There’s been a lot of excitement recently about stem cell transplants and progress toward using this as a functional cure for type 1. There are a few separate groups working on this, this week we're talking to ViaCyte to get past the hype and look at the real progress here.
You'll hear from ViaCyte’s Head of Clinical Development Dr. Manasi Jaiman. ViaCyte has been studying stem cell transplants for several years – and recently started working with the gene editing technology CRISPR. We’re going to talk about what this is all about, how close they really are, and who would even be in line to benefit.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
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In February, the FDA approved the Eversense E3 for 180 day wear. That means you could have a CGM working – with no sensor changes needed – for up to six months. That’s been available in Europe for a while, but in the US it’s been a maximum of three months. As you’ll hear, the people at Eversense have even bigger goals.
This week, you'll hear from Senseonics Chief Medical Officer, Dr. Fran Kaufman. We get the basic info about the device, the plan for working with pump companies, a look ahead and much more. Imagine one year without a sensor change!
Dr. Kaufman is also a practicing endocrinologist and she’s been seeing patients for more than 40 years. She has a passion for this community and a lot to say about what truly helps patients thrive with diabetes.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
..
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
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Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
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Episode Transcription Below (or coming soon!)
Please visit our Sponsors & Partners - they help make the show possible!
Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921, where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms
This week Eversense is an implantable continuous glucose monitor. It just got FDA approval for a 180 day where that's six months with the dose sensor changes. Something else that makes it different. It can vibrate to let you know if you're low or high.
Dr. Fran Kaufman 0:39
And then people really, really enjoy that long term concept, as well as vibratory alerts. We've got people who work on the tarmac at the airport and they can't hear anything. So the only way they can actually do this is with the vibratory alerts.
Stacey Simms 0:52
That's the company's chief medical officer, Dr. Fran Kaufman, we go in depth on the Eversense system talking about how it all works, accuracy, and looking ahead to whether they'll partner with any insulin pumps for a closed loop. And they have big plans to make the system last even longer. 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 the show. Oh, we so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. If you are new, my son was diagnosed with type one right before he turned two that was back in 2006. He is now 17 years old. My husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting. And that is how you get the podcast.
And I have been doing this podcast since June of 2015. I looked back in the show archives. They're all on the website. You can use a search box to find what you're looking for. But I looked back and we first talked to Eversense in October of 2018. We actually talked about Eversense at that time, not with the company. I talked to Darryl Greene. He was one of the first people in the US to get the sensor implanted. He is a news anchor. And he did it for his show, he showed the video of the implant the whole thing. I will link that up in the show notes so you can hear what Darrell had to say at the time and see an early version of Eversenseit has changed a bit since then.
But as you will hear this week, it is subcutaneous it's just under the skin. And that is where the Dexcom or libre or Medtronic Guardian sensor lies, but you can't insert it yourself. It is a quick outpatient procedure. It's minor but it is still a procedure. The flip side that's it for six months, no supply orders, no changing sensors. My guest here to talk about it and answer a bunch of your questions is Dr. Fred Kaufman. She is the Chief Medical Officer of sin psionics. The company that makes Eversense she is a pediatric endocrinologist who still sees patients and I could take the whole episode to read off her accomplishments. She's been in practice for 40 years, director of the comprehensive childhood Diabetes Center and head of the Center for endocrinology, diabetes and metabolism at Children's Hospital Los Angeles, former president of the American Diabetes Association, chair of the National Diabetes Education Program, on and on. And she has authored over 250 Scientific manuscripts and numerous books. I love talking to people like Dr. Kaufman, because yes, she's a very accomplished woman. She obviously knows her stuff. But you will hear her passion for this community. She is really in it to help all patients living with diabetes.
Quick note, I realized, as I was listening back, I do that a lot with these interviews for editing and you know, editorial reasons, I didn't ask about the capacity to share the sensor data in real time, right share and follow for something like this, Eversense has had that for a while. They don't use the same terms. They call it Eversense Now. And that doesn't change with the three the latest iteration of Eversense does have the capacity for other people to follow the user’s numbers. And I know that's important to a lot of you. I didn't want to imply that it isn't available by leaving it out of this interview. So you don't hear about it. That's on me. But it is there.
Here's my interview with Dr. Kaufman.
Dr. Kaufman, thank you so much for joining me. There's so much to learn about this system. My listeners are very interested. Thanks for spending some time with us.
Dr. Fran Kaufman 4:30
Well, thanks for having me.
Stacey Simms 4:31
I would usually start by asking you to talk about the latest and greatest this FDA approval that came through. But let's back up just for a minute. For people who are not familiar. Can you take us through what the system consists of here kind of set the table of what we're talking about when we say ever since? Well, I'd
Dr. Fran Kaufman 4:48
love to because I think understanding the system really enables you to understand this new innovation we have with our Eversense three system, the overall Eversense CGM Is three components. It is a fully implanted sensor very small, it's about three millimeters by 13 millimeters, and it's placed under the skin in the subcutaneous space, which is where all the sensors are working. They're all measuring the same glucose values in that interstitial space in what we call the interstitial fluid. But this is placed minor office procedure done by healthcare providers that we train and certify, we also give them the tools to be able to do both the insertion. And then when the time comes the removal of the sensor and the insertion of the next sensor. That's the center. It is a fluorescent technology, all the other CGM systems are enzymatic. So that is another distinguishing feature for us, and then placed over the sensor with a very mild silicone-based adhesive is a transmitter and the transmitter through near field energy powers the center, and that enables the sensor to read the interstitial glucose, give it back to the transmitter, the transmitter then sends it to the app on your smartphone. And that's where you can visualize your glucose value. But our transmitter held in place, again with a very mild silicone-based adhesive. So there are fewer skin reactions, also has a very unique capability of on body vibratory alerts. So if you don't have to have your smartphone sitting in your lap, you want to run upstairs for something you want to run outside, you want to take a bike ride without your cell phone, then you will get the alerts right on body, the transmitter itself will vibrate. And you'll know whether you're going high or low with your glucose values. And that's a feature that many many people truly enjoy and appreciate. And then the app is pretty much like all the apps, you can view your glucose every five minutes, the arrows for the directional change of your glucose-to-glucose curve for the last three hours, six hours, whatever you'd like. And it also, of course, has alert both auditory as well as visual on the cell phone itself. So those are the three major components and lots that differentiate us.
Stacey Simms 7:16
Yeah, I let me go through a little bit of what you said kind of break it down even further, you mentioned that the sensor uses something different to measure glucose level this is based on light or fluorescence, can you kind of explain that a little bit more or as much as you can, some of its proprietary,
Dr. Fran Kaufman 7:34
you well, and then lay terms so that I can understand it. I am a physician at OSI you know not a an engineer. But essentially, this sensor is composed of a sensing surface where glucose attaches reversibly dependent on how much glucose the sensor is exposed to at that point in time. And of course, this interstitial fluid is moving. So you know it's bringing glucose continuously to the sensing surface. And then the power is to turn on little LEDs that light up that sensing surface in a full arrest by how much glucose is attached. And that fluorescence n is equal to the concentration of glucose.
Stacey Simms 8:18
Can you see that under your skin? Can you see that happening? Do like is there like a little light show going on?
Dr. Fran Kaufman 8:23
No. Other Yep. Could it be cool?
Stacey Simms 8:29
Maybe that's an add on feature for the future. I'd also heard this was a while ago. So this may have changed. I had heard that earlier iteration of this technology made it that it was sensitive to light. In other words, if you were exposing that site to sunlight a lot, it didn't work as well. Well. So
Dr. Fran Kaufman 8:45
there it rarely occurs. But there is something called an ambient light alert, if there is a lot of sun exposure. And this is mainly because that tape is peeling. So the sides of the transmitter are a little bit more exposed. It will pick up in ambient light tell you what can't reliably read the glucose and ask you to you know, either cover it or you know, get out of the sunlight.
Stacey Simms 9:09
Also, if, as I said, kind of going through it step by step of what you mentioned, let's talk a little bit more about how the transmitter connects. I saw someone on Instagram recently showing how it is, for lack of a better word seems very easy to Ristic she was kind of taking it on and off on and off quickly showing how easy and how different it is. Does that sound accurate? In other words, I think we're used to these devices staying on and we want to stick them as tight as humanly possible and then we rip them off like a really tight bandage. This is very different.
Dr. Fran Kaufman 9:40
Well this is very different so it's not holding the sensor in place right the sensor is fully implanted. So if this falls off, you do not lose a sensor. You just place it back on so the adhesive tape you know obviously sticks on one side to you on the other side to the transmitter and a few hit a door way or Your reference tumbling with your kids and a falls off, you can just place it right back on to that same adhesive. Or if you need a new adhesive, you know, there, you're just carrying a one little piece of adhesive in your purse or in your pocket. And that's all you really need to carry around with you.
Stacey Simms 10:16
I don't know if this will ring a bell with you. But it seems to me like your color forms, which were like kind of stickers, but kind of not you could take them on and off a few times. That's what this reminds me of.
Dr. Fran Kaufman 10:27
I'm not sure exactly know what you mean. But what what this is, is something that's very mild on the skin, we do ask you to replace it every day, take it off, clean the skin, let it breathe for a little bit while you're taking your shower, drying off and then place it right back on. So it's not that you have a piece of tape on for now what will be six months, you're changing that tape and letting the skin breathe. And of course, the tape is breathable as well.
Stacey Simms 10:55
That's a great point. I didn't want to imply that when I say take it on and off a bunch of times that it's more than a day. What changed recently, what did the FDA approve, that got everybody so excited?
Dr. Fran Kaufman 11:05
Well, we're like everybody, right? We are continuously innovating listening to the voice of our customer who is the person with diabetes healthcare provider. And one of the things we continuously heard was people want a sensor that lasts even longer. I mean, we're lasting 90 days in the US, it was already 180 days outside of the US. But for both, this is the next iteration for both. So this is our really, we call it a three because it's really our third sensor iteration. So some chemistry changed is you can imagine some of the other little minor things also changed. But the major change was in that sensing surface, allowing it to have a chemistry change that enables it to last really reliably for the six month time period. You know, whenever we put something in the body, the body reacts, and the way the body reacts to our sensor and the other sensors is it kind of oxidizes it, it surrounds it, it does a lot of other things to it. This chemistry change enables that reaction to be less significant over time, so that the sensing capability remains really excellent for a much longer period of time before we can get the six month indication. Talk to me a little
Stacey Simms 12:23
bit about the clinical trials that I'm sure were done for this when you're talking about six months. The questions my listeners had mostly about this was like, well, what could go wrong? Right? What if I want to get this taken out? Or what if it irritates me, it tell me a little bit about the people who've already done this.
Dr. Fran Kaufman 12:39
So there's our clinical trial, the promise trial that involved 181 individuals wearing actually more than one sensor for the most part. And then there's our vast really commercial experience both outside the US as well as the inside of the US where 1000s of patients have used the sensors. worse, worse, worst worst case scenario, you decide you don't want to have a CGM at all you can get it removed, or you could actually leave it in place till the time duration is up and get it removed, then there's really no compelling indication that you have to get it removed right away. If you don't want it or if it stops working. It actually is kind of okay as a permanent implant. Although that is not what we're asking people to do. We are asking them, as well as the FDA asking them to get it removed when the time comes. So that would be worst case scenario. For the most part, once it's placed in the skin, the skin is healed. Again, the mild adhesive on the scan, really, people enjoy it want it needed if but our system, rather than have no sensor at all, if you decide for a period of time, you don't want to wear the transmitter. Maybe you're getting married, maybe you're going to Hawaii and you willing to go without your CGM, which of course, for me and my patients, that would be a big no, no, then you can just take the transmitter off, charge it, then put it in a drawer and put it back on when you come back home. So it gives you that option. If you don't want to wear the transmitter to take it off for a period of time, or take it off, you know, an hour a day or two hours a day, whatever you'd like to do. There's a lot more flexibility because you're not losing the sensor at that point.
Stacey Simms 14:23
Yeah, talk to me about that, because I'm imagining and I've shared this on the show before my son is very interested in this, especially because of sports and wrestling in particular, he thought it would be so great to be able to take the transmitter on and off. Well, you haven't off. You've already mentioned the sensor will still alert you you know it'll vibrate.
Dr. Fran Kaufman 14:39
As soon as that transmitter is off. You do not get any sensor readings at all. So
Stacey Simms 14:45
my mistake. Yeah, my mistake. I thought for some reason it vibrated under the skin even without it.
Dr. Fran Kaufman 14:49
No, no, it's not the sensors not vibrating in your body. It's a transmitter on top of your skin that's vibrating.
Stacey Simms 14:55
Got it. Okay, talk to us a little bit about accuracy. What you found commercially as you mentioned clinical trials. I think my listeners are pretty familiar with Mark. But can you speak to that?
Dr. Fran Kaufman 15:04
Absolutely. I have been in the field of diabetes since 1978. So I'm old. And I'm really proud of it. And I've seen so much what I started with animal insulin and urine testing. And obviously, what I've seen in my own career a lifetime is awe inspiring. Unfortunately, it hasn't gotten us all where we want to be, which is done with this disease all together. But it has made obviously management. So much more important, easier, better, difficult, whatever you want to say. But we do now have a lot of tools and technology that can improve people's management. One of them is CGM. And those early CGM, which I was involved with, when I was in academic medicine, as an investigator were wonderful, you couldn't rely on them to make a dose adjustment, for sure. But you could get patterns and trends and see what was kind of happening overnight, it was really an amazing advancement, then as the accuracy continued to get better for these devices, we were able to look at a point in time and say, That's what my glucose value is, I can dose off that glucose value, which of course is what you're able to do with our sensor. And then you got more and more accuracy. And now, that's what you know, really, your value is. So our accuracy is measured by Maher during our promise trial. And one of the issues we have to face is, the longer the duration the sensor last, the longer our clinical trials have to last. So if you got a sensor that last seven days, your trial seven days, if it last 14 days, your trials, 14 days, in the last 180 days, your trials, 180 days, and one day, we'll get up to 365. So we'll have these really long trials that will be arduous for the patient and our clinical investigators, and a long time to get the results. But so for the six month trial, people came in 10 times about 10 hours each time, we drove them high and low, so that we could get across the sensor life as well as across all the glucose values from 40 to 400. To see the accuracy of our EversenseII three system and the MAR turnout overall to be 8.5, which is excellent. We're really happy with that Mart, it's you know, it's among best in class for CGM center available. And as always, the mart is leased. On the first day, of course, we only have one first day every six months, whereas sensors it's every week or every 10 days or every 14 days. And then it really settles down and all the way till the end of sensor life. 180 days they are busy was at that point still below eight, below eight below eight. Wow, you know, you have to put all the seven days first. So we did first day seven, day 14, day 21, day 30, day 60, day 90 day 120 150 and 180 day evaluation. So when you put all those together, it turns out to be a mark of 8.5. And then of course it's in the hypo range, we had an excellent mark, also a little bit less than eight in the hyper we had an excellent Mark less than eight. So it really is a pretty excellent system.
Stacey Simms 18:24
Is it simplistic to assume that gets better as it goes? Or does it get better for a certain point, and then it gets a little higher? Well, actually,
Dr. Fran Kaufman 18:32
we could have assumed that. But it turns out it's highest at the beginning and then pretty much stayed around the low aids, high sevens the rest of the time period.
Stacey Simms 18:42
I'll confirm this. But I don't believe any other CGM in the US has a mark that is under eight. I don't know that you can talk about it like that, as you said it's 8.5 for the whole life of the sensor. But that's really interesting.
Dr. Fran Kaufman 18:54
Well, there are depending on the conditions and other things. There are some marks that are under eight as well. And does Mark need to be five is marking to be six, we're probably pretty close to good enough, or excellent enough in that eight range. You know, when we started March, the first month was I think 25. Yeah,
Stacey Simms 19:16
yeah, it's come a long way. Yeah. Talk to us about calibration. The system does need to be calibrated, but the E three less than before.
Dr. Fran Kaufman 19:24
Absolutely. So as you can imagine a sensor lasting 180 days and when we get to the year long sensor, we'll likely not ever be able to get away from any kind of calibration. Now we're hoping with 108 with a 365 Our year long sensor, which will be a real Mark change to some of the platform configurations that we might be able to only have to calibrate once a week. But right now we're at a calibration of for the first 21 days it's twice a day. So the first calibration is really easy. You wake up in the morning, you take the transmitter off, it does need to be charged. It takes about 10 to 15 minutes charge to take your shower, you clean your skin, it put the transmitter back on, and you do your calibration. And then 12 hours later, you need another calibration for the first 21 days. And then after that it's mainly one calibration a day.
Stacey Simms 20:20
I'm pausing because I'm intrigued. We'll have to come back later to the 365. Okay, we talked about what's next is the goal, ultimately, no calibration, or you've already kind of hinted that as it gets longer and longer where you don't anticipate with a year long sensor you anticipate continuing to have to have some kind but but once a month is the goal. Yeah, hello,
Dr. Fran Kaufman 20:38
once we start once a week, we're not exactly sure. But it's hard to imagine that we would have something that long, that would not require some calibration.
Stacey Simms 20:50
Let's talk a little bit about one of the biggest questions that my listeners sent in, which was, when will this work with my pump? Do you have any plan? I mean, I'm assuming you have plans in place. But I let you jump in, you already started to answer
Dr. Fran Kaufman 21:02
it. Yeah, well, that's obviously our goal, as well. And so we're working towards that I can't really give a timeframe because it's not just dependent on us. And as you can imagine, some of the companies coming out or are just trying to get their first product out that first iteration. So they'll be a bit of a lag, but we're doing everything we can to facilitate it. I do have
Stacey Simms 21:25
to be nosy I understand if you can answer this, any of the existing pump companies in the US on the table with you? Well, we help
Dr. Fran Kaufman 21:31
every pump come and he's going to be on the table with us when you know when the time comes.
Stacey Simms 21:35
And what would have to happen. Is there another designation? Is it IC GM that you all need to get?
Dr. Fran Kaufman 21:40
It's pretty much IC GM. And then of course, even once you get that you've got to do some coordination with the pump companies open the API, how do they talk to each other, it is a bit away. But we're working on it, trust me.
Stacey Simms 21:55
My husband was joking last night, when I was telling him we were going to speak and he was like, gosh, all then they need to implant the pump. Because I put it all under the skin. I was like, you know what you're getting ahead of yourself. Like let's,
Dr. Fran Kaufman 22:05
you know, it is interesting, when you talk to cardiologists, you know, everything they have is implanted. When you talk to endocrinologist, they're not quite as familiar with the concept of implanting things. And the reason the implant makes so much sense is is one is you can't knock it off, it's obviously easy to put in and to retrieve, and it takes some of the burden. You may have to calibrate. But you don't have to change sensors every week or every other week. And it takes you don't have to order things anymore. So there's a trade off on our goal, which is to make life easier, more simple for people with diabetes. So that implant does in and of itself make things in a different framework, where I just don't have to, I travel, I don't have take anything but my little adhesive patches, versus somebody otherwise has to take a half their suitcase full of sensors.
Stacey Simms 22:59
Yeah. You mentioned endocrinologist and the implant? How is the physician training going? And Pardon my ignorance? Is it an endocrinologist that you trained to do this? Is it another kind of Doctor Who puts it in?
Dr. Fran Kaufman 23:09
Well, if the answer is yes to all of that, so endocrinologists have come forth and been interested in learning how to do it, you were not the only implantable drug or the you know, system that they have. They've got the implantable birth control. So some that are very, very interested love during the procedure kind of gets back to why they wanted to be physicians. And then others of course, who don't feel they want to really do it. So they're, they refer their patients to somebody who is doing it. So it mainly endocrinologist, we've got dermatologists, primary care, you name it, and they are there, as well as not just physicians and osteopathic doctors, but also nurse practitioners and physician's assistants do it as well.
Stacey Simms 23:53
I remember when we first started talking about this a few years ago, there were very few doctors who did it. I remember talking to our endo here, he was like, I don't know anybody in Charlotte, I'm imagining that that is changed. Do you have any numbers? Or how people would find out if it's done in their area?
Dr. Fran Kaufman 24:07
Well, absolutely, we can help them find out if it's done in their area if their own physician isn't doing it. But we certainly have picked up more and more physicians when a patient comes to the doctor and says, you know, hey, you know about this, I saw it, I'm really captivated by some of its qualities and differentiators. And the doc says, I don't know much let me contact and they contact us. We talked about, you know what it would be like to become a procedure list. And many of them say yes, so we have been able to increase the number of people learning how to do the procedure, particularly in some of the large groups and the large practices. A lot of them just really enjoy that aspect of medicine that they hadn't done maybe for a while and certainly the new endocrinologists coming out they're much more technology based than people my generation. What Chris wants to be my generation of retired do not intend to do. They want to have a procedure, they want to be able to break up the day, and many of them in their practices, you know, do it like Wednesday afternoons or Friday mornings, to accommodate their patients. And of course, they get reimbursed for that part of their time part of their, you know, they need to be trained, it's a way to be a little closer to your patients in some way. A couple of that clinicians have told me, it's enhanced my relationship with some of my patients, when you know, we have that opportunity for me to really impact in this significant way. Yeah,
Stacey Simms 25:33
that makes sense. You mentioned supplies, I was also thinking about costs when you said that, because write anything with a surgical procedure, even though it's very minor is going to have a cost associated with it. But I was assumed that's balanced out by as you said, you're not ordering supplies, you're not getting new stuff. Every couple of weeks. Can you talk a little bit about the insurance side of this is this well covered,
Dr. Fran Kaufman 25:53
it is well covered, we'd like it to be universally covered. We're working towards that as well. As you can imagine, we have a whole group of people, some insights, and CX mainly with our partner associate diabetes care, who is our partner in the sales and marketing of the Eversense CGM systems. And now of course, very, very excited about having Eversensethe three, so they're, they're working hard with the payers as well. Medicare pays for it. I think we have over 200 million covered lives. And we're hoping to be able to continue to have every insurance company cover this. Now if your insurance company doesn't cover it, there's appeals that can occur. And for the most part, those appeals work because the insurance company realizes the benefit of patients having CGM and we're, you know, really differentiated. So who's a patient who wants to use an implanted CGM, somebody who you know just travels a lot and doesn't want to worry about reordering, just want to put something in themselves, for whatever reason, dexterity cognitive, just don't like taking out all those needles and looking at them and putting things in themselves. And then people really, really enjoy that long term concept, as well as vibratory alerts, we've got people who work on the tarmac at the airport, and they can't hear anything. So the only way they can actually do this is with the vibratory alerts, do you really have somebody
Stacey Simms 27:18
who's works at an airport like that? We do. That's just fabulous.
Dr. Fran Kaufman 27:23
And these are some of the people who have come forth. And you know, they're our ambassadors. Somebody works in an elevator shaft and can't have anything big on their body. And this enables them to be down there and still feel the vibratory alert,
Stacey Simms 27:38
I have a bunch of questions that are more forward looking. But before we kind of move on to that, I'd be curious what you have learned. I mean, the system has been around in a shorter wear form since 2016, in Europe, and I'm curious, what has changed? or what have you learned from the people who have used it?
Dr. Fran Kaufman 27:56
Well, what's been really interesting is once somebody gets their second sensor, they're hooked for life. You know, there are some who use it, and then meal wasn't right for them. The same with other CGM, the same with pumps the same with any kind of technology. But once somebody said, I like my first one, let me get a second one, then they're pretty much hooked for life. And what are they want, they want longer duration, with the same level of accuracy, people really appreciate the accuracy of our system. As a result, they continue to use it. We've got patients on their 10th 15th I don't even know how many sensors, some of them I've had they've were on early and have never left.
Stacey Simms 28:36
Does it always go in the same place? Is it always on the arm and then they just kind of switch back and forth to either arm? They do.
Dr. Fran Kaufman 28:42
And I'm probably the only one who can say this and say I'm a physician. There are of course as always off label use of things.
Stacey Simms 28:51
Okay, we will leave that there. But very interesting. This might be a very dumb question. Can you go through airport sensors with this, you know, the the different devices, metal detectors, all that kind of stuff?
Dr. Fran Kaufman 29:02
You can you can even have a MRI, you know, the other sensors need to be removed for an MRI, but you must remove the transmitter.
Stacey Simms 29:09
Got it? That's interesting, and MRI and X rays and all that. Yep. Without the transmitter on, you've already mentioned that the the goal here is longer were one whole year. That's something that you all are working toward. I'm curious to, again, not to bring this personal or anything. My son is not yet 18. And he's been talking about this for a while, are you looking into pediatrics,
Dr. Fran Kaufman 29:31
we are looking to be there too. So we're hoping to have our 365 Day sensor in clinical trial in 2022. It's our hope we're working towards it. And that will have a pediatric component.
Stacey Simms 29:46
You've already alluded to the fact that you've been in diabetes for a while, you know, you worked directly with patients. I'm curious, could you give us some perspective on this? I mean, there are some people that look at a device like Eversenseand say yes, give me I want that, you know, for my child for myself. This is terrific. There are others who are squeamish about it can't possibly think about it just aren't interested. I'm curious when you were thinking about your patients, you know, how do you talk to them about things like this? Do you see patients anymore?
Dr. Fran Kaufman 30:12
I do see patients, I couldn't imagine not seeing patients. And I have, I will admit, I've been very unusual and that I've been out of my academic practice since 2009. And I'm still seeing my same patients and picking up some new ones here and there. You know, everybody has what they think is going to work for them. They try things, maybe it does work, maybe it doesn't work. But what I think what kind of captivates somebody about Eversenseis that it is long term, no longer does the patient have to worry about reordering and where they're going to be on Saturday, because they've got to change their sensor. And what happens if the sensor comes out early, where's the, you know, all those kinds of issues. So with a fully implantable sensor, it's there, and it's in there, lots of people like that as kind of really reducing some of the burden of diabetes for them. You know, once they hear about that, and they hear about, you know, if I want to I can take off the transmitter without sacrificing I like the idea, I don't have to have my phone with me all the time. I mean, just all these advantages kind of Captivate many, many people. And as a result, they want that opportunity. And once they have it and they see those advantages, they stick with it, for the most part, it has to be the right person I you know, we are by no means saying that 90% of people who are on intensive insulin management should be using ever since. But probably 1015 20% should be. And when you look at really kind of what the recommendations are now as a healthcare provider for me to manage my patients on intensive insulin, it's hard to imagine doing it without a CGM. That means you know, there's 1.6 million type ones they all likely need to CGM. 3 million type twos likely need a CGM, with all that number of patients, there need to be choices, there need to be differentiators, not just the same over and over again, whether it's seven days, or 10 days or 14 days. And that's really where we're kind of captivating the healthcare provider, as well as captivating the patient, I'd love for
Stacey Simms 32:17
you to come back on perhaps without, with maybe half the Eversensehat on and what I'm getting at is to talk to somebody like yourself, who has been in this world for so long, who has seen a lot of changes, who has adapted with and help their patients take advantage of all of the changes that have come through, I feel like it's an opportunity to really kind of dig into more about diabetes. So hope you don't mind if I call you again in the future.
Dr. Fran Kaufman 32:39
I'd love to I'll probably have a little bit of a bonnet on for what we
Stacey Simms 32:45
can make that that's fine. We can go with that. But before I let you go here, let me ask you about it. I don't know if you've seen new patients anymore. But when you talk to your patients, you know, I assume I'm just picturing. Gosh, I know I'm not trying to butter you up, I promise but lucky patients, right, they've got an endo, who's passionate, who really cares about this, who's really you know, we were lucky to have one as well like that, when you're talking to your patients these days. So much technology has changed in just the last five years and so much more cool stuff is coming. I assume you don't just focus on that tech, right? You're not just hey, here's a CGM go home. Can you give us kind of a peek into what you think makes a really good start or really good continuation? Or I guess it's a really good plan for people living with type one right now?
