Seem to have fun doing these. Where should we start? It's been a long few days. Lots of data, lots of numbers. Maybe because I'm a simple guy, let's talk about Type 1 to start. We'll start Type 1 and then go down from there. Type 1, your RADIANT trial.
Yes.
That was probably the newest data that you guys had out.
Yeah, that's right, yeah.
hundred eighty-eight patients, France, U.K., Belgium. It was with the Libre 2 sensor. Why don't you just give me your takeaways from that trial and what was important about it?
Yeah, so I think what is different about this trial from the other studies is, as you mentioned, we use the Omnipod 5 connected with Freestyle Libre 2 sensor. Also, this is not a group of patients who normally participate in trials early on. It was a more representative group of people. These were people who were on multiple daily injections who had an elevated A1C, so above 7.5%. These are all people who are waiting on the sidelines. In the market, there are tubed AID options, but no tubeless options. Despite the fact that there were other competitive AID systems out there, people were still not switching from MDI.
We took both children and adults who were on MDI and already using a Libre sensor, and then we put them onto Omnipod 5 and kept them on their Freestyle Libre 2 sensor and then studied them for three months. It was a randomized control trial and we saw a really fantastic reduction in A1C. Their A1Cs dropped by 0.8% and also saw a really massive increase in time in range. Their time in range increased by 22% and we got to 66% time in range. If you look across all the Type 1 data, that's a massive improvement in time in range. Very minimal hypoglycemia, no serious adverse events. Very proud of that data. Especially because we took people who were on injections and we put them straight onto Omnipod 5.
In some of the other AID systems, people have to go through a run-in period where they're using the pump only for a couple of weeks before they go on to AID. It really just goes to show the. One of the key differentiators of Omnipod 5 is the simplicity of the product.
Yeah, no, that's fair. And you know, you talked about this is a challenging patient population. Is that why the time in range at startup was 39%? Is that kind of what that's indicative of. I would assume that's right. And then when I think back to your Omnipod 5 pivotal data back from a couple years ago, I think the time in range there was up to 74% or 75%.
That's right.
Is the better metric here to look at that change in time in range, the 20 some points you talked about here? I think the O5 was like nine points because you started with healthier patients, is that right?
That's right. When you compare these studies, you know, across the different studies, you always have to take a look at, you know, what is the population that we're testing, what are the baseline metrics? Is that representative of the general population or is it a representation of all the early adopters with better glucose control who come in and they can reach those, you know, 74% we got to in the study and, you know, we certainly can get there and actually 25% of our patients in our real world data sets get greater than 78% time in range. We can certainly get there. What, you know, we often care about is how is the whole population doing and can we shift that whole population up so that we can really see improvement in a broader population of patients?
Okay, that's great. Let me ask you a question. Maybe on type one, just kind of a, I don't know, it's a little bit of an underlying kind of feeling I'm just getting from the meetings here and that is that in type one. You know, I think over the last several ATTD's you hear about, well, NHS isn't yet paying necessarily for AID pumps. They have been now over the last year or two, but some of the other markets haven't and things like that. It just feels like there's an accelerating movement maybe to AID uptake, even here in Europe. Obviously we've seen that for a few years now in.
Yes.
In the U.S. Just want to comment there. Then I want to ask you about some numbers I heard out of a study in Leicester or Leicester or whatever in the U.K. Just generally speaking, how is AID uptake in Europe today versus maybe even a couple years ago?
Yeah. The NHS has recommended the NICE guidelines, have recommended hybrid closed loop for people living with Type 1 diabetes. There is a mandate to get the majority of people onto AID systems and it is because of the incredibly strong evidence for superior outcomes with technology and AID. Especially in the last year, in the last 12 months, we've seen really massive adoption in the U.K., but what I will say is the, you know, resources are constrained across the U.K. and so there were very long wait times at a lot of clinics. I spoke to one of our clinicians in the U.K. and she said this was in April of last year.
