Insulet Corporation (PODD) Earnings Call Transcript & Summary

Good morning, and thanks for doing this again.

Of course. Happy to, Jeff.

Yes. Yes. We seem to have fun doing these. So where should we start? It's been a long few days, lots of data, lots of numbers. Let's 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. So type 1, your RADIANT trial. That was probably the newest data that you guys had out.

Yes, that's right.

Yes. So 188 patients, France, U.K., Belgium, it was with the L2 sensor. Why don't you just give me your takeaways from that trial? And what was important about it?

Yes. So I think what is different about this trial from the other studies is, as you mentioned, we used the Omnipod 5 connected with FreeStyle Libre 2 sensor. But also, this is not a group of patients who normally participate in trials early on. So it was a more representative group of people. So these were people who were on multiple daily injections, who had an elevated A1c, so above 7.5%. So these are all people who are waiting on the sidelines as in the market, there are tubed AID options, but no tubeless options. So despite the fact that there were other competitive AID systems out there, people were still not switching from MDI. So we took both children and adults who were on MDI and already using a Libre sensor, and then we put them on to Omnipod 5 and kept them on their FreeStyle Libre 2 sensor, and then studied them for 3 months. It was a randomized controlled trial, and we saw a really fantastic reduction in A1c. So their A1Cs dropped by 0.8% and also saw a really massive increase in time and range. So the time and range increased by 22%, and we got to 66% time and range. And if you look across all the type 1 data, there's some massive improvement in time and range, very minimal hypoglycemia, no serious adverse events. Very proud of that data and especially because we took people who were on injections, we put them straight on to 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. And it really just goes to show the -- one of the key differentiators of Omnipod 5 is the simplicity of the product.

Yes. No, that's fair. And you talked about this as a challenging patient population. Is that why the time and range at start-up 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 of years ago, I think the time and range there was 74 or 75.

That's right.

But is the better metric here to look at that change in time and range, the 20-some points you talked about here? I think the 05 was like 9 points because you started with healthier patients. Is that right?

That's right. So when you compare these studies, across the different studies, you always have to take a look at 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 74% we got to in the study, and we certainly can get there. And actually, 25% of our patients in our real-world data sets get greater than 78% time and range. So we can certainly get there. But what 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 1. Just kind of -- 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 1, I think over the last several ATTDs, you hear about, well, NHS isn't yet paying necessarily for AID pumps. So they have been now over the last year or 2, but some of the other markets have it 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 the U.S. Just want to comment there, and then I want to ask you about some numbers I heard out of a study in [ Leicester or Lester ] or whatever in the U.K. But just generally speaking, how is AID uptake in Europe today versus maybe even a couple of years ago?

Yes. So the NHS has recommended -- the NICE guidelines have recommended hybrid closed loop for people living with type 1 diabetes, and there's a mandate to get the majority of people on to AID systems. And it is because of the incredibly strong evidence for superior outcomes with technology and AID. And so especially in the last year, in the last 12 months, we've seen really a massive adoption in the U.K. But what I will say is the 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 on to an AID system, brand-new, newly diagnosed if someone walked into her office, it would be 2 years before they could get on to AID, which is like mind blowing. And so I think I think the technology -- the outcomes are proven, but the clinical sites capacity and actual implementation of that has been challenging. So I think your next follow-up question...

Yes. Well, no, 2 years. That's like Canada time line. And I love Canada, just to be clear. That has no comment on anything other than I love Canada. But the [ Leicester ] study, so Leicester. Okay. So I didn't even hear you said there, sorry. All right, Leicester. So interesting here, at least the presentation I said 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. But in the presentation today, they were doing 30 AID starts a year -- a year or 2 ago. And from a CGM perspective, they figured out a couple of years ago, like you could have these huge training sessions, like literally fill up an auditorium. And so they started doing that on AIDs. And 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 8 months after doing 30 a year -- a year ago.

Yes. Yes.

What does that say, one, about the need for AIDs. But more importantly, I don't know that they used all 05, but I'll bet a lot of it was. What does it say about the training, the ease of training with 05 versus maybe a tubed pump?

Yes. No, it is actually on the Omnipod...

Is it all 05? Okay. I wasn't sure on that.

Yes. So the -- it's because it is so easy to use and simple. So the U.K., there's a lot of centers taking some really innovative approaches. And it is because of the ease of use of CGMs, you said and their experience with that. So 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. So 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. And so I think that combination has allowed sites like Leicester to really increase the trainings tenfold. And in the same vein, there was a publication that came out of Manchester U.K. from [indiscernible] Group, where they did 56 trainings in 1 day...

