Diabetes Connections with Stacey Simms Type 1 Diabetes

The T1D news show you've been waiting for! Long-time broadcaster, blogger and diabetes mom Stacey Simms interviews prominent advocates, authors and speakers. Stacey asks hard questions of healthcare companies and tech developers and brings on "everyday' people living with type 1. Great for parents of T1D kids, adults with type 1 and anyone who loves a person with diabetes.
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Diabetes Connections with Stacey Simms Type 1 Diabetes









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Jun 28, 2022

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.

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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Jun 14, 2022

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.

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!

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD*

*Click here to learn more about AFREZZA*

*Click here to learn more about DEXCOM*

Jun 7, 2022

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.

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!

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD*

*Click here to learn more about AFREZZA*

*Click here to learn more about DEXCOM*

May 10, 2022

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.

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!

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about AFREZZA*

*Click here to learn more about OMNIPOD*

*Click here to learn more about DEXCOM*

Apr 26, 2022

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.

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!

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about AFREZZA*

*Click here to learn more about OMNIPOD*

*Click here to learn more about DEXCOM*

Mar 22, 2022

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.

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!

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD*

*Click here to learn more about DEXCOM*

Mar 1, 2022

In February, the FDA approved the Eversense E3 for 180 day wear. That means you could have a CGM working – with no sensor changes needed – for up to six months. That’s been available in Europe for a while, but in the US it’s been a maximum of three months. As you’ll hear, the people at Eversense have even bigger goals.

This week, you'll hear from Senseonics Chief Medical Officer, Dr. Fran Kaufman. We get the basic info about the device, the plan for working with pump companies, a look ahead and much more. Imagine one year without a sensor change!

Dr. Kaufman is also a practicing endocrinologist and she’s been seeing patients for more than 40 years. She has a passion for this community and a lot to say about what truly helps patients thrive with diabetes.

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

Check out Stacey's book: The World's Worst Diabetes Mom!

Join the Diabetes Connections Facebook Group!

Sign up for our newsletter here


Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners!

Episode Transcription Below (or coming soon!)

Please visit our Sponsors & Partners - they help make the show possible!

*Click here to learn more about OMNIPOD*

*Click here to learn more about DEXCOM*

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 Wherever you are listening, there should be extensive show notes. If not, you can always go back to diabetes 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 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 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

Feb 15, 2022

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 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

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 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


Feb 1, 2022

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.

Omnipod 5 FAQs from Insulet 

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 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 backslash veterans. But if you don't want to write that down again, it'll be in our show notes at diabetes 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 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 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, 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 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 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

Jan 25, 2022

Take a deep dive into the future of Tandem Diabetes. In December, the company laid out an ambitious 5-year plan to update software, move to a smaller pump and ultimately a tubeless version. Company leaders say they want to think even bigger and we're talking to Chief Strategy Officer Elizabeth Gasser. We’ll go through the short term changes Tandem has in the pipeline like the tiny Mobi pump and talk about philosophy and more.

Tandem R&D Presentation (slides) 

Tandem R&D Presentation (replay) 

This podcast is not intended as medical advice. If you have those kinds of questions, please contact your health care provider.

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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 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

  1. I figured you would like the the world is obviously a very unpredictable place these days, not least when it comes to projecting FDA timelines. That said, we still feel very confident and we're planning on an early 2022 approval. So I can't say much more than watch this space. But we're still leaning into the timelines. We talked about it R&D Day and looking at getting this much requested feature to our user base as soon as we can.


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 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, 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, 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



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