It’s that time of year - diabetes camps are in full swing. As remote monitoring technology changes, many camps are adapting as well. There’s a new system that lets camp staff monitor everyone’s CGM, all at once. That’s Sarah Gleich, executive director of the Nevada California Diabetes Association. We’ll find out more about what’s called CampViews, where it’s already in place, how it’s going and whether it’ll change diabetes camp for good. This technology could also make a big difference for hospitals, nursing homes and other health facilities.
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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This summer we get a behind the scenes look at the evolution of stem cells as a functional cure for type 1. The Human Trial is new documentary that follows the process and the filmmakers are incredibly optimistic about what they’ve seen. Co-director Lisa Hepner lives with type 1. She’s says she’s knows to be careful about “the cure in five years’ kind of statements but is convinced this is the real deal. We’ll talk about the the film, the process, the science and a lot more.
Listen to our first interview with Lisa Hepner from 2016
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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Big news from Sernova, one of the companies hoping that implantable stem cells will be a functional cure for diabetes. They recently announced that the first person in their trials with type 1 is completely off injected or infused insulin – and is making their own.
Stacey talks to Dr. Philip Toleikis, Sernova’s president and CEO. He explains how their process differs from some of the other companies looking at stem cells, talks about their partnerships and shares more about the patients doing well in this clinical trial.
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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Dexcom CEO Kevin Sayer joins Stacey from the American Diabetes Association’s Scientific Sessions with new G7 information, a response to Abbott’s Libre 3 approval, addressing rumors about acquiring another diabetes company and a lot more.
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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Dexcom's G7 is in front of the FDA right now. There are some significant changes to the system, including what’s basically a snooze for essential alarms, including the urgent low. Dexcom’s Chief Technology Officer Jake Leach answers your questions about adhesive, direct to watch, accuracy, and even mentions the G8.
Here's more information about the European approval (includes a video of the system)
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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Could this finally be a big shake up in the price of insulin? Civica Rx plans to sell the most popular types of fast and long acting insulin for a flat price of 30-dollars a vial. This week you'll hear from Ned McCoy, Civica’s Chief Operating Officer. He explains why they’re confident this will work, who will be able to buy the finished product, when it will be available and what Civica RX is all about.
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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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.
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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 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.
Check out Stacey's book: The World's Worst Diabetes Mom!
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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, 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
-----
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.
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Now back to Chris answering my question about FDA submissions.
Kamil Armacki 12:00
Yeah, so for the pandemic, the main reason as to as to why we have a backlog is that regulators that used to regulate that were in charge of regulating medical devices like continuous glucose monitors, hybrid closed loop systems. And this is across actually Europe and US it's very similar, simply because of the pandemic, they were actually responsible for overseeing all of the medical queries related to the pandemic from, you know, vaccines emergency authorizations. So that's what we call when a product is used in a slightly different way to kind of simplify it. And so using a CGM and hospital was a good example of that we seen an emergency authorization of that, so they've kind of, you know, dos thinks took priority. So too, you know, that's where we have a backlog, but now they from my understanding, kind of back on on track, and, you know, four hands on that backlog, working their way through it.
Chris Wilson 12:57
There's just only so many people to do the work. And I mean, even when stuffs in development, there's always a lot of back and forth between the company that's developing it and the FDA, what are you going to require us to do, and so then they alter the product design sometimes to make it fit what the FDA wants, and that can even go into is as deep as the training modules. And the other information that gets given to patients when the product is prescribed, they're looking at all of that they're looking at human factors testing are people you know, able to follow the directions and use it the way that it's intended to be used, are they going to do something stupid and mess it up? They're looking at all of that. And then they're going through all of that data on all the different aspects of the devices and needing to decide, okay, is this safe enough to actually be effective? And there are different standards in Europe versus in the US? The FDA has much higher safety thresholds, whereas the European standard is basically does it do what it says it's going to do?
Kamil Armacki 13:58
And just to close up Omnipod 5, I think FDA has added it Chrissie would agree this is just my personal opinion. I think FDA has been pretty scared of going to full control. And the biggest today there isn't an insulin pump, which offers, you know, remote bolus capabilities. And that's part of Omnipod 5, you know, that's what they've submitted to them. So, you know, my speculation would be that if actually they didn't submit full control within that first submission, maybe we already you know, maybe it would be here already. You know, it is an area that FDA has been very cautious about. So I guess that's a significant factor contributing to to the to the backlog as well to the delight.
Stacey Simms 14:40
Well, and that brings us to our next item that's in front of the FDA. Thank you for setting that up. So Tandem has also submitted in the last year and is waiting for bolus by phone. You know, that's not the official name of it. But I agree with you. I think the FDA is really taking a very, very careful look at that bit of technology. And Tandem, you know, I believe, to your point, Chris, there has been some back and forth. You know, they don't issue press releases. Every time they asked for that, but it is happening, I think, to me, you know, as a mom of a kid who takes his phone everywhere, you know, this is something that I cannot wait for. I mean, bullets by phone just seems like such a basic capability in 2021. But of course, it's a medical device, and it's your phone. Chris, are you hearing anything? Or do you have any opinion on that?
Chris Wilson 15:29
I mean, at least as far as Tandem goes, I think there's less of a risk because you still actually have the physical pump that can be used to do something if for some reason, there's a problem with the phone. If you're relying exclusively on the phone, you've got to worry about what happens if it gets lost. What happens if they're dead batteries? What happens if you unlock it and hand it to your kid to play a game and the kid goes into your bolus app and accidentally gives you 15 or 20 units of bolus while they're chatting around? I mean, all of those things need to need to be taken into consideration and mitigated as much as possible.
Stacey Simms 16:01
I wonder Kamil, it's interesting to think about Omnipod because they've when I've talked to them, I've always asked like, why can't you put some buttons on the pod. And their point was, and I think this leads to Chris's point from the phone, their point has always been well, it's for safety with the pediatric patients, they don't want the kids touching the pod pressing buttons, this makes perfect sense. I was a parent of two small children, they're gonna touch everything. But it's kind of the flip side now on the phone, right. So it's an interesting look to see what you trade off in a way.
Kamil Armacki 16:31
So actually, to that point, in the UK, we do have an insulin pump from rush called accucheck. Solo. And on the high level, it's kind of like a nominal pot, where the pot like device that you put on your body and actually has two buttons on it. So you can actually bolus from the patch itself. And the way they've actually engineered it is that you need to press both buttons at the same time, ensure that you don't kind of you know, lean on the you know, you could very easily lean on a button and just press it, you know, other companies have gone down that route as an Omnipod. To use that I do use a monopod. So I use Dexcom and Omnipod in a DIY setting. And yeah, I love the simplicity of it. So yeah, massive, massive fan.
Stacey Simms 17:14
I think it's just all trade offs. Right. I mean, there's no perfect system, I don't think but people want to perfect. Exactly. Right. Exactly. Chris, what do you use? If you don't mind me asking?
Chris Wilson 17:25
I am on a Tandem with control IQ, although I don't use it exactly as designed. I've been working with better bullet strategies and playing with the modes that have put that it gets put in be an exercise or sleep that change some of the the targets that it's trying to hit to get it to behave a little bit more like I think it should.
Stacey Simms 17:47
So you're using Ctrl Q and Kamil, you're using
Kamil Armacki 17:50
loop? Yeah, that's right. Yeah. on any iPhone. Yeah.
Stacey Simms 17:53
All right. I don't want to move on from Tandem quite yet. But I want to talk about loop in a moment. So we've got bolus by phone in front of the FDA, which we also think could come approval could come by the end of the year, but Tandem moved their submission for TSport. Right. They were going to submit that in 2021. Chris, they are moving that to 2022. Right.
Chris Wilson 18:12
That was the last that I heard. Yes. To me.
Stacey Simms 18:16
I see you nodding.
Kamil Armacki 18:17
Yeah, I agree that that's what my understanding of the T sport is, I think they had some communication with FDA with the phone control, which obviously plays into T sports as well. Like the point Chris was making, you know, there's no display I don't think on the although, you know, it's a patch, you know, it's kind of moving into that kind of tubeless to pipe bridge mode kind of pump. So yeah, I'm pretty sure they've decided it's pushed back further.
Stacey Simms 18:48
And I should have set that up better if you're not familiar with a tee sport is a very tiny version of the T slim it is been to me it looks kind of like a beefed up cartridge and it sticks somehow to your body. There is still a tube and there is still an inset, but it kind of I don't know if it dangles off, or it sticks some I don't know. So they haven't they haven't released that I've asked a bunch of people when Lily a while ago was coming up with its own pump and it was supposed to be inset and sticky. I'm still trying to figure out how it supposed to stick to your body with an inset and they haven't really explained that. So maybe at some point, but clearly you made a 3D version of this yourself right? Didn't you like mock up a Teesport at one point and freak everybody out? Because we thought you had one?
Kamil Armacki 19:27
I did. So just on that entire idea in general, there's actually a pump in it's been kind of out here in Europe and has been taken off the market and I think it's coming back at some point called collider which uses a similar idea of where three colors bright colors. Yeah, so So that's kind of it's an interesting concept because you have an infusion set and like a sticky dye upon your body. And I think it that's what Tandem has gone off as well. But yeah, I did. It's very interesting how people often will look at especially on YouTube because it's a very visual form, they will look at a picture without watching the video. And yeah, a lot of people thought I had some insider info on the T spot, which was a very interesting experiment and a lot of comments about that go like, where did you get this? And I'm like, I didn't Freeview print hello, it's 2020.
Kamil Armacki 20:19
Be careful, be careful, hey,
Chris Wilson 20:21
I need to take some of the blame, actually, I think for potential delays on the other Teesport, I was involved in some of the Human Factors testing. And based on some of the questions that I got asked afterwards, I think I may have done some things that they weren't expecting it some stupid things or something that was not dissipated. So that may actually be the source of some of the
Stacey Simms 20:45
Alright, well, if you can't answer I understand what the heck could you have done? What
Chris Wilson 20:52
I think it was, it was just in case of directions weren't necessarily clear. Or I was expecting, you know, think about this, rather than actually do it. I obviously can't go into specifics. But needless to say, I clearly wasn't doing everything that they expected as part of the tasks in the testing. So who knows that may be part of the the reason that things got delayed, but hey, if it prevents somebody else from doing the stupid things that I did, and having a problem later on, then that's actually a good thing. And actually,
Kamil Armacki 21:24
I'm so glad that you did, Chris, because so many companies have tried this idea of you know, having a patch and in a short tube. So novo, they went out of business Kaleido also really struggling, we don't really know if they're gonna come back. And Tandem is now trying, they're kind of stab at it. No one has really made this idea work. So
Stacey Simms 21:43
yeah, it's a good point. But one thing I do like, again, I don't have diabetes, I don't wear the devices. But the idea I like is that with an inset, you do have a choice of how it connects angled or what the cannula length is, or steel, you know, with Omnipod, or you don't have as many options in terms of how it connects. Now, many people will say to counter that, well, you have many more options of where you can put it, you know, so it really just depends on how you wear it where you're comfortable with. But I think that's why they keep trying cumulus because there's that different kind of inset that people can use. So who knows? But I think that's a really good point.
Chris Wilson 22:18
Well, it's a great example of how your diabetes may vary. Yeah, no one solution is going to work for everyone. So that's why it's important that we have these options.
Stacey Simms 22:27
Alright, so let's talk about loop. One of the other submissions. This is such a laundry list in front of the FDA is tide pool loop. And that was submitted earlier in 2021. It's been very quiet, but it is it's hanging out there. Anybody here anything? Anybody know anything? Any comments?
Chris Wilson 22:45
I really haven't heard anything. I mean, it's so pure speculation. Obviously, this coming from the open source community is going to be subject to a lot probably more scrutiny than if it's coming from an established player. And I was not entirely clear on exactly what the trials for approval looked like. It sounded like some of the DIY data from DIY loot may have actually been used as part of the submission. So I would imagine that that's probably at least one of the things that may be taking a little bit extra time because I'm feeling the FDA is probably going to look a little bit more closely at that than they would if it was coming directly from Insulet. Or someone else.
Stacey Simms 23:28
That's a good point and was used I believe, that's what they told me earlier this year was a lot of that open source a lot of that DIY community data was put in so you wonder what then the FDA came back and asked for no, no, what we really need is or no, that is enough. I mean, we'll find out later, but it's very interesting stuff.
Kamil Armacki 23:46
And in some ways, it is a perfect storm, because it is using, you know, using that DIY technology, which is just absolutely amazing. I mean, the whole title team has been so tremendous in this project. So it's you know, taking that DIY, but then also the phone control point that we mentioned earlier, where it's an Omnipod. So actually, you know if your battery dies, I'm sure everybody's asking those questions. You know, if your iPhone dies, how is the child going to bolus? I'm sure that those are the questions that you know regulated system has to they need to have that usually answers for that. So I'm sure they face in similar scrutiny on the phone point just like Omnipod 5 does with eventually
Stacey Simms 24:26
this just occurred to me and again, I don't use the system so that's probably way to think about it, but these DIY systems that already use the phone can you use your watch to control them to Kamil, I wonder if that's something that's done? Yes.
Kamil Armacki 24:39
It's it's just like with Dexcom you still need your phone. So phones like the the house the home of the of the whole system, you can remotely you know, bolus and enter carbohydrates and Al's meals etc. Using your Apple Watch. Bought a phone is still required to actually do all of the calculations the brain behind all of it on Omnipod, five doc, this all happened on the pod both title loop that's all happening on the phone just like with a DIY system. Oh, yeah, that's a really good point. So you really need that to to make this system work. And there are all of those you know, your phone die in, you know, someone's stealing your phone cases that you know, I'm sure FDA is wants answers for
Stacey Simms 25:22
it to be clear, because a lot a lot of information there. I think this is a good point Omnipod 5, as you said, controlled by the pod. So you lose your phone, it keeps on trucking, it's going to deliver basil, the loop will continue a tide pool loop and loop DIY, whatever it's called right now is all controlled by the phone. So if your phone dies, the system won't continue.
Kamil Armacki 25:40
Well, so by design, it will always deliver background insulin in the way that it's intended. I mean, my phone dies, sometimes you know, it's live, right? I'm a 23 year old. Me because it is difficult to keep it charged in the pub. So you know it does happen. So and those are kind of a real world cases that you know, I'm sure FDA is also asking about. So with the DIY system, and I would assume with Title loop as well. But that is just my speculation. When your phone dies with the DIY system, it automatically goes to the default background rates for you kind of bolus because you need your phone to do that. And I would assume it would be relatively similar of tide pool loop, because I don't think there would be making a separate backup device like Omnipod just doing with Omnipod 5. Okay,
Stacey Simms 26:31
thanks. Alright, last item that is in front of the FDA, I think is the Medtronic 780, which is already available in Europe.
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Now back to Kamil answering my question about whether the Medtronic 780 is available in Europe?
Kamil Armacki 27:34
That's right. Okay. So 780 G has been here for it's been approved last summer. So kind of just as COVID was kind of a couple of months in, and it's been rolled out across various countries in Europe. I think we got it in the UK earlier this year. Well, I think the 770 G's, the newest version that you guys have in the US. So the 700 pumps, they all have Bluetooth built in. So you can have your pump alarms, all of that on your phone, no control. But you can view everything by the 780s, kind of the newest pump in that line, which has a new brain new algorithm. In my view, it is completely different. Because actually, it's not really made by Medtronic. It's made by an Israeli company called Dream met.
Stacey Simms 28:23
So that's free. That's right. The algorithm is from Dream Med, I've interviewed them, I forgot to actually
Kamil Armacki 28:28
said that in one of my videos, and Medtronic wasn't really happy with me. So
Stacey Simms 28:32
I feel like we have it's ours. Now. It's been,
Kamil Armacki 28:35
they officially said something like it's built by a dream met with Medtronic engineers. So you know, it is a partnership. And that's apparently true. You know, I have no reason to deny that. So I'm sure they work together on it. But you know, the the foundation of seven ATG is actually completely different. It's not like they took 670 and added a couple of capabilities. You know, it's a great we design I mean, on the outside, it looks the same, but actually the the actual brain inside is completely different. And I guess one of the one of the key things that we mentioned is actually the ability to have your glucose set as low as 100. You know, people have diabetes across Europe, they've they've been really kind of enjoying that. And it has automatic corrections as well. So a lot of people listening to this might not be as techie as we are. So just in simple terms, it kind of matches control IQ, I would kind of say in terms of the feature set, maybe slightly better, because you can reduce your target to 100, which I know a lot of people have been asking about. I don't know if you agree, Chris, without saying it's kind of at the same level as control like you
Chris Wilson 29:37
from a tech perspective. Yeah, they both the the key difference or the key feature there is the automated correction boluses, which is what differentiates what they call an advanced hybrid closed loop from just a standard hybrid closed loop, which is what the 670 and 770 were, it's nice to see more high tech options coming to the market from more players. says it gives people more options.
Stacey Simms 30:01
That's interesting, though about any kind of criticism for mentioning dream, Ed, because I mean, control IQ was developed by type zero technology, right? Wasn't it like a University of Virginia thing that then Tandem bought? Yeah, well,
Chris Wilson 30:14
it got bought by Dexcom Dexcom, bought type zero and then license the tech to Tandem. So
Stacey Simms 30:22
interesting times. And we should also mention that all the Medtronic systems use their sensors. This is not yet a mix and match world, I believe the Medtronic sensors, and I keep hearing that they're much better, but still need to be calibrated. So even the latest version No, your shake your head, Kamil tell Oh, that's right. We're waiting for that approval in the US.
Kamil Armacki 30:42
Well, so. So guardian for has been approved in three guardians. And so that's the no calibration version. And it's I know, like one person who's using it. So it's not I think they slowly roll in and out. They haven't really started shipping it yet. But it's basically what we all know, as guardian free just with with no calibrations. As far as I'm understanding the accuracy is not improved. It's kind of the same, if not slightly worse, from a margin perspective with Guardian four, compared to Guardian three. And yeah, I think it's in the FDA backlog as well. I'm gonna go ahead and
Stacey Simms 31:21
just double check that on my end only because it'll be good to know the actual mark from their studies and things like that. So we'll pop that into the show notes. But I think you're exactly right, because I was just doing the time. It'll be interesting to see what the time shift is, in terms of episodes being released, because we were just doing our game show. Wait, wait, don't poke me for friends for life. And I actually I can't believe I forgot I asked this question about Guardian four. Because the codename for it or at least the in house name for it was Zeus. So we had been talking about Zeus for Medtronic for a long time, no calibrations I know this is the I get in the weeds of the trivia and then I forget what I know. So thanks for correcting me. Alright, and then Alright, let's talk about Dexcom. Because Dexcom g7, as we're taping g7 has not been submitted to the US FDA, but it has been submitted for European approval. Kamil, you had Dexcom CEO on your show, wearing and showing off the device. I was so jealous when I saw that I'm gonna yell at Kevin Sayer. Next time I talked to him. But yeah, tell us what that was like and what you thought of it when you saw it.
Kamil Armacki 32:27
You know, I've been the massive Dexcom advocate, I pay for my own decks because I'm not an ambassador, I just genuinely it's been a life changing product for me. And yeah, it's been it's been an honor speaking to him. So you've spoken to him a couple of weeks after they announced that they submitted for the for the European European approval. I mean, it looks tiny, as I'm sure you've seen, if you've seen the video, I'm incredibly excited to see kind of how that one develops, and from literally a couple of days. So they kind of in the investors call, like Chris was saying, I also sometimes tune into those, and they confirmed that the expecting to get that approved in Europe by the end of the year.
Stacey Simms 33:07
It's interesting. And Chris, maybe you could speak to this, for people who might not be that familiar, the Dexcom technology, while it is very different from the G6, the speed at which it might get approval, Europe is one thing, right us is another this is not like an insulin pump, we don't expect it at least to take quite as long as insulin pumps are different systems because it's not putting insulin into your body, right? It's just measuring,
Chris Wilson 33:28
but it is being used to calculate doses of a high risk medication, which is insulin, there's definitely still some concern as far as how accurate it is. And if it's off it, how off? Is it? Is it going to cause a problem? But I'm really excited with the clinical data that they presented. I think it was at EASD Earlier this year, showing that the g7 the marred the that measure of accuracy that they use is actually now under 8%. With the g7 which I mean we're getting into how much more accurate can we reasonably get just because there's so much variation in human body that I mean, you can take six fingerprints from six different fingers and get six different answers from his standard meter. The fact that we're really dialing in the accuracy is as tight as we can and actually ever since is almost in the same boat with their new Wow, what any product they had. I think two versions I recall, but that's coming as well. And the the 180 day version as long as we're talking CGM. Yeah, there is no absolute answer for anything. This is actually I was in a study last Thursday, where they were seeing how long I could go without insulin. But as part of it, they're they're monitoring it with a y si, which is this reference grade laboratory meter that they actually do a blood draw and they centrifuge it down. And then they measured the glucose level in the plasma without any of the blood cells in it. And that device in the lab was actually not putting out the correct numbers, there was some sort of hiccup, they had to restart it to get it to come up. But my Dexcom was matching, and then they compared it to multiple Ultra accurate fingerstick meters and set to figure out what was going on. But, you know, nothing's perfect. This was, you know, elaborate reference glucometer. That's the most accurate one that you can get. And they don't even make them anymore.
Stacey Simms 35:23
I will never forget, when Betty was little like poking the same finger, you said six different fingers, who put the same finger three times in a row because it was confusing or something. And it was always three different numbers. It's crazy.
Chris Wilson 35:33
I just think it's important that people keep in mind that you know, nothing is ever going to be perfect. whatever device you're wearing, however, you're measuring your stuff, there's always going to be variation, it's never going to be exactly the same number every time on every device
Stacey Simms 35:46
you mentioned ever since that's the CGM that goes under your skin. And then the transmitter goes on top. And Kamil, you are you've got a little bit are you using the libre as well like to test it out? Or did you? What did you show us earlier,
Kamil Armacki 36:00
I am trying the free celebrate free, which is like the newest version. It's not available in the UK, I should make it very clear. But someone bought it for me in Germany. And they imported it over to the UK is actually it's actually been a very interesting over here. Because obviously it's it's not available in the UK. So I had to enter freestyling briefly, there was no physical receipt, but you need to get an app. So only use your phone, you can only use your phone, there's no physical reader, there's no physical device, which I don't know how that's going to work with, you know, children going to school and you know, having to carry phones, but anyway, but it's not available in the British App Store. So I had to create a German Apple ID. And everything on my phone is German. So I gem Apple Music, German podcasts, everything is in German, it's still English. But other than that I have been enjoying my German lifestyle over the last I've had it for four days now. So it's been it's been fun.
Stacey Simms 37:03
What are the different features like what's I'm not as familiar with the Libre system. So what is new with the three,
Kamil Armacki 37:08
it's much smaller, it's much smaller compared to the first two. And on a high level, it works exactly like you would expect a CGM to work like Dexcom web, no scan and it just always shows the value and the glucose your trends alarms ever found on your phone. So they kind of made it work in exactly the same way as at the center of Dexcom. But most importantly for me, they keep them the same price. And I think that's very important for a lot of people have diabetes here in Europe because I mean, Libra has been a giant success in the UK for example, just because actually, because of its price point it is accessible to the National Health Service. So it is you know reimbursed to you know, vast majority pretty much every single person of type one who wants it to get can get it. And libre two is the same price point is libre one and now libre free. In Germany, when they did launch, it's also the same price. So they keeping it the same, which is which is very reassuring
Stacey Simms 38:08
process, we'll see what happens in the US. But that is very reassuring for our friends in Europe. I went device I meant to ask about and didn't but I don't think it's been submitted. And that is beta bionics and the iLet. And Chris, you kind of alluded to this much earlier in our talk, because you were I believe in one of those trials,
Chris Wilson 38:25
I was at least told that I was patient number one at the trial site that I was at.
Stacey Simms 38:33
But we don't think we don't know for sure they have not submitted down or have they?
Chris Wilson 38:38
Well, I keep hearing parents and other patients still people diabetes, still saying, you know, I just finished my time in the primary phase of the trial for the eyelids, or now my kid is going into the extension phase, things like that. So if the trial is ongoing, clearly, I don't think they've they've submitted yet. It's definitely more hands off. I won't lie my time and range did go down a little bit when I was on it.
Stacey Simms 39:03
But your your time and range we should specify is extremely high.
Chris Wilson 39:06
Right? My 90 day average right now is 94% a week going into the current trial, the arm of the trial that I just finished was actually 97.
Stacey Simms 39:20
So it's all relative, but otherwise. Yeah. But it's a good point in that, you know, the eyelid is much more hands off, as you mentioned,
Chris Wilson 39:32
right? It's you know, no correction boluses there's not even mechanism to do it. All you can really do is tell it when you're eating and give it a rough guesstimate as to the meal size. So I would imagine especially for people who want to be more hands off with their diabetes and have good control because of the control wasn't bad by any stretch of the imagination, that it'll be a very good option for a lot of people once it does get approved. And this is the Insulet only version. We've still got The version with insulin and glucagon having both a gas and a brake will definitely make it easier to drive the car going forward in the next version. So we're looking forward to, to them starting the trials on that as well.
Stacey Simms 40:13
Yeah, it is all relative. I mean, I just think about my son, you know, he misses a couple of meal boluses a week for sure. And I think he would happily trade off control, you know, to just have that kind of stuff be taken care of. It's so interesting to see how I mean, I'm, I'm, I know, we're gonna get somebody questions as Chris gets so much time and range, what is he doing with control IQ? So that'll be another episode tips and tricks from Chris to or maybe the maybe the tips and tricks, Kamil is just spent a lot of your time in diabetes trials? Yeah. I mean, I kidding. I know. That's not it. But
Kamil Armacki 40:48
well, you're my time and ranges, but it's knowing me about? Very, very happy with it. I like to say that my time and happiness, though is 98. If not 100%?
Kamil Armacki 41:00
Go? And that's what matters. Yeah, right.
Stacey Simms 41:04
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
How much do you really know about the only inhalable insulin? This week, Stacey interviews the CEO of MannKind, makers of Afrezza. Mike Castagna talks about how Afrezza works, misconceptions about the product, the worldwide market, pediatric studies and lots more.
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:
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 all about Afrezza How much do you really know about the inhalable Insulet. I had a great conversation with the people who make it
Mike Castagna 0:34
For me, it's about using the right product to meet your needs to get you in control. And if you're doing well, great, we're going to avoid the long term complications. But if you're not doing your health, and you gotta really try to find the best set of tools, they're gonna make you successful and fit your lifestyle.
Stacey Simms 0:47
That's mankind CEO Mike Castagna. We talked about how Afrezza works misconceptions the worldwide market pediatric studies and lots 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. We so glad to have you here we aim to educate and inspire about diabetes with a focus on people who use insulin. And this week, we're talking about the use of the only inhalable insulin, my son was diagnosed with type one right before he turned two, he is 16. My husband has type two diabetes, I don't have diabetes at all. But I have a background in broadcasting. And that is how you get the podcast, I have to say that personally, my family is very interested in Afrezza Benny really would like to try this seat. Of course, as I mentioned in that tease up there, they're looking at pediatrics, he is still under 18. So it's not proof for his age group. But we're watching it really closely. And I have a lot of friends. A lot of bloggers and people in the diabetes community have talked about this for years. And some things have changed. So I wanted to have them on the show and find out more. So a little bit of background for you. If you are brand new to all this, Afrezza was approved in the United States in 2014. And the company that makes it is mankind. For a while it was sold by Santa Fe, but then mankind took it back. It's one of those things where sometimes the business side seems to have gotten more attention than the product itself. So what is Afrezza it is a powder, it comes in cartridges, and you suck it in you inhale it with a special inhaler device. To me, it looks more like a whistle than a traditional inhaler like an asthma inhaler. It's not like a big tube. I'll link up some photos in the show notes. I'll also link up the Afrezza website so you can learn more and see their information.
And my guest this week is Dr. Mike Castagna, the CEO of mankind now he has a Doctorate of pharmacy, he worked as a pharmacist behind the counter for CVS at the start of his career. But then he went back to school and he got an MBA from the Wharton School of Business. He's fun to talk to he doesn't mince words, and he truly believes in this product, I do have to tell you that Mike mentions monomeric insulin a couple of times, I'm going to come back after the interview and explain more about that give you a better definition. All you really need to know is that it's faster than how liquid insulin is made. And all of that in just a moment.
But first Diabetes Connections is brought to you by Daario. And over the years I find we manage diabetes better when we're thinking less about all the stuff of diabetes tasks. That's why I love partnering with people who take the load off on things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends with suggestions on how to succeed, get the diabetes management plan that works with you and for you, Daria is published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash Diabetes Connections.
Mike, thanks for joining me, I'm really excited to catch up. And look, I'm stuttering because I can't believe this is the first time we're talking to you. But thanks for coming on. Oh, thank you, Rodney. I'm super excited before we jump in and start talking about Afrezza Can you give us some perspective kind of dial back because mankind is not. It's not a name that came out of nowhere? There's really important history. Can you kind of talk about that a little bit first?
Mike Castagna 4:14
Sure. Mankind comes from our founder named after Al Mann and Al Mann was a true innovator. He started I think 17 companies and everything from the cochlear implant to the pacemaker to insulin pumps that many of us know today as Medtronic used to be called mini med. And Al Mann built the insulin pumps over the 80s and 90s and was very successful and sold that company to Medtronic. And then he took literally $1 billion of his own money and invested in mankind. And he had put this company together through three companies he owned the technology to make Afrezza was really a combination of companies and the reason he was so dedicated as he saw in the pump market, which we now see today on CGM was that the variability in mealtime control was so high and the fluctuations you see that the influence takes about an hour and a half to kick in. And it's hard to get real time control if you can't get a faster acting insulin. And so he set out to make a real time acting insulin, so phrases and hailed as monomeric. And that was really what the magic was in our technology making a dry powder was was free dryness, if you heard of dippin dots ice cream, we have basically large dipping machines in our factory, but we free dry the particles to make a freezer and under stabilize the monomeric form. So when you're inhaling, you're inhaling influenza, as soon as it's in your blood is active, or when you inject it has to hold hexamer and has to break down there were about 45 minutes. And that's how you can make it stabilize an injectable form. But it has to break down and then it starts working. And that's why there's always this lag effect between we see injectable and foam in and help us is very different products were categorized with real time rapid acting, but the name mankind comes from elmen and the guy who probably 60% of people on pumps have their own pumps that he created. So amazing gentlemen, huge contributions to diabetes and millions of people were alive today because of his work and his generosity and roven to take that forward here and kids and frozen inhaled insulin.
Stacey Simms 6:06
I mean, never look at dippin dots the same again.
Mike Castagna 6:10
I see a large factory of they don't like it, you know, we can always make different types of things don't go well.
Stacey Simms 6:15
I love it. Let me ask you to go into a little bit more detail about how someone who uses Afrezza would actually use it. Can you talk a little bit about like a daily routine?
Mike Castagna 6:25
Yeah, I mean, I know, you know, well, you're in this disease. I mean, people sometimes graze all day, and they just kind of ride their sugars and take a little bit some along the way or many boluses. And some people you know, eat once or twice a day, or some people, you know, carb restricted and everyone has a different way. And I think that you know, the big thing difference was for the patients that I see is, it's in the moment, meaning you don't have to time your meal and your insulin, when you're going to take it and where you're going to be. As soon as your food arrives. You take your first dose.
Stacey Simms 6:50
Most people I know who use Afrezza take a long acting insulin with it. Is that pretty standard for people with type one?
Mike Castagna 6:57
Yeah, I'll take one year, right? Yeah, you need a basal insulin of some sort, you know, and, and a meal time was held, we do have some patients on pumps where they will use their punches for their basil, for example, and use a phrase for real time corrections. So you know, the average patient is very different. We have some patients that are type twos, you know not not on any basil, you'll need to be on basil for if you're type two. But if you're type one, you need to basil, long acting insulin, and you need your meal time. And we know the biggest problem in this country is still mealtime control is the number one thing people with diabetes struggle with. And it's a big reason why, you know, six, or seven or eight, you know, eight out of 10 people basically are not a goal on insulin because of the mealtime control. So it's a daily challenge for everybody.
Stacey Simms 7:39
Can you talk a little bit about how Afrezza is kind of measured out? Because when we think of mealtime, insulin, everything's a carb ratios. And especially as I mentioned, if you're on an insulin pump, you're you're putting in the carbs that you eat. So how does that work?
Mike Castagna 7:51
Yeah, it's funny, I get into many debates with people because, you know, I'm a pharmacist by training, but I'm not the smartest guy. But I couldn't do all the work people do every day to influence sensitivity ratios and carb counting and timing. And all I can tell you is everyone's masks off by 50%, one direction or another. And so we have this false pretense that we're that accurate. And dosing are influenced by down to the half a unit or one unit. And the reality is your angle of injection can decrease, you know, change your absorption by 25%, your site of injection can change absorption, your your stress level can change your impact with your insulin, there's so many things that go into your daily dosing of insulin, that, you know, being that precise, down to the unit is not as accurate as we all think. And I think that's that's one of the misnomers of, you know, the timing is what you really struggle with when you're using injectable insulin, and you just don't know what's going to happen. You know, when people I guess doctors often you know, you don't have to carb count with Afrezza . And they give me funny looks. And the reality is, you know, we've never done a study where you're carb counting to get your dose of insulin, that's, you know, so becomes a four 812 dose linear all the way up to 48 units, it's additive, and you just got to be close enough. And so it's about a two to one ratio, you know, there's no direct pulmonary equivalent to injectable insulin, unfortunately, but, you know, people are taking five units of injectable insulin per meal, they're gonna need about eight units of Afrezza and maybe even 12. And you're gonna figure that out, it's your first meal or two what what the right dose is for you. But you just got to be close enough. And that's a big misunderstanding for people of how accurate the dose has to be. This is the sixth dose cartridge is a big problem. I know plenty of type one patients who take for a 1224 meal, especially they haven't Chinese food or sushi, they just they dose a lot. So I think that's something people have been comfortable, so dramatically different than anything they've ever been trained or taught in their history of living with diabetes.
Stacey Simms 9:36
I would assume that a prescription for Afrezza comes with a doctor's visit where someone whether it's someone who works for Afrezza, or the endocrinologist talks to you about how to do this dosing. You said you figure it out, but I've got to assume that you're not just sending people home with this inhalable and say, just test it, I mean, right somebody, you're at a ratio
Mike Castagna 9:59
and I think That's the key thing is, you know, having patients understand because it's odorless and tasteless. So you inhale, and you're like, what did I get it? And I'm like, yeah, if you inhaled, and I have the second, it's in your blood, it's in your lungs, it's breath activated. So you can't really, of course, you can try to mess up something. But we have something called Blue Hill, where we can show proper inhalation technique in the office on an iPhone app or an Android. And so you know, we hope that patients are being trained either by our trainers or the doctors offices, and will propagation technique looks like that's number one. And then number two is the right dosing. And as you know, individualized dosing is important and fun. And, again, that's why I say we take a lot of the math out because it's either gonna be a four or an eight, and all of a sudden, you're like, Oh my god, I'm gonna take an eight units, it's a lot it's really not when you're taking inhalation units versus injectable units and that's what people got to get comfortable with if their first or second dose so they really do figure out this meal did this or pizza is going to take longer so pick another dose and now our people do figure it out pretty much within the first week. And then there's one thing actually I want to mention because I often forget this is because injectable insulin is such a long tail it's in your body for four to six hours before it's out and that feeds into your basal rate your long acting and so when people switch over presence pretty much out of your body in a net roughly an hour and a half. Sometimes people need to adjust their basil and that's something to watch out for if you do switch to Afrezza enter you're struggling with with some of the basil rates. Some patients you know I hear people anecdotally you know, we don't want to study their the bump up their basil 10 15% on Lantus. And I've heard patients on to see that because it does have that long tail of down there in front sometimes on the basil. So there are the other metrics patients have to watch out for when they are switching to the product. It's not just the uptime, it's also something that basil where you look at
Stacey Simms 11:38
I have a question and I i apologize because it's a it's a bit ridiculous. I'm gonna ask it anyway.
Right back to the interview in just a moment. But first Diabetes Connections is brought to you by Gvoke Hypopen. And our endo always told us that if you use insulin, you need to have emergency glucagon on hand as well. Low blood sugars are one thing we're usually able to treat those with fast acting glucose tabs or juice. But a very low blood sugar can be very frightening. Which is why I'm so glad there's a different option for emergency glucagon, it's Gvoke Hypopen. Gvoke Hypopen is pre mixed and ready to go with no visible needle, you pull off the red cap, push the yellow end onto bare skin and hold it for five seconds. That's it, 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 slash risk. Now back to my interview with Mike, where I will ask that ridiculous question.
You had mentioned it's tasteless, odorless, I recall hearing and I'll have to fact check this. But I recall hearing that years ago dandruff shampoo, they had to add like that tingly feeling because people didn't think it was working like it's totally fake. But people just didn't believe it was a medicated shampoo because it didn't have an unpleasant sensation. Have you thought or talked at all about adding like a flavor or a feeling to so people really know that they got it? Or is that just really bananas?
Mike Castagna 13:12
If somebody might company come and talk to you ahead of time? There's somebody internally who wants us to look at like cherry flavor Afrezza especially as they go into pediatrics? And the answer is, look, there's blueberry Metformin because the metformin smells awful and tastes awful, probably. So you know, those things are possible. We've never done them. And to my knowledge in this industry with dry powders, it is a question that came up recently. Is that should we be thinking about the cherry flavor Afrezza or some other flavor? And I think the answer is TBD. We I don't know what the date is on inhaling the food coloring dye or whatever. Yeah. But that's some of the stuff we have to justify that it's safe and effective. And along with FDA would want us to test but they come up recently and another internal discussion. And since you're asking, I think we'll look at it, even if maybe there's a way to even show a placebo, that's a cherry flavor or something right a one time dose to see what it's like. So I don't know. But now, but people like I said, it's sometimes you get a call, like you know, when you take a phrase of one out of four people will get a cough initially. And generally there were the first four weeks that cough goes away 97% of the people. So I always tell people, you're having a cough, like as long as not interrupting your life, it should slowly get to your first refill. And it should be mostly resolved by that your body's getting used to putting a powder in your lungs. But that's uh, you know, when people ask, what's the difference between injectable and inhaled in terms of safety, you know, you're putting a drug powder in for the first time in your body and your body could choose that. And the number one thing that's different, were injectable insulin. You know, you have other other things. You're dealing with injection sites and pump sites and scar tissue and things like that.
Stacey Simms 14:48
Does the body actually acclimate to the powder or is it just a question of someone gets better and used to the inhalation sensation?
Mike Castagna 14:55
You know, it's it's a good question. I don't know if I have a black and white answer here. bodies give. Yeah, my guess is the body's getting used to putting a dry powder in and just exit and you get used to like weed. You can drink a glass of water before and after and help you minimize it. But it's generally like that's what it feels like it's not a productive call frightening, there's not a call to happens 10 minutes later, it usually happens. We have to inhale.
Stacey Simms 15:17
You mentioned BlueHale , can you tell us a little bit more about what that is?
Mike Castagna 15:21
Yeah, so BlueHale is to two different things. The first one that we're looking at is with the patient training device. So we can show you whether you had a good emulation or not a good emulation and show you that technique. The second version, actually, you can detect with those you put in the cartridge and hilar. So it has a proprietary software there that we can see what cartridge you put in for the adapter. And it'll tell you on your app, if you took a for a 12 or 16, how much you took in that session. And then we hooked integrate that with the CGM data. So now you can show those response curves on CGM one day and eventually I want to get into AI and predictive analytics. But we're not there yet. But we think that's the magic of what people really want, which is one that I use the thing when you live with diabetes, you just must remember and be that perfect to know exactly what those you did with them. You took it, what meal you were and then I simulated being a patient for a week. And I realized I could remember if I took a four and eight, I take a six or 620 is that 30 minutes or one hour like it was it was amazing. When you just think about life and people are human. They're there. They're human. So they're not keeping track. And they're not that accurate. They're just estimating. And that's when I talked about the dosing of insulin, like we're always estimating everything, we're estimating the time our food is going to come and how long it's going to work. You know, what the carbs are? How much am I gonna eat or drink? Like, it's all accurate? It's all off. None of it's that accurate. That to me is the thing I realized when I was thinking of doing one of those a disease, you don't you think they're perfect. They're not. They're human beings. And that's when I see one out of five doses of injectable insulin are intentionally missed. And the predominant one that's missed is actually lunchtime, which makes sense to wear out in a social environment. They don't want to inject. And by the time they get back, they forget it's probably too late. Or you're already high.
Stacey Simms 17:00
What do you mean by intentionally Miss? You mean? Like they people just forget?
Mike Castagna 17:03
No, no, they intentionally knew they should take a dose of insulin, but they're in a lunch conversation, or they forgot their insulin in the office. Or they'll have their CGM receiver on the bike, or they essentially don't they miss one of the five doses. So if you're missing 20% of your doses, it's really hard to get in control. And there's all kinds of reasons, but that's intentional omission versus unintentional. Which is I forgotten.
Stacey Simms 17:23
I'm curious what the sources on that that's, I mean, I don't doubt it. I'm just curious.
Mike Castagna 17:27
Yeah, I couldn't find it. follow up on that. I have your email, I'll look for it. Yeah, no, because I didn't believe it. And then there was a study done with one of the pens coming out that has digital connectivity. And I looked at it and I looked at the data and like, wait, if a person needs three times a day, seven days a week, that's at least 1721 doses, right? And I think the average person is taking like 1212 shots a week. And I'm like, Well, that doesn't make sense. But you realize, you know, again, we're human, people aren't always as compliant as we want, or they don't eat three times a day perfectly are the two big meals, you know, everyone does something different. So having insulin that meets your needs, and your lifestyle, I think is really important in the world. And you know, look, we like our products, obviously, we're here, we love the Afrezza. But But I also just for me, it's about using the right product that meets your needs to get you in control. And if you're doing well, great, you're gonna avoid the long term complications. But if you're not, you own your health, and you got to really try to find the best set of tools that are going to make you successful and fit your lifestyle. And, you know, obviously, we're not doing well when 80% of people on insulin on a boat. I mean, that's that, to me is the number one thing, I look at this country and say, well, despite all the adoption of pumps, and technology and CGM, we still have not made a meaningful difference in percent of people to go. And that's frustrating.
Stacey Simms 18:35
Way back in the beginning of this interview, we talked about Chinese food and pizza. And I'm just curious, you know, these are things that are hard to dos for, because they they kind of they come later, you know, what most people listening are very familiar with, and I think probably have their own system for dosing, whether it's an extended bolus or injecting more than once. How would you do something like that on a Friday? Is it a question of you would take what you think when you're eating, and then again, in a bit later, like, how do you account for those high fat foods?
