Episode 43: Tandem Control-IQ+ and Mobi, with Laurel Messer

A pump can be technically excellent and still deliver mediocre results, because the two settings that decide the outcome are the ones most clinicians tune last. Laurel Messer, VP of Global Medical Affairs at Tandem Diabetes Care, returns to open the GNL AID series. She and John go through the real-world data behind Control-IQ's most powerful lever, what Control-IQ+ changes for the very young and the very high dose, the new sick day and extended bolus tools, the fresh FDA clearance for pregnancy, and the Tandem Mobi. IN THIS EPISODE - Why correction factor, not basal rate or target, is the setting with the biggest real-world effect on time in range (Messer 2023, n equals 20,764) - Control-IQ+, the total daily dose range extended to 5 to 200 units, opening the system to very young children and very high insulin users - Control-IQ+, the correction factor ceiling raised from 11 to 33 mmol/L (200 to 600 mg/dL) - The new sick day hack, a temp basal that runs without leaving automation - The extended bolus, up to eight hours, for high fat meals and delayed gastric emptying - Fresh FDA clearance for Control-IQ in pregnancy, and what the CIRCUIT trial found for time in pregnancy range - The Tandem Mobi, a matchbox sized on-body pump running the same Control-IQ algorithm CHAPTERS 00:00 Introduction, launching the AID series 01:43 Welcome back, Laurel Messer 03:55 The 2023 registry paper, correction factor as the secret sauce 10:40 A basal and correction factor formula in practice 12:39 Time blocks across the day, the dusk phenomenon 15:37 Control-IQ+, wider total daily dose range 17:27 Control-IQ+, correction factor ceiling raised 20:50 Recap, basal at 50 percent, correction factor as the dial 22:36 Temp basal with automation on, the sick day hack 26:32 Extended bolus, up to eight hours 28:17 The pizza test 30:23 The science, why fat blocks insulin 32:21 FDA clearance for pregnancy 36:06 CIRCUIT trial results 44:22 Sleep Activity in pregnancy 49:14 Introducing the Tandem Mobi 53:41 Mobi minimum fill and early feedback 57:16 Takeaways, the two levers to know GUEST Laurel Messer, VP of Global Medical Affairs, Tandem Diabetes Care. Host: John Pemberton, founder of The Glucose Never Lies and a paediatric diabetes dietitian, and a person living with type 1 diabetes. LINKS (all full absolute URLs) Show notes: https://www.theglucoseneverlies.com/episode-43-tandem-control-iq-plus-mobi/ Watch on YouTube: https://youtu.be/2Zq2XALSnYA Apple Podcasts: https://podcasts.apple.com/gb/podcast/the-glucose-never-lies/id1795741144 Spotify: https://open.spotify.com/show/2MlGlz2G8LsbDnuGtAh77W AID Algorithm Optimiser: https://www.theglucoseneverlies.com/aid-system-explorer/ Previous episode: https://www.theglucoseneverlies.com/episode-42-dice-2026-highlights/ ASK GRACE Have more questions? Ask GNL Grace, a diabetes educational adviser built by a team with skin in the game. Grace gets you 80 per cent of the way there with 20 per cent of the effort; the final 20 per cent takes self-discovery, guided by human expertise and trial-and-error learning. Check out Grace at https://www.theglucoseneverlies.com/gnl-grace/ SUPPORT THIS PODCAST The Glucose Never Lies is independent by design. We take no sponsorship and no advertising, so the podcast stays answerable only to the people who listen to it. If it has been useful, you can help keep it that way: drop a one-off tip, or set up a small monthly amount to keep the show ad-free. Either way, every penny goes back into making episodes. Buy us a coffee (one-off or keep-it-ad-free): https://www.buymeacoffee.com/gnlfree FOLLOW Website: https://www.theglucoseneverlies.com/ Instagram: https://www.instagram.com/theglucoseneverlies LinkedIn: https://www.linkedin.com/company/theglucoseneverlies X: https://twitter.com/GlucoseNLies DISCLAIMER This podcast is for education only. It is not medical advice and is not a substitute for individualised care from your diabetes team. This episode reflects the independent clinical perspective of John Pemberton; Laurel Messer speaks in her role at Tandem Diabetes Care. It is not an endorsement by GNL of any product. The Glucose Never Lies is a registered trademark of The GNL Ltd. Company No. 16733595. UK VAT No. GB 516 3272 08.

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Transcript

SPEAKER_01 0:11

Welcome to the Glucose Nevalize podcast, and this is now the first of the AID series. So if you've been listening recently, we have just been through the CGM series where we talk through all about the accuracy data for CGM systems, the ones that we are comfortable with understanding the risk, and then we've been through the DEXCOM options, the Freestyle Libre options, the Medtronic options, and now the Rush Smart Guide options. There will be a couple more to come. But now it's turned to switch frames and talk about automated insulin delivery systems. So obviously, we're only going to be talking about the CGMs that connect with these. And bearing in mind, following the same principles, we're only going to talk on the glucose level eyes about systems where the data is clear, the data is understood, the risk is understood, and the data is extremely positive for people with type 1 and type 2 diabetes of various different subpopulations. So you will recognize that we have Laurel Messa, if you saw the previous episode on skincare, she's back for a second time. It's the second guest who's got a second appearance, other than our scientific advisor, Othner. So the crowd obviously loves you. So welcome back. And you obviously made a big impression the first time because it was a great episode. You know, we covered so many practicalities. And I think what people really liked is at heart, you're a full-on professional who's a clinician. You know, you kind of you really support people with diabetes and you've got some great tips and tricks. And now you've gone over to the dark side. You're now kind of establishing that that on a different plane, but to a wider audience, but making sure that the people with diabetes come first. So, first of all, welcome back to the show.

SPEAKER_00 1:45

John, thank you so much. And I have to say, even though I have gone to the dark side, my absolute favorite thing to do still is talk to HCPs and talk to people with diabetes about how to make AID and diabetes technology tangible. I'm all about the tips and the tricks because at the end of the day, this is about making lives easier to handle. So thank you so much for having me back.

SPEAKER_01 2:09

You're welcome. Um, and obviously you're here, so you you work for tandem. We're going to be talking all things control IQ. We're going to be talking control IQ Plus, we're going to be talking potentially Mobi at the end. So basically anything to do with the tandem platform, some tandem source, potentially we'll chuck in the next. I have some recent experience too. But before we sort of get into that, I think regardless of whatever system you're going to be on. So the control IQ Plus is coming. The Mobi is coming. There'll be all sorts of platforms that are coming out of tandem. But one thing that will remain, I should imagine, for quite a bit of time is how do you get the most out of these systems with regards to as much time in the glucose range that you want, whether that's time in tight range or time in range, without sacrificing hypoglycemia. So that's the holy grail, isn't it? It's kind of like how do you tweak these systems to get more time in range, but without sending you too far a time below range? We'd be remiss not to kind of talk about, we mentioned it a little bit last time, but I think it's it's really worth at the start now a real deep dive into how this system ticks, what what level or levers are the key ones to tweak, and what have we learned since 2019, which is a lot. And that what the reason why I say that is because your 2023 paper with Mark Breeson, which I think just looking at my notes here, over 220,000 users, you analyzed using the control IQ system, what levers make a huge difference with improving timing range without the consequence time below range. So tell us a little bit about what you found, how that has evolved, and kind of what is the strong message that you're trying to kind of help all people, healthcare professionals and people with diabetes to get the most out of the tandem system.

