At this point in 2021, we thought there would be several new pieces of diabetes technology on the market. COVID delayed several FDA submissions and approvals so where do we stand? Stacey sits down with Kamil Armacki, AKA Nerdabetic, and Chris Wilson to talk tech. Both Kamil and Chris keep a close eye on everything from filings to clinical trials to investor calls and neither is affiliated with any diabetes company.
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Episode transcription below
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Stacey Simms 0:00
Diabetes Connections is brought to you by Dario Health. Manage your blood glucose levels increase your possibilities by Gvoke Hypopen the first premixed auto injector for very low blood sugar, and by Dexcom, take control of your diabetes and live life to the fullest with Dexcom.
This is Diabetes Connections with Stacey Simms.
This week, I wanted to try something a little different as we enter the end of 2021. And look ahead to next year, I thought it would be a good time to sort of take stock of diabetes Technology. Welcome to another week of Diabetes Connections. I’m your host, Stacey Simms. And we aim to educate and inspire about diabetes with a focus on people who use insulin. And while this community likes to say we are not waiting, frankly, there was a lot of stuff that we are waiting for right now, I asked a couple of friends who really have their finger on the pulse of this stuff to come on and share their thoughts. The only problem we really like to talk. So this is a longer episode than I expected. And frankly, it’s not just that we’d like to talk there’s just a lot of technology that we are waiting for. So to that end, I’m just going to jump right in, we’ll do the quick add that we always do at the top and then we’ll get to the panel. There is also video if you prefer to watch our conversation that’s over on the YouTube channel. I’ll link it up in the show notes but we are not showing any product. So it’s really just about whether you prefer audio or video.
Alright, Diabetes Connections is brought to you by Dario health. And the bottom line is you need a plan of action with diabetes. We’ve been lucky that Benny’s endocrinologist has helped us with that and that he understands the plan has to change as Benny my son gets older, he wants that kind of support. So take your diabetes management to the next level with Dario health. Their published studies demonstrate high impact results for active users like improved in range percentage within three hypoglycemic events. Try Dario’s diabetes success plan and make a difference in your diabetes management. Go to my dario.com forward slash diabetes dash connections for more proven results and for information about the plan. And as always, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
All right, welcome. We’re trying something new on Diabetes Connections. And that is the first of its kind kind of tech panel. And I am joined in this conversation by Chris Wilson and Kamil Armacki . And these are two guys that I’m gonna let them introduce themselves a little bit, but that I follow for technology news, as well as for some analysis. So thank you both for jumping on with me. You’re not industry people. But let me ask you to kind of describe yourselves first, Chris, you are somebody that I always turn to for the insight and information about technology. But this is not what you do for a living?
Chris Wilson 3:00
No, not really. I sort of jumped into the online diabetes online community when I reached a point where I had access to insurance and could actually look at diabetes technology because it became affordable. And at that point sort of started jumping into a lot of the groups and online discussions tried to figure out what I was interested in for myself at the time. And then over time, I wound up being asked to join the admin team of a couple of the bigger Facebook groups getting involved on Twitter and other platforms. And so now i is part of that role. I sort of find and analyze listen to the investor calls that the companies do, you know, sort of keep an ear to the ground here what people’s sales reps and endos are whispering about to to their patient populations and glean some information from that. I’ve also been a frequent participant in research, especially in clinical trials. I was in the clinical trial for the G6 that prove that acetaminophen didn’t interfere with it. I was in the clinical trial for the Xeris Gvoke. I was in the clinical trial for the Ilet, which is still apparently ongoing. I’ve got a fair amount of experience for playing with stuff that isn’t necessarily out yet. And sort of seeing things from a different perspective than just the end product that people see when they finally get a prescribe from their doctors.
Stacey Simms 4:23
That’s great and comedic view or better known as Nerdabetic. On social media, many people probably recognize your Omnipod. Those are Omnipod pods lit up right behind you.
Kamil Armacki 4:34
That is absolutely right. That is 550 inch LED Omnipods. Most of them this is very DIY. Most of them actually placed with LED lights and painted and we saved them on a temporary wall kind of thing and we glued them off. So we had this is one of the proudest things I’ve ever done as Nerdabetic I also can’t really take credit my dad that 95% I only paid a couple of walls, and I feel like I’m taking all the credit. So massive shout out to him.
Stacey Simms 5:07
I love it. I love it. And as Nerdabetic, you are known for interviewing CEOs getting all sorts of tech information out there. And we’ll probably mentioned this at least once later on, you do a lot of both, you do some 3D printing, right to see what the items might look like. Yeah, so
Kamil Armacki 5:23
I’ve been running my YouTube channel for I think four years at this point, just when I started university, and I just graduated this summer. So it kind of it was over four years ago. So you just been trying out different things within within that channel. One of them was 3D printing. I’m absolutely fascinated by that technology. I don’t own a 3D printer. But I think it is a very interesting way of giving an idea, a bit of a tangible feel to it. So for doing that, and all of those things they mentioned. And most recently, I had the honor of speaking to some pretty pretty important people in the industry to see what’s been happening over there as well.