She said that for a new patient waiting to get onto an AID system, brand new, newly diagnosed, if someone walked into her office it would be two years before they could get onto AID, which is like mind blowing. I think the technology, the outcomes are proven, but the clinical sites capacity and actual implementation of that has been challenging. I think your next follow up question.
Yeah, no, two years, that's like Canada timelines almost and I love Canada. Just to be clear, that has no comment on anything other than I love Canada. The Leicester study, or Leicester. Leicester, Leicester. Thank you.
Lester.
Lester. Okay, see I didn't even hear what you said there. Sorry. All right, Lester. Interesting here, at least the presentation I sat in earlier today and I think some of this even came out at your symposium yesterday that I apologize, I did not attend because other data was coming out elsewhere. In the presentation today they were doing 30 AID starts a year. A year or two ago, yeah. From a CGM perspective they figured out a couple years ago like you could have these huge training sessions like literally fill up an auditorium. They started doing that on AIDs.
Yes.
They started running two 20 person training sessions a day. I don't know how many days a week or whatever. I guess I didn't get that data. They did 367 AID starts in eight months after doing 30 a year.
Yes.
A year ago.
Yes, yes.
What does that say one about the need for AID. More importantly, I don't know that they used all O5 but I'll bet a lot of it was. What does it say about the training? The ease of training with O5 versus maybe a tubed pump?
Yeah, no, it is actually on Omnipod.
Is it all five? Okay, I wasn't sure on that.
Yeah, so it's because it is so easy to use and simple. In the U.K. there's a lot of centers taking some really innovative approaches and it is because of the ease of use of CGM you said and their experience with that. Their philosophy is rather than carefully doing one at a time, let's just get everybody on and then prioritize the follow-up through the data. One, your product has to be simple and easy to use, which Omnipod 5 is, and then the other key differentiator is the data. Our data automatically goes to the cloud so the physician can log on a week later and see all their patients and see all their outcomes and not have to rely on patients like knowing how to upload to the cloud in order to get the data.
I think that combination has allowed sites like Leicester to really increase their trainings tenfold. In the same vein, there was a publication that came out of Manchester, U.K. from Hood Thabit's group where they did 56 trainings in one day and O5 on. O5 . That was just with O5. That's an incredible amount of patients. Like to give people an idea, there are some clinics in the U.K. that are doing 56 in a year.
Oh yeah.
They think that that's a good, good number. To do 56 in a day is phenomenal. That's not with all AID systems. It's because of Omnipod 5 and the data package that comes with it.
Yeah, no, they had a flash poll in, whose symposium was it today, in Abbott's symposium.
Okay.
Asked just how many CGMs do you do a year? Yeah, I mean this is a pretty biased crowd. This is like a tech favoring crowd.
Yeah. Early adopters.
Yeah, early adopter. 80% of people said they do 1-100 CGM starts a year. That was a lot lower than I thought for a biased, tech savvy early adopter population here at this show.
Yeah.
I do not know if that means much, but I thought it was interesting. There was one other thing I wanted to—oh no, you brought up the standardization and I think in the Leicester stuff it was like they just went with what they set basal rate. It is like 40% of TDD of total daily dose and some other standardization stuff and all that. It kind of segues into a couple things I want to talk to, especially on Type 2. Anything else on Type 1?
Yeah, I think that you want to.
Talk about before we go to Type 2 .
I think we've covered it. RADIANT, you know, great results. Randomized control trial. Now we've got, you know, Insulet has a couple of randomized controls off that has come out recently and then all the real world data has come out as well. All supportive make, you know, it's clear that there are superior outcomes using AID in Type 1. That's clear.
