Good afternoon, everyone. I'm Deb Gordon, Vice President of Investor Relations, and thank you for joining us today for Insulet's investor webcast to discuss our Omnipod 5 pivotal trial results that were just presented a little while ago at ENDO 2021. A PDF of the data that we're presenting today, as well as a replay of this event, will be available on our investor relations website. Today's event will last about an hour, starting with prepared remarks, followed by a Q&A session. Dr. Trang Ly, our Senior Vice President and Medical Director, will present the Omnipod 5 pivotal data, followed by a discussion with Dr. Bruce Bode. And we're very excited to have Dr. Bode join us today.
Not only is he Principal Investigator for our Omnipod 5 pivotal trial, he's Principal Investigator for our type 2 study, and he's also been involved in the research for all of the systems. Dr. Bode is a diabetes specialist with Atlanta Diabetes Associates and Clinical Associate Professor in the Department of Medicine at Emory University. He's considered one of the world's leading experts on insulin delivery and glucose sensing. Following this dialogue, we'll transition to our Q&A session, where we'll be joined by Shacey Petrovic, our President and Chief Executive Officer, as well as Eric Benjamin, our Senior Vice President of Innovation and Strategy.
We remind our covering sell-side analysts that you can submit your questions through the Q&A function on the ON24 platform we're using today, and we've already received some great questions in advance through email, and I see some coming through right now on the Q&A function, so thank you for that. If we can't get to all of your questions today, we're happy to follow up with you. Also, please note that we're not providing any business updates during this event, as it's our intent to keep the conversation focused on the exciting clinical data presented today. Before we begin, you'll see our forward-looking statement on this slide, so please refer to the cautionary statements in our SEC filings for a detailed explanation of the inherent limitations of such forward-looking statements. And with that, I'll turn the presentation over to Dr. Ly.
Thanks, Deb. Good morning, everyone. Welcome. I'm excited to share our data. But first, I wanted to introduce you to Kate. So this is Kate, and I met Kate at Stanford. I took care of her when she was about six years of age. And at that time, she was very dependent on her mom for her everyday diabetes care. And I was privy to the many sacrifices this family had to make because of diabetes. And as her endocrinologist, there was only so much that I could do. I couldn't be around at night to treat her hypos, and I certainly couldn't be around during the day to remind her to bolus. And despite all the advances that we had seen with diabetes technology, I couldn't promise Kate a normal adolescence.
What I had vividly witnessed through my research with Bruce Buckingham and others was the powerful transformation of automated insulin delivery. And I am delighted to share that in December of 2019, we put Kate on the very first commercial configuration of Omnipod 5. And after just the first four days on system, her mom wrote to me. She said that this system had allowed her daughter to function normally as a child and enabled her mom to sleep through the night uninterrupted for the first time in 11 years. This had, in turn, made mom a better mother for her children and a better partner for her husband. It was an awakening of sorts that speaks to the transformational nature of this innovation.
We are proud to deliver Omnipod 5 as the embodiment of fully wearable automated insulin delivery consisting of two simple on-body components: the pod and the CGM. In 2015, we set out to build the best hybrid closed-loop system imaginable, which would provide superior glycemic outcomes with minimal hypoglycemia. We challenged ourselves to keep the algorithm running inside the pod for the best user experience without any additional hardware. The pod had to stay the same size, and aside from using the app to bolus periodically, the user would just rely on these two on-body devices for uninterrupted automated glucose control. It also had to be intuitive and simple, and Omnipod 5 is exactly that. We have built a system that provides dynamic insulin dosing every five minutes to keep the user at their target glucose.
The user can stay in closed loop without needing to disconnect or interrupt insulin dosing, and we've tested the system in a broad range of patients, age two to 70 years of age, with very wide insulin needs, and by the time Omnipod 5 is launched, we will have accrued over 100,000 patient days on system. 100,000 days. That's a lot of days. We are beyond excited to bring simple but revolutionary innovation to all our users in the form of Omnipod 5. This will be the first fully on-body automated insulin delivery system. The pod communicates directly with the Dexcom G6. It has a personalized adaptive treat-to-target algorithm embedded in the pod. We're calling this the on-target technology, and information from the pod carries over with each pod change to adapt insulin delivery to individual user needs.
This means less work for the user and providers to optimize basal settings. There is full smartphone control for all system functions, including changing pods, delivering a meal bolus. It is the only system with customizable glucose targets for different times of day. The HypoProtect function can be used in times of greater hypo risk, and there is a novel SmartBolus Calculator that recommends more or less insulin depending on your CGM and trend, so not just your CGM value only, and the pod, as I'm sure all of you know, fires in the cannula automatically so that the patient never has to handle needles, but even more important than the system features is how the system performs in patients, and this is where our clinical data comes in.