Stacey Simms 6:01
Cool. All right. And Kamil is in the UK, obviously, you sound like you’re based in the UK, but you are there now, which means some of this discussion will include information from the US FDA, or at least we’re gonna speculate about that same thing, European CE mark, but some differentiation of products there. But I just thought it’d be fun to talk to you guys. So all right, we’ve got it out there. And I’m a diabetes mom, I read stuff, I listen to stuff, I don’t think quite as much as Chris, or Kamil, but that’s my knowledge base. So just to be clear, nobody who works for the FDA, nobody who works for diabetes company, we are just observing and birth speculating, which I think would be some pretty fun and interesting conversation we’ll see. So let’s start by talking about what is in front of the FDA right now, because this year, and last year had seen some big delays due to COVID. So we’re waiting. I mean, it’s been a long time. Let’s start with Omnipod 5. And that is, of course, still as we are speaking, I mean, who knows what will happen today or tomorrow, but it is still in front of the FDA. But what’s interesting is when they submitted and Phil, I know you talked to their CEO recently I talked to her I believe right before they submitted, it was going to be very different from the other commercial hybrid close loops in that the range was going to be lower. In other words, your blood sugar range, initially, I believe, was supposed to be able to get below 100 As a set point, but now it’s 110. And they do have all sorts of really interesting other features. What did Shacey Petrovic, the CEO of Omnipod share with you recently, when you talk to her anything changed, or anything that stood out to you?
Kamil Armacki 7:36
Yeah, so I’ve spoken to her a couple of weeks ago at this point. And the product that they’ve submitted to the FDA, for my understanding, has a target glucose, which goes as low as 110, and can be customized up to 150 milligrams per deciliter. In terms of the actual product, I think I’m very excited about Omnipod 5, because it will be the first product, the first pump, which actually talks directly to the Dexcom G6 continuous glucose monitor. So there’ll be no need to carry a physical controller, which obviously, I think makes sense for a product like Omnipod because you know, you wear it on your body. And so it will connect directly in terms of actual updates to submission as of a couple of weeks ago, she said they still expect an A by the end of the year, with a limited release in the US. And during that interview, which was slightly kind of European focused. We talked about many things including Omnipod on the runway during Italy’s Fashion Week in Milan. But she also mentioned that they are hoping to bring that technology to their to Europe to the UK, once they get their FDA approval.
Stacey Simms 8:48
When you said the first one or the only one do you mean in the UK? Because we’ve got Dexcom talking to Tandem, at least here in the States.
Kamil Armacki 8:55
First one where you don’t need so where the pod talks wearable talks throughout behind okay. Yeah, I thought directly to the G 610.
Stacey Simms 9:05
Is control IQ approved in the
Kamil Armacki 9:06
UK stupid question. Yes, we have. So at the moment, we have control IQ and seven ATG which we will I’m sure mentioned Oh, yeah. Okay. I didn’t come EPS actually. So we have three other countries across Europe. They have other systems like dialup as well, France, Germany, but we don’t have that one here. Yeah. Hashtag Brexit.
Stacey Simms 9:28
I was gonna say show off, but then right. It’s not in the UK. Lots of and there’s other systems coming to that we may get to, Chris, anything that you have heard over the last year in terms of Omnipod? Five. I mean, I just feel like we’re kind of waiting.
Chris Wilson 9:40
I mean, just from my view on the outside. I think that insolence estimates of hopefully getting it before the end of the year, probably right. I know that it did qualify as a breakthrough device. So it’s supposed to have a faster review at the FDA, but we’re still dealing with the COVID backlog with all kinds of stuff. For me, there’s things that we probably expected six months ago, there’s still pending. And I know there’s always rumors circulating that this got approved, but it hasn’t been released yet. And so half the time I’m going and checking the FDA database for what approvals were announced in the last week.
Kamil Armacki 10:16
Only Chris does this kind of stuff.
Stacey Simms 10:20
I did have an interesting question from a listener who was talking about Okay, so as we’re taping, Dexcom g7 has not yet been submitted to the US FDA, it has been submitted in Europe. And her her thought was like, Oh, my gosh, if Omnipod has been sitting there all this time, and Dexcom hasn’t even submitted, how much longer is it going to take? And my point to her was, it’s not as though Omnipod and these other submissions are just sitting in a file cabinet. Right? I mean, they are actively being looked at. You’re both nodding. Can you tell me a little bit about what we know I mean, these submissions again, they don’t just land on a desk and then one day someone opens them and rubber stamps them.
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Now back to Chris answering my question about FDA submissions.
Kamil Armacki 12:00
Yeah, so for the pandemic, the main reason as to as to why we have a backlog is that regulators that used to regulate that were in charge of regulating medical devices like continuous glucose monitors, hybrid closed loop systems. And this is across actually Europe and US it’s very similar, simply because of the pandemic, they were actually responsible for overseeing all of the medical queries related to the pandemic from, you know, vaccines emergency authorizations. So that’s what we call when a product is used in a slightly different way to kind of simplify it. And so using a CGM and hospital was a good example of that we seen an emergency authorization of that, so they’ve kind of, you know, dos thinks took priority. So too, you know, that’s where we have a backlog, but now they from my understanding, kind of back on on track, and, you know, four hands on that backlog, working their way through it.
Chris Wilson 12:57
There’s just only so many people to do the work. And I mean, even when stuffs in development, there’s always a lot of back and forth between the company that’s developing it and the FDA, what are you going to require us to do, and so then they alter the product design sometimes to make it fit what the FDA wants, and that can even go into is as deep as the training modules. And the other information that gets given to patients when the product is prescribed, they’re looking at all of that they’re looking at human factors testing are people you know, able to follow the directions and use it the way that it’s intended to be used, are they going to do something stupid and mess it up? They’re looking at all of that. And then they’re going through all of that data on all the different aspects of the devices and needing to decide, okay, is this safe enough to actually be effective? And there are different standards in Europe versus in the US? The FDA has much higher safety thresholds, whereas the European standard is basically does it do what it says it’s going to do?