Yeah. You do have sensor of choice now. I guess maybe we'll talk that before we go to Type 2 . You know, what does that mean, do you have a personal favorite in one of your two partners, which I'm sure on camera the answer is no, but I'll let you answer that question. It's also interesting, you know, you walk around here and there's probably, I don't know, what, seven or eight CGM companies outside of the ones US investors know about. That's right, most of them from Asia. Most of them will tell me they have a MARD of eight, nine, nine and a half, something like that. If you really look at the 20/20 data , the 15/15 data
Would you ever consider stepping out of your kind of core sensor of choice partners today?
Yeah, what I would say is, you know we are really proud of our sensor integrations with both Dexcom and Abbott. These are both industry leading sensors with excellent accuracy. When you're using a CGM to power an AID system since the accuracy, reliability, usability are all incredibly important. I think that the experience that I've seen in clinical practice with all the data that we see, you know those two are definitely differentiated from some of the sensors that I've seen on the market. I think there's also emerging evidence that, you know, not all sensors are equal and certainly the real world performance is sometimes not quite mirroring what some of the regulatory studies showed.
There was a recent publication that came out of the German group, Guido Freckmann's group, that showed they took about 24 adults with diabetes and they got them to wear all three sensors. So a Dexcom G7 sensor, a Libre 3 sensor, and also a Medtronic sensor. They did YSI measurements. That's the gold standard where you're taking blood and you're checking it as a reference and then also BG measurements over two, two weeks and the, the curves are clear. Both Dexcom and Libre were very, very close to the YSI, almost indistinguishable. And you know, great MAD, but you know, Medtronic sensor actually did show a negative bias towards the YSI. What that means is that that's going to impact the time in range outcomes that they're reporting.
It was underreporting.
Right. It was under. The sensor was under reading.
Under reading.
That would lead to an over reporting of time in range for the exact same patient. It was fairly significant. For these 24 patients, they reported a difference of actually up to 8% difference in time in range with Medtronic in the 80s and the other two sensors in the 70s. It is just something for people to think about that not all sensors are equal. You know, as an insulin pump company, we take sensor accuracy and performance very seriously and we are very confident in our current sensor partners.
Yeah, all right, fair enough. Let's move on to that Type 2 topic then. On the Type 2, you had a couple sub analyses out this week on your SECURE-T2D data, which I always struggle to say that, so I got it out clearly. On that data, I think two things stood out to me other than just the strength of the overall SECURE data. If you want to rehash that for the call here, you can. I think generally speaking, you know, I want to look first at a subcut on the GLP-1 data.
Yes.
Where you definitely showed that patients coming into the trial who were on a GLP-1, you put them on Omnipod 5 and they got the same level of A1C drop and the same increase in time in range.
Yes.
I think a lot of investors ask me, Jeff, if they're on a GLP-1, doesn't that stop their diabetes, their progression of Type 2? They don't need a pump, they don't need a CGM, they don't need any. I think this data clearly shows to me anyway that, yeah, you might be on a GLP-1 and controlling your diabetes, you might be on a GLP-1 and controlling your obesity if you also have obesity, but there's still improvements that an AID can bring to the table, like meaningful improvements.
That's right. I think what the data shows is that even if you're on a GLP-1, if you have diabetes, then there's still progressive beta cell loss that occurs over time. I think the one finding is, look, there are people with Type 2 diabetes on a GLP-1 and oh my gosh, their A1C is still in the nines and we managed to recruit them into the study. Both us and others have shown that. Not everyone is cured on a GLP-1. I think that's one finding, right, that people on GLP-1 still have high A1C. What we showed through our study is that whether you came in on a GLP-1 or not, you still got the same significant A1C reduction.
In our study, 305 patients with Type 2 diabetes, single arm study, we saw A1C come down by 0.8% and those who came in with A1C greater than 9% came down by 2.1%. Greater than 2% reduction if you had a higher baseline A1C.
Yeah, fair enough. The other group, similar to the GLP-1 that I thought was interesting was—now I'm blanking. Help me out. I asked you about this yesterday. What was it? Oh, no, no, no, not SGLT2, the simple bolusing.
Yes.