SPEAKER_00 3:54

John, you sound exactly like I did when I went to tandem. So when I joined on the back end, I'm like, okay, guys, so tell me the secret. How do we get better outcomes with control IQ? And their answer was interesting. They're like, well, you can tune anything. You can tune a correction factor, you can tune a basal rate, you can tune a carb ratio. And I said, I know that, but I want to know which one is going to be the most important. And so what this analysis did was it looked at real world users and said, who is getting better time and range and what settings are they using that are associated with that? So um again, I think that the control AQ piece that we've known since 2019 is that those are your levers. It's the basal rate correction factor and ba and ICR carb ratio. And when we looked at the data, it's no surprise that anybody who used stronger settings had a higher time and range. But what we noticed from a predictive analysis is that in addition to tighter settings leading to higher time and range, some of the settings also impacted hypoglycemia a little bit more. The interesting piece, and this was this was where I was actually proven right because this was my hypothesis all along, is that correction factor, when that is strengthened, it leads to higher time and range. It did not seem to predict hypoglycemia in the same way that basal and insulin to carb ratios did. So I want to be clear, all of these settings can dramatically improve time and range. Um, and then, but there's a little bit of cost with hypoglycemia if you're looking at basal rates or carb ratios. But with correction factor, it seemed in this analysis that people could crank that up. And there wasn't a measurable clinical difference in the hypoglycemia they were experiencing. So while I think all the levers are really important, especially knowing that we have a robust protection against hypoglycemia, correction factor is the piece that I think of as the secret sauce, the secret tuning for better outcomes with control IQ.

SPEAKER_01 5:57

Yeah, and I would well, I personally have changed my practice because I but the last the last discussion that we had, I mean I tried tried all the systems, um, but tried it control IQ personally. The thing that used to frustrate the most about that particular one and the things about all of them do certain things, but the one that one was, I would give my insulin, I would tend to have quite a low basal rate and a high carb ratio. So when you do that, you you would then end up with a lot of insulin on board, which means if you've kind of underestimated your carbs or you've given your bull a slate, quite rightly the system is saying there's still a lot of insulin on board, therefore it's not able to kind of give the insulin that you would think. Then when we had sort of that discussion and said, well, look, the insulin on board is recognized by user-delivered insulin or when the algorithm's going above. So if you have your basal rate, at least kind of 50%, maybe 60% of your insulin, or the algorithm-delivered insulin, if you include the correction factor on top, doing 60% of the work, then you can have a weaker carb ratio, and therefore the system can be extremely responsive. So I I just got back on it. I thought I'm gonna give it a go and have a have a crack. So my insulin, I'm on about roughly about 30 units of insulin a day. Now previously I'd only have the baselit 10, so that's 30%. So I was like, okay, I'm gonna go in at like 17, 18, 19 units, push it up to 60%. Make my correction factor in in our speak is an 80 rule, which is uh 80 divided by total daily dose. In your speak, it's like 1600 or 1400, is it?

SPEAKER_00 7:25

Yeah, that's closer to 1400. So yeah, the magic number in the analysis was like 88. People who had 88 or lower had the highest time and range. But I mean, these are these are all made-up numbers, right? Like ethic is what's important is go stronger for that higher time and range. It's really hard. People ask me, what is the magic number? What is the formula? And unfortunately, I think all of us who practice in diabetes know there's an art and a science where we can give you a ballpark number, 88, 85. Some people use 80. And it should work for many people. But of course, you know, if diabetes care is individualized, as long as you know where to go, go not go lower on that correction factor number, you're gonna see higher time and range.

SPEAKER_01 8:08

Yeah. I mean, just from my experience there, what I ended up doing was, like I said, putting setting my basal instead of at like would have been 0.45 units per hour, it was up at like 0.7.8. So it's delivering 18, 19 units. And then my correction factor would be set like normally be like one drops and by three. So I went like one drops and by two. Um, quite strong. And actually, I was surprised that well, I was I was pleasantly surprised at how much more responsive it was after a meal because you didn't have the same level of incident on board. The algorithm could tune in extra, but then I didn't get the downside later on. So that was a massive, it was to see that personally for me was a big thing because then we started addressing all the people who were on these systems and we were looking, we're like, wow, we uh traditionally you leave correction factors till the end. It's always like adjust the basal rate, adjust the carb ratio. You're like, we'll give it a little thought to correction factor like 15 years down the line, but it's like the other way around. It's just like if you understand the system, you've got to get that basal rate overall above 50% or at least 50, and then tune that correction factor because then if you underestimate your carbs, bang, it's gonna be on it. So you don't end up with these prolonged highs.

SPEAKER_00 9:17

Or even if you're not bolusing, if you're not able to consistently deliver boluses, that correction factor is that magical piece that's going to help with the missed boluses. And I will absolutely validate what you just said. When I was in practice and including my own practice, correction factor was sort of this like, yeah, yeah, there's that too. I never looked at it, which is why when I did this analysis and I thought about it more, and I'm like, but it seems like that correction factor should matter. And it turns out it did. I've been, I've been a little bit like a revolutionary about this. I'm like, everybody, this is really important. And as a clinician, I know we probably don't think about this very much, especially knowing that these other AID systems, they haven't, they have an easy lever with a target, which is pretty understandable by most clinicians and people with diabetes. It's like, well, if I lower my target, the system will work to give more insulin and drive time and range up. And that is true, and it's very helpful with those systems. You know, I'm shouting from the rooftops from the control IQ piece, is it's like we can do all of that too. It's just knowing that the name of the setting you want to work with is that correction factor. And so um, this was somewhat of a light bulb moment for me three years ago. I keep perseverating on it because I just want every person to feel empowered to know how to get the best outcomes from their control IQ system.

SPEAKER_01 10:40

Yeah, no, absolutely. And we we've we've changed actually a lot of our young people's and seen a dramatic difference in bringing the time above range right now because the system's much more responsive. It basils at least, I mean, simple formula for us is basal rate total at least 50%, and then correction factor in our speak at least 90, maybe 85, 80, if we were getting really strong. And if someone's not bold, if someone's not bolusing, we're pushing basal rates up to 60% and we're getting the correction factor at 80, 75, because then it is super on the game. Um and it's made a huge difference. Huge difference.

SPEAKER_00 11:13

Yeah, absolutely. And this is where, John, I love how you you make a lot of this very practical with some of the tools that you offer with glucose never lies, like your grace algorithm and stuff. I know that um Dr. Pratik Chowdhury from the UK, woohoo, UK helped author uh a paper in this last year called Rethinking Control IQ. And these are very much the um the similar themes from that paper. It's like increase that basal, increase that carb ratio, don't be afraid to do it. Even though, you know, you may feel this concern about hypoglycemia. This is the beauty of automated insulin delivery. With a system like control IQ, there's such robust hypoglycemia mitigation that I, you know, I want people to feel empowered to play, drive that correction factor stronger, increase those basals to 50, 60%, because the algorithm is working on the back end to avoid hypoglycemia. The one other thing I'll just caveat though, for any listeners out there, it's a little bit different with children. I would probably not recommend settings that strong, especially in young children where insulin sensitivity is all over the place. They just need a little bit less. So while these ethics are important, these broad understandings of what levers you pull, it's of course always nuanced to the person and what their actual needs are. Which again, it's like I try to drive away from there's an exact formula for everyone because we all know there's not.

