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Scott Benner 0:00
Hello friends, and welcome to episode 620 of the Juicebox Podcast.

It isn't often that I bring you a podcast episode that was recorded on the same day that you're hearing it. But today is a special special event. It is Friday, January 28. And this morning at 6am insolate, makers of the Omni pod dash announced that their automated insulin delivery system Omni pod five has received clearance from the FDA. If you're like me, you've been waiting for Omni pod five for quite some time. And this is a very, very happy day for you. I can't wait for my daughter to try it. And I know you might feel the same. So I thought you might want to hear directly from JC Petrovac, President and CEO of insolate. Joining JC and I today is Dr. Trang Lai, Senior Vice President and medical director at insolate. We're going to talk all about on the pod five get as many of the listener questions that I compiled in in this hour as we can I lose AAC after an hour, but trying hangs on for another 25 minutes to talk about insulin pumping with the Omnipod five. Please remember while you're listening that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise. I want you to be able to listen straight through so no ads today, but please do remember to support the advertisers of the Juicebox Podcast. If you're interested in getting a Dexcom use my link. If you want a great blood glucose meter, check out the Contour Next One at my link. If you want to get an omni pod, please use my link. If you're going to take the T one D exchange survey and please do it's super simple to do and it supports the podcast. Use my link Are you looking for glucagon try the G vo hype open at my link. And don't forget about touched by type one my favorite diabetes organization dexcom.com forward slash juice box on the pod.com forward slash juice box contour next one.com forward slash juice box Chivo glucagon.com forward slash juice box T one D exchange.org. Forward slash juice box and touched by type one.org. There are links in the show notes of your podcast player and links at juicebox podcast.com. To these and all of the sponsors. When you use the links you're supporting the show. Last thing before we get started with chasing and trying if you're looking for a great community online, my Facebook group Juicebox Podcast type one diabetes is a private group with over 20,000 members just like you it's a great place to chat, learn or just watch what people do Juicebox Podcast type one diabetes. At the end of the episode I'm going to give you a link special for Juicebox Podcast listeners where you can go learn more about the Omni pod five. This episode is the only place where you'll be able to get this link today. If this is your first episode of the Juicebox Podcast and you're enjoying it, there's so much more that you might love. Subscribe now in the audio app that you're listening in. And if you're listening online, get yourself an audio app and find the Juicebox Podcast Subscribe and follow today for more great content like this.

Shacey Petrovic 3:24
Scott, great to be with you. I'm JC Petrovac, the President and CEO of insolate.

Dr. Trang Ly 3:28
Hi, Scott. I'm trying Lai as senior vice president medical director at insolate.

Scott Benner 3:35
The person to me that wants to make the most of the hour wants to just jump in and start asking questions. But I think it would be wrong just not to ask you like what this feels like. Because I know the process has been long. And it was made more difficult by COVID. And I just wonder how you're feeling this morning.

Shacey Petrovic 3:51
I could not be more excited. And I know I can speak on behalf of trainers. She is also incredibly excited. You know, excited. This has been you know, the better part of a decade in the making and 1000s of people have been involved across the company across the diabetes community. And you know, many, many technical challenges hurdles it just was it was not a straight road. And so to tackle all of those challenges, be here really pushing the field forward with an incredibly novel technology that brings a lot of firsts to market and that we know has the potential to dramatically improve the lives of people living with type one diabetes. I mean it is for me, it's it is it is very much the proudest moment in my career. And so I'm really really thrilled.

Scott Benner 4:42
That's amazing. It really is trying do you have any feelings on the process?

Dr. Trang Ly 4:48
Yeah, I'm super excited and it's been a long time in the making, but I cannot wait to get this product out to patients.

Scott Benner 4:56
Excellent. Well, I can't either I'm gonna say from you know, the But I don't know if there are many people that speak to as many people with diabetes as I do. And I just think that what it's going to accomplish for just the general public of people who use insulin in general, it's going to be, it's going to be, I mean, life changing, seems trite to say, but I do think that's right, I watched an algorithm work in my house, I can't wait to try this one. And I know what it's going to do for people who struggle and who feel more of a, I mean, not just the health impact, I guess, but a psychological impact of having diabetes that sort of all over the place all the time and not having to think about that my daughter is getting ready to leave for college, you know, and so are a lot of other people's sons and daughters. So it's a really exciting time. All right, so I guess, I'll give you my understanding, you'll make sure I have it right. You know, there are, you know, algorithms you have won. And I want to know how it works. So I, I just I want to know, nuts and bolts how it goes. So I'm looking for just maybe a high level overview of what the system does, and then we can pick through it a little more.

Shacey Petrovic 6:08
Sure. Yeah. Well, I mean, I think, you know, we probably don't need to start at the high level, you and your, your listeners know better than anybody, just how hard diabetes is and how much work it takes to manage. So Omnipod five, and the smart adjust technology, which is the algorithm are really designed to be an incredibly easy to use system that reduces the amount of work that a person has to put in to manage their diabetes. The system itself is, consists of the same kind of small, wearable, waterproof pod, but there's been a lot of really exciting technology packed into that pod. And one of the big technical challenges of the program actually was getting the smart adjust technology onto the pod. You know, it's it's a very sophisticated algorithm, lots of processing power, and the team worked very hard to get that technology onto the pod. So that smarter just technology automatically, the pod connects automatically, with the Dexcom G SIX sensor, it takes a reading every five minutes, and it adjusts insulin every five minutes. The algorithm predicts where your blood glucose is going to be an hour from now, and then adjusts insulin in five minute increments to prevent against highs and lows both during the day and overnight. So you know, one of maybe try and can speak a bit to the uniqueness of the algorithm relative to others that you may have had experience with Scott. But what I can say as the clinical data was extraordinary, and demonstrates really improved glycemic control, improved time and range, lower agency and minimal hypoglycemia. So kind of the trifecta of the clinical results we're looking for for people with diabetes. Well,

Scott Benner 7:57
that must be true, because no fewer than three people in my Facebook group said I'm in this trial, they better not take it from me now that it came to market. So people seem excited and happy with it, for sure. You have a trend? What are your thoughts on on how it works?

Dr. Trang Ly 8:13
Yeah, I think she covered it. At a high level, I think, you know, very similar to what we expect from AIG systems. Now, the algorithm adjusts insulin dynamically every five minutes so that people don't have to make these decisions. And, you know, Scott, just how much better glucose control you get when you're adjusting and had that feedback loop from the CGM. So I think, you know, one of the unique features of our system is the customizable glucose targets that you can set at different times of day. And that really allows flexibility for people who might want to run a little higher at certain times, like maybe when you're going for a sleepover or night, or you know, you might be new to AD and be hyperglycemia unaware, and you might want to run out a higher setpoint. So that it does give that optionality. And yeah, it's a great algorithm, our clinical data proof site,

Scott Benner 9:12
well, I already pitched my marketing idea to you, I think you should give away a coupon for a new mattress and pillow because people are gonna finally get to sleep and they're gonna want to become they don't even know their beds are uncomfortable. They're gonna find out pretty soon.

Shacey Petrovic 9:25
Scott, by the way, we heard that time and time again, from clinical trial participants, you know, not just from people on the system, but from their families, their parents, and so I remember what six years ago when you and I first spoke, you said that that was the most important gift that we could give to you, you know, in terms of your health and your reduction of stress is just a night's sleep. So we're really excited to bring that to people with diabetes.

Scott Benner 9:53
I feel like I I have to tell you the I've sort of been on the inside of this for a little while. I don't know how you guys Take the stress of all this. I'm nervous right now, I have no stake in this whatsoever. And I'm feel like I can't believe this happen. Alright, so So okay, so somebody's going to get on the pod five, right? And they're going to get a selection of pods that will last them a certain amount of time, I'm assuming you're going to offer them a PDM as well. Right? Yes. Okay. Yes. Is that going to look like the dash PDM.

Shacey Petrovic 10:27
I'll let try and talk a little bit about the handheld controller. But every, every new user will receive a handheld controller, along with the system, we're really excited to offer Omni pod five through the pharmacy. And what that enables us to do similar to what we do with Omnipod dash today is allow people to use the system without a long term commitment. And without an upfront cost, like we see with other systems. And so we will provide this handheld controller free of charge. And, and you know, today actually, in the pharmacy Omnipod dash users can try the system for free for 30 days. And this promise that we have and offering the technology through the pharmacy means that people can upgrade without an upgrade fee, or without waiting out there, lock in periods. So that's the benefit of, of kind of getting on dash in the pharmacy. And that's our commitment, you know, in terms of the technology that we bring to the community is that we want to do that in the most cost effective way. Without and in the most consumer friendly way, you know, without making people wait out their contracts or pay large upfront costs.