Mike Castagna 19:02
Yeah, you know, I'm going to pick on Anthony Hightower, who I know you interviewed before. So I actually met Anthony on a bed over social media. And he had showed me your servers where he ate pizza. So I'll pick on him because I want the public discussion here, sir. He pizza and his sugars are basically flat over the two, three hours post meal. And I said, I'm like, shocked. He's like, this is something people cannot do naturally on the history of injectable insulin, they they always struggle. And when you eat pizza, you're going to struggle not just for hours, but potentially for the next day because just throws everything off. I think in his case, right? I've watched him he took a big dose up front, you know, let's say he's gonna take 12 units of injectable he took 24 units of Afrezza. And then he washed her wasn't an hour, and then an hour she was above where he started. He took another dose, maybe took a four and he has to tap it off. And then an hour later, just thought was too high or not right. But you can always keep your sugars in that kind of control. That's one of the studies we did back in 2018, called this test study was showing that you could do as soon as one hour with no more hyper risk. And that was a big concern of people, how can I do that one hour, well, pretty much hit its peak effect in one hour. So if your servers are still moving in the wrong direction, you can correct them at that point. And so that's where someone on pizza or Chinese food, like, yeah, it's a high dose up front and may manage it through the whole system. Or they may see an hour or two later, they're still high and to take another dose, that they can bring it down at some point.
Stacey Simms 20:20
Alright, let's talk about the big questions that people generally have. And that the one I hear the most is, Is it safe? Right? Is it? Is it okay to inhale this stuff into my lungs? Can you talk about the studies that you've done?
Mike Castagna 20:32
Yeah, I think if we were able to make inhaled insulin 100 years ago, we'd be scratching our heads those who would inject themselves three times a day. So I think it's just an unfortunate matter of 100 years of difference. But we studied a phrase that probably over 3000 patients 70, some trials $3 billion over 20 years, like, that's how much money time and energy is going into prove the safety and effectiveness of this product. And you know, and I tell people like you know, there is no data to say that it's not safe. We have all the rodent studies, all the CT scans that along looking for fibrosis looking for pulmonary issues, we found nothing. So it doesn't sit in the lung. There's an old product called exubera on the market years ago. And exubera was a sugar based manatal formulation which got absorbed over time into your lungs in a friend this case, the it's got water and human influence. So when we ask about what ingredients are you worried about the human influence, human influence, it's the whole AI base, but it's human influence characteristic, and water is purified. So we know that safe and the other only other carrier in our products SDK p which is a excluded product that is not metabolized in the body, it's just 100% extruded. So you know, there's three ingredients in our product. One is human insulin, one is water, and one is tkp. And SDK p comes out of the system. So I don't I don't think the body is afraid of human insulin. And what are so I think, you know, I always struggle with this topic. Because, you know, what happened is there was some lung cancer cases and Newser, were they there was a couple of our data. But you know, in the seven years since FDA approval, we've seen no safety signals come up in the postmarketing. We have almost 10,000 patients on the presidency. I know people in the drug for 1012 years. And so, you know, we don't see anything that gives us concern. And we're going into kids now, who would have to take the drug for 40 5060 years. So I think it's hard to prove something that you've never seen. But safety comes with time. And I think the good news is product has been approved by the FDA for seven years now. And we've not seeing any safety signals in our database, which we look every year, our rems program ended early by the FDA and and we've continued to show good data and all the studies we've done, we've not seen anything new come up in our anywhere safety issues. So if you're, you know, the populations, I would say if you have COPD, and asthma, this is not the right drug for you.
Stacey Simms 22:41
So a dumb question, though. If you have diabetes, and you smoke, can you get an Afrezza? prescription?
Mike Castagna 22:48
We would say you should not? Yes, we have a warning for that.
Stacey Simms 22:52
Well, I just wanted to be clear that there was an actual warning, it wasn't just a please don't because it's bad for
Mike Castagna 22:57
warning. Don't
Stacey Simms 23:00
tell me about the study with kids. Because I've got one, I've got a 16 year old who was quite interested in this product.
Mike Castagna 23:06
Yeah, no, I just found out Unfortunately, the dagga three year old cousin in the family have just come down with type one. And she will, she'll be four and our studies gonna go down to four years old to 17 years old, when we launch it. So I'm excited, we had to do a study to show that the pharmacokinetics and dynamics of inhaled insulin are similar in kids as it as adults. And so once that study was complete, we we wrote a protocol down to the FDA and said, We'd like to go into the next phase, and now run a larger study head to head against the standard of care. And the FDA has pretty much signed off on that protocol at this point. And we have contracted with a third party to now run that trial. And we'll be having our investigator meeting here in next month. And so hopefully, we'll see our first patient in the four to 17 year old range, probably here in September, October time frame. So super excited, long time to get here took too long from my perspective, but can't wait to help kids. But our founder Outman invested, he became very wealthy when he sold the insulin pump company. And he took $1 billion of his own money and made Afrezza inhaled insulin because he felt the problem with the injectable subcutaneous delivered insulin was it just took too long to work. And you know, somebody has an hour lag effects from food. That's real timing, it's always hard to catch those two even. And so he really wanted to make an inhaled insulin that really mimic a physiologic insulin that you see in the body. And he felt the only way you could get there was through a dry powder, lung delivered instantaneous insulin, you can also get there through an implantable pump. But that didn't work out when they tried that back in the 90s. I recall. So people got infections and things like that. So that would that didn't work. So they really were going to get a in my mind that physiologic inform that's gonna be monomeric stabilized is probably going to happen only through the inhaled route. So we have we have to get comfortable with this from overall efficacy and safety. Otherwise, you're not going to really ever get this control that people are looking for real time.
Stacey Simms 24:55
No man, he lived long enough to see Afrezza approved, didn't he?
Mike Castagna 24:59
He's All approved. And unfortunately, I'm here because he died on my daughter's birthday. So I was debating whether to come to mankind or not. And I'm very superstitious, the Al Mann pick the day he died. And he died February 25 2016. And then they made decision to join and help save the company and save a frozen kick on the market. Because I think, you know, I saw all these wonderful patients stories online. And I said, these patients like Anthony Hightower is one of them, what they did something that no one else did, they did something we never did in our clinical trials. And so I got to talk to them. And I realized we just didn't dose it properly. So you go back to the development of the product, a lot of the challenges were under dosing because everybody's trying to compare one to one to injectable insulin, and therefore one of underdosing patients, and therefore, they got equal outcomes didn't do any worse than injectable insulin per se. But could they have gotten better outcomes if we dosed improperly? Right? And I think that's, that's the state of we're now trying to generate to show that the kids buddy now be head to head, or if he knows him properly, what happens? Right, and that's we're really focused on right now.
Stacey Simms 26:01
Is there anything that you wanted to talk about that I haven't answered?
Mike Castagna 26:04
No. I mean, we're only available in the US, we're in the process of going to Europe. So I don't know if you have any. Yeah, we do. Though, so I know, we have patients on a name patient basis in Germany, and UK and Italy. So you know, their governments are actually important a president and pay for it. We're in the middle of filing for Australia. We were approved in Brazil, and we're going to India so so you'll see this more and more around the world. You have listeners in those markets. There's not gonna happen this year. And hopefully, the next year or the following year in some of these markets, we'll be looking at bringing it to more patients in those markets.
Stacey Simms 26:37
Well, and just got a big approval here in the United States for Medicare patients. Right.
Mike Castagna 26:42
Yeah. So that one, I, you know, we get a lot of questions on that one. And so you know, this market CGM patients were told you need to be injecting yourself, I think four times a day, we couldn't get your CGM. So then doctors were not getting patients Afrezza. And so we were able to ask CMS to change that, and they did to the year but rather haven't done they're not done. And so here we are a year later that that policy is now being updated. I want to thank CMS and all that you're helped make that happen. And I think it helps in people in CGN, because I understand that removes some of the other requirements to get CGM, even an injectable these patients so little mankind was the one who started that process. And then we're able to help a lot more people. So it's great. And we're trying to get Medicare $30 a month insulin. So we have Medicare listeners. And you know, we're trying to make sure we help get patients access that are on Medicare. I think that's important.
Stacey Simms 27:33
That doesn't stack up in terms of cost in the United States.
Mike Castagna 27:36
Yeah, I mean, you know, fortunately, the billion dollar debacle in this country is drug pricing, as we all know, and as a pharmacist, I know firsthand when people go through an LMS they're on how many co pays are on. And so we really have tried hard to make sure that no patients pay no more than $15. So we have copay card programs, we actually have a free drug programs, they really can't afford it, we'll give it to you for free. If you're going through the prior authorization process, we give it to you for free while you're going through that. So we all want payers and reimbursement to be the excuse of why a patient can't get access to our product, we think that people will do well on our product, we're willing to take that bet that they'll see good results. And if they see good results, the payers will usually pay for it. And it says you may or may not know that there's a monopoly in diabetes between two insulin players, and three payers, who are all working together to make sure there's no competition. You know, that's unfortunate, but they pay to make sure that patients have a difficult time getting Afrezza . And that's always one of my frustrations of competition or diseases. You know, 400 years, we've seen the precise the dispensing from 20 hours a while 95 and let's say miles, hundreds of dollars. You know, for me on the payer side, we want to make sure patients we try to bring it down to about $15 on commercial and Medicare, you know, they generally pay comparable to what they would and some Medicare plans a little bit higher I can you know, that's a hit or miss when you when you go to submit for reimbursement, but we try to do everything we can to make sure people will have access to our product
Stacey Simms 28:57
$15 for $15 for commercial patients, no, no, but what is it? What is it for? What do you get for $15? Is it a month? Is it a
Mike Castagna 29:05
my week? Yeah, whatever, whatever. You gave two boxes, three boxes, whatever is on that prescription for that month,
Stacey Simms 29:10
for the month. Okay, I didn't mean to interrupt you.
Mike Castagna 29:12
I don't think I know, I was gonna say I forgot we actually have a cash pay program. And people are paying cash for their insulin. And we do see several 1000 people a month paying cash for injectable insulin, we have influenced savings comm where it's $99 a month for frezza. And you know, can you a bigger box or more doses, you might pay 199 but we tried to make the cash price, you know, roughly $100 a month. If we if you had no insurance, for example.
Stacey Simms 29:37
I'm not sure you can answer this question. But I will ask it anyway, is the biggest challenge for you all the failure of exubera? Is it just people not knowing what this is? You know, as you move forward, you know, what is the big challenge to get more people to adopt us?
Mike Castagna 29:51
I mean, for me, the biggest challenge are the doctors. We created a program we basically gave it for free to patients for two years for 15 bucks. Like no no priority. Nothing, we just charge you $15. And that didn't change a lot of doctors from jumping on board. And doctors just don't know our data. And so they think this product doesn't have a lot of data behind it. And they don't know our data, they don't know. Like when I would ask a doctor, how fast from the time you inject your bolus, your pump to the time you look on a CGM, that your institute sugars are coming down, and I get in these endocrinologist, I'll get five minutes and mediate and 20 minutes an hour, the answers, I need 90 minutes, 220 minutes, that's the answer. And so they don't even know the pharmacokinetics and pharmacodynamics differences between injectable insulin inhaled, and then you have doctors, right, you know, calling some of these ultra acting drugs faster, we'll look at the package inserts, they're no faster than their old products. And there's a lot of misperceptions out there some of these newer launches of old tracking insulin, and to me they're, they're really not that much different than the predecessor and look at the data, you know, there's not a faster, there's not dramatically faster onset or offset or, you know, a one c lowering or weight gains on very much the same. So, no, I think it's just a matter of doctors trying to really understand the data.
Stacey Simms 31:02
Before I let you go, are there any plans in the future to change anything about the way it looks? or different colors? I mean, I know it sounds kind of silly, when you're just trying to get people to adopt the new technology, but from a user standpoint, and look, I know, you've heard all the jokes of my friends who use this will make you can't comment on designers. They don't say anything, they'll make comments like, you know, taking a hit or whatever, right? I mean, it's it's inhaling, it's this little thing that you're, you're inhaling, it looks a certain way. I'm curious if the cosmetics of it are anything that are on your radar, or needs to be improved even?
Mike Castagna 31:36
No, I mean, I think when you spend, you know, $3,000,000,000.20 years doing a new drug development or taking 100 year old product and reinventing it, you had to get that right in terms of device design and airflow dynamics and consistency. And those. And I think all that's really important because, you know, misperception that oh, my God, it's going to be less can be more variable than injectable insulin. And the data just doesn't support that statement. And so for us, we have one of the world's most unique installation platforms across the entire pharmaceutical industry, we deliver more power to the lung, the most technologies out there. So that's why you can get consistency, those two those, and you don't have a lot of variabilities, because our technology and our device is called a low velocity inhaler. And what that means is there's a resistor that helps slow the powders as they're coming out of the inhaler. So they get deep into the lungs. And that's why you get that nice absorption curves that we see. And we're most inhalers or high gloss inhalers. So it's just enough sucking air as hard as you can, and hoping you get you know, 20 30% of lung drug into your lungs, and mostly stuck in your teeth to device in the back of your throat. That's most dry powder inhaler technologies out there today. And so that's something unique to us and our technology and our device, they all work really well together, you couldn't just take our powder and put into another inhaler, and or just as well would not work. So yeah, we're pretty happy with the device I we are going to other diseases. So you know, we're we're going down to the FDA with our partner for an approval in October for pulmonary hypertension patients. And we have several other orphan lung areas we're going into to help more patients with lung disorders. So you know, I think that's important, like our, our technology, our inhaler, our platform is gonna be used in more and more patients over the next decade than just diabetes.
Stacey Simms 33:13
Well, that's what I was gonna ask is, if it works, so well, you know, will you partner with other medications? That's great to hear.
Mike Castagna 33:18
Yeah, you know, we're really busy, we probably have about 10 to 12 formulations of products working on this year and five marone products in the pipeline. And so it's it's a really good time of mankind, we're super excited to be here. And it was a turnaround, the company struggled for many, many years. And we're on our way to success. And I think, firstly, you'll be you'll be hearing more about it. So I know it's been a long time. And maybe you didn't talk to us yet. But hopefully you'll talk to us more and more as we continue to generate new data and more more patients start using it.
Stacey Simms 33:45
I'd love to, I'd love to, especially with the kids programs. And like I said, I've got a 16 year old who is very curious about this. And, you know, once once safe and effective. Once we get all that safety stuff in here. It's mom says, you know, I'll definitely I know, I would like to check it out. So I really appreciate you coming on and spending so much time with me and my listeners and explaining all this and we'll definitely talk again. Thanks, Mike.
You're listening to Diabetes Connections with Stacey Simms.
More information at Diabetes connections.com. Always on the episode homepage. I also have a transcription as well, sometimes those podcast players don't display the show notes and the links. So if you have any trouble, just go back to Diabetes connections.com. And I just want to say that I did reach out to have Mike or somebody from Afrezza on the show. And you heard him say, you know, it's been a while, um, you know, it just took a while to connect to the right person. Let's just say that, and I will have them back on because lots of good stuff is happening. As you heard.
I want to take a second and kind of explain Monomeric insulin and, you know, I'll be honest with you. The scientific points here are really not my strong suit. I'm a communications major, right. So I did what I always do, and I am People who know a lot more than I do to help me explain it. I went to the Facebook group Diabetes Connections as a group. And you know, I said, How do you explain monomeric insulin I know it's faster. And Tim Street, who is just wonderful and runs the diabettech.com page that's like diabetes tech diabetic, and I'll link that up as well. He provided this explanation, which really brought it home for me, and boy, I hope I'm pronouncing everything correctly.
So Tim wrote, insulin naturally links its chains together to form stable molecules. Typically it connects two together and then links three of those two chains together. Additionally, to create six This is highly stable and described as hexameric. In order to use these chains, you have to break the molecules apart to single chains, which are monomers. Typically fast acting insulins are stored as dimers, two monomers connected, which are easier to split, then hexamers. by storing the insulin as a single chain, a monomer, the body doesn't have to break the chains to instantly use the insulin molecule it receives. And that is why Afreeza wraps the monomeric form in the capsules, to make it ultra fast.
Thank you, Tim, that actually made a lot of sense. I gotta tell you, we have the smartest people and the kindest people in this Facebook group. If you're not there yet, and you want to join, come on in, I highly recommend it. You don't have to be a Tim Street. You don't have to be able to explain these concepts. You do have to be nice. And you do have to not post a lot of drama. I'm very tough on my diabetes groups. I run two of them. They're very nice and friendly places for a reason. But Tim, seriously, thank you so much. That was a great explanation. And I really appreciate it.
Diabetes Connections is brought to you by Dexcom. If you're a veteran, the Dexcom g six continuous glucose monitoring system is now available at VA pharmacies in the United States. Qualified veterans with type one and type two diabetes may be covered. Picking up your Dexcom supplies at the pharmacy may save you a lot of time to connect with your doctor for more info Dexcom even has a discussion guide you can bring with you get that guide and find out more about eligibility. It's all@dexcom.com backslash veterans, and all the information is always at Diabetes connections.com.
Before I let you go, just a quick note about back to school, I have never done less. I packed up a bag for Benny to bring to the nurse. He brings his daily supplies with him every day in his backpack. But of course, like most people, our nurse has backup supplies for him. So I put those together. He brought them in along with our plan or orders, you know from our endo. And that was it. I haven't set foot in the building. I'm not sure when I will go in or if I will go in probably when you forget something or they run out there. But I've never done less work. You know, I did a lot of work over the years to go to school and meet with people and he's got it. So not much to report. It feels very strange. All right.
Please join me this Wednesday when we have our in the news live on Facebook every Wednesday at 430 and then we turn that into a podcast episode. I love doing that. It's been a lot of fun. I hope you're enjoying it. Give me your news tips. If you've got any from this week, just email me Stacey at Diabetes connections.com thanks 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 in a couple of days until then be kind to yourself.
Benny 38:27
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Anticipation just keeps growing for the new Omnipod system, still waiting for FDA approval. This week, we talk to Dr. Trang Ly, Senior Vice President & Medical Director at Insulet Corporation. We’ll get an in-depth run through of the features of Omnipod 5 with Horizon, what makes it different from the other hybrid closed loops already on the market, and many other questions you all had.
Our previous interview with Insulet CEO Shacey Petrovic
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
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 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:26
This week anticipation growing for the new Omnipod 5 system still waiting for FDA approval. Many of the people behind it have waited a long time to knowing the promise of closed loop systems for people with diabetes and their families.
Dr. Trang Ly 0:42
I still remember the very first time the very first patient that I put the system on and, and I was watching that insulin being delivered. And I remember just like hugging the participants, Mom, because we just both knew how incredible this was going to be if, if this could reach masses of people.
Stacey Simms 1:04
That's Dr. Trang Ly, Senior Vice President and medical director at insulin Corporation, we'll get an in depth run through of the features of Omnipod 5 with horizon. What makes it different from the other hybrid closed loops already on the market and many other questions you all sent in.
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 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. As you listen to this particular episode couple of things to keep in mind, Omnipod 5 with Horizon the full name of the system we are talking about today is not out yet it is not commercially available as of this taping. This episode is live on August 3 2021. The FDA is still mulling it over. If you are looking for even more information and some of the history of this, it may be worth going back to our first episode about this system that was almost exactly two years ago with the company CEO Shacey Petrovic. And I will link that interview up in the show notes at Diabetes connections.com
COVID, really through this submission for a loop with the delays. And I didn't mean upon there with the word loop. But I know there has been frustration in the community. And there's frustration with an Insulet as well. But it really is close. Now, if you are not familiar and I know we have a lot of new listeners who've joined the show more recently. I know some of you have been hearing about this for years. But bear with me for just a moment as I explain it very quickly. You've got your Omnipod pod. That's the thing that holds and infuses the insulin, it's an all in one. It sits on the body, there's no buttons, there's no display, there's nothing to read, you've got your separate handheld controller, the thing with the display on it and the buttons are the touchscreen of how you actually control the pod when it comes to giving insulin for meals or for correction doses, that sort of thing. And for Omnipod five with horizon, you also have the Dexcom G6, the continuous glucose monitor, the pod and the CGM work together to give less or give more insulin to try to keep you in range. Now that is very, very simple. But Dr. Ly will explain it in much better detail. And I will also link up more information as always in the show notes. If you haven't ever seen what this looks like if you're curious, we'll link you up to all of the information.
Dr. Trang Ly, my guest is the Senior Vice President and medical director at Insulet. Corporation, she leads their Omnipod five automated insulin delivery system clinical program before her time at Insulet. Dr. Ly was a pediatric endocrinologist in Australia. And toward the end of the interview, we talk about how personally knowing families that will benefit from this system and systems like it, you know what that is like for her.
So my interview with Dr. Ly in just a moment, but first Diabetes Connections is brought to you buy Daario health and over the years, I finally managed diabetes better when we're thinking less about all the stuff of diabetes tasks, and that's why I love partnering with people who take the load off on things like ordering supplies, so I can really focus on Benny, the Dario diabetes success plan is all about you all the strips and lancets you need delivered to your door, one on one coaching so you can meet your milestones, weekly insights into your trends with suggestions on how to succeed get the diabetes management plan that works with you and for you, Dario is published Studies demonstrate high impact clinical results, find out more go to my dario.com forward slash diabetes dash connections.
Dr. Ly, thank you so much for spending some time with me. My listeners are very excited to get all the information that they can about this. So thanks for being with me today.
Dr. Trang Ly 4:58
Yeah, great to be program. Thanks, Stacey
Stacey Simms 5:01
you got it. Let's start with an overview. I know that most people listening are probably very familiar with what we think Omnipod 5 with horizon will be. But can you start by just giving us an update and taking us through what is in front of the FDA for approval as you and I are speaking today?
Dr. Trang Ly 5:17
Yeah, so happy to do so the Omnipod five system that you're referring to is Omnipod, or Insulet, first automated insulin delivery system. So this system, he has previously known as horizon or the Omnipod, five algorithm on the pod itself. And it talks directly with the ICGM, which is the Dexcom G6 sensor, and also has a separate controller device as well to be able to remotely deliver boluses and stop and start automated mode, the system that some kind of FDA just requires you to wear a pod and a CGM to stay in automated delivery, because the algorithm is on the pod itself. And I think that is the key feature of the Omnipod five system,
Stacey Simms 6:14
a lot to break down there. And we'll get to each of the components. But let's start there with the kind of the brains of the operation being on the pod. What does that mean, in a practical sense when someone is wearing the system that they don't have to worry about it stopping that sort of thing?
Dr. Trang Ly 6:27
Yeah. So the The key difference between previous products is that with our current Omnipod dash and earlier versions of Omnipod, the pod delivers the basil programs and the bolus delivery that the user has initiated. And so insulin is not under automated delivery. But in our future system with Omnipod. Five watch the pod does is that takes the CGM value which you wear on body and so that value directly communicate with the pod itself. And then the system and the algorithm on the pod takes that CGM value and determines how much insulin you need every five minutes. If you're running high, and you need a little bit more influence, the pod will automatically increase insulin delivery. And if you're at your target or dropping low, it will augment insulin delivery, so it might suspend or it might reduce the insulin that you need. That is the key difference between the product that is available today. And the future with Omnipod. Five,
Stacey Simms 7:38
you would still use the PDM or the phone and we'll get to that to give yourself a meal bolus or a correction bolus.
Dr. Trang Ly 7:47
That's right. For those instances where you're about to have a meal. Or if you're running high for whatever reason, like you underestimated carbs earlier, and you want to give a manual bolus, you can do that any time. And you would do that by using the controller device or PDM, to enter in your carbs, and use our bolus calculator to deliver that insulin. So all of those features are very similar to the current production on the pod dash, which again, is very similar to our earlier version. So that's on the pod.
Stacey Simms 8:24
Let's talk about the algorithm a little bit. I know there's a lot that's proprietary here. But I'm curious, we've seen over the last couple of years, Medtronic come out with a you know, an automated device. Tandem has control IQ, I believe my listeners are pretty familiar with the workings of those, what would be the biggest differences between how those systems work and how Omnipod 5 with horizon will work.
Dr. Trang Ly 8:49
I'm very familiar with those algorithms. Because I, you know, in my previous life, I worked very quickly with those systems as they were being developed. And so I say, you know, having been in this role for the last five years and been running the clinical trials. For them, I can tell you that the main difference I'd say would be that our algorithm, you can set the target glucose for whatever time of day. And the range we have is between 110 to 150, in 10 milligram per deciliter increments. And you might have a family where you want to go overnight, you want to run out and 20 because you feel more comfortable at 120 overnight, and then but during the day you want to run at 110 you can set up a profile so that the algorithm augments insulin delivery to your preferred target glucose level. And, you know, we we knew when we were coming to market that we were not going we certainly weren't the first and not the second product market. So we knew that we had to deliver a level of personalization for our users. So we really listened to what people wanted. And people do want that level of personalization and customization. And so we implemented that design feature into our clinical trial to demonstrate that our system performs very safely across those different target glucose level. Until our clinical studies which show we'll get into Dude, what was tested across a very wide range of patients, for initially, we did a beam study, which was for patients aged six to 70 years of age. And then most recently, just a couple weeks ago, we were reported on our preschool age participants who were between two to six years of age, and they see I'm sure you'll appreciate that they're young. glucose control is just very variable, very unpredictable. And, you know, I think strength of our algorithm is that it works very well, even if you, you know, Miss or skip a bolus, occasionally, you know, that algorithm is going to kick in, it's going to deliver, you know, a decent amount of insulin to get you back in range, it's going to happen immediately, but it's calling to do its best to keep you in the range as much as possible. And similar, I'd say to the other systems, especially, I'd say more second generation systems is that we are getting, you know, excellent timing range, especially in the overnight period.
Stacey Simms 11:32
It was I laughed a little when you said preschool, as you know, My son was diagnosed before he was two. And whenever I see studies with little kids that work so well, it's so exciting, because you know, that age group, they can't even tell you when they're feeling weird. They can't stomach my son couldn't even pronounce the word diabetes. So it's a different age group altogether. So I was thrilled to see those results.
Dr. Trang Ly 11:53
I know, well, I have two kids under five right now, and they don't have diabetes. And I have no idea how much they're going to ace or whether or not you know how much activity they're going to do. And I just can't even fathom how challenging it would be to have a child with diabetes. And are they low? Or are they or as I just grumpy? asleep,
Stacey Simms 12:18
I didn't have enough. Oh, my goodness, I should have said this towards the beginning. And I know, I know Dr. Like that, you know, this, we use control IQ. We're very happy with the Tandem, but we're not rooting for any system here. I think that the and I say we I mean me, I it's so exciting to see all of these systems beginning to come to market beginning to really have an impact to have differences in their algorithms so that people can pick and choose exactly what they want. And we're just at the beginning of it. So I am so excited to see the study's going so well, I have a couple of questions about what you've already mentioned, on that target of 110 to 150, just to be crystal clear about it, you're talking about not just putting the pump into say using Tandem, for example, exercise mode or sleep mode, you're seeing in you know, my weekday profile, for example, I know my son plays basketball every day from three to seven so we're going to create a profile that changes his blood glucose target for that period of time, perhaps starting you know, before he plays a little bit and then extending after and that's an actual profile in the pump that you then could change. Okay, perfect. All right, that's really interesting. Is there an Is there a and I hate to use Tandem is word sorry, is there an exercise mode or a sleep mode? Or is it just the user sets it as they want?
Right back to Dr. Ly answering that question. But first Diabetes Connections is brought to you by tchibo hypo pin and you know, low blood sugar feels horrible. You can get shaky and sweaty or even feel like you're gonna pass out there are a lot of symptoms and they can be different for everyone. I'm so glad we have a different option to treat very low blood sugar Jeeva hypo pen, it's the first auto injector to treat very low blood sugar chivo Kibo pen is premixed and are ready to go with no visible needle before Jeeva 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. I'm grateful we have it on hand find out more go to Diabetes connections.com and click on the G book logo g book shouldn't be used in patients with pheochromocytoma or insulinoma visit Jeeva glucagon comm slash risk. Now back to Dr. Ly. Going into more detail about how the Omnipod 5with horizon system works.
Dr. Trang Ly 14:36
Separate but yes, what you describe is exactly how our product works or during the day. It might be that you want your son to run out 110 through the day but maybe between the hours of three and seven you'd run at 140 that is an option. And you can set that up pre programmed so that he doesn't have to remember to do that every day or you can run in what we call a hyper protect mode, which is work similarly to like attempt days or that you you'll be familiar with. So that's more of an ad hoc, oh, I feel like exercising for the next two hours, I'm going to set my program in hyper protect mode. And hyper protect, what the system does is it adjusts your target glucose to 150. And it actually gives you less insulin than your basal insulin. So you're running essentially with less insulin on board than you would normally would during that period. And so we we did a lot of studies to kind of land on that design. And we feel that he does a good job of preventing hyperglycemia for, for people without problems asked afterwards. So it has worked well, because it doesn't, you know, sometimes, when you're preparing for exercise, you might take a snack, and that drives your blood glucose up. And then if you have a really robust algorithm that might kick in and give you a fair amount of insulin. So that's what we were trying to avoid with our design was that not just that the setpoint is elevated, but also that the system can't give too much insulin during that time. So that's sort of our equivalent exercise mode. We don't have anything called sleep mode. But as I said, our set point of 110, you know, once were created will be the lowest available in the United States.
Stacey Simms 16:30
One of the things I've learned recently, and I I feel like I haven't seen this reported very widely, is that, unlike Tandem control IQ, the Omnipod system, the Omnipod, five with horizon, learns the user it changes, it has a little bit of I guess I call it artificial intelligence. Is that correct? And can you walk me through what I'm saying? What I mean by that? Yeah.
Dr. Trang Ly 16:56
Yes, yeah, I think I think you're I'm getting to a really key difference between our, our system and others. So with, with our system, when we, when we were developing it, we wanted to reduce the work that comes with diabetes, as well. And so you know, a lot of the work that comes with that is adjusting those or rate adjusting, you know, all the settings and things like that. And so our system, initially, when you, when you have it out of the box, it does rely on your basal rate to start off, automated insulin delivery. But over time, the system learns through the turtle Gary informed that is delivered by the system. So the system knows about this, and can rely on this information, because it's reliable come through the system to augment insulin delivery. So you might have a small child who only has 10 units of insulin per day. Now system is not going to give too much insulin, based upon the fact that it knows that in the last few days, it's never given more than 10 units a day. And so the safety constraints are personalized for that user. And on the opposite end of the spectrum, know, we have users that use 100 units a day. And in that case, the algorithm knows that it can give a lot more insulin, and this person will tolerate it quite fine. Because you know, when you have insulin is unlikely to make much difference for this person who takes 100 units a day. And so as it accrues that information over time, the algorithm does adapt the ability to know how much insulin it delivers based on that information. So what it means is that, in order to get the results we got, you know, you're not having to tweak basil rates on an hourly basis. Sometimes I've seen, you know, people have different basil rates every hour. And what we're really striving to do here at Insulet is create products that reduce burden for people. And that includes including, you know, optimizing settings, so that people can get, you know, so that everybody can get good glucose control and, and not have to rely on perhaps educators and clinicians at the academic centers who are familiar with these devices to really get those good results.
Stacey Simms 19:38
So I'm just trying to understand the the automatic adjustment that you're talking about there based on the total daily insulin. So if after a few weeks of using Omnipod five with Horizon, a person should expect to not adjust basil rates should like what should they be seeing because if like let's say as someone has six different basil, right When they start on the system, what what's happening? Right? What's going on? Are they Is it like the other systems where it's adjusting every five minutes, it's giving you boluses. If needed you How is the smartness of the of the pump working there?
Dr. Trang Ly 20:12
Yes, if you had six different rates running for 24 hours, initially, the algorithm would take that information and would have bent in front of every every five minutes based upon the inputs that were provided to the system, as well as how your CGM is tracking how much insulin on board, you have all of those things. So at all times, the system makes a influence decision every five minutes. So that occurs, as soon as you put the system into automated mode. That happens all the time. And when people ask me about order corrections, I say, yes, this system automates and make some adjustments every five minutes to drive you towards your target glucose. So corrections are incorporated within the system, we don't consider any difference between basil modulation and what was modulation of insulin is insulin. So every five minutes, you're getting a essentially order correction if you need it. But that works very similarly to, you know, the systems that are currently on the market. And over time, the those six basil programs that you have really not utilized in the system at all beyond that first part. And so if you are running high for whatever reason, and you know, you you tweak other things, but not your basal rate. And so I'd say in in that way, you know, our system is more similar to the Medtronic system. And in that way that the basil rates do not directly inform automated insulin delivery. But things that are still under your control at all times is influence coverage, share your correction factor, target glucose, correct above all those settings that have always been within on the pod, and also very similar across many bolus calculators all stay the same. So you're always going to be sort of always going to be directly in control of all those fat. And so if you're running high, it might might be that you need more corrections over time before your system adjusts to that higher insulin requirement. But
Stacey Simms 22:34
you're in control, oh, wait, target number, but only only down to 110? That's right. Gosh, I have so many questions with the automated systems. I think you mentioned this, but I'm not sure. What about insulin duration, is that something that the user can change? Or is that something that is set,
Dr. Trang Ly 22:50
so there, so the Dow system, the user can change that, and how it manifests itself is that it will inform the duration of insulin action for all those manual boluses that you deliver. So if you're someone who's very sensitive to insulin, and it hangs around for a really long time in your body, and you have a six hour early insulin action, then you can program that until you know your bolus of insulin that you deliver at 6am in the morning, that's going to take till midday before it disappears from the system, as it knows that all of those will still be accounted in the same way with the duration of insulin action that you provide to the system. In terms of the automated insulin delivery, we have the intellects, proprietary duration of insulin delivery, that is the input to the insulin model from which we deliver that insulin that is consistent, and is just one value. And it's the same value and the algorithm that's been tested across the board from in all of our clinical trials. So that does not change, and is within the algorithm that dictates that five minutes away insulin delivery.
Stacey Simms 24:11
To me, that was one of the big surprises of using an automated system. We have, you know, My son is 16. And we started using an automated system when he was what 14. So you're in the middle of those fabulous teenage years, and he's using tons and tons of insulin. And it seemed to me that we needed an insulin duration of like two to three hours. And when they switched it on Tandem. It's it's five, I really fought on that thinking this is going to be a disaster, and it was fine. It worked really well. So it's one of those interesting things once you get an automated system and realize this is my opinion, once you realize how much work you were doing to try to stay in range. It's kind of nice to let that system take over once you trust it. And I would assume that that's what you found in these studies. I mean, you mentioned that people spent more time in range, but let me give you the floor. Take a minute or two to talk about. I've seen the study You know, you've been kind of putting them out with different age groups over the last couple of weeks and months, take a moment to brag about the studies.
Dr. Trang Ly 25:08
Yeah, we're so grateful to the diabetes community who really gave this product life through our clinical studies. So I'm just deeply grateful for every patient and family who took part in it. Because without them, you know, be a product, but it wouldn't be Omnipod. Five. And so it was really a ton of work that we I feel like has been many years in the making. Yeah, we've worked really hard on this algorithm to get it pretty much as good as it could be. And, you know, back in 2019, as we were preparing to do these clinical studies, I really wasn't sure about how our results would stack up. But I have to say that I'm completely blown away by how well our algorithm has performed. So in the talk first about our six to 70 year old age group. So the first lot of results that came out came out in March of this year, we had essentially two groups. So we had the children, which were six to 14 years of age, and then the 14 to 17 years of age, which is the adolescent and adult group. So I was just covered the adult group there. So we saw and time in range improvement to 74% in the adult Group, a once the reduction down to 6.8%. And then very minimal hyperglycemia. If you look at our hypo compared to other published data out there, it's the lowest hypo, which we measured by time under 70, compared to all the other groups. And in terms of the children, there's six to 13.9 years of age group, we got to a timing range of 68%. And this was equivalent to 3.7 hours per day improvement. So really remarkable improvement in timing range. And in terms of a one see improvement, we got that down from 7.7%, down to 6.99%. So really remarkable reduction in a one C. And what's super, super exciting is that just recently at Ada to see or wishes a couple of weeks ago, we showed that in the extension faces after the main three month pivotal study, everyone could continue using it if they chose to. And we saw a further reduction in a one C, which is just incredible. So in both the adults and children, we saw a continued decline in a one C. So just really super exciting to see that, you know, our product continues to be helpful for these patients with diabetes.
Stacey Simms 28:05
Let's talk a little bit about the the setup of the system. You know, when in the very beginning of the interview, I asked you to kind of describe it. And it's Omnipod Dexcom, G6, and then a controller of some kind. Let's talk about the controller. Last I had heard this was going to be the PDM. If needed, the more traditional I guess you'd call it but you'll expLyn it to me or an Android phone. Tell me about the controller in the short term. And then we can talk about what you're planning.
Dr. Trang Ly 28:32
Yeah, that's right. So we will have the controller device. So we have an Insulet provided controller, which our were choosing to use that word over PDM. Because not everyone knows what a PDM is that yes, that controller device, we will always ship with our product. And so you will be able to use that in a locked down device which can only communicate with pods and can't really do much else with it. And but users will have the option to download an app from their from selected android phone to also have that same experience. So it's the exact same app that would be that would exist on the controller. And you would be able to essentially control your parts and replace that controller with the Android app.
Stacey Simms 29:25
I should have said the PDM stands for what personal diabetes manager. That's right. Okay. So that's an antiquated term now, though, so we'll put that aside. But to be clear, so if I have the right Android phone, you're seeing this is not a lockdown Android phone, I can get this the app and I can use my personal phone to control my Omnipod five with horizon system.
Dr. Trang Ly 29:47
Yes, that's right. That's what's currently in front of FDA right now.
Stacey Simms 29:51
Do you know and again, if it's up to them, or you can say I know we're limited sometimes what models or is there a list somewhere?
Dr. Trang Ly 29:57
Yeah, we haven't. I don't think We have indicators or phone models that will be available at any time. But we'll do that soon after launch will list those out that they will be as the first offering selected Android phones.
Stacey Simms 30:14
And I would assume the plan is to eventually go to all types of phones, including apple. That's right. My question for Omnipod is always what I'm about to ask you. But phone control makes it a little bit obsolete. And that is why no button on the pod why not even like a one dose one unit or something on the pod?
Dr. Trang Ly 30:34
I've been asking this, since I've had the podcast. Yeah, I think he just originated with the original design. And I think perhaps, because it really started originally with the idea of children using our device, and having that separate controller to track all the information. I think just at that time, because it was primarily a product for children, we wanted to make sure that infant delivery was always, you know, very intentional, and not unintentional. And so would always to have that remote control potential and and not have any, you know, button on the pod, which could lead to accidental or insulin deliveries, unintended,
Stacey Simms 31:21
or just a couple of laundry list type questions. Dexcom has already announced that they're going to seek FDA approval for the g7. Soon, I would assume that Omnipod will eventually, you know, work with the g7, which should users should be concerned at all about that kind of compatibility?
Dr. Trang Ly 31:38
Yeah, I think eventually, you can expect that, you know, systems that are integrated with G6 Today, we'll be working towards g seven in future. You know, I think the whole idea of interoperability reach was beheaded by the FDA really enables companies to work faster to integrate with future versions of systems. So you know, we we want to be at the leading edge of that innovation. And I think that will come with time. We I don't think we've announced any times or dates regarding that. But it is something that, you know, we fully intend to support.
Stacey Simms 32:17
And this may be another business type question. But everyone who's using Omnipod right now, what's the plan for current customers? We're getting ahead of ourselves, I know the system's not approved. But can people using arrow so dash expect to kind of be seamlessly switched over to Omnipod? Five with horizon?
Dr. Trang Ly 32:35
Yeah, I don't think we have released all the information regarding how we're going to transition our current customers. Yes, I don't think that that is publicly available yet. But we, you know, one thing we do strongly believe in is supporting our current customers. And what we have said is that Omnipod five will be available via the pharmacy channel at price parity kadesh. And so what that means that if you are already receiving cash today that you're going to be in a very good position to have coverage for Omnipod. fi. And but we haven't detailed the information regarding you know, how we're specifically transitioning every single patient at this, at this point,
Stacey Simms 33:25
separately from the pod. tide pool loop is also in front of the FDA, as you and I are speaking, I'm not even quite sure really what to ask you about this doctor, like because I know it's coming from tide pool. But can you share anything about the relationship from Omnipod to Tandem? And how the loop project is going? It's kind of a it's a different animal kind of out there. But I don't want to leave without asking you about it.
Dr. Trang Ly 33:51
Yeah, you just said Omnipod to Tandem, but I'm
Stacey Simms 33:54
so sorry. Yes.
Dr. Trang Ly 33:58
Yes, yeah. Well, that is title program. So it's best that you speak to Howard about that. But it is a program that we support. And and we certainly, you know, believe in interoperability and supporting points for our users. And yes, you're right. I believe the last update is that it is currently under review with FDA wouldn't use the dash parts, or does it use it with Omnipod? Five. So it's, it's not it's not going to be backwards compatible with dash pod
Stacey Simms 34:35
guidance. My next question was, so if Omnipod five with horizon is approved, Omnipod is manufacturing the same pods for both systems. That's right. I know you know, I'm not sure we're supposed to talk about it. But I know you know, because you've spoken to the loopers groups and you speak to people all the time that there's a bunch of people using the older pods, the arrows, pods, I believe for a nod FDA approved system, they're looping with the separate from title loop, they're looping with those pods is only going to keep making those pods once this new system is approved,
Dr. Trang Ly 35:10
we haven't said exactly when we will stop making those pods. But I think the community should expect which and I know that they already do that at some point in time in the near future, we would need to stop making those pods. And that's for a variety of reasons. But as you will know, Stacy, and many of your audience will know, you know, that is much older technology. And you know, we prioritize innovation that is going to work well and be safe for our users. You know, that's partly why we moved to dash to integrate Bluetooth technology. And then which has enabled us with Omnipod, five to talk via Bluetooth to CGM. So that type of safe integration is really important to us in our future offerings of product. And so at some point in time, that will, we will need to start making that and also, you know, that is with all the technology, all the components, and etc. So, once that happens, though, we will let the community know with sufficient time so that people can prepare for alternative methods of therapy. And hopefully that will be Omnipod. Five,
Stacey Simms 36:25
you've been so generous with your time, I just have a couple of more questions. I really appreciate it. One of the questions that was asked in the podcast Facebook group was when approved, how will the training for this go? In other words, with control IQ, I sat down, I took a course I took a quiz. And once I passed it, my doctor had written a prescription. And we got the downloadable, you know, into the pump. And we were off and running did not meet with a diabetes educator or an endocrinologist to learn how to use control IQ. What will the system be for teaching people and getting Omnipod? Five to them?