SPEAKER_01 12:39

I mean, that's a perfect segue, actually, because we have used off license to control IQ for many reasons with our young people. And the main one being is as you know, you can have different basal rates and different correction factors for the time of day. Now, two children who are between one and five, if you've dealt with those people, they have a wicked insulin resistance or dust phenomenon from 5 p.m. to 10 p.m. It is bonkers. It is bonkers how like they go from requiring this and then boom. And the reality is the other systems can't keep up because the shift in what the algorithm is required to do, it's like an eight-fold increase. Oh, it's that the systems are capped. They capped. But with the control IQ, you're not capped. You can up the base rate, you can make the correction factor stronger to whatever you want. But it does require a bit of skill as a clinician. But so that's brilliant. But the downside is from the current control IQ, and that's why it's not licensed for under sixes, the correction factor is capped at 11 or 200 uh milligrams per deciliter, which means that sometimes it's a bit too strong. But on the control IQ plus, if I'm right in saying it it goes up to like 30 uh or 600 milligrams per deciliter. Yeah, yeah, perfect. Then the the beauty of the why that's so needed, you need a strong one at 5 pm to like 10 pm, but then 10 pm to 2 at 2am, you better back off. You better back off quick, and otherwise you are gonna have a very unhappy family. So you know, and that's the problem with some of the other systems is that they're slow at ramping up, and then by the time they've ramped up, it's too much for two in the morning. With a control IQ, we were fine. You could like ramp it up and then drop it down. But now with the control IQ plus, the key part is overnight. We've previously had to set zero basal rate to mitigate the correction factor at 11. We're not gonna need to do that anymore because you could have it set at like 25:30. So I think for certainly pediatric centres who have no doubt of just listening to this going, I hate that 5 pm to 10 pm. It's which is an absolute shocker. You're now gonna have a tool where it almost like gives you the power back a little bit as a healthcare professional to really support these families because you end up on the other systems doing fake carbs. You have to put fake carbs in to keep up, and then it's all a bit of a mess, it's all over. If you can automate it with the settings, you end up then with the best of both worlds. So I think on that on that, tell us a bit about control IQ. So there's one difference. Instead of the the correction factor of the algorithm being stuck at 200 or 11, it goes all the way up to 33 or 600, whatever. What what else is within that?

SPEAKER_00 15:05

Um, I'm I'm laughing because when I when I talk to like pediatric fellows or or new trainees and pediatrics, I sort of explain I explain insulin sensitivity with young children versus teenagers as like completely opposite trajectories. You know, you're talking about there's not enough insulin in the world before midnight in these young children, but then after midnight, you breathe a molecule of insulin on them and they drop low. And then it's exactly opposite in teenagers, where they're more likely to go low in the earlier part of the night, and then there's not enough insulin in the world to battle the growth hormones and the early dawn phenomenon. So this is this is a great segue to control AQ Plus because the system, the algorithm with Control AQ Plus now has been optimized for very low TDI users. So people who require five units or more can now use the system. And also on the very high end, people who are using up to 200 units of insulin a day. So the algorithm has been less constrained to be able to help people who have these very, very low insulin needs and very, very high.

SPEAKER_01 16:11

And just did you want to check before it was like 25 was the bottom layer.

SPEAKER_00 16:15

Yeah, before well, before it was 10 to 100 units, and now it's it's five to 200. And what you're getting at clearly um is for very young children who have low total daily insulin needs and have this diurnal pattern of insulin sensitivity, which is just crazy. Every parent of a young child with diabetes knows that you're just you're riding this roller coaster of insulin sensitivity. So having a system that can work in blocks of time to mirror that is incredibly helpful. And I will say that from my personal practice as well. So what you're getting at, John, many people actually were not aware of this. Um, it was kind of this algorithm quirk with control IQ, where even if you program a very, very, very weak correction factor, like 300 or 400, um, it when control IQ was active, the system would sort of cap it at 11. And those decisions were made way back with regulatory bodies to put constraints on things. This was um changed with the newest indication with control IQ plus indication for ages two and up, five units a day and up, where you can truly program it up to 33. Um, sorry, I'm I'm switching millimoles. No, it's okay.

SPEAKER_01 17:27

No, I'm saying it's like 18.

SPEAKER_00 17:31

It now um caps it up at 33. So you could have a very, very weak correction factor. But John, you just you just picked on something really important as well, which is with control IQ, again, because basal is one of the settings that you can tune, you can truly set a zero per zero unit per hour basal. And it's safe to do that. Why? Because control IQ, if glucose levels are predicted to rise, it will give insulin, even if the basal rate is set at zero. So this is a lever that HCPs um should have in their back pocket with those young children. Crank that correction factor to be as weak as you want to, set your basal rate at zero, and know that if that person does need some insulin after all, the control IQ algorithm is going to override the zero basal if needed. So I do think it's a it's not so much a hack of the system, it's a beauty of the system that that you have all the confidence of they're not gonna need much insulin at all. I'm gonna set it at zero, but control IQ will give it if it's needed. So I think you brought you you're keyed into a really powerful tip for those clinicians working with very young children.

SPEAKER_01 18:42

Yeah, I think there's a lot of people, obviously when the indication drops from if it's six to two to two years old, yes. Yeah, I think they will resonate with what we've just said. Absolutely, because you you see it all the time, it's such a pain. And you're asking families to do things, and you know, it depends on which healthcare professional speak to, just makes me laugh when people say, No, you've got to trust the system, you've got to trust the system. It's like, yeah, you've been trusting the system for two months and it's the same problem every single night. It's not gonna change. It ain't gonna change. Nothing magic's gonna happen in another month's time or three months' time. You need to do something because unfortunately, because the constraints quite rightly with these systems for the average person need to be there. You can't go up to eight, nine times it because there, but with the other systems you can. So, you know, if the if the AID systems were that good, the average timing range would be 95%, but it's not, it's about 65-70. So it means that if you know the human body is very complex, sometimes these systems are amazing, but they require a little bit of skill, a bit of intuition, a little bit of magic from the people who know what they're doing, and just the people who know people who experience it every day, the people who are living it and they're going, I'm flying high between 5 and 10 p.m. I need to do something. Like they're down in these numbers and they come back and they're scared to tell you that, like, oh, um, I was having a little snack. You weren't, you were just putting extra insulin because you knew you needed it, weren't you? It's like, yeah, that's fine.

SPEAKER_00 19:58

Well, you know, and it's interesting because you tie this across the lifespan, these chunks of time where there's such dramatic insulin sensitivity differences in young children, ages two to six, in teenagers, but it's that inverse. It does seem the good news is for anyone out there listening who has a child with diabetes, is it does even out eventually in adult medicine. There's been, there have been studies with control IQ that show some people they set one basal rate all day. And because of the automation, it can deal with some of that fluctuation in sensitivity, which of course still occurs because we are humans, but it's not quite the dramatic differences in childhood. But again, because control IQ is so responsive by setting correction factor and by setting the baseline, which is that basal rate, you have so much control to handle, to handle those roller coasters.

SPEAKER_01 20:50

Cool. So control IQ, we've extended the range. Five units to 200 was 10 to 100. So we've got to 200, yeah, five to 200. Yeah, and we've got now kind of obviously people on much higher doses, which is great. Um, we've talked about the ability of the correction factor now doing the full range, which will be involved in the decisions of the algorithm. So you now got certainly from the younger age, again, full flexibility. We've talked about, regardless of whether it's control IQ or control IQ plus, you want to be getting the basal rate, ideally 50% of the insulin delivery, and then really kind of you know dialing in on the correction factor and the abuse of I guess the control IQ. You can have that in sections across the day if you know that, like you said, a young person requires a really aggressive one, sorry, an adolescent in the you know pre-pubertal early stages of the morning, the young children differently. So if you know your insulin across a life lifespan, and uh Dr. Bister's paper is amazing from the DPV, it just gives you like you look at it, it just goes, When you're two to six, this is what happens. When you're six to twelve, this is what happens. When you're eighteen above, this is what happens. You can just look at it and you can you can almost set your four or five blocks. You don't need more than that. I mean, anyone who's got eight or nine on 10 blocks across a day, stop it. You're just you're overthinking it. You know, three. A hundred percent.