Dr. Fran Kaufman 33:29
Yeah, well, I mean, yeah, probably the most important thing is to find support. Nobody can do this alone, ever. I don't care how old you are. I don't care how independent you think you are. And whether that support is with your healthcare team, with your family members. I mean, it's all the better when it's multi faceted. I'm very involved with my patients, they all have my home phone number call me whenever they want text me all day long, mainly because it's such a burden that we transfer over to them on a we teach them we do this diabetes education, you know, stay in this lane, don't go too high. Don't go too low. Don't eat that. Don't you know, don't do this. And it's hard. And they really need support. So you know, camps, groups, your podcast. I mean, what a difference all this makes. And I really had to say what's the biggest difference I've seen over my career, it's that we've gotten diabetes into the open, people aren't hiding it anymore. And as a result, it's part of normal life. And it's trials and tribulations, the time it takes isn't as difficult when people can see the benefit and feel that support in their community, their parents, their friends, their spouse, their co workers. And I think for the most part, people are fascinated by the technology when you show it to them when I patient show it to them very interested in helping out however they can. And that's to me the biggest change when I First of my career, we spend so much time trying to tell people not to hide diabetes. When I patient told me the other day, she's just got a new job, she brought her co workers together, show them her sensor, her meter her glucagon. And, you know, kind of felt it was a badge of honor that they offered to learn about, uh, to help her if need be. And she felt, you know, kind of automatically brought into a community of people who care and I think the vast, vast, vast majority of people do care. And then of course, the technology is just the advances have been monumental, since I've been met, began my career patients being involved in their care doing what needs to be done, looking towards the future, understanding their own lab tests, coming with questions. I mean, that's that's where the fun is. I was in clinic yesterday, I saw a relatively new patient, he's about nine. And you know, the father is the fact what he's has learned. These two parents have learned in a short period of time, I rivals what my fellows can learn.
Stacey Simms 36:07
You know, I said, I was going to ask you this one question and let you go. But I have to follow up with Why are you still working? You said, I'm never going to retire. You already said that. You're like, that's it? Why are you so passionate about this?
Dr. Fran Kaufman 36:18
Well, first of all, I'm in my early 70s, which is the new 40s I think, I feel great. And I have spent so much of my career getting to where I am and the understanding, I personally have that, what would I do all day? Why wouldn't I want to continue to do whatever I can. And that's just how I am, I guess, and what my friends have retired, and they're happy, and they're doing what they need to be doing. I mean, the beauty of my end of the age spectrum is that you can do what you want. There's no I have to go to school, or I should get married, and I got to get a job. I mean, by this time, you get to do what you want. Finally,
Stacey Simms 36:58
where are we lucky? This is what you want to do. Gosh, thank you so much for joining me. I'd love to have you back. You can bring your bonnet, and we'll work
Dr. Fran Kaufman 37:05
it out. Okay,
Stacey Simms 37:06
thank you so much.
You're listening to Diabetes Connections with Stacey Simms.
More information about Eversense three at diabetes connections.com. Wherever you are listening, there should be extensive show notes. If not, you can always go back to diabetes connections.com. And check out the episode homepage,
I reached out to Darryl Greene, the gentleman that I spoke to a couple of years ago to get his thoughts on what he thinks of the system now. So I'm going to report back and let you know what he thinks if he's still using it. And if you are using EversenseI'd love to hear from you as well, I will also link up a couple of reviews that were in the community a couple of years ago for an earlier version. But if you are in Europe, perhaps you've been using the 180 day for a while or you're newer, you want to use the E three in the US as it rolls out. Let me know I'd love to follow up because there's so much curiosity about this system. And for so many people, it comes down to the actual procedure. Right, once it's in, people seem to love it. The questions people have are about how does the procedure go is easy to find a doctor is it easy to get it removed. So I'd love to hear from you if you have experience in that way.
All right. Coming up, I want to give you a sneak peek into what we're talking about next week. And that is all about Pixar is Turning Red. And boy, I'm so excited about the show I have for you. But first Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom, and that was in December of 2013, long time ago now, shared follow ups were not an option. They hadn't released that technology yet. I know that using sharing follow makes a big difference. I think it's really important though, to talk to the person you're following or sharing with and get comfortable with how you want to use the system. Even if you're following your young child. I mean, Benny was nine when we started with that. These are great conversations to have and they change over time. What number are you going to text your kid at how long you're going to wait to call your spouse that sort of thing. And that way the whole system gives everybody real peace of mind. I have loved helping Benny with any blood glucose issues using the data from the whole day and night. And not just one moment. Internet connectivity is required to access separate Dexcom follow app to learn more, go to diabetes connections.com and click on the Dexcom logo.
Next week's episode is one I cannot wait to share with you it is all about Pixar’s Turning Red. If you're not familiar, the plot of this movie has nothing to do with diabetes. It's all about adolescents. You know there's a girl she turns into a giant panda red panda when she gets excited and then she has to become to turn back unto herself. I don't know any more than that because I haven't seen the movie yet. But I do know is as you've seen if you see the trailers that there are two what they call background characters with diabetes technology. And as soon as we saw that trailer, there were two of them that were released. Actually, the diabetes community went bananas. And I used some of my contacts to reach out to Pixar. So I have an interview with the person at Pixar who is responsible for this.
I've seen a lot of interesting rumors online. It is not John Lasseter, he is no longer with Pixar. He is the former CEO there and he has a child with type blenders probably an adult now, he was responsible for developing Elsa in Frozen from a bad guy. She was supposed to be real villain in that movie to a much more sympathetic character with powers she could control because Lasseter saw a parallel to diabetes in that character. His son has diabetes. It's something that he didn't choose, right didn't want, but it's a part of him. And it doesn't make them bad. And he saw that parallel and Elsa and it helped guide the character. And I'll link that up. He's talked about that publicly before if you're not familiar with that story, but it wasn't him. And it wasn't a person on set or a voice actor who had a child with type one. I can't tell you more because it is embargoed until a little bit closer to the movies release. But I am going to put the episode out early.
So here's how the schedule is gonna go. We're gonna have in the news that will be Wednesday live on social media, I do it you can watch it on Facebook, LinkedIn, YouTube and Instagram. And that becomes an audio only episode that will be released on Friday. And then on Sunday, March 6, I will be releasing the following weeks long format interview episode in advance of the march 11th release of turning red. If you follow or subscribe to the show different podcast apps use different terminology, you will get it no problem it'll automatically come to you if you follow me on social media. You'll see it if you subscribe to the newsletter. If you don't, that's the best way really to keep in touch with me off of social media, you can subscribe just by going to diabetes connections.com and scrolling all the way down or the pop up will come up but the the newsletter will go out to remind you so I'm really excited about that. I'm thrilled to have had this interview and to get more insight and I hope we've made a new friend for the show. I know she listens I'm rubbish even say that but I hope she sticks around.
Alright, that'll do it. Thanks as always to my editor John Bukenas from audio editing solutions. And thank you so much for listening. A lot coming by we'll see you back here soon Until then be kind to yourself.
Benny 42:23
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Last fall, Sigi pump received Breakthrough Device Designation from the US FDA. Although it's still a long way from being released, Sigi is very intriguing; it uses some of the best parts of existing pump systems.
Pim Von Wesel is Co-CEO of AMF Medical, the company that makes the Sigi Pump. We’ll talk about what makes this system unique, which partners they're eying for collaboration and the timeline for submitting to the FDA really looks like.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
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Episode Transcription Below (or coming soon!)
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Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921, where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, it's called Sigi pump. And last fall it received breakthrough device designation from the US FDA, there's still a long way to go before this tubeless rechargeable pump could be on the market. And company leaders say that's okay by them.
Pim van Wesel 0:37
We're biding our time to make it short is excellent in every respect, technically, from a usability point of view, of course, which has a huge focus to us lowering therapy burden, and also just being able to produce it in sufficient quantities.
Stacey Simms 0:51
Pim van Wesel is Co-CEO of AMF Medical, the company that makes the Sigi pump, we'll talk about what makes this system unique, which partners they're eyeing for collaboration, and what the timeline for submitting to the FDA really looks like,
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 the show, always so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. Before we jump in, I want to give a big shout out to the amazing people in our Facebook group. If you're not there, it's Diabetes Connections, the group and I just want to single them out, because I think that it is the smartest diabetes Facebook group that's out there. I know I'm a little biased. But you know, it's not the kind of group that's going to tell you how to eat or how to dose or you must do this, or how dare you do that. As you know, if you listen to the show, that's not our deal at all. And I just want to take a moment because I've been asking the folks in there many of whom have lived with diabetes for 50, 60 years, many of whom work for technology companies, many of whom have been blogging about diabetes for many, many years. And I've been bringing them questions that have come up in my local group, things like cannula length, making a difference, some questions I had about summer camps for this year. And they all also have fabulous conversations. So I know we're all if you're on Facebook, you're in a ton of groups already. I do think that it's a really good one. If you'd like to hear from people who have lived with this condition for a long time who are very knowledgeable and frankly, very opinionated, which I like a lot. I do run a very tight ship. I do this in my local group as well as this one, you're not going to get away with any nonsense. Any weird stuff, a snake oil. Yeah, we will have none of them. But it's a great group. And I just was given them a shout out because they've been very, very helpful, especially lately.
Okay. Sigi pump caught my attention when it received that breakthrough designation that I mentioned. And to be clear, that means the FDA will try to speed it through the process. It does not mean it's approved for that it's guaranteed approval. And Sigi by the way is S-i-g-i. I did share some photos of it in the Facebook group. And my guest is Pim van Wesel , the CO CEO of AMF medical, that is the Swiss company behind Sigi pump. They are very early on here. Clinical trials have not yet started, but they do plan that when they get through the process to launch in the US first while it looks a bit like an omnipod, but the pod part is reusable. You recharge it as needed, and they give you two so you don't have to stop pumping while you're recharging. One of them. The only disposable part is the infusion set, although they call it something else, the part that connects to the body. Lots more information about Sigi in my interview with Pim van Wesel
Pim thanks for joining me. I am excited to find out more about this product in this company. Thanks for coming on the show.
Pim van Wesel 3:54
Thanks for having me. Stacey. Very excited to share what we have.
Stacey Simms 3:57
Yeah, I have so many questions for you. But let me just start by asking, just tell you a little bit about the company that makes Sigi what is A M F medical? What do you all do?
Pim van Wesel 4:08
Well, AMF medical was really spun out as a standalone company in 2021. But the history of the company goes back to 2014 when the founders hit upon a technology which they initially started using in some high end components for laboratory equipment. But a number of the founders had a history from a previous startup in insulin delivery. It didn't work so well then. But when they analyze this particular technology, they said, Wait a minute, we can probably make a insulin pump with this technology that would work that would not destroy insulin and being a large, fragile hormone. And they started a project in 2015. Over time, the project got big enough that they decided what we decided I joined since then to make it a separate company just because the investment story is very big. Different for insulin technology versus, you know, high end led components. So, company started in 2014, on off separately in 2021. Around the time we kind of came out of stealth. And, you know, I joined a little over a year ago, basically to help build a business after the founders started with a technology hired a great r&d leader pair who turn it into a product and then meet to help make it a business.
Stacey Simms 5:27
Or you mentioned coming out of stealth mode. The first time I heard about this was when the US FDA gave what they call breakthrough device designation. What does that mean? And why is that important?
Pim van Wesel 5:40
Well, it's important to us because we feel we have a few capabilities, particularly around usability and lowering the therapy burden that we wanted to test with the FDA, if it deserves to some recognition. Practically, it means that that puts us a little bit earlier and faster into the approval process. But we have an ongoing conversation with the FDA that started with a pre submission conversation there. And we decided to that we would try for this designation to get some recognition for some of the capabilities that we have, they picked up on a number of them, which got everybody very excited. You know, in a way, it's, you know, recognition that we're addressing unmet patient's needs.
Stacey Simms 6:18
Okay, so I got a little bit ahead of myself there by starting by asking about the FDA, let's just back up and talk about what the product is. Tell me about the Sigi pump. What makes this different,
Pim van Wesel 6:28
it is a patch pump, we have designed it for interoperability with multiple systems, so multiple third party glucose monitors and multiple algorithms. And I think one of the novelties that we'd like to bring is just tremendous ease of use. So we use standard prefilled insulin cartridges, I think that's in a nutshell, the product, it is a semi reusable product, the pump itself is reusable, you would have to as a user, with a dedicated charger, and whenever you need to switch it out. Because your cartridge is empty, you take your second pump, pump, pump into cartridge, use a new sterile cap to close it and then put it back onto your pad. The pad is a or tray, but we call it a pad is basically placed on your skin. And you can clip your palm on and off as needed.
Stacey Simms 7:17
I'm going to describe this probably pretty poorly. But in my mind's eye using existing technology, this seems to me like you use sort of a pump infusion set. So you would insert the tray the base as you called it onto the skin. And then that's temporary, right, you would take that off every couple of days like you do right now. But the patch pump is more like a more durable pump like a Medtronic or a Tandem, but you physically clip it flat, it connects to that infusion, well, I'm calling an infusion set. And is that close to accurate?
Pim van Wesel 7:52
That is I think that is a very good description with the one caveat that we have the ambition for the pads to last a little bit longer than a couple of days. Which basically means that once the pad is on the skin, let's just say for a moment that it lasts a week, as you run out of insulin you your take your pump off, you put in a new cartridge, and you clip your pump back on as long as the pad lasts, or what you could imagine somebody who has a very high use in need of insulin, they might for instance less in people that are in type two, not that that's our primary focus. But if they were to go through 160 units in less than two days, they wouldn't have to change the insertion of the pad or to disposable if you will. So that's the idea. Absolutely.
Stacey Simms 8:38
Got it. We're going to talk about more features, and you know a lot more about what the system is about. But before we go any further is what we're talking about in existence yet. In other words, is somebody wearing this? Is this in clinical trials? Where are you in the process?
Pim van Wesel 8:53
So we have functioning prototypes? We have not, and we've tested the usability of those we published something at ATDD last year. And we'll we'll have some more information at ATDD coming up in March sort of product exists. But formally speaking, we have not done the first human yet and as planned for later this year towards the end of 2022.
Stacey Simms 9:16
Got it? Well, the next question I know my listeners are going to have is can they take part in that are those are those first people in Europe or in the United States?
Pim van Wesel 9:24
There? I'll be very honest W in Europe. And that is primarily just to you know, we're startups. So we're trying to keep it manageable and coordination effort. So to do this in the US is probably a little bit beyond what we can can do at the moment. But clearly, I mean, just to answer the following question. Our intent is to first go in marketing United States and that's why we have these conversations with the FDA.
Stacey Simms 9:48
Got it. Got it. Well, we have lots of listeners in Europe too. So we'll put all the information out is as you're able to send to us. Alright, so let's talk a little bit more about the product itself, or the system itself, I should say the public Um, you mentioned you know, refilling insulin, this is prefilled pump cartridges as designed, right? This is not, you don't have to draw it out and fill it correct.
Pim van Wesel 10:09
There's no, if the term here fiddling to fill it, you basically take it out of the, you know, insulin caps in the refrigerator, and you pop it in straightaway you you don't have to wait 20 minutes for it to warm up, the system is compensating for that. So there's no air bubbles. And these cartridges, they already exist, they're already on the market. They're just being used today, with, you know, the Tethered pumps, or, you know, the pumps you were in a belt or in a pocket. So, you you mentioned the Medtronic pumps. Actually, there's other products out there that use this exact same existing cartridge. And I think you've spoken about some of these pumps in other podcasts.
Stacey Simms 10:46
Yeah, it's interesting. You know, we're so US centric sometimes that I certainly tend to forget, I believe what, Ypsomed uses the cartridges?
Pim van Wesel 10:54
Yes, Ypsomed uses that cartridge here in Europe And they have their agreement with Lily in United States. And there's a Roche product as well that uses this. But to our knowledge, this is the only patch pump that's designed around this cartridge. And it's actually a big part of why the pump has the size that it has, we couldn't make it much smaller and, and still fit the cartridge in
Stacey Simms 11:16
tiny a little bit more about the pump design itself. As I'm reading through, it looks like it is controlled from a phone or controlled by a separate controller. Are there any buttons on the pump itself,
Pim van Wesel 11:27
there are no buttons on the pump itself. And it is operated via your own smartphone. That's definitely the ID that we're working towards. We don't think people need another personal device manager in their pocket. So keep it simple.
Stacey Simms 11:40
And now I've talked about system a few times. Let's talk about that. So Bluetooth unable to go to a smartphone to go to an AI Controller talk about that a little bit.
Pim van Wesel 11:49
It is in no technical parlance. It's it's designed in the discussions with FDA RS ultimate controller enabled pumps. So nice pump, and it has everything that you could, you know design to so we're not trying to backwards integrate an algorithm and interoperability with third party CGM is designed to be able to do that. And when we say designed to be able to do that it has the communication capabilities with Bluetooth, it has the processing power to have an algorithm on board, and it has the battery life to deal with it as well. It's a rechargeable battery, of course, all of that is designed to be able to communicate and to calculate in, you know, work with dosing algorithms, if you will, that would be onboard. There's some systems that have the dosing algorithm on a personal device manager or in the future on the phone. We can accommodate that as well. We think that there's some advantages to having the algorithm actually embedded on the pump. And we've designed it to be able to do that.
Stacey Simms 12:46
I may have missed this point. You're not creating an algorithm for the pump?
Pim van Wesel 12:52
No, I think when we initially I think the ambitions were for the company were quite large. But if we really look at the core competencies, the core capabilities that his team has is around fluidics management and is around miniaturization. So over time, we also realized that, you know, we should better stick to what we do well, and is just make an excellent pump a truly excellent pump. Otherwise, we don't think we have any right to be on the market. And we have this open ID, you know, collaborating with, as far as we're concerned with any algorithm that's approved with any CGM, that is that is available. So we really have an open protocol or an open system mindset there. I think that's a little bit. You know, if we read the documentation, what the what the FDA is doing with the creation of these new product categories, such as ace pump, an IC, GM and I control, or we read a little bit with the JDRF has as a position statement around your artificial pancreas. We're fully subscribed to that philosophy, because we're open. Yeah,
Stacey Simms 13:59
it's really interesting, because ideally, and we've been talking with this for a couple of years now ideally, right, you'd get your pump, you get your CGM, you'd be able to pick and choose and then say, Okay, I want this algorithm I you know, I want my, I mean, I'll put the blue sky thing I want to Sigi I want my libre, and I want to use the control IQ. Correct? Is that something you think is a real possibility here?
Right back to Pim in just a moment, but first Diabetes Connections is brought to you by Dexcom. And we've been using the Dexcom system since Benny was nine years old. We started with them back in December of 2013. The system just keeps getting better. The Dexcom G6 is FDA permitted for no finger sticks for calibration and diabetes treatment decisions you can share with up to 10 people from your smart device. The G6 has 10 Day sensor wear and the applicator is so easy. I have not done one insertion since we got it. Benny does them all himself. He's a busy kid, and no way he can just take a quick glance at his blood glucose numbers to make better treatment decisions. is reassuring. Of course, we still love the alerts and alarms and that we can set them how we want it for glucose alerts and readings and the G six do not match symptoms or expectations use a blood glucose meter to make diabetes treatment decisions. To learn more, go to diabetes connections.com and click on the Dexcom logo.
Now back to Pim talking about interoperability and whether the system will work with other algorithms and devices.
Pim van Wesel 15:27
Well, we're definitely building our product for that to work, and depends a lot, of course, on the collaboration that that you can put in place with some of his companies. And being a startup, you know, a number of these collaborations are actually, you know, very enthusiastic, and other ones are a little bit more and wait and see, because we're still startup at this point in time. And I understand some of the bigger CGM companies, they might say like, well, let's wait and see if these guys actually gonna make it to market before we spend an awful lot of time co developing with them. But a number of areas septic, and we have good conversation. So will it work with all depends? You know, I don't think it's so much a technical question as a question of, you know, is there the will to make it happen. But we're very encouraged by some of the collaborations that that have been put in place, still early days, but we plan to do our first human and fairly soon thereafter have a what we call a hybrid loop trial with with a select number of patients.
Stacey Simms 16:26
Not to belabor the point here, it would be too early to ask you which CGM you would work with because you're, you're still
Pim van Wesel 16:33
Well, let me turned the question around. Which CGM? Would you first like to see on our pump?
Stacey Simms 16:39
I would. But I first like to say, good question here in the US, right, we only have a Dexcom and Libre, and Medtronic, I'd left them out of that, because they're so proprietary, you know, they only work within their system. So you know, if you ask me, I'm going to say Dexcom? Because that's what we use. But I would also say, I mean, I'll speak out of both sides of my mouth, everybody.
Unknown Speaker 17:03
So
Stacey Simms 17:07
in the works, probably two of which will come to market?
Pim van Wesel 17:09
Well, yeah, it's interesting that you mentioned that, Stacy, because the other day, with, you know, we basically had an inventory of the number of CGM projects out there. And I think it was getting to about close to 40. If you kind of all add them up, and we don't have 40 agreements in place, we have some agreements in place, and when I can talk about it, because there's confidentiality there, but you probably won't be disappointed with some of the names that we're talking about. But to your earlier point, you know, there's different form factors, right. Some people are very comfortable with having, you know, every six months or every 12 months, a minor intervention, not to have, you know, not as a wearable other people are actually, you know, preferring a wearable. And I think we want to accommodate that, as you said, different form factors, different dosing algorithms. So that that's our philosophy. And we're sticking to that for an hour and see how much of that we can make happen. But clearly, when we make our selection the same way these big companies do it, right. They say, I'm not going to work with this startup, well, how much do I believe they actually going to exist five years from now? Those same considerations apply to us as well? Yes, we have some conversation with early startups. But if you want to be successful, we'll probably have to partner with one or two of the bigger ones first, just being very pragmatic. And that's what we're doing.
Stacey Simms 18:28
And I left out one apologies to ever since the folks at Sensionics , who I'm sure you're very well familiar with, but I did not mention them as the US CGM company are available here. And they certainly are. I'm always gonna say work with everybody. It's so interesting to think about how it's changed in the last Gosh, even the last five
Pim van Wesel 18:45
years now. Right. But that's despite debts. It's going so fast. We think there's really just only only one really successful patch pump on the market. And we think we have something to offer in that space where we're at. And we're focused on that.
Stacey Simms 19:00
Is it waterproof? Yep. The fast answer. That's easy.
Pim van Wesel 19:05
No, I think, do the way we think about hedge pumps and look, and I've worked at some of the larger companies that have projects or had projects or have projects in the works on it. There have been so many attempts, I think, and there have been so many bridges burned in that space that are we get a lot of pressure from investors and from, you know, people that pick up with us on the websites to go fast and our philosophy and less our product is excellent. We don't have the right to be on the market. And we're biding our time to make sure it's excellent in every respect, technically, from a usability point of view, of course, which has a huge focus to us lowering therapy burden, and also just being able to produce it in sufficient quantities. It's a high hurdle. We don't want to come out unless we're absolutely excellent. And I'll tell you the story what what I discussed with our r&d people. I said look, we'll go to market when we are confident that we can Then pick a handful of influencers in diabetes technology world, and we'll give them flutter for three months. And we say, do what you want, write whatever you want. If we're totally comfortable doing that, then we're ready to go to market.
Stacey Simms 20:13
I had a question from a couple of listeners. And you've answered this a little bit about the differences between Sigi and the Omni pod, which is, you know, pretty much the closest to something like that, that we already have right here. And you've mentioned things that it's, you know, it's smaller, it's lighter, it is rechargeable, so you're not throwing the pump itself away. Are there other differences you'd like to point out?
Pim van Wesel 20:34
Well, I think the other one you pointed out as well, and that we we put a lot of effort in is the fact that it uses a prefilled cartridge, then this is designed upfront for interoperability, and we'll think we'll be very open. But I think you hit on most of them. Plus, of course, the fact that we use this prefilled cartridge, which we think is also looking at, you know, the feedback that we're getting on the website. There's there's an encouraging number of Omnipod users who've picked up on our website and are sending us comments. So we'll keep working at it. From that perspective.
Stacey Simms 21:05
I'm curious, we I've been talking a lot in the last couple of weeks on the show about infusion sets. You know, we had the folks from convatec on talking about the different types that they're looking to make you already mentioned, hopefully longer. Where can you talk a little bit about that part of this system, I know you can't, you know, there's a lot of proprietary and I'm sure information you can't share. But just in terms of he would seems to be that it would be a different type of insertion, just because it to me and it could be wrong, it seems like it might be have to be bigger, I'll let you talk about it.
Pim van Wesel 21:33
Let's talk about the insertion is designed to be very fast and fast in this respect often means, you know, limited, limited pain, right? If you do it very quickly. That's number one, or insertion is intended to be very quiet, particularly with very young patients in mind, this should not be a scary experience. So that's the insertion the cannula itself, we have a number of ideas around it to make it 470. Where and of course, because the pump, and isn't just the the setup itself, but the pump itself is very, very lightweight, we aim to make it you know, very wearable from that perspective, as well. We are doing a number of tests around you, we've done some testing or the wearability, and we've made some changes to the adhesive. And that's, you know, continues to be a big focus, just trying to work with the best adhesive companies out there. And in terms of the cannula, we are doing some tests around making sure that that you know, we don't have clogging and that we actually can get to seven days without, you know, too much inconvenience. Putting for sale is a pretty high hurdle there for seven day use and need to see if we can get there that's still already work. But I do wonder what are the thing I will say compared to some other pumps is we have no tubing at all right? So the the fluid path, if you will, from the cartridge to the skin of the user is actually very, very short. And that of course has the advantage as well, which other patch pumps have as well, not all of them, but some for sure is that it has very little incident wastage involved, of course, we really aim to completely empty the cartridge.
Stacey Simms 23:12
Are you making the infusion set or the connector? Are you all making that yourselves?
Pim van Wesel 23:17
Yeah, we make everything ourselves except the insulin cartridges which are available, but we are doing everything ourselves. We have from our micro fluidics technology background, we have a lot of information on what works. And we've done extensive insulin compatibility testing with insulins that we believe will be available in this cartridge just so we have the data, which is very encouraging that, you know, it lasts and that doesn't create any you know, material interaction issues. For instance,
Stacey Simms 23:45
I mentioned at the beginning of our chat here that you are relatively new to the company. And you also talked about you're already getting input, I'm sure criticism, comments from the diabetes community from the website. What were you doing before this? And what has it been like to move into the diabetes space where well are very, very passionate?
Pim van Wesel 24:06
Absolutely. It's, I've been with the company formally for about a year, I've, you know, been helping the management team, the executive team and the board a little bit before that. I have a longer experience in diabetes. I worked for about five years in diabetes with Medtronic and Europe. So this is not my my first rodeo. It is a very engaged community and very passionate and very vocal. I've also worked in incontinence and I can tell you that the people who have incontinence problems are a lot less vocal than people living with diabetes for sure. And people stay around right. It's been very encouraging to to reconnect with some of the experts, the clinical experts I had the privilege of working with in the past and they're still around and you're still advising and they're still happy to have a discussion and give very solid input. So quite a bit of experience with diabetes been in medical technology for since 2003. if you will, so coming up to almost 20 years, but I must say that working in diabetes is in the diabetes technology field is particularly gratifying you, you're actually much closer to what's happening than in many other areas of medical technology. So it's been good. It's been good to be back. Absolutely.
