kevin, thanks so much for talking to me. It hasn't been so long. Since we last spoke, but with the ADA once I get a roundup of everything that was happening, thanks for jumping on.
Kevin Sayer 6:06
Well, thanks for having me again, Stacey. It's always fun,
Stacey Simms 6:09
we have a lot to catch up on some things that we just talked about a few weeks ago. I'm going to start if I may, with something that may seem very mundane, but really caught my eye. And that is the approval in Europe, of placement on the upper back of the arm. We are a largely US based podcast, we do have large international listeners who are very interested in Dexcom. But can you talk a little bit about how that came to be? And as we have talked about before, many people here in the US were on the back of their arm, even though it's not FDA approved. So I guess the second part of that question is, are you submitting for approval here too?
Kevin Sayer 6:48
Well, I'll answer all those questions. And let's start with your You are correct. People have been wearing this thing on the back of their arm for a long time, even though legally and regulatory, I cannot encourage that on a podcast. The fact is when you go to, in particular to like a kid's diabetes meeting, that's where you see all the sensors. And so we've seen that a lot in Europe, we had done some studies and there was some evidence presented that was compelling enough to the authorities that we can get that arm indication. And so we filed that and we got it. Also combining that in Europe, we got a pregnancy indication as well. So we were in a really good position with with respect to C mark. With US regulations, we have that iCGM standard. And the evidence that we presented in Europe for approval isn't strong enough to meet those iCGM standards that we have with our G6 system. But we are working on putting together some evidence in the US that we think would work and will be good enough. So we will ultimately seek a G6 arm indication. I think the other thing to look forward to as far as that when we run our G7 pivotal study, we're going to run the study on In the back of the arm and on the abdomen and on for pediatric patients and on the upper medics as well. So we'll have three labeled sites there. And that will give our patients literally the optionality labor for label indications where the center and the in the most popular places.
Stacey Simms 8:17
It's interesting, when you have a chance, I understand why you wouldn't go back with the G6 and redo things like that, you know, I would imagine the cost alone would be prohibitive. But with the G7 in new systems, it must be interesting to hear from customers, not only things like arm placement, or I wonder if there are other things that you might test. In other words, I have always heard and I guess you can confirm I don't know if it's the case, that the reason that pumps and CGM should not be put through airport scanners is because it wasn't tested there. Is that the kind of thing that in the future we might see you You trying? You know, hey, let's test it with this condition. Let's test it under that condition. I mean, does that come into play?
Kevin Sayer 8:55
we do all of the testing required under federal regs. For those things, I mean, I've worn my CGM through scanner, never worn anything through the scanner through the suitcase, mind you better but I will tell you some of the things we do there is, you do have a very good question there. Because you do ask, do we listen and what are some of the things we try before we lock in on our product design and what do we test and some of the things we've we've talked through and thought about what G7 because we've been at this for quite a while we've had multiple size configurations. Before we locked in on what we did.
We've made it smaller, we've made it bigger. We've liked it on the size we like it on because that was the optimal configuration for the electronics and you get to a point sometimes when things are so small, you can almost lose dexterity or the ability to use it properly. We know people want a smaller less visible sensor. As we look going forward. We will continue to focus on that. we tried numerous adhesives with G7 in our research work, what sticks the most without causing problems, etc. We, we even experiment, not just from a customer standpoint or customer feedback standpoint, but from a scientific standpoint, what's the shortest we can make the sensor and still get the outcome and the accuracy that we want. So we've spent enough time on the G7 system, to whereby we've tested a number of things of that nature to figure out what the best configuration we can get is. And we balance that with getting the product approved, and again, through the iCGM standards. So there will always be when we launch a new product, there will always be some features that we leave on the table that we don't put in it that we would like to put in the next generation. But ultimately, we have to stop and say that this is good enough. It's my job to make them stop. I promise you, the guys have more great ideas than you could ever imagine. But that is a very important part of our process to really listen and test those things. As we go.