Scott Benner 11:41
Let me kind of go a little farther on that then. So my two questions are, will they will it not be covered as a durable medical product?

Shacey Petrovic 11:50
It's right, it will be offered through the pharmacy. So not through DME the vast majority actually of our users today with Omni pod dash are going through the pharmacy. And the reason we like that channel is because it is a very predictable low out of pocket costs for our users. And it enables us to offer Omni pod dash today and Omni pod five shortly without that upfront cost and that long term lock in period that people experience in the Durable Medical Equipment channel.

Scott Benner 12:20
No, I'm hearing it. And I'm excited to say that you're also going to be able to run on the pod five from an Android phone. Is that right?

Shacey Petrovic 12:28
That's right. That's right. Yeah, we will launch with compatibility with a number of Android phones. And which means that they that you and your users will be able to download a secure app on their Android phone and can control the system without biocompatible phone without the need for the handheld device. But the experience with the handheld device is fantastic too. And I think maybe trying you can talk to some of that experience with the the handheld controller. Please,

Dr. Trang Ly 13:00
yeah, happy to. So Scott, you asked whether it was similar to dash, the user interface, and it it is it is built on the Omnipod dash platform. And so for our users who are familiar with Dash already, it's a very smooth and easy transition to Omnipod. Five. And in fact, if if you're already on Omnipod dash and A Dexcom G six, you can go through our onboarding, self service onboarding platform to be able to get yourself on to Omnipod. Five. So you know, we are really trying to innovate not just in the product, but the way we serve and train and assist our users in getting on to the technology. So the that was important to us that the user interface was not too different from Darshan. It's a very, very similar setup.

Scott Benner 13:53
Well, there. I have questions from from the audience. Well, I see the Dexcom information right. On the on the on the on the pipe screen.

Shacey Petrovic 14:03
Okay. Yes, you will. Front and center, actually. Excellent.

Scott Benner 14:08
Well, here's, here's a down deep question from somebody, will multiple profiles be available?

Dr. Trang Ly 14:15
And in terms of multiple Basal profiles, yeah. Is that what they mean? Are they

Scott Benner 14:20
Yes, yeah. Okay. So you'll be able to as by way of an example, my daughter can have a profile for different times of the month as an example. Yes, I just found myself being demure for reasons I don't understand. That's not usually how I am. Do different insulins yield different results? Because or does the algorithm adjust to it?

Dr. Trang Ly 14:47
Yeah, the Omnipod. Five was tested using humor log Novolog and admelog insolence and that's what they're cleared for. So we do not test them with other insolence. And so that's the indication. Gotcha.

Scott Benner 15:03
Okay. When I set the, I get the device and I'm super excited and I set it up, What settings do I have access to? Like, what do I have to tell it carb ratios, my Basal rate and, and then what happens from there.

Dr. Trang Ly 15:17
So the, when you set up dash, the exact same setups that you require settings that you would enter into dash, you would require those to be entered into Omnipod five. So that would include all the Basal settings, the insulin to carb ratio, as you mentioned, correction factor, the the key difference is the target glucose. So in Bolus calculators, you generally set up a target glucose so that the user can the Bolus calculator can help assist you in determining how much insulin your system is going to calculate for you for a Bolus. But what our system does is it also uses that information to drive the algorithm. So whatever customized target you choose, say you're choosing one 110, you know, all the time, 24 hours, then the algorithm is always going to be driving towards that target.

Scott Benner 16:15
Let me ask you this, if I tell it my Basal rates one unit an hour, and it realizes it's more like 110 or 1.1? Will it make that adjustment on its own in the way the algorithm works?

Dr. Trang Ly 16:26
That's right, that's what the system will do?

Scott Benner 16:29
Will it tell me that? Well, let's say, hey, chucklehead, I know you think your your Basal is one, but it's 1.1? Is there a little pop up? Or how do I know that that's happening?

Dr. Trang Ly 16:37
No. So it actually just takes care of it for you, you know, one of the philosophically what one of our really, you know, in Yeah, design principles and with Omni pod is really to simplify the experience for our users. And that means not telling you every single time we adjust insulin, if it's unnecessary, so we really want people to live their lives and, you know, not worry about their Basal rates. And we do ask them to Bolus for their meals. So it is a hybrid closed loop system where they are expected to interact with their device for boluses. But in between times, really, they just wearing their pod and their CGM. And the system takes care of them.

Scott Benner 17:29
How do I handle the transition that and if I put it on a prepubescent child, and suddenly they hit puberty, and their Basal rates go from point five to 1.2? Like I don't want the algorithm just keep doing do I want the algorithm to just keep doing it? Or do I have to go back in there and make a change ever?

Dr. Trang Ly 17:46
Yeah, it's a very important question for ARD systems. So we have an activity. And what that does is it adjust to the person's actual insulin use over time. And so if you do that, too quickly, you can, if you add activities too quick, you could deliver too much insulin, say you run into a couple of days where you have in, you know, infusion issues, or you know, your pod falls off, and you're actually delivering a lot of insulin, but, you know, it may it may not be your body may not be as sensitive, and then a couple of days later, you need less insulin, you don't want to a system that is adapting too quickly. And so we think our activity is just right, because, you know, it's worked really well in our clinical trials, and it will adapt over time for a growing child, you know, a teenager going through puberty, all of that. So, you know, that's why you test these systems over a long period of time, to see how well it works. And, and, you know, what, it's important to me when I look at all the different systems is not just how they work in the beginning, but how how they work over a period of time. And, you know, we've got Todman data now to show that the systems have really durable clinical benefit.

Scott Benner 19:03
Can I leave the algorithm and use the pod like a regular insulin pump? If i Yes,

Dr. Trang Ly 19:09
yes, yeah, it will, you can use it in in a very similar fashion to Omnipod dash. So if you didn't have a CGM, it will function just like dash and then with CGM, you will have the ability to switch into automated mode. Okay.

Shacey Petrovic 19:28
And train highlights a really important point, you know, we designed the system with sort of the rallying cry of simplicity. So, you know, toggling in and out of closed loop and open loop, it's just the touch of a button, you know, and we did try to provide just the information that people really want and not the information that most people really just don't need on a very regular basis. I think when we think about these systems and the ability to bring the the, you know, improved outcomes that Omnipod five can can really deliver for people with diabetes, you know, one of the hurdles to more people adopting Omni pod. And AAD has been the complexity and the cost. And so you know, when we set out on this mission, when he said, We've got to solve for the access issues, and we believe pharmacy offers a much better, much easier, much more kind of cost effective opportunity for the customer. And then we've got to make the system as simple to use as possible for multiple daily injection users, for kids for, you know, older people for the masses, essentially. And I think the team has done just a remarkable job taking what is incredibly sophisticated, you know, technology, elegant technology, but making it really, really simple for users.

Scott Benner 20:50
So I think it's important as well, one of the biggest issues that I've seen with other looping systems so far is that the, the, the things you need to know to use them sometimes are a barrier to using them. So it's not easy to just, you know, you start turning the wrong dial the wrong way. And and suddenly, things are upside down. So I think that's absolutely fantastic. I have a couple other questions. And then I'm gonna jump onto another. Another topic, minimum fill is 85 units. That's right,

Shacey Petrovic 21:19
same pod, just a lot more technology. And

Scott Benner 21:23
are there modes? Like, is there a deep sleep mode exercise mode? Or is it just how does that work?

Dr. Trang Ly 21:30
Yeah, so it has an activity feature. And during when you activate this feature, what happens is their target glucose goes to 150. And also our algorithm delivers less insulin as well. So that's our feature for reduced algorithm, insulin delivery,

Scott Benner 21:51
is there an increase? Setting, there isn't like a Thanksgiving setting or something like that.

Shacey Petrovic 21:59
You can target a higher setpoint for Thanksgiving, which is a great idea.

Scott Benner 22:04
So sort of bare bones like simple works, does it learn? Yes. Okay. It absolutely does. Yes. And but it learns over, like a short shelf life, like my like, point is that if I start wearing Omnipod, I keep saying I don't have diabetes, if someone starts if someone starts wearing Omnipod, five, let's say three months from now. And you know, they wear it for five years, is it like a supercomputer five years from now? Or is it just sort of like learning in the, in the now like, it learns from the past pod and applies what it knows from the past pod to the current pod? Yeah,

Dr. Trang Ly 22:39
it learns from the last several pods, in fact, Scott, and it updates accordingly, depending on how much the device is actually delivered insulin, rather than based off of Basal rate settings. So you know, what was important for us was, we don't want you or your daughter wouldn't be constantly having to tweak the algorithm in order to get optimal glucose control, it was important that we reduce the burden for people and families by growing with the user and augmenting that insulin delivery over time based on the information that we have. And so there is an activity. And probably the most dark example of that was actually, during one of our studies, which involved actually adults with type two, where we saw very quite large increase. So you know, these were people who had sub optimal glucose control when they came in, and the doctor put them on, you know, roughly 30 units a day, actually, it was 27 units, in fact, and then, over a couple of weeks, we actually, you know, the system because of persistent hyperglycemia, ramped that up to about 60 units over time. So it does have that ability to detect that persistent hyperglycemia react to that, and then kind of reset that baseline of required insulin delivery.