On 05?

On 05. That was just with 05. And 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. And I think that's a good, good number. So to do 56 in a day is phenomenal. And that's not with all AID systems. It's because of Omnipod 5 and the data package that comes with it.

Yes. No, they had a flash pull in -- whose symposium was it today? In Abbott's Symposium. Asked just how many CGMs do you do a year? I mean this is a pretty biased crowd. This is like a tech favoring crowd...

Yes, early adaptors...

Yes, early adaptors. 80% of people said they do 1 to 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. So I don't know what -- if that means much. But I thought it was interesting. But 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's like 40% of TDD of total daily dose and some other standardization stuff and all that. It kind of segues into a couple of things I want to talk to, especially on type 2, but anything else on type 1 that you want to talk about before the type 2?

Yes, I think -- no, I think we've covered it. RADIANT, great results, randomized controlled trial. Now we've got -- Insulet has a couple of randomized controls of that has come out recently and then all the real-world data has come out as well. So all supportive. It's clear that there are superior outcomes using AID in type 1. That's clear.

Yes. You do have sensor of choice now. So I guess maybe we'll talk to that before we go to type 2. What does that mean? Do you have a personal favorite in one of your two partners, which I'm sure on cameras, the answer is no, but I'll let you answer that question. But then it's also interesting, you walk around here and there's probably, I don't know, what, 7 or 8 CGM companies outside of the ones U.S. investors know about?

That's right.

Most of them from Asia. Most of them will tell me they have a [ MADD ] of 8, 9, 9.5, something like that. But if you really look at the 2020 data, the 15, 15 days -- it's -- they're not as good. And there's a little bit of backlash that I feel like is starting up at this show for me, I'm sure, throughout Europe. But even some European practitioners, I'm talking to talk about maybe going to like an ECGM standard, trying to tighten up the standards, like in the U.S. for iCGM. How comfortable are you, I guess, with the breadth of the different CGMs we're seeing out here? I mean, do you imagine Insulet, as a company, sticking with the kind of core 2 or 3 sensors, and I don't even know who the third might be if you guys would, but the core kind of small number? Or as I see all these sensors around here, would you ever consider stepping out of your kind of core sensor of choice partners today?

Yes. What I would say is, we are really proud of our center integrations with both Dexcom and Abbott. These are both industry-leading sensors with excellent accuracy. And when you're using a CGM to power an AID system, since the accuracy, reliability, usability are all incredibly important. And so I think that the experience that I've seen in clinical practice with all the data that we see, those 2 are definitely differentiated from some of the sensors that I've seen on the market. I think there's also emerging evidence that not all sensors are equal. And certainly, the real-world performance is sometimes not quite mirroring what some of the regulatory studies showed. So 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 where all 3 sensors. So a Dexcom G7 sensor, a Libre 3 sensor and also a Medtronic sensor. They did YSI measurements. So that's the gold standard, where you're taking blood and you're checking it as the reference. And then also BG measurements over 2 weeks. And the curves are clear. So both Dexcom and Libre were very, very close to the YSI, almost indistinguishable, great MADD. But the Medtronic sensor actually did show a negative bias towards the YSI. And what that means is that that's going to impact the time and range outcomes that they're reporting...

And it was underreporting, right?

It was under -- the sensor was under reading...

Under reading the CGM...

And so that would lead to an overreporting of timing range for the exact same patient. So it was fairly significant. So for these 24 patients they reported a difference of actually up to 8% difference in time and range, with Medtronic in the 80s and the other 2 sensors in 70s. So it's just something for people to think about that not all sensors are equal. And as an insulin pump company, we take sensor accuracy and performance very seriously, and we're very confident in our current sensor partners.

Yes. All right. Fair enough. Well, let's move on to that type 2 topic then.

Yes.

So on the type 2, you had a couple of sub-analyses out this week on your secure T2D data, which I always struggle to say that. So I got it out clearly. But on that data, I think 2 things stood out to me other than just the strength of the overall secured data. And if you want to rehash that for the call here, you can. But I think generally speaking, I want to look first at a subcut on the GLP-1 data, where you definitely showed that patients coming into the trial, who are on a GLP-1, you put them on 05, and they got the same level of A1c drop and the same increase in time and range. And I think a lot of investors ask me, Jeff, well, 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 anything. But I think this data clearly shows to me anyway that, yes, you might be on a GLP-1 controlling your diabetes, you might be on a GLP-1 in 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. So I think the -- 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. And so 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 9s, and we managed to recruit them into the study, both us and others have shown that. So not everyone is cured on a GLP-1. So I think that's one finding, right? That people on GLP-1 still have high A1c. And then 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. So 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%. So greater than 2% reduction if you had a higher baseline A1c.