Unknown Speaker 11:00
Okay, so you mentioned you've brought up now the G7. So let's jump ahead. I do have some G6 questions, but let's jump ahead and look at that. Where are you on the G7? Did the has COVID delayed things? I know you hate to put dates out there..
Kevin Sayer 11:13
All right, and I won't put a final date out there. But COVID has delayed things on a couple of fronts. The major one is the clinical study any of your listeners and involved in one of our pivotal studies where our patients go into the clinic for you know, at least half a day, at least 12 hours to have blood drawn and tested in the lab instrument is glucose values are raised and lowered. All those types of activities have ceased due to the COVID situation and we had a very aggressive clinical trial schedule. Literally, it was in full force in March and was going to continue throughout the rest of the year that came to a grinding halt.
We are in the process now of resuming and re planning that schedule, but we still don't know all the dynamics of the schedule and the best example I can give you if you go to a large Diabetes Center They might have had four or five patients at the same time in the room being monitored, while the social distancing Are we going to have to? Are we going to be able to have four or five? And what protocols are the various centers going to be running with respect to those clinical trials? So we are really literally out there rescheduling the pivotal study for the G7 system. That is the biggest delay. The other thing we have experienced, and it's to a lesser extent, is just the effect of COVID-19 on all of the people involved in this process. You know, I was talking to somebody the other day, and they used to quote, it takes a village to raise a child it sure as heck takes a community to build a product. And we do depend on a number of other suppliers who encountered their own COVID difficulties, the easiest one that comes to mind which you summon the molds for the plastic or an 18 month lead time and the molding company was hit by COVID and literally shut their whole factory down for a month. And that's not the mold makers. That's not a problem that just does Just reality, we put all of the operational pieces of the schedule back together. We're comfortable with those timeframes.
Now we've got to get the pivotal study up and running and get it big enough. And I will go back to you know, I've talked about iCGM and the bar that the FDA has said, This isn't a study, we can go run with 80 patients and call it a day, there's going to be several hundred patients here. To the extent statistically we can come up with models to decrease the size of this study, we will, but we do analyze it, because the criteria are such and the one that they explained to me that rang the truest in the mid range of the good range of sensors, you know, timing range between 70 and 180. If we have 1000 data points, and if seven of those are off by 40 points, or 40%, the whole trials done, and our biggest source of error in the studies is not the sensor, and it's not because the centers aren't great because they are, there's just so many pieces of paper and so many things that have to happen. So we are really refining that process. Given the fact that we can't run studies now, we're very optimistic once we get them going, and we'll do well. We're going to run a study for Europe, in addition to that, and file that separately, so you'll hear more timeframes from us. But it's going to take longer than even a couple of months to have the perfect schedule laid out a timeframe is not coming for a while.
Stacey Simms 14:17
Can you share anything about the G7? In terms of what makes it different? And why move ahead with a new type of sensor?
Kevin Sayer 14:26
and I'll go back to my first statement to listening. The one feature our patients have all said they want a smaller, and that's pretty universal. When we embarked on this many years ago, we literally started with something the size of an m&m. Now the G7 is a little bigger than a nickel. It's not as small as an m&m, but it's still pretty small. And we wanted to do that. We wanted to eliminate some of the difficulties with respect to transmitters and pairing the whole G7 system is disposable. We also when we looked at G7, and when we started down this path We designed this from the very beginning to manufacturer in an automated manner. There will be humans manning the machines but these aren't going to be human lives. Everything else we've done we designed around the fact that we manually put everything together or have many manual processes now G6 is about to the point where that will be pretty much all automated or manual lines will go away but we wanted to build a product that we could build 10s if not hundreds of millions of in a repeatable manner and our previous generations or product, even G6 up until now I think G6 has now crossed the barrier where we can build lots of them but build g five system says you could have never got to the volumes we anticipate getting to as as technology continues to expand and explode and i and i think what we've created and our goal which he said is to give us a product configuration that anybody can wear and then it will have multi uses. It's as big a step forward from G6 is G6 was for G five.