Dr. Trang Ly 36:58
Yeah, so for people who are already using Omnipod dash, you can expect that the experience will be similar to what you just described for control IQ. So you will not have to meet someone in person in order for you to start that system up. So it will be similar in a training quiz, number of steps. But you can do it all self directed and be often running on Omnipod. Five, or you can choose to speak to someone or meet in person with an educator if you wanted more information about for instance, how the algorithm works or whatever question you had on your mind. But for brand new users who've never used a pump before, then it will there will always be in person training, or virtual training. You know, there's some things that you we still feel that is necessary to cover, you know, basics of pump therapy that will require meeting with their certified trainer to go through. But yes, we're current on the Pog dashes as you can expect the transition to be fairly seamless.
Stacey Simms 38:08
Another question that came up was about insurance coverage, but particularly Medicare. Can you speak to that? Yeah. So
Dr. Trang Ly 38:15
currently, we have Medicare coverage under Part D, which allows for pharmacy coverage of the pod. So we do have that. And they only came in recently in the last I'd say three years or so. So once that came through CMS, we worked with many plans to get Omnipod covered under that peptides for Medicare. So one of the things that, you know, we're working on well, FDA clearances, is still under review, we are working on making sure that we get as many people covered as possible. When Lord, they come. So yeah, it's a major priority for us to make sure that our patients get covered for this product.
Stacey Simms 39:06
You referred back a couple times to your days as a pediatric endocrinologist. How exciting is this for you? You know, the people that use this product, you know, the people that use other automated pumps. Can you speak a little bit just from your personal side about the excitement because you know, this is going to help people?
Dr. Trang Ly 39:25
Yeah, it's just incredibly exciting. And maybe not everyone knows about this. But yes, Stacy, as you mentioned, I am a pediatric endocrinologist. And it's actually about 10 years ago now, but I did my very first study in automated insulin delivery and that was back in Perth in Western Australia. And in that study, we use a Medtronic pump add to Medtronic sensors and a blackberry phone and the algorithm was on a blackberry phone and it was I haven't mentioned this to many people. But those those sensors were, you know, were challenging at times to deliver insulin from. But it was such important studies, in terms of proof of concept to show that, you know, we could augment insulin delivery and, and making that decision every five minutes gets you in better glucose control. And it was really extraordinary. And I still remember the very first time, the very first patient that I put the system on, and, you know, and I was watching that insulin being delivered. And I remember just like hugging the participants, Mom, because, you know, we just both knew how incredible this was going to be if, if this could reach masses of people, it's always been for me, something that will be realized. And, you know, it has been through really great products like control IQ. And you know, soon Omnipod five will be out with a great algorithm. And because we just know that this type of technology is what is going to allow parents to sleep at night and let people be comfortable with their diabetes and be more confident about it so that they can focus their brains on other life decisions and not be so consumed by their diabetes. And so it is really incredible for me to be able to see the results of our algorithm just works so well in such a huge population of patients, even in just in clinical trials today. And I just know that there's going to be incredible impact from this product in future when we launched.
Stacey Simms 41:47
Well, thank you so much for coming on and sharing so much information. We're all excited to see what happens next. And I hope that you are you know, other folks or Insulet will come on and share more information, you know, fingers crossed as the rollout happens. So thanks so much for joining me.
Dr. Trang Ly 42:02
Thank you so much. So happy to be on.
Announcer 42:09
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 42:15
Lots more information at Diabetes connections.com. I know the one question everybody asks that we cannot answer is when will this be available, it will be available when the FDA approves it. And you know, that could come any minute it could come in a few months, you know, we are not privy to that information. But once it is available, it will take a little while to roll out. So Omnipod I'm sure we'll make a lot more information available as we move forward. We'll talk to them again. And we will answer as many questions as possible. Also got a lot of questions about insurers, that's going to depend as well, quite often, insurers will not initially cover new products. I know Omnipod is talking with everybody. But it may take a little bit of time. So we'll circle back on all of that it is difficult to pick and choose the listener questions that I asked but I really try to focus on what I know the person that I'm talking to can answer and I thought Dr. Ly was was really fabulous and spoke to me frankly, for longer than I expected. So I really appreciate her sharing so much information with us. And I hope you found that helpful.
All right. Diabetes Connections is brought to you by Dexcom. And I do want to talk for a moment about control IQ. You heard me mention that several times during the interview. That is the Dexcom G6 Tandem pump software integration. When it comes to Benny's numbers, you know, I hardly expect perfection I want I'm happy I'm healthy. I have to say control IQ has exceeded my expectations, Vinny is able to do less checking and bolusing and is spending more time in range. His last couple of Awan C's were his lowest ever and this isn't a teenager, the time when I was really prepared for him to be struggling. His sleep is better to with basil adjustments possible every five minutes, the system is working hard to keep them in range. And that means we hear far fewer Dexcom alerts, which means everybody's sleeping better. I'm really so grateful for this. Of course individual results may vary. To learn more, go to Diabetes connections.com and click on the Dexcom logo.
Before I let you go, we're actually traveling this week. So the interview with Benny about Israel is coming up and thank you so much for all of the questions that you have sent in. There was a Facebook group posted Diabetes Connections of the group. If you want to chime in and ask me some questions to ask my son who recently got home from one month overseas. He is 16 and he was with a camp group but it was not a diabetes camp. He's home safe and I've done some debriefing with him. It was really interesting. And Gosh, teenage boys. So interesting. I can't wait to share some of his stuff with you. And some things I'm not sure I will share. No I mean we're pretty much an open book but he right he doesn't really handle diabetes exactly the same as I would but home safe and sound and really did very, very well. reminder that on Wednesdays I do in the news live On Facebook on Diabetes Connections, the Facebook page, and that becomes a podcast episode on Fridays I, as I said, I'm traveling, so hopefully technically all will go well, we shall see. But that in the news episode has become a lot of fun, frankly, and people really enjoy that still short, so I'll put that out as well.
And then in the weeks to come, I have some great interviews for you. We have interviews about sports and being very active. I have an interview with the folks that have Afrezza that I'm really excited to bring to you. It's been a while since we spoke to them. And of course, that interview with Benny, so lots to come. thank you as always to my editor John Bukenas from audio editing solutions. I 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.
Benny 45:46
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
What do we know about the upcoming Dexcom G7? Find out in this conversation with company CEO Kevin Sayer. As usual we have a long list of questions from you covering everything from adhesives to watches to more. Sayer shares details about how they’re preparing for the G7 rollout (it has not yet been submitted to the FDA), as well as issues with Medicare, integration with their current pump partners and when arms will become an approved wear site for US customers.
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
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 autoinjector for very low blood sugar, and by Dexcom: help make knowledge your superpower with the Dexcom G6 continuous glucose monitoring system.
Announcer 0:23
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:29
This week, a Dexcom update from the company's CEO. As usual, we have a long list of questions from you, covering everything from adhesives to watches to more about the upcoming G7.
Kevin Sayer 0:41
And the goal is to simplify CGM for everybody across the board. What I often say is everything you love about G6, you'll love more about G7. The size is so small, you don't really recognize it's on your body. It's really a great profile, a little bigger than a nickel.
Stacey Simms 0:56
CEO Kevin Sayer will also share details about how they're preparing for the G7 rollout once it's approved, as well as details about Medicare and use but their pump partners. This podcast is not intended as medical advice. If you have those kinds of questions, 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. I'm your host, Stacey Simms, my son Benny was diagnosed back in 2006, just before he turned two. He is now 16 and a half. My husband lives with Type 2 Diabetes. I do not have diabetes, but I have a background in broadcasting. And that is how you get the podcast. My usual disclaimer, whenever we have them on, Dexcom is a sponsor of this show, you will hear their commercial later on. It's because we love the products. But when we have people from Dexcom on as guests to give you information, they don't tell me what to ask or what to say outside of that commercial. And I just want to take a minute to say, I very much appreciate Kevin Sayer and others from Dexcom being so accessible over the years, you know, they don't always answer my questions, but at least they come on and address them and listen to them. There are a lot of companies that are very reluctant to even do that, who won't come on the show. And that's really unfortunate because you, as you listen, and you know the diabetes community overall, I'm very much entitled to speak to these people and to these companies. So I will keep pushing nicely, but I'll keep pushing, I promise.
Quick heads up, there will likely be no longer format episode like this one next week. I'm still gonna do the "In the News" episodes that I have added live on Facebook and then turning them into podcast episodes. But I am, as you listen, if you're listening as this episode is going live, I'm at Friends for Life. I'm at that conference. They're having it again. I'm so excited. It's the first diabetes conference I have attended since February, no, since the first week of March of 2020. I went to a JDRF conference in Wilmington, just as COVID was beginning, it was very weird. If you did anything, any kind of public event in March of 2020, you remember that. But I'm back, they're back, I'm at Friends for Life. And I really don't want to rush out an episode. But if anything exciting or you know, breaking news happens or I'm able to record something and put it out, I will. But just a heads up, likely no episode next week.
Alright, and this week, not much of an introduction needed. Kevin Sayer is the CEO of Dexcom. And this interview focuses on some of what came out of the recent ADA scientific sessions and ATTD conferences. But mostly I share your concerns and your questions. We've covered a lot of these issues before, I don't ask a lot of follow up about things that, in my opinion, you can easily Google up. As usual, I had limited time with Sayer, who was doing back-to-back interviews. So if you have a specific question or if things went by very quickly, definitely jump into the Facebook group. You can comment on the post with this episode. We have some amazing members who will answer your questions, who will show you where to find the information. It's likely a previous episode, but we have people in clinical trials, we have people who were in on a lot of the investor calls. They listen, they take notes, they're fantastic. So if you haven't joined Diabetes Connections the group on Facebook, I highly recommend it.
My interview with Kevin Sayer here 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 or sweaty or even feel like you're gonna pass out. There are lots 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, it's the first auto-injector to treat very low blood sugar. Gvoke HypoPen is pre-mixed, it's 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 gvokeglucagon.com/risk.
Kevin, thank you so much for jumping on with me. Another busy time for you, as so many presentations, lots of studies, lots of news, lots of upcoming and anticipated news. So I appreciate you spending some time with me and my listeners.
Kevin Sayer 5:11
Oh, thank you for having me. It's always fun.
Stacey Simms 5:13
Let's set the table a little bit here. We are following up on the ATTD conference and you are in the midst. Dexcom, as we're speaking of ADA, this is all still virtual though, right?
Kevin Sayer 5:25
It's all still virtual, yeah. I was looking, was hopeful earlier this year it might be in person, but not yet, probably not till next year.
Stacey Simms 5:33
Well, as we look through the news that is coming out of both of these conferences, I could just start out by saying it's kind of, I'm not sure victory lap is the right phrase here. But it does seem that almost every study is basically, Kevin. CGM works, it's good, it helps, we get better outcomes from it. So let me just give you a moment to talk about some of that. Because there were so many, we can't really touch on all those studies.
Kevin Sayer 5:58
There are so many studies, and it's good for a number of different groups as well. You've got all the automated insulin delivery studies, and other than Medtronic's product, all these other studies are powered by Dexcom. You've got stuff in the UK, France, Insulet Tandem in the US, there's a lot of good news on the automated insulin delivery system front. And all these works are powered by Dexcom G6 right now, you've got studies that we presented at ATTD ast week, or that were presented by physicians that we're very well aware of. The mobile study, which was for patients with Type Two Diabetes who are on basal insulin only. You know, when you start a study like that, it's kind of a risk, because you ask yourself the question, "What happens if it doesn't work?" Well, it works. And what we learned is these patients, even though they're not making a decision every four or five, six hours, for eating, they are making decisions about what they eat, and what they do and how they exercise when they can see data. And they can see the effects of what goes on in their lives. And their time in range goes up significantly, if they can see what their time and range is, you know, they've been operating in the dark, and people would argue that they don't need it all the time, like I do. And so that study, we think is just really good and will be the basis, hopefully someday for getting CGM coverage for that group of patients. And so we'll push on that one. There was another study we had last week, or at ATTD. Early in the month, published in Belgium, where a coalition of diabetes gurus I guess, over there's the best I'd call them, it's really all the leaders in the Belgian diabetes community, took a bunch of intermittent CGM users and put them on Dexcom G6 for an extended period of time. And then we looked to see what happened. And what we saw is on real time CGM, the patients are better in every category, every single category, time in range, hyper(glycemia), hypo(glycemia), you name it, they did better. So we really did validate the Dexcom equation over competitors with that study. And we think it's very important and they realize real time CGM, it is important, it is important for data (to) be accessible. And the alerts are something that you can use. There are other studies being presented by other people in the Type Two, Arena-Kiser's got a study where they show patients do well on, Doulas got several studies, they're across the board. And the evidence is building for these other markets. But it starts at the beginning, obviously with automated insulin delivery and, and we work our way down. But we've had information presented across the board showing the utility of Dexcom. And if you've been to this study, this meeting 10 years ago, like I was when I first started here, my literally, my first month was my first Dexcom ADA, nobody even knew who we were. And those who did said yeah, the product's not real great. So times have changed pretty dramatically.
Stacey Simms 8:41
Do you remember what that first study that was presented at ADA or ATTD? Which one it was that you were there for 10 years ago? I'm curious of that.
Kevin Sayer 8:50
Back in the day?
Stacey Simms 8:50
Yeah.
Kevin Sayer 8:51
First study, we didn't even present studies. Back then, we, I will tell you the most important study we did, we did a study in where we first got ADA recognition, we did a study with our G4 system against a competitor in Europe. And we got a bunch of recognition there. And then the next study that really got us a lot of recognition in ADA meeting was our DIaMonD study where we show the people on multiple daily injections. If they went to CGM, they would get much better results. What it was hard for me to learn is you don't say I want to do a study like this and get it done in a week. It takes a couple of years to accumulate all the proper data, process it, develop all the subsets and everything. And so my patience has been has been level set with respect to studies like this. And there's multiple studies going on in the field that will be presented over the next several years.
Stacey Simms 9:44
All right. Well, that's a really good segue to moving ahead, because, as you know, my listeners are very interested in this technology. And the slide that probably got the most attention in our groups was one that was presented at ATTD about introducing the Dexcom G7, showing all of the features of this. So let me, I'm not going to go through all of them, obviously. And you and I've talked about this many times before, but faster warm up. It's smaller, simple application, all in one. This is all still part of the plan, as we had talked about before.
Kevin Sayer 10:19
Oh, yes.
Stacey Simms 10:19
Okay.
Kevin Sayer 10:20
Yeah. And, you know, we started working on the G7 before G6 was even in clinical trials. The G7 is a project we've envisioned for a long time, Verily, actually it was Google Health before then, Verily was a partner with us in designing this product, and we (were) working out for quite some time. And the goal is to simplify CGM for everybody across the board, what I often say is everything you love about G6, you'll love more about G7, the size is so small, you don't really recognize that it's on your body. It's really a great profile, a little bigger than a nickel. We're running this study with arm and abdomen indications. And while patients wear them wherever they want, we're going to show you that it can be worn wherever you want. And I think that's a big deal, that we go ahead and do the work to do that. The faster warmup is kind of mind-blowing when you put a G7 up and then you look after you pair it. And then you look and see you only got 25 minutes left, it's like, oh, wow, I don't have to do the two hour countdown. You know the accuracy and performance that Jake presented at ATTD shows that we're not, we're not ever going to go easier on the performance side and say good enough, we always push ourselves to offer something that will keep people safe and confident with what they have. The app is completely new, we'll build things into the app over time, like automated, the frequently asked questions feature we have now but we're just gonna keep making it better. Some of the features of our Clarity system will ultimately be in the app. So you'll get more information. When you go to it and look at it out of the get go. You know, we'll get it approved. It'll be a while before our partners have integrated their systems. But we're working with Insulet and Tandem already on G7 integration, it'll be able to talk to multiple devices at the same time. Its manufacturing cost ultimately will be less expensive. It's been designed for an automated process. And we've got fully automated lines up and running to assemble the G7 sensors. We have, in fairness, have automated G6 lines up and running now too, but we've got special transmitter lines and center lines and those kinds of things. It is going to be, a really, the most advanced CGM ever.
Stacey Simms 12:25
Well, you've touched on a couple of listener questions already in that testing alternate sites, including arms, integration with the systems that are already using G6, so I don't want to spend a lot of time going in depth on things that you've mentioned. But in the slide it said direct to watch capability.
Right back to Kevin clarifying what was meant in that slide. But first, Diabetes Connections is brought to you by Dario Health and bottom line, you need a plan of action with diabetes. We've been lucky that Benny's endo has helped us with that and that he understands the plan has to change as Benny he gets older, you want that kind of support so take your diabetes management to the next level with Dario. Their published studies demonstrate high impact results for active users like improved in-range percentage within three months, reduction of A1C within three months and a 58% decrease in occurrences of severe hyperglycemic events. Try Dario's diabetes success plan and make a difference in your diabetes management. Go to https://mydario.com/diabetes-connections for more proven results and for information about the plan. Now back to Kevin Sayer, answering my question about what the company means when it says the Dexcom G7 has direct to watch capability.
Kevin Sayer 13:44
Capability. Yeah, it won't go there first pass. But we had to have different electronics and a different radio set to go direct to watch than what we have in G6. And it's easier to get us to change than it is to get Apple changed or to change their watch. And so as we were doing the G7 system, we did contemplate that. So it is configured to do so, I do not believe it's in the first release. But it will be not long after that. We'll have a direct to watch capability. And we know people really want that, the watch presents interesting problems. And we can all sit and say we want that. But you have to charge your watch every day or at least every 36 hours. Where are you getting your alerts if you're direct to watch and it's on the charger? And you're in different parts of your house? There's complexities to the watch that go far beyond just direct to connect. And particularly with the FDA who've used the alerts in the alarms and the connectivity is so important that we had to make sure we do it right. So we'll work on that and get it wired appropriately. But I look, I know what something I would want If I were a user. So we continue to push for it.
Stacey Simms 14:44
Just to follow up on that. When you say it won't be in the first iteration of it but you know, it'll be, it's capable, it'll come, that it kind of implies that you figured out what to do with the alerts and alarms when someone hangs it up to charge.
Kevin Sayer 14:56
I don't know what they have figured out. I just know they're addressing it all. I have to plead the fifth, I just, as I've asked that question, they said, "Well, here's a problem. How are you going to deal with that?" I said, "Well, you guys don't have to tell me." They'll come up with the right answer, Stacey.
Stacey Simms 15:09
Alright, so, I'm sure they will, but to say direct to watch capability, there's a little parentheses that says when we figure it out,
Kevin Sayer 15:15
Oh, I know we're working on it, but...
Stacey Simms 15:17
Okay.
Kevin Sayer 15:18
But Stacey, we couldn't even go direct to watch before with the electronics. We couldn't go direct to watch with a G6 transmitter, the G7 electronics stack and configuration is such that it can go direct to the watch, we could not with G6.
Stacey Simms 15:32
Okay. Many more questions. My listeners are very, of course, interested in the adhesive changes. Is the G6 to G7 change, I know you're addressing this, I know you're testing it, we've got emails from people who are in different trials for adhesive and reactions and things like that. And I have lots of questions, people say it's getting better, other people say it's getting worse. Anecdotally, it's very difficult, obviously, for me to know. Talk to me a little bit about those changes and how it's improving.
Kevin Sayer 15:58
Well, we've tested numerous adhesives before we landed on the adhesive we selected for G7. One of the reasons we kept the product life down to 10 days is to make sure we have enough adhesive to get to that 10 days. We'll be putting the overpatch in every box. So if somebody wants an overpatch, they don't have to call us. So everybody should be thrilled with that one. And it's quite easy to use, we're hopeful that there's no allergy with G7. Somebody's always gonna have a reaction, that's just physiology, but we're working with new tapes for G6 already, where it will hopefully have something. The things that cause a lot of the allergic reaction in G6 we've eliminated from the G7 manufacturing process. So we're hopeful that a lot of this stuff goes away on its own, we'll monitor it very quickly. But we've already got four or five other G7 adhesives in test in addition to the ones that we're going to launch with, to make sure we can create better options in the future if we need to. So, you know, stay tuned on that one, we are comfortable. As I sit here, we will not have the same level of reaction that we would have at G6 when we change it. But yeah, we won't know till we're out there.
Stacey Simms 17:09
Yeah. And you mentioned the 10-day wear and part of that being for adhesive. But my understanding is that the idea is for 14-day wear for Dexcom G7.
Kevin Sayer 17:19
Eventually.
Stacey Simms 17:20
Eventually.
Kevin Sayer 17:21
Eventually, not again, not first pass. We'll get it approved with 10-day data, very important to us is that we provide our customers with the experience they paid for and they signed up for. And we've looked at competitors' reliability data, how many make it out to 14 days, or how many make it to seven days if they only have seven, and we look at, it's one of the key management indicators, we monitor how many of our sensors are making it out to 10 days, and we've set a pretty high bar for how we want our system to work. And while we could have launched a longer lasting product, we wouldn't have hit the percentages with the configuration that we have. And so we said, OK, 10 days is enough. Our patient base is fine with 10 days as long as we deliver on the 10 days that we promise. And we'll get into longer live trials literally as soon as we're done with these and hopefully move it over. Because that does cost us a lot less and give us more pricing flexibility over time for the various groups. But for now we'll go 10 days, mainly, so we have more reliability. That's the biggest reason.
Stacey Simms 18:22
I have a few more G7 questions, but they're about pricing and accessibility.
Kevin Sayer 18:26
Well, I, you know what I can, I can't answer most of them...
Stacey Simms 18:28
Okay.
Kevin Sayer 18:29
...because we can't really go address pricing until it's approved.
Stacey Simms 18:32
Right.
Kevin Sayer 18:33
And we have as we put our G6 contracts together over the past couple of years, done so in anticipation of a G7 product to whereby, for example, for Medicare, it's a fixed charge per month. And for many of our insurance contracts, it's resembling more that type of business arrangement, we're hopeful that we can transition to G7 very quickly. But we will have to go to all your payers and get G7 covered before they'll pay for it. We're hopeful that'll be a quick process. But in the meantime, G6 is a great product and people will be able to use it. I can't give you a timeframe as to how long that'll take, we'll have to go to CMS, we'll have to go to all the Medicaid groups as well. What we're trying to avoid, and let me repeat what I don't want to deal with, is one of the things I dealt with with the G6 for a long time, we didn't have enough inventory of production capacity to get it to every group. So the Medicare population was stuck with G5 for quite some time. Those emails were not good. We want to make sure it's equal access when we can get it in the channel for everybody. And we're trying to build that type of capacity.
Stacey Simms 19:34
A couple of "what-if?" questions, just kind of looking down the road. JDRF recently announced that they are looking for and this is the very beginning. So as you listen or as you're watching, this is not in the works yet, this is a call for research, that they are looking for a CGM that could also measure ketones, and I haven't seen any companies step up yet publicly to say yes, we're working on that, we'd like to be part of that. Is that anything that Dexcom is thinking of doing?
Kevin Sayer 20:02
We've explored this for quite some time long before the JDRF initiative. And the question I keep asking, is continuous ketone measurement important? We know that for the pediatric world, that if you measure ketones continuously, you might predict dangerous DKA moment before it happens. But at what cost to the system? And is there a cost benefit associated with this? So we're setting all those things. We're in the learning phases, we think we have a platform that can do that. But we've got to decide do you sacrifice glucose accuracy? If you throw a ketone sensor on there? There's a lot of answers we don't have yet. But we're in the early phases. And we've talked with JDRF and others about it, is there a better way to measure ketones that might be easier and less expensive? I don't know. We've looked at several other analytes to go with our system over time. And I think in the future, that'll be something but that's not coming from us for at least three years, if not longer.
Stacey Simms 20:56
Got it. You've looked at other...
Kevin Sayer 20:58
Analytes
Stacey Simms 20:59
Analytes, tell me about what else has been looked at just for, you know.
Kevin Sayer 21:03
Well, I won't go into all of them. I certainly look at lactate from a stress level. And for physical fitness, for example, there are a lot of athletes who'd like us to produce a lactate sensor to whereby they can measure the progress of their physical fitness. There's also a use for lactate in the hospital environment with we think with respect to predicting sepsis over time, but those are you know, that's one of them. And we've looked at a few others and failed, I won't go into all those.
Stacey Simms 21:31
That's okay.
Kevin Sayer 21:31
We've looked at some that may be promising. What we find from time to time is yeah, what we'd love to measure but we can't is insulin on our wire. If there are any way we could measure insulin in addition to glucose, wouldn't that be awesome? We know exactly how much insulin you have on board. And we know exactly well, we, we've not been successful at that one. That would require different technology than what we have. So we look at all of them. And over time, we think we'll have some good stuff there. But not for a while.
Stacey Simms 22:00
Um, you know, you mentioned hospitalizations. And last year we talked about the CGM program in hospitals. Forgive me I, there were so many studies at ADA and ATTD, I don't know if this was presented. But let me ask a general, how is it going? Are hospitals adopting and adapting to using a CGM?
Kevin Sayer 22:16
They are adopting and adapting is harder than adopting.
Stacey Simms 22:19
Yeah.
Kevin Sayer 22:20
Because, you know, this is a device that was designed for your listeners. And for you. It wasn't a device that was designed to be used in a hospital room. With all of the cybersecurity and connectivity issues of a hospital, where do we send the information? How do we get it there? And so we've got to solve the workflow issue to make this meaningful in the hospital environment over time. What we have learned is our technology is more than good enough to go there. And that the places particularly where you have an endocrinologist very heavily involved in treating the diabetes patients in the hospital rather than a cardiologist or somebody else, when there's an endocrinologist involved, we can go very quickly, they can learn. Some of the hospitals would take an approach, let's put this on everybody. Others would only take an approach, let's put this on severe cases. So there have been different protocols used. But by and large, the response to CGM in the hospital has been very, very good. And we think it is a great market for us over time, we've got to work on the proper configuration for workflow. I mean, one of the best examples, how do you get the data to the medical record? Because everything in the hospital goes to the medical record. How do we make that seamless? We haven't figured that out yet. And that'd be important for all of our users even outside the hospital. Imagine how much easier would be to go to your doctor and have your Dexcom data already sitting in the medical record when you get there. We're not there yet. But we're having a lot of good discussions on that front.
Stacey Simms 23:41
Got it. One of the topics that's been kind of in the community recently, and I don't think it's so much Dexcom. But I want to ask you, anyway, is this issue of and you mentioned, athletes who want to measure certain things, of people without diabetes, using Flash glucose monitoring, or continuous glucose monitoring. I'm curious is that a market that Dexcom is looking to pursue? I mean, the G7 is smaller, it's lighter. And you know that I'm asking this because we've talked many times before. People who use insulin are very much afraid of not being able to afford, being left behind if many, many, many people who may not use it in the same way, start adopting these products.
Kevin Sayer 24:19
Let me address that in a couple of steps. Let's talk about the use case first. There are people, a lot of people using Dexcom, who do not have diabetes, as a health and wellness tool. And there are a number of apps that are being developed that require glucose information to level set your nutrition. Now, possibly Type Two diabetes or prediabetes, but there are groups and some groups with some very interesting ideas as to how to change your diet based on glucose data to make you healthier. We were used many years ago on The Biggest Loser with every patient that came in the door and one of the production people, I don't remember which one, might have even been the physician, came to me and said, "You need to get out of the diabetes business. You can make a lot more money in weight loss." Well, we're not getting out of the diabetes business, that's where we are and where we stay. One of the things we've contemplated with G7 is the fact that we're going to go to more people. And we're going to go to more people than just the Type One population. We plan on having capacity to build over 200 million sensors, before the end of 2023. 200 million sensors is gonna be more than enough for the intensive insulin using community. And as far as cost, well cost comes down if we can sell that much in volume. Now,
Stacey Simms 25:29
Well, hello...
Kevin Sayer 25:29
I would also argue...
Stacey Simms 25:30
You're in the American healthcare system, Kevin. You know this is not a market-based device, we don't...
Kevin Sayer 25:36
I'm aware, I'm aware of that.
Stacey Simms 25:38
I'll let you finish, I'm sorry.
Kevin Sayer 25:39
Let me keep going. At the end of the day, as you look at what somebody pays for taking care of themselves with delivering insulin and powering the insulin pump, that's a very complex task that requires a lot of customer service and support. If somebody is only losing weight, that's a different problem we're trying to solve, or if somebody is trying to titrate a Type Two drug, that's a different problem. I think we can find a way to make everybody happy. I don't think we're gonna disappoint anybody. And we planned this company and built this company to make sure that we have capacity to do all this, it's, you know. It's, one would look at me, I mean, we're gonna spend over a billion dollars on these factories over the next two, three years here. This is not a simple endeavor, it is a large investment. And this technology first goes to the community that we serve, now worldwide. We have to expand worldwide, but get it to the group in the US as well. After that, we'll go the other places, but we're going to have more than enough capacity to do that. In fact, one might question if I'm insane, or we're insane to create so much capacity and the 200 million, quite candidly, the wave design, the G7 lines, if we need to sample at a factory, we can do it very quickly. So this is a, this is a long term play for us. We believe this technology be beneficial to a number of people. And so if we can get, if we can get all these sensors out there and all these uses, I think it'll benefit your audience more than it'll detract from.
Stacey Simms 27:00
I know we're going to run out of time. I've got two more questions. You've mentioned,
Kevin Sayer 27:03
You got them, I'll give you time for two questions. Let's finish.
Stacey Simms 27:06
Okay, alright.
Kevin Sayer 27:07
Finish the way you want.
Stacey Simms 27:09
You mentioned already, lots of different apps are being developed, not all diabetes. You know, a couple years ago, Dexcom announced the availability of the API, you know, developers can get data through third party apps. I'm curious, is there anything going on maybe behind the scenes? Or are you doing anything further to kind of foster more innovation in the early stage, like the development of other companies? Or is that a thing of the past?
Kevin Sayer 27:31
No, I'll give you two things that we're doing. Number one, we have a live API use where you can have a live display of the data. That's on file with the agency right now, it'll eventually get approved. So you'll be able to run the Dexcom app, data'll go to the cloud, comes straight down to another one. I think that is a very good use of the technology and it shows our willingness to work with others. So that is a good use. One of the other things we have coming, then we'll see where it goes. Our intended use case in the beginning was with major healthcare systems. But we have another app that we've shown pictures of, it's an app inside an app. So let's say for example, you go to Scripts here in San Diego, I'll pick Scripts, and Scripts has their own healthcare app. And they also want to be the center of your diabetes care, particularly for Type Two diabetes, and they might have you wearing a sensor for something other than isulin delivery. We've developed an app that can reside inside another app, to whereby you can have your Scripts experience, but you can touch an icon and you go to a Dexcom experience. And it, it's an app that resides inside the app and for security, we're able to keep others out. That app inside the app concept is nothing we've done to commit to others, to give them an opportunity to use Dexcom technology in a different way. And yet preserving create their own experiences. We're very cognizant of the fact that we can't solve every problem, and there might be better experiences. And we can create. Okay, got time for one more.
Stacey Simms 28:54
All right, last question. And it's more of a request. But the question is when you, and this is from a couple of listeners, when you start rolling out the G7, any consideration for including and this may be an insurance question too, one extra sensor a year? So three in a month.
Kevin Sayer 29:10
What a wonderful question. And let me tell you something, we spend an inordinate amount of time analyzing sensor failure and returns and those types of things. We have run models that say if we give everybody, if we just gave everybody x more sensors a year, we could avoid all the phone calls and all of the issues and all that stuff. We analyze this warranty policy all the time. And I think what you'll see with G7, we'll have better tools. My hope someday just for your users, I would love to just diagnose this in the app in general, to whereby if your sensor fails, we know when we say your sensor failed, tap on this icon to get a new one. The flip side of that is we have a business to run and we can't do all free centers. So if it comes to the time, if you buy 12 months for the sensors, and pay for 12 months for the sensors, let's make sure you get 12 months worth of use. And if that means we ship you a free one because one failed, that's fine. But we're still, you know, we found one patient in another country, I won't say which one, they got 48 free sensors and purchased all of three, because they spent all this time. Those are the far exceptions from the rule, people will just want care. And so we are doing everything we can to come up with better policies to make it easier for you. Because quite honestly, those phone calls cost us way more money and they cause you guys frustration, we are going to make this better over time. That's a promise I can make. And let's talk about it in a future conversation and I'll tell you some of the things we've done.
Stacey Simms 30:35
All right, we'll hold up for a baker's dozen one of these days. But Kevin, thank you so much. You're always very accessible...
Kevin Sayer 30:41
Thank you.
Stacey Simms 30:41
...and I really do appreciate your time.
Announcer 30:48
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 30:54
Lots of more information at Diabetes-connections.com. If you haven't seen it yet, a while back Dexcom sent me what they call a sizzle reel of their G7, what it looks like. So I'll put that video in the show notes as well. We have a YouTube channel. I don't put a lot of extra stuff there. But things like that Dexcom video, and the "In the News," you can watch it if you'd prefer, I always put that on YouTube. And all these episodes are there as well, although they're mostly just the audio, but a lot of people listen, watch, they listen that way on YouTube. So that'll be linked up in the show notes. And I realized I haven't mentioned it on the show yet. But you know, this time of year getting your Dexcom or getting any gear to stick can be difficult, lots of wet and sweat in the summer. And I've created a guide, seven top tips to get your diabetes gear to stick in the hot summer. Over the years, we've tried so many things. Benny has had a pump since he was two. He's had a Dexcom since he was nine. So a lot of, you know, trial and error. And this guide is available, absolutely free. So I will put a link in the show notes. If you get the newsletter, you may have already seen it. But just in case you don't. And the show notes are always at Diabetes-connections.com. Every episode has its own homepage with a transcription, started that in 2020 and we are working our way back. If you're listening on a podcast app, there are shownotes there, but in case you have problems with links or whatever, you can always go to the episode homepage.
And as I mentioned, Diabetes Connections is brought to you by Dexcom. It is hard to remember what things were like before we started using the Dexcom. I just said Benny was nine, right? But he had diabetes for seven years before we started using it. And I guess I haven't really forgotten what that was like. But it's just so different now. When he was a toddler, we were doing something like 10 finger sticks a day. And even when he got older, we still did at least six to eight every day, more when he wasn't feeling well or when something was off. But with each iteration of Dexcom, we have done fewer and fewer sticks. The latest generation the Dexcom G6 eliminates finger sticks for calibration and diabetes treatment decisions. Just thinking about Benny's little worn out fingertips makes me so glad that Dexcom has helped us come so far. It's an incredible tool. And Benny's fingertips are healthy and smooth, which I never thought would happen when he was in preschool. If your glucose alerts and readings from the G6 do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. Learn more, go to Diabetes-connections.com and click on the Dexcom logo.
As I mentioned at the top of the show, I am at Friends for Life right now as you're listening. If you're listening as this goes live, on the day that it goes out there, I'm traveling to Friends for Life, and I'll be here for the week. If you're not familiar, this is the largest family diabetes conference in the country. It takes place every July in beautiful Orlando, it's so hot, but it's a great time, it's on the Disney World property. I don't usually go to the parks if my kids aren't coming. They're not coming with me this year, so I doubt I will be going into a Disney park. But it's a fabulous conference. And I just want to let you know, I'm doing a new presentation. I'm working up some new stuff. I'm very excited about it. And this one is called "Reframe your Diabetes Parent Brain." And I gotta tell you, I am really sick and tired of seeing people berate themselves and talk about mom fail and tell themselves how terrible they are as parents. So this is going to be a session where we talk about the mistakes we've made. But then I want to help people reframe them so that they see what they've learned. You know, my whole philosophy is you mess up and you learn. And that's what this is all about. So I'm really excited to try it out. Will it go over well? I don't know. You know, I think so many diabetes parents are so wrapped up in perfect now that they feel like if they go above 120 or 150 that they failed their children. So, gosh, I feel really passionate about it. And we're going to try that. And then for the fall, I've been getting a lot of questions about sending kids to camp, and I've gotten more and more of these over the years. You know, how do I send my Type One kid to regular sleepaway camp. So I'm working on a presentation about that because fall, August, September, is when a lot of people sign their kids up for next summer. So as you listen, if you're affiliated with a group that does meetups or zoom calls, or in-person conferences, let me know. I would love to speak to you and start these dialogues and help you really help your kids thrive with Type One. We're not done. We're far from done, right? Benny's 16. But you know, he's a confident and happy kid. So knock wood. Where's all my wood to knock? I say all the superstitious stuff, right? I mean, I don't kid, you know how superstitious I am. But I really hope that I can help other parents. You know, the idea here is that you don't worry. The idea here is that you do it anyway.
All right. Thank you so much for joining me. Thank you, as always to my editor, John Bukenas from Audio Editing Solutions. I will see you back here in a couple days for the "In the News" episode, but again, no long format episode, the following week. Alright, I'm Stacey Simms. Until then, be kind to yourself.
Benny 35:49
Diabetes Connections is a production of Stacey Simms Media. All rights reserved, all wrongs avenged.
We are very excited to catch up with the folks from Beta Bionics! Their fully automated bionic pancreas is called the iLet. They are getting closer to submitting to the US FDA and were able to give us an update on some of the most anticipated features.
Kate Farnsworth is a consultant for Beta Bionics currently acting as Digital Marketing and Communications Manager. She walks us through what makes the iLet a very different insulin pump, including: a system that only needs the user's weight (no basal rates or carb ratios), software that will learn from the user and make adjustments, how the system charges, waterproof status and much more. All dependent on FDA approval.
Kate's daughter was diagnosed at age 8 and we first spoke in July of 2015 about Nightscout.
Past episode with Beta Bionics:
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
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, catching up with Beta Bionics . Their fully automated bionic pancreas, called the iLet has some new features not available in existing devices. And that's helped to ease the burden of diabetes in new ways.
Kate Farnsworth 0:33
Working for companies like Beta Bionics give us the opportunity to reach a much wider group of people and really gives us the opportunity because we are a public benefit company to try and engage those people that aren't being engaged currently with the tools that are available.
Stacey Simms 1:02
That's Kate Farnsworth a well known name from the DIY community. Now with Beta Bionics . She'll give us the latest news on the iLet’s development and share some personal stories of her family's journey with type one.
Also this week, a big anniversary for the show, as well as for some of our listeners. 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 on, we aim to educate and inspire about diabetes with a focus on people who use insulin, guys, it has been six years of Diabetes Connections this month, work six years I started in June of 2015. It kind of snuck up on me to be honest with you. I had started the show in May of 2015, actually, but it was just audio that I put on my blog. We didn't get accepted into Apple podcasts and all the rest until June. So that's where I'm marking it from. I had been working on it for months and months. And I kind of wish I had started earlier. But hey, I'm thrilled with how it's gone. Almost 400 episodes now, so many of you wonderful listeners who I hear from all the time. Thank you so much for sticking with me. And if you could just do me a favor, the best thing you could do, I'm not doing much to celebrate this anniversary, I'm not doing a big thing on social or anything like that. But if you could do me a favor, just share the show, share this episode, share whatever episode you like, or just share a link to Diabetes connections.com on your social media, you can put it on your own timeline. Better yet share it in the diabetes Facebook group. It really does help get the word out. You can leave a review that's always fun, but sharing the show itself or telling somebody about showing them even to this day, how to listen to a podcast really goes a long way. So will we be here for another six years? I don't know, man. I hope so. I'm not slowing down. I'm really excited about where we're going. And I love talking to people like my guest this week.
Alright, let's get into it. My guest is Kate Farnsworth. She's a consultant for Beta Bionics currently acting as Digital Marketing and Communications Manager. Many of you know Kate from the DIY community. Her daughter was diagnosed at age eight, and we actually first spoke she was on the podcast in July of 2015. Just after we got started, we talk then about Nightscout she helped so many people get watchfaces set up back in the day among so many other things that she did. Now she helps run the Facebook loop to group with 10s of 1000s of members. Now the iLet, as many of you know has been one of the most heavily watched and anticipated devices in the diabetes space. First human testing was done in 2008. At Damiano the company founder has kept everybody up to speed over the years he has been very public showing the progress in presentations at conferences, and he's been on the show a couple of times himself, I will pick up those older episodes. for newer listeners. The iLet is meant to be a dual chambered pump. That means it will hold and infuse insulin and glucagon to help achieve better time in range.
Just so we're all clear. Putting glucagon into your body isn't like eating sugar or infusing quick acting sugar like glucose or dextrose. Very simply put, injecting glucagon or infusing glucagon stimulates the liver to convert its stored glycogen into glucose which it can then release into the body. The eyelid is being designed with two cartridges and two infusion sets one each for the insulin and glucagon. But the plan right now is to move forward with just the insulin so just one chamber like a quote regular insulin pump for now. I know that was a lot but after Kate and I finished the interview, we realized that a quick description like that and some information about glucagon because I still explain it I still have a lot of people who are newer in the community who don't quite understand. So I really hope that that helped.
Okay, a lot more in just a moment but first diabetes These connections is brought to you by Dario health. And we first noticed Dario a couple of years ago at a conference, and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Dario offers even more now, the Dario diabetes success plan gives you all the supplies and support you need to succeed, you'll get a glucometer that fits in your pocket unlimited test strips and lancets delivered to your door and a mobile app with a complete view of your data. The plan is tailored for you with coaching when and how you need it. And personalized reports based on your activity. Find out more, go to my dario.com forward slash Diabetes Connections.
Kate, thanks, thank you so much for joining me, Boy, am I excited to talk to you.
I'm so happy to be here. Before we jump in, my listeners know that I promised this year that in 2021, I was gonna be very heavy on technology. There's so much in front of the FDA, there's so much going into pivotal trials and heading to the FDA that I thought it would be so easy to do all of these interviews. But I realized as we got further along that the very timing of all of this makes it very difficult for the companies to actually come on and share a lot of information because you are limited in what you can say and understandably so. So before we even get started. I know you have a disclaimer that you're probably going to bring out a couple of times during the interview. But why don't you go ahead and say that now.
Kate Farnsworth 6:21
Thanks, Stacey. So the iLet bionic pancreas is an investigational device and it's limited by federal or United States law to investigational use is not available for sale
Stacey Simms 6:34
as we go forward. And as you listen, I should also let you know that I've given Kate the opportunity as I did when I talked to Howard look from tide pool or you know anybody else who is in this phase of their device or technology, the opportunity to kind of let me know when I've crossed the line. So I may ask a question that you can't answer, Kate. But um, I think we all we kind of understand where we are. So I appreciate that. All right. Having said that, give us the lay of the land, if you can, where is the iLet? In terms of development, let's go high level as far as we can right now.