So this morning, we shared the results from our three-month pivotal trial of Omnipod 5 in children and adults with type 1 diabetes. And now I'm going to walk you through the study design and results. So the study was designed to evaluate the safety and effectiveness of the Omnipod 5 system in type 1 diabetes in a broad range of patients. The primary effectiveness endpoints were A1C and time in range. And the primary safety endpoints were diabetic ketoacidosis and severe hypoglycemia. There were 241 participants enrolled at 17 sites across the United States. The study included a two-week standard therapy phase followed by a three-month automated insulin delivery phase. And of note, subjects did not have to be on a pump prior to starting the system. They could come straight from MDI straight onto the system.
And the protocol also allowed for an optional continued use extension phase of 12 months. So during the study, there was a three-month pause to correct a software anomaly. No adverse events occurred as a result of this. And during the pause, subjects could continue using our system without automated insulin delivery. This is essentially our DASH product, or they could use another insulin delivery system of their choice. 99% of subjects resumed use of Omnipod 5 after the pause. And this essentially allowed us to do an unplanned crossover analysis of Omnipod 5 versus other therapy. These are the baseline characteristics for all subjects. The children had a baseline A1C of 7.7%, and the adults had a baseline average of 7.2%, although the range was quite broad from 5.2%- 10.3%.
And as I mentioned, MDI users were also eligible, and they made up 12% of the pediatric population and 18% of the adult population. And now the results that you've all been waiting for. These are the primary outcome results for A1C. In the pediatric group, we saw a reduction in A1C down to 6.99% and in adults down to 6.78%. So overall, 1/2 of the children and 2/3 of our adults achieved an A1C under 7%. These are impressive results. So this is my favorite slide. Each dot represents a patient, patience and generosity of our patients that created Omnipod 5. And I just love seeing them all here represented. What it shows is a baseline A1C compared to the end-of-study A1C. And what you can see is that most people are showing improvement and fall to the right of the line.
As I was reviewing the data, I was struck by how consistently people improved across the board. This figure on the right shows the stratification by the baseline A1C being either greater than 8% or lower than 8% at baseline. You can see here that both groups show a reduction in A1C, but there is a larger reduction for subjects starting above 8% with an average close to 1% improvement. These are the results in children, which are even more striking. Actually, this one's my favorite slide. You can see here that practically everyone improves. Here are the much-anticipated time in range results. Time in range improved by almost four hours a day to 68% in children and by 2.2 hours per day to 74% in adults. This was achieved from an already high baseline.
33% of our adults achieved a time in range of 80% or higher. These are the time in range and A1C results throughout the study, including the pause, and as I mentioned earlier, the pause allowed us to conduct an unplanned crossover analysis of Omnipod 5 versus other therapies, which included for the majority really was our system in manual mode, and you can see the direct effect of the algorithm on time in range, so during the pause, time in range fell to almost standard therapy levels and then increased again when subjects were back on the system. Because of the timing of the pause, we sought to obtain A1C levels in subjects who were willing to provide it. There is a lag with A1C compared to time in range, and for this subset of participants, we saw improvement, which was sustained.
We saw similar but even more striking results in our pediatric cohort. Again, time in range increases with Omnipod 5, comes down with the pause, and then back up again during the last seven weeks on system. This very clearly isolates the effect of the algorithm from the pump and CGM. So this slide here shows the time in range results across the entire age spectrum. And we saw time in range improve across the age groups and saw absolute improvement between 8%-16% from children to older adults. And what's impressive is that there is no ceiling effect, with the largest absolute change being seen in those in the pediatric group and young adult group. And these are the people who have the lowest starting at the lowest baseline.
But even in our older adults with a high time in range at baseline, close to 70%, we still saw an improvement of 9% to almost 80%. I think this is Bruce's favorite slide. So time in range improvement was enabled by a reduction in both hyperglycemia and hypoglycemia. And these are some of the lowest rates of hypo that we've seen with any AID system. We saw very similar improvement in children. The gains in time in range are through reduction in hyperglycemia without worsening hypoglycemia. And finally, our best results were seen with a target glucose of 110, with time in range up to 76%. And this was the target most commonly used in our adults and adolescents, reaching 81% of cumulative study time. So this was not in a small subset of power users. It was 80% of all of our entire study time.
And we achieved this with no additional increase in hypoglycemia. So in conclusion, the Omnipod 5 system was safe and performed well in children and adults with type 1 diabetes. We saw three main findings: reduction in A1C, improvement in time in range, and minimal hypoglycemia. The time in Automated Mode totaled 95% of the study duration, which speaks to the simplicity of the device. And the majority of our subjects opted into a 12-month extension phase. And this is indicative of their overall satisfaction with their device. I've been working with closed loop algorithms for the past 15 years, and these are tremendous results for any closed loop system. And I believe that the usability of the Omnipod 5 system, combined with the clinical trial results that you've just seen, will undoubtedly change the disease trajectory for every patient that will use this product.