Stacey Simms 15:56
When you say the whole system is disposable in the size of a nickel Retreat you want to avoid transmitter issues? Is it all in one is the transmitter and the sensor
Kevin Sayer 16:04
transmitter and sensor all built into one unit yes
Stacey Simms 16:07
I'm you know, having been with Dexcom for more than six years now and I think we started in the g4 Platinum I'm trying to visualize
Kevin Sayer 16:16
No, it's much smaller and much thinner and it literally if you wear a G7 you have no idea it’s on your body.
Stacey Simms 16:25
Really interesting and you anticipated having a similar more similar you know accuracy as the G6
Kevin Sayer 16:31
yes, yes, it has to meet the iCGM standards and and so we've we're designing it that way. We're designing the algorithm the pivotal studies along those lines. And right now what what is becoming very clear to us as we go through these statistics, while MARD is always important from an overall perspective, the iCGM standards are more important than than just the margin number is important that these things be reliable and offer the same experience every time. So we Certainly you have to have a good MARD to be approved on those iCGM standards, but the reliability of the sensors is every bit as important. We're focused on both.
Stacey Simms 17:09
Well, as we look forward to that, as you said, it'll be a while because of COVID and other delays. My listeners, as always have questions and one that has come up quite a bit. We'll go back here to the G6 and current manufacturing is a question about whether the adhesive had changed recently on the G6. As always with me, it's anecdotal. I don't have access to studies or thousands of people. But we've noticed within the Facebook group that I run for the podcast that more people are reporting, rashes and problems with the adhesive with the G6 than they had in months and years past and the question came up is has something changed?
Kevin Sayer 17:43
Yes, it has. There's a very fine balance. On the adhesive side. We warranty our product for 10 days. We say this as a 10 day sensor, and one of our most common occurrences of replacing a sensor as it falls off, in fact, the most common one so for years, we have studied adhesives and wanted to make an adhesive change that would give patients a better experience and have that sensor last the entire 10 days. And so we did change the adhesive out to something that was more sticky on the one and we are very happy to report that we are seeing a great reduction in the number of sensors that fall off people. So we are delivering on end to the experience. On the other side of that we have seen an increase in allergic reaction to that new adhesive. We have some data on our website. And we have done some clinically based work for those patients to give them some options to whereby the adhesive will not have that same effect that there's some mitigate mitigations that you can make to do that. So if you contact us, again, I believe it's on our website or also you can contact our tech support. There are some clinically based solutions that we can offer.
Stacey Simms 18:46
All right, so I will refer people to the website and we'll keep helping each other but I think people wanted to make sure and just get confirmation that something had changed.
Kevin Sayer 18:53
Well we did change it we did
Stacey Simms 18:54
Dexcom offers the free over patch when people request it you know to help it be more simple. Has that changed at all? Or that seems to be the same?
Kevin Sayer 19:02
I believe, yeah, the over patches are the same.
Stacey Simms 19:04
Okay, I feel like this is almost like when I used to ask you about Android, but it popped up in my timeline that three years ago, the Apple Watch product came out and it was a huge press release from Apple about this is gonna change your health, this is going to change you know, everything. And in that article was, of course, and you'll be able to see your blood glucose from your Dexcom. They also would hope to get on your watch on your watch.
Kevin Sayer 19:27
We're always supported it. We're not direct to watch it yet. That project has has proved to be extremely difficult. The architecture of a watch is different than the architecture of the of the mobile phone. And in the middle of that I believe there have been changes made to the watch architecture as well. We as we've looked at and prioritized our projects and our resources and we look at software things we need to work on. While that project is still on our list, getting more reliability went to patients each and every day has been above that. And this taken some precedent to it, we will eventually get there.
