Hi everyone, good afternoon. So I would like to open the American Diabetes Association webinars and how to make an AI the system work case-based review. And this is the hands-on tips to improve diabetes care webinar series. And our panel will share their expertise today with you and I have two wonderful speakers and let me introduce myself first briefly. My name is Dr. Akturk, I'm Associate Professor of Medicine and Pediatrics at the University of Colorado at the Barbara Davis Center for Diabetes. So I'm also serving as the ADA, Diabetes Technology Interest Group, as the Communications Director. So I will be moderating this session. And we have an agenda today that we'll be using a system, it's called Kahoot. And then, and we will be also using our chat box for interactions. So you will be asking questions from the Q&A or in the chat section. So I will be reading them at the end. So when our presenters are presenting, you can just put your questions there. So you don't need to wait at the end. But we will be doing the Q&A at the end. And so we'll be using a platform, which is called Kahoot. And Kahoot is an interactive tool that is a game-like platform that you will have pin numbers that you need to enter. So you can use your phone or a tablet or any device, or it will be easier, actually. If not, you can use the internet browser and type kahoot.it. And then you put the game pin, and then you will be able to answer the questions there. And then it will be more interactive. And you can see in the chat section the game pin. So I will give everybody a little time to, before I introduce our speakers and move on for the other announcements, so you can just try to join the Kahoot. And that pin number will be in the chat section. So even if you join a little late, and you can always see that link and the pin number there. So I would like to announce a couple other webinars that are coming up and other sessions. That's the next hands-on webinar is the Typhoon Diabetes Sports and Exercise from Research to Practice. And it will be on January 9th from 3 to 4 p.m. Eastern Time. And there will be a registration link in your chat box. And it will be with well-known Dr. Peters joining with an athlete. And Dr. Kolenberg will be moderating that session. And we have also innovations and latest treatments in Typhoon Diabetes, online self-pacement and self-assessment. There will be a Typhoon Diabetes online self-paced program. And you can get 6 CE CME credits. And there will be learning.diabetes.org will be, you can register and visit. And it's open for all providers and all the ADA members that would like to learn more about Typhoon Diabetes. Now I would like to introduce you our presenters today. Dr. Wilson and Dr. Benson is joining from Florida. He's a pediatric endocrinologist from Newmars Children's Health Hospital. And he's a board-certified pediatrician and pediatric endocrinologist and a junior clinical scientist. He's an assistant professor of pediatrics in the Mayo College of Medicine. And we have Dr. Wilson. Dr. Wilson is an assistant professor at the Oregon Health and Science University. And she's also the program director of the endocrinology fellowship program. And both of them have quite experienced physicians and researchers for the Typhoon Diabetes and diabetes technologies. So I will let them in the next slide. They can say hi and they can disclose their conflict of interest. So I'm Dr. Benson. My disclosure is for Key Health, Novo Nordisk, Beta Bionics, Diurnal, and RO1 looking at glycemic outcomes in diabetes distress. Hello, I'm Leah Wilson. I have research support from NIH and IDDK and the Helmsley Charitable Trust as well. Thank you. So if your Kahoot is ready, if you are also beginning, we will be starting our presentations very soon. And I think we can start with the Dr. Wisson. Go ahead, Dr. Wisson, please. All right. Okay, thank you all for being here today and listening to our talks. So this will be a case-based review on automated insulin delivery systems. And I'll go ahead and get started. Let's see if I can. Okay. So as an overview of my session, we'll talk about the increasing number of AID systems on the market now. And this number is only gonna be increasing from here. So talking about some kind of systematic ways of understanding current and upcoming systems and some good source of unbiased information for comparison of different systems. And then we'll talk a little bit about use of AID in a wide range of patients, including patients with comorbidities and those with hypo or hyperglycemia. They may actually have the most benefit from these systems. We'll talk about glycemic benefits and kind of the timing of when to expect those when starting AID and some real world evidence for using AID systems without meal announcement or with simplified meal announcement. Okay, so this is a little bit of a timeline leading up to the present day, you know, we had our early IV insulin pump, I'm sure you may have all seen this picture, this is kind of a cartoon version of that one. And then moving through to more recent times with sensor augmented pumps, and then most recently AID systems. And you can see like the years are just starting to get closer together. And so even within the last couple of years, we've had more and more of these come out on the market. And so it's important, I think, to come up with like a standardized framework of how to think about these systems and how to talk about them with patients to help them make the best choices, and, you know, learn, you know, what to adjust and how to manage these systems and practice. So this is a really nice framework, the Panther framework out of the Barbara Davis Center. And they have