SPEAKER_00 22:05

When someone comes in and I see 13 time segments, I'm like, oh no, no, no, we got to cut this down four max, five max.

SPEAKER_01 22:13

Yeah, exactly. You three is usually generally good, eighteen times a day, three or four. Um, but you do have that. So I think from a control IQ perspective, from the algorithm, that makes sense. There's a lot more flexibility, there is a lot more personalization, but it still keeps pretty simple. Get the baseline around 50, 60%, tweak the correction factor, and that's where you're golden. What what else is what else is the plus version bringing us from a functionality perspective that you didn't have on the standard one?

SPEAKER_00 22:38

So two additional functions are part of the new algorithm, one of which is my favorite. And again, this this is probably the pediatric clinician in me, but there's now a temp basal that can be programmed when control IQ automation is turned on. And let me tell you why I love this. Because I have been in practice 22 years with diabetes. And when automation came up, it was like, okay, CGM's probably the best thing that's ever happened in the last 20 years. Automation, automated insulin delivery is a very close second. The problem was when children got sick. Because we all know with illness, um, insulin sensitivity can be quite decreased. They have larger insulin needs most of the time, unless they have a GI bug. And then it's like insulin is always going to be too much. So the problem with this in the last 10 years with automation is you say, well, shoot, the algorithm is not going to be able to keep up with such a dramatic instant change. And so you need to go out of automation and start a temporary rate and do things manually. And that was really the answer we had for dramatic shifts like sick day. So as soon as the temp with control IQ plus, this temp basil can now be programmed with control IQ turned on. What I'm telling every person I see in clinic now is this is your sick day hack. You don't need to program a second profile. You don't need to go out of automation. You crank up that basil 150%, 125%, eight hours, 24 hours, three days if you need to. You still have that hypoglycemia protection, that automation to optimize time and range. And you can tell the system, hey, for this period of time, I'm going to need more. So as a, and this is true for adults too, but I think in general, sick day is a very stressful event in the lives of children and parents with diabetes. So temp rate with control AQ plus on is your hack to stay in automation while mitigating, you know, navigating these challenges in life.

SPEAKER_01 24:40

Having profiles is nice, but it's a pain in the ass in clinics. It's a pain in the ass. I'm just thinking now, is like um that you for the sick days, you just say, well, just whack you, you know, got 150 to 100%. But then for exercise as well, previous video I have exercise profiles, like, oh my god, you don't just put it down to 50%. Put you know, put temporary basal on 50%. So you you only need one profile, you don't need to switch between the two, and you can use your temporary basal as the the fluctuations. And the good part, as you say, there, it's not learning anything. Like the one good thing I quite like about the control IQ, it's not earning that that particular period of time is then going to impact the next three days. So, for example, you know, if I was on another system and I just have a totally lazy three days, I'm gonna eat crap and you know, whatever, and then my insulin dose goes up by 30%. That then kicks in to the next three days when I'm back to my normal self. So um, yeah, I think that that actually, from a practicality standpoint, is I'm just thinking from a he from a healthcare professional, a person with diabetes, you don't need two or three profiles anymore. You can just use this temporary basal rate to do what you were trying to do with the other rates and just kind of like go bum, bum, bum, bum. And also testing, like uh this is another great way of just thinking now is you come back to clinic, I see your kid and it's like, do you know what? I think the basal rate needs bumping by 25%. Rather than commit to it now, I'll just put 125% on for 24 hours and see what happens. Is it golden right? Bang, boom, drop them, but pop them up. So you can kind of like test it and then change it.

SPEAKER_00 26:03

That is fascinating. I have not thought about it in that way. But it could very much be a learning tool, like, let's try this out. And if you like it, then we'll change the profile.

SPEAKER_01 26:12

Yeah, yeah, exactly. But rather than committing to it, because if you commit to it all, then it's like trying to do it all back, isn't it? It's kind of like, you know, there. So you can you can have that one for free on me.

unknown 26:21

Yeah.

SPEAKER_00 26:21

So that temp basil can be programmed for up to three days at a time before it will expire. So that might be a perfect thing. We usually say three days, right? Pump it up and see what happens. Yeah. So the other, the other um feature that has been added with Control IQ Plus is an extended bolus up to eight hours. So previously, you you could extend a bolus for a short amount of time for two hours with automation turned on. But if you wanted an extended bolus longer than that, you were gonna have to exit the automation. So that extended bolus for up to eight hours. This again, I think of our very young children, that age two to six, which I have so much empathy and admiration for those parents who are who are becoming their child's pancreas. But um, you know, behaviorally, young children, you don't know what they're gonna eat. They don't know what they're going to eat. They'll tell you one thing, do the opposite. And so the ability to have an extended bolus for up to eight hours allows some fudge time for the parent. You say, okay, I think you're gonna eat, but I don't know. I will give, you know, 40% of this bait, this bolus up front, and then I'm gonna extend the rest for four hours. Let's see what you do. You're at a party, you're grazing, you're doing a drive-by on the cupcakes, but then you're going out to play. Um, that it it gives it affords a little bit of wiggle room for when you don't know who's gonna eat what and when. And the other, the other piece that it can be very helpful with is when there's delayed gastric emptying, you know, gastroparesis, which is something that many adults living with diabetes struggle with. So there are functional reasons that an extended bolus can be useful with delayed absorption, with unclear eating patterns. But the great thing is too, if it's no longer needed, you cancel it. You know, you programmed it for four and five hours, and then the situation completely changes, just cancel the rest of it. You know, so it it works as long as you need it to, and then you can cut it off if you don't need it for the whole duration you programmed.

SPEAKER_01 28:17

So I've got another one for you here then. Then I'm gonna test your knowledge. Are you ready? So No, I'm not ready.

SPEAKER_00 28:22

I have I've only had one cup of coffee because unlike you, it is morning over here in the United States.

SPEAKER_01 28:28

I'm about 15 by now, so I'm all good. Um right then. So Kirstine Bell did a paper, it's a while back. She took 10 people with diabetes, took them on uh one day, had the sort of standard pizza base with no topping, and then on the second day came in, given the full like meat, feast, cheese, etc. etc. Okay. How much extra insulin? So if you think of like the first day is 100% of insulin, what percentage was needed on average for these 10 people for the um the pizza day? How much extra do you reckon?

SPEAKER_00 28:57

Oh goodness. Okay, this is a quiz. I would say of bolus insulin or two.

SPEAKER_01 29:02

Yeah, bolus insulin. Well, total extra insulin to cover the high fat and protein, basically.

SPEAKER_00 29:07

I would say 35% more.

SPEAKER_01 29:10

On average, 65%. Oh my god.

SPEAKER_00 29:13

So my first instinct is as little as 25.

SPEAKER_01 29:15

As little as 25, but some people need as much as 125. So if someone's eating a 10-unit bolus, it goes to 22.5. So the reason why I say that, it doesn't go over two hours. That is like a seven or eight hour situation. So and what we teach where I work is when we talk about extra insulin for high fat and high protein, even on AID systems, because they often can't keep up, you start with 25% extra. If that doesn't work, you go to 50, 75, but you may end up at 100% extra. Like if I get a Domino's pizza, I am in trouble. I am in trouble from the insulin perspective, unless I am walking my ass off massively. So I'm so mad.

SPEAKER_00 29:52

My gut was gonna say 50%, but then I'm like, oh, I don't want to seem too histrionic about this.

SPEAKER_01 29:57

Yeah, no, I suppose.