But there's also some interesting issues with the watch that we didn't even contemplate when that release came out. And I'll give you the perfect example. You've got to charge your watch every day. How do you get that alert on your wrist? When your watches charging, and things of that nature, there is a different experience, and different safety features are going to be required to be implemented over time. We're working through it and thinking about it. We aren't ready and in all fairness, as we've looked at resources, if we're picking for example, between G7 and the watch, look, I love to watch you use I use all these tech gadgets all the time, and I put different ones on, we will eventually get there is a lot more complex than we envisioned when we started down the path. Probably the most loyal Apple Watch, customers are Dexcom patients. If you're an apple watch on an Apple phone and use an apple watch those patients use the Dexcom app on that watch a lot. Even through the phone. The watch experience has been a very good experience for our patients who use it
Unknown Speaker 21:00
What about other watches like Fitbit or devices like that
Kevin Sayer 21:03
we display on the samsung watches or some of the Android platforms now we've had discussions with Fitbit. Fitbit just got acquired. And I think they're regrouping and figuring out where they go. I think it'd be wonderful to offer our patients solutions along those lines, it becomes a question of do you get the whole device safety experience on that display? And how do we label it and what do we do? But these are the things we're looking at and pursuing?
Stacey Simms 21:27
Another question I got from a listener was all about can Kevin talk about other Dexcom partnerships with newer pumps, at least new to the US like, Ypsodmed if I'm saying it correctly, and other you know, European and worldwide, pump companies, is there anything new to talk about with those partners?
Kevin Sayer 21:45
You know what? We just signed an arrangement with Ypsomed to work with them, their pump will pair with our sensor. It'll be in Europe first. They will bring it to the United States at some point in time. They have also signed an agreement to license, our type zero technology, the algorithm that we have that has been involved in numerous studies around the world and is the basis for control IQ as well. So they will use that algorithm and it will continue to work with our sensor. I don't know all their US plans, I won't speak on their behalf. So we'll see where that ends up.
We do have research relationships with a number of entities getting to commercialization, we'll just have to see these partnerships. You know, I would tell you that the 10 of joint product offering is doing extremely well we get great feedback. The Insulet study has started back up. I look forward to the day when all these things are on the market. Stacey, giving patients the choice to have these automated systems will be a wonderful thing for patients and they've been very patient waiting for us and for our partners to get them out. I think when the day comes it will be fabulous but we cannot pair with every single. It is kind of a hard balance. pairing with every single pump is a lot of work to support in house but we want To be interoperable, that we want to get products out, we really want to get solutions out there. And we're happy with the partners that we have. In the US, I think initiatives like the loop initiative where they're gonna develop an algorithm that could work on a number of pumps and number systems might be a very good option for Dexcom to pair with others because the pairing is done by them in the app, not necessarily by work by us. So over time, the interoperability strategies one will continue to challenge and we are prepared to work with anybody that can enhance patient's lives and help our business
Stacey Simms 23:32
it just a clarification question you mentioned Dexcom owns the type zero algorithm, which is the brains let's say of control IQ really are the basis of it if it's used in another pump, if it's in the Ypsomed pump, is it the same exact bit of software? Or do they are there changes or
Kevin Sayer 23:50
tweaks? No, I'm I know that Tandem has made changes to the app and how it works, but the fundamental math and the algorithm will more than likely be the same. I can't speak Exactly. To what Tandem’s done, but I'm pretty confident it'll be a similar experience from an accuracy and from a patient perspective is the way it works. And then we're working with our type zero team to develop other algorithms, and advanced versions of what they've learned in the past. We are free to license to others as well.
Stacey Simms 24:15
It'll be interesting to see how that evolves. And when we talk about interoperability, I actually have a little bit of trouble with that, because in my head, and I've described it like this before, it seems like it should be more like Mr. Potato Head, right? Like I have the base, and then I get to put the ears on that I want the eyes on that I want the feet or whatever. But it's not exactly that easy, right? It wouldn't be a question of like, grab a Medtronic pump, but I get to slap a Dexcom sensor on or you know, buy or anything like that, right? It's not No,
Kevin Sayer 24:42
no, it's not that simple at all. And in all fairness, I think Dexcom has done a better job and design our product to be interoperable better than anybody else. And I can give you a very simple example. I tried to close this many years ago. Our transmitters designed to talk to multiple devices at this Same time to more than one. And that took a lot of time and a lot of engineering and a lot of dollars. And so I raised the question, why are we talking to multiple things? Let's just talk to one. They all kind of like I should know. Well, now think about things. Now you can talk to your tandem pumpers. You can also talk to a phone app at the same time. What a wonderful feature for our patients. And what a wonderful feature as our software changes or gets an advanced feature, that maybe our pump partners or a pen partner or somebody else doesn't have be able to talk to both is a wonderful opportunity for our patients if they want to use both apps. And I think over time, particularly as we look at refining your software experience, it seems to be more important.