You know, when we saw this, I hate to say 2 IQP from Tandem, but you're up in your competitors' T2 data that came out yesterday or on Wednesday, they showed a similar. I'll come back to that, maybe in a second, but they showed. What did they show? I'm gonna have to look at my notes now because I don't remember. Oh, instead of carb counters, which some patients are strict carb counters, but in Type 2, there's not as many carb counters out there. Right. A lot of these patients are older, they haven't grown up with diabetes, so they don't know how to carb count. They haven't been trained. You could put in, say, I'm eating 30 grams of carbs for every single meal, just kind of guess at it and just put the same one for breakfast, for lunch, for dinner.
Yes.
You could say, I'm eating a big breakfast, I'm eating a small dinner. You could do either meal size, you could do just a fixed kind of carb count at every meal, and yet same thing versus those two. Strictly carb counted. The A1C reduction was almost exactly the same and the time in range improvement was almost exactly the same. What does that tell us about the importance of carb counting versus, you know, you can just kind of get close enough and these systems work pretty darn good. Well,
yeah. Can I share this story about carb counting? About eight years ago, I attended a diabetes educator conference and we were supposed to have a celebrity chef and his apartment in New York caught on fire so he could not make it. I had to be on stage cooking. I was the entertainment and I cooked. I made shrimp and grits and you.
Look like a southern girl. Yeah, I mean that's just natural.
It was just and only time I've made shrimp and grits. I had a room full of diabetes dietitians and educators and they all had the recipes on their table. They were watching a video of me cooking. They could see the serving sizes. I cooked it, I plated it up, we served everyone. I asked them, what do you think the carb count is in this, on the plate that I have served you? Right. Like a pretty fair question, right? Educate a group, the people who are teaching our patients. The estimates for the carb content range between 15 grams to 90 grams.
15 to 90. I'll take the upper end of that with grits.
A six fold difference. Yeah, six fold difference. I was like, if we can't get a little closer in this room full of educated people, how do we expect our patients to do any good on this run? I don't think anyone is great at carb counting. Unless you're carrying a, you know, a set of scales around with you, which nobody does, I just don't think it's a very accurate craft. It's probably something we've made up over time to make us all feel better that we're doing something for our patients. Actually, it's just more work, more burden that the community has put on our patients unnecessarily. What we've shown through SECURE T2D is that our patients don't need to carb count and it's not required. People do very well on our product with very simple bolusing.
We actually have a custom foods feature in the product for all of our Android and iOS users where doctors and clinicians can go in and program a small, medium, large meal or their breakfast of choice, lunch of choice and the associated grams so that people do not have to do that math every day to make life simpler for patients. I think all of those things. At this conference, Georgia Davis yesterday presented that poster and there was a lot of interest because a lot of what we do here at these conferences is talk to healthcare professionals about how to implement this technology for patients, and actually how to implement faster and get AID to as many people as possible.
Yeah, that's very interesting. I mean, do you imagine over the next couple years and maybe this gets into SmartAdjust 2.0? I don't know. Maybe we'll segue over to that in a few minutes. Is that where we're going, just getting completely away from carb counting, or, hey, if you want to do it. Is there a difference in Type 1s, or could Type 1s kind of do this simplified bolusing strategy as well?
Yeah, I think anyone could benefit from simplified bolusing. I don't think that carb counting is necessary for Type 1 or Type 2. I actually think our data from both Type 1 and Type 2, we showed that in a poster yesterday. Dr. Virali Shah did a retrospective review of the patients in our pivotal trials for both Type 1 and Type 2 and looked back at time in range outcomes. Very, very similar outcomes for time in range. Hypoglycemia was less in the Type 2 group, but time in range was about the same. All that to say, the carbs. I don't think carb counting is necessary.