Yes. Fair enough. And 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? No, no -- the simple bolusing. So 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, and I'll come back to that maybe in a second. But they showed -- what did they show? I'm going to have to look at my notes now because I don't remember. But instead of carb counters, which some patients are strict carb counters, but in type 2, there's not as many card 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 counter, they haven't been trained. You could put in, say, I am 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. Or you could say I'm eating a big breakfast, I'm eating a small dinner. So you could do either meal size, you could do just a fixed kind of carb count at every meal, and yet the same thing versus those who strictly carb counted, the A1c reduction was almost exactly the same and the time and range improvement was almost exactly the same. So what does that tell us about the importance of carb counting versus you can just kind of get close enough and these systems work pretty darn good?

Yes. So can I share the story about carb counting. So about 8 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 couldn't make it. So I had to be on stage, cooking, and I was the entertainment. And I cooked -- I made shrimp and grits, and we had...

You look like a southern girl. Yes. I mean that's just natural.

I mean, it was the first and only time, I have made shrimp and grits. But 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, and I cooked it, I plated it up, we served everyone. And then I ask them what do you think the carb count is in this, on the plate that I have served with you, right? Like a pretty fair question right, educated group, the people who are teaching our patients. And 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 sixfold difference. Sixfold difference. And 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 front? So I don't think anyone is great at curb counting. And unless you're carrying 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. But actually, it's just more work, more burden that the community has put on our patients unnecessarily. And what we've shown through SECURE-T2D is that our patients don't need to carb count, and it's not required and people do very well on our product with very simple bolusing. And we actually have a Custom Foods feature in the products for all of our Android and iOS users, where doctors can -- 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 don't have to do that math every day to make life simpler for patients. So I think all of those things -- and now at this conference, Georgia Davis yesterday presented that poster. And there's a lot of interest because that's a lot of what we do here at these conferences is talk to health care professionals about how to implement this technology for patients and actually how to implement faster and get AID to as many people as possible.

Yes. That's very interesting. So I mean, do you imagine over the next couple of years and maybe this gets into SmartAdjust 2.0, I don't know, maybe we'll segue over that in a few minutes. But is that where we're going, is just getting completely away from carb counting? Or, hey, if you want to do it, and is there a difference in type 1s, or could type 1s kind of do this simplified bolusing strategy as well?

Yes. I think anyone can benefit from simplified bolusing. I don't think that it's carb counting is necessary for type 1 or type 2. And I actually think -- actually, our data from both type 1 and type 2. So we showed that in our poster yesterday. Dr. Viral Shah did a retrospective review of the patients in our pivotal trials for both type 1 and type 2 and looked back at time and range outcomes. Very, very similar outcomes for time and range. Hypoglycemia was less in the type 2 group, but time and range was about the same. And 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 have -- 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? I think what struck me last year after your T2D data was presented, and I said this in my note afterwards, were a couple U.S. KOLs, who got up to the podium was, like, look, this is a 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, U.S. KOLs. And a couple of European KOLs stood up and say, yes, it must be nice to me, American, which they're probably not saying at this conference now, but they might have said it must be nice to be American because we're not going to get reimbursement for type 2 in a long time. So what's your view of the type 2 uptake of AID is, one, in the U.S.? What are you hearing from docs there? Are the KOL views starting to percolate down to other academics to PCPs, things like that? So what are you thinking about type 2 uptake of AIDs in the U.S.? And then how do you think about it in Europe, where obviously, reimbursement is going to be a much bigger hurdle?

Yes. So 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 lower out-of-pocket costs for patients to start. So I think those are very key things. And we saw, I think, in our last earnings, we said up to 30% of our patient starts had type 2 diabetes...

It was just over 30%...

What was that...

Jim will tell me if I'm wrong on that, but I think it was just -- that was a good number, a good number.

It's a great number. And 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. So the ENDOs that I've been speaking to certainly a much more confident to prescribe it, given the new data. And there's a lot of interest in the -- with the PCP population as well. So I think -- so we're doing great in the U.S. 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 efficacy that needs to be done. But we're excited to see that as another opportunity for Insulet to help more patients.