Okay, so now we have our special guest Bruce, Dr. Bruce Bode, from Atlanta Diabetes Associates. Now, Bruce has been part of our clinical strategy and an investigator on our Omnipod 5 studies for both type 1 and type 2 diabetes. He's been a close advisor of mine, and it has really been his impressions of the system that has really influenced our clinical strategy, especially in the type 2 space. So we're super excited to have Bruce on the line. Bruce, do you remember about four and a half years ago? I'd been in this job for like one hot minute, and I came down to Atlanta to visit you, and you were one of the first people that I'd met, and basically you gave me a really hard time for not having a closed loop system.
So many years later, and the clinical trial results that you've just seen, what do you think about Omnipod 5?
Well, this data is incredible. One, for one, it's very simple. You're using a G6, which is simple. You're using the Omnipod, which is very simple. They're using an Android phone, and that was very easy for them to use. And what was amazing is it adapted quickly. Every three days, you put a new pod on. They're getting better all the time. And this is both for type 1 and type 2. Especially, it's amazing that the children got up to an A1C at 7%. I mean, that's unheard of. And adults got down to 6.8%. And both of these happened with this crossover, and it showed by this pause they had.
The crossover showed that if you're in auto mode, which they are 95% of the time, you're going to get your time in range down easily by 70%-80% time in range. And nobody yet today has been able to get up to 80% at this time.
Thanks, Bruce. I wanted to pick up on what you said about adaptivity. So I think when we set out to build this product, as I mentioned, it was really about usability and reducing burden for our patients and physicians. And as you mentioned, the adaptivity is really important. The basal rate informs the algorithm, and as the insulin needs increase for the user, each pod iterates and updates that information. Do you think that will be a meaningful difference to other products that our product can do that?
Yeah, there's no question about that. I have no idea how you did this, but your engineers and your software, nobody's been able to do that, to bring it up to what is there, and then you throw that away, the pod, then you put another pod in, it knows what's going. It's amazing, and I initially thought Omnipod would not be successful because you have a new pod each day, but what you did is you put all of the algorithms in the pod itself, and it works, and it adapts, which is amazing.
That's great, so thank you for the kind words that you said about our data, and I just clarify, this is our type 1 data. Bruce has a poster also at Endo, but it's on a very small subset of type 2, but we're mainly focused on the type 1 here.
The results that I just covered, what would you say were the most compelling aspects of that data compared to the other published data that's out there, including data you've presented?
Yeah, so I mean, obviously, there's two competitors. One's Tandem, Tandem Control-IQ. Their time in range, it gets you to right around 70%. They're higher, for sure. Their hypoglycemia, Omnipod has the lowest hypoglycemia so far I've seen. But obviously, this was not. It didn't have a control. But the control itself with this pause is essentially a control. But I think overall, comparing to Tandem, the pump itself has some issues. It tears up insulin. It takes time to fill it, and people get frustrated. People don't like this rechargeable. So a lot of people go to Medtronic because of that. But Tandem works very well if you follow what it does.
However, it goes both off your settings. It goes off your basal. It adapts from that. And with both Medtronic and the Omnipod, it does its own self. It'll adapt accordingly. And again, Medtronic also has the 70%-80%. We've done all of that work. And they are also up in the 74%-76% range and almost 80% in adults. But they themselves, you still have to prick your finger. You're pricking your finger four times a day. And in the Omnipod, these people weren't pricking their finger at all, very rarely. And that's the same with Tandem because using the G6. And so Medtronic is similar to this, except it's a lot more work using the Medtronic system, calibrating it in the middle of the night and all these other times. And then you have all these alerts. With Omnipod, we just didn't have any alerts.
We didn't really have to help people except adjust their carb ratio, encourage them to be more aggressive.
Thanks, Bruce. I think what's compelling about what you say is because you have been so involved with diabetes technology and every new therapy that comes out essentially gets tested in your center, so really great to hear you say that. How do you think endocrinologists will perceive these data?
Yeah, I think obviously Omnipod has been growing, and my Omnipod rep talks to me all the time and saying, "A lot of people are going on with type 2," and obviously, he says about 30% of the patients are going with type 2, and then you can use Omnipod 5 in type 2. This is a huge market for them.