Scott Benner 24:11
It's interesting that you use that as an example because the other day in my group, a gentleman with type two, told me that he had found the podcast got himself an omni pod. Since then, his a one C is incredibly lower his time and range is crazy. He's lost, like 70 pounds, you know, and I didn't even make the podcast for people with type two diabetes when I wasn't till years later when I thought, I think this is as valuable for anyone using insulin. So I can't wait for it to help. Like there's such a such JC tell me for a second about seeing all the benefit in front of view. And, I mean, I know you're your next leap. I have the same leap to I have a completely different business than you but I have this thing. I know it's valuable. And how do I tell you about it? How do I get you to listen do an episode right? Like, is that nerve racking? Are you excited about that, because this is,

Shacey Petrovic 25:05
I am really, really excited, you know, there's there, we know that there is tremendous enthusiasm in the marketplace for this technology. We've already had, you know, 1000s of clinicians participate in webinars and sign up for education around it, I get outreach multiple times a day from people in the community that want access to the technology. So we're in a strong kind of strong foundation right now from which to really build awareness around the benefits of the technology. And our job now is to, you know, move into limited market release. And that will enable us to ensure that we test all of our systems, our processes, our trainings, to prepare for what we know is going to be tremendous demand for the technology. And once we've done that, we will really start to ramp up awareness and education in the community around Omnipod. Five and its benefits, you know, but you know, I stand here on the cusp of all of that, and I, I just am looking to the next several years, and we've got, we've probably got a decade in front of us, of improving outcomes for people with diabetes, first, for people living with type one diabetes, which is what this system will be indicated for ages six to 70, we will follow on that with what we call our preschool indication, down to age two. So we will be expanding our benefit for people living with type one down to really young, young people. And then we will, you know, we have work underway evaluating the algorithm in the type to user. So to your point, we're going to follow with multiple phone platforms, multiple centers, more and more patients who can benefit from this technology. So we're at the cusp of years of impact, but this this moment, we're we're about to bring this technology to, you know, the vast majority of people living with type one diabetes. You know, like I said, it's the better part of a decade in the making. And it's our job now to take the incredible technical and clinical work that training and our technology teams did, and, and help educate people on how this can change their lives. And, you know, forever, we've been changing lives really by, you know, improving the user experience, and to now take that and be able to add the incredible improved outcomes that we saw with Omnipod. Five, it's just, you know, it is very, very exciting. There's some anxiety because we know that demand, I'll tell you what the anxiety is there, because we know demand is there. And because we have moved to a business model where we don't have any constraints, you know, we're not making our customers wait four years for the next technology. And we're not charging upgrade fees. So technically, anybody who wants this technology can get it as soon as they have access to it. And that's the anxiety inducing thing. Are we prepared for that? But I know we're prepared for

Scott Benner 28:00
that. If you went one more word of that sentence, I would have launched into my Omni pod promise that that I know by heart. How long do you expect the LMR to be?

Shacey Petrovic 28:11
Well, we, we haven't really defined it because we do have to take the latitude to learn, you know, the whole purpose of a limited market release, which is not an FDA requirement. It's just a best practice in industry. But the whole purpose of this is to ensure that we are ready for larger demand. So for example, trying reference that the the easiest and fastest way to get on to Omnipod. Five is to be an Omnipod dash user with a Dexcom six user Dexcom six experience, because what that means is you will be able to essentially train via online tools and not have to meet with any sort of clinician or support. So that's one training pathway. But we know that plenty of people who today use multiple daily injections will be interested in the technology. We know that Omnipod users without Dexcom, GS six experience will be interested. And we know that people using traditional tube pump therapies will be interested. Each of those are different training pathways, and we have to test those and make sure that everything is in order.

Scott Benner 29:13
So I'm gonna ask an incredibly unfair and difficult question because you're literally this is the morning I don't know if people realize this or not. But you guys announced this like three and a half hours ago. And we're

Shacey Petrovic 29:23
Yes, you have impeccable timing set.

Scott Benner 29:26
I said, I said to somebody this morning, I was like, how did we randomly pick Friday and it worked out like oh my god for like a week, we kept saying like, are we gonna have to record this and it didn't happen, and we pretend it happened, and I'll put it out later. That'll seem weird. So this is an incredibly it's an unfair question, but it's a technology question that happens all the time. I'm not asking you what's next. But I'm hearing questions in my own head as you're talking. And I'm hoping that you're doing that stuff behind the scenes, for instance, integrating with G seven and like, my heart is like, I hope there are people in a room working on that. Lowering the target glucose, like, in my heart, I hope that you're like going to take a big deep breath, go on vacation and then be like, alright, FDA, we're doing it again. You know, like, I don't know, but but I think people will, you know, you're making a great point, like, I want to preface it by saying, if you're on MDI, right now, if you're using a pump that doesn't do this, no brainer, right? Like, it's an absolutely a no brainer. But I sit here in front of you, my daughter has a one, C has been between five, two and six, two for eight years. And we know how to do that, like so. But we do that with the do it yourself, algorithm. And before that, we did it manually. I can do it with an algorithm, I can do it without an algorithm, but my daughter's leaving for college and in my heart, here's what I think I look at the two of you. And here's what I see. I see the ladies that brought me algorithm on the pump, no link between a controller and a phone, and the pump. And my daughter doesn't have to be an app developer to use her, because I'm pretty sure if I sent my daughter to school with a laptop, and I was like, Okay, now listen, if something goes wrong with the loop, here's what we're gonna do. Because she'll be like, I'm not doing that then I was like, okay, so I love I love the system idea. Like, I cannot literally wait to get it like I would drive to Boston right now, if you told me I can have a box of it, you know what I mean? But and I think for the vast majority of people, that's exactly what it's going to be. But what do you do? If you're a five a one C, but you want the automation? Like, is there a way to live with that time?

Dr. Trang Ly 31:42
Yeah, I, you know, I think I hope that your family tries this, and really see the benefits of not having to worry about all the technical things of putting it together and, and give you the peace of mind that you've been after all this time. I, you know, in our clinical trial results for our adults and adolescents, down to age 14, a third of our patients had a time in range greater than 80%, which is really just quite remarkable. And for our kids, so the six to 14 group actually are two to six year olds as well. The mean, a one C was 6.9%. And but you know, what that means is that half the patients had an A one C with a six in front of it, which is just mind blowing, compared to, you know, where, where we are today in clinical practice? And so, yes, I definitely think that you know, that all the things that is driving good control with your daughter, it's likely, you know, to be attributed to things like diet, and exercise as well, not just the automated insulin delivery. And I think that she'll get really great results on our system.

Scott Benner 33:07
To be fair, and I want to be fair, part of the way we accomplish that is that we, with some frequency, leave the automated system and make adjustments to kind of stay ahead of things. So that's why I asked about that earlier. Look, seriously, I can't wait, I'm super excited.

Shacey Petrovic 33:23
And I think what we want for, you know, somebody like you and Arden is to be able to get that outcome with a lot less work. You know, I mean, that's, that is one of the major benefits of Omnipod. Five is just the reduction of burden all those hundreds of decisions and, you know, the constant interaction, that we can take some of that away from you so that you can get great outcomes without having to put in so much work.

Scott Benner 33:49
I can't wait, I'm genuinely. So G seven is probably going to, it's probably gonna pop fairly soon. And so I'm assuming you're working on that. Do you have thoughts about that, that you could share with people? Or no,

Shacey Petrovic 34:03
yes. So as I mentioned, you know, this is the start of what I think is going to be a really exciting several years of innovation. So we have shared publicly that we've got great partnerships, we have a wonderful partnership with Dexcom. They have an incredibly exciting pipeline. And we are hard at work integrating with their future technologies like g7. The same thing is true for Abbott, another great partner of ours, we're hard at work integrating with their sensor pipelines. And then of course, we've also mentioned publicly that we are hard at work integrating with future phone platforms like iOS. So all of that is underway. And the last thing I would say is we are hard at work also to bring this technology to people across the world. So we're starting with, you know, launch here in the United States. This clearance is a great milestone as we think about bringing the technology to other parts of the world, because it just is the final step in the clinical and regulatory hurdle and then we can start the work actually The work is already underway to really bring this technology to other markets outside the US.