Stacey Simms 25:17
That's great. Yeah. And then the past few years, as well, there's been this push from the pump is, you know, this clunky medical device to realizing that people, you know, it's such a part of the day to day life of someone with diabetes, and our phones look great, Why can't our pumps look great. And I'm assuming that that is part of the design here to this is kind of silly to ask, but I did get this question. And I like silly. Is there any planning here to make it different colors to have any designs on it, things like that,
Pim van Wesel 25:48
let me Well, a couple of things. Colors is not the high priority, we have a project extension matrix and colors is actually on there. We think it's a fairly low efforts, we're just questioning in terms of user benefits, if there's not other things we need to focus on first.
Stacey Simms 26:06
And also getting it to market probably is the top priority,
Pim van Wesel 26:08
for sure. But you know, when you talk to two people in the diabetes investment community, they want to see some ideas of what else you can think about for the future. And we have a number of ideas in this. But particularly for young, young users and pediatric patients, for instance, we know these things are important to my, in my former life, I've spent a lot of time coming up with cool stickers that worked on a pump, if you will. But we were already worked very hard on the design. If I show you one day, the first prototypes, they looked very different and quite a bit bigger. And we're very fortunate to work with an excellent design company around some of these four factors, things, I didn't fully appreciate that necessarily when I started. But for instance, the applicator has gone through numerous separations, iterations to allow for single hand application at all different body parts so that the angle still works. And one of our investors, you know, said, Oh, I get it. And I'm not sure if this analogy resonates in the United States. I think it does. But one of the investors said, Wait a minute, you're like the Nespresso, of insulin therapy. And I don't know, if you, you know, if you made an espresso in the old fashioned way, you had to get the amount of coffee, right, you had to get the pressure, right, you had to get the temperature, right. It's quite involved, right, and espresso comes around, and kind of makes it, you know, standard and repeatable and very, very easy to use, come and take a little bit further, it's so happens that the design company that we've worked with, on route a form factor, not that technology run the form factor, actually happens to be the same company that designs the Nespresso machines. They liked our project very much. And I wouldn't say they're doing it for free, but I think we're getting a better rate. And then this person is,
Stacey Simms 27:55
you know, a friend of mine makes a t shirt that says I run on coffee and insulin will have to send them one of
Pim van Wesel 28:00
those. Absolutely. And I'll share it with my espresso friends as well.
Stacey Simms 28:05
Hey, I meant to ask you earlier, and this is a question I got from a listener, you have mentioned, you know, we've talked several times about the prefilled insulin cartridges, do you anticipate a certain type of insulin? Will it work with most of the types that are out right now,
Pim van Wesel 28:19
we have tested it for insulin compatibility with for insulins today, we've tested it with Nova rapid, we've tested with fierce, we've tested with Lumia F, and we've tested with Humalog. And we think that we that we cover a very significant portion of the US market, because there are some, you know, various there is a sell Fill option as well for this product, although that's probably not the benefit that we you know, we we kind of put forward that much but we're very interested in working with with multiple intell insolence, particularly if they could be available in in prefilled insulin cartridges. And we have some ideas are as well, particularly for for type two, to work with higher concentrated insolence. And we have some discussions around well, could the pump identify which type of insulin you're actually putting in your pump? You don't want to confuse you 200 or higher. Right? Right, you 100 Of course, the further discussion around that. And this may be a little bit too far ahead. And you know is well wait a minute, you have different types of insulins, our future algorithms going to take different types of insulin rapid, ultra rapid and to take take into account in their calculations. And how could we ccommodate that the some of the discussions we're having with insulin manufacturers around Okay, would you pump be able to tell which insulin type you have actually just loaded your pump with snakes. Interesting.
Stacey Simms 29:50
Yeah. Yeah. It's very interesting to think about that. My goodness. I was just thinking like, could you use Humalog, Novolog? The four you mentioned, I guess Apidra would be the only one I would have a question about but it just doesn't sound like you've tested it.
Pim van Wesel 30:00
You know, we've not tested it yet. And there's no other reason than that. We know that the insolence I just mentioned, they might be available in the cartridge form factor, or Nofal. Rapids. And, and fill us with, that's public information that they're available in pump cart. And we've all learned about the lily project with Ypsomed, and we kind of figure that they will use a similar cartridge, we don't think that it's going to be very different form factor wise. So that's why we focused on those four,
Stacey Simms 30:33
we've already started looking probably further ahead than we should with something like this. But you mentioned the next time there may be more information will be in in March, and then more trials on people starting later this year. Do I have that correct. Anything else that you want to add that's happening in the near future?
Pim van Wesel 30:50
Will will hopefully well, one feature that we haven't discussed and which we are exploring very actively, and we announced this last HDD is that we have very fast Ultra very fast occlusion detection. And we have now independent data, which will hopefully see published at attd, about comparison to comparative data, how fast our occlusion detection is, and we're exploring what are some of the benefits of that, of course, we tried to balance it against alarm fatigue, of course, we don't want everything to become, you know, an alarm and basically drives people crazy. But we think there's some real benefits to having very faster collision detection, particularly if you go to very young patients. And I think we're seeing more and more people with diabetes getting diagnosed earlier and earlier. And here in Europe, at least, they almost instantaneously go on a pump. And then we think we want to accommodate that. So that's going to be some clinical work we need to do, how do we how do we position the ability to, you know, very, very quickly, we're talking minutes, not hours, right? If you have a very low basal rate, you might not see an alarm in days. And we're actually minutes in that respect and that support very encouraging that we, we still need to think about. So maybe that's one feature we haven't talked about, and we're gonna do some clinical work around.
Stacey Simms 32:09
Interesting. Well, thank you so much for joining me. I look forward to learning more. I appreciate you starting the conversation. Tell your folks when they send those pumps for people to try. Certainly espresso machine. We all love espresso, they can handle that. Very good.
Pim van Wesel 32:23
I like the idea. Well, I wanted to thank you Stacey for the opportunity. And we're always available to answer questions.
Stacey Simms 32:29
Fabulous. We'll talk soon. Thank you so much.
You're listening to Diabetes Connections with Stacey Simms.
Lots more information about Sigi at diabetes connections.com. Every episode has its own homepage with a transcription and more information. If you go there, and the transcription isn't there. And it's an episode after January of 2020. It's coming. It just may take a couple of days to get it posted. But I promise it's there. And we are working our way backwards through the other episodes since we started the show in June of 2015.
I did want to add one thing I forgot to ask during the interview and I asked it later, why the heck is it named Sigi. I emailed them after the interview. And they told me that they came up with the name through an internal naming competition. The chairman of the co founder proposed it kind of a little tongue in cheek was tribute to one of his fellow co founders, an older gentleman, he is 84 years old now. And he was at the origin of what they call the system's core a microfluidic pumping technology idea. His name is Siegfried Strassler and Sigi is his nickname. They said everybody liked it. Also, because I love this it evokes a certain friendly, reliable swiftness. And so it was voted. So that's why it's called Sigi. I love names, I just love to find out why these things are called what they are. I mean, sometimes it's just a number like Omnipod. Five is the next one, Dash was number four and back from there, they're keeping it simple. I liked horizon. I like with control IQ. I hope that they keep names like that. So we don't have to just remember numbers, it makes it easier and it gives a little bit more personality. So thanks for the definition of Sigi and congratulation to Mr. Sigi Sigfrid strassler. Although I guess if it's his nickname, I would not call him Mr. Sigi. I'm calling him Mr. Sigi.
Anyway, we will keep you posted on how the Sigi system moves through the pipeline. And of course, I'm following closely on technology and hoping that we're getting more approvals and more movement for the US FDA for stuff that's already in front of them and that is in the pipeline.
What's coming up. I will say that if you are interested in sending your child to diabetes camp, jump on that most of the camps have opened registration, they usually do that in mid February or by mid February. So chances are if you've got a local camp near you or you want to send your kid to a camp that's not local. Go ahead, look that up. I actually thought I remember when Betty was diagnosed because campus such a big part of our lives as the kids got older, I was thinking, Okay, we're going to do like a diabetes camp tour. I'm going to send him for a week to the local one, I'm going to send three weeks to that one, because that goes for three weeks. I'll send him for two weeks to that, like, I was just gonna trick them around the country. But then of course, he said, No, he was going to go to the regular camp where his sister went, and that was the end of that. And I don't know if I've mentioned here before, I think I have, but he's gone for eight weeks this summer to be a CIT. I'm so excited about that. But eight weeks, man, no share, no follow up. I don't have WiFi at this camp. He'll be fine. We're going to talk about how he wants to do it. I mean, he's 17 years old at this point, so I'm really excited for him.
Okay, we have lots coming up. Please join me for in the news we do that live on social media on Wednesdays, and that it becomes an audio only podcast on Fridays. Thank you, as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon. Until then be kind to yourself.
Unknown Speaker 36:01
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
The US FDA has approved Insulet’s Omnipod 5 Automated Insulin Delivery System. This system was submitted more than a year ago but has been delayed due to COVID 19. Stacey talks to Dr. Trang Ly, Senior Vice President & Medical Director at Insulet Corporation who explains what makes this system different from the other AID systems on the market, what phone control means, what the roll out will look like, insurance issues, Medicare and more.
DiabetesMine's write up of Omnipod 5
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
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Episode Transcription Below (or coming soon!)
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Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 Where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, the US FDA approves Insulet’s Omnipod 5 automated insulin delivery system. This was submitted more than a year ago but has been delayed due to COVID 19. Let's hope this approval signals at least the beginning of the end of that logjam at the FDA.
Welcome to another week of the show. I am always so glad to have you here I am your host, Stacey Simms, and we aim to educate and inspire about diabetes with a focus on people who use insulin. If you are new to the show, my son was diagnosed with type one right before he turned two back in 2006. He is now 17. My husband lives with type two diabetes. I do not have any kind of diabetes. I have background in broadcasting. And that is how you get the podcast. And for this episode, I am so excited to speak to Dr. Trang Ly, Senior Vice President and medical director at Insulet Corporation. Insulet, of course, makers of the Omnipod. I asked for questions within our Facebook group. It's Diabetes Connections, the group and boy to do come through. But because Dr. Ly is part of the medical side of Insulet, I'm sure you understand there are some questions she just can't answer she it's not her realm of expertise. But I promise we will follow up in the weeks and months to come. And I will do a deep dive into what is such a huge story for our community. I am always so excited to see more choice for people with diabetes and automated insulin delivery is a game changer.
Let's go through the basics. Because while many of you just want to get to “when can I get this in my hands. And I've used this product for years. And it's basic forms, I just want to get the loop..” Let me just take a quick second and set the table because there are a lot of people new to pumping and to pods. And I just want to be absolutely clear. And this is going to be very simplistic Dr. Ly we'll get into many more details. But the pod is what sits on the body. That's what holds the insulin and infuses the insulin into the body. There are no buttons, there's no display, there is a separate handheld controller. This could be a phone, we will talk about that. And that is how you control the pod when it comes to giving insulin for meals, you still must give insulin for meals with this system. With Omnipod 5, you also have the Dexcom G6 that is the continuous glucose monitor. The pod and the CGM work together, it very simplistically gives you more or less insulin to try to keep you in range.
There are similar systems on the market already. The Medtronic 670 was the first like this in the United States. Now they have their 770 G system. Tandem has the control IQ system. For the record. That is what my son has used since January of 2020. And Omnipod system is a little different on these systems all have differences from one another. But as you'll hear the Omnipod system is the first in the US that will actually learn from you. And we'll talk about what that means Omnipod 5 is going to launch through the pharmacy channel just like previous products and will still have no contract. And they are offering what they're calling a limited market release. So this is not going to be available tomorrow to most people Insulet has a Frequently Asked Questions section on their website that I got to say it is one of the most robust I have ever seen in my 15 years of diabetes. So please go there. If you don't hear your question answered by Dr. Ly. I'm going to link it up at diabetes connections.com There will be a link in the show notes.
And as I said, we're going to be covering this a lot more this year. And make sure you tune in every week I do a short newscast episode. We do that every Wednesday live at 430 on Facebook and YouTube. And then I turn that into an audio podcast which comes out on Friday. Those are five or six minutes long, and I'm sure we're gonna have Omnipod updates there. Okay, usual disclaimer, this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Dr. Trang Ly, welcome back. And congratulations.
Dr. Trang Ly 4:28
Thank you, Stacey. I'm super excited to be here with you.
Stacey Simms 4:31
I feel like we should have a confetti cannon that started this episode.
Dr. Trang Ly 4:36
Just Oh, it's been incredible few days.
Stacey Simms 4:39
I'd like to talk a little bit later, perhaps about more of your personal feelings. You've been involved in this for so long. And when we spoke in August, you were really generous about sharing some more of your experiences, but I know everyone who's listening wants to get into the nuts and bolts. So let's start by just jumping right in. Tell me what was approved by the US FDA. Let's talk about what Omnipod five is.
Dr. Trang Ly 5:02
Yeah, so Omnipod five is our tubeless automated insulin delivery system that we've been working on for quite some time, and that the whole entire community is excited about. I'll talk about it in terms of the components of the system. So we have the tubeless pod that many people will know and love today. And that essentially stays the same that has added features. So it has the smart adjust technology, which is our algorithm inside the pod, and that delivers insulin every five minutes and can increase decrease or pause insulin delivery based upon the CGM value, so the sensor glucose value, so we are connected to a very important part of the system, which is the Dexcom G6 sensor, great sensor accurate. And that is connected wirelessly to the pod, the person wears the pod and the CGM. And they can have on body closed loop control. Another key component is our controller device. So every person who is prescribed Omnipod 5 will have access to our Insulet provided controller, which is basically the remote controller for the system. And on that is our Omnipod 5 app, where they're able to control their pod and do all their settings for the algorithm. And what is really quite unique about what got cleared and announced on Friday is that patients will also have the option to control their pods from compatible smartphones. And so that is really quite a unique advancement in technology in diabetes, for automated insulin delivery systems. You don't have to use the smartphone to control the pods, but that optionality is there for compatible smartphones. So that would in certain cases, replace the need to carry the Insulet provided controller?
Stacey Simms 7:13
Yeah, we'll definitely talk about the smartphone aspect. As you said, this is a first in many ways. So I want to talk about that in more detail a little bit later on. And another component of the system then is the Dexcom G6.
Dr. Trang Ly 7:25
That's right. And I think what is unique about this is that you'll be able to control the G6 from the G6 app. So all of that start stop sensor, all the calibration, all of that, and the Dexcom follow all that functionality that people are familiar with today stays the same in the Omnipod 5 system.
Stacey Simms 7:49
Okay, we know I needed to clear that up. Because you started off by saying you control it from the G6 app, do you control it from the Omnipod 5 app?
Dr. Trang Ly 7:56
No, you actually control it from the G6. Yeah, that is slightly different to other systems that are on the market, the G6 sensor is stopped and stopped through the G6 app. And then you have the functionality of the Dexcom follow with our system with Omnipod. Five, when you set it up, you enter in the transmitter ID for the Dexcom. And what that allows the Omnipod 5 system to do is connect to that transmitter and display that information front and center of the Omnipod 5 system.
Stacey Simms 8:37
You know, it's funny, I'm sure as we're talking, we're gonna get into a lot of the weeds here because they went straight into the weeds. And I know that we'll talk a lot more as this year goes on. And there's more and more people use the system. But I do want to kind of try to stick to some of the nuts and bolts. Yeah, I'll catch myself here. It's definitely it's not you, it's me as we're going through this. Let's talk about how the system tries to keep people in range, because one of the things that many in my audience are watching very closely are the customizable targets. So you can take Omnipod 5 and customize your glucose target from 110 to 150. Is that still the case that that's what was approved?
Dr. Trang Ly 9:14
Yes, that's correct. That was what was approved. So you can set up see during the day, you want to be at 120. And then overnight, you want to be 110, you can set up a profile that would reflect that, you know, if you're someone who is new to AI, D and you generally tend to run a little bit higher, you don't want to be at 110 straightaway and you want to you know, run at 130. For a while you can set that profile, you can set that 24 hour profile with glucose targets. And that is a unique feature of our system. And that's what was tested in our clinical trials and we're really pleased to be able to offer this level of customization for our patients.
Stacey Simms 9:57
Tell me a little bit more about smart adjust, my listeners And I almost hesitate to ask this. But my listeners are incredibly in tuned to their devices. They have already taken so many of these devices and tried to customize them as much as possible. Many people are trying to adjust their glucose many times an hour. I wonder sometimes about the the adjustment, and no, no pun intended with smart adjust. But the adjustment of people who you kind of need to leave these systems alone, I guess is what I'm trying to get at Have you already come up against that? Or is there any advice you tell people to kind of like ease into the system like this when they're used to making a ton of adjustments themselves?
Dr. Trang Ly 10:34
Yeah, I do think there is some adjustment that needs to be made when adapting to an automated insulin delivery system. But I think a lot of your listeners will be fairly familiar with this type of technology. And really, it is the ability for the system to react to the CGM that's coming in and dynamically adjust insulin every five minutes. I mean, that is what is really the value here in within our system. So smart adjust is our algorithm. And the feature that is really going to set Omnipod 5, apart from the other systems out there. And it is what we tested in our clinical trials, which, as I mentioned, you on our last poll, you know really had extraordinary results in terms of timing range, a one seat reduction, and then that hyperglycemia profile, which was very low hypoglycemia. So I'm really proud of the system that we have built, it is something that we, you know, made improved upon, over the years through our clinical trials. And it was really developed from learning from our patients and all of the of the participants who took part in in our trial. So it really is a real love letter to the community who have advocated so hard for this level of innovation.
Stacey Simms 12:00
One of the very unique things about Omnipod 5 is that in reading about it, you always say it learns the user, right? It kind of changes as it goes in, it adapts which is brand new, this is not something that any of the other automated systems on the market commercial systems do. Can you explain what that means? Yes.
Dr. Trang Ly 12:18
What about design philosophies going into this is simplicity for the user. We know diabetes is an incredibly burdensome condition. And it was important for us that we did not, you know, through delivering automated insulin that we didn't make life even more challenging for people and requiring more attention. We really wanted to create more headspace for people to forget about their diabetes and do other things. Omnipod 5 is a real advance on that front. What we talk about in terms of learning and adapting is that our system initially takes the basal rates that are entered by the system as a starting point for the automatic controller, and then the algorithm as more information comes in, which includes the CGM values, and then the total insulin that is delivered by the system. Based upon that information, the algorithm will augment how much insulin the patient needs at baseline, and then with hyperglycemia, and hypoglycemia as well. Perhaps the most stark example of this was when we had a adult patient who came in who had relatively high A1C, starting point, so probably was not getting as much insulin as she needed. And so had a starting insulin program of around 27 units a day. And then over time, it was about two weeks where the insulin delivered by the system actually ramped up to close to 70 units a day. And that's just in basal insulin
Stacey Simms 14:03
from 27 to 70. Seven Zero. That's correct. Wow.
Dr. Trang Ly 14:07
Yeah. And so that that's a fairly extreme example. But what it shows is the capability of the system to take in new information and make adjustments along the way. And the whole point of that is really to reduce the work that people and parents have to make in terms of, you know, tweaking those basal rates, because, you know, we want to add a system that would reduce that type of burden for these. We're doing as much as we can for our users in this first system. But there will still be the ability for, for users to augment the insulin to carb ratio and correction factor. That all works exactly the same. So if your insulin sensitivity changes over time, you may need to make those adjustments, but the ability for the algorithm to adjust that baseline insulin delivery that day Damage Control does adapt based on new information coming in over time.
Stacey Simms 15:04
I said, Wow. And I want to be very clear on why I am. So I want to stand remember the confetti cannon, I said at the beginning, I want to fire it again. I, I fought I mean, I can only speak to my personal experience. I'm not a health care provider, I'm not an endocrinologist. But I talk to so many parents who feel like their kids aren't doing what they're supposed to be doing, quote, unquote. And then the doctor says, Oh, my gosh, you have to double the basal rates. And suddenly, it's working again, because things can change so much. And we don't know exactly. I can just think of my family as an example, when Benny was a tween to teenager, his basal rate doubled within two years, and then doubled again. And he was getting these incredible amounts of insulin. And when I would tell my friends, a few of them would say like, I could never do that, that sounds so dangerous. I can't believe how much he's getting. And I mean, I've shared he was getting 80 units of basal a day of just basal. And he's back down. It's not it's not even close to that anymore. But he needed it. And I just feel like, gosh, I was gonna ask you to give an example. And I'm so glad you gave that one. Because to know that the system can learn that much and safely give that big of a change is remarkable. I'm curious, did you have any changes in the other direction, like people who were really worried about people who were really experiencing? hyperglycemia?
Dr. Trang Ly 16:23
Yeah, Stacey, going down is easy. Going up is hard. It's, you know, and I'll tell you, it takes some courage to do these types of things. And people are scared, and I will share that I was scared in making, you know, some of these decisions. But, you know, I have learned so much from patients, I've taken care of teenage boys, like your soul, you know, who, who need more than 100 units a day who fluctuate between 70 and 120 units a day in a week. And that's what we need to be doing is helping people like that, you know, who who really struggle and have different insulin sensitive Rudy's on a daily basis and different requirements who are at risk of both hyperglycemia and hypo. And honestly, I carry that with me every day, you know, all those learnings and say, you know, we have to create products that can, you know, address this, because this is what we're trying to help here
Stacey Simms 17:39
right back to Dr. Ly, in just a moment, but first Diabetes Connections is brought to you by Dexcom. If you're a veteran, the Dexcom G6 continuous glucose monitoring system is now available at Veterans Affairs, VA pharmacies in the United States, qualified veterans with type one and type two diabetes may be covered. Picking your Dexcom supplies up at the pharmacy may save you a lot of time to connect with your doctor for more information. Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. Here's the link, I'm going to put this in the show notes, it'll be easy to find it's dexcom.com backslash veterans. But if you don't want to write that down again, it'll be in our show notes at diabetes connections.com. And now back to our conversation with Dr. Trang Ly.
This next question may not make sense with the system. But you tell me, I wanted to know about the percentage of correction bolus that Omnipod 5 gives. And you know, my frame of reference is the Tandem control IQ which my son has used, which the system adjusts basal, if you get close to 160, it gives you a partial bolus if you get close to 180. Is there anything like that going on here?
Dr. Trang Ly 18:51
Yeah, for sure. And what I'd say is that rather than having that modular approach that the other system has, you know, als really has that dynamic insulin delivery every five minutes. And it's pretty straightforward. Basically, whatever target you said, the system is always driving towards that target. So, you know, you can be 110 all day and do that. And, you know, when we did our clinical study, the adult and adolescent population, so this is the 14 and older age group, the target that they used most frequently was the 110 target. And in those patients during the time that they were using that lowest target of 110, they were able to achieve 76% time in range, really great to be able to do that. And so I would say it's basically that straightforward. Whatever target you set the insulin, we're going to adjust insulin to try and get you there as quickly and as safely as possible.
Stacey Simms 19:55
If I'm hearing correctly, though, maybe with this system, we don't think about it as Adjusting basal giving a bolus. It's more, there's an algorithm in here. And it's proprietary. But there's an algorithm in here, and it's just giving insulin as needed. Is that what I'm hearing?
Dr. Trang Ly 20:11
That's right. It is a hybrid closed loop systems that people are still expected to bolus for meals. Right. So that's really important for people to do. And you know, to in order to really get good glucose control, it's important that people premium bolus and work with their healthcare providers to really optimize that insulin to carb ratio and correction factor that yes, our pancreas don't think in terms of basal and correction, those are concepts that we made up, you know, as I tell my team insulin is insulin, you know, it's basal correction, whatever, it's really, you know, how much insulin on board there is, what the trajectory is, and you just make the adjustment accordingly. So, yeah, I don't really separate it
Stacey Simms 20:57
out. new way of thinking really interesting. Again, I'm going to get us off topic here. But I am thinking of the people who've never pumped before and jumping into a system like this, and how much different that must be.
Dr. Trang Ly 21:08
Yeah, we always think about those patients, because we think pump therapy is just a much better therapy in terms of the physiology of insulin delivery, and it's just a much safer, and modality there. So, you know, actually, in our clinical trial, we had about 15% of our users who were on multiple daily injections. So they came in, and we put them straight on Omnipod 5, so they didn't have to first use a pump, or first use the CGM, they just came straight in, we put them on Omnipod, five, and they did really, really well. And we've presented that data at various conferences. So they really did, ultimately, just as well as the people who had previously been pumpers, it is very simple and easy to use. And that really, the simplicity of our system is what makes it so great. And it really reduces that burden of you know, having to pull out pens and syringes when you're out and about and, and be able to discreetly deliver insulin from a phone device. I think, really, that is what sets our system apart from other systems is it's the simplicity and ease of use.
Stacey Simms 22:23
I'm gonna give you a couple of specific questions from our listeners, if you can't answer that. We understand. And I actually have worked in a bunch of questions already. As you listen, I'm getting to as many as I can. But one came up that I thought was interesting, which was, is the system robust enough to defeat a 350 blood sugar on its own, you know, I think everybody's been there. They forget to bolus they're eating a big meal, they realize it too late. And then with these automated systems, you have to be very careful about how much you correct. And then there's a second part of this question, which is, if I do want to give an additional shot for any reason, will the system keep track of something like that?
Dr. Trang Ly 22:58
I guess it depends on why your 350 in the first place. So if it's from food and underestimation of carbs, or you forgot to bolus then I will tell you that by the time you are 350, the algorithm has already known that and it has already delivered a bunch of insulin to bring you down, it will bring you down and it will generally do that in two to three hours and get you within range below 180. Within that time. And we know that because the development of Omnipod 5, we specifically gave people these large meals and didn't bolus for them and watch the algorithm and see what it would do. And, and part of the reason why that's so important is because we know this happens to people all the time, and we want to safely bring them down, but not cause rebound hypoglycemia, because that is not good. And people will not trust the system and will stop using it. So that is exactly the type of testing that we do. So I would say that it is very robust and is very specifically targeted for that in terms of the question of if you give a shot not through the pump, then no, the system would not know about that. But what it will detect is, you know, a falling blood glucose level, and it will be able to suspend insulin delivery very quickly. And depending on the rate of change of glucose, it could suspend, you know, even if it's in the two hundreds, it could suspend very quickly. And as far as I'm aware, actually, none of the commercial systems are able to import that information. So you would have to do that very cautiously because the system isn't aware of that external insulin.
Stacey Simms 24:51
It's an interesting question. You know, we've we've done that, you know, sometimes there will be a bad infusion set or things will happen. I mean, obviously the pod it's a little different and you'll want to give them Manual injection. I understand what you're saying. And I think it was, it was a good question, but it's practically speaking, we're not gonna be able to do every circumstance.
Dr. Trang Ly 25:07
That's right. Yeah. Unless we had like this really special insulin detector.
Stacey Simms 25:16
Why don't we have that yet? Special insulin detector get on that?
Dr. Trang Ly 25:21
Well, you know, well, technically, it's very hard to do insulin assays. So, yeah, anyway.
Stacey Simms 25:28
I guess, you know, in layman's terms, what I what I think of a lot is, okay, if my son needs to give an injection, can he just put in Okay, pump. I gave myself this much. Because with the older non smart pumps, or before there were any hyper close loops, you really could do that. You could kind of fake a dose.
Dr. Trang Ly 25:44
Yeah, you can't with our system. Yeah. Yeah.
