#275 Dexcom Pro and COMISAIR
Dexcom Pro and the COMISAIR study…
Dexcom's Senior Medical Director Tomas Walker is back to explain Dexcom Pro and the COMISAIR study.
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DISCLAIMER: This text is the output of AI based transcribing from an audio recording. Although the transcription is largely accurate, in some cases it is incomplete or inaccurate due to inaudible passages or transcription errors and should not be treated as an authoritative record. Nothing that you read here constitutes advice medical or otherwise. Always consult with a healthcare professional before making changes to a healthcare plan.
Scott Benner 0:00
Hello, everyone, and welcome to Episode 275 of the Juicebox Podcast. Today, you're probably expecting an ask Scott and Jenny are defining diabetes. But instead, they're bringing something that I think is just as valuable. Every once in a while there's research done around diabetes, that when you stop and listen to it helps you do better. And this falls under that category. This is just going to be a quick 20 minutes, but it's packed with good information. Today's episode of The Juicebox Podcast is sponsored by companion medical makers of the in pen, go to companion medical.com. To find out more.
Please remember that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise. And always consult a physician before making any changes to your health care plan. or becoming bold within quick announcement for those of you living in Pennsylvania, particularly in the Valley Forge, or more specifically trap PA Area on November 10 2019, it's a Sunday, but don't worry, the Eagles are in Dubai. I recently shared all my speaking engagements online and somebody came to me and said privately, I wish you would come to this area. And I said I you know, I can't control who invites me to come where. And this person told me well I can find a space for you to speak. Will you come if I do that? And I was like, Yeah, sure. So this isn't sponsored by anybody. It's not for the jdrf or anything, just gonna be me showing up at a church that was nice enough to donate some space for us. We're going to talk about being bold with insulin go over the tenants of the podcast, the protests kind of stuff. And then there's going to be huge q&a, where we're just going to chat and try to figure out people's problems. So if you're in the area, and you're interested, I think there's about 20 people coming now I think the space holds about 100. Go to the Events tab on my Facebook page, and RSVP.
Tomas Walker 2:04
I'm Tomas Walker, I am the senior us medical director with Dexcom.
Scott Benner 2:09
Those of you who love data and understand how it helps people will remember Tomas from Episode 66, which is still relevant to this day, and you should listen to. So when I heard that Tomas had some data, some new data from a really incredible study from the Czech Republic that he thought was important enough to share. I booked him on the show immediately. And as a bonus, there's a little something called Dexcom Pro that he's here to tell us about as well, that may help a lot of you at your doctor's office. You're ready. Let's do this. So there's two things going on right now with Dexcom. One is the Dexcom. Is it called pro?
Tomas Walker 2:48
Yeah, the Dexcom g six Pro has just been just received FDA approval. All right.
Scott Benner 2:52
And then the other thing is like an acronym that I don't know, am I right?
Tomas Walker 2:57
The commissar study
Scott Benner 2:58
is that with this, I think of it as an acronym, because there's a lot of capital letters. But that may be
Tomas Walker 3:02
the comments or study. Yeah. So yeah, which was a study on the impact of sensor augmented insulin regimens, which essentially looked at the benefit of using CGM compared to multiple daily injections and finger sticks, insulin pumps and finger sticks and then insulin pumps and CGM and multiple daily injections and CGM. So wanted to see the benefit of adding continuous glucose monitoring to the classic regimens of diabetes therapy and compare them to each other.
Scott Benner 3:32
Okay. And that was something you would like to share. I guess it's a must. It must be interesting. If you're assuming if it wasn't interesting. You guys wouldn't be interested in sharing it. You feel like nothing happened? Just a big waste of time. Nevermind. Yeah. going on.
Tomas Walker 3:49
Everybody.