Stacey Simms 25:41
Last listener question was about compression lows. I don't know if what they're really called. But anecdotally you sleep on the place for the Dexcom is the circulation slows or for whatever reason you get a fake low. I'm sure you're all aware of this. are you addressing it you think it will be cleared up with the G7
Kevin Sayer 25:59
I don't know. It'll be completely cleared up for G7, I would hope it decreases because, and I can only speak from a theoretical perspective, the sensor is smaller and the transmitter is less bulky. So there might be less pressure pressed on it. But compression has existed in all sensors forever. I have asked the team to look at other ways to deal with the compression issue and come up with some ideas. And they have some very good ones. It wouldn't be in the first version of G7. But I we've got a couple of thoughts that I won't share, because they're very proprietary. I think we have some good answers for compression over time. The question becomes, though, Stacey, and this gets back to the patient experience. And since your listeners are familiar with us, if it's compression low, do we still alert you and wake you up and tell you to roll over? Or do we guess what your glucose value should be and just keep going? What is much safer is to alert you and wake you up and say you're having a compression error roll over? It's not a real low. But do you all want to be woke up for with that type of error or would you rather is Wait for a half an hour and say I was just compressions con, these are the kind of things we shouldn't talk about, and contemplate within the engineering group, which is why these guys want to work here. It's really interesting.
Stacey Simms 27:10
Hey, there's so much information that is coming out at ADA that we haven't even touched on. And I you know, as you listen, I will link up a lot of the information. There's the G6 two year anniversary study. There’s a lot of information about the hybrid closed loop partnerships that's coming out. I'm curious, the launch of the G6 Pro. Honestly, I'm not sure that too many listeners of this podcast would use a product like that, whether it's blinded or they just get it temporarily from their their provider. But talk to us a little bit about that. Who is that for? What was the demand like for that?
Kevin Sayer 27:42
Well, the demand on that has been huge. And the demand starts in the physician offices. And literally, if you think about Dexcom, our pro product right now is a g4. It's not even G5 and our physicians have never had the opportunity to be able to say to a patient, let me Let you have a CGM experience similar to what you would have if you're one. So for your audience in particular for patients who would like to know what CGM is like the physician can output a unit on it. This is exactly the G6 system. The G6 Pro is a transmitter to sensor in a single box. Patient wears it and it's disposed of at the end of the sensor where period, the reason you have the blinded app physicians have asked for it. We think for patients unblinded is obviously the way to go because they can learn what to do with their own management. But the fact is, for a physician, there's a baseline check as to, hey, how's my treatment working? Or how's this treatment working in a type two non insulin taking patient in particular, you can put that sensor on blinded for a 10 day period and get a readout and go, wow, this is working.
the audience is very much from an educational and therapeutic perspective. In the professional environment. We have priced it in a manner to whereby the physicians can really acquire this at a reasonable cost. It will also be you know, at As you look at what's happened with COVID, as well, taking newly diagnosed patient and telemedicine, you can put a patient on this professional system. And if the patient uses the date alive, the physician can use the data live. As we've gone through the the virus situation, the the learnings we've had from our physicians about how CGM actually works. It's been really interesting. I mean, I get phone calls, do you know I can watch my patients from home I didn't know you could watch your patients from home and clarity, we reduce the three hour time lag, we've got near real time. And that's helpful. So you know, in this new age, where you have telemedicine and all the information that physicians need to get, we think G6 pro fits in very nicely and we want patients to be able to have that experience and learn what index comm is like rather than than other things and learn the information they can get ultimately for us as timing range becomes the measure. Now let's take it a step further. If you're a physician and your key measure Simon range Your patient doesn't wear a sensor, you can just put a blinded Dexcom on him, send him home for 10 days and come back, download it, you can read it. And you know what that patient assignment ranges. It has a number of great uses for us and will be a platform for growth going forward, we think is going to be very, very, very important.