Stacey Simms 25:50
I don't think you can do that with any of the automated systems. Now, another quick question, before we move on to smartphone, can you extend a bolus, this was something that came up, can you still do that, or if you can't do you even need to, you can
Dr. Trang Ly 26:02
if you're in manual mode. So manual mode is basically on the pod Dash. And that is when you set it up with the settings that, you know, you discuss with your healthcare provider, and they preset basals and bolus settings. So if you're running that mode, or if you happen to, you know, not have a CGM and you don't want to run an automated mode, then you will have that functionality to have extended bolus. And there are a number of reasons. But we actually looked at this in a clinical trial that we did specifically looking at high fat meals and using extended bolus with our algorithm versus just letting the algorithm work. And what the results showed was that with high fat meals, the algorithm was better in terms of figuring out how much insulin you needed, then a person trying to figure out okay, how much do I give up for and how much do I extend? And because of that data, we decided not to include the extended bolus with our algorithm. side. So in automated mode, extended bolus does not work.
Stacey Simms 27:17
Great. And, and you lead me then into the next point, which is, can you expLyn the manual mode? This is not something that the system decides you're in, right? This is the user saying, okay, I'd like to be in manual mode or no, I'm going to be in auto mode. In other words, you can't get kicked out like on the Medtronic system.
Dr. Trang Ly 27:31
Exactly. So the manual mode, as I mentioned, is all the preset settings that are programmed into the system. And then automated mode is when you have a CGM connected to it. And as long as you have CGM transmitter ID entered you are and you know, your targets set up, you can off you go. And so the setup of the system is very similar to Omnipod dash, except there is an additional step where you enter in the transmitter ID so that the pod knows which CGM to search for. And then once that value comes in, and in fact, you don't actually have to wait for that value to come in, you can just start automated mode, and then the system will use the information that it has to augment insulin delivery. Got it?
Stacey Simms 28:25
Let's talk about the phone. Because I think this is incredibly significant. It's a first for the FDA, it's just going to open the door in my opinion to so much other technology. Yes, right. Now, as you and I were talking, there's only two smartphone models that works with that's gonna change. But let's go down and talk about these features. This is full control allowed from a smartphone, right?
Dr. Trang Ly 28:44
Yeah, I was so excited about this feature. I mean, see, it's the number one feature that our patients ask for over ad over automated insulin delivery, which kind of really blows my mind. I will I
Stacey Simms 28:57
was, you know, I've shared with you, I was gonna say I'm actually a little bit more excited about this. And I, I kind of ended high because automated control is so is so incredible. But phone control is also I mean, my son is he cannot wait for this. It's just, we don't even again, we don't use your system. But yeah, wait, it's just such a great thing. So before I start getting all crazy, let's go through some of the features full control from the phone.
Dr. Trang Ly 29:21
Yeah, and I want to say that, you know, as a pediatric endocrinologist, I totally under appreciated the how our patients valued having phone control, and being able to control their devices from their phone. And it wasn't really until I saw the data that where everybody might have this is their number one request that I was like, huh, we better start listening to patients. Because in my mind, you know, if people aren't using their devices, they're not getting any benefit from automated insulin delivery. So it's really important that we address all the pain points. For our patients, I am really proud of the team for getting this through and getting this clear, it is just so meaningful for our patients, I think it's really important to clarify that if we don't have the phones that we currently have available, it doesn't mean you can't use a ID, that you can't use Omnipod 5, you know, our system will always come with an Insulet provided controller, and you know, you can use it as a separate device. But you know, very, very quickly, we're going to have many phones available where you can download an app, it's as simple as that it, it works on your phone, just like any other app, you open it up, and you input your settings, just like you would setting up a brand new controller, and then you start and stop your pods and manage everything just from your phone, and then you're getting rid of that controller device, you know, you're carrying fewer devices. That's what it is. And you know, in future, we will have iOS and Apple devices in future. We haven't set a timing for that. But you know, all of that is in the works. Because, you know, we care a lot about reducing the friction for people to use and access Apple devices. So I'm very excited about it. All right,
Stacey Simms 31:21
I know you can't give me a timeline. But you said very quickly is very quickly this year for Android and next year for Omnipod is very quickly quarter two for Android and end of this year for kind of get any timeline for
Dr. Trang Ly 31:34
I know, I can't provide any timelines. But you know, the team's working on it. And you know, I get to see the prototypes, and I get to test things out. So it's super fun for me, but I am sorry, I can't provide any time timeline
Stacey Simms 31:47
updates. You know, one of the big questions that came up Omnipod, five is going to come out with limited release. What does that actually mean? And how do you decide who gets it first? And who gets it next? Is it geography? Is it when people signed up? How does it work?
Dr. Trang Ly 32:01
I know everyone is super excited about Omnipod. Five, and especially us as a company, I think it's really best practice before we do anything big in life to start small and make sure that you know everything, all systems are working. And you know, we are doing a lot of innovation actually, not just with the product, but also the way we serve patients in terms of our onboarding platform, our self guided training, ordering, product support all of that. So it's quite a large undertaking for our company. So what we're doing here is making sure that everything goes well and, and is smooth for our users before we embark on the full launch. So right now, just in the next few days, we'll be rolling out our limited market release. And then once we have all the information we need, and all the data to make sure that we can handle all the demand that comes in will be then announcing our full locker release. And we expect that to be in terms of timely, just shortly after the limited. Release is complete.
Stacey Simms 33:10
Okay, but I have to ask a follow up on that. But to be clear, then it's a limited release for the people you've decided we'll get it. Yes. And then it goes to everybody. So it's not going to be a rolling limited release? No, it's a so then my next question is the first question. How did you decide the limited release? Who are these people,
Dr. Trang Ly 33:29
we haven't provided details about that. And part of it is really to make sure that we have, as I mentioned, you know, really assessed our full systems and making sure that, you know, we can address the demand that will be coming in. So I think what people what our patients really need to know is, you know, how did they get on products? That's certainly the number one question that I'm getting is, how do I go on Omnipod? Five? And how do I prescribe it? So you know, for that, I would say that today, you know, getting on Omnipod dash is the fastest way to get Omnipod 5, because for those users, that means that they are most likely have access through the pharmacy channel. And then we expect that our Omnipod 5 coverage will be very similar to our Omnipod dash coverage. So if you're already on the dash, it's expected that you know once Omnipod 5 is available and there is insurance coverage which you know, we're ramping and growing every day then that transition should be very very smooth. And also you know in terms of devices you know, if you're already on and only Pradesh and you're on a G6 you can go through our self guided training and so you know already being familiar with our system and devices that makes it a lot easier in terms of training and transition but also it in enables you to get onto our interest list for Omnipod. Five. And what we'll be doing once it's fully available is really going through that list in in order of people's names on it to make sure that they have coverage and getting them Omnipod. Five as quickly as possible. We're really committed to our current dash users. I mean, all of our new pod users were fully committed to
Stacey Simms 35:23
do people need a new prescription to move from Dash to Omnipod 5?
Dr. Trang Ly 35:27
yes, it's a different product, it's an entirely different product. So yes, they will need a new prescription. Okay,
Stacey Simms 35:33
because that was one of the interesting things with when Tandem rolled out control IQ. Sometimes as you listen, you know, you got to get in touch with your endocrinologist once once it starts rolling out. Right. That's one piece of the puzzle we have to make sure to include, um, you mentioned Dexcom, questions came up Dexcom G7, knock on wood could be approved in the United States this year? What will that change over look like when it goes from G6 to G7 for Omnipod 5?
Dr. Trang Ly 35:57
Yeah, so were working on next in terms of integration of the physical integration with G seven. We're working on that and future sensors. So we haven't announced any timing in terms of when Omnipod 5 would be available with G seven. That is something that we're working on. Even if G seven gets cleared this year. We certainly haven't announced any thing in terms of Omnipod 5 compatibility with that, at this point in time
Stacey Simms 36:29
about Medicare, it is the Medicare coverage expected to be seamless, and supplies seamless for that population. Yeah,
Dr. Trang Ly 36:36
so in that population, you know, we have fairly good coverage for that. And again, growing and as well, and Omnipod dash is available through the pharmacy channel. And as I mentioned, we have great coverage. And already today with Omnipod. Five, we actually have more covered lives right now than we had even just, you know, a few months after Dash was launched. So the team has, you know, our team has made extraordinary progress on that front to ensure that you know, when we're at for release, our patients can get access to that as quickly as possible.
Stacey Simms 37:19
And I should ask the clinical trials where ages six to 70, while the lower limit is something that you have talked to your endocrinologist about people over the age of 70 can still use this device, right?
Dr. Trang Ly 37:30
correct way, clade full six and over no problems for our 70 plus population.
Stacey Simms 37:36
Excellent. What about the rest of the world? The question was, has it been submitted for CE marking Europe, my friends in Australia, your friends in Australia are like what's going on?
Dr. Trang Ly 37:45
I know I I'm like really behind in my emails. Because everyone in Australia wants it, it's gonna come, we have to get it cleared. And you know, our first hurdle was getting across the line in the US. So you know, I'm just super, super excited to get it. And it means we have a great product and you know, our clinical trials prove it. And in time, it will get to all of those places.
Stacey Simms 38:16
I know have kept you longer. I have two more quick questions for you. The second last here is will Omnipod and Dexcom work together on the customer service side now that you are linked as a system? Will customers be able to work with both? If you're not familiar, as you listen with Tandem? Sometimes you call Dexcom? Sometimes you call Tandem. When you have issues. The Tandem can send you replacement sensors, things like that. It's not it's not a seamless partnership. They want help with everything. But I'm curious if Omnipod and Dexcom will start working together in that way.
Dr. Trang Ly 38:47
Yeah, we have. We've been working together for years, in fact, to get this right, because we care a lot about customer service and taking care of our patients. So the teams have been working together very, very closely to make sure that there is warm transfer between both companies for our patients. And that means you know, whatever we can address we address and whatever Dexcom addresses they'll be addressing. Yeah, so as you point out, it is different to some other models that are out there, in that these are really two separate devices. And that means that we're not handling Insulet is not handling any of the sensor orders. But we're just really focusing on on the pod. And I think what that allows us to do is you know, allows each company to do what we're really good at and not like try and figure out how to be dispensers of sensors, that allows us to really scale and move quickly in this space. And again, it's a different type of way to serve customers. But at the end of the day, we don't want to be wasting our time. It's time over these things because they got better things to
Stacey Simms 40:03
do. I meant to ask when we talked about the phone control, and the phone display is a follow feature going to be part of Omnipod 5? So caregivers, spouses can look, yes, we
Dr. Trang Ly 40:13
already have that today with Omnipod View app with the Omnipod dash. So, you know, that's really great and really great, especially for our pediatric population. So that capability already exists today. And we will be providing that later in the year.
Stacey Simms 40:30
And then before I let you go, you and I've talked several times during this interview, and when we last spoke about how you have worked with patients for a very long time, you've seen the burden that diabetes puts on people and how systems like this can start to alleviate some of that. I can't imagine that you've had that much time to reflect it just got approved last week. But you know, how are you feeling about this going forward? It's a combination of so many people's work over the last several years. I mean, I guess what I'm saying is, take a second take a victory lap.
Dr. Trang Ly 41:02
Yeah. See, it's been a pretty emotional week for me to be able to bring this to fruition, I think I really carry the spirit of many of my patients, you know, those types of interactions just never leave you. And just a lot of gratitude this week for what we'll be able to do for a lot of families. I love
Stacey Simms 41:28
it. I'd love to have you come back on or maybe when the system has been out for a while we can talk to some folks who've been using it and and kind of dig a little bit more into how it's helping. But thank you so much for being so accessible for answering so many of my questions and congratulations, I it's I know it's been a long time coming. And I'm so excited for my friends who use Omnipod to have this new choice. Thank you so much.
Thanks, Stacey.
You're listening to Diabetes Connections with Stacey Simms.
More information about this I know you probably still have questions, go to diabetes connections.com for a couple of links, including that frequently asked questions section, it really is very robust, and can answer a lot of what Dr. Ly was unable to get to. It's so exciting. Boy, I know. You know, we're not Podder's, we have not used the Omnipod. But oh my gosh, I know the community has been waiting so long for this. I'm so thrilled for more people to get an automated insulin delivery system, it has made a huge difference with my son. And I can't wait to hear what you all think I know some of you. And some of the people in our Facebook group were in the clinical trials. I don't know how much you all can talk about that. But if you want to post about it, if you'd like to tell me more, you can shoot me an email Stacey at diabetes connections.com. I'm just so excited.
Two quick things before I let you go. First, at the top of the show, I briefly mentioned Club 1921. This is our brand new project, it is still in beta. And it is where anyone with any type of diabetes can find events anywhere in the United States. If you have diabetes, or you love someone who does, you are already a member of club in 1921. If you go to the website, club 1920 one.com, you will find that it's very easy to sign up for free. And we will send you the events you're interested in, you never have to come back to the website, you just click a couple of boxes, tell us what you're interested in. And we will send you the events. If you'd like to list events, you can also sign up and this is for everything from big conferences, to educational events at hospitals, to you know, a Hangout moms at a playground, going for coffee, whatever you want for the diabetes community, any type of diabetes, any type of event anywhere in the United States. As I said, we're still in beta, I'd love for you to sign up and let me know what you think. And if you haven't already guessed why Club 1921 I'm sure most of you have guessed that is the year that Banting. And best and the rest of their team are credited with the discovery of insulin.
The second thing I want to address is it's a little selfish, but I want to share the Omnipod story, this kind of breaking news. This kind of stuff is why I started the podcast. Many of you have heard the story before. But if you are new, I started the podcast in 2015. Because there were and there still are a lot of really good diabetes podcasts out there. But most of them were people telling their personal stories. And that's great. And they were mostly adults. And you know, as a parent of a young child at the time with type one I could relate but it wasn't exactly for me. But more to the point. There was nobody doing diabetes news and that's my background. I was a local TV reporter and Radio News host for my entire career for 25 years plus, and I had just left a career in morning radio because I was so tired to get up at three o'clock in the morning. That's I'm sure you can imagine I did that for 13 years. And I was trying to figure out what to do next. And I realized that There was no one covering diabetes news. And it's not just saying, Oh Omnipod 5 is approved. It's asking the questions that you just heard. I mean, I guess it kind of sounds kind of braggy to talk about this. But to be frank, as the parent of a child with type one, and as the spouse of somebody with type two, I want to know this information. I want to hear it from these companies, I want to ask follow up questions, I want to call them on it, when we have questions that they aren't answering, or we have issues that they're not addressing, whether that's a technology company, or more to the point the insulin companies and things like that.
So if you're new, I hope you go back, we have a great search box on diabetes connections.com. It's in the upper right hand corner. And there's if you click on the episode page, you can get there's more than 400 episodes, you can go through the archive, but I urge you to search for what you like whether it's technology or issues, that sort of thing. And you can really see these products, we started talking about them five or six years ago, and follow them through development, see how things have changed to me. It's so interesting. And there are very few places to get our questions answered. Your a lot of these folks will go on the financial channels and talk about the company. And I'm thrilled, as you probably know, Omnipod stock went up, I don't own Omnipod stock or Insulet stock, but it went up last week. Hurray, that's fantastic. But I care less about that than I do about knowing what they mean by you know, the system learns you, right. So thanks for giving me the opportunity to just kind of share why I find this stuff. So exciting. This is why I started the show. And I hope you enjoy listening.
if you have questions, if there's issues you want to hear more about, please let me know you can always reach me through diabetes connections.com or on social media. And boy, what do you think is next has this loosened up the logjam at the FDA are we gonna see other issues that have been waiting? We've got bullets by phone from Tandem. We've got stuff from Medtronic that's out there waiting, we got tide pool loop. Oh my gosh, I hope 2022 proves as exciting as it has started out. Please join me every Wednesday for in the news. I do that live on Facebook, YouTube, LinkedIn, and at 445 on Instagram. And then we turn that into a regular podcast episode that comes out on Fridays. That's just five or six minutes of the top news headlines in our community every week. And then on Tuesdays, I do these longer format interviews. They usually go up at four o'clock in the morning Eastern time. This was a little different if you're listening as it is first released because I did the interview with Dr. Ly today. It did it at one o'clock this afternoon. And then we turned it around and got it out as quickly as possible.
Thank you as always, speaking of those kinds of audio heroics, to my editor, John Bukenas from audio editing solutions, and thank you so much for listening. I'm Stacey Simms. I'll see you back here soon until then, be kind to yourself.
Benny 47:49
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
Take a deep dive into the future of Tandem Diabetes. In December, the company laid out an ambitious 5-year plan to update software, move to a smaller pump and ultimately a tubeless version. Company leaders say they want to think even bigger and we're talking to Chief Strategy Officer Elizabeth Gasser. We’ll go through the short term changes Tandem has in the pipeline like the tiny Mobi pump and talk about philosophy and more.
Tandem R&D Presentation (slides)
Tandem R&D Presentation (replay)
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
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Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921 where Diabetes Connections are made.
This is Diabetes Connections with Stacey Simms.
This week, a deep dive into the future of Tandem diabetes. That company laid out an ambitious five-year plan to update software, move to a smaller pump and ultimately move to a tubeless version. company leaders say they want to think even bigger.
Elizabeth Gasser 0:37
we have thermostats that manage our home temperature for us. We have self-driving cars we have on demand consumption services that you know, help us get our groceries and plan our meals. Come on. We should demand that level of ease of use in what we're doing here as well.
Stacey Simms 0:54
That's Tandem Chief Strategy Officer Elizabeth Gasser. We’ll go through the short term changes Tandem has in the pipeline like the tiny Mobi pump, she'll answer a bunch of your questions. We'll talk about the philosophy of the company moving forward, and more. 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 the show, I am only so glad to have you here. You know, we aim to educate and inspire about diabetes with a focus on people who use insulin. back in December Tandem made a big splash with their very first research and development presentation. If you haven't seen that, I highly recommend that it is rather long, but it's definitely worth checking out. I'll link that up in the show notes. And you can always find out more at diabetes connections.com. But in this R&D presentation, they laid out a very ambitious five-year plan for the company, which we're going to go through and talk about in detail today.
Quick date check for you This interview was taped on January 10 2022. And we're releasing it on January 25 2022. So as of right now, the FDA has not approved anything new for Tandem no Mobile bolus that is in front of the FDA, and we'll talk about that and so much more. There were a few questions I didn't have time to get to or that you sent in after the interview. So I sent those to Tandem and I will come back after the interview. I'll update you and answer what I can also after the interview, if you are a health care provider, a diabetes educator and endocrinologist if you work in those offices. And a very specific question for you. Please come back. I'll make it quick. But I need some information. And I know you will can help me. Okay.
My guest this week is Tandem Chief Strategy Officer Elizabeth Gasser she says Call me Liz. So I do. Her background isn't in diabetes, it is in strategy and corporate development, working at Qualcomm in their internet services division and at open wave systems, the world's leading Mobile browser provider at that time, and we talk about what it's like to come from that world to this one, I think it's really important to kind of get an idea for these individuals, you know who they are, who are making these decisions that affect so many of us. And of course, we go through that 10 to five year plan product by product.
Liz, welcome to Diabetes Connections. Thank you so much for joining me, we have a lot to talk about today. Thanks for being here.
Elizabeth Gasser 3:24
Oh, my pleasure. I'm excited to chat.
Stacey Simms 3:27
There are a lot of items that Tandem announced in December, there's a lot to go through there. But I wonder if we could start kind of by backing up a little bit I've heard that you Tandem is kind of talking about being less of a hardware company, right, the pump, which will always be there in some way, shape, or form. But thinking more about the software, can we step back a little bit from the products here and talk a little bit more about kind of the philosophy or the vision? Oh, happy
Elizabeth Gasser 3:53
to and if you've watched our R&D day, you'll you'll know that I do enjoy expanding on this particular topic. You know, as with any connected device, the minute you take a piece of hardware, and you give it a cellular connection or or a Wi Fi connection or a connection to the Internet, you've opened up the potential way to do an awful lot of creative things with both data but also with software, it really opens up the potential for continuous update functions and capability. And then also the ability to pull and push data back and forth from a device and and once you've done that, you you really crossed into that that world of the Internet of Things which requires you to be both an excellent hardware company, because you're managing the device, the functions of that device. It's touchpoints through connectivity, but it also requires you to be an excellent software company along the way. And if you look at the Tandem journey over the past five to seven years, you really do see the company's products moving down that pathway. Of course, the pump remains front and center for us it you know, the delivery of insulin is what we do. It's how we bring that therapy benefit to our users. But you also see a start to do things like the ability to update the pump software itself that unlocks new features and functionalities, including the algorithms which we can now continuously update, it allows us to update the different types of devices we integrate with, you'll see we've obviously moved from supporting Dexcom, G5, two, G6, and we're moving to G7. That's all done through software updates. And so it's really hard to be in this space and to be talking about connectivity and connected devices without also embracing the fact that you really are a software company and have to be incredibly good at it to deliver the value that you want to deliver to your customer base.
Stacey Simms 5:59
I do remember years ago, our first pump and I say our work has been he was to when he got it. So it was definitely it was a group effort. But it was the Animas pump. And then a few years or months who remembers after he got that there was an update, where you could bolus from the remote meter. But we had to wait until our insurance would cover until we were up for a new pump. We had to wait I think three and a half years before we could get that. And so when we switched over to Tandem, I think we had the pump for a month when we there was a software update. So it really has changed. And to your point it is it is really remarkable to see that. Let's talk about, as you mentioned, the R&D presentation and some of what's in development. And of course, the usual disclaimer, I am sure that a lot of what we're going to talk about here is in development, it is not FDA approved. So there are limitations, I'm sure about what you can and cannot speak about. And if you can't answer something we totally understand. But let's just jump on in and kind of go through a list here. My listeners are extremely interested in getting some kind of update on the bolus by phone, which is in the FDA hands. But I have to ask you about
Elizabeth Gasser 7:07
Stacey Simms 7:39
Can you share with the rollout process may be? In other words, will it be a simple update to the T Connect app? Will there be some kind of required or prescription required online patient training?
Elizabeth Gasser 7:49
Yeah, happy to and this this kind of ties to the conversation we were just having about, you know, being a software company, right? The introduction of this feature will be straightforward software updates. And so what does that mean? In practical terms, that means updating the iOS or Android Android application to the newest version, which will have the Mobile bolus capability. And at the same time, making sure you do a pump software update so that both sides of that dialogue can happen. And as part of the pumps software update, which happens through the Tandem device updater. There will be some online training, music click through to make sure that they understand the capabilities that we're introducing. And many of our users will be familiar with how you do that.
Stacey Simms 8:33
Would there be a prescription needed for that kind of feature? A
Elizabeth Gasser 8:36
Mobile bonus? Yeah, no,
Stacey Simms 8:39
this may be a silly question. But can you share any details of what Mobile bolus actually means? In other words, I visioned this as Benny will take the his phone out and have full functionality controlling the pump from the phone. Is that accurate?
Elizabeth Gasser 8:53
Yes or no, in that the primary goal of Mobile bolus is to allow for the delivery of a bolus from the phone. So in that sense, you're absolutely right, it will become for most of the day, the app will be the vehicle through which you can interact with the pump the piece, it won't do his full control of the pump. Meaning when you need to go in and look at changing settings, for example, that's not going to be in the Mobile bolus release. That's something that you don't have to do all the time, and can reasonably be done by taking the pump out and using the user interface on the device. As we get to the movie launch. Obviously, that will not have a screen. And so those control features, what we call full control will migrate into the app as well, for the movie pump.
Stacey Simms 9:46
Of course, yes, that makes perfect sense. I'm not going to let myself get too far ahead because boy do I want to ask you about but to just stay on on Mobile bolus for one one or two more questions, but with Mobile bolus are there other There are features that will be on the phone, obviously, it
Elizabeth Gasser 10:03
will marry with the app that currently exists today, right. And so that that is predominantly today, a secondary display tool allows you to see all of the things that are going on with the pump allows you to see blood glucose readings allows you to see insulin on board allows you to see the insulin delivery that you've conducted through the day. And so all of those features will remain. And the focus here really is on augmenting it with the ability to deliver a bolus from the phone. And so that sort of feels like it downplays. No. But it's incredibly, it's an incredibly exciting augmentation, and one that we think is an incredibly important first step towards that for control. Because it is the hardest use case, we have to get that absolutely right.
Stacey Simms 10:49
Will that have share and follow? Is that something that you're working on for down the line? Or is that something that may come sooner? So really
Elizabeth Gasser 10:56
good question. And we do recognize that share follow is incredibly important to our users and their families. Were continuing to look at where explicit share and follow capabilities for on our roadmap and what the best path to implementing that is, in large part because there's a diversity of CGM follow options out there, including our own Sugarmate application, which which can be used for blood glucose monitoring in a follow capacity. And so we don't have roadmap dates to share at this point in time, just know that we're sensitive to figuring out what the best possible implementation is for our customers here. And we want to make sure we're getting as much experience as we can, in the meantime, really understanding how to do good follow. And as I say, we're getting some of that through the Sugarmate app that we're operating, which actually just went live with the Dexcom real time API, right. And so there's a little complexity to thinking through what the best implementation model is. We're working on it and watch this space.
Stacey Simms 12:00
Well, since you brought up Sugarmate, I have to ask with Sugarmate, which is if it's not clear, Tandem owns as you said, many people don't realize that is sugar beet, something that people could use, kind of as a bit of a workaround for a Tandem share and follow or Sugarmate only displays Dexcom data right now.
Elizabeth Gasser 12:18
So today, sugar is explicitly a CGM companion application. It displays data from the Dexcom CGM. Over time we're looking at what features need to be added to that to ensure it delivers the best value proposition to our users. Really interesting
Stacey Simms 12:33
stuff. All right, you segwayed beautifully into my question about Dexcom. How soon after Dexcom G7 is FDA approved, do anticipate it being available on the x two and again, is that a simple software update?
Right back to our conversation, but first Diabetes Connections is brought to you by Dexcom. just about to talk about there. And one of the most common questions I get is about helping children become more independent. You know, those transitional times are very tricky elementary school to middle school middle to high school you get but I'm talking about using the Dexcom has made a big difference. For us. It is not all about sharing follow. I mean, that is very helpful. But think about how much easier it is for a middle schooler to just look at their Dexcom rather than do four to five finger sticks at school, or for a second grader to show their care team the number before Jim at one point, but he was up to 10 finger sticks a day and sometimes more and not having to do that makes his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at diabetes connections.com and click on the Dexcom logo. And now back to Liz I just asked about tandems planned integration of Dexcom G7 when it is approved and released.
Elizabeth Gasser 13:53
We are intending to implement Dexcom G7 With both pump models so that means X2 and that means Mobi, down the road, our current goal, and this remains our goal is to deliver that within a quarter of FDA approval of the G7. And in terms of how they gets rolled out. I mean, it's very consistent with the software conversation we were just having right. The beauty of the software model is you know, as that gets approved, and as the implementation is ready, we'll be making it available to customers through a simple software update.
Stacey Simms 14:26
Let's move on and talk about the December R&D presentation where this large plan, I think very ambitious and exciting was laid out for the next five years. And we've already mentioned a couple of the products. We're going to go through it in some more detail, but I am curious kind of, you know just what it was like that day and if you didn't see it or hear it, I can link up the video. I'm assuming that it's still up there. But I guess I'm asking this is what were you all talking about that day? There were so many people involved in the presentation, kind of doing handoffs and saying, here's the product, here's the software, here's the philosophy, it had to be a big deal. Tandem had to be a lot of relief when all the technology worked. And everybody got their presentations through with it. You were done.
Elizabeth Gasser 15:07
Oh, absolutely. I couldn't agree more with that sense of it was momentous. And certainly at the end of it, we're all pretty tired. But no, it was, it was exhilarating, too. And I think, you know, we spend a lot of time because of because we're in a regulated space, we spend a lot of time talking day to day about the here and now the stuff that's approved, the stuff that's in market, and the reality is a lot of what we shared R&D day we've been working on for a while now. And you know, some of it's been skunkworks. Some of it's been more formal programs, you know, you just ticking along. And it was really exciting to have a vehicle to share a lot of that thinking and a lot of that innovation that we get to see day in day out. But we don't always get to tell the world about because of the rules and regulations in our space.
