Good afternoon, everyone. Thank you for joining us for Baird's ADA 2024 webcast, takeaways from the American Diabetes Association conference that is wrapping up as of today, and we spent all weekend here. With us today, we're thrilled to have Insulet's SVP and Medical Director, Dr. Trang Ly. Insulet has probably had the most data, the most updated data, and the fullest pipeline coming out of ADA this week. So I thought it would be a good opportunity here to talk with Dr. Ly about some of the study results we saw this weekend and maybe go over some of the other key takeaways from the conference. I do need to read one disclosure. Let me get to that. That disclosure would be, "Please refer to the event calendar, published research, or Baird's website for important disclosures regarding the companies discussed during this presentation." With that, Dr.
Ly, thank you. Good to do this again with you.
Great to do this. Thanks for having us, Jeff.
Yeah, happy to do so. All right, so I thought we'd start where most of the new data came out from, which was the SECURE-T2D study. I have a hard time saying that every time. Obviously, that was your Type 2 pivotal trial to try to extend the label on Omnipod 5 to Type 2. 305-patient study, 13-week study. I wanted to start with the study population. It was a diverse population. I think there were 24% Black and non-Hispanics, 22% Hispanics. You had a third, a third, a third that were high school diploma, post-secondary, undergrad. 28% of the population under $50,000 in annual income. Why was that so important to Insulet and really to the industry in starting with such a diverse patient population?
Yeah, thanks, Jeff. So we're incredibly proud of the results from SECURE-T2D. And I think the use of AID in Type 2 diabetes is still brand new, and it's really the next frontier for technology. And what we've done has never been done before. So I would say a couple of years ago, we first started with feasibility data, and because there was still some disbelief that Type 2 diabetes would really even need automated insulin delivery. And so we had done that feasibility data, and we'd also done some studies inpatient in hospital with people with Type 2 diabetes. And what we saw was such great results in A1C reduction, as well as improvement in time in range and very minimal hypoglycemia. So that led us to think more seriously about expanding our indication for Type 2 diabetes.
So today, we already have an indication for Type 1 diabetes for children down to the age of two years of age, and we are the number one most prescribed automated insulin delivery system in the U.S. However, Type 2 diabetes is still brand new. Pump penetration, as you know, is very low in that space. And so it was very important to us to recruit a diverse population of people. And so how we did this was we went to sort of non-traditional sites, including PCP sites, in fact, not just endocrinologists.
It was important to us to recruit both people, the people who we see actually who are not getting great outcomes in the real world, and that includes people who are on multiple daily injections, as well as a really large population of people who are on basal-only insulin, who do not get insulin intensification because of fear of hypoglycemia. And then on top of that, it was important for us to recruit a population that is in need of better care, so a representative population of the U.S. population. So as you said, 305 patients, 21 sites across the U.S., endos, PCPs, and what we saw there was a very diverse population. Everyone I've spoken to at the conference who does Type 2 diabetes is just amazed at how we were able to do this.
It is the largest and most diverse study in diabetes technology, which we're incredibly proud of, and it is taking the work of many, many investigators and research teams for us to get there. So it's a remarkable testament to the simplicity and ease of use of the product that allowed us to enroll quickly and finish the study and get incredible results and then submit to FDA. I think it's because our product is differentiated. So it's not just the fact that it's automated insulin delivery. It's the fact that it is a tubeless system, and it's simple and easy to use. Clinicians can use it. Patients can use it. At the end of our study, which I know we're just getting started, but at the end of the study, patients were highly satisfied, and they wanted to continue on product.
And so to us, if we could show that it works in a diverse population, then we know that it's going to work in the real world, where today pump penetration is low and there's enormous opportunity for us.
Yeah, well, you've brought up a few different points I'm going to come back to on the primary care side and maybe some of the other outcomes related. I'm going to go off my script already and ask you one question. How nervous have you been over the last year, year and a half when you start in that diverse patient population that maybe compliance wouldn't be as good as you hoped, and then results might not look as good? Because they were fantastic results.
Yeah.
Were there some sleepless nights on, "Ooh, I hope we didn't, we were right in not cherry picking and having those patients we knew were going to be highly compliant, and we knew we could lock in good results"?