this CARES framework, so that that's an acronym. So calculate, adjust, revert, educate, and sensor share. And they have some really nice PDF handouts on all of the different pump systems that are available, AID systems, and break down how these systems work in terms of this framework. So calculate how does the algorithm calculate the insulin delivery, how, as a provider or a patient, how can these settings be adjusted, revert, referring to what happens when you go into manual mode, what are the key education pieces, and then what sensors does it work with, how does sharing work, other important pieces to best understand how to work with these systems. So as a little bit of a look into that, so here's one of the handouts from their website. So you can see the main AID systems there across the top. And this is the calculate section. So you can look through and look about basal automation, bolus automation, you know, what are those features of these, within these different pump systems, and target ranges, everything like that. So it's a nice, quick, easy way to refer back to all of these like key pieces of these different systems. And here is also the adjust section, another relevant piece for us providers. You know, it's gotten more complicated, okay, well, with this system, what do I adjust? With this system, it's something else. How do I remember all of that? So this is a good place to refer back to, to quickly figure out how you can make changes when you're in an appointment or between appointments with a patient. And then I also wanted to mention this, this resources as well. This is a great, both for providers, but also nice patient facing information. This website was really a nice source of unbiased information comparing the different systems. And has this nice feature, or sorry, this is like the front page of that, that website. But then on the next slide here, I've got, they have a nice comparison feature. So you can pick, you know, if somebody's trying to decide between two different systems, you might pull this up or they might, you might send them this link. And so they can look at these different, two different systems and compare different features of those. And as new systems come out, they'll be adding that to the, these to that, this website. They also have like a really nice section on continuous glucose monitors as well. So some resources for you to check out as you're seeing patients interested in AID or already on AID. Okay. So let's talk about some cases. So my first case today. that I have is a 36-year-old woman and she has type 1 diabetes that was diagnosed when she was 3 years old. Over the past 10 years she's had an A1c in the range of 10 to 16 percent and her diabetes has been complicated by end-stage renal disease and she's been on home dialysis for the last two years. She also has retinopathy resulting in legal blindness and she's being evaluated for simultaneous kidney and pancreas transplant but her A1c needed to be less than 9% to be listed and at the time I was seeing her shortly before she got listed her A1c was like 10, 10 and a half in that range. She had challenges with adherence to finger stick testing and multiple daily injection regimens and she really had a notable fear of hypoglycemia. She had some really severe events when she was a child that kind of lingered on in her ability to, you know, cope with hypoglycemia. So on the left-hand panel this is her continuous glucose monitor data for the two weeks prior to us starting her on a closed-loop system and she'd been on CGM for three months and had seen a little bit of improvement just using the CGM but as you can see still really quite high pretty much all of the time. And then on the right-hand panel this is her CGM data after just the first two weeks of using automated insulin delivery. So really a marked improvement and luckily mostly able to avoid low blood sugar. So this was a little bit of a leap, you know, I think she had talked to other providers prior to me about diabetes technology and I think there was concerns about her renal disease and her blindness and also just, you know, she hadn't been quite ready to follow through with the tasks needed to get going on those but, you know, the motivation to get listed for transplant was big for her and so we kind of took the leap and got her started and it was a little bit of an anxious time but it really, you know, worked out quite well for her. And so here is her data two years later. And when I'm seeing, just recently saw her in follow-up and she had a simultaneous kidney and pancreas transplant about I think a year ago, but then unfortunately had an asthmatic failure with her pancreas and they had to explant that. So she had a brief period of time of a few weeks with that pancreas working for her. But then after that, she's needed to go back to relying on diabetes technology, AID system to help her manage her blood sugars. And so you can see like control has deteriorated somewhat, maybe not quite as good as that first two weeks, but luckily no low blood sugars. And I think the thing that we've seen for her, maybe not bolusing quite firm for meals as much as we would hope. So we have been talking about that quite a lot. And then just in terms of making AID systems work, this is something that I saw in her download and somehow she had accidentally turned on her activity mode since the last time I saw her in clinic. And so she was running with that target of 150 instead of the typical 120 for this system. So just a practical point, always good to be checking, what is their current settings and making sure that those are as intended. Okay, so regarding making that leap with this patient with renal disease