Scott Benner 35:04
I've already gotten a message this morning from a person in Canada, a person in Sweden and a person in Australia. Please ask about us. So anyway, there it wasn't, you didn't have to ask also, you did me, I'm just gonna take my little whiteboard and erase where I wrote iPhone, question mark. Is there any kind of timeframe for iPhone that you have in mind, we have not

Shacey Petrovic 35:29
shared that publicly, what we have shared is the work has been underway for quite some time. So we our goal is to follow as quickly as we can. But you know, one thing we do is prioritize the user experience, which means we have to build a native app in both operating systems to ensure that we deliver the best possible user experience. So it is and the systems do work differently. You know, the operating systems work differently. So it is not a small technical undertaking. But that works been underway. We've got a very talented group of software developers and others working on that and and certainly understand that, you know, our customers want it and we're going to get it to them as quickly as we can.

Scott Benner 36:09
Excellent. A question about the sensors trying on day one, or with a failing sensor? How does the algorithm handle spotty information? Or how does the user handle it?

Dr. Trang Ly 36:21
Yeah, so I think the, the, the sensor issues that we used to see have definitely vastly improved. And I just really love the GC sensor every time I see the data coming in. And actually, you know, those sensor failures are definitely infrequent compared to what they used to be. So our algorithm has all the safety mitigations built in for loss of CGM signal. So it will actually use the prediction to deliver insulin for a certain period of time. But it actually depends on what the previous prediction is. So say, You were crushing low and you were predicted to be you know, 60 or less, and you were low, then the algorithm would actually suspend. And even if you didn't have the CGM come in, it would actually stay suspended for an hour. So there are a number of safety mitigations in place. And then when the CGM value comes back, it will actually just revert back and not like make you do stuff to put yourself back into automated mode. So you know that the whole user experience is really important to us. And, and you know, we're very lucky to be working with GSX, which is a really great sensor.

Scott Benner 37:36
That's well thought out. That's that's an excellent virtue of it for sure. Line of sight. So my, my satellite needs to see the Earth or my cell phone doesn't work, right. Does the CGM and the pod need to be in line of sight of each other? Or how does that

Dr. Trang Ly 37:51
work? Yeah, yeah, it does have to be within line of sight. And you know, I'm really proud of our engineering team. Scott, you know, when we first started the clinical study, I was a little bit nervous, I have to tell you about the connection between CGM and pod, because as you know, and can appreciate, it's all about how well those two devices talk to one another as to how good your glucose control is going to be. But you know, we have a fantastic antenna in our pod, the connection is remarkably good. Between the two in children and adults who were you know, CGM, obviously, for the 10 days, and then the pod button change every three days. So even with all of that, you know, every day use we have overall connectivity is

Scott Benner 38:42
excellent. Do you happen to see difference with people's body masses? Is there a change there?

Dr. Trang Ly 38:47
Yeah, there is. So it, so Bluetooth doesn't work well through body. But I have to say that because of the changes we've made to the antenna, the connectivity is excellent. It is one of the reasons why we have such good clinical trial results. Actually.

Scott Benner 39:08
Tracy, can I ask you what you've taken away from this process? I mean, about between making a product and the FDA like or do you have a notebook on the side of your desk that you're gonna that you were like, remember this next time? Or, I mean, honestly, Blizzard? Uh, I can't imagine it wasn't a learning experience. But like, was it valuable?

Shacey Petrovic 39:30
Yeah, it was incredibly valuable and incredibly valuable learning experience, I would say. I mean, I would never speak for the FDA, but I would guess it's a learning experience on both sides. Because this you know, we were designated as a breakthrough technology. This is brand new innovation that has never been delivered before. So phone control. This is the first time ever that somebody will be able to control their insulin delivery system, their Omni pod with a mobile a smartphone. You know, just the technology of getting the algorithm onto the pod, which, by the way, you know, when we started this venture seven years ago, the technology didn't exist yet, you know, the in train will tell you and the early clinical trials, people were walking around with backpacks of, you know, tablets, etc, it was a different system, but we knew the technology was in the pipeline of, you know, Chip companies, etc. And so we knew it was coming. And we had to take a bit of a leap of faith. And so, you know, it is really incredible to see the FDA lean in create pathways like breakthrough technology, like interoperability to help us bring new groundbreaking innovation to people living with diabetes. And for us, you know, incredibly learning experience, because nobody had done it before. We were taking advantage of new pathways, we were kind of working through what that needed to look like the FDA was extremely helpful in sharing their perspective on what needed to be in place, you know, clinically, and in terms of technical documentation and testing, to be able to feel confident that we could deliver this technology to the community. And so that's all, you know, that's plowing incredible amount of new ground. Yeah. And now, now we know what it takes. And so that's, that's a really exciting place to be in. You know, we've got certainly the battle scars to prove it in terms of the development process, the clinical process, but, you know, this has been building new muscles for our company. And frankly, you know, just bringing brand new technology that many people said, you know, even just a few years ago, couldn't be done to the community.

Scott Benner 41:43
Let me tell people listening, why that's more exciting than they think. So when you get a breakthrough designation, what that means is, the FDA does not see enough similarities between your product and any existing product. Because if they did, you could have piggybacked off of another company's filing look at me showing off what I know about the FDA. Hold on a second.

Shacey Petrovic 42:02
I think this is your wife, right? She's the regulatory affairs professional

Scott Benner 42:05
whispers in my ear. So I don't know anything. I just know how to make this podcast, honestly, and take out the garbage beyond that I'm kind of useless. So so. So here's why that seems exciting to me. It's because what you're telling me is you are bringing something to the world that does not exist yet. That's right. Yeah. If it did exist, and you were just putting it on the pod, we would have been using this thing. A year and a half ago, probably.

Shacey Petrovic 42:30
Right. Yeah, that's, that's right. This is brand new technology. And I think, you know, trying, obviously interacted with the FDA on a highly frequent basis. So she probably has additional insight to offer. But you know, what, what's exciting for me is that we are moving the field forward, you know, we we've known for years that people want to be able to control their Omni pod with their smartphone. And now we're finally here, having worked through all of the technical and regulatory hurdles to be able to bring that to people along with, you know, the algorithm and automated insulin delivery with Omni pod five. But this is no small feat. Nobody's done it before. We're the first and we're thrilled to be able to bring this to the community.

Scott Benner 43:12
I have more questions, but I'm going to ask trying a question in front of Chasey. Who's Chase, he's going to have to leave first. So I want Chang to be comfortable or trying to be comfortable whether or not she can answer this or not. Are we anywhere near the ceiling of what this algorithm is going to do?

Dr. Trang Ly 43:28
And there's no ceiling. Okay. I think, you know, I, I think you'll be pleased when you try it? Yeah,

Scott Benner 43:40
but am I going to wake up here, I'll tell you the fastest story. My daughter is 17. She'll be 18. This summer. We put her on an insulin pump when she was four, because we didn't want to send her to school using shots because I was like, What am I gonna let somebody I don't know, stick my kid with a pin every day. I was like, that doesn't sound right. So we went to our local children's hospital, they had an insulin pump there. And trying you'll love this story. There was a table in the middle of a conference room and it had all of the insulin pumps that were available. They were set out, like like I was buying jewelry, okay, there was everything but lights shining on them. Now, keeping in mind, this was 2007 or eight. And I'm walking around the room, I don't see anything that I particularly am excited about. In the far back corner of this conference from this like little cutout wedge, there's a little fold up table, and there's something on it. And I walk over to see what it is. And it looks like someone had an omni pod in their hand, got about 10 feet from the table decided they didn't want to walk any further pitched it into the wall and it landed on the table. Okay. So I pick it up and I take it over to the nurse practitioner and I go, Hey, what is this? And they're like, Oh, you don't want that. It doesn't have tubes. It won't work on your daughter. She's too thin. They said everything in the world to me about why I wouldn't want this thing. I took it over to my wife and I said this is a this is a contained device. And my wife's like, who cares? I'm like big cuz every time they change it, I started saying like, what are they going to do make 75 versions of this thing I was like, every time they upgraded, like, we're gonna move up with it. I was like, this looks mobile to me. I didn't know anything about you guys. I didn't know if even what I was saying was right or wrong. And that turned out to be true. Basically, I just like being right when I say something to my wife, but it's a long time payoff for me. But But overall, I think that's like, that's where my question comes from, like, in my mind, I'm like, three years from now? Like, am I going to be able to turn the targeted 85? Like, is it gonna get smaller when the technology keeps growing, like what can happen here, and I just, I want you all to stay. I want you all to say super excited about it. Like, I feel like I'm your cheerleader unnecessarily. But for everybody else, like don't stop, like seriously little vacation, I except maybe a week on a beach. Okay. And then we're right back in Boston to freeze our butts off and work on Omnipod. Six,

Shacey Petrovic 45:55
no one's taking a vacation, Scott, and we could not be more excited. And I think, you know, Trang Trang. And her team and many others in the company are already you know, they've already distilled the data from our pivotal distill the data from our type two feasibility studies, and they're already hard at work at our next generation algorithms. This is you know, our mission is to improve the lives of people with diabetes. So we don't stop that. And you know, bringing innovation to market is how we do that. And so we could not be more excited. This is a huge milestone for us. But you know, we expect many more milestones as we look forward.