Okay, all right, let's see. Maybe that is the time to transition over. No, you don't want one other question on Type 2 and then maybe we'll go over to SA 2.0, but just T2 in general. I asked you the same kind of thing. What are you hearing on Type 1 uptake? You know, I think what struck me last year after your T2D data was presented, and I said this in my note afterwards, were a couple US KOLs who got up at the podium and was like, look, this is fantastic data. We need to rethink about getting all of our Type 2s on an AID system, on an 05 especially. That's what they said last year. The US KOLs and a couple of Europeans KOLs stood up and say, it must be nice to be American.
Which they're probably not saying at this conference now, but they might have said, must be nice to be American because we're not going to get reimbursement for Type 2 in a long time.
Yeah.
What's your view of the Type 2 uptake of AID in the US? What are you hearing from docs there? Are the KOL views starting to percolate down to other academics, to PCPs, things like that? What are you thinking about Type 2 uptake of AID in the US, and then how do you think about it in Europe, where obviously reimbursement is going to be a much bigger hurdle?
Yeah. In the U.S. we're doing very well in Type 2 and I do think it's differentiated because of our clinical outcomes and also our pharmacy access and low out of pocket costs for patients to start. I think those are very key things. We saw, I think in our last earnings, we said up to 30% of our new patient starts had Type 2 diabetes.
It was just over 30%.
It was, it.
Jim will tell me if I'm wrong on that, but I think it was just. Okay, that was a good number. It was a good number.
It's a great number. I think what that shows is we are getting the word out and I do think it does definitely first start with our endo population. The endos that I've been speaking to certainly are much more confident to prescribe it, given the new data. There's a lot of interest with the PCP population as well. I think we're doing great in the US and that's borne out through our numbers. I think internationally there's a lot of work to do in terms of reimbursement and data and advocacy that needs to be done, but we're excited to see that as another opportunity for Insulet to help more patients.
Fair enough. Can we use the learnings from the Leicester conversation we had earlier about just how easy it is to get on a pump and the training, the lack of training that you have to do with these patients in that anyway, that in the PCP channel in the U.S., is there a kind of a read from one to the other?
Yeah, absolutely. I think, you know, going into PCPs, we've got to really rethink our training strategy and how do we scale training and data management and all of those things. I think what the Leicester experience, the Manchester experience clearly shows is that it is simple and easy to use and it can be done. We have some market development to do in the PCP world in the US because before it really blows. I'd say,
I mean, the way I talk with investors about it and just tell me if you think I'm wrong on this, but there's so much room to penetrate in the endo channel for the next couple years. You guys could probably put almost all of your efforts there, which I know you're not going to do, but you probably could.
Yes.
You have plenty of room to run there before you even have to worry about getting down into the PCP part of the channel.
That's right, yeah. We want to and that totally makes sense as well because the endos are in general taking care of some of the sicker patients. That's where the resources should go. We should help those patients first, those on MDI who are being seen there. Certainly we're reaching those diabetologists focused PCPs as well. If you're prescribing Omnipod for Type 1, generally, you're pretty comfortable with prescribing it for Type 2 is what we've shown the data shows.
Okay, that's helpful. I won't bring up too much of the two IQP data. No, no, I don't want to see your face get all red and you get all mad and mean. Trang Ly . Mean Dr. Ly comes out now. Here, let me ask you this. The data looked good, right? I mean, the time in range for them and for you looks good.
In Type 2,
we're slightly ahead at 66% and they came in at 60%.
Different patient populations. Let's be fair and keep it all level. Time in range is good for both. A1C reduction is good for both. What I did notice, and I just don't understand, and maybe you can help me understand. I think there was a bigger reduction in insulin use in your using Omnipod 5 versus Control-IQ.
Yes.
I didn't understand why. It was like meaningful difference in reduction in insulin use by a percentage and total daily dose at the end of the study, if I remember. I just, I couldn't figure that one out.