and visual impairment, this is kind of the way this world is going. So really strongly considering AID systems in all people with type 1 diabetes to improve glycemic control. And I think the most recent ADA guidelines also have a similar statement. This is from endocrine society, but the ADA guidelines this most recent year have a very similar sentiment about AID systems. So not just in children, but adults with, older adults, people with moderate or severe hypo or hyperglycemia and including CKD, chronic renal failure, gastroparesis on this list, and including other types of insulin deficient diabetes as well. So these systems really should be considered in a real wide population of people with type 1. And here's just one study to support the use of AID systems in patients on dialysis. So this is for type 2 diabetes, but I thought it was a nice visual. So closed loop control in red over the course of a 24 hour day there versus control in gray and also time and range improving and hypoglycemia improving. So while these systems maybe weren't, the algorithms weren't designed specifically for people on dialysis, they seem to work pretty well. And probably in a lot of situations will be better than other options, MDI or open loop pump. So something to consider in your patients. And my second case is a 31 year old woman and she was diagnosed with type 1 diabetes at age six. She has no known complications. She has a history of, sorry, no history of DKA. She does bootcamp or spin classes four to five times per week. So pretty active person. And her A1C is averaged about seven and a half over the last five years. And the thing about her is despite us frequently talking about it, she hasn't been able to work in pre-meal boluses into her routine and often doesn't bolus for meals at all. And so this is a typical download from her AID system. And so I don't know if some of you may be more familiar with these downloads than others. These little blue ones with the cross hatches in them are the automated correction boluses. And then this light blue is a meal bolus, dark blue being a correction bolus. So you can see maybe like once a day that she's bolusing before meals or bolusing for food, I guess I should say. So just not very often. And that's captured here also in her bolus usage summary where her food only boluses on correction plus food boluses represent just a minority of the time. And she's really relying a lot on the basal insulin delivery from her AID system. And here's a typical AGP for her showing better control overnight and higher glucoses during the day related to food intake. But this has been pretty typical for her, 64% time and range, not a lot of hypoglycemia and some higher glucoses would average 175. So this is maybe not how the optimal use of the system and not how they were designed to be used, but quite a few people are using them in this way. And so I just wanted to show some evidence that's growing on using AID systems without meal announcement or simplified meal announcement. So this is some data that was presented at the artificial pancreas meeting at NIH eight months ago or something like that. So this is a large dataset with control IQ where they looked at days where people were either bolusing for meals or not bolusing for meals and hybrid closed loop being the typical way of using and announcing meals, fully closed loop, meaning that they're actually not announcing their meals to the system. And so there are some users that pretty much all of the time or most of the time in this real world dataset are using it without pre-meal bolus announcement. And they showed a time and range on those days when they were not announcing any meals of 68%. And actually interestingly on the days that they did announce some meals, slightly lower 62.8% versus those users who do announce multiple meals per day, 72%. So not quite as good as using it as intended, but most reasonable results and probably better than a lot of other situations for these patients. And a similar kind of data coming out on another one of the AID systems. So this is about the MiniMed 780G, a study that came out, I think this was 2023 actually, where they either had simplified meal announcement versus typical carb counting with the fix being three preset carb amounts, either small, medium and large or flex or typical hybrid closed loop with announcing carbs. And so you can see, run in three days, one week, two week across the course of the study. And the fix group is showing lower time and range, but pretty close to our goals of 70%, above 70%. And with much simpler meal announcement. And I think didn't include this data, but with the islet system also that kind of simplified meal announcement there. So overall time and range achieved 73% for fix versus 80% for flex. And the P value was significant there with favoring flex, but the A1C and the time below range did not differ between the groups. So just an interesting thing to consider. And if you have somebody who is not consistently taking boluses before meals, still, I think reasonable to try them on an AID system and they can actually get pretty good results. Okay, third case. So this is a 41 year old woman with type one diabetes complicated by mild non-proliferative retinopathy. She was diagnosed with diabetes, 18 months presenting NDKA and her A1C has ranged eight to 9% for the last five years. And this is kind of when I was originally seeing her coming into me with that A1C. So her last CKA episode was 10 years ago and she'd previously been on pumps during pregnancy but didn't really like having something on her body. And when she first came to me in clinic, she'd had a recent move between states with a lapse in insurance