Scott Benner 46:31
Okay. I'm going to ask a question, it's going to lead into another question JC for you. What's going to happen to the arrows pod? Are you going to keep making it? Or I mean, now we have dash we have on the pod five and we for people don't know we have the arrows, which isn't the original pod. It's the OG pod smaller.

Shacey Petrovic 46:49
Yeah, I like to call it the classic Omni pod.

Scott Benner 46:51
I think that's what we should go. So are you going to so here's my I interviewed chuck a few months ago, I don't know if you heard it. I did. I love Chuck. The minute I met chuck in person, I sent a text to somebody, I was like, I need to interview this guy is fantastic. But I tried to get out of Chuck, how much on the pod five product was piled up in Boston, and he wouldn't tell me. But I imagine you've only got so much space and so many resources, and you can't make an unlimited number of devices. Right. So you have a plan for that.

Shacey Petrovic 47:23
We don't have a plan to discontinue our other Omni pod systems on the market today. You know, we recognize that people want choice. I think that there, you know, I think there's going to be incredible demand for Omni pod five, and most people are going to want to move to that product. But we don't have plans to discontinue our classic Omni pod or Omni pod dash.

Scott Benner 47:44
That's very cool. So now that question leads me into this, which is I want to know your thoughts as much as you can share them with me about the do it yourself loop system and that people use Omni pod arrows to run an algorithm that has never seen the FDA and was written by people online? Have Oh, yeah, I've always wanted to ask you what you thought about that. So?

Shacey Petrovic 48:04
Well, you know, what I can say is that we wouldn't be here today with you know, now, multiple system, multiple automated insulin delivery systems on the market without the DIY community. You know, I think the DIY community helped push innovation forward, it probably helped inform some of the regulatory pathways that are leading to interoperability of systems. And so for that we are entirely grateful. And We involved members of the DIY community into the development of Omnipod. Five, because there was a lot to learn from the experience out there that existed. I think the challenge is that, you know, these systems are not they haven't been through the clinical and regulatory, rigorous pathways that Omnipod. Five has. And so we're so excited to be able to kind of provide, you know, provide a system that has the incredible clinical performance and the full muscle of insolate support, clinical technical product support behind it, and, but we're grateful for, you know, the paving of the way that the DIY community did, and it's a remarkable group of, you know, engaged, motivated, talented people, and we've benefited from their expertise,

Scott Benner 49:22
is that partly why you got involved with tide pool because they are taking that algorithm and trying to bring it to market through the FDA. So one day when tide pool gets the okay for their algorithm? Is it as simple as I'll be able to decide if I want to use the one on the board or the one in a tide pool out?

Shacey Petrovic 49:38
I'm not sure it's that simple. You know, we've had a development program for tide with tide pool for quite some time now supporting their regulatory and clinical development efforts. I think it's great that they're working to get this system, you know, through the regulatory process, which is, you know, quite rigorous. But we don't have a commercial agreement with them yet. And I think that's the interesting question. is a big benefit, you know, is the product support, technical support, warranty, all of that stuff that comes with it. So we've got to figure those things out. But, but certainly, you know, delighted to be helping support their clinical and regulatory work.

Scott Benner 50:16
You know, I'm sort of laughing to myself, because I'm thinking back to your previous answer, and I'm imagining, imagining about 10,000 people who use the DIY loop who have been prepping and saving the arrows, pods and clauses and fine. They're like, Wait, I didn't have to stock up on these things. I don't know. I got a couple of drivers. I don't know what to do with all this. It's very, it's a very enlightening conversation. Thank you. It really is. I mean, to your point about that, the DIY group I've seen over my years it push, I think that they're the reason why Dexcom got through so quickly, when they got in the beginning, like, you know, just to what you said, like people are doing this thing already, like, let them do it. i How many years ago? Did I say to you? Are we ever gonna be able to use this on a phone? And you were like, definitely, what is it like six years later? You know, it is. I mean, people are never going to understand the process, and how slow it moves. Right. And I mean, you talked already about you're redesigning a thing, you're packing technology into this little pod, it's not just one, but you don't give me one pod, you give me 10 of them in a bar, how many come in a box, now you changed it can or five? In a box, I need so many I need for a week for a month for a year, that technology lives inside of each one of them. And it just, it bounces online? Because I think most people do see it like, wow, why didn't they like, you know, for instance, like, Well, why is it available for Android? Now that iPhone? Don't they just have to copy and paste that into an iPhone app? Like yeah, I mean, like, it's hard to know, the whole thing. It just takes

Shacey Petrovic 51:57
no, you're right. And, you know, you think about it, we manufacture 10s of millions of pods every year. So you know, part of the FDA clearance processes, ensuring the quality systems, everything's in place to do that reliably high quality, you know, and consistently and with resilience. And so those are that's the you know, that's the not the burden. But that's the that that is why it's a lengthy, rigorous process with the FDA and why consumers that and can be very confident in the technology, like Omnipod phi that we're bringing to them.

Scott Benner 52:32
I, when I saw your your production floor in Massachusetts, I was so blown away with just how amazing it is, you know, the automation and all the technology that goes into building the technology is fascinating. It's why I asked Chuck to come on, because I thought if that guy thought of like this, like, I need an

Shacey Petrovic 52:51
incredible, incredible investment and incredible operation. I'm so glad you were able to see it. I wish I could show it to everybody. I think there's videos on our website, actually, if people are interested in the technology, but you know, just incredible automation, which brings a high level of quality, consistency reliability, to the manufacturing process. And you know, now we've grown so rapidly, you know, more than a quarter of a million people rely on us for their pods, you know, we've got to be able to and we're gonna see a lot more than that with Omnipod. Five, we got to make sure that we have a very high quality, scalable, reliable manufacturing process.

Scott Benner 53:27
Let me let me say something nice to you. For a second Tracy. I have my daughter's had diabetes since she was two. And she was diagnosed in 2004. I started writing a blog in 2007. And not long after that, I started writing little pieces for on the pods website. So that's my the time I go back with all this I've been involved somehow with on the pod before you were here before probably anybody that I deal with was here. There is this, I love the product. And I all I wanted was for my daughter to have it. And I lived with a tiny bit of fear every day before you got to Omni pod that a lot of business people owned it. And they were trying to build it up to sell it to somebody else. That was always a background fear in my heart. And then you got there and I thought oh, this lady wants to sell insulin pumps. And it just like, I mean, I was just so excited. You know, so I can't thank you enough for showing up and and doing that. I can't imagine the one ad you must have. It might have taken some real pulling to pull that those horses around into another direction I would imagine so. I mean, this thing is the it's the greatest thing that's ever happened to my daughter. Like it really has. She's worn one every day since she was four years old. It's almost 14 years.

Shacey Petrovic 54:43
Yeah, that is just I mean, you know, that makes my day that, you know, I'll share that with the team. I can say two things. You know, actually it's not just that I want to sell insulin pumps. I you know, my father lives with type one diabetes. What I want to do is improve the lives of people living with diabetes and you You know, we get to do that it's such a privilege, frankly, to lead this company and be able to see that our technology makes a real difference for people like you and Arden. And the last thing I'll say is, you know, what made the last, you know, several years possible, in terms of really strengthening the company, being able to deliver on the promise of the innovation roadmap, is just adding people like training to our team, you know, we have an extraordinarily talented, committed group of people that are working every day, you know, to deliver technologies like Omnipod, five to the community,

Scott Benner 55:37
you guys do little things that people don't know about, like, I've spoken to your employees a couple of times, just so this, you don't realize there are people that work there that don't have diabetes. And in their mind, they're making a little plastic thing, right, it's their job, and they just know what they're supposed to do. And you go to the trouble of making sure that they understand who it's impacting, and, and why it means so much. And I love coming and making people cry at your thing.