Kamil Armacki 13:58
And just to close up Omnipod 5, I think FDA has added it Chrissie would agree this is just my personal opinion. I think FDA has been pretty scared of going to full control. And the biggest today there isn’t an insulin pump, which offers, you know, remote bolus capabilities. And that’s part of Omnipod 5, you know, that’s what they’ve submitted to them. So, you know, my speculation would be that if actually they didn’t submit full control within that first submission, maybe we already you know, maybe it would be here already. You know, it is an area that FDA has been very cautious about. So I guess that’s a significant factor contributing to to the to the backlog as well to the delight.
Stacey Simms 14:40
Well, and that brings us to our next item that’s in front of the FDA. Thank you for setting that up. So Tandem has also submitted in the last year and is waiting for bolus by phone. You know, that’s not the official name of it. But I agree with you. I think the FDA is really taking a very, very careful look at that bit of technology. And Tandem, you know, I believe, to your point, Chris, there has been some back and forth. You know, they don’t issue press releases. Every time they asked for that, but it is happening, I think, to me, you know, as a mom of a kid who takes his phone everywhere, you know, this is something that I cannot wait for. I mean, bullets by phone just seems like such a basic capability in 2021. But of course, it’s a medical device, and it’s your phone. Chris, are you hearing anything? Or do you have any opinion on that?
Chris Wilson 15:29
I mean, at least as far as Tandem goes, I think there’s less of a risk because you still actually have the physical pump that can be used to do something if for some reason, there’s a problem with the phone. If you’re relying exclusively on the phone, you’ve got to worry about what happens if it gets lost. What happens if they’re dead batteries? What happens if you unlock it and hand it to your kid to play a game and the kid goes into your bolus app and accidentally gives you 15 or 20 units of bolus while they’re chatting around? I mean, all of those things need to need to be taken into consideration and mitigated as much as possible.
Stacey Simms 16:01
I wonder Kamil, it’s interesting to think about Omnipod because they’ve when I’ve talked to them, I’ve always asked like, why can’t you put some buttons on the pod. And their point was, and I think this leads to Chris’s point from the phone, their point has always been well, it’s for safety with the pediatric patients, they don’t want the kids touching the pod pressing buttons, this makes perfect sense. I was a parent of two small children, they’re gonna touch everything. But it’s kind of the flip side now on the phone, right. So it’s an interesting look to see what you trade off in a way.
Kamil Armacki 16:31
So actually, to that point, in the UK, we do have an insulin pump from rush called accucheck. Solo. And on the high level, it’s kind of like a nominal pot, where the pot like device that you put on your body and actually has two buttons on it. So you can actually bolus from the patch itself. And the way they’ve actually engineered it is that you need to press both buttons at the same time, ensure that you don’t kind of you know, lean on the you know, you could very easily lean on a button and just press it, you know, other companies have gone down that route as an Omnipod. To use that I do use a monopod. So I use Dexcom and Omnipod in a DIY setting. And yeah, I love the simplicity of it. So yeah, massive, massive fan.
Stacey Simms 17:14
I think it’s just all trade offs. Right. I mean, there’s no perfect system, I don’t think but people want to perfect. Exactly. Right. Exactly. Chris, what do you use? If you don’t mind me asking?
Chris Wilson 17:25
I am on a Tandem with control IQ, although I don’t use it exactly as designed. I’ve been working with better bullet strategies and playing with the modes that have put that it gets put in be an exercise or sleep that change some of the the targets that it’s trying to hit to get it to behave a little bit more like I think it should.
Stacey Simms 17:47
So you’re using Ctrl Q and Kamil, you’re using
Kamil Armacki 17:50
loop? Yeah, that’s right. Yeah. on any iPhone. Yeah.
Stacey Simms 17:53
All right. I don’t want to move on from Tandem quite yet. But I want to talk about loop in a moment. So we’ve got bolus by phone in front of the FDA, which we also think could come approval could come by the end of the year, but Tandem moved their submission for TSport. Right. They were going to submit that in 2021. Chris, they are moving that to 2022. Right.
Chris Wilson 18:12
That was the last that I heard. Yes. To me.
Stacey Simms 18:16
I see you nodding.
Kamil Armacki 18:17
Yeah, I agree that that’s what my understanding of the T sport is, I think they had some communication with FDA with the phone control, which obviously plays into T sports as well. Like the point Chris was making, you know, there’s no display I don’t think on the although, you know, it’s a patch, you know, it’s kind of moving into that kind of tubeless to pipe bridge mode kind of pump. So yeah, I’m pretty sure they’ve decided it’s pushed back further.
Stacey Simms 18:48
And I should have set that up better if you’re not familiar with a tee sport is a very tiny version of the T slim it is been to me it looks kind of like a beefed up cartridge and it sticks somehow to your body. There is still a tube and there is still an inset, but it kind of I don’t know if it dangles off, or it sticks some I don’t know. So they haven’t they haven’t released that I’ve asked a bunch of people when Lily a while ago was coming up with its own pump and it was supposed to be inset and sticky. I’m still trying to figure out how it supposed to stick to your body with an inset and they haven’t really explained that. So maybe at some point, but clearly you made a 3D version of this yourself right? Didn’t you like mock up a Teesport at one point and freak everybody out? Because we thought you had one?
Kamil Armacki 19:27
I did. So just on that entire idea in general, there’s actually a pump in it’s been kind of out here in Europe and has been taken off the market and I think it’s coming back at some point called collider which uses a similar idea of where three colors bright colors. Yeah, so So that’s kind of it’s an interesting concept because you have an infusion set and like a sticky dye upon your body. And I think it that’s what Tandem has gone off as well. But yeah, I did. It’s very interesting how people often will look at especially on YouTube because it’s a very visual form, they will look at a picture without watching the video. And yeah, a lot of people thought I had some insider info on the T spot, which was a very interesting experiment and a lot of comments about that go like, where did you get this? And I’m like, I didn’t Freeview print hello, it’s 2020.