Know that. So either. It's a fun study that came out of the Czech Republic by Dr. Yan Schauble and Dr. Martin progeny. And what the study actually did was recruit 90 some patients who were coming into their diabetes clinic training sessions, and they put them all into a three four day intensive clinic training session at the end of it, they essentially pick the treatment option they want for the next four years of therapy. Okay, so the patients could choose I want to stay on MDI and finger sticks. I want to go on a pump, but I'm going to stick with finger sticks. I want to go on a pump, but I want to use a CGM, or I want to stay on MDI. But I'd like to use a CGM. So the patients were allowed to self select for which therapy option they want it. They were then enrolled in this study, which was really just more of an observational study. And they were followed out three years now, which makes this the longest study of people using diabetes technology ever completed. So that's what's really exciting to me is prior to this the longest studies we had of people using CGM were six or 12 months We have completely blown that out of the water now and pushed it out three years. And I'm very pleased to tell you that they actually have the funding to complete the fourth year of study. So you know, most of the time you get an insulin pump. It's a warranty for four or five years. So now we're going to be able to say this is the entire life cycle of someone using CGM technology out four years,
Scott Benner 5:19
and the CGM you're talking about is I'm assuming that GE six,
Tomas Walker 5:22
they've No Actually this study was based around the Dexcom, g4 this was in Europe at some of the patients did have G five, none of these patients were using Gen six.
Scott Benner 5:31
Okay. Okay. And, and varying pumps. Not though, do they give them all one, sir?
Tomas Walker 5:36
It was, my understanding was that they had a choice of two pumps in the Czech Republic, they could use the Medtronic pumps, or they could use the Animas pumps with the g4 centers. But
Scott Benner 5:46
see, you know, you start looking back a couple of years you start hearing words you don't hear anymore,
like Exactly.
That so far, that's amazing. And who put the study together again.
Tomas Walker 5:57
So this was done by Dr. Leon Schauble and Dr. Martin prizemoney, who are two endocrinologists out of the Czech Republic, and this was funded by the Czech health ministry. So people ask me, what's my favorite part of this study? My favorite part of this study is, is nobody in industry had anything to do with this. This was done entirely by this group of clinicians and the Czech government to look at the impact of these technologies on diabetes care.
Scott Benner 6:22
That's very cool. That's great that people are thinking that way stolen? Yeah. Because it's and so how did you get involved in I mean, other than I'm assuming they had to come to Dexcom. And say, we want to use the G for for the study, or
Tomas Walker 6:32
no, no, actually, we didn't get involved with it at all. There is no Dexcom sponsorship of this study. That's why we didn't actually know about this study until we saw the first poster regarding it a few years ago and saw that the protocol had been submitted to the NCT trials database. So again, this is this is a study that was done without the contributions of Dexcom, or Medtronic or anyone in industry, it was done entirely by the Czech government and the the Charles University and in the Czech Republic. So three years
Scott Benner 7:04
worth of data, Is it broken down by how you chose like, or what is it? What is it telling you?
Tomas Walker 7:11
It is broken down by how you by how by this by the approach you chose, basically, it wasn't quite equal groups, but it was almost equal between the the subjects of 25 subjects in each group in MBI, excuse me an MBI and finger sticks, pump and finger sticks. MBI and CGM are pump and CGM. And then they were tracked out every three months for four years. And at the end of this three year period, they have 88 of these 94 subjects still active in the trial. So great, a great retention, great follow through. And what they've been able to show is that the patients who went on pump and CGM or MDI and CGM have a 0.1% difference in their a one C, out three years later. And this has been consistent since six months after starting the therapies. And the interesting thing is this is mirrored almost exactly in the patients who stuck with finger sticks. So the patients who are on MDA finger sticks and pump and finger sticks also have a difference of about point 1%. And they're a one see out three years. Now they're a one C is about 1% higher than the patients who were using CGM. So that's also a strong message that the insulin delivery method doesn't matter. What matters is using CGM is what improves diabetes care, because patients are able to make those real time decisions they need to manage their disease.
Scott Benner 8:36
What do you have an idea for the range? So people pumping with CGM and people shooting with CGM? You said they're about a percentage off. But what where does the range fall? Like? Are they a seven and an eight or a six and a seven? Yeah,
Tomas Walker 8:51
you're looking at 6.9 to 7.1. That's where everybody was CGM was falling. Okay.
Scott Benner 8:57
Okay. People using finger sticks were more like 8.1.
Tomas Walker 9:02
Like in that video. They were sitting around 8%. Yeah.