Yes. 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 in 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?

Yes, absolutely. I think 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. But 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. But we have some market development to do in the PCP world in the U.S. before it really blows up, I'd say.

Yes. 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 of 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, and 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. Yes. We want to -- and that totally makes sense as well because the ENDOs are, in general, taking care of some of the sicker patients and that's where the resources should go, and we should help those patients first, those on MDI who are being seen there. But certainly, we're reaching those diabetologists focused PCPs as well. And 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 2 IQP data...

That's okay. That's very...

No, no, I don't want to see your face get all red and you get all mad and mean Dr. Ly comes out. No. But here, let me ask you this. So 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...

Different patient populations, let's be fair and keep it all level. But time and 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 05 versus Control-IQ. And 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. And I just -- I couldn't figure that one out?

Yes. So you're spot on, very similar in terms of patient profile demographics, baseline demographics. So yes, 2 completely different studies, different patient population, but we -- both studies actually started at baseline A1c of 8.1%. And we had very similar recruitment targets to recruit a diverse group of patients with different insulin requirements. So what we showed in our study was the total daily dose dropping from about 80 units a day, down to 57 units a day. So that was a 29% reduction in insulin use, whereas in their study, they started at 95 units, and they got down to 87 units. So there's a big difference in the total insulin that the 2 companies needed in order to get pretty similar time and range results. So I think -- what I'd say is more to come from that front, but they also saw also more weight gain as well. So if you look at the total weight gain in their intervention group, it was a mean of 2.4 kilos. And if you minus the control arm out, it's still 1.5 kilos as opposed to in SECURE-T2D, we saw 0.8 kilos. So we saw less insulin used, less weight gain. We also saw fewer boluses given as well. So less work. So 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. And that's actually still a new concept outside of this conference. So I think it's great. And 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. So all in all, pretty similar results in efficacy, but I do think we're ahead in terms of the weight gain and insulin utilization.

Okay. On the insulin -- and 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 TDI was roughly the same in the 90s. I do think -- I think there's a lot to be said about the form factor of Pod. So because Omnipod is always on the body, they're always getting insulin, they're getting continuous insulin delivery. And with a tubed pump, people do take it off. They take it off for sharing. They take it off when they exercise, if they're swimming. And so you just -- sometimes you don't know exactly if they're getting all that insulin that is being delivered. And 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 and range. And so there are multiple reasons contributing to that. But I do think having continuous insulin delivery into the body all the time is a physiological advantage of the form factor of Pod.

Okay. On the weight gain, again, I just -- what Dr. Pinsker said yesterday, and you can believe this, not believe this, that's fine. But what he did say yesterday is, I think I'm saying this right, that they think they reverse some insulinopenia or something. Is that how I think about it? Are these patients were then unhealthy patients and you kind of...

Well, they weren't that thin. They were...

Well, yes, 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. Is that fair? Somebody asking if that's fair because I don't want to put you against him. I'm just saying that made some sense to me.

No, no. 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 the same rationale that we provided when we saw our small weight gain results. And -- but -- so the rationale is right, but I would say, again, back to the population, very similar A1c, very similar starting weight...

Yes, that's right. And I'm not trying to play you off each other. I just defend them, that's what he said, and he's not here to comment on that. So okay, let's talk about kind of some future algo works. So I don't -- there was no STRIVE data here because -- I guess, because you're just starting to enroll in southern campy. But that is a pivotal. I think it's -- I thought I had it written down, and I didn't hear. So remind me how many patients?

Roughly 160.

160 or something -- 160 patients. It's big enough to be a pivotal, it will be a pivotal enrolling now next week. I think next week. So let's say, it's a few months to enroll. It's a 13-week trial. Few months there. So we get it by early fall. You work on it for a few months, you submit it. So we could have 2.0 out somewhere in kind of mid-'26?

So we haven't provided timing for when it will be. And so the -- 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, but we haven't said exactly when with timing. So when we roll these things out, it will require changes in products. So we just got to orchestrate all of that.

Okay. And 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 in that you'll show...

We show everything. I'm saying...

The data looks best when you use the most aggressive setting. And is that 100 or 110? I just can't remember.

So it's 110.

110. And I think the lowest setting -- is that sequel is coming out at like 87 or something? I think will -- they'll be the lowest, right?

Yes. That's what we've heard.

Have you guys talked about what -- how low you'll go with the setting? And I guess the corollary of that is, I would assume it's because you're seeing such a lack of hypo that you're comfortable going even lower in more aggressive settings?