Stacey Simms 15:59
Alright, let's talk about it as much as we can. You've mentioned Mobi several times, this had been referred to and I had been told this was not gonna be the name. So we didn't know that. But this had been formally referred to as T-Sport. Now, it is Tandem Mobi. Can you go through the features? Can you go through what this product is?
Elizabeth Gasser 16:19
Absolutely. Where to start? First at it. It's the world's smallest durable pump. So if you're familiar with with the X2, it's half the size, that's really small, durable, four year lifespan hardware. So that in and of itself is exciting. In terms of where we go with the software on top of Mobi, it's going to support Control IQ. So same great algorithm that's in market today, it will be deployed on on both pumps in the same way. And so we get to bring that algorithm across the entire portfolio when Mobi launches, it will be controlled by phone as we were talking about earlier. And that means full control at this point in time, obviously, because there's no screen on the device itself. So what does that mean? Everything you need to do to interact with the pump settings, whether it's bolusing, whether it's looking at your statistics throughout the day, that will come from the phone, it will be charged inductively, which that you know, not something you don't really focus on. But that's that's pretty cool. With we're getting used to wireless charging for all of our consumer electronics devices not having to hunt around for a cord to plug it in. That's what we're doing with with Mobi as well. It'll sit on a little charging station, very easy, very straightforward, less pieces to worry about on pump bolus button. And this one we think is a little differentiated. Certainly in the on body arena, I think it will be the only one only pump out there of this size that has the option to fall back to a button push on the pump just to make sure because obviously, when you are interacting with your pump solely through a phone, we need to build in some measure of failsafe fallback, right if you find himself without the phone, and needs to bolus. And then lastly, waterproof. We're going to support waterproof capabilities through IPX8, which I think is pretty competitive. So lots of stuff packed into a really, really tiny device.
Stacey Simms 18:25
I'm sorry, what is IPX? Eight mean?
Elizabeth Gasser 18:28
The best way to articulate it, it's really just the standards we comply with and IPX eight means fully waterproof, you'll be able to swim and shower with it.
Stacey Simms 18:36
One question about Mobi is I'm trying to visualize how it connects. My understanding is that it uses the standard pumping fusion set that like my son's Tslim currently uses, is that correct? It just sits closer to the body.
Elizabeth Gasser 18:51
That is correct. The Mobi pump will work with the Tandem portfolio of infusion sets. And with the Mobi pump launch, we will also be introducing a shorter infusion set that four or five inches long, that allows for greater diversity of wear options.
Stacey Simms 19:09
I'm so fascinated to see how this works because I'm a very visual person. So he could put it on like my son could put it on his arm and it kind of dangles off. Does it also stick to the body in a way? Or does it just kind of hang there on the tubing, the tiny tubing
Elizabeth Gasser 19:24
work, we're working on the accessories to allow for a diversity of wear options, whether the belt clips or sleeves or a body worn adhesive patch through which you can that you can pop the pump into. So there's a variety of places you can push
Stacey Simms 19:39
it interesting, alright. And like I said, I will link up so you can you can really dial down if you want to and see all of the features of everything we're going to talk about. But just for time limitations, we're not able to go through every single thing. Let's move on to the T slim x three that seemed to be next in the pipeline. What is that?
Elizabeth Gasser 19:55
x three. That's the next iteration for the T slim X To pump. And really the focus there is to continue really honing the capabilities of the T slim form factor, right. And so we recognize that over time t slim continues to play a role in the portfolio, many of our users will continue to want a pump with a built in user interface. And so really the x three programs emphasis is on further developing the processor capabilities of that device, looking at battery life, looking at durability, reliability, looking at wireless software update capabilities, really to make sure that the T slim x two kind of line has continued vibrancy as part of the portfolio over time. And we're making the appropriate investments to support the diversity of software and user interfaces that we want to bring to the portfolio at large. So
Stacey Simms 20:54
right now, it sounds like the changes you're talking about aren't something that, you know, I would look at the pump and say that is significantly different, right? Or that works completely did you've changed at all, it's making small improvements and things that the user, frankly, may not notice? Or will they're, you know, things will just run better, like you said battery life, that sort of thing. Are there significant changes that you could think of that would be coming to the pump itself?
Elizabeth Gasser 21:16
Oh, no, that's absolutely right. I think this one's a little fun for me, because I come from the consumer electronics space, originally and spent 20 years you know, working on phones. And as you think about the types of releases, you do with consumer electronics, year to year, a lot of them are under the hood, that it's really focused on making it connect better, giving it more horsepower, making the battery last longer. And those things aren't always visible on the surface to a user, but may manifest through the quality of the user experience they get from interacting with that device.
Stacey Simms 21:50
The next product is Mobi tubeless. We've talked about what Mobi is, I'm assuming this means know to tell me a little bit about Mobile tubeless. This is
Elizabeth Gasser 22:01
a certain creativity and the naming convention there isn't so
Stacey Simms 22:06
we shouldn't laugh. It's a very big deal. It's a very big deal.
Elizabeth Gasser 22:09
No, I say that affectionately. And look, it's back to the conversation we were having on kind of the Mobi, shorter infusion set and different Bodywear options, more ways to air Mobi, right, we recognize that not everyone ultimately wants a pump with a tube. And so we've been pushing ourselves to say, okay, how can we improve the wearability and the wear option, so that we're reaching the broadest possible base of customers here. And, and this one's kind of an example of the things that we've had in the hopper for a while that not everyone gets to see, we took a little trip in the Wayback Machine and dusted off some of our earliest thinking on movie here. And maybe a tubeless infusion site option has been in our minds for a while. And so we felt it was the right time to bring that idea back to look at how to make it a reality as we get closer to the official launch of Mobi. And so this sits in the roadmap for Mobi as additional ways to utilize and engage with the product. And hopefully, it will give users choices, right? Some days, I don't want to wear my pump on my body, I might want to have it in my pocket and connect via a standard infusion site. Other days, I may be a little more active and find a really need to have a have a tubeless wear option, we get rid of the tube, the goal for us is to satisfy all of those use cases.
Stacey Simms 23:34
And then the last one is the completely disposable patch pump that's in the pipeline. Is this a different form factor than Mobi? Is it a different design? Or is it similar?
Elizabeth Gasser 23:44
So this is a different program? I can absolutely share that. I can't say a whole lot. This is one we want to keep fairly tight under wraps for competitive reasons. But the emphasis there is is very much on miniaturization. Got it. Can we really push the design envelope here on form factor for the device?
Stacey Simms 24:06
You know, it's so interesting. We've been in this community as a family for 15 years. So now you're certainly not as long as many other people but in that time, we've seen and heard a lot of products, right? We've heard about new things coming. We've seen some really great advancements, we see things go away. This is a very ambitious portfolio that we're looking at and five years is it doesn't seem like a long time really certainly as I get older, it seems less than less. Seems everything's going more and more quickly. But a lot can happen in five years is the is the plan here that all of these products will exist together. As you said, you know, the movie tubeless you kind of made it sound like I might be able to take out my Tandem movie with the longer tube and then switch to the tubeless another day is the idea that all of these would exist side by side.
Elizabeth Gasser 24:50
That's a great question, Stacey. I think the best way to answer that is to really reflect on the fact that we do fundamentally believe the day Diabetes space and particularly insulin dependent diabetes is a far more segmented market than every industry analysis would lead us to believe. You know, we often talk about type one and type two, as if those are the only segmentations that are relevant, we do actually think there's various needs, that we should appropriately be segmenting around, including, where preference form factor and user and interface size. And so as we look at the portfolio, we're really looking at how we can satisfy the broadest array of user needs. That may mean there is on occasion, some overlap in functionality between different products that sit in the mix. But the goal is really to provide the right device for the right group at the right time. And so as we think about where we go from here, the roadmap as we have sketched it out, for the 22 to 27 period really is very much about a tube pump offering with a screen, that's Tslim X2, a smaller form factor, more discreet phone operated screen, this option in the form of Mobi and there, the goal really is to create as diverse an array of wear options as we can to satisfy the needs of different user groups and their day to day activities, and then pass that as you think about the idea of a passionate disposable patch that exists as a third category that overtime will, we'll have to see how these different offerings play out with the segments that they're serving, and they are likely to coexist.
Stacey Simms 26:39
So interesting. As we begin to kind of wrap this up, I did have a couple of questions from listeners I wanted to get to, and one of them was about control IQ, frankly, and any changes coming. In other words, we had heard a lot about changing the adjustable, changing the target rates lower than 160 and 180, that they are right now not the target rates. That's when the pump takes action, that kind of thing. And I remember hearing that there was something in front of the FDA, I don't know how much you can share. But can you talk to us about changes coming to control like you, yeah, happy to
Elizabeth Gasser 27:09
talk about the design goals. In terms of control IQ today, it's delivering great outcomes. And in its current instantiation, I think one of the things that's helpful to understand about algorithms is that they're all going to work in different ways. It's like chocolate chip cookie recipes. If you think about it, lots of people have them, but it's how you put the pieces together and in what order and it's the secret sauce that affects how it tastes. Similarly, with algorithms, a lot of it comes down to how you put it together. And it's not always practical to compare from one to another. The real test is, you know, are you getting users to where they need to be in terms of, you know, being able to achieve their time and range goals, for example. So I think it's worth wrapping your head around that idea upfront. Now, having said that, for the control IQ roadmap, our next development frontier really is very much around personalization, and usability. While we're not going to get into very specific, you know, roadmap feature intersections at this time, we're exploring quite a bit here. And Jordan alluded to this a little bit in our R&D Day discussion, part of personalization for us does include exploring lower target ranges, and personalized target ranges, and looking at what it would take to deliver on those capabilities.
Stacey Simms 28:32
Here's a real speculative question that I don't expect you to answer. I'm hearing in the DIY space, that more and more people are coming up with algorithms that don't need meal announcements, or don't even need meal boluses. Is that something that Tandem is working on for an algorithm? Or I guess the real personal question is, could you please Liz, help me because my son forgets to bolus for many meals. He's 17. He's very independent. But oh my gosh, when I see people working on things like that, I just feel like that would be life changing.
Elizabeth Gasser 29:05
Yeah, mail handling unannounced meals on lounge consumption. Yeah, it's the hardest thing to confirm it with the algorithm here. It is fair to say that as part of our ongoing roadmap explorations, we are looking at what it means to improve unannounced meal handling.
Stacey Simms 29:24
I'll take it. I'll take it. Thank you. Another question came up about new infusion sets. And you had mentioned this, you touched on this briefly, but we talked to folks at ConvaTec who make many of the infusion sets and they were talking about longer life improvements to the cannulas or those sorts of things coming to Tandem. Yeah, so we
Elizabeth Gasser 29:46
did talk a little bit about our goals here. During R&D day. You know, it is only one piece of the system but we do recognize infusion set issues can be a real pain point for customers and so we have programs IPs that are ongoing. Some of them are internal driven by us. Some of them are in conjunction with our partners working on a diversity of things. Some of it is extended wear time, which we know is important. But we're also looking at insertion, ease and usability there, we're looking at how to reduce infusion site failures, specifically around occlusions, obviously continuing to look at things like adhesives, reduction of material waste. And so this one, it's a pretty diverse view that we're taking. It's not all necessarily anchored solely in the idea of extended wear, I can't give you any specific breaking news in terms of you know, what we're coming up with and the products we'd like to bring to market. But this one we're paying serious attention to, we recognize that our customers want to see progression here.
Stacey Simms 30:57
Yeah, I have been amazed since day one of pumping, I feel like the infusion sets have, at least for us, and everybody is different. And everybody's skin is different. Everybody's insertion technique is different, which is part of the problem. But you know, I've just been amazed to me, that has always been the weakest link of pumping. And the idea that I'm using pretty much the exact same infusion set that I put on my son's body 15 years ago, just with all the advances that we've had to me, that's the one that needs much more attention. So I'm really, really glad to hear you're working on that. Alright, so this is not a question. But this was a thought that ran through many of the comments. Many people wanted to say, thank you for getting this is terrible. Thank you for getting control IQ through the FDA before COVID. Because oh my gosh, nothing has happened since like, this was approved, what December of 2019. And many people started getting it I think the earliest was January of 2020. And the diabetes community it feels like very little, although there have been there have been approvals. But it feels like everything is moving so slowly now. So I'm sure Tandem is happy about that. But I know the community as well. So I'm not sure if I can even ask you to answer. There's no question there. But thank you.
Elizabeth Gasser 32:05
Oh, I'm not sure there's any good answers there either. Stacey, I certainly applaud the the yeoman's work going on at the FDA to manage through this crisis. And certainly while it's frustrating to have extended approval cycles, and yes, in retrospect, a blessing that we secured approval prior to COVID. I can't do anything but feel respect, admiration and a little bit of sympathy for our friends at the FDA. Yeah. And
Stacey Simms 32:35
again, I don't know if you can answer something like this. Have you heard that they are they're kind of making their way through it just seems like there was such a log jam, I understandably so any feeling any word that they are kind of clearing the deck, so
Elizabeth Gasser 32:47
to speak? I don't think it's my place to comment on my workflow there. I
Unknown Speaker 32:50
tried. You can we do have good
Elizabeth Gasser 32:52
back and forth with the FDA, you communicate with them regularly. And so they continue to engage with the industry constructively, productively.
Stacey Simms 33:02
Alright, before I let you go, you don't live with diabetes, as you said at the very beginning, you know, you come from a software background and that sort of thing. But what is it like to come from that and work in in diabetes, where the work that you do I mean, here I am complaining about infusion sets, and, you know, change the bolus, from what you know, before it reaches 180? You know, we're talking about all of these little things add up to such quality of life issues for people, you know, what does it been like for you to work in this space?
Elizabeth Gasser 33:28
That's a great question. It's one that I think you're the first person to ask me to reflect on. You know, I think it is both sobering and invigorating, sobering because, you know, when you come from a world that's, you know, focusing on clicks and engagement and eyeballs, and consumption of media, you can get lost in the little things, and really stepping back and recognizing just the enormity of what type 1 diabetes is, and the burden it places on people's lives, day to day, and feeling like I can show up to work and even in a little way, help with that. That's sobering and profoundly rewarding. It's also invigorating, because, you know, coming from a consumer electronics environment, you see what's possible with the technology as it exists today, and many of those technologies have not yet come to medical devices in a very fulsome way. And so I certainly get out of bed day in day out wondering how we can help therapy benefit from all of the innovation that is going on, in the consumer electronics world, right. You know, we have thermostats that manage our home temperature for us. We have self driving cars we have on demand consumption services that you know, help us get our groceries and plan our meals. I don't mean to trivialize the differences that are involved in translate I think that to medical devices, but I also think as you look at that and say, Come on, we should demand that level of ease of use in what we're doing here as well. And so that that's profoundly motivating.
Stacey Simms 35:13
That's great. Well, thank you so much for sharing so much information for answering what you could answer. And I hope we talk again soon. My pleasure.
Elizabeth Gasser 35:21
Thank you, Stacey.
Stacey Simms 35:27
You're listening to Diabetes Connections with Stacey Simms
more information at diabetes connections.com, including the link to the research and development presentation. If you'd like to watch that or just listen to it, I will link that up over on the website along with the transcription. I really appreciate your patience with the transcriptions. I think we do a great job. But my transcription software doesn't speak diabetes, I try to teach it but it is a little unreliable. That way we go through and try to catch the big stuff. But if you do see anything egregious, or very confusing, please let me know. And I can pretty easily fix that.
I want to take a moment and address a couple of the questions that we ran out of time with Tandem or your questions came in late. I'm going to do that in just a moment. But first, I mentioned at the beginning of the show that I had a question for healthcare providers, I have a question for you, I have a favor to ask of you. You may have heard me talk about Club 1921. I mentioned it right at the beginning of the show, I'm only talking about if you're at the end of some of the podcast episodes, and in the Facebook group, we are in beta. It is my new project. It's all about events in the diabetes community nationwide, any type of diabetes anywhere in the United States.
I need your help, because it's very easy for me to find the big events, right friends for life, JDRF, even ADA stuff online. What I would like to add to the website, and what I think will be vital to its success are all of the events going on in your hospitals. Almost every hospital has a nutrition program for people with type two, an education program for gestational diabetes, things like that. They can be virtual, they can be in person, but I need to find those programs, I need to get into those hospitals, I need to reach the people who want to add those events. This is not a community calendar, where I hope a couple of groups post their events. And we all go from there. I want this to grow into a site where 1000s of people with diabetes, any type of diabetes, find their community find help find what's being offered. And I know that these hospitals want to connect with these folks. So if you could help me do that point me in the right directions to meet with the association's it doesn't have to be one on one with hospital systems, although that would be great, too. But whatever you think might be a help, I would really appreciate it, you can email me Stacey at diabetes connections.com, you can message me on social media, thank you so much, because this will only succeed if we reach out beyond the community that we are already talking to. So thanks.
Okay, let's get to the kind of leftover questions from Tandem, the most common one had to do with international rollout. And I unfortunately, I don't really have any good answers for you. I'll tell you what Tandem said I asked specifically about Australia, I had two people who emailed me asking about what is going on in Australia with the rollout of Control, IQ, nevermind all these other features. And they just said we do not have an update at this time. And then asking about other international markets. So let me read that response in full Tandem says we have launched in a large majority of the international markets, and we're near to medium term focuses on ensuring we work to make our technology broadly available to these customers. We don't have anything to disclose with regard to additional markets at this time. So I know not the answer you were hoping for. I will keep asking on this one. And I do apologize, we are a very US centric podcast because I am US centric. But I appreciate the reminder. And I will try to keep that focused and you know on my list of questions as we move forward with lots of different technology this year.
And then I had also asked them about changes to the current controller queue algorithm. I had asked during the interview if it could take action at a lower number than 160, which is where it jumps up to basil and 180 where it gives an auto bolus at 60% of the bolus rate that the person programs in and Liz did answer that question in the abstract, but I wish I had pushed on it. So I followed up because I thought I had heard that Tandem had already submitted a change on that to the FDA. They responded quote, as Liz mentioned in the interview, we are working on personalization features which include lower targets and thresholds. We've begun to engage the FDA and started our design work, but we're not currently providing any of the feature details and quote, I will add this editorial comment. Every pump company I talked to has started out saying we're going to have lower ranges, we're going to have tighter ranges, we're going to have customizable ranges and every time it hits the FDA that kind of starts to change set You know, Omnipod, if you'll go back and listen to the interviews from two or three years ago, they were going to submit with I think it was 80 to 100 as one of their ranges. And that didn't happen they've submitted with higher ranges, just like Tandem did. I think, again, this is my speculation, I think these will all gradually come down. But if you are looking now for tighter control with these hybrid closed loops, you might want to go the DIY route. Although if you keep your pump in sleep mode, you know you're sleeping beauties with Tandem it's trying to keep you at like one 12.5 The whole time you just have to remember to bolus which works beautifully for some people, and not at all for the person in my house.
Okay, before I let you go quick look ahead. Of course in the news is every Wednesday we do that live on Facebook, and YouTube and I added LinkedIn this week. My goodness, we're also live on Instagram a little bit later, still can't do all of that at once we're working on it. And then I turned that into an audio podcast episode that is released on Fridays, upcoming longer format shows we'll cover more technology including a new pump called Sigi. We've also got some really interesting community interviews. What is it like right now when you live with type one, but you also live with another autoimmune condition that makes it very difficult to get a COVID vaccine. And I'm going to be talking to some of the Joslin medalists who are this is a theme right living longer with type one and the issues that have cropped up for them that nobody really far, we would have to think about so I'm excited about that and so much more.
Thank you as always to my editor John Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon until then, be kind to yourself.
Benny 41:48
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
This week, Dexcom CEO Kevin Sayer spoke to the JP Morgan Healthcare Conference about the G7 and beyond. We talk about information from that presentation and get to as many of your questions as time allows.
This interview took place on Tuesday Jan 11 and much of what we discussed isn't FDA approved.
Our usual disclaimer: Dexcom is a sponsor of this podcast, but they don’t dictate content and they don’t tell me what to ask their executives.
Recent Dexcom episodes:
CTO Jake Leach talks about Garmin, Dexcom One & more
CEO Kevin Sayer talks about G7, Direct to Watch, Adhesive and more
CEO Kevin Sayer talks about Dexcom in Hospital, G7, VA program and more
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
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Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
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Episode Transcription Below
Stacey Simms 0:00
Diabetes Connections is brought to you by Dexcom. Take control of your diabetes and live life to the fullest with Dexcom and by Club 1921. Where Diabetes Connections are made
This is Diabetes Connections with Stacey Simms.
Welcome to another week of the show. You know I'm always so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. And I'm talking with Dexcom CEO this week, it's Kevin Sayer, he is back to check in with us again. And in the interest of getting this episode out to you as soon as I could. It might sound a little different right here at the beginning. But Dexcom episodes are always so high interest that it really merits a quick turnaround. I didn't want to sit on this interview for a week. So here's the setup. Dexcom CEO Kevin Sayer gave a presentation to the JP Morgan healthcare conference, if you're listening as this episode goes live, that was just Monday of this week, January 10, the interview you're about to hear took place on Tuesday, January 11.
My usual disclaimer Dexcom is a sponsor of this podcast, but they don't dictate content and they don't tell me what to ask their executives. I asked the Diabetes Connections podcast Facebook group for questions. And Whoa, boy, did you have a lot as always not a surprise. And I really appreciate you sending those in, I got to as many as I could, while also trying to include what the folks at Dexcom had really asked me to bring up there are some topics that they wanted Kevin to make sure to address. And I think we do a pretty good job of trying to reach a balance here.
Kevin, welcome and Happy New Year,
Kevin Sayer 1:46
and Happy New Year to you.
Stacey Simms 1:48
Thank you. Well, this seems to have started out in pretty happy way on the headline, just from this week. Dexcom CEO touts unprecedented performance of G7 in clinical trial. This is after your talk at the annual JP Morgan healthcare conference. Tell me a little bit about that unprecedented performance data.
Kevin Sayer 2:08
I'm happy to. And I just have to qualify it by saying no, I can't send it to all your listeners at the end of the call yet. We're still waiting for approval in Europe. And we have filed this with the FDA, I'm going to take you back a little bit, we made a decision when we were going through the G7 development process that we wanted to answer that performed better than G6. And all of our scientists looked at us and they go oh, really, you're sure because this is really good. And so we spent a lot of time new algorithms and new manufacturing techniques, there's a lot of things in G7 that make it different. We also wanted to validate that performance with a study that was so large, nobody could refute it. So as you look at the data that I presented at the conference yesterday, over 300 patients 39,000 Match pairs all across since one ranges and on the I CGM standard side, but with the 5% 95% lower bound, and even the absolute points, you can see we are well within all of the iCGM standards, which are very technical and actually are a very good measure of how a sensor actually performs in reality. And they were very thoughtful in developing these standards to try and pick the centers that don't work to put you statistically in a bind to whereby if you really aren't performing in the low range or wherever, you're not going to get that iCGM designation. We're very comfortably there.
And the overall MARD in the study, Stacey is eight point, you know I it's in the low eight for adults and pediatrics. And if you start looking at the data, we gather the data sets in three periods, you know, days one and two, the middle days, four, or five and six, and the last days nine and 10. It's pretty low, I think it's below 10. In the first group a day, the first days, which are always a little bit higher, traditionally in our centers than the other days. But in those middle and end days, it's it's near seven, and strips for six. I mean, we have done something that I've been in this business for since 1994. I didn't think we'd ever do this when I started. As far as being this good. This is really, really good data. And we're going to continue to deliver the experience to our customers that they demand from us. So as you can as you think about an iCGM that's driving an automated insulin delivery system. And not only is the performance great, the user where it's 60% smaller, it's a 30 minute warm up. It's a new app. From our perspective, we've got a lot of the clarity data, your listeners will know about clarity. We've got a lot of your clarity data right on the app. There's new alarm configurations.
Stacey Simms 4:48
I'm gonna just jump in with a couple of quick clarifications before we go on. You mentioned a number of there that went by quickly I apologize when you talked about the 300 people in this trial 39,000 match what I missed that one
Kevin Sayer 5:00
matched pairs. That's where you compare the CGM value to the blood glucose value from the laboratory instrument. So the way our studies work is literally we draw blood samples from the individuals in the study at intervals, and then we actually match the CGM data to that laboratory blood instrument. So 39,000 points from these 300 people in this study were matched. Got it?
Stacey Simms 5:27
And you mentioned the MARD mean absolute relative difference. Most of you, as you listen are very familiar with this, the lower the better for CGM G6, I, my understanding was G6 was in the low nines. This is 8.1 for peds. 8.2 for adults, as I'm reading it, that's right. I know you can't tell me I'll ask you anyway, why? What made the difference here? Is it sighs is it algorithm? Do you have anything you can point to? Or is that a trade secret
Kevin Sayer 5:49
it's combination, I think the algorithm has been the most, the algorithm changes were really extensive here. And, you know, we always have manufacturing processes to get better, the way we build the G7 centers different in every step of the way. Literally, our G6 manufacturing processes go away and the G7 ones take over the summer, we're a little similar on the actual sensor wire itself, and that manufacturing, but everything else is different. We just think it it's smaller, it's a lot shorter than G6 was. And so it is it's going to be a completely different experience for everybody.
Stacey Simms 6:28
So to go back to what you were talking about, before I jumped in there, you were starting to talk about alarms, is there something different for the alarm,
Kevin Sayer 6:35
the app is different. And so access to them, and, and just how you use them, if we try to get to be more consumer, thoughtful, as we configured the alarms, we'll see how everybody loves him. It'll be interesting. The alarms are one of the things we get the most comments on when we launch a product initially, we try and please everyone, but we never please everyone. And then you get you know, the agency at one time. I don't know if your call. I think one of our other discussions, we had to make the mute override not work on the low end. Boy, we got a lot of people mad at us about that one. So we've tried to comply with what our users want, and also comply with what the FDA has asked us to do. But I think users will find the alarm experience. Good as well. I like I think it's just gonna be a home run. Yeah, well, I
Stacey Simms 7:24
mean, my son would be happy if an alarm never made a noise again. And I know other people who put like it to alarm every time there's any movement. So I hear where you're coming from, can you give any insight into the G7 app in terms of what the differences that we may see as users? And I guess especially one of the questions I always get is about follow any changes of significance coming that you can share follows
Kevin Sayer 7:47
on a separate software track. And so the G7 system, the app is just we tried to get more data in the app itself, versus what we have with G6. So a lot of the clarity data, or at least summary query data is sitting there right in your app. And that will be i we think people will like that just to see how they're doing over time you got your time in range data for, you know, three 714, you know, a month, 90 days, see how you're doing time in range wise and the app is other than that it's relatively similar. The startup is different and you know, in the interface is going to be different. I think over time, what you'll see with us is that app is now going to get more sophisticated, we changed the entire software platform for G7 and started over again, and we developed a software platform, we can now really change and add on to a lot easier than we could in the past. And so we're hoping to have more frequent software releases.
But we've also learned that CGM is not like Battlestar Galactica game, a game where you want to get a new release every two weeks to fire everybody up. We can't do a release every two weeks, because people depend on this for their, you know, for their lives. And if you do too frequent releases, and you botch a release, you do some wrong, you remember what happened, if we ever make a mistake on the software, the data side, we can't do that. But we do want to add more features more quickly in this platform will enable us to do that. I think one of the things you'll see going forward on the software side, we really want to automate a lot of the tech support features.