Scott Benner 9:05
Wow. So if you so if you see. So I guess the other thing is that it has to show that the people who are injecting, not afraid to inject more like they
Tomas Walker 9:17
sold. So that that's one of the interesting, one of the interesting findings of the study was when they looked at the data, we assumed that the patients on the pumps would be more likely to take multiple boluses. Right, there was an old study done called the switch study, which showed that when you gave patients on pumps, CGM, they were more inclined to take an extra bonus. Like I'm so high after lunch, I'm going to take an extra unit. They were willing to take more injections, and that was part of what improved their control. Well, when you look at the commissar data, they actually they actually track the number of injections per day. And the number of injections per day was like 6.6 of fast acting insulin per day, which matched like 6.8 micro boluses per day using insulin pump two extra against that. There's no difference. This, there was no statistically significant difference between the number of bonuses the pumpers, were giving, versus the patients on multiple daily injections. I actually thought that was kind of interesting, because if I had had to make a guess and predict, I would have said that people injecting were probably going to be taking a little bit less injections in the patients on the pumps. But it wasn't what was shown what it showed was up, the patients were on multiple daily injections. And they were doing just as inclined to do an extra bolus of insulin as a patient using an insulin pump. It's something I
Scott Benner 10:27
I thought, what you would probably find you are finding, which is that when you get the data, you can start making better decisions. And those decisions then lead to not needing to make more decisions later. You know what I mean? Like, once you've seen a meal, go, you know what I did an episode Tomas, the other day there will be cursed on it. I almost said something that I shouldn't say. So let me start over again, when after you see a meal go the wrong way, a couple of times, you can make the decision. You know what I keep Bolus and four units for this. But obviously, it's five. So why don't I just do five and you can start injecting more thoughtfully after you've seen it once or twice. I listen, I can't agree more. I wanted to have you on to talk about this, because I'm a huge believer, obviously. So that is really something and and that they didn't. Now they're adults, too. I guess that's important to keep in mind, right? Are these all adults?
Tomas Walker 11:21
These are all adults, this is entirely adult population.
Scott Benner 11:23
And I would say to an adult population have probably motivated people or they wouldn't be involved to they're not a passive group, I would imagine.
Tomas Walker 11:32
You know, if they were following through on their routine care every three months, but the fact that they had 88 of the 94 that enrolled still present in three years tell you tells you that this group was really at least committed at some level to this care.
Scott Benner 11:46
Yeah, yeah, they were not cherry picked. But they were people who were interested enough to follow through. My point is, then they're interested enough to pay attention to the data and make adjustments to Sure. Yeah, that's excellent. That's really cool. Oh, my God. So now where do you go from here with that? What do you do with this data?
Tomas Walker 12:03
So where this goes from here is this goes to four years now. So they're going to finish getting the fourth year of data. And then they were discussing the group running the study how they want to take the next, the next study forward, they really raised the bar here, you know, bringing in four years of data on 100 patients with type one diabetes, like Stand back, this is groundbreaking. No one has done this sort of diabetes technology study before. I'm glad to see they've done it, they've really raised the bar. I think that they're discussing themselves the best way to go forward. Yeah, I wonder if this isn't something you can use to pressure health agencies or insurance coverage or that sort of thing? I mean, it would you would think that saying to them, putting putting this person on this should lower their a one c appoint that would be a big motivator, I would think for them. So you know, one of one of the comments I make when I talk about this study when I talk to payers is I don't want to hear any more griping about not enough longitudinal data. Okay, know what else is coming in with three and four years worth of data if you you have to look at this and recognize the uniqueness of this data set?
Scott Benner 13:10
Yeah, I appreciate that. Because I just I just heard the other day from a person an adult who was flat told him in America you're a one sees too good. We're not gonna let you have it CGM. Like I don't even know what that means. You don't even but but it's it's too so your your health isn't poor enough for us to cover this the the CGM for you is something it's fascinating.
Tomas Walker 13:33
got an A anyone see is is not a perfect marker. I mean, all you have to do is look at what some of the work from right back in the djabe Center to say that, you know, a one C, it doesn't always correlate as closely to time and range as we think it might.
Scott Benner 13:45
Yeah. Did this data show anything around variability of time and range?
Tomas Walker 13:49
Yeah, they showed this the patients with CGM had significantly less glucose variability and significantly more time and range regardless of the insulin delivery method.