Yeah, so you're spot on. Very similar in terms of a patient profile, demographics, baseline demographics. Yes, two completely different studies, different patient population. Both studies actually started at a baseline A1C of 8.1%. We had very similar recruitment targets to recruit a diverse group of patients with different insulin requirements. What we showed in our study was the total daily dose dropping from about 80 units a day down to 57 units a day. That was a 29% reduction in insulin use. Whereas in their study, they started at 95 units and they got down to 87 units. There's a big difference in the total insulin that the two companies needed in order to get pretty similar time in range results.
I think what I'd say is, you know, more to come from that front, but they also saw more weight gain as well. If you look at their total weight gain in their intervention group, it was a mean of 2.4 kg. If you minus the control arm out, it's still 1.5 kg, as opposed to in SECURE-T2D, we saw 0.8 kg. We saw less insulin used, less weight gain. We also saw fewer boluses given as well, so, you know, less work. I think all in all, actually, these results are great for the community because it shows that AID systems are highly effective for people with Type 2 diabetes. That's actually still a new concept outside of this conference. I think it's great.
I think the more companies that are talking about the effectiveness of AID in Type 2 diabetes is better for the community and better for our company. All in all, you know, pretty similar results in efficacy. I do think we're ahead in terms of the weight gain and insulin utilization.
Okay. On the insulin utilization, we can't rack that up to just different patient study populations. Their population maybe just happen to be higher insulin users. Could it be that simple?
It could be, but actually, if we just looked at our MDI patients versus theirs, the starting TDD was roughly the same in the 90s.
Okay, I didn't see that.
I do think. I think there's a lot to be said about the form factor of pod. Because Omnipod is always on the body, they're always getting insulin. They're getting continuous insulin delivery. With a tubed pump, people do take it off. They take it off for showering, they take it off when they exercise, if they're swimming. You just sometimes you don't know exactly if they're getting all that insulin that is being delivered. I think the other thing that is challenging in the Type 2 space is sometimes they're so insulin resistant that even if you're giving more insulin, you're not necessarily getting more improvement in time in range. You know, there are multiple reasons contributing to that.
You know, I do think having continuous insulin delivering into the body all the time is a physiological advantage of the form factor of pod.
Okay. On the weight gain, again, I just.
Yes.
What Dr. Pinsker said yesterday, and you can believe this, not believe this, that's fine. What he did say yesterday is, I think I'm saying this right, that they think they reverse some insulin or something. Is that how I'd think about it? Or these patients were thin, unhealthy patients, and you kind of.
They. They weren't that thin. They were.
Yeah, that's fair. Maybe thin wasn't the right word, but I guess in New England Journal and hit from the podium. They kind of said some of that might have been they took some sicker patients and made them healthier.
Yes.
Is that fair? I'm not asking if that's fair because I don't want to put you against him. I'm just saying, you know, that that made some sense to me.
It's a true statement in that. Yes. When you take a person with Type 2 diabetes who is insulin deficient and they have an elevated A1C and you give them insulin, there is more of a chance of increasing weight. Also, same rationale that we provided when we saw our small weight gain results. The rationale is right. I would say again, back to the population. Very similar A1C, very similar starting weight.
Yeah. I'm not trying to play off each other. I just defend them. That's what he said. He's not here to comment on that. Okay, let's talk about kind of some future algo work. Yeah, I don't. There was no STRIVE data here because I guess you're just starting to enroll it, so there can't be. That is a pivotal. I think it's. I thought I had it written down and I didn't hear. Remind me how many. How many patients? Roughly 160 or something. 160 patients. It's big enough to be a pivotal. It will be a pivotal.
Yes.
Enrolling now? Yes, next week, I think next week. Let's say it's a few months to enroll. It's a 13-week trial. Yes, a few months there. We get it by early fall, you work on it for a few months, you submit it. We could have 2.0 out somewhere in kind of mid 2026.