and was actually only using short acting insulin four times a day. So really not ideal case study and how important it is to have consistent insurance access for our patients. Okay, so with these sub-optimal blood sugar control and she'd finally kind of come around to the idea of trying an AID system after talking about it over a period of quite some time. So she opted to try the Omnipod 5, which I think for people who maybe don't like wearing something on their body, not having that tubing can be a real advantage. So she got to meet with our diabetes educators and they presented her all the different systems. This is the one she chose. So I think this was probably a good option for her. This is the month before she started on AID. She'd been on MDI with continuous glucose monitoring for the last two years and just really kind of consistently running high. And then occasionally you can see by our kind of confidence intervals having some dips at times as well. And then this is her data for the first kind of 15 days on automated insulin delivery. So really a rapid improvement in glucose control. And this was even, we started her off with the higher target of 150 because she had been consistently running high. And so felt that that would be less of kind of a shock to her system to kind of slowly work that target down over time. And so this is actually, this is not just this one off for this patient, but this is borne out in the data as well. That the glycemic improvement that you see on starting AID systems happens within days, even a couple of weeks, and then maintains over time. And so this is some data from Control IQ on the left and Minimed 780G on the right, showing at that 14 day point, pretty much the full amount of improvement that the participants had, and then similar data also for the 780G. So I think we'll get to talk some more about the individual systems on our next speaker, Dr. Benson. But I think this is a good reminder, just like if you aren't seeing those improvements in that first couple of weeks, it's a good time to be following up with the patient and like making sure things are set up correctly. Your targets are where you want them to be. The settings look correct. You've adjusted what you need to, because really you should be able to see that improvement happen pretty quickly. All right. So this is my group here at OHSU and my research group, and just wanted to throw it out there. We are also hiring endocrinologists. So if anybody's interested, that's the link there to our website for more information on that. So thank you so much for your time and I'll go ahead and pass it over to Dr. Matthew Benson to present his slides. Oh, sorry. I forgot. I forgot that the question was going to pop up there at the end. Is there any way we can... Oh, the question's at the top. So the question is, in the PANTHER program framework for AID systems, CARE stands for... And then you can see your various options there down at the bottom. So hopefully you've been able to log into the Kahoot! system and pick an answer there. Great. Yes. So calculate, adjust, revert, educate, censor, and share. Awesome. All right. Now I'll actually pass it over to you, Dr. Benson. Thank you very much. So I'm going to talk as well, tips to improve diabetes care, how to make an AID system work, a case-based review. We've already reviewed my disclosures. We're going to review the four most recently FDA-approved AID systems, the main CGMs that can also be paired with those various insulin pumps to allow us to close the loop and allow automated insulin delivery in your patients. And I'm going to try to compare and contrast these four major devices and then look at a case, mainly myself. I'm a type 1 diabetic now for about 30 years. And I'll give you some other tips as well that you could use for your patients. And hopefully in the question and answer period, you can focus on that. So first, there's going to be a question. Most children with type 1 diabetes mellitus meet the glycemic target set by the American Diabetes Association at less than 7%. Is that true or false? Excellent, that's great. So most definitely, diabetes is a very demanding chronic condition. One of the most common chronic diseases after asthma and ADHD and based on data from the type one diabetes exchange and other data sets, we know a minority of children and it's really around 20% of children and adults, 17% of children, even lower, and in adults it's around 20% who meet the current ADA targets. But we know that with AID, we can see impressive improvement in glycemic outcomes and glycemic control, regardless of age group, gender, diabetes duration, prior insulin delivery modality, or even baseline glycated hemoglobin A1c. In fact, the higher the A1c, often the greater glycemic benefit with AID systems. Unfortunately, poor glycemic control is far too common. And this is from 2019, published in the Diabetes Technology and Therapeutics. You can see the massive spike in A1c that we see in childhood, especially during those teenage years. We have the antagonizing effects of growth and growth hormone and the stress of a developing child during their youth, but the diabetes control is very, very poor and poor diabetes control, we know over many, many decades, increases the risk of major diabetes-related complications with loss of life years of about 17.7 years in men and 13.7 years in women. So this is a very important issue to get our glycemic control as close to target as we safely can. We also know that there's a great deal of ethnic disparity in the use of diabetes technology. And this is just showing you glycemic control that's looked at by ethnic background, non-Hispanic white, non-Hispanic