Yes. So we -- so it's not all about the target. But yes, we are going to a lower target. And we think that will 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 -- that will be beneficial in our next round. And what we see from our data is actually across the board, only 50% of our patients consistently use the 110 target...

Was that right? Okay. I didn't know.

Yes. So people actually do like running at 120 and sometimes a little bit higher for hyper protection. And 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. So they'd start off, say, at 140 and drop down to 110. And I think that gives people flexibility because there is -- actually in the U.K., there's a poster here showing the -- discussing if you drop people too quickly, it can exacerbate retinopathy. And so I think there is that worry still that if you improve glycemic control too quickly, that can cause issues. And so I think the -- 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. And so 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. But I think we'll be very competitive today. We'll continue to be competitive in our next iteration. And for me, I think safety is really important. Or -- it is why we have such 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 moms and dads out there, who are thinking about what product to have for their child. And 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.

Yes. 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?

Yes. There we can't say exactly what it is, but we already have that simplified bolusing today through the Custom Foods. Yes. So I think we're -- 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 what therapy is the easiest and most effective way to get that done.

Okay. Fair enough. So EVOLUTION. You showed some very early data on like 6 patients or something last year. Was it more than that?

It was more than that. It was 8 to 12-ish.

It was 8 to 12. Okay. Sorry, I was trying to remember.

Ballpark.

Ballpark 6, 8.

12.

Yes, I'm only off by 100%. Don't -- next-gen algo, 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. So in the symposium that you missed, what I talked about was...

I heard it was a stunner.

600 people.

I know. Lining the doors. I know. I heard. I heard. That's why I didn't go. That's why I went to Tandem. It was too busy. It wasn't worth my time. I can't sit, I don't go.

Well, you know there's always a seat out in the front stage for you, Jeff. So I talked about EVOLUTION 2, which is our next generation of feasibility studies. And we did declare that it is our next-gen algorithms for type 2 diabetes, and it will be full closed loop. So no meal announcement, no pre-meal 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 uptake to really make a difference on a population level for type 2 diabetes. You're right. So 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. So we share 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. And what we saw was actually -- although it were -- from a type 2 perspective, although it works really well across the board, we saw 65% time and range for -- and with no bolusing, which is pretty amazing. The -- with that time and range, there were a couple of patients there, who we couldn't improve their time and range, even though we were delivering a lot of insulin. And so we're -- we're looking at making sure that we can really optimize insulin delivery to get the optimal time and range. So 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. So super exciting, full closed loop in type 2, and we're constantly looking at opportunities to improve both in type 1 and type 2.

Yes. And if that's a feasibility study, then I kind of fast forward a year until you'd get past that and then you kind of maybe another feasibility who knows and then a pivotal. So we're still talking a couple of few years before we'd probably start to see a CLC kind of T2 option?

Yes. 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. Yes.

Okay. And one question I've always had on CLC, or in closed loop is even here, you're seeing data like if you -- even if you don't carb count, if you at least announce something before the meal, so much less risk of drift in rebound hypo and all that. Even if you've just bolus 10 minutes after your meal, it's a lot worse. Do you need to have like a meal detection strategy of some sort?

Yes. Yes. And -- so people who have 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. So...

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 and that's when I start bolusing insulin. It doesn't feel like an exogenous or an external...

No, no, no...

No. Okay. You're saying through an algo kind of meal recognition?

Yes. That's right.

Okay. That's a lot easier, I guess, for me to...

And I think full closed loop can't depend on patients' pre-meal announcing anything. I think if you're all requiring the patient to do any work, that's not going to count as full closed loop. So we want to really deliver something that is reducing burden for everybody and 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 right glucose control.

Okay. We are going to go to like closing remarks in a second, but I forgot to read the disclosures at the beginning, and I'm in trouble back in the office. So 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 company's discussed during this wonderful, fantastic event that we felt. So Dr. Ly, it's always fun. I always enjoy it. I think this is our third webcast. And after the first 2, you got promoted to Chief Medical Officer?

Yes.

So its Chief, Chief coming? Or Super Chief Medical Officer or something next. I think it went well enough. Jim's got to think of 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 5. We'll be sharing more about our medium, long-range plan there and learning more about the innovation and that will be hosted in Acton, Massachusetts. So save the date.

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, and you've seen our notes here on diabetes stuff over the last couple of days. So thanks, everyone, for joining us, and we'll hopefully see you at ADA in a few months. Have a good day.