Kate Farnsworth 7:07
Okay, so Beta Bionics is the company behind the iLet. And we're really different company because we're a certified B Corporation and the public benefit corporation. And that means our company is measured by an independent resource based on how our company's operations and business model impacts our workers, our community, our environment and our customers from our supply chain and input materials to our charitable giving an employee benefits. B Corp certification proves our business meet the highest standards of verified performance. For Beta Bionics . That means the people with diabetes and their loved ones have a seat at the table in our decision making. In that context that we're working to bring the commercial version of the iLet to market. There is currently a pivotal clinical trial testing the eyelid and people living with type 1 diabetes ages six enough. This trial is large and involves 17 different clinical trials sites across the United States. results from this clinical trial will potentially support our application to the FDA for regulatory clearance of the insulin configuration of the device in that population. Once the FDA application is filed, FDA review of 510 k market applications typically take about six months, which includes 90 days of FDA review time and time for response to questions that may come up during the review.
Stacey Simms 8:39
My understanding is that the iLet is a device it's we're talking about an insulin pump here. And I guess what I would call an artificial pancreas or hybrid closed loop system, where it communicates with a CGM to help you stay in a certain range. But the island has always been talked about as needing minimal input. In other words, last time I talked to Ed he was talking about you put your weight in. And that's really the only information it needs from the user to get started. Is all of that still the case? Is that what's in these pivotal trials?
Kate Farnsworth 9:09
Yeah, so that was designed to be initialized by weight alone. It doesn't require users to set curry shows or basal rates for instance, insulin sensitivity factors, the system uses your weight as a starting point and then learns quickly what your unique responses are based on CGM values that receives every five minutes. So with that in mind, we hope that once the FDA clears it, the iLet can be an automated insulin delivery device that requires very few inputs from healthcare providers and people with diabetes or caregivers. For us this solution isn't just about the feature is it's about the benefit that it could potentially give people reduced cognitive and emotional burden. You might recall Adam Brown has talked about the 42 factors that impact blood glucose at Ada conference and in his book bright spots and landmine, those of us in the community can definitely relate based on our own experiences. There are a number of diverse factors that pay people with diabetes on a whim, combine that juggling act with up to 180 diabetes related decisions that people with diabetes or their caregivers make each day. And we really do have a cognitive and emotional workload that those living without diabetes don't face. So our hope is that the iLet is cleared may reduce that burden, since it's offering a solution to type 1 diabetes management without the same numerical input as traditional employment therapy.
Stacey Simms 10:43
Can you speak to the idea of just entering weight and like announcing meals, I mean, I think for those of us my son's used an insulin pump since he was two. So we're coming up on, we're coming up on almost 15 years of using an insulin pump. And the idea of interacting with it less is a little bit mind boggling. You're a mom of a person with type one, you have a child with Type One Diabetes, can you just speak to that idea? You've already talked about the burden being lifted a little bit, but is it difficult for people to kind of wrap their brains around and the reaction of when it does work as well as
Kate Farnsworth 11:16
we assume I can't speak about the clinical trial right now or the results that we're getting. But what I can tell you as a mom of a child with diabetes, is that the cognitive and emotional burden that she feels just having to constantly worry about her diabetes is immense. And I think that we even as parents don't fully understand, you know, how much our kids have to think about diabetes, how much it impacts every moment of every day, and interacting with friends or going out or making decisions on whether or not they're going to sleep over at a friend's. And if there was a device that could potentially relieve some of that burden to me, you know, that's huge, that would be amazing for my daughter. So with the eyelid, when you're entering a meal, you would select whether the meal is the usual amount of carbs for you more or less, it's designed not to require you to count the actual number of cartons over time, the system's designed to learn what that means to you personally. So for my daughter, for example, might have a totally different usual meal than your son. So the system is designed to learn and adapt to each individual user. While there's, you know, that's the practical application. There are other considerations for wide the eyelid has been designed that way. There are 1000s of Americans who don't have access to an endocrinologist, we want him to engage them, we want to meet them where they are and help them get closer to their diabetes goals. I feel passionately about improving the lives of people living with diabetes and easing the burden they live with every day. And research has documented racial and ethnic disparities in diabetes treatments and outcomes. Technology uptake, for example, is much higher for white youth than black or Hispanic youth. As a public benefit corporation. Our goal is to get our solutions to as many people as possible. So we're actively exploring how we can reach the underserved populations and hope to be able to provide all people with diabetes, the same level of care,
Stacey Simms 13:33
I want to make a note and come back to that because there's been such a wonderful, I don't know how to say it, I want to make a note and come back to that. Because years ago, we talked about the DIY community, how it was reaching so few people, it was such a great benefit, but really not for a lot of people. And so many of you are passionate and wanted to bring this commercial product out. And now it's being done. So I'm gonna I want to follow up on that in just a little bit if I could, but let's continue to kind of talk about where we are, thank you. But the idea of no carb counting, to me, would be such a relief, because one of the shocking things that happened in my brain was within the first year of Benny being diagnosed, I think he was too he wasn't eating as much food as he does now at 16. But we realized that carb counting was so inexact and such guesswork, because you could try to be as exact as possible at home. But then you would go to a restaurant, and you really had no idea. And as you listen, my husband owned and operated a restaurant for many years. So you can tell somebody, this dish has this many carbs in it. But first of all, restaurants put so much more butter and fat, and seasonings and things in your food because that's what makes it taste so delicious at the restaurant, which affects how it breaks down in your body. But also, one person can make it to the next day even at a fast food restaurant, it's not going to be exactly the same. So what was the thinking behind it? Is it really just to make it easier on people or did the researchers and the founders here also kind of think that carb counting really isn't that exact
Right back to Kate answering that question, 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 gonna pass out. There are lots of symptoms and they can't 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 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. This made emergency situations even more challenging and stressful. This is so much better. I am 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 slash risk. Now back to Kate answering my question about the inexact science of counting carbs.
Kate Farnsworth 16:03
Yeah, carb counting is not very accurate. People are notoriously bad at carb counting, my daughter might be looking at her meal and see 15 carbs, another person with diabetes might count those curves completely differently, it's really helpful to be able to look at your plate and say, you know, this is usual for me, or this is more for me, this breakfast is way more than I would typically eat. So I'm gonna let the system know about that. Rather than counting the exact numbers in that restaurant meal.
Stacey Simms 16:43
I could talk about that for an hour. That to me is so revolutionary Benny the other day, we got these big cookies, which is you know, a real tree. We don't eat a ton of junk food, but we don't eat super low carb either. But there were these giant chocolate chip cookies. And he was higher than usual later. And I just asked him, I'm like, Hey, I'm just curious, because I don't look at everything he eats or talked about every bolus anymore. So what did you think those cookies were? And he said, Oh, I think it was I think I put in 35. I was like, dude, those were like, 65. Easy, right? And he was what I did. He's had diabetes for 14 years. Right? It doesn't mean he's a bad person. He just didn't. He just took a guess.
Kate Farnsworth 17:19
Yeah, exactly. Exactly. We have the same with my daughter. I don't manage her diabetes, you know, as actively as I used to when she was little, but occasionally I'll ask her, you know, how many carbs Did you think were in that, and then we'll compare it to the package. One really big example that we have, we have those flat pretzels, and they're in a big container. And she'll just pour herself a bowl. And, you know, she guesses on how many carbs are in that bowl. But one time we actually put it on the scale and calculated and she was 45 carbs consistently, because she had been doing this for some time. And I know the same thing happens with cereal, for example, once we move past that carrying a scale with us phase, our eyeballs are the judges and they're not very good. So yeah,
Stacey Simms 18:10
I think some people listening might be saying, Well, why don't you carry scales with you anymore? What kind of parents are you, but I got to say I'm not into adding any more diabetes burden, then we need to so I'm thrilled with letting technology replaced my brain on this, you know, control IQ has done a wonderful job for us and really helping and you know, what you're talking about is only going to help as well. So the big question with the iLet has always been about the dual chambered pump. This was a pump that years ago was talked about and I know you're still working toward a dual chambered pump with insulin and with glucagon in it, but my understanding is that what we're talking about today, what the pivotal trials are all about is insulin only. Can you talk a little bit, just kind of give the listeners an update on what we're talking about in terms of the one chambered pump and what you're working toward, with the dual chamber pump.
Kate Farnsworth 19:00
So the iLet’s designed with two chambers, one for an insulin cartridge and the other for our glucagon cartridge. Her initial device after an FDA clearance will have the insulin chamber available to users while the glucagon chamber will not be usable. Once the dual hormone configuration has been also cleared through the FDA through a subsequent 510 k application. The glucagon chamber will also be made available to users. Our hope is that it would be the same device just the second chamber would then become available.
Stacey Simms 19:34
I understand you may not be able to answer this. But if and when it becomes dual chamber pump. The hardware as you say would be the same. Is it just a question of software updates or is that looking too far in the future?
Kate Farnsworth 19:47
It is my understanding that it will be a software update. But we definitely are getting ahead of ourselves there. We have to go through the whole FDA and 510 k application for that company.
Stacey Simms 20:00
Got it. Okay. I'll be I'll tread lightly on Be careful on that. Of course, a couple of weeks ago, I talked to the folks at ziggo log, which I'm still not sure I'm saying correctly, which is the glucagon that I believe you all are working with.
Unknown Speaker 20:19
Is that still the case?
Kate Farnsworth 20:20
Yes. Yes. So we are working with Zealand to provide the glucagon that will be used in the clinical trial for the by hormonal device. And they recently got approval for adaptive glucagon for the treatment of severe hypoglycemia. And they're marketing it under the brand name Tagalog. I hope I am saying that.
Unknown Speaker 20:42
I think we're good.
Stacey Simms 20:43
I guess my only question on that, because I know it's a separate company. But it was so many years that we were waiting not just for the eyelid, but we were waiting for that shelf stable glucagon, so we didn't have to emergencies or for low treatment, reconstitute or kind of open that red box or that orange emergency box. So it was a big relief in many ways when the different types of shelf stable glue gun were approved. I mean, there's three options. Now, I know you can't speak in detail about a lot of this. But I got a question from a listener about how this would work. And the question wasn't so much about the mechanisms or the software. I know that's proprietary. But the question was, you know, it's always risky to use glucagon too much, right? It's also why we don't want to have too many lows in a row that your liver has to help out with because you can deplete the glucagon supply. And I'm curious, this listener wants to know, is there any danger of depleting the body's own sources if you're always giving it from an external glucagon, injection or infusion?
Kate Farnsworth 21:49
So we're deeply aware of the risks of severe hypoglycemia until we know more from a pivotal trial, it would be best at that question to an MD with expertise in glucagon storage and depletion. But what I can tell you is that we're partnering with seeland to provide the glucagon that will be used in the clinical trial for our bio hormonal device. As you know, they recently got approval for his ecolog. And we plan to use that same shelf stable ready to use quizzes on with the island in our bio hormonal pivotal trials. It's really important to note though, that the amount of glucagon that will be dispensed in the iLet will be substantially lower than the amount dispensed in the cycle of injection or prefilled pen. That's because the ladders for severe or hypo rescue and the amount the iLet would dispense is intended to be hypoglycemia prevention. So that iLet is designed to micro dose very small amounts of glucagon as needed based on the person with diabetes CGM readings and the speed of their glucose decline. So it's really important for people to know that they wouldn't be getting a rescue dose of glucagon in that scenario. Of course, the use of Desa glucagon with the iLet will need additional FDA approval for Depo glucagon. And the iLet will also need FDA clearance for dispensing deathly glucagon.
Stacey Simms 23:12
I mentioned earlier that the system and you mentioned this as well, is working with a CGM. And my understanding is that this is Dexcom g six.
Kate Farnsworth 23:21
That's correct. The eyelid is designed to work with the Dexcom CGM, but we're open to working with other CGM manufacturers in the future. Because we understand that choice is really important to people living with diabetes.
Stacey Simms 23:36
That's great. Dexcom g seven is moving forward. I assume that as that moves forward, this iLet will move forward with it.
Kate Farnsworth 23:45
I would think that's a fairly safe assumption. Okay, good answer. Can you tell me
Stacey Simms 23:50
any details? Again? I feel like I'm fishing here. But can I can you tell me any details about the pump itself? You know, we've got Omni pod, which has the remote PDM that is used with it. We have Tandem, which has buttons on the pump, and they're hoping to get bolus by phone pretty soon. Is the eyelid buttons on the pump? Is it a phone control? Anything you can tell me about that?
Kate Farnsworth 24:13
Yeah, so everything currently is designed to be done from the iLet itself. It has a touchscreen interface. And the infusion says at launch will be similar to the inside. So people are familiar with john caustic and our team are working on some of the potential mobile solutions for the iLet’s. And we hope to have more information about those as we get closer to launch.
Stacey Simms 24:38
I know that you have had a lot of input from the community because I've seen the the posts that you will have put out there asking for help from the community in terms of I guess what is called human factors and things like that. Can you share a little bit about anything that you've learned just anecdotally about what people like and don't like about using an insulin pump, or what you could any kind of feedback that you got along The way that might be of interest.
Kate Farnsworth 25:01
Unfortunately, I can't share that information. I'm sorry. Yeah, I can talk a little bit about the fact that we have a lot of preclinical data that's available on our website. So if anybody is interested in looking at bat, it's Beta Bionics calm, and I can't comment on the results of our pivotal trial as it's still in progress. We do hope to have those results later this year and look forward to sharing them. Our goal backed by appropriate research, and continuously advancing technology is to create a solution that people with diabetes don't have to spend so much time micromanaging decisions that impact their condition, and that they can spend more time focusing on other things in their lives.
Stacey Simms 25:51
This is another question from a listener. And this is about changing the reservoirs out and I this would be when it is dual chambered. So do you have to change them together? Or can you change out the one that is empty? And I'll add to that, again, knowing I don't know if you can answer that, you know, right now, we are all told to change out an insulin cartridge within three days, do you have to change the glucagon in a period of time as well.
Kate Farnsworth 26:16
So as designed the insulin cartridge use that the iLet can be changed actually independently of the infusion set. So you can change your insulin cartridge, but not your infusion set. And we intend to have prefilled cartridges and user filled cartridges available if FDA clear, as for the glucagon, that's one of the things we hope to uncover during the by hormonal pivotal trial is the duration that people can leave the Deathly the carton cartridge in the device, and how often it needs to be changed.
Stacey Simms 26:52
You I didn't ask about infusion sets, and I'm not a big fan of any of them on the market. I think that's the weak link of pumping. I'm not alone in that assessment. Two questions there. So when it is dual chamber, do you anticipate two infusion lines and two infusion sets? I assume you're not mixing these two together? Right?
Kate Farnsworth 27:13
Yes, we anticipate using two inpatients.
Stacey Simms 27:16
And then the other question is, can you share what you're using is? Is there a new one coming from Beta Bionics or are you planning to use one that's already on the market?
Kate Farnsworth 27:24
For our pivotal trials, we're using ones that are very similar to in test that are currently available for no medical. And that is what we plan to use that launch.
Stacey Simms 27:38
Couple other just kind of life style questions, I guess about the pump? How is it charged? Is it a battery is it is an external? How do you charge the pump.
Kate Farnsworth 27:48
So the iLets designed for inductive charging like modern mobile phones, so no cords or cables are required to charge it. The batteries designed to typically last about five days on a single charge and a full charge takes about two hours.
Stacey Simms 28:04
So wait, I think that went by too quickly for my brain. Okay, you mean like lay it on a charger? You don't plug it in? Correct? Do I have to get a special charger? Or can you use anything? Like you said a cell phone charger? I mean, no, I don't use one of those, which is why you're hear me stammering around I'm thinking like, do I get one on Amazon? Do you buy that this is easy. These are easily available for regular people.
Kate Farnsworth 28:25
Our hope is to ship you a charger with the device, but that it would also work with another charger of similar design that you might have around your house. Okay,
Stacey Simms 28:38
and is I'm probably said it's so old fashioned to everybody listening. But you know, what are you gonna do? And talk a little bit about the pump? Is it waterproof? Can it get wet? It is designed to be waterproof. Yes. So wait, now I have to ask. So like I can you can swim with it. It's not just waterproof to a certain amount.
Kate Farnsworth 28:57
So you remember those animals bubbling water displays that they used to have when they had their pumps floating in the water. So their devices were certified the same level that the iLet, we hope that the iLet will be certified to as well.
Stacey Simms 29:15
Very cool. Anybody have those old animist displays? You guys could grab those. I think I was at a display once they had fish swimming in the water once.
Kate Farnsworth 29:22
Yeah, exactly. I that's how it was explained to me by one of our engineers was the old venomous, complex the same way and they had the bubbler with the fish in it.
Stacey Simms 29:34
I think I have a photo because you know, I used to work with animals. And I'm pretty sure I spoke at an event where they had these centerpieces at a table and it was a fish tank and the pumps were ended. I'll have to search that up. And that's great. Let me ask you. I'm sure that my listeners will have many more questions about the eyelet. And hopefully we can speak again we'll get more information as it moves forward. But you and I have known each other for a long time in the community as fellow diabetes parents. Do you mind As a couple of questions about how you're doing and your daughter was diagnosed when she was what, eight, nine years old?
Kate Farnsworth 30:05
That's a incident. He was diagnosed when she was eight. And she just turned 18. Wow, she is now an adult. Oh, my
Stacey Simms 30:13
gosh, how is she doing? I mean, we've already talked about her a little bit, but it sounds like me, you have backed off quite a bit of the diabetes parenting, although we never really back
Kate Farnsworth 30:24
off. Yeah, so she's doing great. She's finishing high school, and she has been accepted to university in September, and she will be living in residence. So we are preparing for her moving out of the house in late August. Wow. Oh, my goodness.
Stacey Simms 30:42
I'm curious. Now, I don't want to get too far off the topic here. But I'm curious, did you all as a family do anything special in terms of college prep, I have a plan in mind. I don't know if I'll do it where like Benny's, second half of his senior year of high school, I really just want to leave him alone, completely, like, stop following him, you
Kate Farnsworth 31:01
know, be here if he really needs me. But I don't know, did you do anything like that. So we have been slowly transitioning and backing off as sort of naturally as the year has progressed. So she takes care of all of her diabetes management side changes all of those things without being reminded by me, which is fantastic. I have started transitioning to her ordering supplies. So I've taught her how to, you know, it's just a login to a website, and you click what you need. And they check our insurance is not very complicated. But I have walked her through how to do that, so that she has a bit more comfort with it, we are really worried about overnight, because she currently does not wake up for low blood sugars. So we've been sort of thinking through how we can do that. And over the summer, we will be backing off that and having her finding ways to get her to wake up to her low blood sugar alarms and try and manage those overnight. Because that is my biggest concern about her moving away.
Stacey Simms 32:11
When you and I first spoke, it was the summer of 2015 was the first year of this podcast. And we were talking about nightscout I can probably dig up the pictures, I had this giant setup that I slept to friends for life that I don't use on the road anymore. When we're back on the road, I'm really excited to see people again, but we talked at the time about the nightscout project and about your help to so many people in designing the Pebble watch face, you know helping people set that up. I'm curious as you look back, I mean, a lot of people from the Do It Yourself community, you already mentioned john kostik, and many others are now working in the commercial space to bring we mentioned this towards the beginning to bring what was better technology, better care. That was really only a very, very small percentage of people to the larger community. Could you speak to that for a minute, it's amazing to me to see how far everything has come.
Kate Farnsworth 33:09
I started out with a real passion for helping people living with diabetes and trying to get you know all of the technology to them. And the problem is that we reach a certain wall with the people that we can reach online, we're sort of in this echo chamber of the same people all the time. And what we've discovered is that technology uptake is much higher in certain populations. You know, I recently did a study and we're finding that people who are Caucasian or higher income are much more likely to be using these tools than the people of color and their counterparts. So working for companies like Beta Bionics give us the opportunity to reach a much wider group of people and really gives us the opportunity because we are a public benefit company to try and engage those people that aren't being engaged currently with the tools that are available.
Stacey Simms 34:13
When you look back at your time in the DIY community. You know what stands out to you. It was such a buzzy busy time between 2013 and 2016, or even 2017. But as commercial offerings have, frankly, gotten better, you know, I know a lot of people still use the DIY stuff, but it seems like there was an energy and there was a really, you know, a time not too long ago were folks like you were I gotta imagine your phone was buzzing all the time with people asking for help. You know, what was
Kate Farnsworth 34:45
all that? Like? Yeah, it was a crazy time. And, you know, to a certain extent, those communities are still really active. The Loop community, which I run has 27,000 people in it, you know, so there's still A lot of activity surrounding these things. But I think as the commercial solutions come around, we're able to provide solutions for so many more people that that sort of aggressive need dies down from a little bit from the DIY community, because a greater number of people without maybe the same technical expertise are able to find solutions with the commercial offering. So I always said, I would keep doing that volunteer job until a commercial offering was able to put me out of business. because ideally, you know, I hope that commercial solutions like that iLet will be able to serve the diabetes community, so that we don't have to look to DIY solutions anymore.
Stacey Simms 35:49
I always hate asking this question, because I know there's probably not going to be an answer at the end of it. But what is the hoped for timeline here? Can you tell us anything about the submission or or things like that?
Kate Farnsworth 36:08
I love the silence. That's okay. I have to ask. Yeah. So as I said, once the clinical trial is completed, then we will submit for FDA regulatory clearance of the insulin only configuration. Once the FDA application is filed, there will be an FDA review of the 510 k market applications, those typically take six months. And then we will have a launch date. Once that has all been completed. This
Stacey Simms 36:38
might be an odd question. But as we start to wrap it up here, when we go to conferences, like friends for life over the last several years, and Ed Damiano speaks about the the product and the process and everything. Anything that has to do with Beta Bionics and the iLet is so closely watched, it has just become, I guess the way to say this, you guys have a lot of fans out there in the community. I mean, it might be a small portion of the entire diabetes world. But this is a really passionate group of people kind of waiting for this. Do you as you talk to each other? Like, do you feel the pressure of that? Is that exciting to you? I just would imagine and I can't answer this for you. But going to work, there must be amazing every day to know that people are so excited about the product
Kate Farnsworth 37:25
is absolutely amazing. We definitely feel the community spirit and presence and pressure to deliver you know, every day, we talked about the fact that, you know, we want to help the people living with diabetes who have been waiting for us. And we don't want to make them wait any longer than they have to. And you know, the process has taken longer than we hoped it would. So we're definitely committed to the people with diabetes that we're trying to help. And we have the most passionate team working on this, everybody is so committed. And we have so many people who are touched by type 1 diabetes, either living with Type One Diabetes, or parents of children with Type One Diabetes, or children of parents with Type One Diabetes. You know, we're part of the community. We really feel passionately about this. So we cannot wait to have this device ready for those people.
Stacey Simms 38:27
Okay, thank you so much for joining me and for being patient with my questions. I know as I said, you're limited in what you can say. But I cannot tell you how much I appreciate Beta Bionics making you accessible and coming in to share this. So and thanks for all your hard work. I cannot wait to learn more. I know you can't wait to tell us more. So thanks so much for being here.
Kate Farnsworth 38:46
Thank you so much for having me. I'm really grateful for this opportunity. And I look forward to talking to you again in the future.
Unknown Speaker 38:58
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 39:04
More information at Diabetes connections.com. Or, of course in the show notes. You can always go to the homepage though, to get the full notes and the transcription of every episode. And there's a lot there. as Kate alluded to, there are some other studies, there's some more information, and it's all at Beta Bionics . So I will link that up in addition to the interviews we've done in the past with Ed Damiano, and I'm gonna link up the first interview I did with Kate back in 2015. Because looking back, that made me laugh and this has nothing to do with Beta Bionics or the pumper or technology or it's my technology. So I use very light technology.
This is just a little bit of inside baseball now on the podcast when I travel and I'm going to be traveling again to conventions this year, which is so exciting. I have a small kind of a studio in your pocket. It's a zoom h5 recorder and I use a couple of ATR 2100s if you're into that kind of microphone technology. Light stuff. I don't even need to plug it into a computer. The h5 is its own little studio. But when I interviewed Kate and I interviewed a bunch of people at that first friend for life that I went to as a podcaster, I brought my Yeti. The Yeti microphone is a brick. It's not that great a microphone actually that don't get me started. But it's a brick. And it's so, so heavy. And I brought like a mini studio, I had this paneling setup. Oh my gosh, I had so many things to check when I got on the airplane. And then I was schlepping it around the hotel at friends for life, which is not the most compact hotel. It's a lot of walking. So I'll see if I can dig up some pictures. But Kate was very patient with me as was everybody I talked to that day. Just funny how things do change over six years.
All right, we've got some Tell me something good coming up with some fantastic anniversaries, not about the podcast, some listeners who are celebrating very long time diversities and are doing great. But first Diabetes Connections is brought to you by Dexcom. And one of the most common questions I get is how to help kids become more independent. You know, those transitional times are pretty tricky. elementary to middle middle to high school. You know what I mean? Using the Dexcom makes a big difference for us. It's not all about share and follow that's helpful. 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 just show their care team their number before Jim at one point Benny was up to 10 finger sticks a day 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 keep your kids more independence. Find out more at Diabetes connections.com and click on the Dexcom logo.
And tell me something good this week big time big diversities. Terry Lopes is celebrating 50 years of type 1 diabetes. She was diagnosed at the age of nine. And she made a really nice Facebook post where she talks about being grateful to the people in her life who helped her and looked out for her early on parents, siblings, friends, teachers, camp counselors, nurses, doctors, she says and thankful for those who still look out for me and for the technology that helps me have better control and live much more freely. And also makes it so that no one needs to be told they may only live to the age of 40 when diagnosed as a young child. Terry, thank you so much for sharing this. She also posted that her dad turned 90 recently as well. So Happy Birthday to him, my goodness. But it really is hard to imagine. And I know I'm so grateful to know many people who have lived with type one for 40,50, even 60,70 years. I mean, it's amazing that you know, I don't know them personally, but we've been connected online. And they were all told as children as children, that they would not live a long and healthy life. Our kids are not told that anymore. And I'm so grateful for that. Terry, I'm thrilled that you're in the group and thank you so much for sharing that.
Yerachamil Altman shared a different kind of diaverary, he posted that he has been using an insulin pump for 40 years. 4-0! he has got to be one of the first people to use an insulin pump. And we've had him on the show. I know he helped design insulin pumps. I mean, my goodness, what a life. And he always posts we're so thankful for this the old technology. So if you're in the Facebook group, Diabetes Connections, the group I'll make sure to repost this. But I mean, the first insulin pump was basically like a syringe taped to what looks like a big pager, and it just stabbed you with the needle and gave you the Insulet I don't know it just it doesn't look like something that would work. It looks like something Benny would have slapped together from spear diabetes parts when he was in second grade. God bless the people who use this and tested everything and made it so like I just said so that our kids and adults diagnosed today can live long and healthy lives. 40 years with an insulin pump, you're off a meal. Thank you for sharing that. And you know, I love sharing the good news. If you've got something Tell me about it. Stacey at Diabetes connections.com or post in the Facebook group. I love to hear it.
Before I let you go quick reminder about in the news, my new feature every Wednesday 4:30pm Eastern live on Facebook. I hope you can join me for that I'm working on some different texts. And to see if I can make it look a little bit more TV newsy. That's been really fun. I got a green screen and oh my gosh, I started out in television. And then I went to radio and then I went to podcasting. And now it's like back in TV reporting. It's bonkers. But I'm also as you know, if you're a regular podcast listener, and putting out those in the news episodes every Friday as well so if you miss it live, or you just want to hear the audio, I definitely want you to have options and like doing this a lot. It's been really fun. I'm trying to keep them short. So if you like it or you don't you've got any constructive criticism, any kind of criticism I can take but come on be nice. Please, please please let me know. I also announced on social media that I have taken a new position I am working with the fabulous folks at she podcasts. I'm Selling sponsorships for she podcasts live, which is coming up in October of this year. I'm going to do friends for life in New York in the beginning of October, and then I'm going to shoot podcasts live in the middle of October in Scottsdale, Arizona. It's going to be a busy month. I also have a big birthday in that month. So we're going to be we're looking forward to October, it's going to be great. But if you are at all involved in podcasting, and you're a woman, please check out she podcasts, I'll put a link if you are interested in reaching 1000s of women who podcast You don't have to be a technology company. But if you want to reach women who are movers and shakers, let me know because I can hook you up. That's my new gig. I'm still gonna be doing the podcast of course, and all my other projects. This is perfect because I get to meet some new people and do some fun stuff. But I don't have to give up anything but maybe some sleep. I don't know. I'm gonna get this done.
Alright, thank you, as always to my editor John Bukeas from audio editing solutions. Thank you so much for listening six years. Oh my gosh. I'm Stacey Simms. I'll see you back here in just a couple of days. Until then, be kind to yourself.
Benny 46:10
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Transcribed by https://otter.ai
Big news for Bigfoot Biomedical as the US FDA approves their insulin pen cap system called Unity – which also includes a CGM and an app. CEO Jeffrey Brewer explains what Unity is all about, gives us an update on Bigfoot’s pump system and opens up about his family’s story – his son was diagnosed almost 20 years ago.
Plus, in Stacey's first in-person diabetes meetup since COVID, she observed something very interesting about the newer families.
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!
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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 help make knowledge your superpower with the Dexcom G6 continuous glucose monitoring system.
Announcer 0:24
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:29
This week, big news from Bigfoot - FDA approval for their insulin pen cap system called Unity, which also includes a CGM and an app. CEO Jeffrey Brewer says their bundle approach is a bit like Apple’s
Jeffrey Brewer 0:42
Apple takes a bunch of different pieces, some of which they licensed and some of which they make and integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well.
Stacey Simms 0:56
Brewer shares what Unity is all about gives us an update on Bigfoot’s pump system and opens up about his family story. His son was diagnosed almost 20 years ago,
plus my first in person diabetes meetup since COVID, where I got good news beyond just seeing my people. 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 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. And when I started Diabetes Connections in the summer of 2015 this week's guest Jeffrey Brewer was my second guest, it is hard to describe what the diabetes technology situation was six years ago. If you were around then you probably remember especially this podcast audience, you know, I tried to talk about it, as I mentioned in the teaser, had a meetup last week with some local parents, which was fantastic. And I'll tell you more about that later. And a mom of a child diagnosed in January of this year asked me what DIY was all about. she'd heard about loop he heard about do it yourself. She wasn't quite sure what it was all about. So that was a long and winding conversation.
If you are brand new, and you want to learn more, I recommend searching out the we are not waiting episodes of this podcast. And you can easily search those up at Diabetes connections.com. There's a search box on the upper right. It's a very robust search of our almost 400 episodes now. And you can search we are not waiting as all one word. I've put that in all of those kind of DIY open APS CGM in the cloud. You know all of those types of episodes.
I know that six years ago, this pen cap system is not the Bigfoot FDA approval many of us thought would come through First, if you've been following this story for a while Bigfoot was founded in 2014. It was under a different name. It got the Bigfoot name in 2015. But it was founded by a small group of dads of children with type 1 diabetes, including Bryan Mazlish, who got that nickname Bigfoot via reporter looking for the elusive person Bryan who had developed a do it yourself closed loop which his wife and son with type one were using, and the initial headlines for Bigfoot, were all about bringing that closed loop system to market you can go back and see their initial funding press releases, which say things like you know, “the funding will support final development activities for Bigfoot’s Smart loop, automated insulin delivery service, the world's first Internet of Things medical device system delivered as a monthly service.”
Bigfoot Unity, which is what we're talking about today is going to launch as that monthly service. It's such a great idea to cut down on the complexity, it's going to help so many people on multiple daily injections, but I know that this podcast audience leans very much into the pump closed loop give me all the tech news group. And I think it's important to acknowledge that that said, My guest is Bigfoot CEO Jeffrey Brewer. His son was diagnosed with type one in 2002 and as the former CEO of JDRF. Brewer led the artificial pancreas project there. In life before diabetes, Brewer founded and led early.com startups including city search and goto.com.
We will find out all about Bigfoot Unity 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'm 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 fever. 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. This made emergency situations even more challenging and stressful. This is so much better. 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 dot com slash risk.
Jeffrey, thank you so much for joining me, I really appreciate it.
Jeffrey Brewer 5:05
Thanks for having me. Glad to be here.
Stacey Simms 5:07
So I looked back at my notes, you were my second guest on Diabetes Connections back in the summer of 2015, talking about the big plans for Bigfoot and holistic systems, and then lots of things that you said at the time you couldn't really talk too much about. And now here we are. So first of all, thanks for being my guest way back when when, you know, probably have three people listening, I really appreciate that.
Jeffrey Brewer 5:29
Well, thank you, and thanks for sticking with us maybe took us a little bit longer than I had hoped. But we're finally here to be able to offer something to people with diabetes, that we hope it's going to improve life and make it a little easier.
Stacey Simms 5:43
Definitely. Well, let's talk about that. So we're talking about Bigfoot Unity, would you mind kind of going through who it's for what it does, this is a system that is going to help people who are on multiple daily injections. So what is big for Unity?
Jeffrey Brewer 5:57
Yeah, so as you know, had Bigfoot developing a range of solutions to help people whose lives are dependent upon insulin to live safely and, and hopefully better lives. We are in this journey, focusing first on multiple daily injections, basically, intensive insulin therapy, once a day, have a basal insulin, and then given shots at mealtimes, or for corrections of rapid acting insulin, that particular therapy, which about 3 million people in the United States today do on a daily basis, about half people with type two diabetes, about half people with type one diabetes, but it's really the same therapy, we have developed a system that we believe solves a lot of the problems that therapy has, when it comes to the ability of people to determine the right dose for themselves on an ongoing basis, and also for health care providers to support them in doing so over a long period of time. I
Stacey Simms 6:53
totally understand because years ago, my son wanted to take an insulin pump break, he has used an insulin pump, since he was two, really six months after diagnosis, we got him on a pump. And we were so frustrated. Because not only did we have to do all the math manually that the insulin pump had done, there wasn't. And this was really before, there were lots of apps and things, there was no way to do all the stuff that the pump does in terms of insulin on board, and that kind of thing. So I assume that those are just a few of the features that Unity will provide
Jeffrey Brewer 7:23
some of the things that a pump does BigfootUnity will help to support your right that for people taking shots, it's mostly a glucometer, a piece of paper with some instructions and a couple of insulin pens. There isn't a lot of technology involved in those people's lives right now. And what we've done is develop a package of technologies that includes some devices, and some software that is knitted together for ease of use, to make life convenient for the person to first of all, be prescribed the therapy to be trained how to use the therapy easily and safely, and then to over time be supported by a healthcare provider who has the responsibility of supporting many of these patients, we are bringing technology to a population of people who I think have been largely overlooked, because most of the innovations have been focused on pumps. And that's really been focused on type one and also focused on very highly engaged people with diabetes that frankly, had to do a lot more in order to support the therapy and seen by doctors who are very excited about the technology. But not everybody sees a clinician like that. And not everybody wants to put everything into their insulin therapy that maybe a pump would require.
Stacey Simms 8:42
So take me through a little bit of it if you could, when I looked at it, I was kind of making notes that I wrote white cap black cap. So the white cap is for the fast acting and that gives you a dose, like a pump would say here's the suggested dose.
Jeffrey Brewer 8:56
Sure Bigfoot Unity is a bunch of different things together at the centerpiece of the system is these taps that are going to be for the particular insulin that a person is prescribed, whether it is an insulin made by Novo Nordisk or Sanofi or Eli Lilly, we have caps that fit all the different disposable insulin pens for both the basal insulin and the rapid acting insulin. First of all, you get these caps that fit the insulin that you've been prescribed. You also get a couple freestyle Li braise, you get a blood glucose meter that talks to the caps as well. You get in this first time experience kit, everything down to the pen needles and the alcohol swabs that are going to be used for parasite before you put on a sensor, literally everything that you need in order to initiate multiple daily injection therapy with the exception of the Insulet itself. It's all in this box. So this box comes to a person with diabetes in their home. We train them to use the system through a digital interface that we've developed support. onboarding to our system but also for people who are cgmp may never have bought a CGM before will literally through a zoom interface, walk them through the first experience with CGM, and then train them on the whole system. And the centerpiece of the system, as I said, as these caps, which basically do a simple thing they keep track of when you last gave yourself insulin. And they do calculations that are necessary in order to recommend how much to take based on your doctor's direction, very simply on the blackcap, which is focused on the basal insulin, you have one button, and you can only press the button and cycle through screens.
So you press the button. first screen says this is when you last took the dose. So it could have been say 23 hours ago, and it's time to take another dose, you press the button again, and it's going to tell you how much you should take. And that's what you were prescribed by your healthcare provider. And what can be updated in the cloud, by your healthcare provider. Rapid acting cap, the white cap is got some additional functionality, but still works the same way. It's got a screen on it, and then you press the button, the first screen is going to have when you last gave a shot, which is particularly important for stacking insulin as you refer to insulin on board. This is one of the big challenges that people who are on shots have is that they don't have a record of when they last took the shot. And so actually making sure that they don't treat the same high glucose reading too quickly, and then end up with too much insulin and end up low. This is something that we help with by actually keeping a person from stacking insulin. So you press this button, it's going to tell you when the last took a dose, if within three hours, you had taken a dose previously, it's going to lock out a correction. And therefore you're not going to make that mistake. This cap also interfaces directly with the freestyle library to or a blood glucose meter, and basically takes that data and directly translates it into a correction dose if you are taking your correction based on again what your healthcare provider had prescribed. So whether it's a correction factor or a sliding scale that was written down on a piece of paper, you don't have to remember or do any calculations, it basically just takes the number from the libri and turns it into here's how much insulin I should take. And if I had previously taken insulin that keeps me from over insulinizing and stacking insulin
Stacey Simms 12:16
over insulinizing? Is that an actual word?
Jeffrey Brewer 12:22
Yeah, I think I heard that from one of the researchers one time, so
Stacey Simms 12:25
we're claiming it if it's not, it's a rage bolus or it’s over-insulinizing
Unknown Speaker 12:29
There you go.
Stacey Simms 12:30
I didn't mean to interrupt you, sorry.
Jeffrey Brewer 12:32
No, no worries, the next step, after you take a correction, maybe you're going to have a meal. And having recommendation for how to dose from mealtime. It actually turns out that small, medium and large is a format that a lot of people are able to understand and work with in terms of how to take carbohydrate content and actually correlate that with an insulin dose. It's actually the minority of people, even in type one, but certainly with type two that carb counts. And so thinking about this in a different way, and a simpler way, where you have maybe small medium and large buckets, and a corresponding number of units for insulin that shows up right on the pen cap. If you want to add the two together, you are going to click the button again. And then it's going to basically add a correction to whatever the meal bolus would be, you're going to pick that value that you're choosing as a patient, because we're not deciding for you, we're just telling you, here's what your doctor would recommend based on all the calculations that you usually would do, if you had to do them. If your doctor were sitting there with you, this is what he or she would recommend you do. But if you know more, because for instance, you know, you're going to be exercising vigorously later, and you want to protect against hyperglycemia a person might decide to take a year or two less. But basically we're going to get them all the information that we can take it and make it actionable for them take as many steps out as we can to just get them to the answer they want. Because I don't actually think people want to know what their blood sugar is. They want to know, what do I What should I do? How much insulin Should I take. And so every step we can remove, and every thing we can take out of this equation to make it easier for people to stay healthy and take the right amount of insulin and then forget about diabetes for another four hours until another meal. That's what we're trying to do. And we're trying to do that for people who take shots, which is most of the world in terms of multiple daily injection therapy is the preponderant therapy for intensive insulin usage.
Stacey Simms 14:28
I appreciate you going through so granularly, I have learned that my listeners really like the deep dive anytime there is something new. So thanks for walking us through that. And you've mentioned the CGM. Let's talk about this. This is all integrated with the Libra when people use the Libra does it alert?
Right back to Jeffrey answering my question but first Diabetes Connections is brought to you by Dario health and one of the things that makes diabetes management difficult for us that really annoys me and Benny isn't actually the big picture stuff. It's all the little tasks adding up. Are you sick of running out of strips? Do you need some direction or encouragement going forward with your diabetes management with visibility into your trends help you on your wellness journey? The Dario diabetes success plan offers all of that and more No more waiting in line at the pharmacy no more searching online for answers. No more wondering about how you're doing with your blood sugar levels, find out more go to my dario.com forward slash diabetes dash connections. Now back to Jeffrey Brewer answering my question about using the abbot libre here, does it alert an alarm?
Jeffrey Brewer 15:40
Very good question. So the way the library works is it gives data in two different manners. One is you take the pen cap and you swipe it over the library. And it gives you an on demand reading for what your glucose is at that particular moment. And that's the value that is used in order to calculate any corrections. But there's another way that libri is communicating, which is directly through Bluetooth to the smartphone. Because we have an app on the smartphone. And that's monitoring. For instance, for hypoglycemia, you have a couple different ways the library is working in order to support a person with diabetes, it's either directly on demand to make the calculation on the pen cap or go into the phone for monitoring for hyperglycemia. These are particular capabilities of the library to
Stacey Simms 16:27
his delivery that is in big for Unity. Are there any different features? Or is it the same one that people can buy separately?
Jeffrey Brewer 16:34
Well, it's the same libri puck. So the sensor itself, the part that you wear on your body, it's the exact same one that gets prescribed and fulfilled at the pharmacy or wherever else a person gets their lead rays. The difference is that we're not using the reader that avid makes, or the app that avid will have on the phone, the libri in our context is talking directly to our pen caps and to the app on the phone. So it's fully integrated into the system. This is an amazing thing that avid has given us, which is the ability to make it very, very simple for the end user such that you don't have to apps you have to worry about all the training is comprehensively designed such that I learned to use the library and the context Bigfoot system, one training one app, one company that's gonna support the whole system, Bigfoot, and then all the data that gets captured, whether we're talking about insulin data or glucose data, and then made available to clinicians in a unified interface to support them in adjusting the therapy over time.