black, and Hispanic. And you can see the rates of A1c is over 9% is common in non-Hispanic white, but it's much more prevalent in our non-Hispanic black and Hispanic patients. And at the same time, we know that automated insulin delivery use in these ethnic minority populations is far lower, unfortunately, in many cases. So the AID systems utilize sophisticated controller algorithms that continually adjust insulin delivery based on response to interstitial glucose levels that are measured by a CGM like Dexcom pictured here. Algorithms accommodate the variability of insulin requirements between and within individual users. Meal announcements, while not essential, as Leah showed in some of her slides, if you do meal announcements, you tend to get obviously much better control. And then we always have to keep in mind that with these systems, we are measuring interstitial glucose. And so there is a lag phase of about four to 10 minutes between the subcutaneous space and the plasma glucose, and also delays in the insulin delivery from the subcutaneous space, taking about 45 to 60 minutes for a dose of say Humalog or Novalog to really start to therapeutically lower blood sugar. There's different algorithms. The Medtronic 780G that's currently on the market uses a proportional integral derivative, which is really a more calculus-based approach. It's a more reactive approach, looking at the proportional component, which is the measured versus the target glucose. Also an integral component that looks at the area under the curve of the measured versus the target glucose. And then a derivative component that really measures the rate of change of glucose at any point in time. This is in contrast to most of the other systems that are based on model predictive control algorithms that are more patient-specific, predicting into the future, maybe five minutes, 30 minutes, or 60 minutes. And then looking at the measured glucose from the CGM as compared to the model predicted glucose, and then adjusting insulin proportionately. So the Medtronic 780G currently works with the Guardian 4 sensor. They obviously do not work with Dexcom. It will be great when we get to a point where you can plug and play different CGMs with different pumps, et cetera. But again, the Medtronic uses a PID algorithm. They do have the lowest target on the market going down to 100 milligram per deciliter, and they can also lower their insulin on board to two hours. They have an activity target as well, and it gives automated correction boluses, and it has a meal detection algorithm as well. The basal is adjusted every five minutes, and there's a max hourly basal. And in contrast, the Tandem Control IQ algorithm that runs in the T-SLIM and the Moby pump is a treat-to-range adaptive MPC that's on both of those pump devices. The target is fixed, and it can range between 112.5 and 160, and it has higher overnight targets, which is a time of day when it's much easier to get glycemic control into range. It also does have an activity mode, which will raise the glucose threshold during exercise as another way to protect the patient, hopefully, from hypoglycemia. It will give an automated correction bolus of 60% of the calculated if the predicted glucose in the next 30 minutes is predicted to go over 180 milligram per deciliter, and similarly, it adjusts basal insulin every five minutes. The Omnipod 5 also pairs with the Dexcom 6. The thing that impacts this algorithm the most is the target, so that has the main determinant of automated insulin delivery. It can be adjusted between 110 and 150 in 10 milligram per deciliter increments, and then that will impact an adaptive basal rate that is also modified by the total daily dose of insulin, and with each pod change every three days based on the total daily dose, and the target will automate a more aggressive correction of insulin, and then the Beta-Bionics Islet is also an MPC algorithm. It's initialized not with any pump settings, but just with body weight. It has a usual target of 120, a lower target of 110, and a higher target of 130. Again, there's no insulin to carb ratios, no programmed basal rates. It's initiated only with weight, and when you have your first meal, it's giving about 0.5 units per kilo of insulin, and then it has three different control algorithms operating simultaneously for the meals correction, et cetera, to help bring glucose in the range. These are just a picture for you of the systems, the Omnipod 5, the Tandem with the Mobi, and the Control IQ, and this is the Beta-Bionic, and then the Medtronic 780G is pictured here. I wanted to show some of the preliminary data. This is the Medtronic 780G. They started with a pivotal trial, actually with an earlier pump, and the Guardian 3 sensor. Many of these patients then were able to transition into a continued access study of 109 patients, and then they also, in this publication, looked at real-world data from patients all around the globe, and you can see the participants in the continued access study were between the ages of seven to 17 years, and you see impressive time and range. This is the 24-hour day time and range, and then you can see even higher percent time and range overnight. This is a common theme in all the published literature that I'm aware of so far, that nocturnal glycemic control is much easier to achieve with all of these systems. Again, this is showing the Control IQ pivotal trial, which occurred at seven university centers in the USA. The inclusion criteria for this were people with a type 1, 14 and older, with a type 1 diabetes diagnosis. They could be on multiple daily injections or pump use. There was also no A1C restriction. They had a two-to-a-week run-in