Scott Benner 13:58
What's the range they used, you know, off the top of your head? And I'm sorry to have to go back and look at the paper again, I don't remember that one. I'm on top of my head is pretty specific. I just took a swing there that wasn't sure if you would know I am I joke sometimes for the people listening that you can't, you can't set your your Dexcom at 65 and 400. And then get online and tell me you were in range haltech. I you know, you get to pick something reasonable.
Tomas Walker 14:23
I'm pretty sure that the range they looked at was 70 to 180 milligrams per deciliter would have been my guess I think that's pretty widely accepted
Scott Benner 14:33
range for people. I know. We keep ours incredibly tight for reaction purposes. So when when I look at some of our data is skewed because ours is 7120. And so I you have to kind of look through some of the numbers, you know what I mean, and figure out what they really mean. And then you can kind of reset that out to 150 and you Oh, okay, this is this is very reasonable. Tomas. We'll be back in a second to talk about that. compro. But first, I'd like to tell you about the in pen from companion medical. So try to imagine that your CGM, your insulin pen, and an app on your phone all connect to each other, creating a sort of triumphant of diabetes care. What is this do? You may be wondering, Scott, why do I care about this? Well, if you're an MDI user, a person using multiple daily injections, and you're just using a regular old dumb pen, this smart pen is a game changer. What it does is it gives you a lot, if not almost all, of the options that you gain with an insulin pump options like understanding insulin on board, which is incredibly important. How do we do that? Well, that's for you to find out. And for me to know, my heart knows, I'm just kidding, I'll tell you. So the intent is like any other injector pen, except it tracks each dose and delivers your data to a secure app on your smartphone. So really, it's not really like every other pen is it way better. The pen app displays your active insulin, blood glucose and the last dose of insulin that you've taken. It also can remind you when to take your insulin, it helps you calculate and recommends your next dose, and it'll warn you if your insulin is expired, or has been stored outside of the recommended temperature range. So if you'd like to eliminate the guesswork, that often comes with injecting the pen is probably for you. There are links in your show notes at Juicebox Podcast COMM But in the end, you just need to go to companion medical.com. To get started. I think that you'll be pleasantly surprised at what you learn when you get there.
Tomas Walker 16:45
The Dexcom Pro is ducks coms most recent professional CGM offering, what places us in a unique position in the market with our professional system is we are offering patients and clinicians the opportunity to have this as either a blinded data gathering system. So you come in to the clinic and you start the system up. And it begins to gather glucose data every five minutes 280 glucose readings a day for 10 days in a completely blinded data logger mode. So there's no interaction from the patient with the device or the clinician with the device, then they can return to the clinic and download it. Or we give you the option of having the patient download an app and have a real time CGM experience with this 10 day professional system also. So the benefit as speaking as a clinician is that in those patients who are maybe they may not want to engage in it, or maybe I don't want them to engage in the data, I have the option of doing that. But the same system can be turned around and use in a real time mode to benefit both the patient and myself by giving them that real time feedback. You know, as someone who lives with Type One Diabetes, you understand that this is a disease of self management, there's 1760 hours in a year, and you might see your doctor for two or three hours a year. The rest of the time you got to figure this out and giving people CGM gives them the ability to do this. And this is the approach we took was that there are there are times when a professional CGM should be real time because it will benefit both the patient and the clinician
Scott Benner 18:21
is one of the uses here. I don't have a CGM, but I can get on one for 10 days. So we can try to figure something out. Is that one of the ideas behind it?
Tomas Walker 18:29
Sure. That's one of the potential is you know, if you come in to see me in the clinic, and I don't know why you're having these high a one sees and your logbooks look good, and maybe we're missing the nocturnal hyperglycemia, maybe you're really high postprandial than we realized. And this gives us the opportunity to get a lot more data instead of bringing me six finger sticks a day, we're going to get 288 readings a day, we're going to get a much better data density.
Scott Benner 18:52
Is it also like a test drive to? I mean, is that one way to think of it or like for somebody who can get covered for it no full coverage for Dexcom. But they not sure if they want it they can try before they drive is that there? Was that not what the thought is?
Tomas Walker 19:08
It could potentially be used as a test drive platform also for patients who are maybe not sure they want to they want to engage in this technology. I'm I'm always kind of surprised that there are a lot of patients who still don't want to engage fully in these technologies. I think it's important as clinicians that we recognize that patients have individual expectations and individual needs, and giving clinicians the flexibility with the our professional systems is something that's really unique in the marketplace.