Shacey Petrovic 55:59
And you did, you did a great job of that almost every few months, we have somebody who comes and makes the company cry, as somebody who benefits from our technology. And we also encourage our new employees to wear the pod for, you know, we call it a 90 day challenge, but do what we can to really connect everybody in the organization, regardless of where they are, you know, finance, HR, or the manufacturing line to the daily life of somebody who relies on our technology so that we all understand that our job is to reduce burden. And everybody in the company has a responsibility to do that, and has the opportunity to do that. And so we take that really seriously. Thank

Scott Benner 56:39
you can you speak to. So I mean, there's no ads on this episode, but because I want people to be able to get through it and listen straight through. But, you know, for the last year, I've been telling people get a dash, get a dash get a dash. And you know, whenever you buy something, inevitably the new one comes out the next day. So for the for the group of people who are like I'm on my third dashpot. Are you kidding me? Can you explain to them if they want on the pod five, what's going to happen? Because it's not like and I know you said it earlier, but I just want to say it again, like in the past, they would have been stuck. So yeah,

Shacey Petrovic 57:14
that's right. And it's really important, because it's trying said earlier, we've thought about the customer experience, and simplifying the customer experience, not just through the technology, which we think we've done to great effect with Omnipod. Five, but also through the whole process of trying to access the technology, which we know is really burdensome for people. So that was the whole point in taking the technology through the pharmacy channel. And it enables us to do a few things, it enables us first of all, to let people just go to their local pharmacy and get pods. So some places they have to go to get their insulin and their other supplies anyways, it enables us to eliminate the upfront cost associated and large, you know, deductibles associated with the Durable Medical Equipment channel. And it enables us to get rid of that four year lock in period. So if you acquire dash tomorrow, and then your insurance covers Omnipod, five in a week, you can move right on to Omnipod five. So that is the benefit of the model. And you know, the great thing about Omnipod dash also is that Omni pod five was based on that platform, so it will make your pathway to Omni pod five, much easier from a training perspective. As training mentioned earlier, if you are in Omni pod dash user, and a Dexcom G six user, it's an online training module to then move from Omni pod dash to Omni pod five, once your insurance covers it, so no, no burden, some process to be able to access the technology, no upgrade fee, and no timing requirements, we're going to be able to let you do that as quickly as possible. So I always encourage everybody, you know, even if you think your insurance is gonna cover it next week, there's a benefit to getting on to Omnipod five and there's no cost I mean to getting on to Omnipod dash and there's no cost to move

Scott Benner 59:02
to five, five, the work you guys had to do getting on the pod dash covered by all the all the myriad of insurance companies. By the way, that's not a job anybody wants. But but getting all that worked out, is that going to translate right over to five? Or are you going to have? I mean, is there going to be a gap of time where you're out there? You know, talking to every insurance company trying to get coverage?

Shacey Petrovic 59:24
Yeah, our team has been hard at work establishing coverage for Omnipod five, and we're doing great. We now have more coverage established for Omni pod five than we did you know, months after we launched Omni pod dash, but there are payers who will not contemplate establishing a reimbursement policy until the product is FDA cleared. So, you know, today is a great day for us because it also will enable us to accelerate even faster on the covered lives or number of people that we can get covered for Omnipod five and all of that work is is underway. We do have a lot of leverage you It will launch in a really strong position. But now from here the teams are going to accelerate and get even more coverage established from the pot five.

Scott Benner 1:00:08
Oddly, I just got an image of you in a smoke filled room with a cigar calling insurance companies gone. Hey, we got the clearance. Let's do this. I don't smoke. I know. But that's what popped into my head. It was just completely ridiculous because looking at you, I don't think you smoked cigars. Well, she's the I'm gonna I know you have to go. But you're gonna let me hold on to trying for a little bit. She's happy to do that. Right. Gird your loins. I'm gonna beat you up pretty good. I got a lot of questions. Thanks so much, JC

Shacey Petrovic 1:00:35
thanks so much.

Unknown Speaker 1:00:36
It was great to talk to you.

Scott Benner 1:00:38
In just a moment, you're gonna hear my 25 minute conversation with Dr. Trang lie. But first, if you've heard about the diabetes, pro tip episodes from the podcast, or any of the other content, and you don't know how to get started, go to juicebox podcast.com. There, you'll find all of the series that are available inside of the Juicebox Podcast, not just the daily episodes, which by the way, the podcast comes out on Monday, Tuesday, Wednesday and Friday, every week. But there's also a protip series with me and a CDE named Jenny Smith, she and I break down all of the ideas that are spoken about in the podcast. And I think if you try those episodes, if you really dig into the Pro Tip series, you're gonna get an A one scene of variability where you want it. If you're just starting with diabetes, we have a defining diabetes series, which takes all the terms that you're going to use every day with type one, and explains them in very, very usable fashion. In layman's terms, it's not going to be all technical and medically and boring. It's going to be quick, easy episodes to get you in line with what it is you need to do. And what it is you need to know. You know how there's all those variables and diabetes, we have a diabetes variable series. There's also an after dark series where topics that don't get spoken about much get tackled. Past topics include heroin addiction, bulimia, other eating disorders, diabetes, complications, being from a family of divorce, sexual assault, PTSD, so much more. There are the things that happen to everyday people just like you that no one talks about, but we talk about it here on the Juicebox Podcast, there's a complete series about algorithm based pumping, which is only going to get longer now that only part five is here. And if you're interested in how we eat well, there's an entire series dedicated to how people eat. Because here are the Juicebox Podcast, I believe that it doesn't matter what eating style you employ. You deserve to know how to use insulin and use it well so you can be happy and healthy, and unencumbered day to day with type one diabetes. Check them out juicebox podcast.com. You can also find the pro tips at diabetes pro tip.com. And don't forget if this is your first episode, subscribe and follow in their audio app that you love using doesn't matter if it's Apple Music, Spotify, wherever you listen to audio, you can get the Juicebox Podcast. I appreciate you listening to all that. Now let's get you back to the show. All right, trying. Let's dig this thing apart. Okay, how's this thing work? What are we going to do? Let's go. Yeah, I'm ready. So let me let me I'll give you a little preamble first. And again, everyone should understand i, we didn't pre plan this, I may ask you something that you're not comfortable asking if that's the case, just say I can't answer that. And we'll keep going. So here's my perspective. I employ a very active insulin management system, like even when my daughter's just using Omnipod five, and I'm using a CGM, and we're making every decision manually. By that, I mean, we are very diligent about a good Basal rate, we Pre-Bolus meals, we understand the differences between the impacts of different glycemic load specific indexes of food, I don't abide high blood sugars. If I miss on a Bolus, I come back at it again, I live by the ethos that I'd rather stop a falling blood sugar than live with a high one. And and that is how we stay very flexible from there. A number of years ago now a listener contacted me and said, I want you to try this Do It Yourself algorithm. Because I you know later I learned that she didn't know how to use it. She thought if I learned I could tell people. So at the time, I did not want to do it. Every reason why a sane person would not want to download an algorithm off the internet and let it give their kid insulin. I had a problem with that. I watched everybody doing it. It was working for people. And overall what I thought was this is the future like algorithm based pumping is going to be the future. If I'm going to do a good job at this for my daughter and for this podcast. Honestly, I need to understand this so I begrudgingly did it. There's a great series of conversations about it in the podcast from me, you know on day one and being like, oh my god, I hate this thing. Why does it shut off the basil when I Bolus like you know, like all this stuff. But now I found a real happy place with with algorithms. And I gotta be honest with you, I'm not going back again, that doesn't make any sense to me, I also got to learn an immense amount more about how insulin works, just by having Nightscout on my phone, and watching the algorithm give and take away insulin, it's a fascinating way to learn how to manage insulin just to watch a computer do it instead,

I meant every word I said earlier, the minute I can have on the pod five for my daughter, I am taking the loop off of my daughter, and we are switching over and it is my wholehearted goal to keep her on it forever. But I feel like there's things I'm gonna have to learn about it. Like there were things I had to learn about the loop to make it as truly like successful endeavor. And so I just want to know what you learned with people wearing it, you know, and then if we can't dig into some of this a little bit.