Stacey Simms 17:38
Well, this may be a really dumb question. I know that the Libra you scan with the phone, when it's separate from Bigfoot in Bigfoot Unity, do you scan with the pen? Or is it just automatic,
Jeffrey Brewer 17:48
it's with the pen, you scan. That's actually the only way you can get right now what's my glucose reading from the CGM is through that NFC interface on the library puck. And one of the key design elements that we felt very strongly about is that you don't have to open up an app on a phone, in order to give yourself a shot. Literally, you're just carrying that pen which you would have with you for meals during the day, it already has the pen cap on it. So you don't carry another device and you're wearing the Libra on the back of your arm, all you have to do is wear the Libra Ray, and then scan that Libra with the pen cap, then it tells you what to do. And no opening an app on the phone, no unlocking the phone, selecting an app opening and navigating through pages, that adds too many steps. And it's frankly, peep something people don't want to do. So we tried to make it as close to what they're doing today, which is you've already got a pen that you're carrying around, we're not adding another device, you don't have to add any additional steps, all you got to do is wear the LIBOR rate and we take that data and then make advice as to what to do.
Stacey Simms 18:54
You know, one of the issues with pens is that they'll switch you insulin brands. So you know the insurance when your will cover human log the next year it wants you to take novolog and the pens aren't the pens different the caps fit and the different pens geoffry.
Jeffrey Brewer 19:08
The pens are different between the different manufacturers. And then some cases from the same manufacturer, you have different designs, different diameters and geometries and clearance for the needles. What we've done is besides designing different pen caps for all the different insulins, we have basically supported this as a service offering. So when you're using Bigfoot, if you didn't buy a pen cap, you are a customer for the entire offering. And if you get switched by your insurance company from humulus, novolog or back, we're just going to send you the new pen cap that fits the insulin that you're currently prescribed, which is we think one of the big challenges that people have and we've heard and we wanted to make sure that that was an easy transition for people.
Stacey Simms 19:54
That's great. And you've already mentioned the way it's packaged, but I'd like to just talk about that. Little bit more I remember. And it was either when we first talked in 2015, or you know, some point very early on that you all were adamant that this was not going to be piecemeal. And you were also going to make it easier for people to purchase things all together. So this is, this is a terrible way to describe it every in my head, I sort of think of those boxes, the subscription boxes, people get right with my kids, it was like, you'd get little fun comic book stuff in them, right, or you'd get a subscription box of exciting bath luxury items. This is obviously not that this is a box with everything in it, right, everything comes together.
Jeffrey Brewer 20:34
That's right, when you first initiate therapy, you don't have to go and get a prescription filled, really braise a prescription field for a blood glucose monitor for test strips for lancets. For pen needles, basically, it's all there in the box. And it's trained and set up in a unified fashion. That frankly, just makes it easier to learn. And it makes it more convenient. And we thought that's an important part of the customer experience. There's a lot of blaming, that takes place of the patient in the world that says, Well, people just aren't working hard enough. They're not doing the things that their clinician told them to do. If they were everything would be better, and diabetes wouldn't be a problem. And frankly, we just don't agree with that. We think that it's too complicated, it's too hard. And that it should be easier. So one of the things that needs to be easier is all the different supplies and getting those and making sure you have the right supply. Having access to the tools is something that needs to take place in order for you to be able to successfully use the therapy, we figure if we make that easier if we make it easier to remember things or you don't even have to remember things because we remind you or we descend them to you without you having to remember all that kind of stuff, I think really adds up to a better experience easier and more convenient use of the system, we firmly believe it's going to end up in better results. Because it's just people are going to do things that are more convenient and easier for them to do. So we make it as easy as possible.
Stacey Simms 22:03
any issues getting insurance and Medicare coverage when it's all bundled like this. I mean, I'm asking is did Bigfoot have any issues getting it? And is it covered for people now?
Jeffrey Brewer 22:13
Why Yeah, there's a lot of innovation that we're having to undertake in order to be able to deliver this to people. One of the aspects of innovation is that we're working through clinics, or endocrinology practices. And this is how we deliver the solution, the clinician will prescribe and then bill for not only the system, but the services of the clinician to use the system and support the system for the person with diabetes. And then when bill comes in, it comes from the clinician. So in order to make this simple, so that there aren't all these different prescriptions. And there aren't all these different places where you have to get all the different pieces, we're working through the clinician. And in this case, there are already codes that are available called remote physiologic monitoring codes that support the treatment of chronic disease and tools in order to support better treatment in chronic disease. And so we're providing these tools to the clinician, and then the clinician basically delivers them through to the patient. And the billing relationship is between the patient and the clinician. All of it gets simplified and makes everybody's life easier. What we're doing is covered by Medicare and private payers more broadly, because we didn't go and get a code for Bigfoot, what we did get is a plan to go and use codes that are already there that clinicians can access in order to reimburse both for what we're providing, and for the services that they have in order to support the effective usage of the system
Stacey Simms 23:46
looking forward, because of course, we can never just let something come out, we always have to see what's next. You know, we talked a lot about interoperability is Unity, going to integrate with different cgms or different systems down the road is that in the plans,
Jeffrey Brewer 24:00
not in the immediate plan, what we did is we said, we're going to pick what we think is the best CGM for what we're trying to do, which is simple, easy, cost effective and very scalable across a large population. And the library has some very unique capabilities that that we feel very much support what we're trying to accomplish. And so we did a deep partnership with avid, as I said, they've given us the ability to integrate their sensor into our system in a way that other systems are not integrated closed loop systems. Today, you have a company that sells you a sensor, you have a company that sells you a pump, they have different apps on the phone that are going to govern, you know their respective products, they're going to be uploaded to clouds that sometimes require clinicians to look into different places to see the full picture for data. We're doing something much simpler. Describe what we're doing is more like what Apple does. Apple takes a bunch of different pieces, some of which they licensed and some of which they may integrates them into the most usable package that actually is going to be accessible to the most people. That's the way we think about it as well. There are other sensors out there and great options for other sensors. We're not trying to say you have to switch to us if you're happy with your other solution. We're trying to go after a population of people who literally don't have any solutions today and are feeling pretty ill served. We think that with all the people out there that are still to use CGM are still to benefit from CGM and the kind of tools we put around CGM. We don't see ourselves as competing with others. We're just trying to get the goodness that we believe we've created out to people who who need it,
Stacey Simms 25:39
I got a question from a listener I meant to ask we were talking about scanning depends. And that was, if a person can still use the the libri, to reader and the librelink app to scan the sensor. Or once you do this, if it is only linked with Bigfoot system?
Jeffrey Brewer 25:53
Well, in order to get the benefit of the system, you need to use the pen caps, because that's where the data is captured. That's where the recommendations get made. And it works best in the context of the Bigfoot system.
Stacey Simms 26:05
So you can't you can't link it to two different things. In other words, you couldn't use the reader and the pen.
Jeffrey Brewer 26:10
Not at the same time, you could use the library separately with a library reader and a librelink. app, but not at the same time.
Stacey Simms 26:20
I'd love to get an update Jeffrey, if you could on what I believe is called Bigfoot autonomy, which was the pump system that we did first talk about all those years ago? Can I ask you what the plan is for that, or what you could share with us about it, it is called Bigfoot autonomy, right?
Jeffrey Brewer 26:35
That is the name that we have picked for it. Yes, autonomy and Unity Unity use for the shots and autonomy is for the pumps, we have, as you know, a pump ourselves, we have developed and done clinical work for algorithms that we have utilized for closed loop insulin delivery. And we've also developed the full package around how to deliver it as a single thing, using a libri. In a very parallel fashion to what we've done with a foot Unity, we had to focus on one product in order to launch the company and to establish ourselves. So we picked this path because we think it gives us the opportUnity to reach the most people most quickly that frankly, don't have other options available to them. And we think we're going to be able to establish a reputation in the marketplace. In the future Bigfoot autonomy is going to complement Bigfoot Unity and present another option for how people can have insulin therapy. That is something we're committed to down the road.
Stacey Simms 27:34
So the people that were very enthusiastic, there's this this whole commUnity that was you know, the DIY commUnity and the we are not waiting commUnity, they should not look at Unity and say, well, Bigfoot has stopped with the pump, right? They shouldn't think that this is not going to go forward. It's not still in the plan.
Jeffrey Brewer 27:51
Well, the plan is always and will remain that we're offering choice and selection of different opportunities for people that have different needs. Just as Medtronic today, in acquiring the companion in pen now realizes it's not about pumps or pen, it's about both, we've been saying the same thing for quite a while, we're just starting with the pens, and then expanding to the pumps, versus everybody else is now interested in pens and started in pumps, it's really the same thing. It's a different way of serving a particular part of the population that has different needs, pumps are great. And they can deliver a lot of value and a lot of quality of life. However, they're not going to be right for everybody. And there's going to be a lot larger population of people who will still take shots for the foreseeable future, especially globally. And so it's not a matter of either or it's both in our minds,
Stacey Simms 28:43
if your son is living with type one for almost 20 years now. And of course, I think most people got familiar with your name when you were at jdrf really pushing the artificial pancreas program. I wonder if you could just take a second to give us some perspective, because I don't know about you. But my son was diagnosed in 2006. And it almost seemed like for the first eight years, maybe even 10 years, there just didn't seem to be that innovation on the commercial side of things. And now, I feel like I know it's it's not there's no cure. I know it's we're not there yet. But I do feel like the technology is finally working hard. You know, we're doing things for my son. And it's not just pump technology, as you said it's pen technology. And I feel like at least he can do a little less work.
Jeffrey Brewer 29:25
I feel the same way. There's been a tremendous amount of progress from 2002 when my son was diagnosed in 2012. There wasn't much of any progress. It has been accelerating in recent years. And I give a lot of credit to jdrf and the work that the volunteers supporting jdrf did to advocate to the executive branch to the legislative branch and then directly to the FDA, we were able to establish a very strong platform for collaboration and the way the FDA has prioritized the innovation in diabetes. enabled it with some clear rules of the road. I believe that's what made it all possible. There has been development of technologies that weren't mature before. But if they didn't have a path through to the marketplace, through the FDA process that worked, we wouldn't benefit from all these things. So it has been a journey. And I think it's been, you know, development of technology. It's been developed in the regulatory practices. It's been greater familiarity and openness amongst clinicians, and also the payers who see value and these tools for patients. So a lot of things that had to change, healthcare is much more complicated and difficult to work in than what I previously did in my high tech career. But it's much more rewarding, because I think it's now having a big benefit and a lot of people and we're happy to join the party, as Bigfootbiomedical.
Unknown Speaker 30:47
Do you mind if I ask how your son's doing?
Jeffrey Brewer 30:48
Yeah, he's actually doing very well with his diabetes, I will tell you that between the ages of like 15 and 22, it was kind of rough. It was a very similar story that I heard from many parents when I was a CEO of jdrf. It's a really challenging condition to live with adolescents and young adults. But he sort of found his way through that, and now has refocused on taking care of himself. And the tools are better now, to enable him to do that. So I think that it's gone hand in hand, his maturation and the development of these tools. And you know, I think he's in a good place. And hopefully, we can make it better over time. You know, it's
Stacey Simms 31:27
funny, I'm not quite sure this is gonna come out appropriately. So I'll try to be careful. But it's kind of nice to free in a way to know that even the head of jdrf. And even the guy at Bigfoot has a kid who was a teen, and struggled. And I know that sounds weird. I don't wish anybody to struggle. Like I wish all the kids went through this, and we're fine. And everybody was the poster child. But I appreciate you sharing that.
Jeffrey Brewer 31:50
It's important because I don't think that people talk about it enough. How hard it is for families, how hard it is for the kids, and how young adults, their brains are just not meant to cope with a responsibility like this. It's just not right. It's not something that they're ready for. And, you know, so nobody should be surprised that it's very hard. And it certainly journey. I think it'd be better if people understood that from the beginning, you know, because some people yeah, you're right, they think it's just my kid that's having this trouble. But it's not, it's that this is really, really hard for any family. And it frankly, is the rare family, where you have just a completely well adjusted and easygoing kid with type 1 diabetes. That's the rarity, not the norm. We're a company that stems from the patient experience, you know, my knee through my son, obviously, it's not the same thing as having it. But you know, having a child that grew up with it, a lot of people at Bigfoot have insulin requiring diabetes and know what it's like to live with this drug. I think it's given us a really great perspective on some of the softer aspects of the experience have been missed by some of the medical device companies, things about making it easier and less stressful and just more convenient. Because when you got to do something every day, multiple times a day for the rest of your life, it's just a different kind of thing. And even small benefits to simplicity can have a huge impact and adding up to much less burden, emotionally or intellectually. And I think that all adds up to better lives. We can't point to any one thing about Bigfoot Unity and say, this is the thing that really makes the difference. It's really a bunch of different things that are really holistically designed to as a system, the sustainable and usable on a daily basis. And I think that's really the future of chronic disease and, and we're glad to be able to help tell that story.
Stacey Simms 33:45
Well, thanks for spending so much time with me. I really appreciate you going through it. And I'm sure we will talk again soon. Jeffrey, thanks so much for being with me.
Unknown Speaker 33:57
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 34:03
Lots more information about Bigfoot. I will link it up in the show notes at Diabetes connections.com. I have been hearing some weird things about Apple podcasts player recently and some of the other apps that feed off of apple. If you're having any trouble getting links, or even listening to the show. Everything you need is a Diabetes connections.com transcripts of every show. And always please get in touch with me I can usually help you find what you need. Because these are pretty information, dense episodes. And if you prefer to read, I want to make sure you get the info. And if the app isn't helping you then we can help you in a moment.
Something really amazing about my recent diabetes, parenting meetup, I met some new families and it was really unusual their experience and what they're doing for the rest of us. It's complicated, but I'll tell you in just a minute. First Diabetes Connections is brought to you by Dexcom. And when we first started with Dexcom back in December of 2013, the share and follow ups weren't not an option. They hadn't come out with Technology yet. So trust me when I say using the share and follow apps makes a big difference. I think it's really important to talk to the person you're following or sharing with. Even if you're following your young child, I'm telling you, these are great conversations to have, you know, at what number will you text? How long will you wait to call that sort of thing. That way the whole system give everyone real peace of mind, I'll tell you what I absolutely love about Dexcom share. And that is helping Benny with any blood sugar issues using the data from the whole day and 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.
Okay, it was jumping out of my skin last week, because I had my first diabetes parent meetup since COVID. I think the last one might have been January or February of 2020. Many of you know I run a very large Facebook group for parents of children with type one in the Charlotte area, I think we have almost 1000 people now when we were starting to pull from all over the state because I have come to find out it's a pretty unique group. If you have a local group that you run, or you're part of what makes it unique is mine is based on meeting in person, I try to really stress and set up you know nothing official, I'm not with any organization, I just say hey, let's meet for coffee here, I stress the idea of let's get together in person, let's get the kids to meet let's get the parents to meet. And it can be kind of hard because not everybody I have found is as I don't know if enthusiastic is the right way to put it or pushy or not shy, maybe it's just I'm not afraid of rejection. If I set up a coffee and I invite you know, the whole 1000 people group, and five people show up or one person shows up, I'm still really happy. And I've come to find out that not everyone feels that way. So don't be shy. Just put your stuff out there, get people to come and meet up with you. It will change your life. It really helps me 14 years into it, I think more than anybody else who comes to these things.
So I set one up, we only had two people come I'm telling you these things are still amazing. But they were both newer diagnosed families. One had a nine year old daughter diagnosed January of 2021, just this past year, and the other had a 16 year old boy who was diagnosed last summer. And it turns out and I knew this before we met we the kids have some mutual friends. And they're both wrestlers. So Benny knew this other kid as well. But what was amazing to me is that both of these families were already enrolled in clinical trials. And they had been presented with this option. So early on. Now we do not live in an area where clinical trials are present. I mean, I've talked about this on the show before it's we've never been able to get in one. We live in Charlotte, North Carolina, most of North Carolina trials and tests and things are in the Raleigh area over by the Research Triangle, or they're in Virginia, at UVA, or Florida. And that's really the closest to us. So that's where these two families both went for separate trials, both at University of Florida health both I believe at trial net, I may have the exact place but both with Dr. Michael Haller, who we've talked to several times before on this show, one of the kids that the 16 year old is in the Teplizumab trial, the other is in the ATG trial. I'm not going to go into detail on both of these, we've actually talked to Dr. Haller about both of them on the show before. So I will link that up in the show notes as well.
But I'll tell you what the ATG trials you've just started. So it's a little too early to tell anything. And of course, this is just with one person. So we should be careful about drawing conclusions. But the 16 year old wrestler, holy cow, so he was diagnosed last year, it's almost a year I believe in In fact, when this episode comes out, it might just be a year. And this is a 16 year old kid. So a teenager who uses probably a lot of insulin, right big kid healthy kid. And I want to say the dad told me that his daily basil is four units. And they're struggling using a pump because he gets such low doses of insulin. They're trying to figure out what to do. Now, who knows, because as I said, it's early on, but it seems to be the thinking that the diploma has really helped make this first year of diabetes, very different than what most 15 or 16 year old kids go through in their first year of diabetes. I'm going to talk to the family. I'll probably circle back around with Dr. Haller again. Because I think that their experience and honestly, it has not been an easy experience. This isn't you know, you go down to Florida, you take a pill you come home, it's a very intense, but brief experience, but they do go I believe, every six months. So I'll tell you more about that as we get there.
But I really wanted to bring up with how amazing that these newer families are helping in this way. Obviously they want to help their own children, but they also understand that this is helping the greater commUnity. These are opportunities that did not exist. 14 years ago, when Benny was diagnosed that did not exist possibly, you know, 10 years ago, we have to pull him up in front of the FDA right now. This is really interesting to me, and I know it is to us. You're listening if you're listening this far into the show, certainly, but man and I know I also live in a more affluent area people have more access to health care and to doctors who know about this stuff. But Wow, I was surprised so happily, so To hear that and and to see that their entry into the diabetes community was also an entry into studies that will help everybody you know whether this stuff works or not, it all helps. So I really appreciate it.
Okay, before I let you go update on events, my next event is not in person, we're still on zoom for a lot of us but getting in person for more, which is so exciting. On June 5, I'll be speaking at Camp Nejeda. They have a great event for adults with type one, I will link this up in the show notes. And in the Diabetes Connections Facebook group, I'm talking about telling your story and advocacy. So this is more about how to get the media to listen when you want to talk and also maybe just about blogging and speaking Yeah, blogging still Sure why not in podcasting, and tik tok and Instagram, but talking about your story, and advocacy. That's what I'm going to be talking about there. If you're listening in the Charlotte area, we are doing another D parent meetup. That's This Week. If you're listening as the episode first goes live, it'll be Thursday evening. So drop me an email or hit me up on social and I'll give you all the details. And of course, every Wednesday, Diabetes Connections in the news, join me 4:30pm Eastern Time live on Facebook for a very brief five, six minute newscast about what's going on in the diabetes world, all types of diabetes, and that's replayed on social through the rest of the week. And the response to that has been great. So I am going to keep doing it. I'm having a lot of fun with it. All right. 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 next week. Until then, be kind to yourself.
Benny 41:40
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
It's getting hot out there and it's vital we keep insulin at the right temperature. However, that's something health care providers say isn’t always front of mind. Stacey talks to Diana Isaacs, a Clinical Pharmacy Specialist and a CDE at the Cleveland Clinic. We’ll get the real deal about insulin temperature and suggest some ways to keep your supply safe.
In Tell Me Something Good… glamorous inspiration and a grateful mom – plus babies! And a big anniversary.
This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Check out VIVI-CAP www.tempramed.com - use promo code DIACON21 to save 10% off your purchase! (promo code valid through 8/31/2021)
EPISODE TEXT HERE...
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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, it's getting hot out there a conversation about keeping your insulin at the right temperature. It's something healthcare providers say isn't always front of mind when we're troubleshooting tough diabetes days.
Diana Isaacs 0:39
Why are the blood sugars out of range this day? Why was it in range this day? And why? What's the difference? And this is really one of those pieces to the puzzle. And I think we spend so much of our time worried about other pieces like food that sometimes this really goes neglected.
Stacey Simms 0:55
Diana Isaac's is a Clinical Pharmacy specialist and a CDE at the Cleveland Clinic, we'll get the real deal about insulin temperature and suggest some ways to keep your supply safe
in Tell me something good, glamorous inspiration, a grateful mom and babies plus a big anniversary.
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'm always so glad to have you here. We aim to educate and inspire about diabetes with a focus on people who use insulin. You know, My son was diagnosed 14 years ago, just before he turned to my husband lives with type two diabetes. I don't have diabetes, but I have a background in broadcasting. And that is how you get the podcast. I live in the southeast us in North Carolina. So it has been warming up for quite a while here. But pretty much all over the United States. We are seeing the warmer weather hot summer is coming. Shout out to our listeners in Australia and elsewhere in the world where summer is not coming please save this episode for a few months. But in addition to the advice here, I've got a thread going in the Diabetes Connections Facebook group about what to use not only to keep insulin cool, but to keep diabetes gear holding tight in the summertime CGM and pump sites as you know, tend to slide off in the wetness sweat. So please check that out. Lots of good suggestions. And as I mentioned, in my book, the world's worst diabetes mom, we really like stay put medical to hold stuff on. But I'll tell you in a pinch Benny will just slap a big waterproof bandaid over his Dexcom I really like the clear tegaderm stuff, but I mean he doesn't care yelled us anything and you can find that in a CVS. So if you're off to the beach and you don't have anything, it really comes in handy. Most of the rest of the stuff that's being suggested in that Facebook group thread has to be special ordered either Amazon or the website from the company that makes it
okay quick housekeeping note, you will hear my guest mention a product called VIVI cap in this interview and I have a promo code for you if you want to buy it you'll get a discount if you use the code, but I'm not being paid by VIVI cap. Although we are talking about doing something together in the near future. My guest is not a paid consultant for VIVI cap. She really likes the product and they know that and they helped coordinate this interview that said this conversation is about a lot more than one product. So whatever you use, keeping insulin at the right temperature is really important that promo code for VIVI cap is DIACON21, which gets you 10% off the product@temperment.com I'm pretty sure you're not listening with a pen. So I will put that in the show notes and on the episode homepage at Diabetes connections.com.
My guest this week is Diana Isaacs, she is a Clinical Pharmacy specialist and the remote monitoring program coordinator at the Cleveland Clinic Diabetes Center. She was the 2020 at CES Diabetes Care and Education Specialist of the year and a Cleveland Clinic. She does have a pretty unique CGM training program. And you'll hear about that during the interview as well.
But first Diabetes Connections is brought to you by Dario health. And we first noticed Daario a couple of years ago at a conference and Benny thought being able to turn your smartphone into a meter was pretty amazing. I'm excited to tell you that Daario offers even more now, the Daario diabetes success plan gives you all the supplies and support you need to succeed. You'll get a glucometer that fits in your pocket, unlimited test strips and lancets delivered to your door and a mobile app with complete view of your data. The plan is tailored for you with coaching when and how you need it and personalized reports based on your activity. Find out more go to my daario.com forward slash diabetes dash connections. Diana Isaac's welcome. Thanks so much for joining me. I'm really interested to talk more about this. Thanks for being here.
Diana Isaacs 4:46
Great. Thank you so much for having me.
Stacey Simms 4:48
Or it is getting hot. I know that not everybody lives like I do in the south where it's been hot for a while. But let's start by talking about what you tell your patients.
Diana Isaacs 4:58
Yeah, so many people don't really The storage and the storage of insulin is so important. It's actually very fragile. And if it's not stored correctly, it actually most commonly it loses its potency. So it ends up you know that 10 units of insulin that you inject doesn't work like 10 units to work like seven units, like six units, you just don't know exactly, it's just will not be as potent.
Stacey Simms 5:18
When we're talking about storage of insulin. I know if I leave it in my hot car, and it gets to be, you know, above 110 degrees, it's going to lose its potency, but day to day, just kind of throwing it in the bag or having it with you, how do you need to store it,
Diana Isaacs 5:33
it's recommended any unused insulin pens or vials or cartridges should actually stay in the refrigerator, once it's been opened, then typically, it's good at room temperature for either 28 days, or some of the newer insulins are good up to 56 days, when it goes above that room temperature, that's when you really can't guarantee the potency anymore, and that's when it can break down and it is not going to be as effective. And in terms of Well, what's the danger of that? Well, a you really have no idea how much you're giving yourself. Because like suddenly, you know, what you usually give yourself isn't going to work as effectively. And you know, the real risk or the big risk would be a complication like diabetes ketoacidosis, where you're just not getting enough insulin and that could be you know, a life threatening complication,
Stacey Simms 6:23
what is considered room temperature
Diana Isaacs 6:25
78.8 degrees, it should be it should not go over 78.8 degrees Fahrenheit or 26 degrees Celsius,
Stacey Simms 6:32
you mentioned that the newer insolence can be out of the fridge for 56 days which insolence.
Diana Isaacs 6:37
So specifically, the ultra long acting like tresiba, insulin degludec, and then toujeo, which is insulin collaging. You 300 those lasts a little bit longer at room temperature.
Stacey Simms 6:49
Do you have any idea why I know those are made up a little differently from like, you know, Lantus or levemir.
Diana Isaacs 6:54
Yeah, the you know, they're just, they're made a little bit differently, which allows them to act longer in the body. And that's how they were studied to show that the potency, you know, still really maintains a fact at that point. And I mean, it's good also, because there's larger pens that holds more units. And so you know, that way a person, if they needed it for 56 days could have that the reality is a lot of people with the doses that they're on, you know, will go through a pen, you know, much faster than been 28 days. All right,
Stacey Simms 7:26
we're gonna do some True Confessions here, because I gotta tell you, we have kept insulin a lot longer than 20 days. And we have, and again, I'm not a diabetes educator, and endocrinologist. So you know, I'm just telling you what we have done as you listen, not just for you. But for example, Benny had a vial of insulin, my son that he took in and out of the fridge at school for almost an entire year, it was like a backup. So he would use it if he needed it. And when he was in elementary school, he used like, drops of insulin. It's not like now and he's a teenager. So we would put it in the fridge at the beginning of the school year, and then he would like take it out, use it, put it back in, take it out music, put it back in. Now, I know that's not advised. But it does work. So I mean, how delicate really is insulin, if we can get away with doing something like that.
Diana Isaacs 8:08
So Oh, man, you're burning my ears as a pharmacist? Oh, I hear that. But yeah, I mean, we know that that is reality that people are doing that. I think, you know, as long as it has maintained its room temperature, or refrigeration, probably a lot of insulins have at least close to the near potency for longer. It's just it really can't be guaranteed beyond that point. Because how it studied, I think, where things become different, or when it's exposed to too much heat, like we know for a fact that when it's exposed to high temperatures, or direct sunlight, it mean it loses its potency almost immediately. And if you've ever had you know, the insulin just sitting in the sun and then try to inject it, I I'm willing to bet it would be different. It wouldn't it would not work as well.
Stacey Simms 8:53
Right? And I think with that example that I gave, it never got below the refrigerator temperature because it was out and in so quickly. But I give that example because I know people who once they take it to the fridge, they think that's it. And it's just it was probably out for less than three minutes.
Diana Isaacs 9:08
Yeah. So I mean, that's interesting, right? So it's still you use it, but right, it wasn't out as much. So obviously, it's not ideal. We can't confirm how you know that it's so potent, but it sounds like in your case it was I have seen a lot of situations though, where people use insulin for example, longer in their pumps, like usually we say to change it out, you know, every three days and an insulin pump and people go five days, seven days and a lot of people notice as they go further out from those three days that it seems like they are needing more insulin that it is losing some of its potency.
Stacey Simms 9:39
I will say one of the only times we had an I refer to it very scientifically, skunky insulin. The only time we had skunky insulin was we had come home from summer camp and had unpacked the car but we had not seen like one of the bags kind of worked its way into the corner. And of course that was the bag that had two vials of insulin and two or three days later in our house. Summer car. We this was years and years ago, we used it anyway, of course, it did nothing. It was like sailing, or it was really bad. So that was a realization like, oh, it really does get terrible.
Unknown Speaker 10:12
Yeah. All that precious insulin law. I know. I know,
Stacey Simms 10:17
well, once we know, it's been 14 and a half years, so it happens, it happens. What do you advise patients then to do I mean, obviously, we can change out pump insulin more often. But as you said, Nobody wants to waste precious insulin like that. What are the tips that you give people to keep their insulin cool in the summertime, whether it's in a pump in a vial, that kind of
Diana Isaacs 10:42
thing? Yeah, so I'm a really big fan of something called the Vivi cap. And this is actually can go over like, it can replace the cap of an insulin pen, and you put it on there, and it guarantees that it stays at room temperature, even if it's exposed to, you know, a really hot car, really extreme temperatures, that is something that I've really been recommending for my patients, because it's just, it's a simple tool. And that way, you don't have to stress about like trying to, you know, I see a lot of people trying to get ice packs and things and that, that's risky, because you could accidentally freeze your insulin. So some a tool like the vivie cap, I find is really, really helpful,
Stacey Simms 11:20
you want to take us through a little bit of what it does.
Diana Isaacs 11:23
Sure, basically, it replaces the cap. So essentially, you know, like, let's say you have a novolog pen, right that you're using for your meal time injection. So you would go ahead and you would take off the cap. And instead, you would go ahead and you would put this Vivi cap directly on it, and you would replace that. And then you honestly, you can just throw it in your purse, in your bag, or whatever. And when you want to be sure that the insulin, you know, let's say you were in extreme temperatures, it was in your 100 degree car, and you're not sure if this insulin is going to be effective or not, there's a button at the top of it, and you go ahead and you press it. And if that button becomes green, then you know that that insulin was stored properly, it is a safe temperature, and it is safe to be able to use it if the D button would turn red, that would tell you Oh, there was an issue, the insulin is not safe. Now the good news is the way it actually you know, through a thermal cooling mechanism is actually getting rid of the heat where the insulin is. And so it's saying, you know, keeping it at room temperature. And why this is important also is because a lot of other things out there will make insulin really cold or accidentally freeze it or just make a cold. And really once it's out, and once it's open, it should say every temperature and so this really ensures that it will happen.
Stacey Simms 12:52
That's interesting. So the V cap doesn't necessarily keep it cold. It keeps it like it doesn't keep it refrigerated.
Diana Isaacs 12:59
Right, it's keeping it at room temperature. So it's really meant for the pen that you're using you're actively using. You can throw this cap on you can put it on your long acting and your mealtime insulin, and you can go on a trip, you can go wherever do whatever and it will stay at room temperature.
Stacey Simms 13:17
Here's a dumb question. We don't use pens very often. So I'm curious, do all pins have the same caps would this fit on pretty much any insulin pen
RIGHT BACK TO DIANA in just a moment 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 comm slash risk.
Now back to Diana answering my question about what type of insulin pen fits in the VIVI cap?
Diana Isaacs 14:25
No, that's a really good question. So they actually make different ones for different types of pens. So for example, if you're using like the novalogic products like novolog, and for siba are similar. There's a V cap for those. If you're using like human log products, they have a different Vivi cap. And so yeah, depending on the type of insulin that you're using, you would just go ahead and get the vivie cap that goes corresponding to the one that you need.
Stacey Simms 14:49
It's amazing that until now, I mean we're seeing a few more products address this, but it seems like you know insulin has been around for a long time and you know until recently cuz I've seen a few products like this until recently, the freo is the only thing I can think of that was really out there affordable, you know, easy to use, do you think people are just kind of catching on to the fact that this is really important?
Diana Isaacs 15:11
Well, I think this is just like a really neglected area. Like I spend a lot of my time like analyzing glucose levels, looking at CGM, and in blood sugars and all that kind of stuff. You know, often you're trying to figure out the puzzle. Why are the blood sugars out of range this day? Why was it in range this day? And why? What's the difference? And this is really one of those pieces to the puzzle. And I think we spend so much of our time worried about other pieces like food that sometimes this really goes neglected. And as it's summer, you know, summer is approaching is really a good opportunity to remind everyone that this is a really important for insulin. I mean, this is so so important and will affect it, if it's not stored properly.
Stacey Simms 15:52
It just sounds like common sense. But I'm curious, have there been studies of this? Do we have any idea how many people are having issues with insulin that's not stored properly, or using insulin that has, you know, been out of the fridge for too long? Is there any information on that?
Diana Isaacs 16:08
Well, I don't know, if we have, you know, we certainly don't have like randomized control trial data on that. I mean, how would you do it? Right? I can tell you anecdotally, I think it's just difficult to capture. Because you could ask people I mean, oh, with any person will say that they've had their insulin at high temperatures at some point. I mean, if you, you know, are a human being that goes outside, you know, it's likely that your, you know, your insulin was exposed to higher than room temperature. It's just a matter of how long and I think in the summer, it's really easy for it to, you know, when you meant for it to just be a couple of minutes, that ends up being hours. And then before you know it, you just don't know. And I think also it's difficult to classify, because there's so many reasons that blood sugars can go higher. And so in the moment, it might be hard for someone to be like, Oh, wait, oh, yeah, I was, you know, I left my insulin in the car for three hours. That's why my blood sugar is so high versus they might be thinking, Oh, was it the food I ate? Or am I under stress? So I think sometimes it's just difficult for people to make that connection that it really was the insulin that made their sugars higher,
Stacey Simms 17:11
because I'm kind of picturing people listening to this episode of had diabetes for a long time going, I don't need that. It's been fine. Right? And I'm kind of one of those people that I'm like, Oh, it's fine. I can't imagine this really happening all the time. But you're exactly right. How would we know?
Diana Isaacs 17:26
Yeah, I would just encourage people to reflect on it. I mean, it likely has happened. If you had diabetes long enough, it's probably happened at some point in your life where your insulin hasn't been stored perfectly, right. I am a really big fan of patient choice, and people knowing what's out there. So if you've come up with a perfect solution, or your insulin is always at home, and you never go out great. You don't need something like the Vivi cat. But you know, if you're out you're traveling or going on a trip, I think it's good to know what options exist out there.
Stacey Simms 17:54
I'm curious too. And this is kind of separate from vicap. My son is using insulin pumps since he was two years old. And he we live in the south, as I've mentioned, and it's always hot, the summer is ridiculous. But he has the insulin next to his body. His body is pretty warm all the time. Is there any Are there any issues with that three days in the pump? Do you see people having more issues in the summertime? And do you ever recommend, you know, changing the insulin at more often because of temperature?
Diana Isaacs 18:20
I do. Yeah. A lot of people have issues is especially in the summer. I'm like I've seen people with like Omni pod. And it's just like boiling in the sun. And it goes bad very quickly. So yeah, I am a fan of encouraging people to change more often, like every two days instead of every three days if they notice that it's wearing off sooner. So I think like a lot of people should consider that in the summer if they noticed that third day there. boluses are just not having the same effects on their blood sugar's.
Stacey Simms 18:46
We've also found that winter to summer, we always have to change basil rates. And that's probably because of activity, but it's also because of heat. And I know that that affects people differently. How do you advise your patients to look at the weather and how it affects their bodies?
Diana Isaacs 19:01
That's a good question. I mean, everyone is affected a little bit differently. I really like Adam brown from diatribe. And he talks about 42 factors that affect glucose levels. And actually a sunburn is one of the things that could affect levels, it could increase glucose. So I think, you know, weather can affect it any kind of stressor on the body can absolutely affect glucose levels, but it is very individualized. For many people, the weather won't be a huge deal. But for some they may be more sensitive. And I think the best thing is to really reflect on it to review data with a diabetes educator or diabetes care and education specialist and really try to determine what are the patterns and who knows, yeah, it could be whether it does create a pattern for someone that if you know that it's helpful, because then you can kind of preemptively prepare for it and give yourself more or less insulin as needed.
Stacey Simms 19:52
Can we talk about sunburn for a minute, because every year in the parenting groups, somebody comes in and says it's their first time can the sunburn I raise my kids blood sugar, and everybody kind of says yes, yes. Why is that? Is it just trauma to the body? Is it like being ill?
Diana Isaacs 20:07
Yeah, I think it's like anytime there's a stressor on the body that can affect it. So yeah, if it's causing stress, you know, sunburns can be pretty painful. And we know pain can increase glucose, so it's likely related to those factors.
Stacey Simms 20:21
I don't wanna change the subject too much, but I'm reading your bio. You know, in researching for this episode, he talks about how you run a CGM shared medical appointment program. Can you tell us what that is?
Diana Isaacs 20:33
Yeah, so I am a big advocate of CGM of continuous glucose monitoring. And in our program, we often introduce people to CGM for the first time. And so with our shared medical appointments, we have usually four to six people with diabetes, and we have a meeting. And then we also have a dietician, and it's a two part shared appointment. And the first part, we get everyone together we place the CGM, and we have a discussion about what are the glucose targets and what kind of things affect glucose levels. We also review how to treat high and low glucose levels. And then everyone comes back after seven days and we download the devices and we we actually show everybody's data on a big screen and we go through it together. It's really interesting because a lot of people there, you know, there's similar things like the overtreating Alo or learning you know how oatmeal affects your blood sugar's you know, like, there's a lot of similarities that kind of it's nice to have that group environment. Yeah, that's
Stacey Simms 21:30
I've so many questions, but my first one would be, you'll have to, you'll have to come back on and just talk CGM with us. I'm curious, how do you manage or handle when people are looking at everybody's CGM numbers? And some must feel like, Oh, that's bad? Or I didn't do that very well. You know, do you talk about that part as well, and kind of managing the data mentally.
Diana Isaacs 21:51
So my rule is data numbers are data, and they cannot be good or bad. So it's simply being in target or out of target. But it's not a judgment, there's no such thing as good or bad numbers. And I'm really careful about this. I mean, even you know, when someone is 100%, in range, and has an agency of 6%, I try really hard not to say, Oh, that's so good. Like, you know, do jumping jacks, because, you know, I don't want someone then to have a higher agency and to be less than range and then not want to come back for their appointment because they think I'm only be happy when it's, you know, in range. So it's really an important point to not be judgmental with with data.
Stacey Simms 22:27
Oh, all right. You're gonna have to come back on and talk to us more about that. I think that's,
Unknown Speaker 22:31
I'd love to Alright, good. Good. Good.
Stacey Simms 22:32
All right, back to the summer, though. So since you work with a lot of people with with CGM, do you find that there are ways for people to keep their gear better on in the summer? Do you have any advice for that? Because diabetes technology can be kind of slippy in the summer?
Diana Isaacs 22:45
Yeah, no, it can be. So I'm a big fan of skin tack and of overlay patches, like sin patch, and stuff for keeping on CGM sensors and sites for the pump. I think technique with everything is really important. Making sure the skin is clean and dry. You know, placing it right after a person has recently showered or bathed just to have the most success with it digging and staying on. But I think absolutely using products like skin tack mass assault, for people that sweat, it's just it's like kind of a must to have those extra, those things can really help.
Stacey Simms 23:17
Yeah, we found or at least just anecdotally, everybody's skin is so different that you know, overlays vary brand to brand. So unfortunately, you kind of have to keep trying until you see what works for you. And one of the nice things we did locally when we could meet up and we're going to start meeting up again, which I'm very excited about is I always tell people, like let's bring samples, right? Because you get like a 20 pack of sim patch, and I get a 20 pack of stay put medical patches and you know, people just bring different brands, and then we can kind of trade because I used four or five different brands on my son before we found what worked. So if you're listening and you have a local group, and you're meeting up again, that's just something you can try cuz it's so frustrating.
Diana Isaacs 23:55
Yeah. And sometimes like, right, you put something on over it, and then you know, it starts peeling off after a couple of days, you have to put another thing over it. So yeah, I agree trial and error. You know, we
Stacey Simms 24:05
spoke a lot about the temperature extremes with insulin on the warm end, we touched on freezing, but let's talk about that again. What's the danger of insulin freezing? I mean, we know it doesn't work well. But is there anything to say about that in terms of why? Or you know, is it just that you mean, obviously, if it's frozen, you can't put it in a syringe, but it does completely lose its potency? Right?
Diana Isaacs 24:26
Well, I don't know if it completely loses its potency, but it very much does. But also, I mean, particles may form to which could make it definitely more difficult injecting and then I mean, I guess it could cause pain with injection as well. So I mean, it's just another reminder to like anything, you should really always visually inspect the insulin as well. And most insolence should be clear. So checking for that is really important as well.
Stacey Simms 24:54
Yeah, that's the the hotel refrigerator syndrome. So many times the fridge In the hotel is not set to the correct temperature. So you put your vial of insulin and it freezes. I've heard that so many times. It's just terrible.
Diana Isaacs 25:07
Yeah, I mean, it's really, it's really a problem. And so yeah, I mean, that's a really good point, when you're traveling, it's often really hard to rely on the hotel refrigerator, which is often is not set correctly for temperature is the right temperature,
Stacey Simms 25:21
what we usually do is, if we're staying for more than one night, is we'll put something you know, water, we'll put whatever in that fridge and kind of see how it does in a couple of hours, to see if we trust the insulin. But that's only helpful if you're going to be there for a couple of days, and you have a way to keep your extra insulin, you know, at a cool temperature, because so much of what we're talking about is not even so much for the the insulin you're using at that moment, although you want to keep it at room temperature, exactly. But you know, we don't have to keep it refrigerated. But when you're traveling with extra insulin, that's really a problem.
Diana Isaacs 25:52
I just would encourage people to think about it and just be just plan. I mean, just have a plan for the summer, whatever that plan is. And just be aware that I think some of the traditional methods that people use, like using like a lunch bag and putting an ice pack in it can, you know, you don't really know that temperature that's going to be in there. So there is an option available that you can be assured it's going to stay at room temperature. And it's just it's really simple. And it doesn't take up all this extra space and everything. I think that's the key. It's just it's a super simple thing. And so I would just encourage people to kind of check it out and go to the website and learn more about it.
Stacey Simms 26:34
It's interesting too, because insulins not alone, I mean, so many medications are temperature sensitive, as newer insulins come out, do you think that the temperature sensitivity will ever be factored out of insulin? Or it's just it's just part of the component?
Diana Isaacs 26:51
It's a really good question. Because I I'm sure you know, there's research in this area to see can insulin be more stable, or it's not? I think the problem is, it's just it's a large peptide. And, like due to its nature, it's just really hard to get it to be stable for a long period of time. I mean, it's one of the reasons why we don't have oral insulin, at least not yet. Like we don't have it in pill form. It's just really, really unstable. I think it's going to be challenging. Maybe one day we'll have that. But it's definitely going to be a challenge to
Stacey Simms 27:19
have that. You mentioned the newer insolence, like the longer acting like to CBOE and toujeo. Is that considered an advancement? Or is it just different, it's not going to apply to the shorter acting?
Diana Isaacs 27:30
Well, I think it is an advancement, in that we have an insulin that they were able to alter to work longer in the body, which I think ultimately really helped to stabilize blood sugars. And when you think about like, where we progressed, we started off with NPH, which you know, only works like half a day. And then we got longer act insulins like lantis and lab Amir, and then now we have these, like ultra long ones, like TJ Oh, and receba. And there's actually a weekly insulin that's in development that hopefully will, you know, see in the near future. So I think we're definitely making advancements and insulin, which is really exciting. Although the other area where we need to make advancements, which is a whole other episode is the affordability of insulin as well. But there are definitely advancements that are are being made. So yes, maybe with the storage, those will be things that will get better. But I don't see it completely resolving, you know, anytime soon.