We've added some, you know, you can get FAQs right from the app now with respect to your sensor, but there are other things we think we can do tech support wise in the app that will you know, reduce everybody's burden. Nobody likes making a phone call and nobody likes picking up the phone. And when we have a sensor fail, and we do have sensors fail, it just doesn't make any sense that you have to call us if we've got data on a phone, it'd be much easier. For example, if we could diagnose that failure right on the app and go through a very quick process to why but where you could get one. I can't give a timeframe when all those things are going to come but the platform is robust enough that over time, we can add features like that. One of the other nice things about G7, since it's fully disposable, you know, every sensor has its own unique serial number. Whereas with G6, that same transmitters used with three months’ worth of sensors. So it will be, it will be fun to be able to follow things like that and see how the sensors go through the channel where everybody gets attract things of that nature. So what we're really looking forward to the change in our business that G7 affords us.
Stacey Simms 10:28
As usual, I have listener questions, I'm going to try to not repeat because you've been really accessible in the last year, we've talked to a couple of folks from Dexcom, besides yourself. So as you listen, if I didn't get to your question, or if you have a question, good chance, we actually answered it in the last year, year and a half. But given let me ask you about compression lows, because that's one of the things we had talked about, about testing the G7. Any update on that in these trials, if you lay on it, you know, circulation slows, and you can get a false reading any better with the G7
Kevin Sayer 10:54
part of the clinical study is in the compression, because you're pretty much sitting in a chair with a needle in your arm drawing blood. So I'm sorry, we can't really test that we'll learn more about compression when it gets in the field. My hope is that it isn't as much but I can't promise that because I don't know, we're not enough people. I think there are ways over time where we can manage compression better, I'm not going to get into all the science on the phone, believe it or not, I do spend a lot of time with the engineers on this specific issue. Because I have it happened to me from time to time too. So I will call them up say Hey, can we do X, Y or Z? And I think there are some some answers, but I can't give them away because I don't want to give away the playbook. So let's let's just see what we can do overtime on that one.
Stacey Simms 11:42
Okay. All right. But you know, the next clinical trial just have them lean against the side of their bed.
Kevin Sayer 11:46
We will we'll have to do well. Diffic very scientific.
Stacey Simms 11:50
Another question came up, and I think I'm gonna knock wood. I think we've been very lucky on this. It's about new iOS launches from Apple. And I'll read the question and it'll tell you, briefly our experience. This person said Dexcom is part of the Apple Developer Network developers have access to new release such as iOS months before launch, why does Dexcom lag behind Apple iOS launches by months in terms of quote, approved use. And our experience, frankly, is that we have not had any issues Benny and I both have, we just got but as a 13. Plus, we both had very old phones. And we have a latest software and no glitches for us. But that's not everyone's experience, can you talk a little bit about that,
Kevin Sayer 12:30
we do get the iOS versions in advance, and we do our best to comply with them, I would I would tell you that it isn't as simple as it's made out to be. And the iOS version that's launched isn't always exactly what we've worked on as they as they make tweaks, not big ones. But you also test for everything that you know about the new iOS versions, and sometimes are things that you don't know, that are in there that come back and may affect the app later on, which is why we delay a little bit, we try and go through every bit of testing that you can imagine. And I'll be honest with your users, Apple's made iOS changes, because of us, we have called up and said, Look, you got to do XY and Z here we have a problem. And they're very good to work with, they've not been difficult at all, you know, when you think about iOS and Android operating system and all the things that they impact. And it's very hard not to impact somebody adversely when you do a new iOS launch.
And you know, the perfect example with us is the home you'd override journey that I brought up earlier. In the beginning, I believe the only app that can overcome the mute override within iOS is authorized manna in the beginning was Apple's alarm clock, but other people would go around it with their apps was a medical device, we can't do a go around, we have to make sure what we do is in compliance and known so they work with us very well to make sure we could do what the FDA wanted with respect to the mute button. And the same thing with Android on that, and that was a very difficult exercise. So if there's a delay, it's because we're taking time to see what might have been put into iOS that would change our app. And it just one more thing that will stop. new operating systems are often designed to minimize power usage to extend battery life. Oftentimes, minimizing power usage affects an app that has to be running continuously. And those are the types of battles that we fight are things that we have to make sure we test as a new iOS minimizes power usage. Just does that turn us off? Does it does that stop Dexcom? And we've had, we've discovered things of that nature where it could affect our app. So there you go. Long answers. All right.
Stacey Simms 14:44
No, no, that's great. And you mentioned you've asked iOS you've asked Apple to make changes. I assume the alarm was one any others that you can share.
Kevin Sayer 14:52
I know that nothing I could share. Nothing major that I like you said they're very cognizant of the Dexcom community there we are. You know, we're we're a very large part of the iOS, you know, we're pretty, it's pretty vocal group when it comes to iOS,
Stacey Simms 15:06
pretty vocal group period, the whole community. Alright, we say that with love. So another question came from my group, which was about Sugarmate. This is a, I would describe it as a third party app that uses the Dexcom information. And now the real time API to display and and act on data in its own way, my understanding is that Tandem owns Sugarmate, just from way of background here. And you know, Dexcom owns a little bit of Tandem. So there's a relationship there. Can you speak a little bit about data sources, but the bottom line question here was using Sugarmate and the situation to ask you, does Dexcom feel like they own the patient data? Or do the patients still own their data, even when going through the Dexcom web API's, we believe
Kevin Sayer 15:49
the patient's own their data, not us, let me rephrase that we believe the patient's control the use of their data, we are the stewards of that data sitting on our servers. And so we have a responsibility to maintain it and to keep it but where that data goes and where that data is used. We do believe, particularly if it's identified data, that the patient absolutely has complete control over that there's vector sugar made, it's interesting, it was not using API's before it was a like many and non authorized use of the data to display it in a different format that people quite candidly, mess, like better than looking at the Dexcom app. And that's fine. That's why we built the live API's, we made a server change to upgrade our server platform, again, more capacity, more safety, more redundancy. It's a project that's been going on for years. And we've come to the end of that project this year. And when doing so there were some technical issues with Sugarmate, they very quickly switched over to the live API's. And now this is an authorized use of the data based on platform and data pipes that we built. So we're willing to share the data with people when they want it. I think that's an attitude of Dexcom. That changed very much over the years, when we first started, we had a hard time with that concept. Because we worked so hard to invent this technology and gather this data, why would we share it with anybody and say, See, you remember the early days and Nightscout, they were mad at us, we were mad at that. Now, we're not mad at anybody anymore. I think it's important that the data sharing be structured and be used for good purposes. But you know, all in all, it's a, it's a good use of the data that we have, because these are still Dexcom customers. If you want to, you're still buying sensors and using them. It's not a bad thing.
Stacey Simms 17:35
Let me ask you a question about the sensors. And this came up in the fall. I've seen it less since but it's still out there. And I don't know if this is something you can answer. But it seems that we have not received this. But it seems that some customers are getting the G6 sensors, the inserters brand new in the original packaging, but a new label on it that says this product meets shelf-life extension requirements. I'm your people I reached out to them in the fall, they told me the stickers, oh, you know, it's all legit. There are updated expiration dates. But I'm curious why this is happening. And you know, what is the shelf life of the G6,
Kevin Sayer 18:10
I can tell you exactly what's going on, you do shelf-life testing for product as selling your product will last. And over the course of our product lifecycle, you trying to extend that shelf life through more testing to make sure the product still works for the same amount of time period, if you manufactured product with 12 months shelf life, and then extend that shelf life to 18 months. And it's still the same product and still same manufacturing process rather than unbox it, put it in a new box or throw it away, we put a sticker on the outside because it's same products been tested, it's been proven that it works for 18 months, that's not a problem. That doesn't mean that it's 18 months old, we never have inventory that sits around that long to my knowledge, but we do extend shelf lives, it's important for us to do that, with respect to the distribution channel, particularly as we go to the pharmacy, you know, in the drugstore and and our distributors, the longer they have, you know that they can keep product, the better. We don't want people throwing product away if they don't have to. So all that means is we've extended our testing and shown that the product still works for a longer period of time and wanted to to label the product accordingly. That's all
Stacey Simms 19:17
Yeah, I think because it came at a time when there is nervousness just in general not just in diabetes about supply chain and, you know, scarcity concerns. It just seemed unexpected, if that makes sense.
Kevin Sayer 19:30
Well I one of the reasons to extend life is in fact supply chain we don't have inventory issues with G6 you know G6 is a very very well running process right now and still, you know, the premier sensor on the market. In fact, we launched a G6 derivation product in Europe, these past three months called Dexcom. One a it's a cash pay product sold on the E commerce platform in four European countries say See now and it's a lower price and geographies. But we did a feature that we took away, share and follow. We're not connecting any devices. It's it's a simpler technology. And again, we have d six supply to be able to go and do things like that. And we are planning to have G7 capacity to do similar things. We are not shooting small on either front will have capacity on both sides. And, you know, listeners on a supply chain perspective, we have been extremely diligent with respect to components for our products. And right now we see things very good today. We my operations team has just been outstanding on this front. So knock on wood, no, no Dexcom problems today.
Stacey Simms 20:40
All right, two more questions for you. As always, we're going to run out of time. And as you're listening, I would refer you again, we did have a conversation about Dexcom. One in a previous show. So I will link that up. This one is more of I've asked this, you answered it, but I still continue to get questions to please ask you please make sure when GS seven comes out that Medicare is taken care of?
Kevin Sayer 21:00
Well, that is a great question. And I think we've learned from our mistakes in the past. So we will when we get G7 done, what we will do is we will file with CMS to get G7 reimbursement. That's a process that I've heard anecdotally takes three to six months. So if we can get it done in three months, we can't file with CMS until it's approved. But we'll file after approval, and then we'll go and it is our plans to have capacity for all of our US users. When we go it is not that Medicare delay for G6 was one of the most emotionally gut-wrenching things I've dealt with here, because you can't imagine how many emails I got. But we didn't have capacity, and we didn't have everything ready. We've learned from our mistakes. And we'll hopefully be ready to go to everybody. That's our plan right now.
Stacey Simms 21:49
That's great. Okay, and my last question is, and I hate doing this to you, but I'm doing it anyways, look into the chapter, we're gonna look, we're gonna come at it sideways, because I did have one listeners and ask him what's planned for the g8? And I said, Come on, let's let him get the G7. Oh, you know what? I'm happy? You can answer that. Let's go for it?
Kevin Sayer 22:07
Well, well, I'll give you two because we did lose some time in the beginning because my computer wasn't functioning properly. As we look to the future, we want performance to continue to be better. And then we ask ourselves, but we're getting to the point where as you get to an eight, Mar D, we're getting close to finger six, I don't know how much more of a gap there's going to be, as we look to the future, and even G7 derivatives, we want to go to a longer life, we want to go to 15 days rather than 10. We'll be running studies doing that over the next couple of years. We've got a couple of plans there. We're always looking to upgrade the electronics, and how much better electronics, you know, I know one of your bigger user complaints is connectivity and loss of data, how do we improve that experience for our customers to make that better over time? Because we can always be better. And phones change faster than medical devices? So what why do we put there, we're looking at ways how we can help the environment for future product launches again, and changes in the next platforms, G6 has a lot more materials than G7 does as far as just raw plastic. So how do we make an impact there? On the cost side, there's some form factor things that are pretty far out there that we look at that I won't go into that are really, really fun. We'll see if we had done that. And if they're feasible from a cost of manufacturing perspective, but again, we're now very much focused on customer preference, rather than can't we make this work well enough, you know, in my early days here, it's Can we can we just get this thing working well enough to whereby people can rely on it. Whereas now it's one of those features that are going to make it a more engaging experience. And the last one will be software and analytics and things like that, as I look out over time, do we end up with analytics to whereby we can offer our users a menu of choices on the software side to whereby they can get more if you want Dexcom when don't want to connect or talk to anybody? You can have that if you want something that literally literally analyzes every glucose measurement that you take and does something scientifically. How do you get there, I think there's a number of experiences we can develop over time for future product generations without changing the form factor. So I don't see any slowdown in investment on the r&d side. And on the product side, G6 is the best product out there now and G7 will just be better in every way. And then we just keep going from there.
Stacey Simms 24:27
And I appreciate you answering that. Thank you. So if you keep going from there, this is the sideways kind of question I wanted to ask. Okay, go ahead. Okay. A couple of days ago, Abbott announced the idea of what they're calling Lingo, which is bio wearables that will track not only glucose, but ketones and lactate and alcohol. And they say these are not medical devices. You know, this is for people who want to be you know, ultra-marathoners and things like that. We're already seeing sensors used in that way right now. Any plans to do something like this?
Kevin Sayer 24:56
You know what our electronics platform for G7 We could put any, if we could develop a sensor wire with membranes and analytes and such for to measure something else, it would fit right into G7. And we design G7. With that in mind, we have advanced technology work going on with the other analytes. But it's still an advanced technology phase, we have to answer a couple of questions. First, have we done all we're supposed to do on the glucose side? Before we run there, and we got a lot to do right now, Stacy, you've heard me talk on this call. And so we need to get done what we started, we need to get G7 launched, we need to scale it up and manufacture it in the 10s. And ultimately, hundreds of millions of products as we stand up a factory in Malaysia and get our Arizona facility built out even more. So we've got to get that work done. The second piece, I'm going to answer this in three pieces. The second piece is what is the commercial opportunity for each of those things. They did announce this line of sensors, but they're all individual sensors.
So I've worn a lactate sensor, I'll be completely honest with you from the lab and seeing what it does to my workouts and it's very cool, I can see which workout is better than another one. But I'm not ultra-marathoner, I probably wouldn't change my life. But it was very interesting to look at. There are other scientific uses of black data, particularly in a hospital setting. But what is the market for those, and so we're gonna kind of take an approach, we'll continue to develop the science and if Abbott wants to go develop a market, I am happy to follow this time rather than create it, like we've done with glucose. The third piece of this is there are a lot of biosensors out there. Now, you have your Apple Watch, and Apple is continuing to gather more and more data or ranks, whoop bands, Fitbits, they're advertised on television all the time, I would love to incorporate data from these other sensing technologies into into Dexcom. And vice versa, share our data with those people, particularly as you head down the health and wellness path. And let's get some other people's sensors into our platform. In all honesty, if Abbott's really good at sensing these other things, we'll take that data on our platform and analyze it to if they want to, I guarantee you, that probably isn't gonna, gonna happen. But we would, you know, let's be open about this. We're going to get our glucose work done to because we've not seen an opportunity that exceeds this.
Stacey Simms 27:13
Got it? Excellent. Well, thank you so much for answering that it really is so interesting to watch and to see if, as you say, if any of this really, really makes a difference commercially, if people do want to adopt it widely. You know, I think the jury's still out, so we shall follow.
Kevin Sayer 27:26
Hey, thanks for having me again.
Stacey Simms 27:27
Thank you so much. Have a great day.
You're listening to Diabetes Connections with Stacey Simms.
More information at the episode homepage, diabetes, Dash connections.com. I'll have the transcription up as soon as I can. But again, quick turnaround on this episode. Thank you so much, again, for sending in the questions. Obviously, I didn't get to all of them. And if you're not in the Facebook group, that's generally where I asked for questions for this kind of thing. It's Diabetes Connections of the group. I'll link it up in the show notes. As always, I know not everybody's on Facebook, please feel free to always email me if you email me now about Dexcom. I'll save those questions until the next time we talk to them. It's Stacey at diabetes connections.com. Again, it's in the show notes and it's on the website. But I get it not everybody is on Facebook these days.
To that point, at the very beginning of the show, in that little sponsor tease before things even begin, I mentioned club 1921. So let me tell you a little bit more might be an update for some of you. Maybe some of you are hearing about this for the very first time. Briefly, club 1921 is a website. It's a project I've been working on for a long time. And it is a place where anyone with any type of diabetes can find events anywhere in the United States. We are in beta right now. I invite you to go to the website club 1920 one.com. Until around, check it out. Let me know what you think we've immediately identified we went into beta, late last fall several things mostly about the signup that need to be fixed, those could be fixed by the time you log in, my guess is closer to the end of January. There's a little bit of confusion there. I'll explain in a moment. But other than that, it's pretty well set.
The idea here is that instead of a Google Calendar or something like that, this would be a website where you go, you sign up, you tell us what kind of events you're looking for, and then you never have to come back, we'll email you automatically. When events that meet your criteria are edit, very easy. So you pick your type of diabetes, you pick your location, you pick which type of events you want, you pick your age, I mean, you can just say I want everything in every category you can kind of go through, but whatever you pick, and you can change those if you want to come back and change your filters, but whatever you pick, we will email you when those events are added.
If you want to add events. There are two types of events you can add one we're very creatively calling events. This is your JDRF walk. This is your friends for life conference. This is your hospital education for people with type two. It's an event by an organization a was a staff an event where they expect lots of people or it's regularly scheduled, or there's a fee, that kind of thing. The other kind of events we're calling Hangouts. These are my favorite types of events. I love what we're calling Hangouts. This is your mom, coffee, your kid play date at a playground, you know, you're going out to a bar, post COVID, with your adult friends with type one, hang outs are not put on by an established organization. They're put on by people like you and me, we don't have a staff, we just want to meet people in our area. When you're adding those. That's where a lot of the confusion came up in the registration process. Because if you want to add events or Hangouts, you actually have to sign up in a different way.
So I'm going to talk more about that as the weeks go on. We're fixing that part of the website. But if you try to sign up and you see some confusion, it may be because you are trying to add an event or a Hangout. If you want to just sign up to learn about the events and Hangouts, it should be pretty simple. But if it's not, if you have any questions, any suggestions, please let me know. Email me Stacey at diabetes connections.com. Pretty soon you'll email me Stacey at Club 1920 one.com You're going to be hearing a lot more about this because I'm so excited about it. Yes, I know, we might not have a lot of events this year, that's fine. We're going to have events, eventually, in the diabetes space. Again, we're gonna have lots of events, and social media, Facebook, even things like Eventbrite are a terrible way to get the word out about them. And it shouldn't be work to find them, you should be able to just raise your hand and say, I want to know about this stuff. And it should automatically come to you. And that's what I'm hoping to do here.
Okay, back to our regular schedule with the podcast. We will have our Wednesday in the news that's live at 430. Eastern on Wednesday on YouTube and Facebook, and then 445 on Instagram. And then that turns into an audio podcast episode for Fridays. And hopefully next week, we're back to Tuesday and Friday. And we won't do any of this nonsense of pushing episodes around. But I do appreciate your patience. Again, I didn't want you to wait a week for this interview. All right, thank you as always to my editor, the very flexible and understanding John Bukenas from audio editing solutions. And thank you so much for listening. I'm Stacey Simms. I'll see you back here in just a couple of days until then, be kind to yourself. Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
We're taking a quick look back at 2021 and a longer look ahead to 2022 and beyond. Stacey is joined by DiabetesMine Managing Editor Mike Hoskins for a fun talk about technology, trends and even few rumors in the diabetes community.
As always, please remember this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider. We’d also add that Mike and Stacey are well-educated about what they're talking here but this isn’t inside information. Don’t set your investments or decide what products to buy from this episode.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
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Episode Transcription Coming Soon!
When we heard about a new seven day infusion set approved this past summer, we had a lot of questions! We've been told since the very first day of pumping to only use the inset for 3 days tops and to always rotate the site. How did they get seven days out of one of these without skin irritation and with good absorption? We asked the folks who make the inset to come on the show and explain.
Turns out, ConvaTec Infusion Care makes the insets for Medtronic, Tandem, Ypsomed, Dana RS and Roche pumps. So while I started off talking about the longer-wear version, the conversation you’ll hear includes everything from proper insertion technique, their challenges teaching users best practices, improvements they're making to the cannula and more. In this interview you will hear: John M Lindskog, President & COO, Matthias Heschel, Vice President, Research & Development and Intellectual Property Rights and Dr. Kerem Ozer, Director Infusion Care Clinical Development
Good article about using insets correctly and understanding the different types.
Check out Stacey's book: The World's Worst Diabetes Mom!
Join the Diabetes Connections Facebook Group!
Sign up for our newsletter here
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Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!
-----
Get the App and listen to Diabetes Connections wherever you go!
Click here for iPhone Click here for Android
Episode Transcription Below:
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, how much have you thought about the way your insulin pump connects to your body? Honestly, it's where a lot can go wrong. The people who make the insets know that they have come a long way. And they're trying to make it better.
Matthias Heschel 0:40
It's what some people call their Achilles heel in the arm therapy were very much aware of it. And our approach simply is instead of doing product design at the drawing board, to the product design in the field, really taking the patient at the core of our design process, really understanding behaviors, understanding what could go wrong, and then design the product accordingly.
Stacey Simms 1:05
That's Dr. Matthias Heschel, head of R&D for ConvaTec infusion care. He, the CEO and the Medical Director sat down with me to talk about longer were tips for users and what's next for this really important part of pumping.
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 the show, you're always so glad to have you here. We aim to educate and inspire about diabetes with a focus on those who use insulin. I am really excited and happy to talk to the guys from ConvaTec. This week, you know, they were frank, they were really up for anything. And I have said for years that insets are the weak link in pumping. And they really opened my eyes to some of the issues and what we can do as users or you know, as parents of users to make things a little bit better. And of course, they're working on improvements as well.
But before we jump in a little bit of housekeeping, I want to talk about the rest of the year schedule for the podcast, I can't believe we're in well into December at this point. Right now the plan is to keep going with these longer format. The interview shows that air on Tuesdays, and we'll have that there shouldn't really be any interruption or any week skipped through the rest of the year and into January. I'll let you know if that changes. But that is the plan right now.
As for the newscast, I will probably not have a newscast on the 22nd of December. Again, I reserve the right to jump in and make a liar out of myself. There is breaking news sometimes late December is when the FDA makes a lot of decisions. So we could have some breaking news. But I would say right now, it looks like at least that one date will not have the live newscast on Wednesday on Facebook, Instagram and YouTube. And so then I will not be turning it into one because that would be a podcast on Christmas Eve and I don't think there's a lot of demand for you to listen on Christmas Eve but you tell me if there is I'm happy to serve and try to put all that together.
Another quick announcement and I'm actually going to talk more about this after the interview is that book number two is in the works. The second World's Worst diabetes mom, I signed on the dotted line to deliver that next year. So we have a timetable. We have a theme. I have lots of stuff. I'll tell you about that again after the interview, but man, I'm really excited about it.
Alright, a little bit more about our guests. ConvaTec infusion care makes insets for both of the tubed pumps available in the US they make for Tandem they make for Medtronic, they don't make Omni pods. They also make insets for Ypsomed and other tubed pumps abroad. But if you use a tubed pump in the US you use their products. In this interview you will hear John Lindskog The President and CEO, Dr. Matthias Heschel, the head of R&D, research and development and Dr. Kerem Ozer, the Medical Director, I worry a bit about three voices. I mean, really, it's for with mine, but we do I think we do make it clear. And there is always a transcript over at diabetes connections.com at the episode homepage, if you find it easier to you know some people follow along, reading as they listen. Some people prefer to read my transcription software. Let me tell you got a workout on this one. It doesn't speak diabetes very well to begin with. And as you can imagine, there was a lot of technical stuff but we did it we got it and it's there for you. But I think that these three were very frank and gave us a lot of information a national here. They have a question for us.
That's coming right up but first Diabetes Connections is brought to you by Dario health. Bottom line you need a plan of action with diabetes. And we've been lucky that Benny's endo has helped us with that and that he understands the plan has to change. As Benny gets older you want 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 months reduction of a one C within three months and a 58% decrease in occurrences of severe 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.
John, Matthias and Kerem, thank you so much for joining me. We have a lot to talk about. And I feel like I've ever been to the company at my disposal. Thank you so much for taking the time to do this.
John Lindskog 5:20
Thank you, Stacey. This is John and thanks for having this opportunity to talk with you. Maybe just a couple of words of ConvaTec infusion care. I'm the president and CEO of that part of ConvaTec. We are based out of Denmark and out of Mexico, we have one plant making a few sets in Denmark, and we have two plants almost side to side in Mexico, and also is fully dedicated to making few sets for subcutaneous infusion. Today with me, I have the Matthias and I Kerem and if you could just kind of introduce yourself briefly.
Matthias Heschel 5:58
Yeah, this is Matthias. I'm heading research and development at ConvaTec Infusion Care. I’ve been with the company for 10 years. Just happy to be here.
Dr. Kerem Ozer 6:07
Hi, everyone. I'm Kerem Moser and I'm the medical director for ConvaTec infusion care. I'm an endocrinologist by background. I've been with ConvaTec for about four months now. And prior to that I was in practice seeing endocrinology and diabetes patients for about 15 years, and very excited to be here.
Stacey Simms 6:28
Wonderful. Well, thank you all so much for joining me. We have a lot of questions, questions for my listeners questions that I have as a mom of a kid who has used insets since he was two years old. So let me jump in and ask about the newest infusion set as I see it, which is with Medtronic and Matthias. Let me ask you about this if I could. we're hearing really interesting things seven day up to seven day wear, which I believe rolled out in Europe first is now approved in the United States. How I don't want to ask you to give any trade secrets away. But how do you get it to last so long when we've been told for years that two to three days is the maximum for an infusion set?
Matthias Heschel 7:03
Yeah, actually, the answer is very simple. Stacey. Medtronic, they provided quite some details about the year back at the virtual conference. So Medtronic, they added a proprietary connector, which connects the tubing to the pump reservoir. And this connector stabilizes the instrument. On top of the canula, a new tubing, which contains the preservatives, contains the antimicrobial effect of the preservatives. And the last thing is that we added a new adhesive to keep the infusion set on the body for up to seven days. So basically three things. New connector, new tubing, containing preservatives and a new adhesive.
Stacey Simms 7:48
So it was kind of a partnership with Medtronic. It's not all on the inset itself.
Matthias Heschel 7:52
It's a partnership with Medtronic, and they in general, talking about new product development, future products. It's all at system level. So we cannot just develop a new infusion set. We need to take the reservoir into account we need to take algorithms into account so it's it's always a close partnership with pump manufacturers.
Stacey Simms 8:15
how have people received it? Or is it working well, is the adhesive doing okay, on people's skin?
Matthias Heschel 8:20
It seems so we have received some first indication Medtronic percent that results at the diabetes technology meeting here this week, actually. And that has shown that there are lower occurrence of hyperglycemic events. There are fewer occlusions. And I think the average wear time was seven days. So it seems that the patients that have come on to an extended wear infusion set are really happy and the infusion sets perform as designed.
Stacey Simms 8:57
Before I move on from this one more question for you Mateus if I could. I'm curious, are you working with other pump companies on longer where infusion sets? Or is this going to be a Medtronic exclusive for the foreseeable future?
Matthias Heschel 9:10
Well, extending the wear time of infusion sets, that's the unmet need, number one among all patients, so and that's in general interest from all pump manufacturers to have extended wear products in the portfolio. So yes, we're working on the portfolio of infusion sets.
Stacey Simms 9:30
Kerem, let me move over to you if I could for this question. As a parent of a child with type one. We were schooled early on the importance of rotating sites, right? You can't let an infusion set go in the same part of the body over and over again. But most kids and frankly most adults I've talked to who use these products do kind of have a favorite spot. The body. Can you talk a little bit about Yes, I guess there the importance of rotating, but something like a seven day wear or what's coming in the future. Is there a possibility that it could be a little less important? to move that around, or am I dreaming?