But it's so easy for typically the people using Omnipod. It's always pediatrics, and it's always older people because it's easy to use. All you do is have to fill up the pod itself. You don't have to put a tube on and do all that other stuff. It's so much easier. You can put it in different places in the back of your arm, wherever you want. You can put it in your back, your front of your abdomen. It doesn't really matter. And it works very well. And so it makes it so simple is the difference with comparing Medtronic or Tandem. And so I think, and obviously, the market here for Omnipod 5 is huge because you get rid of hypoglycemia. You get the 70% time in range, which is unheard of in any system that is not a hybrid closed loop.
So obviously, these hybrid closed loops are certainly in the future going to be standard of care. And that will also become standard of care in type 2 diabetes with people needing insulin.
Yeah, that's great for you to hear you say that. I agree with you. I do think Omnipod 5, with the results that we've seen, that combination of time in range and hypo and the fact that we use it with the Dexcom G6, I do think it will change the way people prescribe therapies. And I do see that eventually this could lead to it being first-line therapy for insulin-intensive patients because it's safer with that hypoglycemia profile. We've touched on MDI, and I think what is unique about our study is we took users who were MDI, and we put them straight onto the system, as you described. And there was no run-in period.
And all of their time on system is captured by this dataset. And we had, as I mentioned, 18% of the adults being MDI. I'm curious. Would you mind sharing your experience of how your MDI patients did on the system?
Yeah, so obviously, the people came in on MDI, they did just as well as the people were on pump already. It works so easy. If you really think somebody managing diabetes with type 1 or even type 2 on four shots a day, that's not easy to do. You have to wear it, and you're wearing a sensor. You might have to have a basal twice daily in type 1. And then if you want to have a snack, then you have to give another injection. And obviously, using a pump, it's much easier.
And if you're going with the Omnipod, it's even much easier than that because you don't have a tube. And then you can just use your phone. Unfortunately, many people, I can't say it's 30% or 40%, but if they go out in public, they will never inject in front of anyone. They would go to the bathroom, or a lot of people just skip it, and then they come home and take their insulin. And they're always chasing their glucoses. If you're using a phone, either an Android or an iOS phone, and you can manage this automatically by putting your dose in or your carbs in, it's so simple. You don't have to worry about overnight because it always wakes you. When you wake up, you're always normal. In every hybrid closed loop, you're always normal.
And the benefit here is you can just use your app on your phone or your Android controller, and it's so simple. And it's so simple for these people. And the market here is even bigger than most people would think in the future because there's so many people with A1Cs above 9% that would do markedly improve because it is simple. And the ones that do so well with diabetes, they're doing everything right. They always look at their carbs. They always put them in before. They are always looking at their glucose six to 15 times a day, looking their sensor and making sure everything's fine. But that's only 20%-25% of the people with diabetes willing to do that. So you have to go for the majority of people and make it easier for them. That's what Omnipod 5 is done.
Right, a solution for the masses. So one last question before we move to Q&A for you, Bruce, is, and I know we're very much focused on our type 1 data and we're very early stage with type 2, but you have the majority of our patients on type 2, and we've been following them very, very closely. Could you just give your impression of how it's worked in the type 2? And I'll just provide a bit of background that when we set out to do the study in type 2, it was for type 2 users who were on MDI or basal insulin, and they had to have an A1C above 8%. So these are people with suboptimal glucose control. And they could be either CGM naive or already using a CGM.
And we basically bring them in and put them straight onto our system, and then kind of off they go. So Bruce, as the principal investigator of all the subjects we have presented today, what is your impression of how our system has worked in that population?
Yeah, so obviously, the people with type 2 that are on insulin, about 50% of those people have an A1C above 9%. And so to get in this trial, they had to be above 8% and up to 12%. So obviously, we can find these people. They're all the time. They're seeing them all in the hospital all the time coming in with A1Cs above 9%. And obviously, nothing works for these people because they're always chasing what they do.
And so the reason why Trang called me about doing this, and I said, "Would you be willing to try this in type 2s with basal or basal bolus?" And I said, "Sure. If your algorithm works, it's going to be perfect." Because to people with type 2 and you're on MDI, and there's about 6 million, maybe 8 million in the U.S. on it, they're always skipping their mealtime. They sometimes skip their long-acting. They have to pay two branded both basal and bolus. And so now you go with one insulin, rapid-acting insulin, you fill it up, and you just start going. And the first person we had was a relatively high up in a laboratory, and she was a supervisor doing night times. And her A1C was, oh, 10.1%. So we started her, and what's remarkable, we came right down, and she dropped down to about 7.3%.