Kamil Armacki 20:19
Be careful, be careful, hey,
Chris Wilson 20:21
I need to take some of the blame, actually, I think for potential delays on the other Teesport, I was involved in some of the Human Factors testing. And based on some of the questions that I got asked afterwards, I think I may have done some things that they weren’t expecting it some stupid things or something that was not dissipated. So that may actually be the source of some of the
Stacey Simms 20:45
Alright, well, if you can’t answer I understand what the heck could you have done? What
Chris Wilson 20:52
I think it was, it was just in case of directions weren’t necessarily clear. Or I was expecting, you know, think about this, rather than actually do it. I obviously can’t go into specifics. But needless to say, I clearly wasn’t doing everything that they expected as part of the tasks in the testing. So who knows that may be part of the the reason that things got delayed, but hey, if it prevents somebody else from doing the stupid things that I did, and having a problem later on, then that’s actually a good thing. And actually,
Kamil Armacki 21:24
I’m so glad that you did, Chris, because so many companies have tried this idea of you know, having a patch and in a short tube. So novo, they went out of business Kaleido also really struggling, we don’t really know if they’re gonna come back. And Tandem is now trying, they’re kind of stab at it. No one has really made this idea work. So
Stacey Simms 21:43
yeah, it’s a good point. But one thing I do like, again, I don’t have diabetes, I don’t wear the devices. But the idea I like is that with an inset, you do have a choice of how it connects angled or what the cannula length is, or steel, you know, with Omnipod, or you don’t have as many options in terms of how it connects. Now, many people will say to counter that, well, you have many more options of where you can put it, you know, so it really just depends on how you wear it where you’re comfortable with. But I think that’s why they keep trying cumulus because there’s that different kind of inset that people can use. So who knows? But I think that’s a really good point.
Chris Wilson 22:18
Well, it’s a great example of how your diabetes may vary. Yeah, no one solution is going to work for everyone. So that’s why it’s important that we have these options.
Stacey Simms 22:27
Alright, so let’s talk about loop. One of the other submissions. This is such a laundry list in front of the FDA is tide pool loop. And that was submitted earlier in 2021. It’s been very quiet, but it is it’s hanging out there. Anybody here anything? Anybody know anything? Any comments?
Chris Wilson 22:45
I really haven’t heard anything. I mean, it’s so pure speculation. Obviously, this coming from the open source community is going to be subject to a lot probably more scrutiny than if it’s coming from an established player. And I was not entirely clear on exactly what the trials for approval looked like. It sounded like some of the DIY data from DIY loot may have actually been used as part of the submission. So I would imagine that that’s probably at least one of the things that may be taking a little bit extra time because I’m feeling the FDA is probably going to look a little bit more closely at that than they would if it was coming directly from Insulet. Or someone else.
Stacey Simms 23:28
That’s a good point and was used I believe, that’s what they told me earlier this year was a lot of that open source a lot of that DIY community data was put in so you wonder what then the FDA came back and asked for no, no, what we really need is or no, that is enough. I mean, we’ll find out later, but it’s very interesting stuff.
Kamil Armacki 23:46
And in some ways, it is a perfect storm, because it is using, you know, using that DIY technology, which is just absolutely amazing. I mean, the whole title team has been so tremendous in this project. So it’s you know, taking that DIY, but then also the phone control point that we mentioned earlier, where it’s an Omnipod. So actually, you know if your battery dies, I’m sure everybody’s asking those questions. You know, if your iPhone dies, how is the child going to bolus? I’m sure that those are the questions that you know regulated system has to they need to have that usually answers for that. So I’m sure they face in similar scrutiny on the phone point just like Omnipod 5 does with eventually
Stacey Simms 24:26
this just occurred to me and again, I don’t use the system so that’s probably way to think about it, but these DIY systems that already use the phone can you use your watch to control them to Kamil, I wonder if that’s something that’s done? Yes.
Kamil Armacki 24:39
It’s it’s just like with Dexcom you still need your phone. So phones like the the house the home of the of the whole system, you can remotely you know, bolus and enter carbohydrates and Al’s meals etc. Using your Apple Watch. Bought a phone is still required to actually do all of the calculations the brain behind all of it on Omnipod, five doc, this all happened on the pod both title loop that’s all happening on the phone just like with a DIY system. Oh, yeah, that’s a really good point. So you really need that to to make this system work. And there are all of those you know, your phone die in, you know, someone’s stealing your phone cases that you know, I’m sure FDA is wants answers for
Stacey Simms 25:22
it to be clear, because a lot a lot of information there. I think this is a good point Omnipod 5, as you said, controlled by the pod. So you lose your phone, it keeps on trucking, it’s going to deliver basil, the loop will continue a tide pool loop and loop DIY, whatever it’s called right now is all controlled by the phone. So if your phone dies, the system won’t continue.
Kamil Armacki 25:40
Well, so by design, it will always deliver background insulin in the way that it’s intended. I mean, my phone dies, sometimes you know, it’s live, right? I’m a 23 year old. Me because it is difficult to keep it charged in the pub. So you know it does happen. So and those are kind of a real world cases that you know, I’m sure FDA is also asking about. So with the DIY system, and I would assume with Title loop as well. But that is just my speculation. When your phone dies with the DIY system, it automatically goes to the default background rates for you kind of bolus because you need your phone to do that. And I would assume it would be relatively similar of tide pool loop, because I don’t think there would be making a separate backup device like Omnipod just doing with Omnipod 5. Okay,
Stacey Simms 26:31
thanks. Alright, last item that is in front of the FDA, I think is the Medtronic 780, which is already available in Europe.