Stacey Simms 28:23
How do pharmacies Sue with this? I mean, as far as I know, we've never had a problem getting our insulin from the pharmacy at the right temperature, of course, then I have to bring it home. And we do a lot with mail order as well and knock on wood. It's always been delivered, I think at the right temperature. Is there a problem from that perspective as well, like in the supply chain,
Diana Isaacs 28:43
know, the supply chain is heavily regulated? So I mean, they are monitoring refrigerators constantly. And they have certain standards, there's inspection so you can feel really good about the supply chain. It's really once it gets to the person that it's not regulated. But yeah, in the pharmacy, it is very, very maintained to a tee to those temperature and they're like specialized refrigerators is not just your it's definitely not your hotel refrigerator that for storing Insulet
Stacey Simms 29:12
Yeah, it's good. That's good. That is good. Before I let you go, I'm just curious. I we have been lucky enough to see my son's endocrinologist in person for the last couple of visits when we did a lot of telehealth. Are you seeing people back in the office? I mean, how are you all doing through all this?
Diana Isaacs 29:29
I never stopped seeing people in the office. So I've been here through the whole pandemic, I've actually come to work every day. Now. A lot of our visits have been virtual out of convenience for people but we are open and people could come here you know, whenever they want. And some For some it's preferred because as much as we've made advances in technology, we you know, we've got some patients who really have challenges downloading their data at home and stuff and it's, it's good to have them in the clinic. So yeah, our doors are open and but I will Say telehealth has flourished. And for a lot of people, it just makes so much more sense. Like today this morning, you know, we trained a person on their new pump. And rather than like me having to have her come in next week, I can just do a virtual and just look at her data that way and make adjustments. That's kind of where we're at with it.
Stacey Simms 30:15
I would imagine your patients have been very happy to walk in and see you during this past year. Like it's very be very reassuring. I was surprised how when we were able to see my son's endocrinologist again. I'm kind of happy we were.
Diana Isaacs 30:29
Yeah, I think it's nice. And I mean, I feel especially now with like the vaccine now that we've all been vaccinated, I feel very, you know, I feel great. It was definitely a little stressful. Like, I'll tell you back in December, we were doing our CGM shared medical appointment. And I had a class of four people and I, you know, you see people starting to like, move their masks down, and you're like, Oh, my gosh, is this safe, like at this stage, because we're doing a class and that was right, when the numbers were really increasing? So we did, we did pause them for a few months till the numbers came down. But But yeah, I think overall, you know, it's good. It has been reassuring. And you know, it's care doesn't stop, like some people are getting new insulin pumps. And yes, while you can get, you could do virtual training. And for many people, we do like some people really want that hands on time, when that was their first time starting upon, they want to come in and see it.
Stacey Simms 31:17
I can't imagine the people who were diagnosed this past year or had children diagnosed and were more isolated than normal. It's isolating enough to have diabetes. And I just can't imagine. So thanks for doing that. And, you know, keeping in touch with everybody, I mean, I'm not your patient. You don't really know me, but I want to say thank you.
Diana Isaacs 31:34
Oh, you're welcome. I mean, I love doing it. I love working with people with diabetes. It's so rewarding. And it's like, I just, yeah, I just feel like I feel very optimistic. With all the new technology and the advances being made. I just feel like, yeah, there's so much opportunity to help people.
Stacey Simms 31:50
Well, thank you so much for spending so much time with me. And we'll have you back on to talk more about CGM and the shared medical stuff. I think that sounds great. Thank you so much.
Unknown Speaker 31:57
Oh, you're very welcome. Yeah, thanks for the opportunity.
Unknown Speaker 32:05
You're listening to Diabetes Connections with Stacey Simms
Stacey Simms 32:11
I’ve got more information about the temperature at which insulin is supposed to stay. We touched on that. But if you'd like to learn more, and there's some more studies that really delve into this, I'll put that at Diabetes connections.com. Every episode has its own homepage there. If you're listening on an app for podcasts, there are always show notes, but some of them don't show these things very well, you can always come back to the main page, and I'll put it there with a transcript as well.
And the promo code for VIVI Cap is DIACON21, like Diabetes Connections, di a co n di a con 21, which gets you 10% off the product. Alright, tell me something good. Coming up help prom photos provided some unexpected inspiration.
But first Diabetes Connections is brought to you by Dexcom. So I was watching a movie with my husband the other night, and I got a Dexcom alert and he was upstairs in his room. And you know, for some reason, that took me back to the days when we basically had blood sugar checks on a timer, we would check doing a finger stick the same time every day at home and at school and you know, whatever extra we needed to. But it's amazing to think about how much our diabetes management has changed with share and follow. I didn't have to stop the movie to get up and check him. I knew what was going on, I could decide whether to just text him or go upstairs and help him out. Using the share and follow apps have really helped us talk less about diabetes, which I never thought would happen with a teenager. Trust me, he loves that part too. That's what's so great about the Dexcom system. I think for the caregiver or the spouse or the friend, you can help the person with diabetes manage in the way that works for your individual situation. Internet connectivity is required to access Dexcom follow separate follow up required, go to Diabetes connections.com and click on the Dexcom logo.
Tell me something good this week, I don't know about you. I'm in a lot of moms groups. And I have seen a bajillion prom photos over the last month and it's really nice. But one of the things that happened that I didn't expect is that it provided diabetes inspiration to families, especially families with younger kids, I don't have permission to share her name. So I'm just gonna tell you the story here. But this woman posted that she was looking at all the pictures of the beautiful girls and their dresses and their Dexcom and their pumps and their Omni pods showing. And you know, she was excited to see that. But her little girl who's totally into the princess phase right now she's six or seven years old, loved seeing the photos of all these grown up girls with diabetes. And it really provided an easier way to get her little girl to feel better about the gear that she is wearing. And I just thought that after all these years was still kind of unexpected. Now let's be honest, not everybody wants to show their gear all the time. And that's okay too. And honestly, I highly doubt that these girls are going to the prom thinking. I'm gonna have my mom posted. On Instagram or Facebook and that's going to inspire somebody else. Right? But man did it ever. So thanks to all of you who did that, who posted the photos? What a cool thing
I have to wish a happy wedding anniversary to Janice and Bill Grigsby they celebrated 50 years married in April. And Janice was cute. I was asking for good news in the Diabetes Connections group and she wrote that may not be what you were looking for, since it doesn't have to do with diabetes. But you know, Janice, we're all together because of diabetes. Janice and Bill's daughter marked 20 years with type one late last year, so I think that counts so congratulations on that amazing milestone. It doesn't all have to be diversities. 50 years married. That is fantastic.
And a big congrats to Alison nim Lowe's, who had a baby last week, little Stellan joins Big Brother Henrik is still in it was a little impatient came into the world a little bit early. So he'll be staying at the hospital for a while. And they helped to bring him home by the end of May. But everybody's doing well. Alison is somebody I've known for years. She's been on the show before I will link up that episode. She's on social media as the diabetic therapist Of course, we talked about therapy and mental health in that episode, but congratulations all around really exciting stuff. If you have something good to share, please let me know Stacy at Diabetes, Connections comm or pop into our Facebook group and share when I asked on a regular basis. Just tell me something good.
Before I let you go, quick reminder that on Wednesdays in May, I am doing in the news, a live diabetes newscast every Wednesday at 4:30pm. Eastern time. I hope you can join me for that. I'm also turning it around to then putting it out on different social platforms. And on this podcast. That episode right usually has been coming up Thursdays or Fridays. And it looks like we may continue this because people are really liking it. I definitely need to know how you feel about it though. So you can email me comment on the post itself. It's a little bit of different work than the podcast to be honest with you. Not necessarily more work, but I do have to brush my hair and put some lipstick on to go live on Facebook. That's just how I am if I continue this, maybe you'll see me eventually in the ponytail and opaque but I'm having a lot of fun doing it. And I think it's a need. We don't really have a diabetes newscast anywhere. So I may continue. I will be deciding probably between this weekend next week's episode, and I'll definitely let you know.
Thanks as always 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 in just a couple of days. Until then be kind to yourself.
Benny 37:42
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
After decades with just one not-so-user-friendly option, another shelf stable rescue glucagon enters the market. It’s called Zegalogue, FDA-approved and coming soon in both an auto injector and a prefilled syringe. One additional future use will be in the Beta Bionics iLet pump with two chambers – one for the insulin and one for this glucagon.
Stacey talks with Frank Sanders, President of Zealand Pharma U.S. and Dr. David Kendall, Senior Global Medical Advisor. This interview covers everything from the use of Zegalogue now to cost and a look at how far treatments have come.
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
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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 autoinjector for very low blood sugar and by Dexcom keeping you in control with an integrated system for diabetes management.
Announcer 0:21
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:27
This week after decades with just one not so user friendly option, another rescue glucagon enters the market. It's called Zegalogue, one future use will be a pump with two chambers, one for the insulin and one for glucagon.
Frank Sanders 0:43
So, with insulin being one side of that equation, when glucose does go lower, instead of simply shutting off the insulin and waiting for it to clear from the system, you have counterbalance, or the ability to counter regulate with the glucagon infusion in small little delivery boluses.
Stacey Simms 1:02
That's Frank Sanders president of Zealand pharmacy in the US, he and Dr. David Kendall, their senior global medical advisor, join me to talk about everything from the use of Zegalogue now to cost and to look at how far treatments have come. And spotting a diabetes pump in the wild never gets old. I'll tell you a quick story about what happened with us. 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'm so glad to have you all here we aim to educate and inspire about diabetes with a focus on people who use insulin. My son Ben in the state is 14 years ago with type one, my husband lives with type two, I don't have diabetes, I have a background in broadcasting. And that is how you get this podcast.
Thank you for the great feedback out last week's not really a bonus episode. But second episode that I've been doing, I changed it up again. And I released Diabetes Connections in the news, many of you have already listened to it. But I'm thrilled that I'm getting reaction. I don't even mind if it's constructive criticism or just I hate it. I really would like to know what you think I'm experimenting throughout the month of May. We're going to do four episodes of in the news live on Facebook first on Wednesdays at 430. And then a podcast episode that will turn around probably Thursday night or Friday morning and get you caught up on the week's news. So please let me know we have a post going in the Facebook group as well.
You know, six years ago, I launched this podcast and I liked that I'm still experimenting with it. And I hope that you do too because the idea is just to get you good information that you can use whether it's long format like we're going to do today, or short headlines, like I'm trying with that in the news stuff. And of course we throw in some personal stories here and there. And after this interview, I'll tell you about Benny's first wrestling match and how you know we spotted diabetes in the wild.
Alright, my guests this week are from Zealand Pharmaceutical, they just got FDA approval a few weeks ago for Zegalogue. The newest shelf stable emergency glucagon, you know, it really is incredible when you think about it the last 40 or 50 years more than that all we've had for emergency glucagon has been the stuff in the red or orange emergency box, the kind that you have to reconstitute yourself you know, and studies show that most people even those trained you don't use it very well especially under stress. And now we have three options vaccine me and G vo hypo pen and Vega log. You're going to hear from Frank Sanders. He's the president of Zealand pharmacy and Dr. David Kendall. He is their senior global medical advisor Frank Sanders has been in the pharmaceutical industry for more than 25 years. He has been with a company called therapeutics he's been with Johnson and Johnson's pharmaceutical arm many of you are familiar with Janssen pharmaceutical. He's been with GlaxoSmithKline and Dr. David Kendall has held many leadership positions in the diabetes community including at mankind at Lilly at the American Diabetes Association and at the International Diabetes Center in Minneapolis. Dr. Kendall and I also go way off topic toward the end because he served as a clinical investigator with the dcct and edic trials here homeless tourists will remember those evidence based on hope episode, which is one of my all time favorites, I will talk about the DCC T and edic trials at the drop of a hat. And I was so excited that Dr. Kendall can too
Okay, quick disclosure gotta tell you, your competitor to this product is a sponsor of this show. In fact, I'm about to read an ad from them. But as you know, Diabetes Connections is here to help you get information about the diabetes community and I don't limit who we talk to because of who spends money on advertising. Now on the flip side, the advertisers are also on board with all of that so I give them a lot of credit to longtime listeners are familiar with all of this, but just in case, I like to talk about it every time and let's keep things on the up and up.
Okay, let me tell you then Diabetes Connections is Brought to you by Gvoke Hypopen and our endo always told us that if you use insulin, you need to have emergency glucagon on hand as well. Low blood sugars are one thing, we're usually able to treat those with fast acting glucose tabs or juice. But a very low blood sugar can be frightening which is why I am so glad there's a different option for emergency glucagon. It's Gvoke Hypopen . Gvoke Hypopen is pre mixed and ready to go with no visible needle, you pull off the red cap and push the yellow end onto bare skin and hold it for five seconds. That's it, 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 gvokeglucagon dot com slash risk.
Frank Sanders, Dr. Kendall, thank you so much for joining me today. I'm really interested to learn more about this. I appreciate you being here.
Unknown Speaker 5:50
Thank you. We're glad to be here as well. Yeah. Thanks so much,
Unknown Speaker 5:52
Stacy.
Stacey Simms 5:53
You got it. So Frank, let me start with you. If I could just, you know, to give us an overview a little bit. We've never talked before, if you could kind of catch me up on what Zealand is all about. And then we'll talk about Zegalogue.
Frank Sanders 6:05
Yeah, sure. Thank you for the question. I appreciate it, Stacy. So I'll start by saying that Zealand is a global biotechnology company and a world leader in peptide therapeutic development. Well, it may seem like a new company, the company was actually founded in 1998. It is headquartered in Copenhagen, Denmark. And we have our US presence and our company in our corporate office in Boston in the seaport area. So the company has approximately 330 employees worldwide. And our we believe our distinguished advantage is our unique peptide platform that allows us to design and engineer highly innovative peptide and peptide like medicines for, you know, for multiple conditions. So we have a 20 year legacy in r&d and peptide therapeutics, and we're very proud of what we've delivered.
Stacey Simms 6:50
Can you take just a second and I when we hear peptide on this podcast, we just think about that C peptide test, right? That helps figure out if it's type one or type two diabetes, what does a peptide therapeutic be?
Dr. David Kendall 7:02
I'm happy to take that one. And Frank, please feel free to chime in. But Stacy, a peptide in the common ones that I'm sure this audience knows about are things like insulin, glucagon, or modifications there. But they are very simply the proteins. In the body peptides generally referred to proteins which are made up of these building blocks we call amino acids, usually up to 25 to 50 of these amino acid segments plugged together glucagon, which we'll be talking about today, and LC glucagon is made up of 37 of these building blocks. So peptides that are commonly known are just those proteins that circulate in the body or makeup, the structure of the body.
Stacey Simms 7:46
Alright, let's talk about Zegalogue. I think most of my listeners are familiar with the concept of needing emergency glucagon sometimes, but tell me the specifics about Zegalogue
Frank Sanders 7:56
So the clinical profile Zegalogue is compelling. And we are actually out in active dialogue with payers right now. And we have been in dialogue with healthcare professionals and patients around the profile through market research before we execute a full product launch following approval. And the approval of Zegalogue is based on the results from three randomized, double blind placebo controlled controlled phase three trials, that's a mouthful in both children and adults with type one diabetes. And what's marketed and notable about Zegalogue is the median time to blood blood glucose recovery of 10 minutes that we've seen across all three phase three trials. More specifically, in the phase three trials. 99% of adults recovered in 15 minutes in the main adult trial, and 95% of pediatric patients recovered and 15 minutes in the pediatric trials. So So we believe the dialogue offers patients and caregivers in an important new choice for the for the management of severe hypoglycemia, which is a condition where minutes obviously matter, so we're eager. So the launch the product, in just over a month and late June,
Stacey Simms 9:02
didn't take me into that study a little bit more in terms of how low people were, if you can share that.
Dr. David Kendall 9:09
Happy to do that, Stacy and as Frank mentioned, glucagon, the native peptide or protein that many people have known about, and I'm sure many of your listeners are familiar with has been around and available for treatments since the 1960s. But what Zegalogue and dasiglucagon the active molecule was able to do is make modifications in that peptide chain to ultimately lead to chemical that we felt was suitable for development that went through those clinical testing programs that Frank talked about, and specific to those trials to bring this forward as a medication that could be reviewed and approved for the treatment of severe little bunch of blood sugar, or what we call severe hypoglycemia required that in controlled fashion, taking volunteers, courageous and really volunteers to whom we are incredibly grateful to use an insulin infusion, so give insulin in their vein in a controlled way, bring their blood sugar below a specific level, usually that level is 70 milligrams per deciliter or lower, slightly higher in the studies with children, and do that in as controlled away as possible, then stop that infusion of insulin. And this is really meant Stacy to mimic what might happen in an unexpected, unanticipated severe low blood trigger event. And those individuals then are given a dose either of placebo medicine, or in the case of these studies, Sega log and its pre Approval Form dasiglucagon, and then in those same trials, not for direct comparison, but just to understand what the world was familiar with, we also gave selected individuals, the traditional glucagon from the emergency kit that many people may know, which is the one that requires that it be reconstituted, mixed up, drawn back up in a syringe and then given so the studies took experimental, low blood sugar, let's say on average, the value is just below 70. Got the dose of medication. And then we measured the so called time to recovery that Frank talked about which in all of these trials was how long it took to see that number no matter where it started to come up by 20 points. So a very consistent measure of recovery time. And as Frank said, the median time to recovery was 10 minutes across each of the three larger phase three trials. And you looked at the 15 minute time point, which is a very important one for watching loved ones recover and making sure that they either are responsive or another dose of medicine can be given 99% of adults, 95% of children had recovery
Unknown Speaker 11:55
in that time period.
Dr. David Kendall 11:56
So very important to understand how the trials were done. But ultimately, it led to our review and approval as a treatment for severe low blood sugar.
Stacey Simms 12:06
Wow, I appreciate you going through so thoroughly, I have a couple of questions, because I have a couple of friends who have gone through clinical trials for products like this. I don't know if they were specifically in this one. But as you said, You don't just sit there and say, Okay, give me all that insulin, no, I'm gonna go low. You know, we really have to thank those people. But you mentioned some of them got a placebo. So I know it was a safe environment. But what does that mean? Like they just sat there and went low for a while?
Frank Sanders 12:32
Yeah, I'm always amazed the Food and Drug Administration, their regulators are thoughtful and cautious about how these studies are designed, we are as well, in placebo, obviously, is done only in a controlled setting where we understand what the potential risks of giving, essentially, no therapy might be. But knowing that in these studies, as I said, Even though zega log is approved for the treatment of truly severe low blood sugar, these were not patients that lost consciousness couldn't manage for themselves, but in a controlled setting where we could give them an intravenous injection of glucose if we needed to, or ultimately rescue them with safety glucagon administration, these were individuals who had to understand that they were going to go low, probably feel something they felt before not necessarily feel comfortable, and then know that there was a chance they were getting just saltwater sailing, or potentially getting one of the other two therapies. And obviously, they were monitored very carefully. And we didn't allow this to go on, you know, indefinitely. They were ultimately treated either with glucose by vain or given something to eat.
Stacey Simms 13:42
I'm curious to, again, I appreciate you letting me go down this rabbit hole. There is an interesting conversation all the time in the diabetes community about letting those go. And I know some of you, as you listen gasped. But I mean, there are some times where you'll sleep through a low or you'll just won't notice although you know, you're 7075 and then you'll, you'll float back up because your liver has kicked in it. You know, I'm curious, I know, this wasn't what the study was designed to do. But was there any information from the placebo folks of them kind of recovering without treatment?
Right back to Dr. Kendall answering that question. But first Diabetes Connections is brought to you by Dario. And the bottom line is you need a plan of action with diabetes. 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. There are 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 now back to Dr. Kendall, answering my questions about those that kind of resolve on their own.
Frank Sanders 15:13
So the the proportion of people who recovered with placebo therapy was extinguishing Lilo, I will say, at least in the 15 minutes time period, by 45 minutes, either they had recovered or we allowed them to recover. I know a bit more about this, because I spent my early years of research doing these experimental low blood sugar studies. And your comment about letting the logo is not something I certainly would advise as a health care professional, but it does happen. And the risks if it's not a severe low, are often you know, an inconvenience or disrupted sleep or in some cases, complete lack of awareness. The risk there, Stacy is any low blood sugar makes a subsequent low blood sugar more likely. And the typical symptoms and responses that the body has, will diminish when the body has seen multiple episodes of low blood sugar. It's as if the body's saying I've seen this before, I'm going to quit warning you and treating it. And that, as we've learned over time is one of the risk factors for an unexpected and more serious and severe hypoglycemic event. So I would not recommend letting the logo
Stacey Simms 16:24
be either, I want to be very clear. But it is something that is discussed. It's not as though that's something that to be very clear as you listen and to you all to, it wasn't something I said in that I endorse it. It's just that it does happen. And we see that sometimes you don't treat a low and sometimes it bounces back. So I didn't mean to imply that we should be twiddling our thumbs while our kids are low.
Dr. David Kendall 16:48
Right? And you're absolutely right, the body does maintain some of those defenses as ecolog. What we're talking about here is there for those circumstances where the defenses are no longer adequate, someone loses consciousness, the ability to care for themselves. Alright,
Stacey Simms 17:05
let's let's get back on track here. Again, thanks for following me down that rabbit hole. And I'm always fascinated by studies and the process. Frank, let me ask you what so what is this is tell me a little bit about the product itself because we have other products on the market. Now you mentioned already the rescue kit that needs to be reconstituted, there's a nasal spray, there's a shot.
Frank Sanders 17:22
Now this was this is so second log is indicated for the treatment of severe hypoglycemia, and pediatric and adult hit and adult patients with diabetes. Ages, six years and above, we're going to be launching it with two forms available. We're one of those is going to be an auto injector a single dose auto injector and the other will be a single dose prefilled syringe, but both of which can be used immediately without requiring reconstitution that may allow for easier use at that moment when it's needed. And so you know, that really at a basic level, that's that's core to what what Zegalogue is. And we again, believe that based on the clinical study that David David has talked about the study data all three is that what distinguishes like a log is really the the median time to recovery of 10 minutes across all clinical trials and the consistency of response rates and adults in pediatric patients again, referring back to the data that David presented. So we're eager to introduce this product again and a couple short weeks here and offer this begin to offer this to patients and caregivers alike.
Stacey Simms 18:25
shelf life, you know, do I need to put in the fridge? Can you speak to that?
Frank Sanders 18:28
Very good question. So I'll talk a little bit about the storage and stability and David if I if there are details to add, please add but Zegalogue has a three year total shelf life when stored in refrigerated conditions in once removed from refrigerated conditions that can be kept at room temperature for up to 12 months. So stability and storage conditions of Zegalogue provide for options for people with diabetes, you're at risk of severe hypoglycemia to have this available at home, you know, in the refrigerated conditions for up to three years or out of you know, refrigerated conditions, either at home or away from home for up to a year and event that it's needed. So we believe that these dual storage conditions will be attractive to the lifestyle of patients with diabetes
Stacey Simms 19:12
couple of years ago, gosh, was it ready for the pandemic It must have been in the fall of 2019. So not too long ago, I ran into Ed Damiano of beta bionics and asked him you know what's going on? How are things and you know, they've got their own, we're actually talking to them in a couple of weeks. So let's talk about this as well. But my understanding correct me if I'm wrong, is that this is the brand of glucagon that they want to put in the dual hormone pump down the line. I don't know how much anyone can speak to any of this. So feel free to say no, because I know it's it's not coming. Now, this is not what we're talking about here To be clear, but this is one of the most anticipated developments in pump therapy. And I'm curious, can you speak to this is that correct?
Frank Sanders 19:57
Well, let me tell you this and then David, you could you can add to this as well. as you see fit, but yes, I mean that's a glucagon we consider this a platform therapy, you know. So obviously we're launching dasiglucagon in the form of Zegalogue as a rescue therapy for severe hypoglycemia. But it's the first of a long string of other potential launches with dasiglucagon. In the future you had mentioned, the partnership that we have in place with beta bionics that what I will say is that it's a great partnership, we're very pleased with the progress that we're making with this program, as we near the initiation of phase three trials. And so you know, everything is really moving forward at a steady rate there with that partnership. And we also have the David can touch on as well with dasiglucagon a program and place for use in congenital hyper and hyper insulin emia as well. So so the product itself is being studied for multiple applications to benefit multiple patients, not just with severe hypoglycemia, but with other with other specialty and rare disease areas. So it's just the beginning, if you will, it's like a log is this really the beginning for the use of the molecule much, much more to come over the next three to five years. Like Frank said, we're
Dr. David Kendall 21:05
really excited to be in the partnership with beta bionics I had in his team dasiglucagon is the platform and that Frank described, we see it as helping us leverage opportunities across what we call the hypoglycemic spectrum. So testing it, we hope in weeks and months ahead in phase three in the bio hormonal we call it artificial pancreas, the bionic pancreas, with beta bionics, but also for other hypoglycemic disorders, some in the setting of diabetes, like small doses that may be used for exercise or during illness, where it's not an emergency situation, all of these are planned investigations, but not yet part of the approved use of Zegalogue. Similarly, the condition, Frank alluded to congenital hyperinsulinism, where children are born with the dysregulated continuous secretion of insulin, so it's not diabetes, but they suffer recurrent and significant hypoglycemia, then there are very limited therapies. Thankfully, it's an ultra rare disease, but one that is really want for better therapies. And similarly, there are other health conditions where unexpected low blood sugars occur outside of the setting of diabetes. And we think because of some of the unique characteristics that deci glucagon has the stability at room temperature that it can and we hope will be applied, certainly in clinical studies, we hope in the future for patients with some of those conditions.
Stacey Simms 22:38
So it's interesting a couple of weeks ago, maybe a couple months ago, now we spoke to Leo Brown, who was on The Amazing Race, we will he lives with diabetes, I guess, but he has congenital hyperinsulinism. And his they basically removed most of his pancreas. And is that the kind of thing you're talking about where this would be an alternative treatment for somebody like that, perhaps?
Frank Sanders 22:57
Precisely. And so that's one of the approaches, historically to this condition, congenital hyperinsulinism was to remove the offending organ, the pancreas, which, as you witnessed, will leave somebody living with insulin deficient diabetes, so a form of type 1 diabetes that's surgically induced, but it was one of the only available therapies, we feel like that see, glucagon. And other approaches can counteract that hyperinsulinism, particularly in the youngest children, where there are the greatest dangers for these low blood sugars. And we hope either limit the need obviate the need for surgical interventions, and add to the tools that pediatricians in particular can use to manage this incredibly challenging disease.
Stacey Simms 23:45
And just back if I could to beta bionics, can you share anything about Gosh, I feel like we've just been waiting for this for a very long time. In terms of how it works. I know that, again, that's in clinical trials coming up. So you can't talk about a lot, but I'm just trying to picture what I you know, we fill the insulin pump with insulin, then we just fill the other chamber with the gun. I mean, it just to me seems so revolutionary. I'm trying to kind of parse any information that you can share with us.
Dr. David Kendall 24:10
Yeah, it's you're spot on Stacy. It's basically a two chamber pump. So think of how current insulin pumps are programmed. And in fact, with the hybrid closed loop systems, they were tied to continuous glucose monitoring to adjust the insulin delivery and those systems that have that capability. Add to that the same sort of functionality, but with glucagon, or in this case, dasiglucagon infusion that is regulated by the pump and by the glucose measurements. So with insulin being one side of that equation, when glucose does go lower, instead of simply shutting off the insulin and waiting for it to clear from the system, you have counterbalance, or the ability to counter regulate with the glucagon infusion and small little delivery boluses just Like insulin does for higher glucose is so similar to and in fact managed in much the same way as the insulin infusion for high glucose. The glucagon chamber and infusion wouldn't give those doses as glucose values declined, or were at certain levels,
Stacey Simms 25:15
if they're a second inset on the body for that I can't imagine goes to the same inset as the insulin.
Dr. David Kendall 25:21
Yeah, so So all of that is part of the development process. Obviously, these are two separate hormones. And one of the components of dasiglucagon, as Frank talked about is it's, it's stable in this so called aqueous solution, which for you will need that saltwater, the things that circulate in the body. So you know, while in theory, they could come through the same system, the plans in place, and the previous studies have been done with two separate fusion sites. But again, connected to the same pump system. So yeah, there's some sophistication involved. And I think back to pre CGM, when people said I have to wear this device now people often do quite well wearing two devices, their CGM and their pump. So depending on the ultimate design and approach to this, we certainly see the clinical promise as being something that's very encouraging. And then overcoming those engineering and technical challenges will be part of what faces our team with the beta bionics team. Really interesting. I
Stacey Simms 26:22
can't wait to talk to them to to get more information. Thanks for sharing what you could I appreciate? Absolutely. Let's talk about cost and access. What is this going to cost? I mean, I know that a lot of it depends on insurance. You started out by saying you were talking to payers, it's so sad that that's the first thing we have to talk about.
Frank Sanders 26:38
That's a good, it's a good question. These are obviously obviously amongst the first questions we always get when we're launching any product. So so we our strategy, from a pricing perspective, is the price Zegalogue at parity meaning add or are the same as existing products on the market? And we've based this strategy really on the value that psychologic provides? I think you're the bigger question is, is it going to be accessible for patients at launch. And you know, and really, that's, that's the reason why we are out actively engaging managed care customers today, both at payers and pbms, and Medicaid providers. And so I'll share that the the conversations have been have been very good that the profile Tagalog is being received very favorably, and we do expect to have favorable accesses, that is ecolog. At launch, that will continue to build as with any new product launch that will continue to build and improve over the first six months of launch. And I think as as you know, Stacey, from our conversations a little bit earlier, as I'm a caregiver myself, in my in my life, my my wife is been, you know, suffering for from stage four cancer for a number of years, and she's doing doing very well. But we we every day, interact with the healthcare system, and really have to think through barriers to access, whether that those are financial barriers or barriers to delivery of the product through specialty pharmacies, and we are really designing our patient support capability at Zealand. With that in mind, meaning, how do we make sure that when we're launching a product, we're able to provide the resources and forms of financial assistance and other resources to help address any sort of access barriers that may exist. So so there's really don't become transparent, so do we, so to speak, or, or, or a barrier for patients. And it's not just things like financial assistance, we are also putting programs in place to be able to make access easy in terms of product acquisition and distribution, for example, by looking at at home delivery solutions and other things so so we really are going to roll out a patient support system that is really fit for launching a product like this, in this error today where we also have to worry about COVID. So we're ready to go on all fronts in that area.
Stacey Simms 28:50
And we'll link up information as it comes out on patients assistance and access and things like that. But I'm always curious. And I I know the US health system is very complex. But why budget parity, why not launch and say we're gonna be $30? Less? How come nobody ever launches and says we're gonna come out and we're gonna make it affordable out of the box?
Frank Sanders 29:09
Yeah, I mean, we we look very carefully at multiple different pricing options and research it very carefully before we make a decision around it. And the price that we choose, really any company chooses. But in this case, I'll just talk about what Zealand does is the one that we that we think is going to ensure that we are going to get the best access possible for the product at a price point that that is representative of the value, the clinical value that the product brings to the market and that and that really led us to a parody pricing strategy, not a premium pricing strategy, not a discounting strategy, but one that is at parity with the rest of the market. And you know, again, based on the feedback that we've had in advance of setting the price and after setting the price and discussing with managed care organizations, we feel that we got it right.
Stacey Simms 29:56
Yeah, but you didn't get that from patients with all due respect. I can't imagine a patient said that's the right price.
Frank Sanders 30:01
Well, I think if we ask anyone, any consumer about about the price of the medicine, you know, the will will always get the response of, can we why that can cannot be lower? Can it be lower? That's absolutely fair.
Stacey Simms 30:14
Before I let you go, as I was looking through everybody's bio here, David, I can't let you go without asking you about the diabetes control and complications trial and the edic trial, I love to talk about these studies. I have I talked to a lot of parents whose children have been diagnosed, you know, recently, I run a very large Facebook group for Charlotte, North Carolina area. And I always say like, you've got to look at these these amazing trials that were done years ago, that show how much better things are getting. And I would love to just, I don't even know what I want to ask you. But I would love to give you the floor to just say that we didn't even know that a one c mattered, we didn't know the control made a difference. And to me, the edic trial is the one that shows me how much things are getting better. I do my right on any of that.
Dr. David Kendall 30:59
And well, you're talking to a very biased audience of one in me. So I grew up in the dcct edic era, I started in diabetes research in 1981, just as dcct was kicking off. So I've been either close to or seeing patients in dcct edic, through its entire history. And we're now 40 years out from the start of that trial. And yes, absolutely. These are 14 141 of the most courageous, incredible people who committed literally decades of their life to helping us understand what benefits may come from improving glucose control, particularly early on in the course of type 1 diabetes. And what I love is that many of these are patients I know to this day who are celebrating their 17th and 18th birthdays, I'm in the setting of type 1 diabetes. And unequivocally dcct, in my mind is one of the 10 great research studies in medicine, it demonstrated the benefit of having blood sugars as well controlled as possible, as early in the course of diabetes as possible. and maintaining that for as long a period as possible that I always catch that by saying, you know doing it as rationally and safely as possible. And what we're talking about here today, meaning severe hyperglycemia was first really made evident to us in the dcct. where, you know, on average, every patient had a severe event per year during the study, because we were working so hard to control glucose. So it ties back to our topic. And yeah, for the next three and a half hours of this podcast. I'd be happy to add more if you'd like. Frank will never invite me back. So
Stacey Simms 32:48
Oh, no, no. Okay, wait, one more question about the dcct edic. Is there a follow up? Will we get another one of all these people soon? Or is it kind of
Dr. David Kendall 32:58
it continues to this day, and there are various components to it, it is much less thorough and intensive in terms of the follow up, but the 30 and soon 40 year follow up of those patients has been and will be published and presented as the years go ahead. So this is the study that probably will only end when we run out of investigators and individual volunteers for the study.
Stacey Simms 33:26
I gotta say I look at those studies. And I'm so glad you mentioned the brave and wonderful people in them. Because that has my son was diagnosed right where he turned to 14 years ago. And what they have done, has changed his outcome. It's just fabulous. So thank them next time you see I'm telling Stacy and Charlotte. Before we finish it, was there anything about that video segment that we didn't cover?
Dr. David Kendall 33:48
Yeah, I'll close and then toss it back to Frank. But I think one of the things that first attracted me to Zealand but also the work around Zegalogue is that hyperglycemia really remains one of those conundrums, one of the rate limiting features of managing diabetes most effectively, and bringing forth the two legs Zegalogue to help patients have the peace of mind make a plan for when the unthinkable might happen, a severe event. And doing so with the data that we've talked about where you have this very rapid and reliable response to Desi glucagon and the clinical trials for this, like many other emergency therapies, you don't want to have it, but you certainly want it on hand if you need it. So all of that, to me is central to what we're doing, not just with the clinical studies, but with the clinical launch of Zegalogue.
Frank Sanders 34:43
Now very good. I would just just close by saying what excites us about this launch in particular, is that there are 4 million people in the United States with diabetes on multiple daily injections of insulin and these patients are at higher risk of having severe hypoglycemic event. And despite the fact that there are 4 million people in the US with diabetes on on multiple daily doses, only approximately 14% of that population is prescribed a glucagon rescue therapy. So So what's been interesting is and positive is this is with the introduction of newer innovative therapies over the last year and a half, two years, more people are becoming aware of these treatment options, and the market is growing by by 10%. And we believe that that's really just the beginning is the you know, having Zegalogue in the market, that's yet another innovative option has the ability to further grow this by increasing awareness. And we're excited about the positive impacts effect that will have on patients and their caregivers.
Stacey Simms 35:44
Well, Frank Sanders, Dr. David Kendall, thank you so much for joining me and explaining all this. I really appreciate you spending so much time with me. Thank you.
Announcer 35:56
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 36:02
I will link up more information about Zegalogue. And about the DCCT EDIC trials as well. And if you haven't heard our episode, evidence-based hope, I highly, highly, highly recommend it, especially for newer diagnosed people and families. It's not just a look how far we've come kind of thing. But it also puts in perspective, a one see numbers, things right now that you can do to live a long and healthy life with diabetes. And it doesn't mean that you need to always have you know, a super low A1C I think especially as parents, we often lose track of the happy, good life thriving with diabetes, because we're so focused on getting that that time and range and those super low a one season those trials really put it in perspective for me, and what you need to really live well. And it's not what a lot of people on Facebook, what have you believe in just a second, I want to give you an update on how Benny's doing and wrestling has started. And oh my goodness,
but first Diabetes Connections is brought to you by Dexcom. And it really is hard to remember what things were like before we started using Dexcom. I had a woman asked me what was our plan for kindergarten. And we were still a good four or five years away from Dexcom at that point, so it's really interesting to look back because it is so different. Now we were doing something like 10 finger sticks a day when Benny was going to kindergarten. I mean, even when he got older, we still did at least six to eight every day more when he wasn't feeling well or something was off. But with each iteration of Dexcom we've done fewer and fewer sticks. The latest generation the Dexcom g six eliminates finger sticks for calibration and diabetes treatment decisions. Just thinking about Benny's little worn out fingertips makes me so glad that Dexcom has helped us come so far. It's an incredible tool and Benny's fingertips are healthy and smooth, which I never thought would happen when he was in kindergarten. He for glucose alerts and readings from the G6 do not make symptoms or expectations. Use a blood glucose meter to make diabetes treatment decisions. learn more, go to Diabetes connections.com and click on the Dexcom logo.
Aren't if you've been listening for a long time or you follow me on social media, then you know that Benny is finishing up his sophomore year in high school and he started wrestling when he was a freshman he got injured right at the beginning of the season. He tore his meniscus. And he was out for the 2020 season, which was right before COVID. They were able to get a full season in and he was part of the team. He was like manager and he went on crutches to every match. And he was pretty incredible season they won the state championships for the first time. It was just a really fun year, but he had to sit on the sidelines. So that was kind of a bummer. But he is back. He's worked really, really hard. And of course with COVID they kept putting off the season. And we always thought there is absolutely no way there's going to be wrestling. So he actually went out and got a job. I've mentioned before he got his vaccine, he's at a grocery store. And he's been working really hard. And so when wrestling came back, it was kind of a tough decision to make. But he was able to work it out with his work schedule. And this kid is so busy, and they had their very first match.
As you're listening it would be last week. So Benny had his very first you know, match. But that's not the story. I want to tell you what was amazing. And by the way, I can't watch wrestling. Do you watch wrestling if your kids wrestle? I can't watch any sport my kids play because I'm the loud mouth mom. So I'm always the one like trying to look at her phone. So I'm not screaming I'm not being rude. I'm not not paying attention. But I'm shockingly I have comments. So I try to keep them to myself. But wrestling is just so gross. It's so rough. I can't stand it. But they come out on the mat and the ref comes out and he's like you know our loved ones with clean Theodora and I'm looking at the ref and I immediately Look at his belt line because there's a T slim pump. He's wearing a T slim next to you know, it's right on his back. And I was sitting very close. So part of me wanted to yell like, excuse me. Hello, sir. But I didn't do anything. I didn't say anything. I did take a couple of pictures which was probably very inappropriate, this poor man, but I couldn't help myself. It was so exciting. They faced two different schools. So it was the match that He was in and then there was another match. They didn't wrestle in, and my daughter had just come home from college. So after that first match, I said goodbye. I said, Okay, if I go and I left, I went home because my daughter, Lea, I haven't seen her in a while. So I wanted to run home to her. And I couldn't talk to the ref, because he went from one match. Immediately, he crossed the gym and went to the other match. Then he came over to kind of talk to me as I was leaving, and I told him and I, you know, it wasn't sure if he'd be like, Mom, it's so lame. You know, who cares. But he lit up, he was excited, and he wants to go say hi, but it was just such a busy night. And these reps are just working, working, working that, you know, as I said, I didn't get a chance to talk to him, but he didn't get a chance to talk to him. So I'm hoping that we see him again, as these wrestling matches go on. But hey, if you're listening ref in Mecklenburg County, North Carolina, drop me a line. And thank you very much for not noticing the bananas lady behind you taking pictures of your back.
Before I let you go quick note I will be speaking at the camp Nejeda event survive and thrive. That is on June 5. It's a virtual event. We are looking forward to friends for life in July, I will be there I'm not sure in what capacity as a speaker yet waiting to hear from them. Because it's very different this year, far fewer speakers, but I will be there as a vendor. So I hope I can meet at least some of you. And please join me tomorrow. If you're listening as this first drops on Wednesday, May 12, as I'm doing every Wednesday in May 4:30pm. Eastern on my Facebook page Diabetes Connections i will be doing in the news, my newscast that I'm trying out and then we'll turn that around and drop it as podcast episode. They're very short. My goal is to make them not only less than 10 minutes, hopefully less than eight or seven minutes. I'm really trying to keep it very tight and just have some headlines. But the top stories of the past week, all types of diabetes really be useful for you to make it bite size make it relevant. So let me know what you think. 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 in just a couple of days. Until then, be kind to yourself.
Benny 42:19
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All rounds avenged
Ben West was a key organizer and architect of Nightscout and OpenAPS software. Even after all of the DIY and commercial development of the last ten years, he says we've barely scratched the surface of removing the mental and physical burdens from people with diabetes. Among those burdens, he says, is what he calls the onus to bolus - the responsibilities of diabetes that even the most advanced current software can't totally relieve.
Ben is now the CEO at Medical Data Networks which has launched its first venture: T1 Pal.
Read the Nightscout email Stacey mentioned (click here)
Check out Stacey's book: The World's Worst Diabetes Mom!
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Episode Transcription (rough draft) 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 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 0:21
This is Diabetes Connections with Stacey Simms
Stacey Simms 0:26
this week talking to someone who is deeply technical, but also deeply thoughtful, who has been an incredible part of the Do It Yourself movement over the last 10 or more years. But who says we've barely scratched the surface of removing the burdens mental and physical from people with diabetes. So welcome to another week of the show. We aim to educate and inspire about diabetes with a focus on people who use insulin. I am Stacey Simms. And yes, this show is already a little different sounding here at the top no big intro or tease. And that's because my interview with Ben West is massive. It is very long. It is the longest one I have done so far on this show. But it is well worth your time.