Yeah, yeah, there's been a lot of sleepless nights. And I'd say, you know, if you have confidence in your product and the results that we've seen, and the results of Omnipod 5 in our real-world use with both Type 1 and Type 2 diabetes has been pretty extraordinary. And so our success on a clinical level as well as a commercial level has given us the confidence that this would work in a very diverse broad population, because that's what we see every single day amongst our commercial teams. But I would say every time you do a clinical study and you go to sites that maybe don't do this every single day and maybe have summer interns as research coordinators, that you know that there's going to be risk.
But it was important to us and important to our investigators that this technology could be proven to be used by a broad population. So we worked really hard to make Spanish option available, as well as our English option. So we had specific consent forms specifically targeting that population. And we had specific enrollment targets to fill. And we went to investigators who see these people every single day. Our chair, Francisco Pasquel, who presented at Product Theater, they recruited almost 10% of our population, and more than 90% of his patients were Black or Hispanic. So these are people who are underrepresented in clinical trials. And not just that. As I said, if we can show that it works in this population, then you know that the adoption is much more likely in the real world.
Yeah. Let's jump into maybe some of the results. Obviously, on the A1C side, you saw a 0.8% reduction. That's pretty much right in line with what you see in Type 1 studies. So obviously, good results there. Why are we still leading in clinical trials with A1C reduction? Is that something doctors still look at? I just think from the investment community, we've talked time in range more than A1C over the last probably five years, more so than A1C. Is that still the first number physicians will look at, is that A1C reduction?
Yeah, absolutely. And I agree with you, Jeff. I think people who are in the diabetes space and do this every single day really understand the correlation between A1C and time in range, and it totally makes sense. I'll tell you, I've done field visits in PCP land where it's the A1C that gets people's attention. So I witnessed a rep showing a marketing material where they were able to show, "Look, with Omnipod DASH, a baseline A1C greater than 9% got us a 2% reduction." A guy literally turned around and was like, "Okay, tell me more about this.
Is that right?
I was like, "Oh, damn, they still care about A1C.
Yeah. All right. Well, you did get that 2.1% reduction in A1C and the 9% higher in this study too, right?
Yes.
So good. Maybe you'll get a few more docs to turn around on that 2.1 data point. One of the data points I thought interesting on the A1C side, you had a very similar, I forget the exact numbers, 0.8 and 0.7 or something like that, reduction in GLP and non-GLP-1 users.
Yes.
So 55% of your patients, which we didn't bring up earlier, were on GLP-1.
Yes.
What does that tell us? I think I know what it tells us, but if you get a similar A1C reduction in GLP users and non-GLP users, to me, that says there's still help these GLP users need where they can benefit. GLP wasn't the magic bullet that they can't benefit from something else like an O5.
That's right. So what we've said all along with all of the news with GLP-1 is that it's not reversing the underlying disease progression. And so what we see in clinical practice is even with GLP-1s in Type 2 diabetes, there is a sort of maximum glucose lowering effect that we see. And so we recruited patients who were already on a stable dose of either GLP-1 or SGLT2. We brought them into the study, and then we gave them Omnipod 5. And then, as you mentioned, we saw similar increase in time in range and A1C reduction in both GLP-1 people on GLP-1 and those who were not. And a very high percentage of those patients were actually on semaglutide and tirzepatide as well.
So it, again, just reinforces and completely validates everything that we've said about these being complementary treatments and that you really need that insulin to be around in order for GLP-1s to work. So as an example, Francisco presented yesterday in Product Theater a case where the patient was already on SGLT2 and a GLP-1 stable dose, maximal dose, and had an A1C of 9%. And that's what's being seen in clinical practice all the time. And so these people need escalation of therapy in order to avoid complications. And I don't know if you noticed the other thing about the cases yesterday, but these were young patients as well. So they're not getting the appropriate treatment and escalation of treatment in the real world.
Options such as Omnipod 5 is just so just really gratifying to see that we're able to help this population and bring their A1C down, even in addition to GLP-1s and SGLT2s.
Yeah. And maybe you brought up those cases. I mean, I think in one of the two cases, if I remember correctly, the insulin dose also came down meaningfully on O5 in Type 2. I think in your study data, I've got it somewhere here in my notes, but I think the average unit reduction total daily dose was 23 units.
That's right. Yes.
In the high insulin users, if you started over 100 units a day, which would not make you a good candidate for Omnipod 5, right? At a 200-unit, a 64% reduction.