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Now back to Kamil answering my question about whether the Medtronic 780 is available in Europe?
Kamil Armacki 27:34
That’s right. Okay. So 780 G has been here for it’s been approved last summer. So kind of just as COVID was kind of a couple of months in, and it’s been rolled out across various countries in Europe. I think we got it in the UK earlier this year. Well, I think the 770 G’s, the newest version that you guys have in the US. So the 700 pumps, they all have Bluetooth built in. So you can have your pump alarms, all of that on your phone, no control. But you can view everything by the 780s, kind of the newest pump in that line, which has a new brain new algorithm. In my view, it is completely different. Because actually, it’s not really made by Medtronic. It’s made by an Israeli company called Dream met.
Stacey Simms 28:23
So that’s free. That’s right. The algorithm is from Dream Med, I’ve interviewed them, I forgot to actually
Kamil Armacki 28:28
said that in one of my videos, and Medtronic wasn’t really happy with me. So
Stacey Simms 28:32
I feel like we have it’s ours. Now. It’s been,
Kamil Armacki 28:35
they officially said something like it’s built by a dream met with Medtronic engineers. So you know, it is a partnership. And that’s apparently true. You know, I have no reason to deny that. So I’m sure they work together on it. But you know, the the foundation of seven ATG is actually completely different. It’s not like they took 670 and added a couple of capabilities. You know, it’s a great we design I mean, on the outside, it looks the same, but actually the the actual brain inside is completely different. And I guess one of the one of the key things that we mentioned is actually the ability to have your glucose set as low as 100. You know, people have diabetes across Europe, they’ve they’ve been really kind of enjoying that. And it has automatic corrections as well. So a lot of people listening to this might not be as techie as we are. So just in simple terms, it kind of matches control IQ, I would kind of say in terms of the feature set, maybe slightly better, because you can reduce your target to 100, which I know a lot of people have been asking about. I don’t know if you agree, Chris, without saying it’s kind of at the same level as control like you
Chris Wilson 29:37
from a tech perspective. Yeah, they both the the key difference or the key feature there is the automated correction boluses, which is what differentiates what they call an advanced hybrid closed loop from just a standard hybrid closed loop, which is what the 670 and 770 were, it’s nice to see more high tech options coming to the market from more players. says it gives people more options.
Stacey Simms 30:01
That’s interesting, though about any kind of criticism for mentioning dream, Ed, because I mean, control IQ was developed by type zero technology, right? Wasn’t it like a University of Virginia thing that then Tandem bought? Yeah, well,
Chris Wilson 30:14
it got bought by Dexcom Dexcom, bought type zero and then license the tech to Tandem. So
Stacey Simms 30:22
interesting times. And we should also mention that all the Medtronic systems use their sensors. This is not yet a mix and match world, I believe the Medtronic sensors, and I keep hearing that they’re much better, but still need to be calibrated. So even the latest version No, your shake your head, Kamil tell Oh, that’s right. We’re waiting for that approval in the US.
Kamil Armacki 30:42
Well, so. So guardian for has been approved in three guardians. And so that’s the no calibration version. And it’s I know, like one person who’s using it. So it’s not I think they slowly roll in and out. They haven’t really started shipping it yet. But it’s basically what we all know, as guardian free just with with no calibrations. As far as I’m understanding the accuracy is not improved. It’s kind of the same, if not slightly worse, from a margin perspective with Guardian four, compared to Guardian three. And yeah, I think it’s in the FDA backlog as well. I’m gonna go ahead and
Stacey Simms 31:21
just double check that on my end only because it’ll be good to know the actual mark from their studies and things like that. So we’ll pop that into the show notes. But I think you’re exactly right, because I was just doing the time. It’ll be interesting to see what the time shift is, in terms of episodes being released, because we were just doing our game show. Wait, wait, don’t poke me for friends for life. And I actually I can’t believe I forgot I asked this question about Guardian four. Because the codename for it or at least the in house name for it was Zeus. So we had been talking about Zeus for Medtronic for a long time, no calibrations I know this is the I get in the weeds of the trivia and then I forget what I know. So thanks for correcting me. Alright, and then Alright, let’s talk about Dexcom. Because Dexcom g7, as we’re taping g7 has not been submitted to the US FDA, but it has been submitted for European approval. Kamil, you had Dexcom CEO on your show, wearing and showing off the device. I was so jealous when I saw that I’m gonna yell at Kevin Sayer. Next time I talked to him. But yeah, tell us what that was like and what you thought of it when you saw it.
Kamil Armacki 32:27
You know, I’ve been the massive Dexcom advocate, I pay for my own decks because I’m not an ambassador, I just genuinely it’s been a life changing product for me. And yeah, it’s been it’s been an honor speaking to him. So you’ve spoken to him a couple of weeks after they announced that they submitted for the for the European European approval. I mean, it looks tiny, as I’m sure you’ve seen, if you’ve seen the video, I’m incredibly excited to see kind of how that one develops, and from literally a couple of days. So they kind of in the investors call, like Chris was saying, I also sometimes tune into those, and they confirmed that the expecting to get that approved in Europe by the end of the year.