phase to include training in the use of the pump, and then they were randomly assigned two-to-one to either closed-loop or a sensor-augmented pump for 26 weeks. They had extensive follow-up throughout the trial, as many of these trials do, and it's important when you're looking at these trials that you incorporate the improvement in glycemic control in both groups when you're trying to assess the improvement, because everybody in a clinical trial is gonna improve their blood sugar control, but it's really the difference between the intervention group, in this case the Control IQ, and the control group to really have an idea how effective it was. But you can see the closed-loop had significantly better time and range across the board. And you can see in the overnight hours, again, upwards of 80 to 90% time and range with Control IQ. You can see the hemoglobin A1C as well in this trial, and glucose less than 70. Again, pretty impressive results across the board. This was an interesting way to sort of look at how do we in the real world, as we're having patients come in on the Control IQ algorithm, maybe you have a patient on the Mobi pump or the T-SLIM pump. And what they tried to look at is how frequently in the real world, they looked at about almost 21,000 patients, and tried to understand based on the ACE guidelines, which we typically use like the 1,700 rule divided by the total daily insulin, or the 450 divided by the total daily insulin for calculating carb ratios. And they looked at trying to see where people fell on that range. And in many cases, we're seeing that a lot of people are not meeting those ACE guidelines, but that when they did basically a linear regression analysis, and they basically found that the correction factor or sensitivity factor predicted higher time and range with a negligible impact on time below range less than 70. And so the biggest bang for your buck with a lot of these systems is optimizing your correction factor. And there are anecdotal reports I hear in clinics sometimes if you really ramp up their sensitivity factor, even for people that aren't doing meal announcement or announcing their meals, you can see significant improvement in glucose control, similar to what Leah showed in her slides earlier. There are also the Omnipod 5 trial. Again, this was a single arm, multi-center prospective trial in 112 children and 129 adults. They also had a two week run-in period. They looked at A1c and time and range. They had a pretty wide inclusion criteria of six to 70 years. You had to have an A1c below 10% at entry and you couldn't have any DKA or severe hypoglycemia in the prior six months before study initiation. A high number of these kids, 96% of the kids and 98% of adults were already using CGM prior to the study. And about 90% of the adults and children were using some version of an insulin pump, which is a bit higher than some of the other trials. But you can see graphing the follow-up A1c's, again, significant improvement in children, less so improved in adults, but the adults had overall better glycemic control. And you can see if you stratified by A1c's over 8%, we're seeing a bigger drop in HbA1c between the baseline and follow-up. And that was seen across the board. So again, those that benefit the most from these AID systems tend to be people that have more poor glycemic control and higher hemoglobin A1c's. Again, this is some similar data from the trial. I'm gonna just move on to the next slide for interest of time. This was the ILET pivotal trial, which we published. We were one of the 16 sites in this study here in Jacksonville. We recruited some adult and pediatric patients for this trial. This is one of the largest trials with an AID system yet. It is the largest trial that I'm aware of. They included over 400 patients. Not published in this paper was a group of patients who were also on FIASP. In this trial, in this paper, we published the data with those on Humalog and Novalog, but we had 219 participants randomized in bionic pancreas. 107 were randomized to standard care. They had to have a diagnosis of type 1 diabetes, be on insulin for one year. There was no cutoff for A1c. And we recruited a very ethnically diverse population. About three quarters were non-Hispanic white. We had good numbers of Hispanic and African-American patients. We also had a lot of people who were on the lower end of education and income, which I think is important to do. And we also had about a third of the patients in this trial on multiple daily injections. They went straight from MDI to the closed-loop pump. And you can see the time and range improved dramatically. And again, this lower right, you can see those with A1Cs over 9%, which was 27% of the 27 out of seven of the patients. They had a, during the course of the trial, their time and range improved by about 7.1 hours and their A1C dropped almost two percentage points. The highest A1C in the study was 13.1%. That particular patient dropped their A1C to 6.8%. That's an extreme example. It's somewhat anecdotal, but it just speaks to the fact that when you get insulin at the right time on a consistent basis, we can definitely improve glycemic control in these patients. And again, this was a reply, just looking at the bionic pancreas and the standard care group. Again, showing that the significant benefits that we saw and the higher the A1C, the better the glycemic control was. So this is actually some my own personal data, easier to share that. This is the report that you would get with an islet. And it gives you very quickly what's the total daily dose of insulin that you're getting per 24 hours. It gives you a graphic of the glucose target over 24 hours as