Dr. Kerem Ozer 10:02
That's a really good question, Stacey sort of looking forward, just taking a quick step back, just like you said, the importance of sort of proper rotation is something we always talk about in clinic yet in real life, we know that people have their favorite sites. And part of the idea of the rotation, of course, is to reduce scarring and is to reduce lipohypertrophy. I know your listeners will be very familiar with this. But of course, when we say lipohypertrophy, we're talking about sort of the hardening that bumpiness of the layer right under the skin, that subcutaneous area. And when I think about lipohypertrophy, there are several factors that increase that risk, you know, multiple daily injections, pumps, continuous glucose monitors, sometimes the type of insulin being used, and that really changes from person to person reusing pen, needles, all those factors, even higher insulin doses tend to cause more of a higher risk, higher diabetes, duration is a higher risk. Now, when I think about those factors, some of them are you can't change those like diabetes, duration. Some of those factors, you can change by rotating things, when you look at something like extended wear, I think one advantage is you are going to need to change it out less often. So you're technically changing it, you know, less often, it's probably best practice to still change the site and rotate the site. But one thing I think that's going to be even clearer, and I see this all the time, you know, when I talk with my patients, is, I think it's going to be important to realize subtle changes in the characteristics of that site, even before you start feeling hardening of the skin, even before one starts feeling that bumpiness if you notice that a site is starting to not respond as well, you know, you're feeling that you're needing more insulin, you're feeling that the dynamics are changing. That's I think, when it's going to be really key to make that site change.
Stacey Simms 12:21
Interesting. I have kind of said, it's a little bit flippant, but I've said since we started pumping, 14 and a half years ago that gosh, these insets are the weak link in pumping. And what I mean by that is they can fall off easier, they can get occluded, they only last a couple of days. John, maybe let me ask you, can you talk us through a little bit about how you're really trying to make these better? Because I feel like I can have the greatest algorithm in the world on my pump and if the darn thing is flapping on my kids off my kids stomach it's not gonna work
right back to our conversation. Yeah, he does answer that question. But first Diabetes Connections is brought to you by Gvoke Hypopen. You know low blood sugar feels horrible. You can get shaky and sweaty or even feel like you are going to pass out – there are lots of symptoms and they can be different for everyone. I’m so glad we have a different option to treat very low blood sugar: Gvoke HypoPen. It’s the first autoinjector to treat very low blood sugar. Gvoke HypoPen is premixed and ready to go, with no visible needle. Before Gvoke, people needed to go through a lot of steps to get glucagon treatments ready to be used. This made emergency situations even more challenging and stressful. This is so much better and I’m grateful we have it on hand! Find out more – go to diabetes dash connections dot com and click on the Gvoke logo. Gvoke shouldn’t be used in patients with pheochromocytoma or insulinoma – visit gvoke glucagon dot com slash risk.
Now back to John Lindskog answering my question about making the insets more foolproof.
John Lindskog 14:00
No, no, no, I totally understand what you're saying I will say and then maybe Matthias can chime in after this that, you know the products like insets, they go through a quite extensive and long development program before they actually come to the market and the products also available on basis on customer feedback. And since this is a medical device, it's very highly regulated in the US through the FDA requirements and Europe through CE and in many, many other countries through local legislation. So the level of rigor and preciseness that you have to do in this work is quite extensive for us to develop a product and mass make it into volumes, which we're talking about millions of units per year does require quite a bit of development work to go there. And there is a little bit of you know there's a lot of factors that play into to the to the development, particularly manufacturing of the infuser set, the quality has, of course, to be the highest possible within the requirements. And there's also, of course, a economical part of it, where you need the competitive cost in order to have these products on the market. So I mean, the process that you see today is actually a combination of all the the user input, and of course, also about, you know, the requirements from regulatory authorities. And, and you know, what can be made in very high scale, we, you know, and strive to improve the products along the way, however, even what may seem as being very small, and my new changes, does actually require a complete change process, which is very well documented, and in that sense, also kind of lengthy process. And I don't know Matthias. If you have any anything to add to that, yeah, quick
Matthias Heschel 15:56
Yeah, but I would like to add is that we have, we have about 1 million pump users worldwide. And as a create variability, it's both the interpatient variability and intra patient variability. So huge differences between patients and also huge differences between the use conditions during a day for the same patient. So what we are going after in our product design is really making as robust designs as as reasonably possible. And best example is, is the newest infusion set on the market, which is the base of the extended wear we talked about earlier, an infusion set we call Mio advance which virtually only has one user step. So you hit the bottom activation button and it produces the soft cannula, retracts the needle and detaches the serter all instantly. I mean, all the steps happening in a fraction of a second. And that means you're basically take the patient out of the equation, the patient cannot do any mistakes during the insertion process. And there we see a huge reduction in in failures on the market. So to your question, Stacey, I mean, we understand that the infusion set is the weakest link, it's what some people call the Achilles heel. In pump therapy, we are very much aware of it. And our approach simply is, instead of doing product design at the drawing board, to the product design, in the field, really taking the patient in the core of our design process, really understanding behaviors, understanding what could go wrong, and then design the product accordingly. And we have seen the first successes and they hope to see further successes.
Stacey Simms 17:40
You know, that's a great point about the very simple insertion of the Medtronic inset. Are there any plans to simplify more brands, because I'm thinking of the one we use for Tandem? And you know, by the time you open it, you peel off the sticky stuff, you, you cock it, you get it ready? You know, sometimes you're already set for error, because if the paper writes up the needle, you know, there's all sorts of different things that can happen if people either press too hard or do it at a weird angle. I know you know this, I don’t have to spell it out for you. But are there plans to simplify other insets in the way that you just described? Since you've seen how successful it is?
Matthias Heschel 18:16
yeah, plans to incremental improvements on existing infusion sets, based on the learnings we have from the field, among others, what we touched upon removing the paper liner from the adhesive, we can certainly redesign this to make it easier for the patient. And that's, that's definitely on our agenda.
Stacey Simms 18:37
I have a bunch of questions that I got from my listeners, they were really interested that we were talking so let me go ahead and grab those. The first one here was really interesting to me. This listener wants to know about the faster acting Fiasp insulin, which seems to have a little bit of difficulty in some pumps, I was wondering if you were looking into that for different faster acting insulins that the manufacturers are coming out with and if you're testing those and working on ways to improve that in the insets
Matthias Heschel 19:06
Yeah, maybe keep a close eye on the market. And every time a new insulin is approved for pumps, therapy, we add this onto our list and do all the necessary trucks stability testing, device stability testing, so you can put this onto our indication for the infusion sets and then it's up to the to the pump manufacturer to also indicate the pump for the new insulin and then the patient can use it. So and that also applies to Fiasp. So we have done all the necessary homework and we know that at least a couple of the pump manufacturers are considering to broaden their pump indication to also include the Fiasp
Dr. Kerem Ozer 19:47
And to that I may also add that we're also going to be looking at Lyumjev ultra rapid lispro insulin from Lilly, which as you know is also approved just recently for pump use. So That will also go through the same processes that Matthias mentioned, whether it's working on biocompatibility, looking at what the system does to the insulin, and its excipients and what the insulin is excipients do to the pump. And so that's in the works as well.
Stacey Simms 20:15
I meant to ask earlier, I had heard about something I don't know if this is the in-house name or something that you're using and research called Lantern technology. Could you explain what that is what you all are working on?
Matthias Heschel 20:27
I was hoping you would ask this question. Lantern is a pretty simple feature tries to mitigate the occlusions we sometimes see for soft cannula infusion sets, when the soft cannula is bent or kinked. And the Lantern features are actually pretty simple. So we provide the soft cannula with additional slits close to the tip of the cannula, and in case the soft cannula experiences any physical impact is spent or even kinked then those slits would open up and would allow to the inset to continue to flow. So it's basically a measure to mitigate the risk that a cannula on the infusion set can get occluded in the cannula.
Stacey Simms 21:15
That sounds really interesting. It sounds like didn't BD medical a few years ago have something that sounded it sounded at least to my ear similar that it had the different slits in the cannula? And it never came out? Is this similar technology.
Matthias Heschel 21:29
It's you could see it as it's different as a similar technology. It's though, quite quite different. I mean, they provided an additional exit hole, just one hole close to the tip of the cannula. And that actually weakened the cannula significantly, and the product was out on the market. They call it a smart flow technology. And the product was marketed by Medtronic as a process that was withdrawn from the market right after. And with our long term technology, putting a number of slits, we have really avoiding this issue that the cannula really occludes. Imagine if you just have one side hole and the cannula kinks or bends, and you would close up this hole. And in our case, having four or six slits, that would be always a couple of slits open and allow the Insulet to flow. So it's a different technology.
Stacey Simms 22:25
Yeah sure. And I don't know how much you can share which brands might get that? In other words, are you working with Medtronic on this? Or you're working with Tandem on this as somebody else? You know, in the should we be watching for this in a more proprietary form? Or will it just going to go in all of your insets?
Matthias Heschel 22:40
Right now we're in the process of implementing technology in our mainstream products, which are the inset two products, which are available to all pump manufacturers, and then we need to see pump manufacturers will pick up on this.
Stacey Simms 22:56
Got it. Kerem, let me ask you if I could, do you have any best practices for your patients when it comes to using the insets and infusion sets? Are there mistakes that are very common that people make, I'd love to kind of hear, you know, what you what you tell your own or in the past what you've told your own patients?
Dr. Kerem Ozer 23:13
Absolutely. The key things, especially if someone is very new to living with diabetes, as you know, there's there's a lot of anxiety there. Everything is new, a lot of new information is coming in, you know, at our clinic, what I always tried to do, what we always tried to do was sort of taking a deep breath, letting people know that there's a lot of resources, there's a lot of support, you know, at the risk of sort of repeating the cliche, it's not a sprint, it's a marathon, and really providing the resources, sort of focusing that more on to the infusion set side, I think one key thing is starting, especially if someone's new to pump therapy, sitting down with them going over the whole process, we had demo kits, sometimes I would demonstrate sets on myself even just to make sure that everyone's feeling comfortable, especially for our younger patients, having the parents there and really taking the time to walk them through the process of what an ideal insertion looks like. And I think doing it in real life really helps in person in real time. As opposed to watching a video which where everything looks so perfect, right? So we definitely emphasize that prioritize that. And then when we start thinking about using the sets, a lot of those things using the alcohol pad and cleaning the area, a lot of things that are repeated, easy to say hard to do every single time. But I think emphasizing the fact that the closer and closer we get to that ideal that the longer we can keep the site's healthy, the longer we can keep the process healthy is important. And as more technology comes in as continuous glucose monitoring gets integrated. As the pumps get smarter, I think there's always the importance of that of that person factor. And making sure that we're really addressing everyone as an individual and sort of seeing where they are and going and holding their hand and walking with them to where they need to be or where they want to be, is key. And then there is as you know, a lot of variation from person to person. And there's a lot of variation from day to day. And being aware of that repeating that message. And sometimes you wake up and you have a perfect day. And sometimes you wake up and there's a lot of obstacles and changes and bringing that message that, yes, diabetes is there. Yes, it brings challenges. But if we see it as part of a larger system, and if we address it as well as we can, as if we can stick with those guidelines, and recommendations. And if we keep open lines of communication between the patient and the family and the clinic, things tend to fall into place. And I'm very proud to say your many, many patients, of course, live decades and decades of healthy lives with diabetes. And I think that the key component there is keeping those lines of communication open and keeping that sort of positive attitude going.
Stacey Simms 26:38
Alright, let's get back to some of the questions that my listeners had. And I thought this was a really interesting one, she asked me when insets are designed is any consideration given to those of us who deal with limited hand strength, or older adults with smaller hands, or even using color tubing to increase the visibility of air bubbles or maybe using color in the cannula. So it'd be easier to see if it was correctly inserted. I've got to believe that you look at this and you do research it but Matthias, can I ask you to just hop in an answer that one?
Matthias Heschel 27:07
Sure. Well, every time when we design a new product, we put a lot of effort into the initial conceptual work. And that means that you propose certain designs, which we then show to the target population. And if the target indication of the product is smaller children or elderly people, those will be included in the assessment of the concept. So we really trying to already in the concept phase to design the product in the way that we can make sure that it can be used by the by the target population. And at the same time, we are compliant with standards. For example, when we have a product that requires activation to push a button, what's the strength of a point of finger for a for a small girl? so we were really trying to incorporate this in our product design.
Stacey Simms 28:05
Another question came in there used to be an infusion set by a different company called an Orbit. I don't recall this, but this sounds great. It rotated so the tubing was less likely to get caught. Any plans to bring that back or something similar.
Matthias Heschel 28:18
Well Orbit is owned by another company Ypsomed in Switzerland, and to our knowledge, the product is still on the market. So we don't have any insights in the in the details. But it's not it's not one of our products.
Stacey Simms 28:35
Got it? It's probably something that's not available in the US yet because we don't have Ypsomed here yet. But it's it's supposed to be coming. Okay, I have a very might be a silly question, but I will ask it anyway, this is a silly question. I get it from listeners all the time. One of the first times I remember getting our box of inserters we had the old one I always describe it looks like a little spaceship. I mean, I know you know exactly what I'm talking about for it was the Animas way back when and now we use Tandem, it came with these little plastic pieces, and no one ever told me what they were for. And as it turns out, then we realize this after my son's inset got filled with sand at the beach, and we could not reconnect. It turns out these little pieces are supposed to go in and protect the site and keep sand out. But I've heard a lot of different versions of what they are really supposed to do and when you are supposed to wear them. So my question is, when you put an inset on the body, it was explained to me like it's almost as though you've got like a vial of insulin with a little rubber on top. You can pierce it, but you can't get into it. In other words, you don't have to cover it every single time you take a shower or go in a pool because nothing is seeping through until you reconnect the needle. Is that the proper use of those inserters
John Lindskog 29:50
Yeah, this is uh, John maybe just a quick comment. So that that is that is true that at the at the time development there were some spare caps. And the idea here was that when you disconnect the tubing from the side, it's true that you know it sealed, the side doesn't seal because there are septums that closes the fluid pathway. However, the idea about providing these small inserts was that you could protect kind of the surface of the septum. With that kind of cover so that you wouldn't have any kind of larger particles being able to, to come in the way like the listener just described getting sand in it. So it was actually, you know, kind of a protection. However, it was not something which was necessary, it was kind of, you know, choice you could make to add that in, though. So that the reason behind that
Stacey Simms 30:48
perfect, there just seems to be a little bit of a misunderstanding in some parts of the community, what people think it keeps bacteria from getting, in other words, if you swim in a lake or something like that, you should pop it in. But it really is just to keep out particles like sand.
John Lindskog 31:01
Yeah, it's only for larger particles. And, you know, the site is perfectly sealed as it is. So it's it's more to kind of say, Okay, I want to make sure that that, you know, I don't have to clean it up afterwards, and so on. So that was the rationale behind that.
Stacey Simms 31:18
I have one or two more questions, kind of to wrap it up. Have I missed anything in particular that you guys wanted to make sure to bring up before I start wrapping up?
John Lindskog 31:26
Actually, there was just one question that I think that at least I had, I would be curious to know about, you know, in each box of the insets, there is an instructions for use, how you deploy, the infusion set. What's out and, you know, that is in some countries made in a number of different languages and so on. And I guess I'm just curious about is that being read all the time, or is that you know, being kept in the place or simply just, you know, put it into the trash can. But what's kind of, because I have a I have an assumption. We have an assumption, what happens to these but but I was just curious to know, if you could share that with us.
Stacey Simms 32:07
I'm so excited that you asked that question, John, I think you know the answer, I can't imagine anyone is really reading the instructions, we all should. In fact, I'm going to take those instructions out and look through them. But it's one of those situations where my book that comes with each box is so thick and intimidating. As I'm telling you this, I'm thinking this is why I don't do it, maybe it's just I'll have to take a look at how long the actual instructions are. Maybe it's in several languages. And that's why it's so thick, but we're so used to and maybe we can blame the iPhone for this. We're so used to opening something up and being able to use it immediately and hoping right that it's very intuitive, that maybe that's why we don't read the instructions. So there's a lot of user error. And frankly, I know there's a lot of user error within sets. I've seen it in my house, I've been the user making the error. So I'll ask my listeners, I mean, I'd be happy to take a quick poll in the Diabetes Connections Facebook group, but I do recall taking a pump class, and we were there for two hours, I came home a couple of days later, I had to change the inset on my two year old I had forgotten everything I had learned. And at the time, this was 2007. I found one video, I mean, think about the days of YouTube back in 2007. And it was in French to show me how to change the inset. But I did that rather than look for the instructions. So John, what a great question. And I will get you more feedback from the community on that.
John Lindskog 33:29
Okay, thanks. Thanks a lot. Thanks. I will say though, that, you know, it is a regulatory requirement that we put those in a box. And we would, you know, like to move it into some kind of, you know, YouTube media or something like that. However, the regulatory requirements are that they should always be there. So we want to see if we can move that in the regulatory requirements. So we can, you know, save some printed matter, and, you know, reduce the waste and make it easier to access.
Stacey Simms 34:02
It's a great point. That is a great point. Before I let you go, here in the United States and I assume in many parts of the world, there's a lot of concerns about supply right now. Any issues, any concerns anything people should be thinking about for the next couple of months?
John Lindskog 34:16
No, I you know, and we have had some issues on supplies in the beginning of the when COVID-19 was at the highest and we have been putting in extra capacity for making progress and investing large sums of money into getting you know, capacity brought up and we should be out of those weeds by the end of this year. And we don't really see any, any issues going forward. But you know, it may take some time to get that all through the supply chain, but I can assure you that we're doing everything which is now a power to always have the capacity to supply the what the demand is.
Stacey Simms 34:57
Let me as we wrap this up, Kerem, let me ask you this. You are new to the company, or you are the newest person here, so the company, what excites you and you know, you've worked with patients for a long time, you've seen how important this part of the device and system is, what excites you about this technology going forward?
Dr. Kerem Ozer 35:15
This is a great question. And this is the reason I'm, I'm here, I'm in the company, I think it really goes back to that point about realizing how important looking at patients insights, their experiences, where they are, what they need, and bring that feedback into the company to help develop new technologies. And I would say, a direct corollary to why I'm so excited about my role here is this is really sort of being a medical person, a physician, and endocrinologist and industry, you really play a bridge role. You're constantly talking with the engineers with the business side, and you're keeping your ear open to your patients, your community and your colleagues. And sort of you're part of that feedback loop, bringing back ideas, presenting your products and saying this will work. This is a great idea, and sort of keeping that momentum going. And I'm very excited about that.
Stacey Simms 36:20
Excellent Matthias you are in r&d, you are the head of r&d, you're in the I wouldn't say the trenches so much. But you're really seeing realistically what's happening on the company every day. Anything you want to add to that. I mean, is there anything that you're really excited about that you'd like to listeners to leave listeners with? Yeah,
Matthias Heschel 36:37
I mean, what, what I always tell the engineers is, you guys, you are directly responsible for how patients or people in the state beat is, how they feel how they are able to manage their daily life. If we do a great job, those people can lean back once in a while and perhaps even forget about the disease, if it will not do a perfect job. They have a terrible day. So that's, that's really what people understand. And that's why at least how I see it. I mean, those people in the medical device industry typically work longer work harder, because they understand they understand the responsibility they have.
Stacey Simms 37:17
Well, thank you so much all of you for spending so much time with me for answering our questions for posing your own questions, which doesn't happen that often. And I'm really glad that you did that. We will get you some answers. Thanks so much, gentlemen.
You're listening to Diabetes Connections with Stacey Simms.
Lots more information at diabetes connections.com at the episode homepage, and I'll link to some of the studies they talked about that longer were the stuff that's in the works. And let me tell you, I went and got the book. I have it right here. Can you hear that? I'm wiggling it, I went and got the book that comes with the insets. And it's right there. Of course, at the top with the little horseshoe thingies that they explained. I hope they cleared up some stuff for you. The book is long, because as I said, it's in many other languages other than English, the directions are maybe two or three pages long. I think it's really just two pages. There's some pictures here. But the English instructions are one to three pages long. And then that's it.
So Benny and I actually sat down and read them. And he does it slightly differently. But what he does works, I mean, we are 15 years into diabetes. So that means we were 14 and a half years into pumping. So he's got it down. But if you're having trouble, I may start a thread in the Facebook group. Because there's some really easy tips and techniques to make sure that you you put these insets on correctly in follow the directions. That's your best bet. But as you know, the community can help too. So we'll we'll put that in there. And of course, I'm going to put a poll up about the and we put I may have already done that by the time the episode airs, because a pull up about have you ever read the directions? I was a little embarrassed. You heard me laughing when he asked, but I'm glad he did.
Alright, I've got some news coming up about next year. Oh my gosh. But first Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom, it was back in 2013. It was about this time here, the share and follow apps were not an option. They just hadn't come out with the technology yet. So trust me when I say using share and follow make a big difference. I think it's important though to talk to the person you're following or sharing with and get comfortable with how you want everyone to use the system. Even if you're following your young child. These are great conversations to have, you know what numbers will make you text, write how long you're going to wait to call that sort of thing. That way the whole system gives everyone real peace of mind. I'll tell you what I absolutely love about Dexcom share and that is helping Benny with any issues using the data from the whole day night. And not just one moment. Internet connectivity is required to access separate Dexcom follow up to learn more, go to diabetes connections.com and click on the Dexcom logo.
A couple of weeks ago I told you I would have some book news and I do I am so excited to announce that the world's worst diabetes mom, part two is going to be out next year, I just signed on with my publisher. We talked this week, actually this morning, as I'm taping this episode, and we laid it all out, because my goodness, with some of the publishing issues, probably hopefully not the shipping issues by next year. But a lot of what's going out of the publishing industry, I have to have everything done earlier than I did last time to have the book Ready by a certain time of year I wanted out for as you can imagine, I wanted for November of next year, because Diabetes Awareness Month is my best bet to get any kind of, I guess, mainstream media attention on diabetes, media attention. And that worked really well. In 2019. When I put out the first book, the name of the book is not part two. I'm not sure what we're going to call it yet.
But I will be sharing that with you all, I'm going to be sharing more of the process this time around, just as I think it'll be fun. And I'm going to be sharing things like cover options and title options in the Facebook group Diabetes Connections, the group. So if you'd like to help me the community was a huge help last time around in terms of how to word things. Because you know, when you're a parent of a child with type one, there are some differences that you want to be respectful about. There's some differences and ways of wording things that that just for clarity, right? A good example is are you a T one D parent, to me, that means a parent who lives with type one, right? So you have to It's little things like that you just have to be careful about and you will help me so much with that the first time around. So I will be asking the second time around, I have an idea for a title, I kind of know what the direction is going to be. I know what the title is going to be. I know what the focus is going to be on. We're going to be addressing a lot of the things that I have been asked about since the first one came out. So really excited, a little bit nervous. But man, I loved writing the first one. So I hope this will be as much fun to put together.
All right, thank you so much to my editor John Buchenas from Audio Editing Solutions. We will be back on Wednesday. We are now live on Facebook and YouTube at 430. Eastern time. And then around 445 I'm live on Instagram. A little bit different for those of you who live on Instagram a lot like evolve. I mean, what a pain. Right? But it's fun. I like doing it. It's only a pain because I share photos. And I'm not that adept. Really. I mean, Instagram is not a friendly platform for sharing photos live and reading a script. Let me just tell you say if you've got advice on that, and you know how to do it, well, let me know. Or you could just listen to the audio podcast that comes out every Friday for in the news. Thank you so much for listening. I'm Stacey Simms. I'll see you back here soon Until then be kind to yourself.
Benny 42:35
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
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.
There is also video of this if you prefer to watch over on the YouTube channel.
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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.
Back to our conversation in just a moment, but first Diabetes Connections is brought to you by Gvoke Hypopen and you know, low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're going to pass out there are a lot of symptoms and they can be different for everyone. I am so glad we have a different option to treat very low blood sugar. Gvoke Hypopen is the first auto injector to treat very low blood sugar. Gvoke Hypopen is pre mixed and ready to go with no visible needle before Gvoke people needed to go through a lot of steps to get glucagon treatments ready to be used. And this made emergency situations even more challenging and stressful. This is so much better. And I'm grateful we have it on hand, find out more go to diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma visit Gvoke glucagon.com/risk.
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
Absolutely.
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.
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged
With Dexcom announcing a big new agreement with Garmin this month, it seemed like a good time to check in on a few issues. Stacey talks with Dexcom’s Chief Technology Officer Jake Leach about Garmin, the upcoming Dexcom G7 and Dexcom One. She asks your questions on everything from G7 features to watch compatibility to the future and possible non invasive monitoring.
Just a reminder - the Dexcom G7 has not yet been submitted to the US FDA and is not available for use as of this episode's release.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Previous episodes with Jake Leach: https://diabetes-connections.com/?s=leach
Previous episodes with CEO Kevin Sayer: https://diabetes-connections.com/?s=sayer
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Episode transcription below:
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.
Announcer 0:20
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:26
This week Dexcom announced a big new agreement with Garmin this month seemed like a good time to check in on a few issues, including what happens to the watches and insulin pump systems that work with G6, when Dexcom G7 it's the market.
Jake Leach 0:41
We're already working with Tandem and Insulet. On integrating G7 with their products have already seen prototypes up and running, they're moving as quickly as possible.
Stacey Simms 0:49
That's Chief Technology Officer Jake leach who reminds us that the G7 has not yet been submitted to the US FDA. He answers lots of questions on everything from G7 features to watch compatibility to the future and possible non invasive monitoring. 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 the show are we so glad to have you here I am the host Stacey Simms, and we aim to educate and inspire about diabetes with a focus on people who use insulin. You know, my son Benny was diagnosed with type one right before he turned to my husband lives with type two diabetes. I don't have diabetes, I have a background in broadcasting. And that is how you get the podcast. And when I saw the news about Garmin, and Dexcom. I knew you'd have some questions. And I thought this would be a good chance to talk about some of the more technical issues that we're all thinking about around Dexcom. These days.
I should note that since I did this interview with CTO Jake Leach on October 19. And that's exactly one week before this episode is being released that Dexcom released some new features for its follow app. I did cover that in my in the news segment. That was this past week, you'd find the link in the show notes. And as I see it for that news that release in the update, the big news there is that now there is a widget or quick glance on the followers home screen, it depends on your device, you know, Apple or Android, there's no tech support, right from the follow up, and a way to check the status of the servers as well. And I think that last one should really be an opt in push notification. If the servers are down, you should tell me right, I shouldn't have to wonder are the servers down and then go look, but that is the update for now. And again that came out after this interview. So I will have to ask those questions next time.
And the usual disclaimer Dexcom, as you've already heard, is a sponsor of the show, but they only pay for the commercial you will hear later on not for any of the content you hear outside of the ad. I love having them as a sponsor, because I love that Vinnie uses the product. I mean, we've used Dexcom since he was nine years old. But that doesn't mean I don't have questions for them. And I do give them credit for coming on and answering them. Not everybody does that. I should also add that this interview is a video interview, we recorded the zoom on screen stuff. You can see that at our YouTube channel. I'll link that up in the show notes if you would rather watch and there always will be a transcript these days in the show notes so lots of options for however it suits you best. I'm here to serve let me know if there's a better way for me to get this show to you. But right now we've got video audio and transcript. Alright Jake leach in just a moment.
But first Diabetes Connections is brought to you by Dario health and you know one of the things that makes diabetes management difficult for us that really annoys me and Benny, it's not really the big picture stuff. It's all the little tasks that add up. Are you sick of running out of strips do you need some direction or encouragement going forward with your diabetes management? Would visibility into your trends help you on your wellness journey? The Dario diabetes success plan offers all of that in more you don't the wavelength the pharmacy you're not searching online for answers. You don’t have to wonder about how you're doing with your blood sugar levels, find out more, go to my dario.com forward slash diabetes dash connections.