I am so excited to bring you this interview with Ben Ben West was a key organizer and architect of the Nightscout and open APS software. He is now the CEO at medical data networks which has launched its first venture T1Pal, I think Ben influenced or work with or sometimes both just about every person I've talked to under the we are not waiting umbrella. And if you're not familiar with that, if this is your first episode, welcome, but we are not waiting is kind of the rallying cry that became a hashtag back in 2013. And if you are new, I use it as a keyword you can search for it all one word, we are not waiting over at Diabetes connections.com and see every episode that has featured those incredible do it yourself, people the community that really rallied together and push the technology side of diabetes forward, I believe many many years ahead where it would have been otherwise, as I said, it is a very long interview. But you know, it's a podcast, listen in chunks. Stop, start, you know, however you want to do it. But please, I really hope you'll listen to Ben because he has so much story to tell and a lot of thoughts on how diabetes care really needs to improve.
In the short time since I spoke to Ben, there has been a bit of a discussion within the Nightscout group about his business. It is part of an ongoing debate about the future of Nightscout and the future of open source in type one, Ben has the full support of the night scout foundation. In fact, they sent out an email on that and some other issues. And I will link to that in the show notes. I think it's a very good read. In addition to touching on this issue, it is a great way to catch up on what's going on in that space. So we'll get to Ben West in just a moment.
But first Diabetes Connections is brought to you buy Gvoke Hypopen . And you know 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 slash risk. And this is a good time to remind you that this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
Ben, it's great to talk to you. Thanks so much for jumping on and sharing some time with me and my listeners.
Ben West 3:55
Oh, thank you, Stacey. I'm happy to be here. Thanks for inviting me.
Stacey Simms 3:59
I'm not even sure where to start. I have so many questions I want to ask you and there's so much history here. So maybe we just start if you don't mind. Back in college when you were diagnosed. You were student right? You were young adult.
Ben West 4:12
Yeah, I was a college student when I was diagnosed and I had all the classic symptoms where I you know, I was going to the bathroom a lot and just didn't know what was happening. My diagnosis story is I went through this for probably a week and one night I realized I had gone to the bathroom like seven times in the one night and I realized that means if that's once an hour like what sleep did I get last night. I'm nowhere near eight hours of sleep. This seems like a serious problem. So I went to a health clinic in my college town. And they said well, you're a skinny young adult, so we don't know what's going on with you. Maybe you did eat something and you didn't tell us I wasn't eating anything either. And they sent me home with some pills and said call us in two weeks. Someone through the grapevine heard that that didn't sound quite right actually came and interrupted one of my music lessons and said, you know, you need to go to the hospital there. Oh, wow, they're expecting you there. So I went to the hospital, and they checked me in over the weekend and diagnosed diagnosed me with type one. Wow,
Stacey Simms 5:13
you were lucky, right? Lucky that they interrupted your lesson there.
Ben West 5:16
Yeah, you know, I mean, I've heard a lot of stories during the work that I do. And yes, as diagnosis stories go that I you know, that's pretty mild. Yeah,
Stacey Simms 5:26
I guess I should ask you some technical questions from the very beginning. What were you using? I assume that in 2003, you didn't immediately start tinkering with an insulin pump. Right? You You went on a more traditional routine at the start?
Ben West 5:38
Well, I actually had to drive 45 minutes to clinic and Little Rock house in a different part of Arkansas going to college. And I had to drive 45 minutes to get to an endocrinologist and the endocrinologist at that time that I thought I was lucky to be getting into the specialist where they actually deal with, they actually specialize in diabetes here. And I met with the nurse, the PA, and the representative from Medtronic was actually in the room. They actually said, You seem like a smart young lad, we'd like to get you out a pump as soon as possible. And it turned out as soon as possible was like nine, you know, nine months later. So I went through the whole syringes and shots and meters and got on the on the pump. But at that time, they actually told me Yeah, the benefit of going on the pump is dispenses insulin automatically. And in the future, we're going to have CGM. There's some CGM already in the works. Those will be here sometime. And then when you get the CGM and the pump combined, it does like all these things together, right, like so I understood right away what they're talking about in that office very early on. Okay, you got you can measure glucose, and you got this pump. And in theory, it should be doing all of these things together. At that time, they even said, You know what, they even have a patient in California right now, it's got a fully implanted version. So sometime in the next five years, we're gonna have a fully implanted CGM insulin pump combo, it'll do all the work for you. This is all just temporary. That's what they told me.
Stacey Simms 7:01
2003 Yeah, just to be clear, though, Ben, the Medtronic rep was in the room with you at your doctor's appointment?
Ben West 7:09
Yeah. Wow. You had some introduction? I was actually I was glad they were honestly, that certainly seemed to be the, you know, take these pills and call us in two weeks approach.
Stacey Simms 7:20
Sure. Yeah. It also beats a bunch of other people who had their doctor say five years to a cure. I mean, yeah, you know, there's a lot of really bad ways to be diagnosed and to have those first conversations, but man, that's fascinating. Who was the person in California who had an implanted pump and CGM? What was this like, fantasy made up? No,
Ben West 7:39
I think I know, I believe him. I, I've toured the Medtronic facilities, again, during the work that I do, and they've invited me over, and they have a hallway of all kinds of awesome stuff that, you know, never made it to market or, you know, there's a lot of cool things that go on behind the doors. I'm still using a 515. I think that was in 2008. So certainly, I I'm a big believer in what they do. There is a lot of potential that I think is clearly been untapped behind this technology.
Stacey Simms 8:12
So fast forward nine months, you jump on to your insulin pump. It's not hooked up with a CGM. At the time I would assume.
Ben West 8:19
No, it the CGM didn't exist yet. Yeah, it wasn't on the market. Yeah.
Stacey Simms 8:23
What was your experience? Like with the pump?
Ben West 8:25
Oh, it's okay. It's fine. I preferred it to the shots. But everything's got trade offs. Right. I had at the time I, you know, was going in or wasn't music major. And I so I had performances that are assessed as part of my official grade. And, you know, I'd go in for these performances, and some one of the teachers would tell me hide that thing. You know, they had wires hanging out, right? And I told him, you know, I'm not trying to hide anything, I shouldn't have to hide it. And he told me, You shouldn't show it off. I thought, wow, here I am going for a performance. And that's, that's the last thing I want to be thinking about right now. Sheesh,
Stacey Simms 9:00
did you win that fight? Or did they make you hide it?
Ben West 9:03
If you're a college student working for a grade? Yeah, you're gonna, you're gonna put it away real fast, right? I mean, that's terrible.
Stacey Simms 9:11
What made you start thinking about tinkering with stuff? Because you started doing that on your own is my understanding, right? This was before you met a lot of people in the community that you started, I don't want to say taken apart, I'll let you tell the story. But you started doing this stuff in 2008 2009,
Ben West 9:28
the winter of 2009 into 2010. I remember that's when I started with a different focus. Actually, I don't know if you've talked to Scott hanselman at all, but he's, he's known. He's known for saying that every person with diabetes ever, right? The first thing they do is they start working on on something less less than the burdens here. And actually, that was true, right? As I was diagnosed, I had some experience as a computer science minor with some programming, and often my side projects, and I remember I built a dashboard. Actually, in 2003, right after I was diagnosed, that allowed me to enter in all the information into a database, right? Because I was walking around with, you know, three by five index cards, trying to write down all these carbohydrates and insulin injections. And it was getting really tedious. But I did that for years with pen and paper and pencil. And I thought, surely, why are the doctors giving me a hand drawn curves on napkins? Like, what is that about? Why are they sketching on these pieces of paper and the way that they were explaining this to me in the hospital, I thought they were going to show me a full on simulation that showed how my body was working. I've been watching too much Star Trek.
Stacey Simms 10:44
Well, you know, I'm with you. We expected things like that, too. When you said you made the dashboard. What did you use for the interface? Was it computer was it?
Ben West 10:53
Yeah, it was this was before web 2.0. This was all PHP and HTML. And I realized I was horrified. At the result, I realized I was never going to use it. It was a wall of inputs, where it's just like tons of inputs. And I wrote for times, and dates and readings. And I realized there's no way I'm going to use that. Look at it. Why would anyone use that. That's why I'm going to use pen and papers, because they're the software for this is very difficult. Then web 2.0 happened, there's a bunch of things in the 2000s, as we approached into 2010, that I, you know, I graduated school, I got into industry moved to San Francisco, the hardest Silicon Valley doing, you know, web dashboards for companies, professionally, where we're really solving people's problems where if you have this complicated problem, you can share the link with a view of that problem, and the tools for solving that problem with someone else. And that ability to share that link made the possibility for solving problems collaboratively possible in new ways, transformative ways that really fundamentally change the workflow for solving problems. So that idea really got into my head professionally, as we kind of approached 2009 in 2010. I had tried my first CGM about five years later, right, so around 2008. And the experience with that CGM was was not great. I had to go through insurance, right, they said, I had to get a new insulin pump to get to the integrated system that would read onto the insulin pump. The insurance said, we're not going to pay for that for this new one. And not only that, but according to our policy, you should never have gotten one. So that seems like an issue. Yeah. So it took us It took another nine months, right. And, you know, it goes to the appeals board. And the appeals board comes back and says no insurance, you should, you know, that's medically necessary, she should pay for it. So I finally got the pump in the CGM. And like a lot of people that I see on social media that are excited by the promise of the benefits of this new technology, I tried to really make it work for me, right, I got all the glue out. Skin all louder than the adhesive and I got the I got it covered, right with all the contact stuff. And then I'm going out for yoga, right and it's hot, and I'm doing you know, bendy stuff. And you know, you take off your shirt is a lot of people do. And then you're in a shirt, you realize you're the only one with like all this stuff. And it's like, it's not just one thing, it's the air, you got your pump over there. And he got your CGM patch over here. And it's like, it's not working out like at night. It's itchy. You know, it tickles. Except it's not tickle, it's you realize it's, it's itchy. And then you realize to your heart that that's actually the chemical burn that's happening with adhesive in your skin. And then the things alarming and I'm getting sick of the readings, I get data, what they call data overload, right where it says 240. And I feel like you know, I don't feel very good. And I take a bunch of insulin. And then, you know, an hour later says, well, you're 230 or whatever. So I don't like that. I still don't like that. So I'm going to take even more insulin. And then yeah, three hours later, you know, your doubt at 60. And the things reading 110. Right. And, you know, you're really not feeling good. This thing, made my life a mess. And I decided I'm gonna have to quit. And I was horrified that I was not going to use this thing that I had gone through so much effort to get to this point to be able to use it and that I wasn't going to get any benefits out of it. And the slap in the face for me as someone that was working on these on these systems of systems that were connected through the internet, and seeing the innovation take off and seeing the technology transform, collaborative decision making. The slap in the face for me was that this data was stuck on this little two inch display in my pocket. And there was like there was no way to get that data where other people could see it or like my doctor could see it where like app developers could put it into the simulator and make a simulator if one was missing, and 2009 and 2010 that really didn't sit with me anymore. So I thought apparently I have some skills here. And, you know, maybe I should try applying them just to see if I can get a time series. You know, wouldn't that be neat? If I can just get a little time series, you know, off the device that I use? Wouldn't that be kind of neat?
Stacey Simms 15:11
All right, I'm gonna stop you there. But as the time series,
Ben West 15:14
just the normal chart that we see where we've got data points along some time. So you've got three hours of time on the chart, just like we see with any other glucose traces data, you've got one dot every five minutes. And that happens, because you get every dot that you see is one of those data points. If you can get a bunch of data points over time, you can generate that time series.
Stacey Simms 15:37
Now I know a lot happened, you know, in those years between 2008 or 2009. And then 2013, when you started a tight pool, can you take us a little bit through that time, how you met people how you got connected with the diabetes community?
Right back to Ben answering that question. 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 isn't actually the big picture stuff. It's all the little tasks adding up. Are you sick of running out of strips, do you need some direction or encouragement going forward with your diabetes management with visibility into your trends help you on your wellness journey? The Daario diabetes success plan offers all of that and more No more waiting in line at the pharmacy no more searching online for answers. No more wondering about how you're doing with your blood sugar levels. Find out more go to my Dario comm forward slash diabetes dash connections. Now back to Ben answering my question about how we found and got connected with the diabetes community.
Ben West 16:48
I need to get more serious about my problem solving. And that means if I want to help, as soon as it seems to get a lot of ground to cover, so if I need help, I need to ask a well formed questions in a targeted way. And I thought, you know, if I need help, the people that can help me are probably other people with diabetes. And so I started looking around on all kinds of social media, I was on to diabetes, for the really early platforms, and several others, there's diabetes has that and there was there are a couple of organizations before Twitter was even really becoming popular. So I kind of reached out on some of those and found some people disagreed with the things that I was expressing they, some people thought that I should just feel grateful for the devices that I had.
Stacey Simms 17:28
I remember this, there was a lot of movement at that time, because I was on some of those boards to where it was, Hey, you know, it's it's okay for now. Like it's better than it was we're not testing with urine. We're not doing right. We're things are changing. Why do you want so much data? He was an interesting time. I didn't mean to interrupt you. But I remember that.
Ben West 17:47
Yeah. It's interesting that for you to say that, thank you for remembering that that really puzzled me. It emphasized for me How important was to frame the right questions. Partly because of that those disputes, I started really focusing on the advocacy of data access. And that became my touchstone issue. Well, up until very recently, I would say, well, I've shifted recently towards embracing language matters a bit more. One of the things I've learned over the last 10 years, I think, is that language matters. And in this data access issue, are actually the same issues with the same solutions. And we will get into that. But
Stacey Simms 18:23
yeah, we'll definitely talk about that. And just trying to, you know, to kind of get the timeline here, but yeah, so you, you've got this really interesting movement within the community, but it's a small part of the community. As I said, I was there. I don't think I grasped it at all. I mean, I had a little kid, my son was a toddler at the time, you know, he was diagnosed in 2006. So I was getting into all of this, but I was definitely more of the rah rah cheerleader, kind of let's do the Big Blue test. If you remember to diabetes, you probably remember that rather than how can I free the data because we didn't have a Dexcom or a CGM for many years.
Ben West 18:53
So at that time, right at the time, I was already familiar with things that have happened in the tech world, the things that, you know, the worldwide web, the web technology that we use, has gone through this where there's lots of companies involved, some of them compete. And in fact, I remember on one of my job interviews, I was shocked to hear the interviewer say, Oh, yeah, we're partners with the, you know, these other people. I said, Wait a minute, are they competitors for this other product? And they said, Yeah, you know, we compete and we cooperate. We do both, you know, it's not, it wasn't an issue in other industries. And somehow innovation that that's unlocked. Now, we have finance, we have healthcare, we have every sector of life we do online now. And if you're not doing it online, it's because you're doing it on your mobile. And actually, it turns out that's done online also. Right, yeah. Behind the scenes. And so that's the same transformation that I saw happening everywhere, regardless of the problem space of even for the most complicated problem spaces. And so I knew that what we need the thing that made that possible on the web, and on the internet on the web, it was Use source. So any web browser that you have, there's a function where you can go in and edit. And you can say view source. And it shows you all of the source code that's used to present that web page for you. It turns out that that's a critical part of that innovation to market pipeline, because more people are able to access the data that makes the thing go, that DIY access, if you will, for the web, that view source that allows anyone to get access to it, that does a couple things. One is that it gives more people access to making things and that network connectivity is what allowed a lot of innovation that we see, in 2008. Nine, that's when I started talking about data 2010. And yeah, through 2013, I started to code switch, which means that I talked about data in the most austere terms possible, in order to attract those other folks that already understood how important that was. So that together with them, I could look to build this ecosystem so that people would start to get it, I knew that if we could deliver a couple of applications that utilize this open architecture, this open ecosystem, the feature set would grow, the popularity would grow. And that would start to shift the things that people were talking about that people would start to talk about, we want access to the data so that we can get things like this, we want access to the data so that we can have bring your own device, we want access to the data so that we can get these innovative systems on the market more quickly.
Stacey Simms 21:37
So put it in perspective for me if you could, one of the touchstones that I come back to again and again, is that D data meeting in 2013? That diabetes mind and Amy tendril put together where we are not waiting was written on the whiteboard. Where were you during that time?
Ben West 21:54
Yeah, I was in the room. There are about a dozen folks in the room. Sarah creepin. Was there a Jana Beck was there, Joyce Lee? Was there, Amy tedric was there? You know, Howard look was there late despereaux. Was there john kostik. And, you know, a bunch of Brandon arbeiter, a bunch of those core typu folks were there. The takeaway, as it's been said many times before, was, you know, john kostik, was there talking about how he had utilized this technology to get some benefits for his son, that was his big story was I really care about my son is my job to deliver these benefits, I'm going to do it somehow, whatever it takes, that's what I'm going to do. And Layne came along and said, You know, we've got this experience with operator fatigue, in control rooms with complex processes that never shut down. And here's the things that I've learned. And here's the display that I put together, and I call it nightscout. And this was before, what we now think of as nightscout didn't really exist. This was before that this was like when there were separate pieces, and like different projects, everyone was just blown away by nightscout. In particular, this idea of what john was doing, getting the data and what Lane was doing, having a really smart interface for it, that and having it operate in real time gave us a really crisp, clear vision of what are the kinds of benefits that we should be talking about that we should be expecting that we should be seeing in the next 12 to 18 months? What is it feasible to make technically. And it turns out some really cool things were technically feasible.
Stacey Simms 23:26
When I speak to people from the DIY movement, or you know, whatever you want to call it. When I talk to you folks, over time, I have learned never to really ask well, what do you do? Right? I know, it's very, very collaborative. And so I stopped asking that question. But I would like to know, if you don't mind, could you share kind of what you were working on? Well, that's
Ben West 23:47
first t data, I was tide pool had just gotten started. So I was actually employee, I was one of the very early employees tide pool. So I was working with tide pool as an engineer trying to launch the MVP, our very first shipping product, we were trying to get that up off the ground from prototype and into production. So I was spending a lot of time on that. On my own time, I was spending a lot of time you know, the reverse engineering stuff, I was spending a lot of time really focusing on on Medtronic pumps, I realized that there were a bunch of devices. And I thought about the network of each kind of device needing some code to work with it. And I had a piece of code for every type of device. And so I was focused kind of on that making sure that I was framing Well, well formed questions, putting them out there saying here's a project just to talk to the Omnipod. Here's a project just to talk to the Dexcom. Here's a project just to talk to the pump. And then here's the thing that can kind of use them all. here's here's some of the title stuff. And so I didn't actually have access to CGM myself, I didn't actually have access to a lot of working stuff. What I had access to was my own research on my pump stuff, which was my main focus and then I had already started networking out and contacting Layne and these other folks, you know, Scott Lybrand and Dana Lewis, meeting all these other folks, and not just in diabetes, you know, for example, Dave bronkart and Hugo compost, I met them going around doing things, advocacy work on data access and privacy and sharing, I would meet those folks and connect them also to the diabetes folks saying, not only is this a unique problem in diabetes, getting your access to your data in healthcare is a problem in other disease states as well. And now what I've come to learn is not only does it affect healthcare, it affects other industries as well. It affects the agriculture industry. Right now, there's a huge issue in the agriculture industry, with farmers not being able to digital tractors and farmers not being able to get their data off of their digital tractor and where it used to be just like the syringe and it used to be a mechanical pump. It used to be a simple mechanical device that anyone could learn about and do it themselves right in front of them, it was obvious how it worked. And that is one of the risks with the adoption of digital technologies. without some support. Without enough documentation, it may not be obvious how it works. So after that D data in the winter, spring started to come around the next year, and I wound up leaving tide pool around April. Now Brandon arbeiter from typo was my roommate at the time. And I remember that about a week after I left tide pool he actually came home with with a bag full of goodies, he came home with a new SIM card, a new cell phone, and he showed me his laptop. And he had all these emails with like source code attached and instructions and websites. And actually, it was kind of a big mess. But I was very excited because this was for the first time all of the pieces in one place. This was the legendary nightscout rig finally in my hands, so I knew exactly what to do. I helped him set up nightscout. I didn't have a working CGM at the time and setting him up with nightscout was actually what convinced me to start using a CGM again, because when I quit, I decided I'm never going to use a CGM. Again, it's not worth it for the discomfort and the quality of life until I can control the data until I can get the data off with nightscout. that possibility came true. And so Brandon came home with that rig. And I helped him set it up. And then I helped set up a bunch of other families. And I converted those emails and those attachments, I converted those into a set of webpages for the very first time, and organized all of the source code. Again, on GitHub, which is the social coding site, I organized all of those projects into well framed projects, the way that programmers would work with these things very, very natively. Very idiomatically. And so I put those up on the web on GitHub, and started calling people over to them. And I showed James wedding and Kate Farnsworth, and Christine dealtrack. Some of these folks, I showed them the new web instructions, and actually walked them through for the first time, once people were able to go on the web, and do a Google search and find it and get all of the instructions in one place. That's when the installs really, really really started taking off. That's when the Facebook group went from 100 to 1000s. And the rest is history right?
Stacey Simms 28:35
down. And this is probably a good time to just say that. I've spoken to several people from the the we're not waiting community, and one of them is Jason Adams, who tells the whole story of the Facebook group, and you know, that community and how that came to be. So we'll link that up for sure. and a bunch of other information. But I remember that too. And it just seemed like he was unbelievable to some as in like, wow, we can finally see this and can you believe we can do it, you know, ordinary people. And you know, you do need to, you know, get some help, but you can do it, you can do it. And then there were other people in the community saying, I can't believe we haven't been able to do this until now. Like I knew we could do this. Like, it was very funny to see the people who really understood kind of the back end of things, at least from my perspective. And once that ball started rolling, it seems like it was just moving really quickly. It was a very exciting time. Do you remember it as one?
Ben West 29:24
Oh, yeah, I mean, tide pool had a one of their global, they pull everyone from across the globe in the area everyone saw about once a year. And so I got to see a bunch of those folks again, and they were all hanging out. And I remember we were on Facebook just watching Facebook blow up. I mean, they're the posts were coming in, he and your grandson was watching this thing. We mocked up little videos of like, here's the next step that we're going to make an automated system with, you know, this is just the beginning and we didn't post it but we were just in awe of the energy that was coming. In behind the post describing nightscout. I mean, here we have what's essentially a webpage. And there's so much momentum behind this project that people were saying things like we're paying it forward, they were saying things like, we are nightscout. And I've never been part of a technology project where people start identifying as the project, I expected the conversation to change, I laid a lot of a lot of stepping stones in place, to enable the conversation to change that we can speak clearly, as people with needs that are unmet, here's what our needs are. But I did not expect people to identify that I am this products that really blew us away.
Stacey Simms 30:42
I'm gonna come back to that, because I think diabetes is very personal. And it was one of the few times where people felt like they not only had a stake in it, but they were also being heard. But I do want to ask you, we've done lots of episodes on nightscout and openaps. And please feel free to jump in if there are things that you would like to share. But you mentioned when we were prepping for this interview testifying for I don't even know how to say this testifying for the 1201 federal DMCA exemption hearing.
Ben West 31:08
Yeah, that's right, is that? Well, like I said, one of the things I started to learn, when I started talking to people, what I would code switch into the data governance language, I started to find that there's other people working on this. There's academics, there's people in other industries, and there's legal scholars. And it turns out, FDA has a role in a lot of what we do in diabetes. But it turns out, there's other regulators that deal with other parts of life, the Library of Congress regulates certain things. And one of the things that they do is they manage these 1201 hearings, our carve outs are ways for the public to say, here's this regulation that exists. But I want to testify to get relief from the regulation that does exist, and the regulation in question, this concept of DMCA, the Digital Millennium Copyright Act, and in part of that regulation, has to do with the technical protections, the technical protective measures that manufacturers place inside of their devices, and the consequences for attempting to manipulate that device, potentially to overcome such a protection. Now, the issue here is that this is a technical means that some firms use to make it difficult to get the data on a very practical level, the one of the things that they can do is they can say, well, we're putting a technical measure in place so that only authorized users can get access to the data. who's an authorized user? Well, the manufacturers, of course, is the patient an authorized user? Well, maybe maybe not. Right? That's kind of the debate that's still playing out to this day. One of the exemptions that I went to testify for was that for medical devices, if what you're seeking to do is to get a copy of your own data, there should be no penalty for doing that. And that exemption was granted. Pardon my ignorance,
Stacey Simms 33:03
is that exemption granted for you? Or was that something that was more blanket for
Ben West 33:07
the Americans, all US citizens,
Stacey Simms 33:09
you think that would be front page news? That's amazing. Very, very cool.
A lot more ahead with them. But first Diabetes Connections is brought to you by Dexcom. If you are a veteran, the Dexcom gs six continuous glucose monitoring system is now available at Veterans Affairs, pharmacies in the United States, qualified veterans with type one and type two diabetes may be covered. picking your Dexcom supplies up at the VA 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 to your doctor, get the guide, find out more about your eligibility go to dexcom.com slash veterans. Now back to my conversation with Ben West.
What is nightscout? Right now? No, the commercial offerings have changed a lot. He was title submitting loop to FDA. What is nightscout as a service offering right now or is that even the right word offering?
Ben West 34:20
So do you want to know about nightscout as a service, or just nightscout? What is nightscout as a whole?
Stacey Simms 34:25
What is it right now? What is it? Like? How do you define it right now? Because it's not the rig? Is it still right? It's not like you're plugging into this into that. I mean, what how it's kind of changed in the last few years. So I guess I'm not sure what I'm asking. I pardon my ignorance there. But
Ben West 34:39
when you bring up the rig, you say what is your asking what is nightscout? right now and you mentioned, you know, for example, it used to be the rig.
Stacey Simms 34:46
That's what I think it was nightscout is I think of people printing a case for this for that and then and then you got to be careful because the wire might break at some point.
Ben West 34:55
Sure. So I think of nightscout as kind of two things. There's the philosophic Typical version of nightscout. And then there's like a piece of software that also exists, right? So and what I mean by that is there's the nightscout ecosystem, right. And this includes the people that are using nightscout. It includes the coaches, the school nurses, the teachers, the clinicians, the parents, the guardians, the caretakers, and the patient's themselves, right. And so there's this thing, that is the network of nightscout. And then there's a piece of software. And in fact, there's a whole bunch of pieces of software and devices, right. So there's the cgms, whether it comes from Abbott, or from Lee Ray are from Medtronic, right? There are the insulin pumps, whether they come from Medtronic or maybe Tandem or maybe Insulet, in the United States. And then there's other kinds of devices, too. There's like cloud devices, right? So some of your Dexcom data goes to Dexcom Cloud, some of your Medtronic data goes to carelink, Medtronic cloud. And so nightscout, there's a lot of ways for data to exist in the world of devices, connected devices that data can come from. And then there's this central hub in the cloud. And that's the piece that usually I think of as nightscout. When people say, Oh, I'm going to go file a bug report on nightscout, or developer says, I'm going to go fix a bug on nightscout. Really, they're talking about this cloud native piece of software that draws the graphs that provides you with a web page, the API that all of the other devices then connect to, right. So that forms when all when you have multiple devices that are talking to nightscout, all of a sudden, you have this nightscout network. And the thing that we think of as nightscout is what I like to think of is that cloud piece of software right in the center of it all.
Stacey Simms 36:44
So this might sound silly for someone who hasn't used it, or doesn't really understand what is nightscout. in that setting, as you mentioned, what is it used for? How does it help somebody with diabetes,
Ben West 36:58
one thing a lot of people talk about is data governance, being able to control your data. And that's certainly true, I have found that the most profound thing I have found is that it's really this, this concept of sharing, when you invoke the buddy system in your life, you know, as you travel through life, is it during the transitionary events, when you start a new therapy, when you have a special day, and you want some help, and that these are the kinds of things that people are sharing, it used to be when we first started nightscout, almost 10 years ago, seven, seven years ago, it was all about let's at least share what we know about the past. You know, let's share the alerts and alarms. Those are retrospective, right, you have to have past data to generate an alerting alarm. And that's kind of like current and past data. And people would use that the classic use case there that that made the news was when parents go to the office, and the children are going through the school day, and maybe going through mixed authorities and different just different realms of concerns across as they travel through life. What we have found since then, is that it's not just the retrospective data in terms of keeping current that people want to share. It's actually every aspect of diabetes. Surely, if you had the technology and the power, to share your alerts and alarms with me, surely you can share the tools to help me prevent those alerts and alarms. That's where the future is going is we're gonna see services that allow sharing, not just alerts and alarms, but managing every aspect of diabetes as we transition through every phase in our lives. So this is a really exciting time to be in because nightscout is years ahead of some of the big vendors here, providing feature sets for all of those things.
Stacey Simms 38:47
It seems like that's a good segue into medical data networks. Can you talk about what that is and what the goal is? Sure.
Ben West 38:54
So I've always been interested in this concept of the power of networks. That's one of the things that really got us interested as we started building out the nightscout ecosystem, making sure that we could talk to connected insulin pumps, making sure that we could talk to connected CGM, and talking to people about the data governance and the technology required to do that. In the past, I worked for a company called muraki. They made software defined networking. And that means if you've ever used Wi Fi in a public space, like Pete's coffee, or an airport or something like that, my software has protect your privacy, govern your use of the network govern the speeds at which you can use the network even govern which sites you can visit. And this is very complex techie stuff, but we made a simple dashboard that allowed people to share the process of managing that experience. This is old hat for us. So we created this company medical data networks. What we want to do is wrap up and respect all these years of innovation that have happened in the DIY space and we want to make Set the norm. We don't think that any of this is controversial at this point, the idea that you'd have remote monitoring, the idea that open source would be a fertile ground for the innovative wetlands, right? Some people like to call it. And so that's part of what we're doing. And so now we're offering nightscout as a service. And we make nightscout. press button easy. And we're working with the FDA to make sure that we can operate it fully compliant.
Stacey Simms 40:28
That sounds to me like you're trying to offer kind of a DIY the nightscout for people like me who, when many others who were you know, reluctant to do DIY stuff? Is that what the service is? It's a Is it a paid service that I can kind of this is an awkward way to say, like commercialize or make simpler what nightscout has been?
Ben West 40:48
That's right. So we want to offer Nightscout as a service and reduce the barrier to entry, make the entire experience much more reliable, predictable and consistent. And we want to increase the benefits of remote monitoring for everyone, whether that's caretakers and parents or temporary guardians, or whether it's just people that just want to find their diet buddy on social media and share it with them.
Stacey Simms 41:10
Thank you. So tell me a little bit about what T1Pal
Ben West 41:13
is? Sure, I'd love to. So T1Pal is our first product from medical data networks. And it leverages all the experience that we had building nightscout. So T one path is Nightscout as a service. So you can think of it as the easy way, it's a new way to get started with nightscout. And it eliminates all of the server and database administration and DIY craft. So it makes it as easy as any other platform where you simply sign up, you pay for your subscription, and you have access to all of the benefits that Nightscout brings.
Stacey Simms 41:46
Is it on the app store? Is it something that people buy? How do they get
Ben West 41:50
Dutch the website to one call.com, you
Stacey Simms 41:52
can go on your browser. Either commercial products have kind of caught up I mean, I can remote monitor my son with a Dexcom. And you know, t slim or Tandem has an app that is on my son's phone. And I guess eventually I'll be able to see that Omni pod is sharing more, what makes this one better?
Ben West 42:11
Well, there's a lot of things. One is the if we go to the connectivity piece, right, this idea of interoperability, and the idea of bring your own device, when we talk about sharing, there's a the base level that I start with is bring your own device I want to share with myself, I want to share I have this Samsung or Apple or whoever created a brand new thing, you know, last week, it's a shiny new thing, I want to go get that and bring that into my therapy, that's going to be part of my system. Now, that's really tough for a lot of these vendors I've been just I've been it's ago, I was looking at a brand new error that someone posted that I've never seen before on, you know, a Dexcom app. And it says it's incompatible in some brand new way. So this idea is really tough for the classic manufacturers who developed these really austere quality systems, right, and those quality systems control for change in the system. And the idea is you want to control your own destiny, and eliminate any possibility of variation. And so in a lot of these systems, what that means is we're going to test on exactly these versions. And anything that we add to that means increased workload that we have to go test. And so we create these haves and have nots. In a world that moves as fast as the one that we're living in where bring your own device, bring your own connectivity, this is the norm. Now, I think the industry, we just need more help, we need more players that are experts in this kind of connectivity in this kind of interoperability to make to satisfy the customer's demands. That's really the area that we specialize in is this idea of Bring Your Own Device connectivity. So that's one and then the other is this idea of sharing a lot of these systems, they're built for that initial use case that we discussed, where it's really oriented around the concept of the nuclear family. And you we know you have exactly these many family members and exactly these roles, and that's the way it's gonna work. Or if you want something else that starts to not work very well. You know, if you want the school nurse to have access during school hours, that doesn't really work very well. The idea of sharing, does it really require installing patient? Or is there a web app that works on any device? Those kinds of things, I think Nightscout still has a really compelling advantage. In addition to all the features, she talked about all the watches, there's more than 20 watch faces just for Garmin for Nightscout.
Stacey Simms 44:44
Right and that's just the one brand Garmin there's the all the other ones the Apple Watches smart, the Google wears, etc. fitbits when you see their watch faces, you still need your phone, right? Has anybody gone direct from Dexcom transmitter to phone yet is that maybe some You're working on?
Ben West 45:01
Oh, no, I, I can't say much about that.
Stacey Simms 45:03
Can you confirm it's really hard because that's what I hear from my friends in the DIY space that I've been bugging for five years about this.
Ben West 45:10
What I will say is that this idea of interoperability and connectivity, the idea that you're actually operating a network networks and decentralized systems operate on fundamentally different rules than closed systems that are composed of one unit. And device manufacturers specialize in kind of making these one units or boxes of units at a time. And they fill the shelves with those units, this mode where you start operating in a network with multiple devices that are connected, and you have decentralized emergent behaviors, this is a difficult area. So a lots of technologists that I've worked with agree that nothing's impossible, it's all software, we can make it do anything. But it does require willing participants that are collaborating.
Stacey Simms 45:54
One thing that I have found of talking to you over this time is you're very generous towards the commercial systems, you know, there is no, and I think this is very genuine, there's no bashing, you're not trying to put anybody down, it seems to me and you can correct me if I'm wrong here, this is how I feel. So maybe I'm projecting that there is a really important place for these commercial systems with their very, you know, big, you know, simplicity, they have to be able to be used by a vast majority of people with diabetes, they have to be understood by clinicians. But there is this also really, really important DIY focus that we've seen over the last almost 10 years now. And I do think that I wish there was more cooperation, but they are almost complimentary. And when they're both needed, am I off the mark there? Or am I kind of reading between the lines that you may feel a similar way?
Ben West 46:42
I agree completely. Stacy, what we have is a market full of people with this inhumane disease, right. And this inhumane disease demands all kinds of things on our time and our resources. And because it's inhumane, there's a lot of needs. Now, these companies solve problems in consistent and reliable ways for people. And that's what we need, we need to all as a market, we need a functional market that's working efficiently. That's providing high fidelity health care that provides a reasonable return on investment in terms of the fidelity of care, the more resources that we spend health care and wellness, we should be seeking a return that yields the kind of fidelity commensurate with the spend, right. So in diabetes for a long time it was you could go try and try and try. And you could try as harder and harder and harder as you'd like, a day to day may not be the same, you may not get the same results. And so trying harder is perceived as not worthwhile. Because there's no feedback loop that provides the yield that's required. I think that what we have is a world that's changing with technology really, really fast. And we have an ethical imperative to use that technology in humane and equitable ways. I open sourced all of this software when we got started, because for me, that was part of this, the scientific methodology of it all is someone else should be able to take this software and debug it audited, etc. That was a really important working principle. For me. That's exactly what we need is we need a working process and all of these domains, we need innovation happening. And we need a pipeline that can deliver the benefits of those innovations in an efficient way to the most number of people possible, as quickly as possible. And why? because as we know, this condition, this intensive insulin therapy is just an inhumane condition, it demands too much. And so I'm imagining a world where we can work together, we can have a bolus free up lane free therapy, we can have Bring Your Own Device connectivity, and have full remote control, we can have the supercomputers and the the networks and the people that are connected to our devices and our data work in a collaborative way to prevent repeated hype hyperglycemia repeated insulin reactions, and we can use that data equitably and humanely to deliver high fidelity healthcare. And
Stacey Simms 49:08
that's the vision. You've talked about diabetes 2.0. Is that what you're referring to?
Ben West 49:14
Well, that's an idea. I've been workshopping. I'm hesitant to use the numbers for all kinds of reasons. I have talked to people, not just children and parents, I have now talked to people that have had type 1 diabetes for 40, for 50 years. And they are telling me that this network effect that we have created is one of the most powerful things that's that's happened in their lives. I don't know how to respond other than to try to do more. We've got feedback now from parents and children from people in their middle age and from people that are now experienced 4050 years with diabetes, telling us that this has had such an impact that everyone This should be the standard of care for everyone. And I think When we look at what we're doing today, we're still in the early days, we still haven't really optimized for the next gen system where people are really living their lives really free of the blame and stigma. You don't have the blame for getting a bolus wrong, or for carb counting wrong. Because either because you can share it with someone, you can share this complex dosing decision as it transpires right, you can share it with your buddy, you can share it with an expert you choose, you can share it with someone you trust on demand, or someone could do it for you. That's what we're seeing it for a lot of these parents in school, now it's run day, or it's Testing Day, and the parent can manage all of that stress remotely. That's where we're going even with automated systems. That's what we're seeing. Because the demands as you travel through life, the demands change, and sometimes it's fine to coast and let the machine handle it. Sometimes it's necessary to find, invoke the buddy system and find a friend. Yeah, you know, you've
Stacey Simms 50:57
mentioned a couple times now bolus free blame free. Can I ask you just to kind of dig in on that a little bit more, because I love that concept of if you aren't deciding to give yourself insulin for a meal or for a high, if you can't mess it up? How can you feel bad about it? And I think when you're an adult with type one, or if you're a parent making decisions for your children about this, this guilt, this mental health part of it is so overlooked.
Ben West 51:22
You're so right, Stacy, I call this the onus to bolus Yeah, the onus to bolus so what we've done is we've made out of necessity, we have a system of intensive insulin therapy that requires multiple daily injections. That's been the standard since the introduction of insulin. And then more recently, continuous subcutaneous insulin injection, right? See a society that's classic pump therapy for a brief while we saw the introduction of what's called sensor augmented therapy, sensor augmented pumps, which is where you pair the glucose readings with the insulin pump. And then more recently, we have the introduction of these automated insulin dosing systems, hybrid, full, etc. What all of these systems do is they help address the symptom of diabetes, which is high, uncontrolled glucose. And insulin is the mechanism that we have to bring that glucose back down and under control. It's amazing that this works at all, I sometimes just marvel at how incredible it is that we can manually take this missing hormone insulin, and just dump it in the body almost anywhere, it seems. And it works in the sense that it does provide this temporary relief of controlling that glucose, as we know that balance is extraordinarily difficult, because it is our responsibility to get that right. What happens is, if you get it wrong, it's kind of your fault, especially if you've been given a calculator where your job is you just have to put in the right number. And you know, the calculator will spit out the right number for you. And now it's your job to carb count, or count the number of fat and then deduct the fat and link out the number of fiber and the deductor fiber. And then by the way, for the delay, you know, due to other effects due to the fat, or any alcohol on board, anything like that, or because of sickness or you know what, maybe not feeling well. And actually, you lose your carbs, right? after you eat and you lose the carbs, it just becomes so tricky. One to even know when it is you're going to eat to know how much it is you're going to eat. Three know how that's going to digest. And we could go on and on and on all day about the trouble with this thing. But the problem is, when the language comes up for how we talk about this, we talk about Did you get it correct? You know, we use the words like correction factor, we use the words like correction bolus. I've heard parents actually talk to their children and say go correct yourself. And I've never had that experience, because I was diagnosed in my 20s. But the experience I have had, and this was in my 30s, I was doing exercise in a class and I had an insulin reaction. And you know, I had to take a break out of the class, I really wasn't feeling well, right. And it's really, it's never pleasant when that happens for so many reasons. But one of the biggest is always you're just you're othered you're not part of the group doing the activity anymore. You're often in this weird thing. And often it's involving bloodletting in front of everyone, right? I mean, this is not good. And then so I'm having this conversation afterwards about, you know, here's my CGM. Here's my pump. And, you know, this instructor goes well, Oh, isn't that great? That is doing all that for you. Great. So the reasonable person when they see all of these devices, they're expecting it to do all of this already. Right? That's that's the reasonable person's expectation. I had to have a 15 to 20 minute conversation explaining, well, no, it doesn't really work like that. I have to take the CGM number, I have to guess if it's right. I have to get some blood to make sure. And then I have to do this thing. And then you know, I have to take the right I'm out. And the response right away, this still affects me was. So does that mean you just did up? When I explained how the mechanics works, the onus is on me the onus to pull this is on me to get it right. And the entire system around this is designed to make sure that it's not anyone else's fault. As it should be, it should not be anyone else's fault. If it's going to be someone's fault, it should be mine. But the entire system is designed to dock the way that you interact with the doctors, the therapy that they start you on is designed so that they're not going to kill you. They don't want to kill you. Yeah. And it's designed to just keep you alive, and they'll try to figure things out. You know, after that, let's keep you alive. First, the way that design happens in manufacturing with these vendors, I call it defensible design. It is designed so that they will not be held responsible for something going wrong. That's the way that it's designed.
Stacey Simms 55:53
It's interesting, because so many thoughts flashed through my head when you were talking about those things in terms of blame a lot of parents and I speak on this to try to get them to stop, but a lot of parents call the a one c visit to the endocrinologist their report card, you know, it's mom's report card. And that's a really tough way to look at this. But I understand why. And another thought I had was when we started with control IQ, about a year and a half ago now, I was just gobsmacked on how many decisions it makes it can make something like 300 decisions a day and how we were and I say we because you know, I mean, Ben, he was diagnosed at two. So I'm still going through the process of saying his diabetes, not our diabetes, so forgive me. But you know, he's a once he went down, his time and range went up. But it really showed me how there was no way for me as a parent of a toddler and a little kid and a middle schooler. And there was no way for him as an individual to keep up with that machine. And that machine couldn't even be perfect. And I got to tell you, well, it was frustrating to say okay, the machine can be perfect. It was so freeing to be able to say I had no chance, if that makes sense.
Ben West 56:58
That's why I chose the word inhumane stage, is when you see what it takes for success, you realize you didn't stand a chance. And we have to find ways other than blaming each other. We have to use technology and in this in this way to make this possible.