Yeah, 65%.
65%. Okay, I'm off by a point. I'll give you the point. But 64%-65% reduction in total daily dose off 100 units, that's a patient who probably wouldn't get an Omnipod 5 in the real world setting and now can.
Yeah. When I saw the data, the baseline data, I was like, "Oh my God." The maximum total daily dose was 357 for one of our patients.
Daily?
Yes. And so there's a lot of patients out there who I think also doctors prescribe it, but patients don't necessarily get all of it. So for multiple reasons. But we believe there's a large segment of patients, as you said. I think there were 85 patients in the greater than 100 units a day meeting segment at baseline and came down 65% reduction there. So I think just with what and that's not really a new finding. We've seen that before with Omnipod DASH in our previous publication with Dr. Anders Carlson from a couple of years ago, where there was also a 30% reduction in insulin as well. So now we've seen that with DASH and with Omnipod 5. And I think number one reason is it's much more physiological insulin delivery. And so people are getting it when they need it. And so that's important.
Then when you're delivering insulin subcutaneously, continuously, it's much more effective insulin as well. Really great to see that large reduction from multiple daily injections.
Okay. Maybe let's talk about the time in range results. Again, I think investors understand the time in range results or it means more to them. We've seen in the pivotals for O5, we've seen in the pivotals for Control-IQ, some of the other AID systems in Type 1. I think investors think 70% or higher is kind of where that time in range should settle out to be a successful study. Yours was 65%. But I think.
66.
See, I'm off by a point in all this. Sorry. I wrote 65. So either I'm wrong or you're wrong.
No, it was 66.
$2? $2 on it? Okay. Okay, 66%. Point being, talk about, again, the diverse patient population. I think when I talked to KOLs about this yesterday and over the last couple of days, it's that 20-point improvement. You started at such a low baseline time and range of 45%. When I went back to your pivotal for, and I might be getting you guys in Control-IQ mixed up, but when I went back to the O5 and the Control-IQ pivotals for Type 1, I think those starting time and ranges were like 50%, 55%. So yeah, you went to 70%, but it was like a 13, a 15, a 17-point increase. You guys saw a 20-point increase. So talk to me about one, that 20-point increase, how clinically relevant is that and how much that will mean more so than the absolute time and range.
Yeah. I mean, Jeff, it's an additional 5 hours a day that people are spending in range where they're thinking better and feeling better because their glucose is in range. So it's an incredible result. And where if we can get mass adoption, that's going to add years of life and reduce complications for people. It's an incredible result. So I think we spent way too much time talking about time in range and comparing between systems. The most important thing is unless these devices get out and get onto people, no one's really benefiting. So it has to be able to reach a broad population of users. And what we see every day in the real world, people don't go see their endocrinologist. They're stuck in PCP land and they don't have great outcomes.
And so it's not a surprise to me that people came in with a lower time in range. What traditionally happens with Type 1 studies, and I can say this because I've recruited for many, is people have waitlists of people who are eager participants of research studies. And they have financial stability and time to come and do research, but that's often not the typical patient that exists in the real world with living and trying to manage their disease and not reflective of the general population. So I think the time in range of 45% starting for us is pretty typical of the general population. If anything, probably a little higher than what the majority of people live with out in the real world. And so seeing that 20% reduction, in fact, Francisco and I were arguing.
He's like, "Well, I like the time and range more." And I'm like, "Well, A1C is important too. So we've got to be excited about both." And he's like, "No, but I'm really excited about the time and range." And I said, "Well, absolutely. But it's because of that that we get the A1C reduction." So I think that if you want to compare us to other systems, show me the diversity, show me the baseline A1C and time and range, and show me that a broad population of people can use your technology.
Yeah. And maybe we can talk about where that time and range came from, that improvement came from, because I think that's just as important if we're talking especially from a payer perspective, which is bringing down the time and hyper. And I think the payers are starting to understand, and you tell me if I'm wrong, you probably know this better than I do, but they're starting to understand that micro and macrovascular complications are driven by those hyper times. And I just wrote them down here. Time above 180, down 20%. Time above 300, which is pretty darn high, only down 5%, but it fell from 8% in baseline down to 2%. You almost took it away above 300. Is that going to be the kind of data you can put in front of payers and kind of support the reimbursement? Obviously, you already have it kind of.