Stacey Simms 33:07
It’s interesting. And Chris, maybe you could speak to this, for people who might not be that familiar, the Dexcom technology, while it is very different from the G6, the speed at which it might get approval, Europe is one thing, right us is another this is not like an insulin pump, we don’t expect it at least to take quite as long as insulin pumps are different systems because it’s not putting insulin into your body, right? It’s just measuring,
Chris Wilson 33:28
but it is being used to calculate doses of a high risk medication, which is insulin, there’s definitely still some concern as far as how accurate it is. And if it’s off it, how off? Is it? Is it going to cause a problem? But I’m really excited with the clinical data that they presented. I think it was at EASD Earlier this year, showing that the g7 the marred the that measure of accuracy that they use is actually now under 8%. With the g7 which I mean we’re getting into how much more accurate can we reasonably get just because there’s so much variation in human body that I mean, you can take six fingerprints from six different fingers and get six different answers from his standard meter. The fact that we’re really dialing in the accuracy is as tight as we can and actually ever since is almost in the same boat with their new Wow, what any product they had. I think two versions I recall, but that’s coming as well. And the the 180 day version as long as we’re talking CGM. Yeah, there is no absolute answer for anything. This is actually I was in a study last Thursday, where they were seeing how long I could go without insulin. But as part of it, they’re they’re monitoring it with a y si, which is this reference grade laboratory meter that they actually do a blood draw and they centrifuge it down. And then they measured the glucose level in the plasma without any of the blood cells in it. And that device in the lab was actually not putting out the correct numbers, there was some sort of hiccup, they had to restart it to get it to come up. But my Dexcom was matching, and then they compared it to multiple Ultra accurate fingerstick meters and set to figure out what was going on. But, you know, nothing’s perfect. This was, you know, elaborate reference glucometer. That’s the most accurate one that you can get. And they don’t even make them anymore.
Stacey Simms 35:23
I will never forget, when Betty was little like poking the same finger, you said six different fingers, who put the same finger three times in a row because it was confusing or something. And it was always three different numbers. It’s crazy.
Chris Wilson 35:33
I just think it’s important that people keep in mind that you know, nothing is ever going to be perfect. whatever device you’re wearing, however, you’re measuring your stuff, there’s always going to be variation, it’s never going to be exactly the same number every time on every device
Stacey Simms 35:46
you mentioned ever since that’s the CGM that goes under your skin. And then the transmitter goes on top. And Kamil, you are you’ve got a little bit are you using the libre as well like to test it out? Or did you? What did you show us earlier,
Kamil Armacki 36:00
I am trying the free celebrate free, which is like the newest version. It’s not available in the UK, I should make it very clear. But someone bought it for me in Germany. And they imported it over to the UK is actually it’s actually been a very interesting over here. Because obviously it’s it’s not available in the UK. So I had to enter freestyling briefly, there was no physical receipt, but you need to get an app. So only use your phone, you can only use your phone, there’s no physical reader, there’s no physical device, which I don’t know how that’s going to work with, you know, children going to school and you know, having to carry phones, but anyway, but it’s not available in the British App Store. So I had to create a German Apple ID. And everything on my phone is German. So I gem Apple Music, German podcasts, everything is in German, it’s still English. But other than that I have been enjoying my German lifestyle over the last I’ve had it for four days now. So it’s been it’s been fun.
Stacey Simms 37:03
What are the different features like what’s I’m not as familiar with the Libre system. So what is new with the three,
Kamil Armacki 37:08
it’s much smaller, it’s much smaller compared to the first two. And on a high level, it works exactly like you would expect a CGM to work like Dexcom web, no scan and it just always shows the value and the glucose your trends alarms ever found on your phone. So they kind of made it work in exactly the same way as at the center of Dexcom. But most importantly for me, they keep them the same price. And I think that’s very important for a lot of people have diabetes here in Europe because I mean, Libra has been a giant success in the UK for example, just because actually, because of its price point it is accessible to the National Health Service. So it is you know reimbursed to you know, vast majority pretty much every single person of type one who wants it to get can get it. And libre two is the same price point is libre one and now libre free. In Germany, when they did launch, it’s also the same price. So they keeping it the same, which is which is very reassuring
Stacey Simms 38:08
process, we’ll see what happens in the US. But that is very reassuring for our friends in Europe. I went device I meant to ask about and didn’t but I don’t think it’s been submitted. And that is beta bionics and the iLet. And Chris, you kind of alluded to this much earlier in our talk, because you were I believe in one of those trials,
Chris Wilson 38:25
I was at least told that I was patient number one at the trial site that I was at.
Stacey Simms 38:33
But we don’t think we don’t know for sure they have not submitted down or have they?
Chris Wilson 38:38
Well, I keep hearing parents and other patients still people diabetes, still saying, you know, I just finished my time in the primary phase of the trial for the eyelids, or now my kid is going into the extension phase, things like that. So if the trial is ongoing, clearly, I don’t think they’ve they’ve submitted yet. It’s definitely more hands off. I won’t lie my time and range did go down a little bit when I was on it.
Stacey Simms 39:03
But your your time and range we should specify is extremely high.
Chris Wilson 39:06
Right? My 90 day average right now is 94% a week going into the current trial, the arm of the trial that I just finished was actually 97.
Stacey Simms 39:20
So it’s all relative, but otherwise. Yeah. But it’s a good point in that, you know, the eyelid is much more hands off, as you mentioned,
Chris Wilson 39:32
right? It’s you know, no correction boluses there’s not even mechanism to do it. All you can really do is tell it when you’re eating and give it a rough guesstimate as to the meal size. So I would imagine especially for people who want to be more hands off with their diabetes and have good control because of the control wasn’t bad by any stretch of the imagination, that it’ll be a very good option for a lot of people once it does get approved. And this is the Insulet only version. We’ve still got The version with insulin and glucagon having both a gas and a brake will definitely make it easier to drive the car going forward in the next version. So we’re looking forward to, to them starting the trials on that as well.