well. Pretty typical, it shows you your time and range percents of hyperglycemia and hypoglycemia. It divides your breakfast. Again, you meal announce, but it's really a carbohydrate aware based system. There's not specific carbohydrate counting. If your usual meal is very low carb, you don't have to even announce a meal. If it's zero carbs like bacon and eggs or something like that, we would instruct the patient not to even do a meal announcement. But if you're eating your usual meal and that's a hundred grams of carbs with breakfast, then you label that your usual meal. If it's typically 50% less, it's less than usual. If it's 50% more, it's more than usual. The nice thing with this system too, is if you lose sensor data during the course of the trial for the first 72 hours, you can input meter glucose readings before the system will completely shut itself off. But it'll also give you, if people need to go back to MDI, what's your typical units with breakfast, your typical units with lunch, your typical units with dinner. So it gives you actionable ways that patients can adjust their insulin on a different system. You can see what these automated correction, you can achieve very good time and range, minimal hypoglycemia. And there are ways to manipulate all these systems to achieve this sort of glycemic control in many of our patients. This is again, just showing in a cohort of youth in a different paper, you can see the significant improvement in A1c and the significant improvement in blood glucose levels with the beta bionic islet. I think it's really important that you try to have a few, just briefly a few tips. I think it's important to collaborate with industry to help support your program. Leo was mentioning how their educators meet with their patients to review these AID systems. I think for these AID systems, there's a lot of adjustment that needs to be made because people need to be educated about, algorithm initiated insulin versus user initiated insulin. I think universal follow-up is very important. When we started putting a lot of patients on the control IQ, the insulin on board is about five hours when you start that system. And if people were on very, not very aggressive insulin to carb ratios or correction factors, they would come back a couple of weeks later and their blood sugars would be higher and the family would be frustrated. Why are my blood sugars going higher? So you've got to be a little bit more aggressive before you put them on the pump, making sure their settings are reasonable and then following up with them one to two weeks later just to make sure they're achieving good control. But it's definitely possible with these systems and I'm excited to answer any questions that you all may have. Thank you very much. I guess, let's see, we're getting another question here. So we have the results of the CAHOOTS, looks like really good, okay. Thank you so much for both of you. So I will be very quick about the questions. We have only 10 minutes. So is there a way to see the ILADD data without a download? And that question is for Dr. Benson. Yeah, so there's an app that you can operate. Certainly on your smartphone and then there's another portal system that you can access. So from a provider standpoint, you just act, you go into their portal, you can download the report. The reports are basically two pages, which I think is beneficial. I think it gives you the most useful information. I think with the ILADD thing, there are not a lot of buttons to adjust. And I think one of the impressive parts about this system is that we're achieving very good blood sugar control with some meal announcements from the patients, but really nothing else is adjusted other than the target. The target, lowering the target would bring your average glucose down by about seven milligram per deciliter. So the target adjustment is really all you're changing with that pump. But yes, the data is downloadable and reviewable easily, like all the systems. So another question is, can you briefly touch on the groups that utilize this, the technologies the least and the reasons why? I think we can expand this question for both of you a little bit. So one, there is no one fits for all, right? So how do you decide which person should be a good candidate and how do you discuss with your patients? I think we can get two perspective from a pediatric and adult endocrinologist on that, how do you decide when somebody says, I want to use an AID and what kind of things that you discuss and who do you think is a good feature, what feature fits to which people and what? Leah, do you want to take that first or? Yeah, so we work a lot with our educators on that because I think I can kind of talk a little bit about the various different systems, but actually having the person hold them in their hands and oftentimes it's a form factor thing that leads someone to pick one over the other or a certain feature, like being able to bullies from your phone or something like that. And so having the educators kind of go through that with them in detail, I think is really helpful. I hope more of the systems will eventually go to these like trial options, like, you know, Islet and Omnipod seem to have like these trial periods now that I think will also be helpful because I don't know, I don't think we're going to make that right choice 100% of the time, like right off the bat and you'd hate to commit someone to four years or however long on one system. But yeah, I think letting them see the systems and hear about the features in detail is really helpful. Yeah, I think the criteria, you know, are a bit nebulous, even if you look at what's published in terms of like, are there really