Jake leach Chief Technology Officer for Dexcom thanks so much for joining me. How are you doing?
Jake Leach 4:22
I'm doing great, Stacey. It's a pleasure to be here.
Stacey Simms 4:24
We really appreciate it. And we are doing this on video as well as audio recording as well. So if we refer to seeing things, I don't think we're sharing screens or showing product. But of course we'll let everybody know if there's anything that you need to watch or share photos of. But let me just jump in and start with the latest news which was all about Garmin. Can you share a little bit about the partnership with Garmin? What this means what people can see what's different?
Jake Leach 4:49
Yeah, certainly so I'm really excited to launch the partnership with Garmin. So last week we released functionality on the Dexcom side and Garmin released their products, the ability to have real time CGM readings displayed on a whole multitude of Garmin devices by computers, and a whole host of their watches. So they've got a lot of different types of watches for, you know, athletics and different things. And so you can now get real time CGM displayed on that on that watch. So they're the first partner to take advantage of some new technology that we got FDA approved earlier in the year, which is our real time cloud API. So that's a a way for companies like Garmin to develop a product that can connect up to users data through the Dexcom, secure cloud and have real time data, we've had the capability to do that with retrospective data that three hour delayed, many partners are taking advantage of that. But we just got the real time system approved. And so Garmins, the first launch with it.
Stacey Simms 5:50
Let me back up for just a second for those who may use these devices, but aren't as technologically focused. What is an API? When you got approval for that earlier in the summer for real time API? What does that what does that mean? Yeah, so
Jake Leach 6:03
it's a API is an application programming interface. And so what it really means is, it's a way for software applications, like a mobile app on your phone, to connect via the Internet to our cloud with very secure authentication, and pull your CGM data in real time from from our cloud. And so it's basically a toolkit that we provide to developers of software to be able to link their application to the Dexcom application, and really on the user side, to take advantage of that feature, you basically enter in your Dexcom credentials, your Dexcom username and password. And that is how we securely authenticate. And that's how you're basically giving access to say, for example, Garmin, to pull the data and put it down onto your devices. What other
Stacey Simms 6:51
apps or companies are in the pipeline for this. Can you share in addition to Garmin? I think I had seen Livongo Are there others?
Jake Leach 6:58
Yeah, so Livongo so Tela doc would purchase the Lubanga technology, they've got a system. They're also in the pipeline for pulling in real time CGM data into their application. And so they're all about remote care. And so trying to connect people with physicians through, you know, technology, and so having real time CGM readings in that type of environment is a really nice use case for them. And so and for the for the customers. And so that's, that's where they're headed with it. And we've got kind of a bunch more partners that are in discussions in development that we haven't announced yet. But we're really see this, the cloud API's are interfaces as a way to expand the ecosystem around a Dexcom CGM. So we really like to provide our users with choice. So how do you want your data displayed? Where do you want it? And so if you want to right place, right time for myself, have a Garmin bike computer so I can see CGM readings right on my handlebars, I don't have to, you know, look down on a watch or even thought phones, it's really convenient. That's what we're about is providing an opportunity for others to amplify the value of CGM.
Stacey Simms 8:06
This was a question that I got from the listener. What happens to the data? Is that a decision up to a company like Garmin, or is that part of your agreement, you know, where everybody's always worried about data privacy? And with good reason?
Jake Leach 8:19
Yeah, data privacy is super important area when when you're handling customer information. And so the way that it works is, when you're using our applications at the beginning, when you sign up, there's some consents, you're basically saying this is what can be done with my data. And the way we design our systems is, for example, with the connection to the Garmin devices, the only way they can access your data is if you type in your credentials into there, it's like it's almost like typing your username and password into the web to be able to access your bank account. It's the same thing, you're granting access to your data. And each company has their own consents around data. And so we all are required by regulatory agencies to stay compliant with all the different rules to Dexcom. We take it very seriously, and are very transparent about what happens with the data that's in we keep it in all of our consent forms that you click into as you as you work through the app.
Stacey Simms 9:13
But to be clear to use the API or to get the Dexcom numbers on your garmin, you said earlier, you have to enter your credentials,
Jake Leach 9:19
you have to you have to enter your Dexcom username and password. And that's how we know that it's okay for us to share that information with Garmins system because you are the one who authorized it.
Stacey Simms 9:30
Right. But that's also how you were going to use it. You just said you have to enter your name and password for them to use the information. So they just have to read individually like okay, Garmin or Livongo or whomever. Yes. Your individual terms of services.
Jake Leach 9:42
Yeah, for each each application that that you want to use you it's important to read the what they do with the data and how to use it.
Stacey Simms 9:49
That's really interesting. And Has anything changed with Dexcom? It's been a long time since we've talked about how you all use the data. My understanding is that it was blinded, you know, you're not turning around over to health insurers and saying yeah, done on this day this or are you?
Jake Leach 10:03
No, no, not at all, we basically use the information to track our product performance. So we look at products there. So it's de identified, we don't know whose product it was, we just can tell how products are performing in the field. That's a really important aspect. But we also use it to improve our products. So we when we see the issues that are occurring with the use of the product, we use it to improve it. So that's, that's our main focus. And the most important thing we do with it is provided to users where, where and when they need it. So you know, follow remote monitoring that the reason we built our data infrastructure was to provide users with features like follow and the clarity app and so forth.
Stacey Simms 10:36
Do those features work on other systems? Can I use Garmin to share or follow?
Jake Leach 10:41
Not today? So right now, it's, it's basically intended for the the person who's wearing the CGM. It's your personal CGM credentials that you type in to link the Carmen account. And so for today, it's specific around the user.
Stacey Simms 10:57
I assume that means you're working on for tomorrow.
Jake Leach 10:59
There's lots of Yeah, lots.
Stacey Simms 11:02
Which leads us of course to Well, I don't have to worry about that right now. Because you can't use any of this without the phone and the Phone is how we could share it follow. So it's not really an issue yet. Jake, talk to me about direct to watch to any of these watches. Yeah, where do we stand? I know G6. It's not going to happen. Where are we with G7?
Right back to Jake answering my question, you knew I was gonna bring that up. But first Diabetes Connections is brought to you by Gvoke Hypopen. And when you have diabetes and use insulin, low blood sugar can happen when you don't expect it. That's why most of us carry fast acting sugar and in the case of very low blood sugar, why we carry emergency glucagon, there's a new option called Gvoke Hypopen the first auto injector to treat very low blood sugar Gvoke Hypopen is pre mixed and ready to go with no visible needle. In usability studies. 99% of people were able to give Gvoke correctly find out more go to diabetes connections.com and click on the Gvoke logo. Gvoke shouldn't be used in patients with pheochromocytoma or insulinoma. Visit Gvoke glucagon.com/risk now back to Dexcom’s jake leach answering my question about direct to watch
Jake Leach 12:19
That's a great question and a really exciting technology. So direct to watch is where through Bluetooth, the CGM wearable communicates directly to a display device like a watch. So today, G6 communicates to the phone and to insulin pumps in our receiver are the displays. With G7, what we've done is we've re architected the Bluetooth interface to be able to also in addition to communicating with an insulin pump or a receiver and your mobile phone, it can also communicate with a wearable device like a Apple Watch, in particular, but other watches have those capabilities, with G7, reducing the capability within the hardware to have the direct communication director watch. And then in a subsequent release, soon after the launch to commercial launches of G7, we'll have a release where we bring the director watch functionality to the customers, there's the Bluetooth aspect, which is really important, you got to make sure it doesn't impact battery life and other things. But there's also the aspect of when it is direct to watch, it becomes your primary display. And so being able to reliably receive alerts on the watch was something that initially in the architecture wasn't possible. But as Apple's come out with multiple versions of the OS for the watch, they've introduced capability for us, so that we can ensure you get your alerts when you're wearing the watch. And so that was a really important aspect for us. And it's also for the FDA to ensure that if that's your main display, you've walked away from your phone, you have no other device to alert you that it's going to be reliable. And so that's exciting progress of last couple years with Apple making sure that can happen. You know,
Stacey Simms 13:56
we're all excited for Direct to watch. Obviously, it's a feature that many people are really clamoring for. But you guys promised it first with the G five in 2017. Do you all kind of regret putting the cart before the horse that way? Because my next follow up question is why should we believe you now?
Jake Leach 14:15
Yeah, you know, it Stacy's a good question. So we are hand was kind of forced because Apple actually announced it before we did. So they basically said we're opening up this capability on the watch to have the direct Bluetooth connectivity. And of course, we were excited to have someone like Apple talking about CGM on that kind of a stage. But then as we got into the details of actually making it work, we, you know, continually ran into another technical challenge after another technical challenge, and I totally agree. I wish it would have been two years later that they talked about at the keynote, but I'm comfortable that we've gotten past those types of issues. And so and it is built into G7. So we've got working systems and so it will introduce it rather quickly with G7
Stacey Simms 14:56
and to confirm G7 has been submitted for the CE mark Because the approval in Europe, but has not yet, as you and I are speaking today has not yet been submitted for FDA approval in the US.
Jake Leach 15:06
Yeah, we're just we're just finishing up our submission, we get some validations that we're running on some of the new manufacturing lines to make sure we can build enough of these for all the customers, we want to focus to move over to G7 as quick as possible. And so we'll we'll submit you seven to the FDA before the end of this year,
Stacey Simms 15:22
just kind of building off what you mentioned about Apple and making these announcements or, you know, sometimes Apple lets news get out there. Because they I don't know if they seem to enjoy it. I'm speculating. I don't have any insight track at Apple. But I wanted to ask you, I don't know if you can say anything about this. For the last year, every time I talk to somebody who's not getting the diabetes community, but they're on a technology podcast, or they're, they're hearing things about non invasive blood glucose monitoring, right, the Apple, Apple series seven or some watch this year, we're supposed to have this incredible, non invasive glucose monitoring was gonna put Dexcom and libre out of business, it was gonna be amazing. Of course, it didn't happen. But a bunch of companies are working on this. And Apple seems to be really happy to say maybe, or we're working on it, too, is Dexcom listening to these things. I mean, obviously, they're not here yet. They they are going to come. I'm curious if this is all you kind of happy to let that lay out their speculation. Or if you guys are thinking about anything like this in the future,
Jake Leach 16:17
we pay a lot of attention to non invasive technologies. We have a an investment component of our company that looks at you know, early stage startups. We also have many partnership discussions around CGM technologies. And so when it comes to non invasive, I think we'd all love to have non invasive sensors that are accurate and reliable. You know, for many, many years since I've been working on CGM, and many years before that, there has been attempts to make a non invasive technologies work. The challenge, though, is it's just sensing glucose in the human body with a non invasive technology is not been proven feasible. It's just there's a lot of different attempts and technologies have tried, and we pay close attention. Because if if something started to show promise, we become very interested in it. And basically making a Dexcom product that uses it, we just haven't seen anything that is accurate and reliable enough for what our customers need. That's to say, there could be a use case where a non invasive sensor doesn't have to be as accurate and reliable as what what Dexcom does. And so maybe there's a product there. But we're very focused on ensuring that the accurate, the numbers that we show, the glucose readings that we present to users are highly accurate, highly reliable, that you can trust them. And so when it comes to non invasive, we just haven't seen a technology that can do that. But I know that there's lots of folks out there working on it. And we're, we stay very close to the community.
Stacey Simms 17:40
Yeah, one of the examples I gave a guy who doesn't he does an Apple technology podcast, and he was like, you know, what, what do you think? And I said, Well, here's an example. He would a scale, and you have no idea if it's accurate. But you know, that once you step on it that that number probably is is stable, then you know, okay, I gained 10 pounds, I lost 10 pounds. But I have no idea if that beginning number makes any sense at all, you might be able to use that if you are a pre diabetic, or if you're worried about blood glucose, but you could never dose insulin using it because you have no idea where you're starting. So I think that's I mean, my lay person speculation. I think that's where that technology is now and to that point, but other people outside the diabetes community are looking to one of the more interesting stories, I think, in the last year or two has been use of CGM and flash glucose monitoring for people without diabetes at all, for athletes, for people who are super excited and interested in seeing what their body's doing. So we have companies like levels and super sapient. And you know, that kind of thing using the Liebreich. I'm curious of a couple of parts of this question. If you think you want to answer it is Dexcom. Considering any of those partnerships with the G7, which is much more simple, right? fewer parts and that kind of thing.
Jake Leach 18:46
Yeah, that's a great point, Stacey. So yes, G7 is a lot simpler. It was designed to be to take the CGM experience to the next level. And part of that is just the ease of use the product deployment the simplicity, someone who's never seen a CGM before, we want to be able to walk up approach G7 And just use it. There's a lot of opportunity we feel for glucose sensing outside of diabetes. Today CGM are indicated for use in diabetes, but in the future, with 30% of the adult population in the US having pre diabetes, meaning the glucose levels are elevated, but not to the point where they've been diagnosed with diabetes. There's just so much opportunity to help people understand their blood sugar and how it impacts lifestyle choices impact their blood sugar. In the immediate feedback you get from a CGM is just a there's nothing else like it. And so I think, you know, pre diabetes and even as you mentioned, kind of in athletics. There's a lot of research going on right now in endurance athletes, and in weight loss around using CGM readings for those different aspects. So I think there's a lot opportunity we're today we're focused on diabetes, both type one and type two and really getting technology to people around the globe. That can benefit from it. That's where our focus is. But we very much have programs where we look at, okay, where else could we use CGM? It's such a powerful tool, you could think in the hospital, there's so much opportunity around around glucose. Alright, so I'm
Stacey Simms 20:13
gonna give you my idea that I've given to the levels people, and they liked it, but then they dropped off the face of the earth. So I'll be contacting them again. Here's my idea. If somebody wants to pay for a CGM, and they don't have diabetes, but they're like paying out of pocket because they like their sleep tracker, and they like this and they like that, or some big companies gonna buy it and give it away for weight loss or whatever. You know, the the shoe company toms, where you buy a pair of shoes and they give one away. People are in the diabetes community are scrimping and saving and doing everything they can to get a CGM. Maybe we could do a program like that. Where if you don't quote unquote medically need a CGM. Your purchase could also help purchase one for an underserved clinic that serves people with diabetes.
Jake Leach 20:54
Getting CGM to those folks that didn't need them, particularly underserved areas, clinics. It's so important. I like the idea. It's a that's if there was a cache component that then provided the CGM to those that are less fortunate. I think that's, I like the idea. Next month is National Diabetes Awareness Month. And one of the things we're focused on for the month of November is how can we bring broader access to CGM? It's something we've been working on, you know, since we had our first commercial product, and there's still, you know, many people in the United States benefit, you know, 99% of in private insurance covers the product. You know, a lot of our customers don't pay anything, they have no copay. But you know, that's not the case for everybody. And so there's, there's definitely areas that we need to we are focusing on some of our non profit partners on bringing that type of greater access to CGM, because it's such a powerful tool and helping you live a more normal life.
Stacey Simms 21:50
In the couple of minutes that we have left. I had a couple more questions, mostly about G7. But you mentioned your hospital use. And last year, I remember talking to CEO Kevin Sayer about Dex comes new hospital program, which I believe launched during COVID. Do you have any kind of update on that or how it's been going?
Jake Leach 22:06
Yeah, so it was a authorization that we got from the FDA to raise special case during COVID, to be able to use G6 in the hospital. And so we had quite a few hospitals contact us early on in COVID, saying, Hey, we've got these patients, many of them have diabetes, they're on steroids. They're in the hospital, and we're trying to manage their glucose. And we're having a hard time because their standard of care in hospitals is either labs or finger sticks. And so we got this authorization with the FDA, we ship the product, many hospitals acquired it, and they were using it pretty successfully. What we'd say about G6 is really designed for personal use your mobile phone or a little receiver device, designed integrated with a hospital patient monitoring system or anything like that. You could imagine in the future that that could be a real strong benefit for CGM, the hospital, you can imagine you put it on, you know, anybody who has glucose control issues comes in the door. And then you basically can help ensure where resources need to be directed based on you know, glucose risk. I've always been passionate about CGM at a hospital. It's one of the early projects I worked on here. Dexcom. And I think it there's a lot of promise, particularly as we've improved the technology. So there's still hospitals today using G 600 of the authorization. And we're interested in designing a product for that market specifically, instead of right now. It's kind of under emergency years. But we think there's there's a great need there. That CGM could could help in basically glucose control in the hospital.
Stacey Simms 23:28
That's interesting, too. Of course, my mind being a mom went to camp as well. Right? If you could have a bunch of people I envision like a screen or you know, hospital monitoring that kind of thing. You wonder if you could do something at camp where there's 100 kids, you know, instead of having their individual phones or receivers at camp, it would be somewhere Central?
Jake Leach 23:46
Well, you know, what, between with the with the real time API, there are folks that are thinking about a camp monitoring system that can basically be deployed on campuses right now with follow. It's great for a family, but it's not really designed to, to follow a whole camp full of campers. But with the real time API, there's opportunities for others to develop an application that could be used like that. So yeah, there you go.
Stacey Simms 24:08
All right, a couple of G7 questions. The one I got mostly from listeners was how soon and I know, timelines can be tricky. But how soon will devices that use the G6? Will they be able to integrate the G7 Insulin pumps, that sort of thing? Sure. It's only Tandem right now. But you know, Omnipod, soon that that kind of thing?
Jake Leach 24:26
Yeah, I mean, that's coming. So I'll start with the digital partners like Garmin and others, that is going to be seamless, because the infrastructure that G6 utilizes to move data to through the API's is the same with G7. So that'll be seamless. When you talk about insulin pumps, so those are the ones that are directly connected to our transmitters that are taking the glucose readings for automated insulin delivery. So those systems were already working with Tandem and Insulet. On integrating G7 with their products have already seen prototypes up and running so they're moving as quickly as possible. So once We have G7 approved, then they can go in and go through their regulatory cycle to get G7 approved for us with their AI D algorithms. Really the timing is dictated mainly by those partners and the FDA, but we're doing everything we can to support them to ensure this as quick as possible.
Stacey Simms 25:17
Take I should have asked at the beginning, I'm so sorry, do you live with type one I've completely forgotten.
Jake Leach 25:21
I don't I made a reference to where I wear them all the time. Because, as you know, kind of leading the r&d team here, I love to experience the products and understand what our users what their experience is. And I just love learning about my glucose readings in the different activities I do. So I don't have type one. But I just I use the products all the time.
Stacey Simms 25:42
So to that end, have you worn the G7? And I guess I'd love to know a little bit more about ease of use. It looks like it's, it just looks like it's so simple.
Jake Leach 25:51
It is. Yeah. So I've participated in a couple of clinical trials where we use G7, it is really simple. One of the most exciting things though, I have to say is that when you put it on, it has this 30 minute warmup. So the two hours that we've all been used to for so many years, by the time you put the device on and you have it paired your phone, it's there's like 24 minutes left before you're getting CGM. So it's like it's it. That part is just one of the things that you it sounds awesome. But then when you actually experience it, it's pretty amazing. But yeah, the ease of use is great, because it's the applicator is simple. It's a push button like G sex where you just press the button and it deploys. But there's other steps where you're not having to remove adhesive liners, the packaging is very, very small. So we really focused on low environmental footprint. And so it's really straightforward. But probably the most the really significant simplification the application process is because the transmitter and the sensor all one component and sterilized and saying altogether, there's no pieces, there's no assembly required, you basically take the device and apply it and then it's up and running. There's no transmitted a snap in or two pieces to assemble before you you do the insertion.
Stacey Simms 26:59
I think I know the answer to this. But I wanted to ask anyway, was it when you applied for the CE mark? And I assume this would be the same for the FDA? Are there alternate locations? In other words, can we use it on our arms?
Jake Leach 27:11
And yeah, that is that is a great question. Yeah, our focus with one of our phones with G7 and the revised form factor, the new new smaller form factor and sensor probe was arm were so yeah, arm wears is really important part of the G7 product.
Stacey Simms 27:26
I got a question about Dexcom. One, which seems to be a less expensive product with fewer features that's available in Europe. Is that what Dexcom? One is?
Jake Leach 27:34
Yeah, so there's a product that we recently launched in Europe in European countries. That is it's called Dexcom. One. And what it is, is it's it's a product that's designed for a broad segment of diabetes, type one, type two, it's a lower price point. It has a reduced feature set from G6. But what it's really about is simplicity. And so in you know it's a available through E commerce solutions. So it's really easy to acquire the product and start using it. It's really to get into certain markets where we either weren't didn't have access to certain customers. And so it's really designed for get generating access for large groups of people that didn't have access to CGM before.
Stacey Simms 28:20
What does e commerce solution mean? No doctor
Jake Leach 28:23
there. So outside the United States CGM isn't no prescription required for many, many countries. So the US is one of the countries that does require prescriptions, other some other countries do too. But there's a large group outside the US that don't, but it's really around, you can basically go to the website, and you can purchase it over a website. So really kind of nice solution around think Amazon, right. You're going you're clicking on add the sensors and you're purchasing it. It's a exciting new product for us that we are happy to continue developing.
Stacey Simms 28:53
I think it might come to the US don't know. Yeah, that's
Jake Leach 28:56
good. Good question. Don't don't know. I mean, I think right now we see CGM coverage is so great access is great for CGM in the US it can always be better and extend your focus on that. But it's really for countries where there wasn't access,
Stacey Simms 29:08
I would think tough to since we do need a prescription differently. Yeah, Jake, you have been with Dexcom, almost 20 years, 18 years now. And a lot has changed. When you're looking back. And looking forward here at Dexcom. I don't really expect you to come up with some words of wisdom off the top of your head. But it's got to be pretty interesting to see the changes that the technology has brought to the diabetes community and how I don't know it just seems from where I sit and you're probably a couple of years ahead. It seems that the last five years have just been lightspeed. It has
Jake Leach 29:39
been things are speeding up in terms of our ability to bring products to market and there's a lot of things one is the development of technology. The other component is working with your groups like the FDA on you know, how do we get products to the customers as fast as possible and that that's been a big part of it right moving cheese six to class to becoming an IC GM that That was a huge part of our ability to get the technology out quickly and also scale it. I think there's a lot of aspects that has been faster. And you know, when I started Dexcom, we had this goal of designing a CGM that was reliable didn't require finger sticks that could make treatment decisions. All that and we were 100% focused on that. And as we got closer and closer, and now we have that which you six and also what you seven, then the opportunity that that product can provide, you start to really understand how impactful CGM can be around the world. And that's what I'm excited about now is I'm still excited about the technology always will be and we still have lots to do on making it better, more reliable and more integrated. But just how much CGM can do around around the globe. There's just so many things. It's beyond diabetes to so very excited about the future.
Stacey Simms 30:47
Many thanks, as always, and we'll talk soon, I am sure but I mean, I could never get to say it enough. I can't imagine doing the teenage years with my son without Dexcom. You guys, I know you did it just for me. You did it just in time. Appreciate it very much. He is doing amazing. And I can't he would not be sticking his fingers 10 times a day. So thank you.
Jake Leach 31:05
That's great to hear. Thanks, Stacy.
Announcer 31:12
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 31:18
As always more information at diabetes connections.com. And yeah, but that last bit there, I can say nice things. I mean, I really do feel that way. And I can still ask not so nice questions. Like if you're new, quite often, I will open up a thread in our Facebook group. It's Diabetes Connections of the group to gather questions for our guests. And I did that here with Dexcom, there's usually quite a lot of questions, I do have to apologize, I missed a big one. Because of the timing of the interview, I promise I will circle back around next time I talk to Dexcom. And that is all about the updates for iOS and for new phones, and how you know, sometimes Dexcom is behind the updates. What I mean by that is that they lag behind the updates. So you can go to the Dexcom website, I'll put a link up for this for Dexcom products that are compatible in terms of which iOS and that kind of thing. And they are behind. And Dexcom will always say they've said very publicly that they are working hard to catch up. But I guess the question that a few people really wanted to know was why, you know, why do they lag behind? What can be done about that? So they know, but I think it would be a good question to ask. So Sarah and others. I appreciate you sending that question. And I apologize that I didn't get to it this time around.
And I'll tell you, you know, it's not something we've experienced, but I think it has to do and I'm speculating here more with the phone with the the newness and the the model of the phone sometimes then for the updates, especially if you don't have your updates on automatic. So I guess I'm kind of saying the same thing. But what I mean by that is Vinny, and I have very old phones. I have an eight. I'm not even sure he has the eight. We are terrible parents and I don't care about my phone, I would still have a Blackberry if that were possible. So I can't commiserate. I'm so embarrassed to even tell you that I can commiserate with the updates, because it's just not something that we have done. Benny, definitely if he were here, trust me. It's like his number. I would say it's his number one complaint that it's really high up on the list of complaints to the parenting department in our house. And yes, Hanukkah is coming. His birthday is coming. There will be some new phones around here. I'm doing an upgrade. I'm sure both of us have cracked phones. Were the worst. Oh, my goodness.
All right. Well, more to come in just a moment. But first Diabetes Connections is brought to you by Dexcom. And this is the ad I was talking about earlier in the interest of full disclosure. But you know, one of the most common questions I get is about helping kids become more independent. I get asked this all the time at conferences for virtual chats in my local group. These transitional times are tricky. And we've gone through this preschool to elementary elementary to middle middle to high school. I can't speak high school to college yet, but you using the Dexcom really makes a big difference. For us. It's not all about sharing follow, although that's very, very helpful. Just think about how much easier it is for a middle schooler to look at their Dexcom rather than do four to five finger sticks at school, or for a second grader to just show their care teams a number. Here's where I am right before Jim. At one point, Ben, he was up to 10 finger sticks a day, he didn't have Dexcom until the end of fourth grade not having to do that made his management a lot easier for him. It's also a lot easier to spot the trends and use the technology to give your kids more independence. Find out more at diabetes connections.com and click on the Dexcom logo.
I don't know about you, but I am getting a ton of email already about Diabetes Awareness Month and that is November this time of year I usually get I'd say 120 emails that are not snake oil, right one in 20 emails that maybe make sense for something we want to talk about on the show here that I would share on social media and I'm just inundated with nonsense. So I hope you are not as well. But I gotta say Diabetes Awareness Month this year. I've been pulling in My local group and talking about what to do because usually I highlight a lot of people and stories and I'll I'll still do that, I think, but I got to tell you people are, um, you know, this, we're all stressed out. And while it's a wonderful thing to educate, I always think Diabetes Awareness Month is not for the diabetes community, right? We are plenty aware of diabetes, this is a chance to educate other people. And that's why I like sharing those pictures and stories on my page, because the families then can share that with their people. And it's about educating people who don't have diabetes. But gosh, I don't know this year, I'm going to be just concentrating on putting out the best shows that I can
I do you have a new project I mentioned last week that we're going to be talking about in the Facebook group. By the time this airs, I will have the webinars scheduled in the Facebook group. So very excited about that. Please check it out. But what are you doing for Diabetes Awareness Month? If you've got something you'd like me to amplify, please let me know. You can email me Stacey at diabetes connections.com. Or you can direct message me on the social media outlet of your choice. We are at YouTube, Facebook, Twitter and Instagram. That's where Diabetes Connections lives. I'm on Tik Tok, or Snapchat or Pinterest. Oh my gosh. All right. Well, that will do it for this week. Thanks as always to my editor John Bukenas from audio editing solutions.
Thank you so much for listening. I will be back on Wednesday. live within the news. Live on Facebook and now on YouTube as well. Until then, be kind to yourself.
Benny:
Diabetes Connections is a production of Stacey Simms media. All rights reserved. All wrongs avenged