Scott Benner 19:33
So if if someone mentions Dexcom prior to me, it's likely going to be my doctor, not me, or should I walk in and mention it if it's something I'm hearing about now,
Tomas Walker 19:42
the way you know, I strongly believe in educated patients is educated patients have better outcomes. So but never hurts to poke your clinician for what you want or what you think might help you. But if this is really this will be a device that is going to be accessible through health care providers. Okay.
Scott Benner 19:58
All right. So Okay, and it, like, tried to help me for a second. There's a pile of them in an office, I did no office or I go into my endo. And I say, hey, look, we can't figure this out. You and I don't seem to be getting anywhere. I heard about the Dexcom. Pro, I want to give it a try for 10 days to see if we can get some data that'll help us, then I get a script
Tomas Walker 20:19
for that, no, this, this will be this will be access to the healthcare providers office. So you won't be you won't be filling this in the pharmacy. You'll be getting through your health care provider.
Scott Benner 20:27
Gotcha. That's what I thought I just wanted to be certainly as I have to tell you, Arden did this a long time ago, and probably with a GE, for what and it was a blinded sensor. And what had happened was, we were asking for CGM. And Arden was having like these crazy lows overnight, but you couldn't like you said, you know, with a finger stick, you don't know what's happening. Like you just you just think this is what's going on. So they put this blind went on or took it off, the insurance company looked at the data and said, okay, you can have a glucose monitor. And it turned out that what was happening was, we were putting art into bed, you know, like you hear a lot of people doing especially in the beginning, when you really don't know how to manage your insulin. Well, we're putting her to bed at like 181 90. And She'd wake up in the morning at like 85 or 90. And I just thought like, wow, we're so good at this, like we've really figured this out. And then you know, then the blind data came back. And it turned out she was going from 192 50 and sitting at 54 hours before she would drift back up to 90 in the morning. And that was happening. Like every night. Yeah, that was very scary. It was frightening. It was like, wow, not only was I not doing a good job, like I thought I was but I don't know what's happening. And she was incredibly low. And you know, so and, and her 81 C, by the way, was still like eight and a half. Like that's how bad we were at it. Like, you know, in the beginning. It's just it's good to have that information. It's
Tomas Walker 21:51
also a strong story there that a one sees only part of the story when you're looking at managing someone's diabetes. It's it gives you one piece of the puzzle, it is not telling you everything that is going on, right? I think getting people access to real time systems in a professional manner is going to help a lot of patients, it's going to really open a lot of eyes. Something I constantly heard from patients in practice when you put them on a professional CGM, and they can see the data is when they used to come back to the clinic to me, the first thing I would ask them is what did you learn? Before I tell you anything that I've discussed? What did you learn? Because people would always have something to tell you, they would say there is no way I can eat Chinese food that white rice just drives my sugar bonkers. You know,
Scott Benner 22:31
it's eye opening for what your insulin needs are for certain a guy something just went out of my head? Do you hope that the pro can maybe also take steps to showing what CGM does to the clinicians? Like there are still plenty who don't? I don't want to say believe in it. But they don't care about it. You don't hear them talking about it with their patients like is that also the hope that maybe they'll see something that they go, Well, why am I not? Why am I not prescribing this?
Tomas Walker 23:00
Yeah, and there's a strong hope that we can get more clinicians engaging more patients with CGM by offering another professional platform and a pathway towards patients, giving them the ability to have this retrospective or this real time data, combining it with our clarity system, which I actually think is pretty good, where we can give patients these great reports. And we can give these reports to clinicians also, and kind of help the clinician to recognize the patterns that patients are having, and see what we can do to help improve them.
Scott Benner 23:27
Is that is the biggest, what is the biggest stumbling block I mean, taking insurance out of it for a second. Is it it? Do you think it's people not wanting more information? Because they're scared of it? They don't know what to do with it? Or do you think it's the doctors who are maybe a little older, I don't want to say out of touch, but maybe just haven't been brought up in this space? where CGM is so prevalent now? No, I,
Tomas Walker 23:48
I don't think we can reduce it to one factor. I think that there's a lot of issues at play here. You know, one of the things that we always struggle with clinically is momentum, there's a momentum on the patient's part, there's momentum on the clinicians part. Because every time you stop and start trying to adjust therapies, it takes time, but it's the right thing to do. And we can give people tools to make that limited time visit because you have a limited time with his clinician, if we can take that visit and make it more efficient and more impactful than we've done something good for everybody.