SPEAKER_00 29:58

In my past life, doing clinical trials with all these AID systems, most of them before they were cleared from regulatory bodies. We used to have in the protocol, if there was a period of time when we were looking at meal behavior, we would say, no pizza and no Chinese food. This would be like codified in protocols because we know how it just completely changes the metabolism, the absorption of glucose. John science. I've got science for you.

SPEAKER_01 30:25

Are you ready for it? You're ready for this, is basically what happens. So when you have more fat than you need, the fatty acids obviously go into your gut, go into your portal vein, and they go into your liver. But the key thing is in your liver. So if you think about a uh fatty acid, it's a glycerol backbone with three little tadpoles on it. If you break off one of the tadpoles, it becomes a glycerol backbone with two little tadpoles. But that glycerol backbone with two little tadpoles jumps to where the insulin combines and it stops it picking up. So when you have more fat than you need, they're called dialysis glycerols, they basically block the insulin working at the cell level. That's why you need 50, 75, 100% extra. It's that high fat level. It just gets in there and it completely locks the um the insulin mechanism, key and lock mechanism at both the muscle and the liver.

SPEAKER_00 31:07

John, you're your uh your dietitian is showing.

SPEAKER_01 31:10

Yeah, well I've I'm feeling I I did a little bit of work at some point. I love it. But yeah, so I mean we see that all the time. The systems can't keep up with Domino's pizza. It's just simple as that. So you're gonna need to do something different. And now with this, you've got an extended period. Yep. So they're they're two very meaningful changes, and they're obviously done because people are fed back, right? People have gone, what you know, we're we're sick and tired of doing all these profiles, but we just want us to be able to go up and down. Okay, let's make it easier for you. Listen, when we have these meals, it is just game over, or they're children, young people. We want to go to a party for eight hours, you know, we'll kind of do whatever. Then you you've you've listened and you've given back. So that's great. So that's control IQ plus in a nut. We've got wider range, total daily doses, younger indications, we've got a correction factor which now goes all the way up and down, and we've also then got the temporary basal on top, and we've got the AR extended. So you've covered quite a big change, and that's going to be available obviously for people who are. Will there be an upgrade to the people who are on existing control IQ? And then it'll be on, obviously, on the new pumps, and then we'll talk about Moby later. It's presumably going to be in there as well. But before we get to that, um, it'd be a miss to say in the states, we just heard indications for pregnancy. Is that correct?

SPEAKER_00 32:21

That is correct. So um, in I guess it was May, uh just in the last week from the time of this recording, we had a clearance from the FDA for women with type one diabetes who were pregnant to use the system. And this was based on a very well-done academic study in Canada and um Australia called the Circuit Trial, which was published last year. But I think because there wasn't an indication for pregnancy anywhere, you know, we couldn't do a lot with these data. We couldn't explain why they're as cool as they are. But now that regulatory bodies are approving us for pregnancy, I just again, you know, talking about shouting from the rooftops, I want everyone to know what control IQ can do for people across the lifespan, including pre-conception, conception gestation through delivery, and how control IQ can offer enormous benefit for people who go through these periods in their lifespan.

SPEAKER_01 33:21

So tell me, so just for because we've had uh Professor Eleanor Scott on and she did a great job of explaining um just the challenges of pregnancy. I mean, the wild changes in insulin requirements to dropping down and then absolutely going through the roof, and then you give birth and then it drops down again. I mean, it sounds like it just sounds like nothing else. Um but what she was explaining is the time in pregnancy range, if I'm right in saying, is 3.5 to 7.8 millimoles per litre, which I believe is like 62 to 140.

SPEAKER_00 33:54

62. 24 to 140. Very good translation.

SPEAKER_01 33:58

Um so and the aim is to get 70% right. So the the aim for best pregnancy um outcomes is aiming for 70%. I mean, that is tight. And I know it's amazing to see because when I speak to some of the adult clinicians, they sort of say, you know, young ladies who've you know maybe not put themselves first with their diabetes management for various reasons, because you know, there's other things to life than managing your glucose levels, but as soon as they get pregnant, they're like, boom, nine months, they are on it. They're on it because if they're doing it for their kid, which is amazing, but it's like a serious graft. So, what was the kind of numbers that were in the circuit trial in terms of percentage time in pregnancy range?

SPEAKER_00 34:36

Yeah. So I first want to start because even people who are experts in diabetes may not be experts in pregnancy diabetes. Oh, 100%. And I will say for myself, I am learning so much, even you know, diving into the pregnancy experience with diabetes. So, yes, that goal is 70, uh sorry, 70% of time between 3.5 and 7.8 throughout the three to three trimesters of pregnancy. The Lancet guidelines, um, there has there's this incredible consensus paper that was just published in February of 2026 saying, hey, it it's gold standard to use an AID system that has been able to demonstrate a meaningful improvement in time and pregnancy range compared to like a control group. And that is exactly the standard that the circuit trial was able to show. So what they did was they took um uh women who were pregnant with type 1 diabetes, enrolling them in the study around 14 weeks of gestation, and randomizing them to either using an AID system, control IQ, or whatever their standard therapy was previously with the CGM. Because there's no way you can, number one, it would be irresponsible to tell people they can't use CGM in pregnancy. That is such a well-known concept. But because it's not fully known yet that AID was effective, even though now we know it is, we could randomize them to control IQ. And so even though the primary outcome of the study was time and pregnancy range, that 3.5 to 7.8, between um 16 weeks of gestation through 34 weeks and six days. That was the primary outcome. And when you compare that time and pregnancy range between those using control IQ and those on their standard therapy, you saw a mean adjusted difference of 12.5%. So, in other words, the um the people using control IQ were able to achieve 65.4% time in pregnancy range, approaching that 70% goal, not quite at it.

SPEAKER_01 36:41

Way above the 50 they would have got. It would have been way above about the 50 they would have got before.

SPEAKER_00 36:46

Yeah, so like the standard care hit 50% time in pregnancy range, and control IQ is 15 points higher than that. When you control for baseline and everything else, it's 12.5. I think what's what's so exciting about this study is that meaningful difference against the control group. You know, in the UK, CAM APS has been approved for pregnancy. They likewise showed this uh mean adjusted difference of 10% better than that control group. What's fun is that if you look at pregnancy outcomes from 16 weeks through the end of pregnancy in these studies. So if you if you look at the same time period, CAM APS and control IQ, their outcomes were within 1.6% time and range different from each other. And what this says to me is that women have options for when they want to get pregnant, when they conceive, and when they want to maximize their time and pregnancy range for maternal outcomes, for fetal outcomes, for overall health of baby and mom. The control IQ is able to meet those demands. And I think it's so great to draw attention to this period in life where these women are probably more motivated than anyone in the world to achieve best Titus outcomes because they're not just working for themselves, they're working for their unborn child. And so to be able to show that meaningful improvement, which um, you know, to reflect better outcomes for baby, better outcomes for mom is just transformational. So having control IQ is an option, being able to help practically help HCPs and people with diabetes partner to get those best outcomes. So much more to come in the next year about that, John.

SPEAKER_01 38:27

And will the control IQ plus maybe included in that?

SPEAKER_00 38:31

Yeah, yeah, yeah, yeah. Oh, yeah. So control IQ, control IQ plus um are both gonna be the thing. It doesn't matter if you have the older algorithm or the newer algorithm for pregnancy management, they're gonna work great.

SPEAKER_01 38:42

Because the reason why the reason why I'm asking that, I'm just my my brain's going now, my brain's uh is on one.

SPEAKER_00 38:47

Of course it is.