We haven't provided timing for when it will be. What we said at this conference was that we're starting the trial and that it will be an update to the SmartAdjust 1.0 that powers Omnipod 5 today. It will have a lower glucose target. It will have improved user experience for our patients. We haven't said exactly when with timing. When we roll these things out, it will require changes in product. We just got to orchestrate all of that.
Okay. On the lower settings, I think most of the data you guys show tends to show when you're using the lowest setting, a lot of times the real world data and that you'll show.
We share everything.
You should. Okay.
No, I know I'm saying no, but.
We have the data looks best. When that's true, you use the most aggressive setting. Is that 100 or 110? I just can't remember.
It's 110, 110.
I think the lowest setting is that Sequel is coming out at like 87 or something, I think. That will be the lowest, right?
Yes. Okay. What we've had,
you guys talked about what, how low you'll go with the setting, and I guess the corollary to that is, I would assume it's because you're seeing such a lack of hypo.
Yeah.
That you're comfortable going even lower and more aggressive settings.
Yeah. It's not all about the target, but yes, we are going to a lower target and we think that'll meet the needs of a lot of our patients. I think it's also how the insulin is getting delivered across different populations as well that will be beneficial in our next round. What we see from our data is actually across the board, only 50% of our patients consistently use the 110 target.
Oh, is that right?
Yeah. People actually do like running at 120 and sometimes a little bit higher for hyper protection. That is actually a unique feature of our system that you could set, like if you have a new Type 2 user. Actually, we saw this in our Type 2 data was when they came in, actually people would run them at a higher target for a few days to get them used to AID and then drop them down to 110. They'd start off, say, at 140 and drop down to 110. I think that gives people flexibility because there is even actually in the U.K. there's a poster here showing the discussing, you know, if you drop people too quickly, it can exacerbate retinopathy. I think there is that worry still that if you improve glycemic control too quickly, that can cause issues.
I think one of the benefits of our system is the ability to customize and have different targets, and clinicians can personalize that glucose control for their patients. Yes, our lowest is 110. A lot of the data that we show is at 110 because the majority of our users do use that. I think we'll be very competitive today. We'll continue to be competitive in our next iteration. For me, I think safety is really important, you know, it is why we have such a great adoption is because our product is both safe and effective. We have the lowest hypoglycemia across the board. When you look at all the companies, and that's really important for all the mums and dads out there who are thinking about what product to have for their child.
Actually, there is no prospective data for 87 target for a general population of users who are not highly engaged. There is no safety data in real patients for that.
Yeah, fair enough. Fair enough. On 2.0, before we talk about Evolution 2.0, the lower settings, will there be any simplified bolus strategies in that? Anything else you can say?
Yeah, we can't say exactly what it is, but we already have that simplified bolusing today through the Custom Foods. Yeah. I think where it's certainly what we want to be messaging is that you just. The whole carb counting thing is a fallacy and we need to be moving to simple measures and you just got to get insulin into people and pod therapy is the easiest and most effective way to get that done.
Okay, fair enough. So evolution.
Yes.
You showed some very early data on like six patients or something last year. Was it more than that?
It's more than that. It was 8 to 12ish.
Oh, was it 8-12. Okay, sorry, I was trying to remember.
Ballpark.
Ballpark. Six, eight,
12. Right. Yeah.
I'm only off by 100%. Next gen algo.
Yes.
Now that is where then maybe we get into things. Like what? Like what would be a next gen higher level that you could talk about kind of thing that algos need to go to closed loop, I would assume.
Yes. In the symposium that you missed, what I talked about was.
I heard it was a stunner.
600 people.
I know. Minding the doors. I know, I heard.
That's why I didn't go.
That's why I went to Tandem. It was too busy. Wasn't worth my time. If I can't sit, I don't go.
You know, there's always a seat out the front saved for you, Jeff. I talked about Evolution 2, which is our next generation of feasibility studies, and we did declare that it is our next gen algorithm for Type 2 diabetes and it will be full closed loop.
Yeah. Okay.