Dr. Trang Ly 1:06:04
Yeah, I think the profile that you're describing someone who has well tuned Basal rates, who Pre-Bolus is their meals, who really understands the impact of low glycemic foods and high glycemic foods, I think all of that really bodes well for excellent glucose control on the Omnipod five system, you know, we if, if you're able to do all those things, and good glucose control is achievable with AD systems. The reality, Scott is that it's really hard to be very regimented about your diabetes every single day for the rest of your life. You know, I tell people, you know, it's like a exercise program, you know, a lot of us can do it for a day, three days a week, but it's really hard to do that for every single day for the rest of your life. And so, you know, we have built this algorithm for when people you know, underestimate their carbs, or or forget to Bolus, you know, for teenagers who do not Bolus. And that that comes from my clinical practice of taking care of a lot of teenagers, over the years. And so we really want it to work for the broad population of users out there who live with diabetes every day. And, and that means, you know, being able to be responsive enough to what we call an unannounced meal, otherwise known as a meal, where you haven't given a Bolus, you know, so that just happens really regularly in everyday life. And that's what we're trying to do. And, and as, you know, the whole art of this is giving just enough to get this person down, and not overshooting and causing, you know, prolonged, severe hypoglycemia. Because, you know, if that happens, then really, you know, you have not succeeded in this area, and you will cause you know, intense mistrust with with your patient. And so, getting that just right, and that formula just right, for our adults, as well as our little kids, was really important to me. And so I think will work really well for Adam.

Scott Benner 1:08:33
Okay, will will I see, when she's low and stable, like away from meal insulin and away from food? Am I going to see a 110 blood sugar? Are there worlds where she'll ride lower than that? Or?

Dr. Trang Ly 1:08:47
Yeah, in some cases, she could ride low, lower, for sure. But those are the sorts of numbers, you know, 110, between 101 10, you know, waking up in the morning was very, very common in the clinical data that we collected. Yeah, that is, I mean, as you know, that is really the impact of this technology is, is really that overnight glucose control and being able to wake up in range and, and not, you know, being agitated by hyperglycemia. And really, you know, really letting it ruin the rest of your day. That is the beauty of AIG technology is really enabling that. That dynamic glucose control in between those big meals,

Scott Benner 1:09:35
okay. Hey, just because it got past me earlier. Ai D, automated insulin delivery.

Dr. Trang Ly 1:09:40
Yes, that's right. Yeah. Very good with my abbreviating. So thank you.

Scott Benner 1:09:46
Make sure I was doing that. Right. So here's, here's a question for you. My daughter goes to Five Guys. She gets a burger and she gets a shake and she gets french fries. And are she

Dr. Trang Ly 1:09:55
gonna get peanuts? Two from five guys? We don't do that. Isn't that interesting to you? Peanut giant, I have the best peanuts. Alright, I'll

Scott Benner 1:10:02
try next time. Just now you're making I feel pressure, I'll eat the peanuts. So we go in. And here's what I know. I know it's a lot of carbs, right. And I make a huge Pre-Bolus. And for a lot of carbs, but what I also know is there is no amount that I can Pre-Bolus or Bolus, that's going to get ahead of the fat rise that comes about 45 minutes or an hour later. Now, right now, on the system we use, or even previously, before algorithms, I would have made a new Bolus about 45 minutes and I would Pre-Bolus the fat rise. You know what I mean? So yeah, I can still do that, right? Because the fats gonna hit like carbs. So they won't mess the algorithm up? Well, it?

Dr. Trang Ly 1:10:44
No. So you can Pre-Bolus For sure. Definitely. And, and you can wait till your daughter starts to kick up again, before you give more, that's totally fine. Or you could could Pre-Bolus and just let the algorithm run with it, as well. I think high fat meals are very hard to manage, it's likely, if your daughter runs at 5.2, she doesn't have that many of them.

Scott Benner 1:11:14
It's more likely that I'm really good at Bolus thing for them.

Dr. Trang Ly 1:11:20
And she's 17 Scott's gonna go to college soon. And you can't go with her.

Scott Benner 1:11:25
I got a text. Don't worry, we'll be good. But I've just, you know, My bigger question is about the algorithm like, can I put that in? If that works? Like, here's my other question does do fake this fake carving mess up the algorithm. So for people who don't know, some people adjust algorithms by lying about carbs that don't exist.

Dr. Trang Ly 1:11:45
So in our Bolus calculator, you can do everything that you do today. So you can set your insulin to carb ratio as aggressively as you want, or, you know, different times of day, you know, if you're more sensitive, or actually more resistant in the morning, which is much more common, then you need more insulin for those morning carbs, you can set those ratios through the day. And then same thing for insulin sensitivity, you can set that as aggressively as you want for different types of days, and none of that changes. So you don't have to kind of fake the system. I think what I've learned, looking, you know, taking care of people with diabetes is, it's really hard to get it right, even without, you know, training, fake things. So what the system knows is insulin on board. So if there is a lot of insulin on board, it notes to kinda like, take it easy. And if there isn't a lot of insulin on board it, it allows itself to be more aggressive in the presence of hyperglycemia.

Scott Benner 1:12:51
Okay. It's, I mean, listen, it sounds terrific. Here's what I mean. My goal is to take it and, and to get the settings in a place where I just fine tune it as best I can. I just, I genuinely meant what I said earlier. I don't I let me be clear, because I don't want to hurt anybody's feelings. I love the do it yourself loop. I think it's astonishing. As a matter of fact, I don't know who Ivan is, but you have to find him and hire the guy. And you know, but but but beyond that, this the ease of use the simplest that you guys have been saying it over and over again. It's what's in my heart. I just don't want I don't think that, that I care. Here's how I think about it, you don't have to answer. If my daughter is five, five right now and she can be six on on your product. My imagination tells me that in the future, you're going to work on getting the target down. So if the next number of years of my daughter's life are spent at a six a one C while she goes to college, and then one day, you and I are talking about this again, you have I look older, you of course look exactly the same. And you're like, Hey, Scott, good news, we got our target to 90 of bah, bah, bah, whatever. I don't think of those three wasted years. And I'll tell you why. Because I've interviewed so many people, adults with type one who had it when they were children who talked about going away to college, and ever it's just a dumpster fire while they're at college. And it gets so bad that they lose their way. And and a lot of them have to have some sort of like a personal awakening to even like try to bring it back again. It's it's an A lot of people don't come back from it. You know, and it's not the stuff we talk about so much. But it is the real like valid truth about diabetes is that you could burn out you could just be not good at it. Your diet might not jive. Well, your doctor might suck like there are so many things that could happen to you, where you're just calling to stay alive instead of a living well, and I as much as I'm happy to tell you that my daughter is a once he is five, five, I would gladly tell you that it's six, and that she doesn't think about diabetes very often that used to be the tagline of the company. Right, long time ago, make diabetes a smaller part of your life or something like that as a long time ago, but I still I shoot for that all the time. And the look on your face tells me I'm gonna find that with this. Yes. So,

Dr. Trang Ly 1:15:13
so sure, it's, it is really about reducing burden for our users. And, you know, all those things you say about. Just, I'm gonna, I mean, I've been crying a lot this week, God,

Scott Benner 1:15:32
just so you know.

Dr. Trang Ly 1:15:36
I'm gonna try really hard not to, but, you know, I have taken care of so many teenagers who have lost their way. And so a, it really is about reducing burden in ways to just allow them to live their life and not think about diabetes. So yes, all the things you're talking about, about lower targets and getting tighter control, we will get there with better insulins and better sensors, we've got to do it safely with the tools that we have today. And I'm really proud of the system we built that has excellent timing range, remarkable hyperglycemia reduction, and thriving children and adults on the system, who can live their lives and, and travel and not have to think about their diabetes. I mean, I have patients who we used to be my patients at Stanford, and I text them now they're on the system. And then Mom doesn't even talk about diabetes. And I'm like, Oh, my God, are you still she's still using the system. She was a year kid still using the system. But, you know, I get this long text about how she's doing really well at school. And she's top of her class. And, you know, that's what makes me so proud to be here today. So, yes, it is all about that. It's never been really about the numbers.

Scott Benner 1:17:03
Yeah. Okay. So a couple of harder questions based on that idea. I, I like to go happy to sad, happy to sad. I like the way it keeps it moving. So I mean, I don't think it's any surprise to anyone who uses an insulin pump that your site doesn't always last, as long as you hope it will. Sometimes it does there, there are times that my daughter rides in on the pod for 80 hours right into the emergency time at the end, and there's nothing wrong. And there are times where five, six hours before it's supposed to expire, I say to her, Hey, if I was you, I'd bail on this pod now. Right? So is the am I gonna see the algorithm like if the if the sight gets gets janky, and you're gonna see the algorithm pumping, pumping, pumping? Trying to get ahead of it? And does it have much luck with that, from what you saw, I

Dr. Trang Ly 1:17:52
think what you're describing, you know, the algorithm responds to that really well, without over responding to that. And, you know, what we've seen is that, yes, that that is a sort of something we see with all the types of pumps, in fact. And, in fact, it's actually more of an issue in tubes, plans, where people tend to, it's a bit like contact lenses, you kind of wear them, and you kind of forget what day you're on, right? So it can, you know, especially if you beyond that three, four day period of of an infusion set, you can generally see that hyperglycemia we don't tend to see, you know, that much of a problem and certainly, you know, the algorithm can really augment for that type of behavior, it really just sees that as sort of, again, just kind of that increased insulin resistance, so that you know, short term increased insulin resistance, so the algorithms able to respond appropriately, and deliver more can actually give up to you know, kind of 300% of kind of Basal settings so it has pretty well good range of being able to adjust to, to your insulin needs.