I mean, payers are paying for O5 and don't really differentiate T1, T2. But I got to think that just helps you when you go to payers next year and the next few years when maybe competition is coming in and saying, "Look, we are going to save you money over the long term.
Yeah, absolutely. I think these are incredible results. And exactly as you say, not just hyperglycemia reduction, but in that high range. The high range that is what causes complications. And complications are a very real thing. It's not something often the far future. It absolutely is direct correlation there. So I think, as you mentioned, we have great reimbursement today. Over 90% of covered lives in the U.S., the majority of our patients pay less than $50 out of pocket. A third actually pays $0 out of pocket for their pods per month, which is incredible. So we're in a great position, but clinical data is what will ensure that payers see the value of this product and clinicians see the value and will continue to advocate for this type of product for their patients.
Yeah. And because you have that, the payers already cover this, essentially, but your doctors have to write it off.
Label.
Off-label. Thank you. To go to Type 2 since you don't have the label for O5. I've heard Jim's explanation, but he's biased. He's going to maybe not lie to me, but he's a little biased. Yeah, he's a little biased. You being down in the trenches and really as a physician understanding this, is it going to help when you can now go in or when your sales reps can go in and really talk openly about Type 2 use of O5 and things like that? How much will getting on-label T2 use of O5 really help in the field?
Yeah. Well, as I mentioned, it's off-label today.
Right. Let's say 6 months from now or whenever you get approved.
Yeah. I think that it's going to open up tremendous opportunity for us. And I would say on two fronts. One is that doctors don't prescribe unless there's a wraparound to tell them the benefits. That's clear from my interactions. They're short on time, short on cognitive space to think about these things. So it's really marketing is incredibly important and having people talking about it and their peers understanding it is really important. So we've got some work to do to really prep the market. We believe that when we get clearance for this product and commercialize next year, we will be first to market.
So there's market development work that we need to do to share the story and show people the results of the study and show people how to be able to feasibly in their practice, their busy practice of prescribing it if they've never prescribed it before. So we think that obviously in endo practices who are already prescribing Omnipod 5 today for their Type 1s, that's not going to be a huge change for them. But in the PCP practice where they're not used to using technology, then there's some work that we need to do there. Enormous opportunity, but that's going to take investment and market development on our part as well.
Yeah. And you brought up that maybe being on label will help even more in the PCPs, I think is kind of what you're saying. Talk to me about the PCP channel. You had a poster out this weekend that showed Omnipod 5, you could virtually train kids and adults. And I think you segmented the data, both kids and adults. And they had just as good onboarding experience, just as good, I believe, time in range and other things after a certain amount of time, as opposed to those patients who went in and got their hand-held and went through a pump class, a 2-hour, 3-hour, maybe multiple visits, things like that.
How many PCP offices out there today or even over the next few years, do you think could truly take on training in office, 2 or 3 hours, pump classes versus how important is it that you can just put an Omnipod on, they go home, they virtually train, and they get great results?
Yeah. So I think it's still work that we're exploring to better understand what's going to work in the PCP market. So I don't think we have all the answers yet, but as you mentioned, what the poster showed, and that actually was from 70,000 real-world users of the product. And what we showed there was really great outcomes regardless of whether it was in-person or virtual or self-guided training. And I think that's just so important to show because there's many parts in the world where there's long waitlists and we need a more scalable model. So in the PCP world, we're going to need a scalable model for sure. But we wanted to understand and learn, and that's why we've worked with PCP physicians such as Sean Oser and Tamara Oser and others to really understand the workflow and how to best bring Omnipod 5 to that market.
All right. And then maybe just bring it home on the SECURE-T2D trial. Pump penetration in Type 2 currently about 5%, probably even less than that in the U.S. Pump penetration for T1 about 40%. Pediatrics pump penetration in T1 probably what, 70%-80%? I think the ADA.
Possibly.
Okay. Maybe not quite that high, but at least 70%-80% of newly diagnosed going on pumps. Does that sound like a fair number? I thought I saw that from somebody.
Yeah. That sounds right.