SPEAKER_01 38:48

Is you're talking. But I mean, and that data's been backed up in real world studies as well. So there's a QS paper, the Spanish paper, where it showed control IQ and CAM APS are extremely similar. And in that paper, actually, I'm just gonna bring something up because I was involved in a paper, and I think it's also very important for people to consider this, especially in pregnancy, especially in pregnancy, is the CGM that you use is important in pregnancy. Now, the reason for this is some CGMs, especially when you start reading above 10, and certainly above 7.8, tend to read conservatively or on the lower side, underreporting slightly the current glucose level. For safety reasons, there's nothing wrong with that. Some CGMs read right where the glucose level is, actually is. And the reason why it's not so much of a difference outside of pregnancy, but when you're trying to drive glucose levels below 7.8 and 140, you want to make sure the CGM that you're using is measuring on the rise after meals exactly in there to allow the algorithm to work quickly. And what we do know from the paper that I was involved in is we know that the Freestyle Libre and the DEXCOM are two CGMs that absolutely read in that spot. And that's also likely why in that Curios paper we saw that the low gestation for age, is that right? Or something like that. Okay, LGA, whatever LGA means.

SPEAKER_00 40:04

Oh, large, just large logistics. Big babies. Yeah, large basically.

SPEAKER_01 40:07

Yeah, so yeah, basically you can't use less big babies using the sensors that measure in that physiological space, not slightly underreporting. So I think it's important to be able to do that. Yeah, they both use both use Libre and they both used XCOM. So I think it's just important for pregnant people just to note that because time and pregnancy ranges don't mean the same thing if you're using different sensors. I'm not gonna go into that too much, but what I am gonna say is the sensors that tandem uses and the sensors that Cam APS uses, we know that they measure in the physiological space. Therefore, that is likely, not for certain, but likely the reason why that large gestational age is a lot less for those two particular products that we just discussed in that Spanish paper. So I think it's when we talked about that with Eleanor Scott, and she was very, very adamant about that. So the people can go back and listen now and get myself in too much trouble. But I think it's important, it's nice to have options. So it's nice to be got that regulated in the US, soon to be in Europe, or by the time this gets released, sort of in Europe, or very soon within Europe. And then um, and then you've got the Cam APS options. Like you say, you've got a few different options, and that's exactly what you need.

SPEAKER_00 41:17

And John, I think, you know, I'm thinking about your comments about CGM and mean glucose levels and stuff, and you know, take understanding that systems read differently. It also reminds me that, you know, with control IQ, some of the some of the chatter I hear out in the world is like, well, control IQ is great, but because you don't, you can't adjust your target setting, it may not work for things like pregnancy or or you know, time and tight range. And I I think it's a it's a great point to illustrate, let's make sure that we understand all these terms are just names for settings and that it doesn't necessarily apply to what the actual outcomes are. You know, some of the some of the settings out, some of the systems out there, you can set a very aggressive target setting, like a target of 5.0. But, you know, this control IQ study, I think helps bring to life that that's not the same thing as mean glucose achieved. So just because you can dial a system down to a target of five does not mean that that's going to be the mean glucose achieved. The correction factor in pregnancy, just like in all of our other papers, that correction factor intensity setting, when that is dialed up, that's how you get that lower mean glucose. So you don't need to have a system with a pregnancy-specific target or or even a target adjustable setting. You do need adjustable settings. And that's that's true of every AID system. And so to achieve the same outcomes in pregnancy with control IQ, it is that correction factor and it's that basal rate. So again, it's just knowing what levers to pull for each system to drive mean glucose level down. And like I said, I think there's gonna be much more information coming to HCPs and people with diabetes about how to drive that tight control with control IQ using correction factor, using basal rates, and you know, using sleep activity, which is a way to tighten up the algorithm as well.

SPEAKER_01 43:14

Yeah, so I want to reflect on a couple of things you said there, because I think it's really important. Number one is when you're looking at um systems and whatever, and people tell you that this does this and this does that, and this is this. It's like, show me what you get in results. That's all I need to see. And what you've told me is 65% timing pregnancy range is the same basically as a CAM APS, and also you've got the same differential, roughly 10 to 12%. And also in the real world study, you've got uh less large gestational for age babies. So that is what I'm saying. That that that yeah, that last one is what matters. It's the size of the baby that makes the difference for the mother and for the child in the future. So that is what matters. What are you when you're looking at something? Don't look at what it's got a setting is look at what are the outcomes. And if you've got outcomes, you know you just enter it back, and like you have done and gone. With yours, it's a correction factor. With something else, it's a target. It doesn't matter. You get the same and it's about how you tweak it. But then coming to that point on the target, I think is an important point because we just said you've got extremely motivated ladies. They are going to be bolusing, they're going to bull using before and after. So that does give you the option to put this the sleep mode on for 24-7. So just as I understand it from a UK perspective, from a control IQ between 6.1 and 8.9, if the glucose is trending and not to go outside those boundaries, it just keeps the same basal level. However, if you change it to sleep mode, 6.1 to 6.7? 6.3? Yeah, 6.77. If it's predicted to go above 6.7, it'll start increasing the insulin. So if you want obviously tighter control in that time in tight pregnancy and you're bolusing regularly, and you've got your basal rates up at 55, 60%, and you've got your correction factors tuned strong, it might make sense to have that on 24-7. Is that absolutely? Yeah.

SPEAKER_00 44:57

Yes. And that and that's what they did in the circuit trial. So they put people on sleep activity 24-7 to tighten the algorithm range from 6.25 up to uh 6.7. And that is that's the starting place. But but you know, by adding, but you know, after 20 weeks of gestation when insulin sensitivity decreases quite a bit, you know, putting those basal rates up to 50 to 20% more than than what's delivered typically just allows that target and basal rate to work together to drive down mean glucose. So these are these are the tips. Again, it doesn't really matter what the setting is called, except to the HCP who needs to know how to use it. And that's where, that's where I want to make sure to equip and empower healthcare providers in the next year or two to really make sure they feel comfortable using the levers available on control IQ to drive that time and tight pregnancy range.

SPEAKER_01 45:52

So I'm gonna put my foot in it now and take a little dip out of my own backyard and start dipping my feet into the pregnancy backyard. But if I was working in pregnancy, this is what I would be doing if I was using this system. I would be pushing that basal to 50-60%. I would be making the correction factor very strong. I'll be encouraging pre-bolishing and walking activity. I'd include seat mode over 24 hours. And then what I would do if you've got control IQ pluses, rather than pretending and giving people these profiles, I would say you come back, I want you put a temporary basal of 125% on and we'll stick there for three days. And if it's working, we'll knock you up. If it's not, we'll go up to 50%. And then you've got that control IQ plus as a lever to practice before you commit. Whereas of the other systems, you've got to wait for that learning to happen, which means you're behind the eight ball because you've got to wait for it to catch up to the insulin rising needs. You can get ahead of the game. And if you know when those trimesters kick in, because you work in that area, I don't even know when that would be, but I just know that it happens at it just happens at some point. I would just follow my nose and go, it's going up. Okay, let's put it by 25%. And you could easily have a protocol. You could go, okay, when you get to 15 weeks, what I want you to do is put 125% basal rate on. And if that's not working, 150, 175%.

SPEAKER_00 47:00

16 to 20 weeks. 20 weeks seems to be sort of the number where really gonna need to start pushing that basil and making sure correction factors dialed in. I I love that, John. You you are the first person to think about with me the idea of using that temp basil as a trial run. Yeah, yeah. Pregnancy might be a wonderful way to find it. But I I think what we're gonna find now that we have regulatory approval for these things, people, you know, clinicians such as yourself are gonna come up with easy strategies to optimize. And this is gonna be where we all benefit from from these uh from from what we find out in real in the real world.