Scott Benner 1:19:19
So if my daughter's Basal is 1.1 an hour, if it sees her like randomly heading up, right, she's she's been 100 for a couple of hours, she starts heading up, it starts predicting more. It will as aggressive as it is, as it feels like it can do without causing a low later it's just going to keep it's going to quickly put up the basil to so there are you're you're you're basically doing micro Bolus is through basil, is that right?

Dr. Trang Ly 1:19:46
That's right. Okay. Yes. So micro Bolus is every five minutes. So yeah, so that's exactly you're exactly right. I will say, just to clarify. So when you first set up an AMI You plug five systems, so your daughter's on, you know, one unit a day just just for ease of math, the system will use that information initially, but later on, like, you know, by the second third pod, it will, in fact, not rely on the Basal rates to augment insulin delivery, it will rely more on her total daily insulin, because, again, we don't want people to spend their lives, you know, trying to figure out whether they need, you know, 1.1 or 1.05 units an hour. And so it is really the algorithms Basal rate that is being adjusted over time. But yes, it has kind of its own power to increase with in the presence of high glucose levels. And then within it has its own safety measures. So these are not related to the max Basal settings. And in fact, not related to max Bolus settings that you would set in a sort of traditional pump setting. It has its own safety mitigations. And based upon all the studies we've done over the last six years,

Scott Benner 1:21:16
so when a wearer puts the pump on on day one, it's collecting data on the on the first pot, then I take that I take that pot off after three days, actually, does it take the whole three days to figure out what it wants to know? Or how long does it take for to?

Dr. Trang Ly 1:21:32
Well, since you asked is 48 hours, so

Scott Benner 1:21:36
So yeah, so will I see a change on day three or not? Until pod two?

Dr. Trang Ly 1:21:41
Not until pod two. Okay.

Scott Benner 1:21:43
But now I wear pod two for three days, I'm getting the benefit of what it learned off of pod one. When I go to pod three, the 48 hours doesn't start over. Right? It just piggybacks on to what it knows from the

Dr. Trang Ly 1:21:54
Yes, you got it just right. Yeah.

Scott Benner 1:21:56
Okay, look at me paying attention. You don't know me. But anytime I'm focused, it's kind of amazing. This podcast is the only thing I'm an adult about the rest of my life, you just be like, why am I talking to this guy? But right here, you got the right guy? Is there anything that I didn't ask you about it that you were like, oh, we should have asked about this?

Dr. Trang Ly 1:22:22
Honestly, I think you've covered everything, I just want people to know, we're really proud of what we've built here. And it's going to change a lot of people's lives. You know, I get asked by patients all the time, you know, when they can get on edge. We we just have wonderful stories of you know, we have a child who is actually taken care of by his grandmother for various reasons. And Grandma said, you know, the system is so easy that she doesn't, she can actually send him off to daycare. So he's, you know, only a three year old boy. But because of the system and the simplicity, you know, other people can take care of him, he can go to school, daycare and be cared for by others. And, you know, I was just really proud of that. And I just, I mean, I have so many incredible stories. You know, I think you'll really appreciate this because your daughter was young. When she was diagnosed, you said to Right, yeah, yeah, so this child was six years of age, right? And wetting the bed because of hyperglycemia. So we'd have soit sheets and mattress because of his diabetes. And because of our system, this child doesn't have to wear diapers anymore. That's a

Scott Benner 1:23:55
big deal. Like, isn't that amazing? It just really is, I find that the ones I try very hard not to lose focus, because the podcast is, is pretty management centric. In some places, I realized that most of the people I interact with are, are, you know, on a higher level and are striving for that higher level. So I'm very careful to make sure to interview people who are not in that situation to so I don't forget that. No matter how many people this show reaches there are far many of them that have type one who never consider stuff like this and never find health or happiness. And it's debilitating. So I'm not I've listened you guys are advertisers. But if you weren't, you'd still be here today talking about I'm incredibly excited about this. So I really appreciate you doing all this with me. You did bring up one last thing before I let you go. You brought about you talked about kids go into preschool or their school for people who don't have an opportunity to Pre-Bolus Because of you know their caregivers won't tell helped them or they forget or something like that would the way I would handle it. And I'm not certainly saying you should have told me that you agree with this. But the way I would handle it is if I can't Pre-Bolus I over Bolus i Pre-Bolus. If I can't Pre-Bolus I Bolus for the food and I Pre-Bolus the rise, I know is going to happen by not Pre-Bolus thing I imagined with the algorithm, I could still do that. But my question is about little kids who can't Pre-Bolus At school? Is the algorithm going to see that rise? And try to stomp on it? And will that? Like, I guess what I see with my daughter when she doesn't Pre-Bolus on this current system is that it does a pretty good job of keeping her under one ad, if we don't Pre-Bolus Is that what do you see on your side?

Dr. Trang Ly 1:25:43
Yeah, for sure, when we did all of our testing, those were the exact scenarios that we look into, you know, every person is different, and you just can't control a toddler, you know, deciding, deciding what to eat, you know, I have a four year old at home who is impossible, he doesn't have diabetes, and I just shudder to think what it would be like. So it is very, very challenging. But it is, you know, it is the reason why we need better tools, like automated insulin delivery. And I think it'll hopefully make things easier for people and worry a little less, that they're going to be crazy out of range, you know, if they had no insulin versus with an algorithm that can augment and give more, when they're high. But you know, they may have just been running that school for, you know, an extra 20 minutes and suddenly be crashing low and actually not need that. Pre-Bolus right. You just don't know. And it's just so hard. And, you know, we can't always be with our children. And this, this system really gives people peace of mind.

Scott Benner 1:26:52
Well, I'm excited, I am going to here's my here's my promise to everybody listening, I am going to get on the pod five as soon as I can. For Arden I am going to become a super user of it. And then I'm going to come on here and ad nauseam beat into your head how it works. So because I think you're all gonna you're about to make a real leap with your lives. So I can't wait to try and thank you so much. I can't tell you how grateful I am for you and JC doing this. Thank

Dr. Trang Ly 1:27:15
you. Yeah, of course, anytime.

Scott Benner 1:27:18
Thank you have a great day.

A huge thanks to a huge thanks to Shashi And a huge thanks to JC and Trang for taking time out of their very busy day to come on the show and talk to me. I mean, this just became public three and a half hours prior to when we started this recording, and you're hearing it just a few hours later. This is hot off the presses kinds of stuff. I also want to thank all the sponsors of the Juicebox Podcast and remind you if you ever need them, they're there and using my links helps the show. All the sponsors are listed in the show notes of your podcast player and at juicebox podcast.com.

If you're a US resident who has type one diabetes, or a US resident who is the caregiver of someone with type one, go to T one D exchange.org. Forward slash juice box now and take a few minutes to fill out their survey. When you do you'll be helping people living with type one diabetes, and supporting the show. If you have any trouble learning how to subscribe to a podcast, go to the Facebook page for the podcast Juicebox Podcast type one diabetes, it's a private group, you'll answer a couple of questions and make sure you're a real person. And once you're in a bevy of information awaits you, and conversations with people all the way from newly diagnosed to people who have been living with type one forever. There's a equal mix of parents of kids with type one and adults living with type one in there. There's also a bunch of type twos, people who have Lada I'm very proud of that group. It is a wonderful place for people using insulin doesn't matter if you have type one, type two, if you're the caregiver, or have type one yourself, and just like the Juicebox Podcast, the Facebook group is absolutely free. Why don't you go check it out. Okay, if you're still here, you probably really want the link to go check out the on the pod five. I appreciate you listening this long and making it to the end. If you want to learn more about the on the pod five, go to my special link Omni pod.com forward slash juice box five, that's juice box and the number five Omni pod.com forward slash juice box five. You'll know you're there when you see the words on the pod five automated insulin delivery system first tubeless system with smartphone control and then that excited feeling goes up your spine. That's how you'll know you're at the link because you're gonna see a tubeless insulin pump running Automated insulin delivery system. Its algorithm pumping with an omni pod from Omni pod. Go check it out on the pod.com forward slash juice box. Oops, I did miss the Omni pod for will give me I'm so used to saying it the other way. Omni pod.com forward slash juicebox five. Thank you so much for listening. I'll be back very soon with another episode of The Juicebox Podcast share this episode Everybody spread the word