Okay. So I've always used that as a, if 70% or 80% of newly diagnosed are going on pumps in Type 1, we waited out a generation. That's where penetration can eventually be for all pumpers in Type 1. So I feel pretty relatively comfortable pump penetration is going to move from 40 to something closer to 70% or plus in Type 1 over time. Where do you think Type 2 can go? Can Type 2 look and walk and talk like Type 1? So penetration gets similar there, or is it always going to be notably lower? Just what's your guess 5 years from now? I don't know what the word was I was looking for.
Yeah. I think it's really hard to predict. I don't think publicly we've given numbers out. But what I'll say is that even in Type 1 diabetes, Jeff, we showed a case yesterday. There was a woman who was on MDI for 31 years who just started Omnipod 5 and G7 this year. And Larry Hirsch, who's a well-known physician Endocrinologist, he started after 66 years. And he said to me, "Trang, I didn't want to use a tube to pump." So I think there's still a significant portion of people out there who are on multiple daily injections who are coasting along, and the physicians just haven't put that option on the table for them. So I think there's still enormous opportunity in the Type 1 space.
A lot of patients are actually taken care of in PCP land as well and don't always have the conversation about pump technology because in the past, it's been that, well, if you're on injections and you're doing okay, why rock the boat? Why add more complexity? But actually, Omnipod 5 is a simpler solution than injections, which is what makes it differentiated from other technologies. So I think we are really leading the way in terms of expanding that T1 penetration in both endos and PCPs for all of our patients, not just new, but also existing patients. So point number one. And then Type 2 diabetes, probably less than 5%. I mean, I talk to a lot of endos, and they're not really prescribing pumps for Type 2. So there I think enormous opportunity there.
I think the fact that CGM has been so incredibly successful in Type 2 gives me a lot of optimism about our runway because if they're using CGM, then they're going to see their glucose excursions and they're going to need insulin. What we're going to show is that our product works better than anything else. If you're thinking about insulin, then you should think about Omnipod 5. That's how far we want to advance our treatment in the treatment pathway.
Yes. Okay. And we've kind of moved into Type 1. So let's continue there. And then I want to come back to some of the GLP-1 data that you guys posted to your website earlier this weekend as well or over the weekend. But on the Type 1 side, we see a couple of new competitors trying to get into the market, talking about coming into the market, things like that. What is the bar to get into the market today? I mean, obviously, Control-IQ is a very good tube pump. You've got to improve form factor with Mobi there. So if you want a tube pump, you've even got now choice in wearability. Obviously, the patch pump with O5 is a fantastic patch pump. Do you have to solve for something that those two pumps are not solving for?
I just think as a physician and a former doc, I think about something, why would I go with something that doesn't have a track record that O5 now has, that even Control-IQ has, unless they're doing something different? Are there things that pumps don't do today that other companies could come in and exploit?
I would say that the bar is pretty high now. I do see that there's emerging technology, but I think people are looking for a patch pump and they're looking for AID. And so when people talk to me about technologies, I'm like, "Guys, the world doesn't need another standalone pump. The world wants AID and they want patch pump technology." So that's where I see it headed in terms of technology. And I think that what we can do better, what Insulet Omnipod can do better is actually doing more in the space with the technology we have. And we already have a head start there. So what we need to be focusing on, what the market wants is actually more reduction in burden for all of our users, both Type 1 and Type 2.
So today, all the hybrid closed-loop systems that are available require premeal bolusing and still require user interaction. And so there's more that we can do there to even further simplify the user experience. And what I will say just back to SECURE-T2D for a second is that we showed improvement in A1C, whether people came from multiple daily injections or basal, whether they came from GLP-1s or not, but also CGM or not. And then when they were on Omnipod 5, whether they were carb counting or using small, medium, large fixed numbers, it didn't really matter just as long as they were getting insulin and as long as they were doing some bolusing. And that was a really refreshing outcome from the study because in the past, we've just put so many barriers up for patients to access technology.
Like, "Oh, you need to be able to carb count," which nobody can do in the real world anyway properly. And so people are, "You have to do that. You have to check your blood sugar levels. You have to know how to give injections for six months." All of these barriers have made pump adoption much harder. And so to be able to show how simple and easy the product is, is incredibly important. So we're doing that. Insulet is doing that in terms of, "Okay, where can Omnipod 5 get better? And how can we improve the user experience for our patients and clinicians as well?" So how do we reduce onboarding requirements for clinicians so that they don't have to figure out insulin-to-carb ratios and things like that?