And she just loved it. And unfortunately, she finished the eight-week, well, it was really a 10-week trial. And then I had to call Trang and I said, "We have to allow her to get back on." And fortunately, the FDA has approved that, and she's doing very well, and it's so much easier. And so we have four of them so far that have finished. And the average went up in the 10s, down in the mid 7s, estimated A1C. They're dropping easily. They started off with time in range and averaged right around 20%, in the mid 20%. And they are now in the mid to high 60%, which is unheard of. You're getting almost 40% more time in range between 70% and 180%. And we have no hypoglycemia. This is remarkable.
And so in the long, if this really works, which I think it will, it will help all these people who are failing, whether it's basal or basal bolus. It's so much easier. And I think this would even go into the nursing home environment because those people are in and out of the hospital costing Medicare huge amounts. And if you can do that and put this on and let them just manage it, it's so easy. And in the future, as you know, it's even going to get easier. You got G7 coming down, the size of a nickel, and then you have the pod. Everything's disposable except for your phone. You're not going to throw that away. And so it's so simple.
Thanks, Bruce. That's fantastic. Yeah, I would say that we really built this as a device that would truly revolutionize diabetes care and for the broadest population possible. This was not built for short-term gains just to be another AID system. So I'm just so heartened to hear you say that because it was the reason why we built this product. So thank you so much. We're going to move to the Q&A portion of the talk.
Thanks, Dr. Ly. That was terrific. And I will tell you, thank you to everybody because we have quite a few questions coming through. We could be on the phone for two hours. And many are actually the same theme, so I'll try to combine as many as I can. So the first one is a two-part question. So Dr. Ly, I'm going to throw this one to you.
This group was relatively well controlled at baseline. So how should we expect results to translate into real-world outcomes with patients whose diabetes has proven more difficult to manage?
Thank you, Deb. I think that our results are quite remarkable in this broad population of patients. And although well controlled, remember that we have MDI users. We had a very broad range, 5.2%-10.3%. And it's actually very hard when you've got a well-controlled population to actually show further improvement in that group. So I am just so pleased to see the results that we got. And not only did we get high time in range reduction in A1C, we got the lowest hypoglycemia as well. And so I think this is an incredible product. And it really is, for me, a landmark time for insulin.
That's great. Thank you, Dr. Ly. And someone just submitted a follow-up to that, and it's for Shacey. How do you see this playing out in the marketplace? Would appreciate any color and perspective you can provide.
Sure. Thanks, Deb. I mean, I think Dr. Ly did a great job walking through the data. And we did see, to the earlier part of the question, we did see even more remarkable impact in patients who were starting with an A1C of 8% or higher. So I do think that bodes well for how the clinical results will translate in the real world. In terms of how this is going to play out in the market, what I can say is we're incredibly excited. The Omnipod customer base has been growing rapidly, and we haven't had CGM integration or automated insulin delivery.
So to combine what we know is a patient-preferred form factor with these incredible clinical results and the ease of use of the system, which I think Dr. Bode and Dr. Ly highlighted so well, we think we're incredibly well positioned in the market, particularly as we get through our limited market release and into full market release towards the end of this year, beginning of next.
Great. Thanks, Shacey. All right, so this next question is an interesting one. So it's two parts. I'll ask the first one to Dr. Ly. In our conversations with endocrinologists, one of the biggest impediments to prescribing insulin is the lack of a hybrid closed-loop option. With the first-half launch of Omnipod 5 and the great data in adults, and especially peds, how does the discussion between endos and patients now change?
Yeah, I'm interested to hear what Bruce thinks, but I personally think that everybody should be on Omnipod 5 as early as possible from diagnosis. I mean, how we treat diabetes today is people get diagnosed, we prescribe insulin, we give them some instructions, and we say, "Good luck." And that is incredibly stressful for families. So this product, the reason why our results are so spectacular is that not just that we got time in range, it was the hypo-reduction that will make this a very compelling device and therapy for all users and all people requiring insulin therapy. But I'm interested to hear what Bruce has to say.
Yeah, obviously, this is the first time Omnipod had an integration with CGM, which is great. And now they came with it hybrid closed-loop too. So the combination of that makes it so easier for people. And I agree.
I think if you get type 1, you initially go maybe for a few months in a honeymoon and fairly easy, and then after a year or two, if you don't make any insulin, you're all over the place. And obviously, you want to make it easy for everyone. And so you could just put a pod on. Most people are often using G6 anyways. And obviously, it's so simple, and then you always wake up normal. And then all you have to do is work on your mealtime. And so some people might go up to 220, but before they'd go up to 400, and before the next meal, they would be 250. They're all over the place. This corrects all of this. And it's so simple. And that's a benefit. And they're also going to be working with Abbott Libre. I know that for sure.
And so that's going to come out once they get their continuous system out. So it's going to be very easy to manage diabetes now, for especially type 1. And obviously, type 1 is much harder than type 2. And so it'll be easy also in type 2.