Scott Benner 24:18
I agree. I tell people all the time, like don't wait till the next appointment. Don't do that thing of like, like, you know, it'd be easier in the summer to do this or it'd be easier. Like everyone always thinks there's gonna be a magical time we're making an adjustment easier. It's just not like you just have to do it and, and get through it. And then it's over. It usually takes a couple weeks to a month, whether you're moving from injection to a pump, or you're moving into a CGM, like you know, it takes it's about a month before you can start making sense of it. And there's not going to be any perfect time. You know, I mean, unless you're a person who could take off for a month and go sit on an island with your new CGM and figure it out. But I don't think that's most of us, you know, most of us, right, right. I just think I'm a I'm a proponent of you know, Don't think you should switch, just a switch. But when the technology is so much better than what you have, it doesn't make a lot of sense to stay in the past. I don't think, you know, this is really great. Thomas, thank you so much. I appreciate you coming on and doing this.
Tomas Walker 25:13
No, I appreciate the chance to talk to you. And it's an exciting time. And we continue to push the envelope and try and improve the lives of people living with Type One Diabetes.
Unknown Speaker 25:21
Thank you so much.
Scott Benner 25:25
Thank you, Tomas for coming on and sharing this exciting stuff. And I mean that I know that often data doesn't sound exciting to people. But what you learned about that study is important. It's impactful. It can change the way you think about your type one diabetes index compro. That's how my daughter found out about Dexcom that so that was our first look into it. Right? We were having trouble way back before people understood what CGM is we're talked about in the community like this just didn't happen. And, you know, doctors like we can put you on this CGM thing and see if we can figure out the problem and look where it's led us. All these years later, it's the core of how we handle things. You never know what's going to be a big benefit to you in the future. So it's good to know about all of it. You know, it's November and that means diabetes Awareness Month is here, right now at the Juicebox Podcast store, the merchandise place where I sell the, you know, its shirts and stuff, but good stuff, I promise. Actually, I just got this from one of you. Thank you. I love my shirt. I ordered yours and another company's November diabetes awareness shirts. Yours is great. Theirs was made horribly. Haha. I'm just kidding. I'm sorry that this person, actually, here's what I responded, hey, I'm glad to know this. Not that you bought a crappy shirt, but that it makes a difference to you. I spent a lot of time researching the company that I'm using. So I'm really happy to hear that you're happy. Anyway, I've got some pretty great merchandise, if you want to go to Juicebox podcast.com. Scroll down to merge. Right now, the know the signed sweatshirts are on sale, I took as much of the cost as I could, there's not a ton of there's not a ton of money to be made in selling quality t shirts, you can sell cheap t shirts to people and make a bunch of money. But a shirt they're gonna love that's gonna hold up, there's not so much there. So I cut a couple dollars out of the sweatshirts, you'll see the sale there. And right now in November of 2019. If you use the code JBP fa n Juicebox Podcast fan at checkout, you'll save even a little more money. So I hope you like that. Also, the Facebook group is really growing. It's like up to 1500 people and I know some people might be like, that's not a lot. But you should see. I guess if you're really interested in talking like nuts and bolts about diabetes with people, it's a great place to be. You can find that on my Facebook page at bold with insulin, you just find the juice box discussion group and you know, try to get in there. Yeah, answer a couple quick questions. So I make sure you're not like you know, a monster. You're a real person. Then you're in what else? Are there kind of stuff can we do? Seriously the thing from November 10. The talk I'm going to do if you're in that area around Valley Forge, Pennsylvania. I'd love to see you there be really great actually, I think you'll find it really beneficial. We'll talk about a lot of stuff in the podcast, q&a, bring your decks calm graphs. We'll do our best to help everybody that's there. Hmm. Is that it? Just say Have a good weekend? No, probably.
Unknown Speaker 28:16
Yeah, that's it. Have a good weekend.
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