We're looking at all of those things to improve user experience for patients and doctors so that device adoption can accelerate and so we can help more people.
Okay. Maybe if we put some formal structure around that, you did talk about yesterday the STRIVE program, the SmartAdjust 2.0. Is that right?
Yes.
Sorry. SmartAdjust 2.0. How are we as investors going to see that? Will there be feasibility trials? Will there be small samples of trial patients that we see over the next 6, 12, 18 months? And just to be clear, that is primarily going to bring set points lower than the 110 set point. So give even additional tighter control for those patients who want it, who maybe aren't as worried about hypo.
Yes. That's right.
What other features? And I know you haven't really said, and so that's probably what you'll tell me, but anything else that you'd be comfortable saying that might get worked in there on a STRIVE SmartAdjust 2.0 pump?
Yeah. Thanks for the mention. So what I will say is that today, Omnipod 5 is a really fantastic product. And we built it to have a SIM card in each controller. And so we get data from every single user in the U.S. and actually over 95% of our users internationally as well who consent to give us data. And what that allows us to do is have a population perspective on how all of our users are doing. And that's really important because in the past, the big data sets you've seen coming out of other pump companies have been heavily reliant on people who manually upload. And so they're only seeing a segment of the population. They're not seeing all the ones.
They're probably a biased segment, right, of those patients who are more willing to be involved in their tests.
Yes. Absolutely. That's been proven out and published that that is a biased, more engaged population who have better outcomes. So we have that advantage of seeing data from everybody. And so with this enormous data set, we've been able to say, "Look, we just need to make small tweaks here and small tweaks here, and we could actually lift the outcomes for so many of our patients." And then the other thing I'll say is that actually, I know our competitors talk a lot about our algorithm, but our algorithm performs incredibly well. I mentioned yesterday 71% time in range for people who come straight from injections onto our product from our real-world data set. And so when we looked at the big data sets, we also look at the utilization of our targets. And Greg showed this yesterday.
So roughly 50% of our users are using the lowest set point of 110. And what that tells me is that actually there's a lot of people who are running very comfortably at those higher targets, and they may be getting 65% time in range, but they're very happy about hypoglycemia protection, and they're not wanting to lower their targets. So I think that's great because we designed a product specifically with multiple glycemic targets to fit everybody's needs. What we saw in the Type 2 study actually was people who had A1Cs in the teens. It's actually dangerous to bring their blood sugar down quickly. You can exacerbate the risk of retinopathy if they suddenly get a lot of insulin without, you can run into edema and other complications.
So what's useful with our system with the higher targets is you can bring people down and bring their glucose range down slowly over time. So we have patients in the study started at 150, slowly brought them down to 130, and they sat very comfortably at 130 for the rest of the study, and they're happy about it. So I think our competitors talk about low targets and things like that, but that's not all we care about. We care about patient satisfaction, safe insulin delivery. Our hypoglycemia data is pristine, right? Across Type 1, Type 2, it's pristine. That's why the moms and dads prescribe want this product for their patients and why people from all over the world want this product. So I think it's a clear advantage for us, but we want to continue to meet the needs of all of our users.
And so that's why our next algorithm will have lower targets as well as a number of enhancements to.
Unnamed enhancements?
Unnamed enhancements. That's for competitive reasons as well. In terms of feasibility, we have a lot of in silico data that we were able to generate just because of the incredible data sets we have. We will be entering studies in clinic shortly with her to prove it out because anytime you're making adjustments to the algorithm that may deliver more insulin, you're going to increase the risk of hypoglycemia. So that's something we clearly care deeply about, and we want to make sure that the product is safe.
Yeah. Well, I think it's a natural Evolution of your company, right? I mean, you were so over-biased towards kids that, of course, you wanted hypo protection initially. And now as you expand more into the adults, or is that an oversimplification on my point?
No. We've always cared about the whole spectrum. The very first studies were done in adults, and then we gradually moved it down. And actually, when we moved it down to kids, we saw a fair bit more hypoglycemia. So we had to dial it back a little bit. And so we've invested heavily in prospective clinical trials that in a diverse population also in terms of insulin needs to really understand how our algorithm performs across the space. And so that's why Omnipod 5 is so successful. And I think also we have a lot of experience in algorithms. In the early days and even today, sensors are not perfect. And so you've got to be really careful if there is a sensor that's overreading and the risk of hypoglycemia. So you need actually constraints within the algorithm that are non-CGM constraints.