No meal announcement, no premeal bolusing. We just want to do full closed loop for Type 2 because we believe that is what people want and need in order for the upcoming take to really make a difference on a population level for Type 2 diabetes. You're right. Regarding Evolution 1, we presented data on that last year at ATTD. Martin de Bock presented that, and it was our first foray into Type 2 with full closed loop and actually Type 1 as well. We shared both Type 1 and Type 2 data, and these studies are just so important for us to learn and understand where the opportunities are to improve insulin delivery. What we saw was actually, although from a Type 2 perspective, although it worked really well across the board, we saw 65% time in range with no bolusing, which is pretty amazing. The.
With that time in range, there were a couple of patients there who we couldn't improve their time in range even though we were delivering a lot of insulin. We are looking at making sure that we can really optimize insulin delivery to get the optimal time in range. This set of studies that we'll do this year will be sort of the next run at that. We just want to make sure we have the best algorithm before it comes to market. Super exciting. Full closed loop in Type 2 . You know, we're constantly looking at opportunities to improve both in Type 1 and Type 2 . Yeah.
If that's a feasibility study, then I kind of fast forward a year until you get past that, and then you kind of maybe another feasibility, who knows? Then a pivotal. We're still talking a couple few years before we'd probably start to see a CLC kind of T2 option.
Yeah, we haven't said anything about timing, but.
At least the way I'm laying it out is logical.
Yes. What you're laying out is logical.
Yeah. Okay. And, you know, one question I've always had on CLC or on closed loop is a lot. Even here you're seeing data, like if you. If you. Even if you don't carb count, if you at least announce something before the meal.
Yes.
Much less risk of drift and rebound hypo and all that. Even if you have just bolus 10 minutes after your meal.
Yes.
It's a lot worse. Do you need to have, like, a meal detection strategy of some sort?
Yeah. Yeah. You know, for people who've been doing this for a long time, like, that's what all these algorithms do, that we're constantly looking for meals. And it's all meal detection.
It is.
Okay, so.
Not just like the cluey, like, oh, I see the arm is moving, and that looks like it's moving like a fork is going to the mouth. That's when I start bolusing insulin. It doesn't have to be like an exogenous or an external.
No, no, no.
Okay. No, you're saying through an algo kind of meal recognition.
Yeah.
Okay. Okay.
That.
That's a lot easier, I guess, for me.
I think full closed loop can't depend on patients premeal announcing anything. I think if you're requiring the patient to do any work, that's not going to count as full closed loop. We want to really deliver something that is reducing burden for everybody. People with Type 2 diabetes, they don't want to be learning about bolus strategies and things like that. They just want to put something on and get great glucose control.
Okay, we are going to go to closing remarks in a second, but I forgot to read the disclosures at the beginning and I'm in trouble back at the office. Please refer all you investors on this call. Please refer to the event calendar, published research, or Baird's website for important disclosures regarding the companies discussed during this wonderful, fantastic event that we've held. Dr. Lai, it's always fun. I always enjoy it. I think this is our third webcast now. After the first two, you got promoted to Chief Medical Officer.
Yes.
Is Chief Chief coming or Super Chief Medical Officer or something next? I think it went well enough. Jim's gotta think of something. Something along those lines. Anyway, thank you for your time. Any final closing remarks? Anything we didn't cover that you want in 30 or 60 seconds to cover?
No, I think we covered the key data that's coming out. I guess a plug for our investor day, which is June 5th. We'll be sharing more about our medium long range plan there and learning more about the innovation. That'll be hosted in Acton, Massachusetts. Save the day.
I have a family event, as I told you, so I won't be there. I apologize for that. I will be at the big old dental conference next week in Cologne, Germany, so don't forget that as well. Investors. We'll have notes out next week, I'm sure, in the great world of dental. You have seen our notes here on diabetes stuff over the last couple days. Thanks everyone for joining us and we'll hopefully see you at ADA in a few months. Have a good day.