Stacey Simms 30:16
I didn't realize it hadn't been updated since g4 that makes a lot of sense. No. And then before I have to go one more quick question. Last time we talked, we talked about CGM in hospitals. I know how long but how is that program going? What is the feedback? And can you talk about how widespread it's been
Kevin Sayer 30:33
able to come? We've had interest from many, many well over 100 hospitals close to 150. And we're in quite a few of them. The interest has been great. It has taken more time for us to do this than we would have thought when we started. when everything started happening very quickly. We were getting requests from hospitals and people didn't quite know what CGM was but read about it that we literally thought 10% of our production might be going to the hospital and it hasn't been that great of a demand. We've learned the intricacies of hospital operations with respect to it and GE, we're sending you free phones fuse the sensor and you guys don't want to use them because you don't know if they're HIPAA safe. We've had to learn all these steps along the way. But where are we got it, and where it's up and running? Well, the results have been everything we'd hoped for the sensors performing the way we want it to it's accurate. We haven't seen major problems due to drug interference, which was a concern that has been an FDA concern over time, the ability of the healthcare providers to monitor from in the hallway, a finger stick administered by a healthcare professional, somebody timed it for many other days, about 15 minutes because you got to gown up, put on gloves, go stick the finger, okay, if you're doing a finger stick an hour, you're saving 15 minutes of nurse time every hour. For every patient, they don't have to stick the finger on. There's been a huge reduction in PPE.
The patients are getting off the insulin drip faster because their diabetes can under control more rapidly. are leaving the ICU faster. They're going home healthier, all the outcomes. We hope for happening, the speed of which the uptake has been slower than we would like, but it is still going on and people are still expressing interest. And I, I think based on the places where it has been, I don't think anybody's going to let it leave. Particularly while we sit and anticipate what could possibly happen in the fall, we are going to gather data. And when we can gather data and get enough data to whereby there's a meaningful submission, or at least a discussion, we'll take that and we'll discuss it with the FDA and decide what next steps would be to get the labeling and to get a hospital usage approved. I think the products always belong there. I went through an experience personally with my mom many years ago, she had a heart valve replaced and it took them longer to get and she had type two diabetes. It took them longer to get her glucose under control than it did to get her heart valve and all the other pieces of her recovery then it was fascinating. I mean, they kept coming in adjusting insulin dosage, taking it up taking it down. And I kept saying I have something we could put on her to make It's easier, and no, no. So I do think it belongs here. It's a great use for the product.
Stacey Simms 33:06
That's really interesting. Well, Kevin, thank you so much for taking some time to talk to me about this. A lot of things happening at once. And I always appreciate your time. And when you start the G7 trials, I know that we all go through the official channels, but you know, call me We'll get my son and
Kevin Sayer 33:24
hey, we appreciate I always love to come on on your show. We always have a great discussion, and I'm happy to deal with any questions that come up. You know, I don't hide.
Stacey Simms 33:33
Yeah, I appreciate that very much.
Unknown Speaker 33:40
You're listening to diabetes connections with Stacey Simms.