Stacey Simms 40:13
Yeah, it is all relative. I mean, I just think about my son, you know, he misses a couple of meal boluses a week for sure. And I think he would happily trade off control, you know, to just have that kind of stuff be taken care of. It’s so interesting to see how I mean, I’m, I’m, I know, we’re gonna get somebody questions as Chris gets so much time and range, what is he doing with control IQ? So that’ll be another episode tips and tricks from Chris to or maybe the maybe the tips and tricks, Kamil is just spent a lot of your time in diabetes trials? Yeah. I mean, I kidding. I know. That’s not it. But
Kamil Armacki 40:48
well, you’re my time and ranges, but it’s knowing me about? Very, very happy with it. I like to say that my time and happiness, though is 98. If not 100%?
Kamil Armacki 41:00
Go? And that’s what matters. Yeah, right.
Stacey Simms 41:04
Chris Wilson 41:05
I mean, that we joke about doable, do a lot of trials. And it helps. But there is definitely some truth to that. I mean, I get to talk to and interact with some of the top endocrinologist in the world, right? Sometimes, you know, on a weekly basis. So I’m going into the clinic to have an injection of something that they’re testing out or to check in and let them download the data from the device that I’m testing in half the time we’re chatting while they’re doing other stuff. And you know, discussing the theories that underlie a lot of this stuff. And it definitely deepens your understanding, if you want to really understand diabetes, more and more like an endocrinologist does that say, it’s a great way to gain some experience?
Stacey Simms 41:49
Let’s talk a little bit. We’ve talked about what’s happening and what we’re waiting for. So let’s talk a little bit about what we’re excited for. And not just the products that we mentioned. But if there’s anything else that’s on your mind, I’m curious what you guys who live with diabetes, you use these devices, you follow this tech? Chris, what are you looking forward to? And I mean, it could be something that we talked about, or something that’s like maybe 10 years from now,
Chris Wilson 42:10
I think probably the thing that that’s most interesting, I mean, to a certain extent, the tech we even if it’s not there yet, we know where it’s going. Yeah, where it’s sort of the end point is the point is you were a sensor, you were a pump, and it does everything for you, and you don’t need to worry about it. But beyond that, I think one of the things that I’m most excited about is seeing the medications that were originally designed for type twos being used in more type ones. Yeah, since most type ones do have some insulin resistance, it’s actually you know, a known thing that happens, it’s partly just due to the fact that normally, insulin gets made on in the middle and spreads out to the edges, and we’re infusing it from the edges and having it go into the middle of the circulation. But things like I know, Stacy, you’ve mentioned in the past the SDLT, two drugs that help us her pee out the excess sugar from your blood, those have shown really great improvements in kidney health, cardiovascular outcomes, and making those safer for type ones, since it can cause an issue with going into DKA even though your blood sugar’s stay relatively normal. That was actually the the test that I was last Thursday was checking a new drug that as an add on to help reduce the chance of that happening if you’re a type one on one of these medications, but there’s lots of different classes of medications that are coming out things that not only enhance the function of insulin, but potentially block some of the functions of glucagon to help improve things since they’ve documented that. A lot of type ones the the sort of regulation and counter regulation in insulin, the insulin glucagon axis, I guess, it does happen with a fair amount of frequency in people with type one. So that may be something moving forward. And actually, it’s not even necessarily just diabetes. They’re testing this medication that they were trying to lay on me as an enhancement for cancer immunotherapy. Wow. In North Carolina, I somebody was asking me about something. And so I went on the clinical trials website, it was digging into what said he’s looking at this drug and found a study that they were looking at it to see if it’ll enhance the ability of some immunotherapies for breast cancer. So I mean, a lot of this stuff may even have ripple effects outside of diabetes.
Stacey Simms 44:33
That’s really amazing. All right. That’s a great point. I love that. All right. You know, you don’t have to go outside of technology. I mean, that is still technology gets medication, but can we what are you looking forward to? Are you looking at down the line? I’m
Kamil Armacki 44:46
going to keep this one very, very simple. I’m just looking forward to seeing more access to all of this. I feel like in terms of getting incredible technology. I feel like we could summarize all of this all of today’s talking Massive tech, right? We have incredible continuous glucose monitors even better on the market. And even better versions of them are common over the next year or so with g7, libre free etc. Same with pumps, that technology so sadly, isn’t really accessible to so many people. And this applies to so many regions, so many countries in the UK, we now have an a trial of 1000 people with diabetes trial in closed loop technology to hopefully have our national proof that it does work is self restraint and actually seeing all of this because, you know, it’s like every single country wants their own proof even though you know, there are so many trials from all over the world proven that yes, actually, it does help people. But you know, it is a very bureaucratic process. So I’m just looking forward to actually see in 1000s, if not millions of people have access to CGM. And then if they choose to hypertrophic therapy.
Stacey Simms 45:55
That’s wonderful. All right. Before I let you go, this last question, it’s not really a great follow up to our discussion about access. But this is one that it just honestly, it drives me bananas, and I want to get your opinion on and that is this every other day, I feel like someone is asking me when the Apple Watch is going to monitor blood glucose with non invasively. Right, that I know, right? You’re gonna get the watch, it’s gonna read your blood glucose and then move on. And I get these questions all the time by people outside the diabetes community, frankly, who read about it or hear about it. What’s your take? I mean, I know what’s coming. I hope it’s coming. I don’t want to I feel like I’m the hope killer. I go on these threads. And I’m like, unless you see a clinical trial, right. It’s not going to happen. But I feel like it is coming it will be useful to some people sometime, right?