Fantastic. Thank you both very much for that. In the second part of that question, Shacey, I'll send it over to you. Can this help drive market expansion and market share gains?
I think the answer to both is yes. Dr. Ly said it well. We designed this system for the masses. It's why we took, frankly, the clinical risk of bringing children down to the age of six, down to the age of two in pre-pivitals, but in our pivotal, down to the age of six, and multiple daily injections users with no run-in period and put them right on the system. It's because it was important to us to have a system that will continue to grow the market and bring our benefit to the vast majority of the market, which today is relying on multiple daily injections. That said, everything about the system that we've talked about today, its clinical outcomes, its simplicity, that is going to be really appealing, I think, to all users.
And you combine that with our business model, the fact that we are offering Omnipod 5 through the pharmacy with no upfront cost and with no lock-in period means that really anybody can try the system, regardless of whether you're using multiple daily injections or a tube pump today. So I think that positions us really well to bring this exciting technology to many people. And we certainly expect that it will help us to grow the overall market as well as take share in the market.
Great. Thanks, Shacey. And a couple of questions have come in. Eric, I'm going to throw these your way, and I'm paraphrasing one or two because we're getting quite a few with the same theme. One of the questions that we're getting as a whole is about the algorithm. So I'll just paraphrase. What makes your algorithm better than others?
Please walk through the key benefit. Great. Thanks, Deb. So I'd say three things differentiate our algorithm from the other systems that are on the market. The first is that our OnTarget Technology makes a customized insulin dosing decision to bring a user to their chosen glucose target every five minutes. Omnipod 5 is the only system that does that. The second thing that stands out for me is something that Dr. Bode described, which is that we entered into this wanting to ensure that everybody, whether they'd been on a pump or were coming straight from MDI, could confidently get on the system and experience great automated insulin delivery outcomes. And to do that, we had to do the work to separate the automated delivery experience from underlying open-loop pump settings. So there's very, very little of the automated experience that has anything to do with traditional pump settings.
And that's part of why we were able to bring folks who were starting on systems straight from MDI and have them experience great outcomes. So that separation and readiness for MDI is the second part. And the third are the fabulous clinical outcomes that we've spent today talking about. We're thrilled with the high time in range, the great A1C results, and the really low hypoglycemia.
Thanks, Eric. That was terrific. And another one for you is Insulet has spent a lot of time focused on improving the user interface. And Dr. Bode even referenced how easy this is. When you say easy, can you compare that to the other interfaces that you've seen? How do you envision the customer experience and the HCP experience?
Yeah, so great questions. Thank you. I guess I'll start where it always starts for us, which is it does start with the pod.
A fully wearable AID experience is just completely different than a tube pump AID experience. You put on a pod, and the pod automatically inserts the cannula. So there's no learning about how to apply an infusion set. There's no learning about what to do when they fail. The system has no tubes, so there's nothing to catch on things or manage under clothing. And because the algorithm's on the pod, it never comes off. So whether it's a parent rolling around on the floor with their kids like I do, or going swimming, exercising, eating, whatever it is that's happening in life, the algorithm's on the pod talking to the CGM, and nobody's thinking about what they have to do to stay enjoying the benefits of closed-loop therapy. That's just a different experience.
From there, we worked on the Smart Bolus Calculator that Dr. Ly described, which is our proprietary bolus calculator that in one click integrates both CGM value and trend to give the best dosing recommendation for a bolus. And then we developed easy-to-use features like HypoProtect so that folks would have a way to confidently manage exercise or for a parent to send a child to a sleepover or to play outside with friends, knowing that they would have some extra protection from hypoglycemia. And so the entire package is one of just tremendous simplicity. And the evidence we've seen so far is that users love it, and HCPs find it easy to prescribe. So we're thrilled.
That's great. Thank you, Eric. So this is a question. It has a slightly different angle because it relates to the view of the market. So I'm going to ask Dr. Ly if you can kick this off.
And then, Shacey, I'll throw the second part of it to you. So, Dr. Ly, if only 15% of your study participants were previously on multiple daily injections, do you expect to get more of your new customers from the pump market, meaning from competitors?
Thanks, Deb. So that 15% really has nothing to do with how we approach this from a market perspective and who would be suitable. So we built this pod out for all users, MDI, and pumpers. And our results show that it's successful. And as Bruce mentioned, people on MDI did just as well as the pumpers. And more data on that will come on those sub-analyses in coming weeks and months. I will say, just to describe a little bit about the MDI experience, we had users who'd never, ever used a pump before. Some users hadn't even used a CGM before.