SPEAKER_01 47:40

So I'm sure there's now people who work in the pregnancy space to go, that guy has got no idea. Get out here, get out of our area and get back into your pediatrics, which is fair enough. I can I can leave it.

SPEAKER_00 47:48

It is, and at the same time, pregnancy is a part of the lifespan, both pediatric endos, adult endos, and even primary care docs to some extent are are going to need to address pregnancy in women with type 1 diabetes at some point in their life. It's not like the majority of pregnancies are planned. It's not like this can't happen to your average 17-year-old. It can. And I I think this is an opportunity on a diabetes level to address the fact that pregnancy is common. Pregnancy is a part of life. It doesn't matter if it's at 16 or 18 or 34. Diabetes is going to make that important to really address. And so pregnancy is not just for pregnancy-specific specialist doctors. Pregnancy is something that all of us in the diabetes community need to learn, need to do better, and be able to offer to people with diabetes systems that can help them achieve their goals.

SPEAKER_01 48:45

And the reason why I'm smiling because it just kind of reminds me of a couple of consultations I've had recently, but with young boys and when I say young boys, teenage boys and teenage girls. Um, and it always ends up with the sort of the final thing is to the lads, it's like, don't be a fool, wrap your tool. And then if it's kind of gonna be it's gonna be, you know, if you're with a lad, don't be a fool, make sure he wraps his tool because you do not want, you do not want that situation going on when you've got diabetes, unless you want a baby, obviously. Right.

SPEAKER_00 49:10

But um, there's no reason that a woman with diabetes should not have a child if they choose to. Yeah, I mean we have the ability to deliver healthy babies with diabetes, and now we have even more tools to do it.

SPEAKER_01 49:22

Yeah. And they've got kind of things to make sure that those tools are in the right place and uh not too expose causing babies. But anyway, enough of that. We'll we'll kick on. What I will say is I can't let you go without a mention of the Mobi. So we've covered, I think, very nicely what Control IQ Plus is bringing, what's different, regardless of whether you're on Control IQ or Control IQ Plus, how you can think about setting that up, and we'll do some show notes and do points and directions to your papers, and we've obviously got the different tools on the glucose devil eyes where people can kind of, you know, try different levels of what the evidence base would suggest based off people's total daily dose, etc. So the Moby, my understanding is it's not a patch pump, it's an on-body pump, which is you have a cannula still with a very small tubing attached to an on-body pump, which is about the size of a matchbox and that is very close to it. So essentially it's an on-body one area where you don't have the dangly wire situation, which bane of my life is getting up in the night and going for a wee, and this like it's swinging around everywhere, and then the cannula pulls out, and you're just like, Come on, come on! Go downstairs and you know, wake the dogs up and change a cannula. I I wear a waistband, but I mean it's not not the sexiest look in the world having uh one of these waistbands on you. You'd rather not. Um what's the you kind of tell us a little bit about the Moby, tell us um how it works, what the form factors are different. Um because obviously now, just just to mention, if people don't know, you have got the the mobile app where you can bolus remotely to both control IQ Plus and standard control IQ, and then you've got the upload to source now, which is great. So your data no longer has to kind of go through a glue co upload, you can do it, which all that thing is great. Tell us about the the Mobi, sort of the next iteration.

SPEAKER_00 51:10

Yeah, so I I want you to think of this as two hardware options. So what you just articulated was our first hardware option, which is the T Slim X2 pump and the mobile app where you can bolus from it, and it it goes to tandem source. Tandem Mobi is about the size of a match box, like you said. It is a smaller form factor that does everything the T Slim X2 does. So except that there's no screen on the pump. So, in order to make this thing as small as it is, about the size of a matchbox, all of the control of the pump is on the phone app. This does not mean you have to have your phone with you at all times because, and this is important, John, the control AQ technology lives in the tandem Moby pump itself. It directly talks to the CGMs. So automation occurs all the time. It never kicks you out of automation. As long as you have a CGM running, automation is running. Doesn't matter if your phone is in the other room, if it's not in your, you know, your belt with the young children. So the automation is all in the pump working on the body with the CGM. The phone app is what you need to interact with the system. So you want a bolus, you want to change basal rates, you want to change your infusion set. That is all done on the app itself. Now, um, there is a button on the pump, a bolus button. So if you did walk away from your phone and you want to deliver a bolus, you can do it from the pump itself, which is really great. And also, even if your phone is with you, you're in a meeting and you want to discreetly give a bolus, you can do it by touch on the pump itself. Now, you mentioned you can wear this on the body. So there's a 12 centimeter tubing that can go with the tandem Mobi pump. And so that that allows wear options where the pump can be stuck to the body. We have this little thing we call it, the Moby sleeve, that can help adhere it to the body. There are all these aftermarket versions too, with cute colors and flowers and and different things so that it makes it a little more fun to wear. But the other thing I want to point out is not everybody wants to wear a pump on their body, especially if they're wearing a swimsuit or different things. They may not want it stuck to their body. So all of the options available with T-Slim, longer tubing, different types of cannulas, those are all available to tandem Moby as well. So think tiny pump, wear it on your body if you want, tuck it in a pocket, tuck it in your shirt, clip it to a waistband. You really have a lot of optionality of how you choose to wear it. And the one other thing, John, we've talked a lot about kids today. Minimum fill. So the minimum amount of insulin you need to put into the tandemobi cartridge is 30 units. So you don't have to fill this thing up to 80-90 just to get it to work. If you have a little or someone who's very insulin sensitive and needs very little, 30 units is the minimum you need. So this can be very helpful when you have those very low total daily insulin users.

SPEAKER_01 54:03

And also, I mean, I'm not in the US, but I've heard that the costs of insulin are kind of ridiculous. So, you know, with certain, you know, people I all the time when people fill up to different options and you have to fill like 80, 90, 100 units, they hate throwing it away. They hate throwing it away. I just totally, totally get it. But I can imagine in the States that's actually got a financial implication as well. So okay. Yeah. And that's out in the States, right? I've heard a few, you know, I've seen a few people online with it kind of like, hey, check out my new pump, guys. It's an on-body thing. It's it's amazing. It's so good.

SPEAKER_00 54:33

It's fun because all of our early users, when we analyzed, you know, what do they think of this? Size was the number one thing everyone said, oh, this is incredible. Now, what's interesting is people who came from previous patch pump versions, yeah, they like the size as well, but they also identified they are so happy about the control IQ algorithm. So the real standout of Tandem Moby is yes, size, finally it's small. Wear it on your body. Don't wear it on your body if you don't want to. But also you have just the gold standard algorithm available in this form factor. So that marriage of our algorithm with a tiny pump is just, in my opinion, it's the best combination, best of both worlds, where you get that wearability and you get unmatched control with the algorithm.

SPEAKER_01 55:17

And then you've had the freestyle Libra 2 for a while in the States, but now the Freestyle Libra 3 is going to be available with um all form factors, presumably. Yeah, yeah.

SPEAKER_00 55:25

So it'll eventually come to Moby. You know, all these things need to be built and rolled out.

SPEAKER_01 55:30

So actually, well, we've we've we've had we've had a session. We've had a session on Freestyle Libre 3. So I'll just kind of give people listening to the first time. It is tiny. I mean, the freestyle three is absolutely tiny. It's 15 days, extremely accurate. Um, the Bluetooth technology, from understanding, is is very good in terms of strength for discussions. Where I know there's been a few challenges of the Freestyle Libre 2 with various different form factors, but I've heard that the uh the Bluetooth optionality with the um the Freestyle Libre 3 in terms of the connection with AID system. And yeah, we had uh the the the team from ABBA on kind of really walking through, and yeah, it's like it's a it's a proper cool little like I mean I I've I've worn it a few times. I I really like it. For me, I'm a freak on the calibration front, so I'm a Dexcom man because I can calibrate it, but I for people like loads of people with the Freestyle Libre 3. So to have the options of the G7 and the Freestyle EB3 is really nice.