Stacey Simms 57:15
Thinking that way, then, let's talk a little pie in the sky here. Obviously, Dream stuff with technology isn't gonna happen next year, or maybe even the next five years. I don't know what the timeline is. But what do you want to see? I mean, can you give me some, and I'm going to put you on the spot, but maybe some concrete examples of how that bonus to bolus could be lifted?
Ben West 57:35
Well, there's, there's a number of ways to address this. You mentioned other technologies, other therapies, there's certainly so many capabilities, we're adding to our tool belt, whether that's new therapeutics, I've heard of people taking other hormones, other injections, supplementary injections, that that seems to really work. Well. For some folks, we've got faster insolence coming relatively soon, some folks are working on, you know, micro dosing, glucagon. And then there's there's other types of therapeutics as well. So there's all kinds of things it's really difficult to know, a lot of that is out of my wheelhouse. I'm a software person, I know how to manage cloud, we know how to do transformational services, digital transformation, right, we know how to manage really complex stuff, using technology to provide a collaborative decision making process, it's in the power of the web, or society as a whole. That's why I wanted to become a technologist and work on the web as a whole was this idea of the collaborative power of sharing. That's my big bet. That's the thing that I get really excited about, I see automated dosing systems are coming faster insulins are coming. And those are all great, they're going to be so profound and helping people. But at the end of the day, with these therapies, you're still facing exactly that you're facing a lifelong journey with other people with this experience. And my big bet is that this need for sharing is so fundamental that that's why sharing is being adopted in every part of software that we look at every piece of technology that we get first. It's like a solo experience. And then eventually, it becomes like a collaborative social experience. that's been true of a lot of different kinds of software. And I think that we're going to see the same thing in diabetes care that we'll see clinics that will embrace the digital technology, so that instead of having appointments once every 90 days, or once every six months or once a year, whatever it is that you're going to get connected to the people you trust in the experts you need just in time and on demand. So if you're someone if you're using one of these fancy pumps that's connected to supercomputer and connected to a network, there should be an agreement for how this is going to work. If you're going low. lifetimes per night. What is the pathway for someone to intervene for us to deliver the help that you need? Because I'm pretty sure no one wants to go for an insulin reaction for a sixth and seventh night. Yeah, I'm pretty sure there's some consent that can be arranged. There's got to be some design there. Right, where we're going to eliminate this. When I think about the remote overrides, and the overrides features that are happening right now we're, you know, we're playing around with things like sleep mode, things like exercise mode, those are dosing decisions. When you decide to invoke sleep mode, or invoke exercise mode, the algorithm is changing its dosing slightly, it turns out that all dosing decisions are just really, really hard. You can't turn on dosing. On exercise mode, when you start exercising, you have to turn it on hours ahead of time, right? Like those kinds of things. Maybe we could share access to those things. One of the examples that I've been learning about recently is, is this remote overrides where the teenager is doing testing, and it's stressful on test day, and your attention is supposed to be on taking the test. It's not supposed to be on managing diabetes, and in fact, playing around with diabetes devices, which is how it's gonna look like to the proctor to the school that you're just playing around with devices, that becomes an issue. Can you trust the proctor to handle these devices, etc? Well, guess what, with remote overrides this idea of remote controls and sharing your dosing decisions, that becomes a non issue. I've heard of parents and teenagers coming up with a plan for the day, okay, it's testing, here's what's going to happen. Here's the schedule we're going to go through, and the parent is able to help coax the automated dosing machine through the day. And all of a sudden, what I don't know how else to handle it. Because that's the nature of life is that Sure, you can schedule some things, you can automate some things. But there's all these edge cases, as you travel through life that demand more they demand attention from humans. And if as long as that's true, it's also true that humans are going to want to share that experience.
Stacey Simms 1:02:04
I have to ask you, Ben, are you saying that there is a system out there that someone could remote, not just communicate but control the insulin pump from from home?
Ben West 1:02:15
Yeah, it's real. You could set exercise mode or eating student mode, things like that.
Stacey Simms 1:02:21
Well, you can set exercise mode before you get somewhere but you can't like I can't at home, like my son right now. Is out running around the neighborhood. I can't say exercise mode go. I know, we are you mean in the future?
Ben West 1:02:34
Not with Tandem but with Nightscout. And that's
Unknown Speaker 1:02:36
what I'm saying. Okay.
Ben West 1:02:38
Yeah, part of what I mean by it's several generations ahead. It's years ahead. In terms of, you know, night with nice guy, you can actually do these things, you can share dosing decisions as they transpire as life demands.
Stacey Simms 1:02:50
I'm still not clear though. I mean, I can not to share the decision, like the son says, I'm doing it, but I'm in my home five miles away, and I press a button on my phone and my son's pump changes when it's doing.
Ben West 1:03:01
I think that's one of the key insights with diabetes as well, Stacy, is that those decisions don't always happen at the time of when something is happening. Sometimes your dosing decision takes place five miles away, or hours before,
Stacey Simms 1:03:14
but I'm still not clear, but I'm so sorry. With Nightscout. Can I control my son's pump from five miles away? At the moment?
Ben West 1:03:21
Yes, you can. You can tell it to go into exercise mode telogen, sleeping mode, things like that. Yes. Okay.
Stacey Simms 1:03:28
Yes. Perfect. That's exactly what I was asking. Okay, sorry, for my ignorance. That's great. Sorry, there's, there's there's a whole other philosophical argument that we could have in the future about how much control parents should have At what age and but that's a different story altogether.
Unknown Speaker 1:03:41
Yeah. So
Unknown Speaker 1:03:42
the choice to make there I want that
Ben West 1:03:44
choice. Right. This is where the really interesting conversations really begins right here is what is your personal data governance policy? What are the boundaries that families want to implement? And like, that's why I mentioned this particular story between this teenager, and I believe it was their mother, they actually have this conversation about like, okay, here's the day schedule, what are our roles for the day? Right? Isn't that such a beautiful thing? To say? Oh, you know, I think it's gonna be a stressful day for me. Could you just handle that?
Stacey Simms 1:04:13
Oh, it's fabulous. Go ahead.
Ben West 1:04:16
Could you just go ahead and handle that, for me? That's something that even as a professional adult, I want access to that kind of therapy. I would love to be able to say, you know what, I got a stressful day to day, could you just handle it for me? The same way that I can buy an Uber, I can get an Uber for the day, I think I should be able to get something like that for the day. I think that's coming. I'm interested in building it. So I do think that's what's coming, though. I think that's those are the kinds of things worth getting excited about. Yeah,
Stacey Simms 1:04:44
I used to give my son what I call the diabetes free day. And it was any time that he was stressed or had been doing things by himself, like he used to go to summer camp for a long time and, you know, not diabetes camp, but a camp where he was responsible for everything. And he was all burned out when he came home. So I would Two or three days of diabetes free, which we meant, and he was still doing finger sticks at the time, he wouldn't do any finger sticks, he wouldn't count any carbs, he wouldn't even touch his pump. And by the end of two days, he was like mom, mom, leave me alone. But he always liked it, you know, for a couple of days. And so if you can give us another diabetes free day, maybe when he's in college, Ben, I would love them.
Ben West 1:05:19
I think that's representative of the masses. I take care of myself most of the time, but every every once in a while, that's what vacations are for. And that restorative power of those vacations. I think that's something that people on intensive insulin therapy deserve.
Stacey Simms 1:05:34
We started this interview by kind of looking back at the beginnings of we are not waiting and and talking about all of the people that are part of that story, and your involvement and everything. You know, you mentioned it's almost 10 years already seven years, maybe since nightscout. When you're looking back, any thoughts on where we are? Now I know we've already said there's a long way to go. But from where I sit, I'm a lot happier with what I have just commercially for my son's diabetes than I was in say, you know, 2011, and I'm curious what your thought is for your own care.
Ben West 1:06:08
I'd like to see several more improvements. We have a problem with supply rationing of all kinds, whether that's CGM supplies, in my case, I ration my CGM supplies very, very carefully. I just cannot imagine when I add up the math, it seems pretty obvious that you don't have enough sensors to provide enough glucose monitoring, in order to make your automated dosing machine work all year round without any breaks. That's something that I'd like to see fixed is no this concept of it's just really difficult for people with diabetes to get enough supplies, whether that's glucose monitoring, or even access to insulin. On a basic level, you know, I have to start there, in some ways.
Stacey Simms 1:06:56
Yeah. And I really, you know, it's funny, it's not at all what I was thinking, and it is the number one thing we need to fix. Last night, Ben, I got in my car at nine o'clock, and brought pump in sets and cartridges to a mom whose insurance company was given her grief, and they had just, you know, it didn't the thing hadn't come, and she needed supplies. And I'm in my car, and a widow driving through town with a little lunchbox bag of diabetes supplies, I have a great group here, we'll help each other, but that shouldn't have to happen.
Ben West 1:07:25
And then for the for community members to be forced into the gray market like this. There's so many patients, and then to be demonized by industry, when there's real needs in the real world here that we're just trying to meet. So we need more collaboration across the board, that's for sure.
Stacey Simms 1:07:44
Alright, so as we wrap this up, and before I let you go, knowing that that's that's pretty serious. Here's a pretty silly one. We are not waiting was the hashtag that took off any predictions for what the next the next hashtag is going to be? love to see honest a bolus hashtag want us to have all this? Yeah, we'd like to get rid of that one. We'd like to use it and then get rid of it.
Ben West 1:08:03
That's right. Language matters and order symbols.
Stacey Simms 1:08:06
And thank you so much for sharing so much time with me. I followed you for years. I'm such an admirer. Even though I feel sometimes like I don't understand half of what's going on. But we you and so many others have done has just pushed this technology and the help for people with diabetes, so far ahead of where it would have been left to, you know, commercial devices. So I'm excited to have a chance to just say thank you for doing that. And thanks for talking with me.
Ben West 1:08:29
Thank you so much, Stacey. I really appreciate your work, too. I've heard so many of the interviews from people that I know and love. So this is truly so special to be a part of this. And I'm so grateful that you've taken up this project. So thank you as well. Oh, my gosh, thank you.
Unknown Speaker 1:08:50
You're listening to Diabetes Connections with Stacey Simms.
Stacey Simms 1:08:55
I could talk to Ben west for hours. And in the interest of full disclosure, I will tell you that we did speak for probably a total of an hour and a half. The first time Ben and I talked, I got a little bit in the weeds after about 30 minutes. And most of the interview became me not understanding a lot of what was happening with nightscout. And I'm telling you this because you know me, I'm always in the interest of full disclosure, and I love behind the scenes stuff with podcasts or interviews shows, we agreed together that we would do another interview, I went through the transcript, I gave Ben a copy of the transcript and we kind of figured out what we had left out. And so I went back and recovered the nightscout. If you really want to pinpoint it, it happens right after the Dexcom commercial. That's where the second interview picks up about 3035 minutes into the first interview. We didn't leave anything on the cutting room floor that was important or would have changed the flow of the interview. But I think I was much more focused than was of course fine twice, but I was much more focused the second time around and you could even hear me and some of that Not understanding. It's so embarrassing sometimes, but not understanding what he is seeing. But I leave all of that in because I think that while many of you, as you listen are super technical, there's a lot of people who really don't understand everything that is being offered non commercially and DIY still. So that is why I left a lot of that in. Thank you so much for listening. I will link up a lot of what we mentioned over at Diabetes connections.com. Of course, there is a transcript as there is beginning in January of 2020. Every episode has one I'm still working to get the backlog done, but we will get there. Huge thanks to Ben west for really spending so much time with me and sharing so much information. Just so happy to have finally gotten him on the show. All right. Thank you as always to my editor John Bukenas for audio editing solutions. I'm Stacey Simms. I'll see you back here in just a couple of days for one of our classic episodes. Until then, be kind to yourself.
Benny 1:10:57
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged
Eight years ago, you could use a CGM but you couldn't share the data. Dexcom transmitters didn't connect to phones and parents and caregivers couldn't Follow anyone. That started to change - and change quickly - in 2013. That's when John Costik posted a photo on Twitter. That photo showed John's laptop, at home, monitoring his son Evan's blood sugar while Evan was miles away, at daycare.
John soon linked up with others who were also working on improving existing diabetes tech. That was the start of Nightscout and a host of other "We are not waiting" improvements, many of which are now integrated into commercial offerings.
This interview with John is from October of 2015. He has since left his job as a supermarket software engineer and is currently the director of digital product development at Beta Bionics. That's the company founded by Ed Damiano that's developing the iLet insulin pump.
Check out Stacey's book: The World's Worst Diabetes Mom!
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Episode Transcription Below
Stacey Simms 0:00
This episode of Diabetes Connections is brought to you by inside the breakthrough, a new history of science podcast full of did you know stuff.
Announcer 0:13
This is Diabetes Connections with Stacey Simms.
Stacey Simms 0:19
Welcome to a classic episode of Diabetes Connections. As always, though, we aim to educate and inspire about diabetes with a focus on people who use insulin. These classic episodes are something new this year, we are bringing back some interviews that are from the very first year of year and a half of the show. We started in 2015, coming up on six years. So there's a lot of episodes that newer listeners haven't heard. And it's kind of fun to go back and give some perspective. I like revisiting. I'm emailing everybody that was featured. If they're getting a classic episode, I'm sending them a text message or a DM or email or you know, I'm just getting in touch with them to say anything you want to share, you know, any new stuff. And it's been really fun to reconnect with some of those previous guests.
I’ll be honest with you, I have really hesitated about bringing by older tech type episodes into this run of classics. We did a lot of interviews, like we do now with the pump companies and technology and things like that. And I think it could just be kind of confusing if you're a newer listener, or if you know, you put a classic episode on and you're thinking it's new. But I mean, let's say I run an episode from 2015, when Dexcom, for example, is talking about an upcoming piece of technology that now in 2021, is outdated or never happened. So I'm purposefully avoiding most of those interviews. If you're interested, though, there's a great search box. I'm really proud of the website. It's very robust, you can go and search the 372 episodes that we have put index calm, see how its evolved over time, put in animists and find out what happened, you know, that kind of stuff. Some of those types of interviews, though, especially from the Do It Yourself community are, in my opinion, very valuable and very much worth revisiting. So that is the topic for this week.
All right, come with me now let us go back to the olden days of diabetes back before 2013. Now I know most of you that's not the olden days for real. But you think about what has changed since then. Before 2013. It was a time where continuous glucose monitors were used. They were around we were at the time using I want to say the g4 Platinum pediatric. But you know, you could use it, you had a nifty little receiver, but you could not share the data. And it I don't believe in 2013 it was on anybody's phone, you definitely couldn't share. Then we saw the tweet. I've been on Twitter since 2008, thanks to my radio days, but I can't say that I was following john Costik at this time, but he was retweeted by somebody else I knew. And I saw this amazing thing. It was a dad watching his young son's blood sugar. On the dad's laptop. The kid was in daycare, the dad was at home, they were across town from each other in 2013. I started following that dad, john Costik. And of course, I was far from the only one john linked up with others who were also working on improving existing diabetes technology. And all of that was really the start of nightscout and a host of other we are not waiting type improvements, many of which are now integrated into commercial offerings. We are going to revisit that time with john Costik in just a moment and catch up on what he's doing now.
But first Diabetes Connections is brought to you by inside the breakthrough on the surface. This podcast is a collection of fun, entertaining and even surprising stories from the history of science. But host Dan riskin digs deeper and he really does entertained while drawing connections between these stories and the challenges faced by modern day medical researchers. The latest episode it was just released a couple of days ago. It is wild Dan explains why it took a dozen people 200 years to discover and then undiscovered a planet. I love this podcast. I'm so glad to partner with them. You can search for inside the breakthrough anywhere you listen to audio wherever you found this podcast and if you are listening through the website or social media, click on Diabetes, Connections COMM And you'll see the insight the breakthrough logo. By the way, good time to remind you this podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.
A couple of things to know before we jump into the interview, I did reach out to john Costik of course, as I mentioned, and he said let's let folks know I'm hard at work on the islet and its digital products. He is currently the Director of digital product development at beta bionics. He would love that and he says hope you're doing well Stacey and if you are not familiar in the islet is the product from Ed Damiano. We've had him on the show a couple of times beta bionics is the company that is now developing it The islet is finishing some clinical trials this year and should be submitted to the FDA. Pretty soon I am speaking to the folks at beta bionics about coming on the show and giving us an update. So we will work on that as well.
But also remember, this is from the fall of 2015, there are going to be dated references. I just want to kind of keep that in your brain. Because while it's fascinating to take a look back, you have to keep in mind as you listen, this is nearly six years ago, but I gotta tell you, I'm just as excited listening back to this interview as I was when I first saw that tweet, John Costik. I am thrilled to have you as my guest this week. Welcome to Diabetes Connections.
John Costik 5:41
Oh, thank you. so thrilled to be here.
Stacey Simms 5:43
Thank you very much. Let's talk about how this all started. Your son was diagnosed in 2012. He was four. But unlike a lot of people who have children diagnosed at any age, you had more technical knowledge than a lot of us. Can you take us through first, you know your diagnosis story, what happened to lead you to find out that your son have diabetes? And then you know, what made you think to look at the equipment and think well, this isn't good enough.
John Costik 6:11
Right? So it was late summer, end of August 2012. And Evan was showing sort of those classic signs that now we know are classic signs, right that he was thirsty all the time peeing all the time and just, you know, little get more lethargic as the day went on. And the 24th was a Friday and my wife Laura went over to pick them up from daycare surprise him with an early lunch. And when she got there that the instructor said, He's so thirsty, he's crying. So she called me and I was out for a run on the canal path. And I remember, she told me what was going on. I said, That's not good. And, you know, he's been really thirsty and really sweaty. past couple days, let's I said just, you know, both of our guts, were telling us, let's get into the doctor. So she called our primary care. And on like most appointments, where they're like, Well, yeah, we'll see you in a couple days, they were really quick to say, Okay, come in, at one o'clock, then, you know, so like a one hour delay from the time they called. So little did we know they I mean, they knew pretty much right away what it was. So as soon as they got there, of course, he had to go to the bathroom. So they did urine check. And he was clearly spilling sugars than they needed to finger check. And he maxed it out. And they basically said, we're gonna call the hospital, you get in the car and just go to the ER, we'll tell them. You're on your way.
Stacey Simms 7:42
Did you know anything about diabetes at that point?
John Costik 7:45
No, no. And this was Laura was at the doctor. So she called me I was at work at this point. And it was just like, getting hit in the head basically. And yeah, my, my knowledge of diabetes was very limited, much some family members that were type two, and I knew there was no type one and type two, and one was curable, one wasn't. And that was mostly because growing up my mother, my mother, she still is a nurse, but she's retired. But she was the school nurse. And there were a couple kids with type one. And I remember just hearing stories of her having to, you know, go to people's homes to pick up their insulin for them if they forgot it. So understanding that type one was distinctly different, I at least knew that much. But the next three days at the hospital, obviously, they put us through the type one boot camp, and send you on your way, basically with vials of insulin, and, in our case, humalog pen, and we had to sort of figure it out from there. Yeah, they gave us the general guidelines for how much insulin he may or may not need, how much lantis to give him. And we were on our way.
Stacey Simms 8:53
Now, it seems like you started on a continuous glucose monitor pretty quickly, how soon after you got home? Did you start thinking about that?
John Costik 9:00
So it was mentioned to us while we were at the hospital by the endocrinologist that diagnosed HIV. And at the time was the Dexcom. Seven, and the I think it was still the Medtronic soft sensor at that point. So those were the only two that were shown to us. And he said, okay, it's a lot of information up front. So we actually went with shots and did a lot of finger checking, initially. But one of the one of the things we recognized real quickly, was the ability to to log this data and communicate this data was sort of hampered you know, if the nurse was writing things down in a log book that didn't inform Laura and I how Evan was doing during the day. So the first thing I did was set up a website for logging, you know, nutritional data, finger checks and how much insulin we were giving him. So that was within probably a week after diagnosis had some semblance of that. And that was to prepare him for going back to daycare. So we could all stay in the loop. So that system would send Lauren an email, a text message whenever a treatment was entered.
Stacey Simms 10:11
Alright, so then a few months later, though, you decided to go with the Dexcom. g4.
John Costik 10:15
Yeah, we started looking around, so around November when I got approved. So I immediately signed up for all the diabetes technology, news letters and everything I could and started, you know, as, as my mind kind of settled down from the diagnosis. You know, I started looking to see what can we use to keep him safer, healthier, both in the short term and long term. And the g4 was approved, I believe it was November in that ballpark of 2012. So I began the process almost immediately to get that it took a while to get it through insurance. Because they actually like to see hypoglycemia before they'll give you tools to avoid it.
Stacey Simms 10:52
I know. And if you do, too well, they want they might take it away. That's the craziest part.
John Costik 10:56
No, no, your son's still healthy doesn't need the thing that's keeping him healthy. Yeah. So. So unfortunately, or, you know, he did have a low in January, that basically put us over the edge. Then they approved it, and we had it in, you know, the second or third week of February 2013. And that's when we began using that. And does that mean immediately it was sort of a revelation to have this second order data, this trend data along with the blood sugar, just so to know directionally where he's going. And you know, what's happening in those periods that we were blind to before. So immediately after meals, we'd see these big spikes that come right down. But, you know, got our mind spinning on, what can we do to improve that? And at the same time, when we sent him to school, is there any way for us to have continued access to the CGM data?
Stacey Simms 11:52
Now you both you and your wife both have backgrounds in engineering? Correct. And so this was something that you looked at, and what did you think of the system because somebody like me, you know, I was a communications major in college, I've worked in broadcasting my whole life. I looked at the CGM. And I thought, Wow, this is so great. How could it get any better? You looked at and thought this is the dumbest device in terms of talking to anything else?
John Costik 12:14
Right, but but I understood the position that everything sort of has, has to go through that growing cycle. So I understood that. So I also my wife worked at an FDA regulated company. So we had some idea that putting a medical device online and presenting that data to people is more daunting for the commercial entity than it would be for us as individuals to just extend it. So we I mean, we were never, I never really railed against Dexcom. In at the time, I think they had sort of shown off some semblance of share, or there'd been some patents that came along that indicated that they were clearly moving towards remote monitoring at some point. But it wasn't something I was going to wait for. Right. So I have the CGM. Now this great device, I have a laptop that can talk to it. And I know, I can take that data off and send it to a cloud service. Or, in our case, we just started with a simple Google spreadsheet that we sent the data to. And then I wrote an iPhone app that pulled that data down and your web app, so the school could just see, you know, his current blood sugar and trend. So we integrated that with with our care portal website. And that was powered by a laptop top load. So initially, I just used a repurposed Dexcom zone, what I call a DLL, linking library dynamic linking library. So that's basically just a program that allows you to interface programmatically with the receiver. So I just repurposed that wrote a fairly simple Windows application to just pull that data every five minutes, and then upload it to that. Like I said, that Google spreadsheet.
Stacey Simms 14:02
Okay, so I'm just curious, was it hard for you to do that? Did it take you a long time? Or did you sit down and tap the tap tap? You know, you're done. You got it?
John Costik 14:10
It wasn't, wasn't challenge. So my background in software, I it was relatively recent background, but it was all focused around windows code, and specifically writing these sorts of libraries for other hardware devices. So I understood if I took their library and put it into what what I would call, you know, a software project, that I wouldn't be able to see exactly the interfaces that could pull that data into my own application. So it really only took probably an hour or two, to write to write the basic windows uploader.
Stacey Simms 14:46
And then you put this picture on Twitter. I don't know how long after that said, Look at what we're doing. Isn't that interesting? And did you expect the reaction that you got which was basically jaws dropping around the country, saying how Do I do that?
John Costik 15:01
Yeah, that's, I took some pictures of the windows one initially. And that didn't get a ton of attention. And when when I started going after a truly ambulatory like a mobile solution, that is what really drew people in. So I knew Evan was going to kindergarten, I wanted him to be able to remotely monitor, monitor, monitor, no matter where he was, was, he was on the bus, in class moving around, so I knew, you know, even a really small laptop wouldn't cut, it just wouldn't be convenient for him. But if I could get a small cell phone, smartphone and do that, great. So I started in Android was really the only choice they make much easier to communicate with USB devices and other accessories. So I started working on that, beginning of May, in about a week or two into may, I had sort of unraveled how Dexcom was communicating with the device and, and what that communication looked like and how to interpret that, and then send it along to to a web service to a cloud service. So those tweets got people's attention. And I think I chimed in on on a bulletin board somewhere. And that's when Wayne Desborough reached out and said, Hey, I'd really like to do the same thing for my son, he's his room is too far for the receiver to be in our room and reach him. So we'd like to do to build a remote monitoring system.
Stacey Simms 16:36
Okay, so let me stop you there and tell me if this is all correct. Lane despereaux. Now with Bigfoot biomedical, yep. He has an engineering background as well, I think you work for Medtronic for a while, but he had designed his own home display system. He He's the guy who came up with the nightscout name, right. But he didn't connect it to the internet.
John Costik 16:56
Now, he, he did so ln really took my uploader and created that open source nightscout back end. So the the website you see today is is an evolution of his original design, and uses the same architecture. So a Mongo database, and a Node JS application sitting on a web server somewhere, and allowing people to view you know, their data or their loved ones data. Okay, so that that core was was Lane's work. And later, he brought on Ross nailer, software engineer, and they sort of refined that and got it to that point where, where it could could go live. So for my part, they, they took my uploader code, you know, I gave that to them. And I took their chart code, and put that into, into our home system. And that's sort of where it took off. So in the middle of the summer, I started using the Pebble watch, because I my whole goal this whole time was just how simple can I make this? How glanceable and easy can I make this for everybody involved, because I don't want to stare at the chart all day at work, I just want to know when something's up, I want to go on my day, but know that this system will tap me on the shoulder when it needs to. So Pebble watch was was a good way to do that. Because you can make it vibrate and do all sorts of things to get your attention.
Stacey Simms 18:25
Okay, so now you've got it on your Pebble watch laying despereaux and other people that you've mentioned, are coming up with their own additions. When did what we now recognize as nightscout? When did that all come into play? Was it a few weeks or months after you all kind of shared your codes?
John Costik 18:45
So I think lane started using that name fairly early on. And we all met Finally, actually, Lane was in Rochester, New York for a sailing competition that I believe he won at the end of August 2013. So he actually was at our house for Evans first diversity. And that was a great time when he and I got talking about, you know, everything, right? Very, just an amazing individual really inspired me and opened my eyes to like, Look, there's a lot of people trying to do this. And right now, between the two of us, we have all the components to make it happen. So it was very inspiring, because up until then, I mean, I was a software engineer at a supermarket. Right? Yeah, that wasn't something I'd considered. You know, I lived in a small town. I never really looked beyond that. I liked my simple life. And part of my response to Evans diabetes was I want my simple life back. So these were the tools I wanted to build that I needed to take it back. Right. Yeah. But now seeing this really large unmet need across the entire, you know, population of people with diabetes. He's in there and their loved ones woke me up to that. And then in November, I went to the data exchange, which is hosted by tide pool and diabetes mine. And then diabetes, mine has their Innovation Summit the same, you know, in that same couple days cycle. And that really sort of sealed the deal for me to see what type who was doing, starts trying to integrate all this data. And I'm like, wow, okay, this is really happening. So I can either join in, or, or not, right, and it just seemed like an obvious thing to, you know, pitch in and see what we could do. So, at that point, it was really just a matter of refining that code, to a certain point where other people could make it work. And personally, I didn't think it would ever grow beyond, you know, a sort of core really technically savvy group of people that could set up their web server set up the cloud service, right, and compile a Java application for their Android phone.
Stacey Simms 21:04
Well, that's what's what's remarkable about this whole movement is that, you know, as you say, this core of people, is making it all available to people who have no real technical knowledge, who are completely intimidated by the whole thing, but want access to this information to the point where they're willing to get in a Facebook group and say, Hey, can you help me? And then people do it, people help. And it's been really remarkable to see how it's grown and how people like you are not just sharing your code, but sharing time to set up all of these systems. When you look back now. I mean, can you imagine that? There's something like 14,000 people in the CGM in the cloud Facebook group. I know not everybody's using the system. But they're they're looking at this stuff. Did you think I would get this big?
John Costik 21:50
No, no, not Not a clue. I mean, Laura and I, we had some inkling that what we built was awesome. Because it really enabled Evan to have as close to like that standard school kindergarten experience, as we could have ever imagined after his diagnosis, right? Oh, he had to carry, you know, a little bag around, but he would have had to anyway, right, he'd always need his glucagon and glucose and finger checker. So it wasn't too much more of a burden to put a cell phone and and the the CGM monitor in their hand. Good. Yeah. So just enabled him and we worked with the school nurse, and we refined, you know, our web application and our care portal, to really be something that that she was comfortable using. And something you know, that that informed us, you know, in real time of what was going on in school. So it's really just a nice experience. And again, like, like the daycare experience we've had an amazing experience with, with the Lavanya School District, the nurse in particular, she's just a wonderful person just wants everyone to be happy and healthy, and every kid in that school, so she's, she's like Laura nine. Now. She just she knows his diabetes really well, because she can just glance at and she gets a really good sense for what's going on in his day and how he's feeling and how that will impact his blood sugar. And there's almost never an occasion where we have to chime in or even text her to say, Hey, can you give him a grammar to, you know, and if we do do that she's already on her way down, are already calling down to make it happen. So it's just it's just been an amazing thing for him and for us, and it's been wonderful.
Stacey Simms 23:34
How's he doing these days? He's in second grade now.
John Costik 23:37
Yeah, second, he's doing a good. So it's, it's nice with the share receiver, we can use the Bluetooth connection so that that Reagan's gotten smaller and simpler for you know, it's wireless now. So we really can get his, you know, physical burden of the devices to a minimum at this point. It's also improved outcomes tremendously is a one C is great, you know, his standard deviation is time and range, all these things improve by having this sort of, always on and easy access to, to all this diabetes data.
Stacey Simms 24:13
And you mentioned the Dexcom share, we should note that Dexcom share Medtronic has is coming out with a system that is similar, where instead of doing it yourself, they're setting it up for you. But that and I don't know if I'm explaining this correctly, but there are still features that you all have set up and that the nightscout folks have set up that are not included in the share, is that correct?
John Costik 24:36
The main missing feature that people really enjoy, is that what folks refer to as raw data. So the ability to see some data during either a restart or a warm up period, or during the dreaded triple question marks. You know, there's there's some visibility data, you're not totally blacked out from that data with nightscout. Whereas, as the standard Dexcom, system will do that.
Stacey Simms 25:11
Let me turn this around for just a moment and play devil's advocate. While many people, obviously 1000s of people use nightscout, and are excited about the Dexcom, share, there are a lot of people who have type 1 diabetes, I'm going to put teenagers in this category, probably a lot of them who feel as though this is a bit overbearing, and who feel as though there needs to come a time when you know, parents, or others, you know, maybe don't have access to their numbers, or that this creates a situation where there's just so much hovering. Now, it's difficult for me to ask you about that, because you're doing this for your family, you didn't do this for everybody else. What's your take on that? And even still pretty little, but what's your take on
John Costik 25:57
that? My take is always in law. And I've always said, you have to you have to find the systems and build your own system to an extent, you know, whether you're selecting devices, or features on those devices, that that suits you, in that time in that context of I have a teenager with diabetes, I have a young child with diabetes. So if you have a teenager that is very trustworthy, and manages their diabetes really well, you know, maybe you're, you're not going to look at that remote monitoring, it's an essential piece. Right. And for folks that may be worried more about their teenagers. I mean, at some point, you you, you do have to stand up and say like, Look, I'm I'm your parent, hovering or not, I want to keep you safe and alive. And I think there probably is a balance that you have to find with the individual child. Right? So if they feel it's really invasive. You How can we make the system less invasive, maybe they don't always have an always on access, but they get alerted to you know, impending hypoglycemia? Right. So there's always ways that since it's an open source system, people could take the system and, and really fine tune it to their particular needs. And for us, with epanet his age, it's less about hovering, and more about actually giving him more freedom. Because us, knowing what his blood sugar is allows him to just be a kid. Right? And it's, we don't he doesn't get bothered nearly as much as he would if we didn't have it. So so there is that sort of aspect that I think gets overlooked, you don't realize that it actually enables more freedom, in most cases?
Stacey Simms 27:45
I think that is a great point. Because it's a parenting question, right? It's not a technical question. The system exists, and it's great. And how you use it is up to you I've shared before I have never used nightscout. It's not something that I first when it first came out, I looked at that and said, we'll break that in about three seconds, if we can even get it set up. It's just not us. And when shear came out, I was one of the people who got the cradle and use it overnight, loved it and never really felt like I needed to get an upgrade because my son is at a point where he's at a terrific school. He's in fifth grade. And I did not feel that I needed to remote monitor because he's at an age. And listen, I can get criticized for this. Or I think it's better for him to make some mistakes, in what I know, after all these years is an incredibly safe and supportive environment. But I got the share receiver. And I use it, as you said, finding it gives him more freedom. There's a tradition in my town, where the fifth graders walk from school on Friday afternoons to our little town and are allowed for like two hours the town tolerates them running around, going to the soda shop, yes, we have a soda shop, going to the green going to the library on their own. And I didn't want him doing that, without at the very least a way to contact me. And we have both found that having the share system. And he only really takes a cell phone to school on Friday so I can see it. He doesn't even need to check in. I know what's going on. I'm not too worried about it. We text about well, what are you going to eat? And how are we going to deal with that. But it's made it so much easier. So as somebody who doesn't remote monitor on a regular basis, that little tool has given him freedom if he was two years old. I mean, my son's diagnosed before he was two, would I feel differently? Probably. But it's it is I think it's more a parenting question than a technical question. So maybe it wasn't fair to ask. You
John Costik 29:36
know, I think it's fine because ultimately I mean, I'm, I'm a parent, there's a lot of all this came out of what I felt were our needs as a family. Definitely one of our, you know, one of our family members safe and happy and to improve the quality of life at all. It does come down to how people you use the tool. It can be very invasive, if you're a parent that is constantly paying that kid to do so. Right So the technology can enable hovering as much as reduce it, I think,
Stacey Simms 30:06
yeah. And ask me again in middle school and ask me again in high school. So you know, these things changes as the kids change, right. And as the setup changes, hey, you also share your information. With some recent guests of mine, I talked to Dana and Scott from the open APS project that do it yourself pancreas system, and they're basically working on the you're operating an artificial pancreas system that Dana has worn for almost two years. Now they close the loop last year, what do you think is going to happen next? What do you look at in technology? And say, yeah, that's going to happen? And I'm going to have that forever? And
John Costik 30:42
that's a good question. So obviously, you know, I want us all to be put out of business, just cure it. Exactly. But if if, if there's a functional cure, whether it's bigfoots product, or Dr. damianos product, or somebody else, you know, whether it's encapsulated islet cells, you know, via site, if they figure it out, and are able to do an implant that reduces the insulin need, significantly, if not eliminated, those those are the sort of things that that make me excited, and I look forward to those and, and Scott, and Dana very clearly showed, like, Look, you need to get this AP stuff rolling, because it can be tremendously beneficial to people with diabetes, right? It reduces their burden makes them much healthier keeps their blood sugar's in range, with a much higher percentage, right? Yeah. So early on, they were I think it was Scott reached out to me saw a couple tweets, he tweeted back and said, hey, how can I get this? So he was one of the folks that I shared the uploader code with early, you know, before it was publicly available for it was open source. You know, I knew you looked into his background, and we talked and it was very clearly the software wise, he was savvy. And so I was happy to share that with with him. And Jason calibres was another person that I gave the uploader to earlier. And Jason Adams, who founded the Facebook group, was another one of these folks that early on, had really reached out to me and got me rolling.
Stacey Simms 32:15
Oh, let me interrupt you here. Why not? Why not? Make it more proprietary? I mean, why? Why make it so easily available? When, obviously, people were clamoring for this and probably would have paid you for it? I feel like I should be twirling my mustache. When I asked you that question.
John Costik 32:32
That was a question. We got a lot, actually. So when people saw our system, even before we made it open source, they said, Oh, that's a million dollar idea. I said, Yeah, but it's not really my idea. Right? Everybody's had this idea. Scott hanselman had the idea 15 years ago, you know, so people we've very smart people know that better, we can access our data, the healthier we're going to be. So this was just, I just happened to be in the right time and right place. And to be honest, I'm not particularly entrepreneurial. So I wasn't super motivated to go out and start my own company and raise funds to get this done and dig my heels in with regulatory issues. You know, it just, again, it was it was me trying to get our simple life back and starting a business around it was would have been a huge risk. And that's something that I was particularly interested in doing.
Stacey Simms 33:22
Are you happy with how it turned out?
John Costik 33:24
Yeah, yeah. I mean, if I had tried to commercialize it, how many people would be using it? Maybe not? Right, maybe it would have fizzled, and people would still perhaps be waiting for the G phi or the share. If if that group hadn't come up and sort of opened the FDA his eyes to that need. So yeah, I think it's, at this point, the best possible outcome I could have imagined and the appreciation from folks, and I don't deserve nearly any that I get, you know, it was a small part of the story. It just happened to be, you know, early on, but just that outpouring of gratitude, I mean, no one could have paid me enough to counter that.
Stacey Simms 34:05
And you are no longer doing software for Wegmans. Which is is that correctly, first of all, which is a fantastic supermarket up in upstate New York and across really the lot of the Northeast that people are familiar with, and I used to shop there all the time when I lived in New York, but you're not there anymore. What are you doing?
John Costik 34:22
So I've moved over to the University of Rochester Medical Center. So I was looking for something in health care, because I knew, you know, that's kind of where my heart was at this point was really to help find similar needs throughout health care. So I didn't want to just do type 1 diabetes work. I really wanted to dig in and see see what else we could do. Across the wide spectrum of, of conditions and, and whatnot. So there was a position open. At the University of Rochester Medical Center, a new group called the Center for Clinical innovation. I came in and got talking with, with the leaders of the group, this surgeon, Dr. Dave Minton. And then Chris de Silva. Were the primary folks in the group. And we kind of hit it off. And I showed him what I built for Evan. And they said, Hey, I think you'd be a perfect fit for our group. And the rest is sort of history. So I left Wegmans at the beginning of June and have been here and working on software that's very patient centric. And
Stacey Simms 35:35
I'm not just for diabetes,
John Costik 35:37
no, not just for diabetes. So the main piece of software that our group has written, will go out to all the clinics, or potentially all the clinics, they'd have to opt in to all the clinics at the University of Rochester Medical Center. So the entire health system, which is a big system, so we've built a tool that can aid all the clinics in gathering and interpreting patient reported outcome data. So that's, that's been a big push. And then I do have some projects that I can't announce yet, for those that are diabetes related, because they obviously know that that's always going to be a passion. So if I can work with the endocrinology groups here, to sort of advanced them along in their technology and how they use it at the clinical level, and how we can ease the movement of patient data to them. And while keeping the patient data, very patient centric, and give them ownership of that data is is sort of sort of a goal there. But there will be some, I'll have some announcements at some point.
Stacey Simms 36:39
That's great. Well, congratulations. It sounds like the perfect job. And it's wonderful for the rest of us who are waiting to see what you're working on.
John Costik 36:46
Yeah, no, it's it's been great. And it's a it's a dream job. I can't complain.
Stacey Simms 36:51
It's nice when those things can happen. Well, I'm curious, does your daughter she's just a couple years older than Evan, right? Does she want the technology if she asked me for a cell phone and that sort of thing.
John Costik 37:01
She does have a cell phone and Pebble watch. But we don't make her run. You know, our watch face on it. But it's for an in basically and we told her it said this is you know, since you have to sit with your brother on the bus anyway, if there were ever an issue where his blood sugar started dropping quickly, we we gave her a tube of glucose tabs and, and a cell phone so we can we can get ahold of her on the phone. You text her and say, Hey, give your brother half a glucose tab, which we've only ever had to do maybe once or twice.
Stacey Simms 37:31
But she said she still likes him probably because I have an older sister younger brother situation here in my house. And when they were under 10 she was super helpful. And now she's a teenager. It's like nothing to do diabetes. It's just your stinky younger brother.
John Kostic 37:43
Yeah, yeah, I could. It seemed that coming.
Stacey Simms 37:47
Still help him she'd always help him. But
John Costik 37:49
I think they're both I mean, I'm biased and all but they're both very sweet and compassionate. How old?
John Costik37:54
Are they?
John Costik37:56
Nine and so yeah,
Stacey Simms 37:57
of course. Yes, of course. Then they always will bait
John Costik38:01
breaking breakfast time where they can just they're just nice. Okay, yeah.
Stacey Simms 38:08
It's all good stuff. It's all good stuff done caustic. Thank you so much for joining me. I spent a lot of time in upstate New York and central New York. So it's fun to talk to you from the Rochester area, right?
John Costik 38:18
Yeah, you weren't circulator.
Stacey Simms 38:20
I was in Syracuse, Utica. My husband is from Utica.
John Costik 38:23
Yeah, my dad went to cert Su and
Stacey Simms 38:25
excellent. Me too. That's great. Well, thank you so much for joining me and I can't wait to see what you're working on. Next. Please let me know. And we'll get the word out.
John Costik38:32
All right. Thank you very much.
John Costik38:39
You're listening to Diabetes Connections
John Costik38:41
with Stacey Simms.
Stacey Simms 38:44
Quick behind the scenes story about this episode from back in the day. I remember when my editor and I think it was I don't remember it was John Bukenas. Sorry, john, as you're editing this, I don't remember if it was john. Or if I was still working with somebody else at that time. I listened back I proof. Listen, I call it to every episode kind of like proofreading your work. And I got it back. And I was so excited because as you know, I'm so excited by the DIY stuff, even though I don't understand half of it. And I couldn't wait to listen to it till I got home and I was at Benny's baseball game. And it was such a great mom. I'm like, No, I have to listen to this. So I'm listening. I'm walking around near the baseball field, kind of watching the game kind of on my phone. And this was at the time when we did not have share. But he did certainly did not have a cell phone. And we used to hang the Dexcom receiver by a clip on the dugout on the wire mesh of the dugout. We just just hang it there and like casually walk by occasionally or just really rely on the alarms to go off. I love baseball for diabetes. For a slow game. Somebody pauses so many times to treat. I mean, the only thing that's problematic is sliding. And you can kind of figure that out by putting the Dexcom or putting your pump site in different places. But I will never forget right by Davidson Elementary School in the ballroom builds over there walking around and listen to playback of that original episode back in 2015.
Okay, well thank you to my editor john Bukenas from audio editing solutions. Thank you so much for listening. I'm Stacey Simms. I will see you back here next Tuesday for our very next episode. Until then, be kind to yourself.
Benny 40:23
Diabetes Connections is a production of Stacey Simms Media. All rights reserved. All wrongs avenged