They came into the study, and I had physicians calling me saying, "What exactly do I do with the receiver? Should I put them in manual mode for a while and then go on to Automated Mode?" And I said, "No, you just take their total daily dose and come up with one basal rate, stick that into the system just like you would with any other pump, and then just let the system take care of it." And these are our results. And so we are really pleased with how the system has performed in MDI, and that's why it gives us the confidence that this will be a really fantastic product for all of our users.
Great. Thanks, Dr. Ly. And, Shacey, the second part of the question is, does this change your view of U.S. type 1 market penetration? You said you could see it doubling over the next few years. Do you view it any differently?
Well, I think these results give us even more confidence in the fact that this market is going to double. And I think Dr. Ly said it well. The fact that this system can be used so successfully by what is still today 2/3 of the market, people relying on multiple daily injections, is really exciting. And I think gives us great confidence that we will bring this system to the masses. And I always combine that with the business model because I think we've talked about the design choices. Eric did a great job doing that. Dr. Ly did a great job talking about the clinical results in our multiple daily injection users.
But the other thing that is burdensome for people living with diabetes is how they have to access these technologies. And so the work that we've done, the decision that we made to offer this system, Omnipod 5, through the pharmacy with price parity to DASH, means we can establish broad, affordable access. Today, the vast majority of people who are accessing DASH through the pharmacy are paying the same out-of-pocket costs that they do for multiple daily injections. So in my mind, there are the three drivers to how we doubled this market. And one is we need very simple technologies like Omnipod 5. We need to make people aware of the benefits and make them easy to access, and we need to make them affordable. And we're doing all of that with Omnipod 5.
So I stand here even more confident that this market is going to double in the coming years.
Great. Thanks, Shacey. So this next one that came through, we touched on a little bit. We touched on the type 2 topic. But I'm going to ask Dr. Ly this one. What are your expectations for publishing the clinical data that was presented today? And what is the timing of Omnipod 5 for type 2?
In terms of type 2, we're still in the middle of recruiting. And actually, the study just started. We didn't have to do this study, but we were just so curious to know how this would work for people with type 2. And it was really Bruce's encouragement.
I was like, "Bruce, do you think this is going to actually work in type 2, or are they going to be too insulin resistant for this?" And it's just been eye-opening, the results that we saw. If you go back and look at the poster, we described this patient who started with about 30 units a day. And over the course of two weeks, the system responded to the hypoglycemia, and we ended up giving 128 units a day. And that was through adaptivity alone of our system. So it's still really, really early days. We're recruiting from different sites because we want diversity represented here, and where we really want to know whether or not we need to make any changes for the next generation product. So it is huge learning for us and expect more data to come later this year.
Thanks, Dr. Ly. Several people have submitted similar questions. Eric, I'm going to ask you this because it's one that we actually get often from a lot of our investors. I'm glad that we can discuss it with a broader group. This question is, what are the next steps Insulet needs to take for the commercial launch of Omnipod 5? What should we expect? And why wouldn't the lack of iOS compatibility hinder adoption for you?
Great. Thanks, Deb. I'll take that in reverse, actually. Let's talk about iOS first. Just I'll start with, when we launch Omnipod 5, every user who starts on Omnipod 5 will receive an Insulet-supplied controller with a SIM card. And that is the same as the experience that folks had in the pivotal trial with all the data and testimonials that we've been talking about today.
So at launch, everybody gets a controller, same as DASH, same as the pivotal trial experience that users have been very, very happy with. We then, with launch, add to that experience the opportunity for those with an Android phone to take that Insulet-supplied controller, stick it in their desk drawer, and experience all the benefits that we've been talking about today with Omnipod 5 through their own mobile device. And we can't wait to bring that same transformative experience to folks who have iOS devices shortly after launch. And we are excited to do so. But everybody can experience the benefits of Omnipod 5 on day one with the Insulet-supplied controller and a SIM card. The second, or I guess the first part of the question was about sort of what happens next. And as we've shared, we are under review with FDA.
It's been a close partnership and collaboration with them over the many years through the Breakthrough Device Program, and our review has been a similarly close partnership for which we are very grateful, and we are getting ready to produce commercial supply, and then we're looking forward to expanding coverage through the second half of the year and towards the full market release next year.
Thanks, Eric. Well, someone just submitted a follow-up for you on iOS, so why launch with Android instead of iOS, and why is it so difficult if others are doing it?
Yeah, great questions, so I guess I'll start with. There's nothing inherently difficult about iOS. We made some design choices for three reasons that said we wanted to write what are called native applications, which means one version for Android and one version for iOS.
And those choices were linked to the simplicity, the experience that we've been talking about today. We were committed to staying true to delivering the simplest experience. And the second was around cybersecurity and ensuring that we would have full confidence in delivering insulin from a user's mobile phone. And the third is just about long-term maintainability. And so for those three reasons, we committed that we were going to have separate versions for Android and iOS. And all that means from a practical standpoint is we have to write the software twice. We have to do it once on Android, and we have to do it once on iOS. It's not complicated to do, but it does mean doing it twice. And because we had gotten started with DASH on Android, we're just a little bit further along on Android. We are well underway on iOS.