Stacey Simms 33:46
For information at Diabetes connections.com. As always, at the episode homepage, we do have a transcript as well if you prefer to share it that way if that's helpful for people that you know, easier to read it than to listen and just to be crystal clear, if it wasn't paying 100% choking. At the end of that interview, I could no more get into a clinical trial by talking to Kevin Sayer than I could, I don't know, get Benny a better wrestling birth by going to the NBS Linux department of his high school. I mean, I don't know about you, but that's not how it works for me. And we joke all the time being Penny never been able to get him in a clinical trial. We keep trying, I'm signed up all over the place. Maybe the word is out on what a pain in the butt I am. But I would love to get him in one of those. So we'll keep trying, but interesting information there. And I will link it all up at the episode homepage. Tell me something good in just a moment. Let's talk about baseball. But first diabetes Connections is brought to you by Dexcom. And you know, when we started using basal IQ a couple of years ago, that's the Dexcom G 610. to pump software program. I was so happy with it. And then with control IQ. It's just amazing. less work. better results with diabetes with a teenager. I mean, Benny always liked seeing his face GM numbers on the pump, right? We got that pretty much right away with tandem. But honestly, it was just more of a cool feature he really took us pump out to just look at it. There's some secret sauce, though, in first basal IQ and now control IQ, right? That just really is incredibly helpful. His range time and range has increased significantly, his agency has come down significantly, you know, I don't talk about specific numbers. Holy cow. Of course individual results may vary. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Intel Tell me something good this week. This is a cool story that just because it's a cool story on its own, but I was alerted to this because in one of the Facebook groups I'm in, a mom posted a picture and this picture had to be at least 10 years old, maybe 1215 years old, of her son on a baseball team with another little boy both kids with type one and the other little boy was just dropped By the Milwaukee Brewers, Garrett Mitchell was selected 20th overall in last week's draft. Now, there's a lot of information here about baseball, I don't know. But I like this sentence, many heads a left handed hitter projected as going into the top 10. So the early take is the Brewers got a gym who dropped further than expected. And then they go in about like, well, his power numbers, and there are questions about this. But Wow, I'll link up one of the articles where Garrett Mitchell is quoted, and he really did talk about it. He said, You know, a lot of these teams, it did come down to diabetes, what teams want to deal with that, you know, what teams are comfortable with that? And he says, personally, I don't really see this challenge. You know, there are a lot of people who questioned him, but he says, I know how my body works. I know what I need to do. And he has been dealing with it since he was a young child. And I think it was really interesting that the story I'm reading this from isn't from a diabetes publication. It's not a profile on jdrf. There's lots of those and I hope we hear much more about Garrett Mitchell, but this is just a regular sport. story where the diabetes stuff comes way, way, way down in the article, so congratulations to him. Thank you for those of you who alerted me to this on Twitter, which is always great if you see something good like this, please tag me let me know. And of course we are efforting an interview with Garrett Mitchell because why not? I would love to talk to him. If you have Tell me something good story. If your child is starting to play sports, and I mean, forget about hitting a home run, you know if they just get through the game, and you don't run on the field. I'm kidding, but I'm not kidding. The parents know what I'm talking about. Right? If you have a Tell me something good story big or small. Let me know this is my favorite part of the show. Every week. I love sharing your stories. You could email me Stacey at Diabetes connections.com or just tag me on social media and tell me something good. Before I let you go more Ada stuff is coming. I am excited to have interviews on tap with a lot of other technology companies and we'll be sharing those in the weeks to come. There's a lot of stuff to unpack here. I also want to let you know and this is kind of selfish and I hate that these are all the same time every year but I guess this is a word season so I want to give you a heads up that the we go health and the independent podcast awards are coming up in a thankfully it's not a vote everyday situation I hate when people do that just just awful that they asked you to get your listeners to vote every single day What a pain in the ass for I'm not gonna win anything with that attitude. But I have been nominated for a we go health award on the voting for that, which is basically just please go ahead and like me on the wiegel Health site will open up in July. And I will be putting that out on social media, the independent podcast awards. We've been very lucky where some wood that I can knock. We have been named a top 10 Health podcast. That's a nationwide independent podcast award every year since the podcast launched and I love keeping that streak going. So I will be asking for your help there as well. Again, it's just a vote once please. And there's lots and lots of podcasts to vote for. Same with legal health. There's lots of categories to vote for. So if you know somebody else in the diabetes community or there's a podcast Guess that you like you'll be able to nominate and vote for them there. So more to come on that just thank you very much. I hate asking but that's the only way to do it. All right, thank you to my editor jump, you can start audio editing solutions. Thank you very much for listening. And Stacey Simms. I'll see you back here next week. Until then, be kind to yourself.
Unknown Speaker 39:25
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