Chris Wilson 46:44
I think, absolutely. I think there’s a couple of companies that are pretty far along. In the process of actually doing non invasive glucose monitoring. I think you had an episode recently, where you mentioned one where they look at the eye, yeah, within the eye, which is cool. I’ve heard of a couple of different texts that are technologies that are being introduced, using either heat at low levels infrared, to potentially sense it, or radio signals, believe there’s a company in Israel that’s working on that as well. Yeah, they’re probably not good enough to necessarily dose insulin from yet, but they’re getting there and the tech keeps getting smaller and more portable and stuff, I think there’s a company in Germany that’s got the tabletop scale right now, where you can just basically put a finger into on the sensor and it will give you an estimate of your blood sugar in there hoping to scale that down to being a portable device that will be non invasive, and then eventually a wearable device that will be non invasive. So it’s, it’s definitely coming, but the stuff takes time, there’s so figuring out serve a lot of the ways that the various sensing technologies interact with the body and figuring out exactly how best to estimate your blood sugar from the readings that they get back. So it’s coming. I’ve seen presentations with actually impressive accuracy, especially considering that it’s non invasive, but I don’t see it any time at least probably not in the next couple of years, but especially integrated into a consumer device like an Apple Watch.
Kamil Armacki 48:13
I completely agree with Chris I think especially as someone living with diabetes we tend to look at this from a you know, kind of a medical point of view but if this ever were to happen, it’s really a health companion and I think that entire trend have actually seen a lot of what I would consider mainstream technology companies you know, Apple Samsung, you know, those kinds of players becoming more involved in health is a good thing because I think you know, we’ve heard of so many stories of you know, people using you know, Apple watches and you know being alerted that actually your heart rate is too low or too high and actually you know, if you deploy that kind of capability on you know, a population scale you know, with with millions of people using Apple Watches, it really drives you know, big changes and cold drives colossal impact on you know, general population you know, how we live our lives for if ever does happen I mean, we hear about this all the time and literally this year I think it was six or seven days after Apple Watch Series seven came out there was already a rumor saying the Apple Watch Series eight Yes. Well habit and I saw on Twitter and I just went I just did this emoji six days, six days the longest amount of time we can have without any rumors about Apple Watch.
Stacey Simms 49:39
It just shows you how much money is in it
Kamil Armacki 49:43
It’s click bait, interesting topic because you know it is the next frontier that you know everyone is trying to tackle. Yeah, so I understand the excitement bore and sometimes I’m probably causing it because I have talked about as well. In my in my printer diabetic days, I I was excited about it. I’ve been excited about as Nerdabetic, and we can’t not be excited.
Stacey Simms 50:05
Well, even this episode, someone could clip out what Chris said it’s coming.
Kamil Armacki 50:09
Yeah. But we do need to be realistic about it that even when it comes in, you know, 1015 years, it probably won’t really have any tangible impact on any buyer lives.
Chris Wilson 50:21
Maintaining being realistic, that’s a very good point. Because it reminds me of the vertex announcement a couple of weeks ago, with the the first patient of their trial, got infusion of stem cell derived Ilet cells, and is, you know, 90% reduction in insulin use. And everybody went nuts over that. And I wound up posting a big, long thread on Twitter explaining that really like this isn’t the hard part yet. It’s great that they’re this far, it’s awesome that people are pursuing different avenues, I hope they succeed. But this isn’t going to be something that people are going to have in the next couple of years to just go in and get your eyelid infusion. And then you don’t need to worry about measuring your blood glucose or worrying your pump or taking injections anymore.
Stacey Simms 51:10
I heard a great point on that, which was if they’ve sent a press release, it’s quite different than if they’ve submitted a for publication in a clinical journal. It was a little bit, I’ll say a little meaner than that. I think the quote was something like, you know, if it’s a press release, they’re looking for money, if it’s a journal they’re looking for, you know, approval. There’s some truth to that, though. And I think that that’s a good thing for us to keep in mind as we stay very hopeful is a very hopeful crowd. And as we stay realistic, as well, I think we’ve run the gamut. There’s always so much more to talk about. So I hope you’ll come back on when these things maybe we hear more, they start to get approved, or we just talk about different things. But this was great. Thank you both so much for jumping on.
Chris Wilson 51:50
It’s always fun to talk to you, Stacey.
Stacey Simms 51:51
Oh, thank you, thank you. It’s always great to get caught up on this stuff and kind of speculate and talk about it. So thanks so much. I appreciate you guys both being here. And we will put lots of links in the show notes and everywhere else we can find them so that people can find you on social and follow your musings and your thoughts, but I really appreciate it. We’ll talk to you soon.
You’re listening to Diabetes Connections with Stacey Simms. Lots of information there. I’m going to link up a couple of articles some things we referenced at diabetes connections.com. At the homepage for this episode, there is a transcription as well as always, what do you think? I mean, I know it was long, and there were a lot of things to get through. But I’d like to do that on a more regular basis, maybe with some different people in the community. Love to hear feedback from you what questions you have, what topics you’d like us to tackle. But man, those guys, really they know the ins and outs of all of this, they really keep their finger on the pulse. So we’ll follow up. We’ll do more on that. This was taped, as I said the very first week of November 2021. So in a couple of days between now and when the episode comes out, maybe something else was approved. If it happened, we will follow up on it here.
All right, thank you, as always to my editor John Bukenas from audio editing solutions. We’ve got in the News Live every Wednesday now 4:30pm Eastern Time, on YouTube and on Facebook Live on both channels, and then we turn it around into an audio podcast episode that airs Fridays. So I hope to see you back here for that until then be kind to yourself.
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