SPEAKER_00 56:21

CGM choice is huge. People have many reasons for choosing the CGM they have. And it, you know, in addition to whether they like to wear it or not, you know, how well it works, cost is an issue. So so the idea of being able to partner with all of these different CGM products, all that does is help users have some choice and be able to wear what works for them. And so I think that's an important principle at tandem is like we want people to be able to use what they want and support them with control IQ technology.

SPEAKER_01 56:50

Yeah, absolutely. And with them being um ICGM approved, which is great, it means that we have certain within the states, when you pass that, you can partner with anyone because we know that the the quality of the CGM is a very important thing.

SPEAKER_00 57:01

Precision and accuracy and bias are all within limits to trust it with AIDS.

SPEAKER_01 57:05

And that that that's massively fun. So that that's that's really helpful. So I want to wrap up with what I have taken away from this because there's a few things I think that will change my practice and it's got my brain going already. So control IQ for me completely misunderstood in terms of how to get the most out of it, partly because of your team at the beginning didn't really know what they were doing, and now that they do, because they've got you on board, obviously, we now know that get the basal to 50% or so or above, correction factor strong is the main thing to do. But you really need to get that basal close to 50%, otherwise, you're gonna end up with too much bolus insulin, and that's gonna constrain how effective the algorithm be. So there's two things you can do regardless of whatever tech you're using. Control IQ plus, we're now gonna have the full range of correction factor from as low as you want to sort of up to 33 or 600, whatever. So now for the children, young people from the age of two, where the license has come in, you can kind of get those time blocks across the day for the young people, very strong in the dust period, very weak overnight.

unknown 58:04

Yes.

SPEAKER_01 58:04

For the adolescents, extremely strong to manage it that part. And then moving on to a pregnancy perspective, you've obviously now got the data to suggest equal outcomes in terms of time in pregnancy specific range. And you just need a pregnancy-specific outcome, not setting, you need an outcome that delivers outcomes pregnancy.

SPEAKER_00 58:24

Pregnancy-specific outcomes being able to demonstrate that 5% or more increase in time and pregnancy range.

SPEAKER_01 58:31

Settings are settings, outcomes are outcomes. People with diabetes want outcomes, they don't want settings. So we have the outcomes delivered both in the circuit trial and in the real world stuff. And we even like have even given maybe a suggestion that you we know when these 16 to 20 weeks is coming up on the bump and insulin sensitivity. Get your temporary basal on bum, bum, bum. Similarly, if you're a clinician, someone's coming, you're like, Do you know what I think we need to tune the basal rate up a little bit? Three days, stick it at you know, an extra 20 or 40%. If so, then bump it up. So you're no longer gonna need the schedules. You don't need the different schedules, which I think is nice. I think it's nice.

SPEAKER_00 59:05

That's a really practical implication of a temp basal. We don't know from the pregnancy trials whether that will work, but we do know that increase in basal rates to be above 20%, what they're actually delivered is very useful, 20 weeks and on. And all John, all these tips you're talking about are highlighted in that rethinking control AQ plus article. So we'll we'll link to that. Anyone who wants to see it, people like Dr. Um Prateek Chowdhury and Beryl Shaw give these very practical tips for anyone, for pregnancy, for children, for you know, different types of diabetes. There's some very practical pieces that you're hammering here too with that correction factor and basal rates.

SPEAKER_01 59:43

Yep. And we'll put some notes in the in the show notes about kind of like if you're in the States, it's like the 1500 rule, and if you're in UK, it's like the 88 rule and what that means. So we'll put that through. And then finally, you know, kind of the control IQ plus is going to be with the Mobi. You've already got the Mobi in the States. It's a you know small on-body pump or you can wear it off-body pump, and then you know you've got your sort of you can use it with your phone and you've got a direct link to source. So all the challenges that I would have said with the tandem, which was maybe one, we didn't know how to tune it. Now we've been through exactly how to do that. Yeah, there wasn't an automatic upload, yes, there is now with the source. Yeah. Um, smaller form factor which you've kind of got in, and now from the age range, you've got the full age range and the pregnancy specific thing. So you're kind of like you're positioning yourself as across the lifespan with various different things.

SPEAKER_00 1:00:28

Absolutely. Control IQ works literally for anyone, from age to pregnancy to older in life, like the entire age range, the entire lifespan of people living with diabetes, control IQ can work exceptionally well. And knowing that correction factor and basal rate as your levers are going to be what get you there.

SPEAKER_01 1:00:48

So this is this is just my opinion, and this would be, I think is borne out by the data, if I'm honest, but I think is something worth reflecting on, not for you, but for people who are listening, is on average the timing range is about 63 to 65% across the board for AID systems in real-world pilot data. I'm talking about UK across the board, and you stick everyone on it, how do they do? They get 62, 65, they don't get the trial outcomes because we cherry pick the right people. That's because for me, you have systems which are catching up catching up with what's happening and often is is a bit too slow. Whereas potentially with a control IQ, if you know what you're doing as a healthcare professional and also a person with diabetes, you have a little bit more options to tweak things according to how you need them to potentially get a little bit higher. So, but that kind of comes into the teaching piece of your job at tandem and jobs for people around is to kind of hammer home what we've discussed and also don't be afraid, self-discovery. Push it.

SPEAKER_00 1:01:51

There it is, John. Push it, push it. That's my message is this is not about complication. This is about don't be afraid. You have exceptional levers that you can use with that correction factor of basal rate. Do not be afraid to use them. Automation is there to give you room to do what you need to, and then it will continue to protect you against hypo. So you just nailed probably the best message that I want to give with Control IQ. Do not be afraid of these levers. They work exceptionally well, and the algorithm protects against hypoglycemia.

SPEAKER_01 1:02:24

So you can pick up with that. That is trained. But no, I just want to say, first of all, obviously you are, you know, kind of global um medical affairs lead at tandem, taking the time out, an hour to come and speak to people. There's a lot of people I know will hopefully open their eyes to what's possible, see what's coming. There isn't a one-size system fits all for everybody, but you're gonna have a lot of people on the existing system and future systems. Hopefully, this has given you the confidence to explore, experiment, teach, enjoy. Um, and also, I think some ways, you know, healthcare professionals, it's kind of like, oh, we just come back and we just, you know, tweak this and we just leave them there. It's kind of like, you got the opportunity to get stuck in, you know, get stuck in and kind of really offer something a bit more unique. And I will say, if you're in pediatrics, read uh Dr. Bister's paper from the DPV. We'll drop a line, we'll drop a line into it. All you need to see is this is what typically instance requirements are across the day. You look at that and you'll go, I know what I need to do. That's where I tune the correction factor and basal rates, and that's where I do that.

SPEAKER_00 1:03:26

Yeah, and the ISPAD guidelines offer really great tips on that as well. And Dr. Beister is part of those as well.

unknown 1:03:32

Cool.

SPEAKER_01 1:03:32

Well, thank you very much for your time and have a wicked day because it's like morning for you and it's mid-afternoon for me. And I'll look forward to catching you up at some conference at some point soon. But yeah, thank you very much for your time.

SPEAKER_00 1:03:44

Absolutely, John. This is such an honor. Thank you so much for having me.