And we expect folks are going to love the iOS experience when we bring it to them.
Hey, Deb, I would add to that. Just something for everybody to keep in mind. The technical work that Eric and his team have accomplished here is pretty extraordinary. When we think about phone control for Omnipod 5, what we're doing is eliminating an entire component of the system. And so Omnipod 5 without phone control is an incredible system. It's the system we've been talking about all day today. That's what people experienced in the pivotal. Add phone control, and it means we can actually remove the entire controller. So when you compare it to others and ask, why are others able to do this? Any other system that adds phone control is actually adding a component to the system. They are not removing anything.
When we add an app on a user's mobile phone, it means we can eliminate the controller. And that's just not true for other systems on the market. So it is extraordinary technical work at the algorithm and the pod to have that one pod be compatible regardless of the phone control and to be able to eliminate an entire component of the system.
Thanks, Shacey. So we have time for a couple more questions. And I do apologize to everyone that we won't get to because we probably have about 65 questions coming through. But I'll ask a couple of the last ones. And, Dr. Ly, here's one about the study design. Tandem has a randomized study. You have a single-arm study. What's unique about your study design, and what factors did you consider when designing it?
I think the strength of our study design is the broad population. 240 patients is a lot of patients across 17 sites across the United States, as I mentioned, and that's a big population of people to demonstrate that our system doesn't just incrementally improve upon pump therapy, but really improves outcomes for people with diabetes, so I think the MDI population and the age range, so as I mentioned, six to 70, but in fact, our preschooler group just finished. There were 80 patients there, and everybody is continuing on the study. In fact, I get messages of very distressed subjects who want to make sure that they can stay on the system, so from the beginning, we built this for everybody, but especially little children, and I think it is very important, personally, as a pediatric endocrinologist, to make sure that it works well in the very vulnerable populations where insulin delivery just can be fraught with so many complications.
I mean, severe hypoglycemia and death is a real fear that people have. And so it was very important to us as a part of our clinical strategy to do those studies during our pre-pivotal phase in the very young children and then very quickly follow up our pivotal study with that preschool age group. So I do think it is the bulk of our data altogether that really makes it stand out from others. And then, obviously, the usability, the ease of use, being able to stay in Automated Mode, people who want to continue on the product, and just the general excitement from our users, I think that speaks a lot for the demand for this product.
Thanks, Dr. Ly. And we are bumping up against the end of the webcast. But I'm going to ask you this one.
I think he answered maybe the first part of this question, but I'll ask it. It says, in your opinion, how strong is your Omnipod 5 data? And did it meet your expectations? And I like this one. Did anything surprise you?
Yeah, going into a large pivotal trial like this, knowing that all eyes would be on us, it's really hard to know when you finish development. And so I was nervous going into this study. I would say the biggest surprise for me was that we were able to obtain such a high Time in Range and low hypoglycemia. And when I looked through the data set, I just saw incredible improvement with almost every single patient. And that is just truly remarkable. And like I said, this is a landmark moment for us. And it's because these results are extraordinary.
Thanks, Dr. Ly. So we've now heard from our clinicians, and we've heard from Insulet. So we're going to close this presentation with a video that one of our trial participants sent to us.
Hi. My name's Cara, and my son is Lucas, and he's 10 years old. And both of us live with type 1 diabetes. And I'm reaching out to you today because I want to say thank you. Both of us have been on the Omnipod 5 system for the past several months. And I have to tell you that it's transformed our lives. Prior to Lucas being on this system, I would wake up throughout the night, whether his blood sugar, his alerts were going off, just kind of dealing with all of that.
And every time I would check on him, even if they weren't, or if there weren't any issues, I would just check on him, and I would put my hand on his heart to make sure that he was alive because I always worry about him at nighttime. And ever since he's been on this system, I'm no longer having to do that. I have so much trust, and I have so much faith in the system. And both my husband and I are sleeping so much better and more peacefully at night. And that means a lot to a working mom. Also, Lucas's blood sugars, his A1C, has gone from a 7.2% to a 6.4%. And that was just the first three months that he was on the system. So thank you so much.
I imagine a lot of you have to make many sacrifices to do the important work that you're doing. And it means so much to me, and it means so much to my family. And I want to thank you for really improving the lives of so many people who live with this disease. Thank you.
Great. So that concludes this program. And I just want to thank everybody for joining us today. And hopefully, you'll enjoy the rest of your weekend. Thank you very much.