So you need a really robust algorithm to handle all of that. And so I know that there's other algorithms out there, but our algorithm is incredibly safe, both safe and effective, and it's validated through our real-world evidence.
Okay. We're down to 5 minutes. So I'm going to ask you just maybe 4 or 5 quick questions, 30 seconds each. You and I both have a propensity to talk, so let's try to keep it.
Are you saying I talk too much?
No, that's not at all what I meant by that. I have a propensity to talk.
Okay. All right. Let's go.
Okay. O5 G7.
Yes.
How excited are the docs to get O5 G7? Do you think there truly have been G7 MDI patients out there just waiting to get O5?
Yes. Yes. Yes.
Yes. That simple?
Let's go. Yes.
Okay. Now I see you're throwing me off my game. Now I'm confused as to where I'm going. Oh, let's go back to you mentioned closed-loop therapy.
Yes.
We're probably several years away from that, I would assume, maybe at the earliest. You did show some data out of New Zealand, very small sample size. Will we see progressively bigger data sets? I know you've had to go back and rejigger even off that small little feasibility. How do we think about the timeline there?
Yeah. It's really important to test clinical trials, as I mentioned. Early studies in New Zealand were really fantastic. It was Type 2 population. I think we got to 65% time in range in our Type 2s without bolusing, which is incredible. But we need to continue to invest in clinical studies there to really prove that out before we can go there. And so no timelines yet, except we did say that Evolution 2 is about to start. So that's our next iteration.
I didn't realize that.
Yeah. I think you maybe had an investor tour yesterday, so maybe you like.
Maybe I wasn't even listening. So, okay. It's been a long weekend. Okay. Let's move on.
That's coming.
Okay. Evolution 2.0 is coming. Okay. iOS G6.
Yes.
Is iOS G6 as important as G7?
I would say G7 is important in terms of our growth. That's really important for growth. G7 is important, but we have started our iOS G6 limited launch just on Thursday. We announced that. So that's super exciting. That's going to be an incredible product teaser for our current users, we believe. Our current base is incredibly excited about that. We're going to launch and then grow the launch slowly or quickly as the data comes in and to get that out to as many people as quickly as possible. So that's really important. We're super excited. We showed a video yesterday. It was beautiful. But G7 is very important for us in terms of growth.
G7 O5.
Yes.
Yeah. What about G7 iOS? I think.
It's coming. We haven't announced timing.
I do think Eric said yesterday in our booth tour, so I do remember some things from that. You weren't here. He said it.
What did he say?
He said that the heavy lifting was getting to iOS G6.
That's true.
The data and communication security protocols for G6 to G7 are not a whole new process. So he made it sound like there can be a quicker move from iOS G6 to iOS G7 as opposed to what we hear L2 plus going to L3 are two completely different communication security protocols, that that's like just starting an entirely new project.
Yeah. That sounds right. Yes. So it's not starting from zero.
I disagree with that.
Yes.
Well, I think we're down to about one minute. I'm going to leave it to you. Is there anything I didn't ask about? I know some GLP-1 stuff we could have gotten to and then things like that, but any message you want to leave investors with or leave me with?
Well, we talked about G7. You always leave out Libre.
I'm a Dexcom guy, and Amber doesn't like me because I'm a Dexcom guy. So that, okay.
No, U.K., Netherlands, full market release of FreeStyle Libre 2 Plus Omnipod 5. That means our patients can choose their sensor of choice with the best tubeless option in those countries. And we're incredibly proud. We announced that on Thursday as well.
Yeah. Fair enough. I will say the response I've seen from U.K. docs is far ahead with O5, both Dexcom and maybe I haven't checked on Libre yet. But I mean, what is it about O5? Is there a U.K. reason? I've been surprised at how passionate some of the U.K. docs I've talked to have been about adopting O5.
Because it's the best.
Okay. Maybe we'll just leave it there because it's the best. We'll just leave it there. Dr. Ly, thank you so much for your time. This was fun again. I appreciate the time. Hopefully, it wasn't too heavy on the science and the data.
Always a pleasure, Jeff.
Mine as well. So thank you, everyone, for joining us. And hopefully, that's a wrap on ADA 2024. Have a good day.
Thanks, everyone.