objective criteria? Who's ready for a pump? But I think with what we're seeing now, especially with the range in A1C and the greater benefit with reduction in A1C, even with people with higher glucose, my personal feeling is I think we need to be, make sure they know how to manage ketones very well. They're reasonably checking their blood sugars. They understand if you have a site failure. During the Islet trial we had, there were a couple of suicide attempts, which we don't think was related to study. And we also did have a couple of episodes of DKA. So, you know, that happens with all these systems if you're not monitoring your sugars. But I think from a safety standpoint, just making sure people know, have a ketone action plan. They know how to use glucagon. They're reasonable monitoring of their sugars. Beyond that, I think you have to individualize it. We bring all our patients to sort of a pump class. The industry partners come in, they show them the pumps. They get to push buttons. Yeah, the fact that like Islet has a 90 day, you can return it if you don't like it. Omnipod's a little easier as well because it's a disposable pump basically. So it's a lot less costly for the insurance. It's much easier for people to switch between pumps. But I think it's a personalized decision. And I meet people all the time. They swim, so they want the Omnipod or there's other factors that, but I think in the future, we need to move towards where you can plug and play different sensors and different pumps and give people as much flexibility and choice as possible because diabetes is hard enough. And I think by making these devices more acceptable to our patients, I think we'll improve adherence and early education about pumps and sensor and all things diabetes technology is really essential to help these people to be successful long-term. So I think this AI, these systems are right now so powerful and effective that actually who gets the most benefit, the people that have the highest A1C, then you see this tremendous decrease in their A1C and they are just very happy about it. So I think that's, I agree both of you that as long as there's a motivation and a follow-up plan and we don't look at the A1C levels or carb counting and other things anymore, obviously if you bolus before meals and if you are carb counting, you will get a better results but these are not any of the requirements anymore. So we have a question about the exercise for the, how do you manage the exercise with the AI, the systems? I will ask generally for both of you, especially and Charlotte is asking about if the target mode is 150 in some pumps is not enough to prevent hyperglycemia. Maybe we can extend this about how management of the exercise with the AI systems from a pediatric and adult standpoint. Yeah, I can start. Yeah, I think we will in the future see more customizable targets. So people have more options and what works for them after some trial of the different options. If people are quite sophisticated then they might actually get better results by going out of auto mode and going into manual mode so they can set a lower temp target or a temp basal in order to do their exercise and hopefully not going low. But I think like the general things like trying to have lower insulin on board before exercise, I mean, either reducing a meal bolus or doing it before a meal, eating that carb containing snack. Although there's, I guess there's some caveats with that. Like if you have control IQ, something that's gonna do an auto bolus, correction bolus for a trend up, sometimes exiting out of that auto mode to go to manual mode to prevent that correction bolus that can fire off after pre-exercise carbs can be helpful. So it's kind of, it is pretty nuanced. I mean, there's a lot of different factors there but it's a tough area for sure. And then sometimes people can go high later. So making sure that they're getting their pump back into auto mode to help take care of that. So some general thoughts, but. Yeah, I think in that you have to be very individualized in terms of your approach and looking at each patient differently. But anecdotally, like during the Islet trial, we saw people do some exercise, even though officially the recommendation is detached during exercise. There's no exercise mode with the Islet. However, with light control IQ, with Omnipod, you can obviously vary the targets. And I do find that helps significantly with exercise in many of the patients. I've also seen with the Islet where people had some tendency to go low remaining attached, but after a couple of days, we know with the Islet, it has a, that's not AI'd exactly, but it has a learning based algorithm to the protocol, to its algorithm. And so it's able to adapt to some of that exercise. And I've seen people who over time, they just, they don't get low and the system has adapted to what they're doing and to the meal that they eat. But I think it's really important that people have glucagon with them when they go to the gym, they have fast acting carbs. Generally, it's better to eat before significant exercise. But I think with all these systems, I think you just have to be careful and individualize it to each patient in each circumstance. Because patients are very variable in what they do. So I think the key is in the AI, the systems are giving the less amount of insulin as possible before starting the exercise, maybe starting one hour early or so in the ones that are requiring, turning on the exercise mode. And you have to be also careful about that when you eat the carbs, it shouldn't trigger the algorithm to give more insulin. So you should be careful about that. But it intends the duration of the exercise. I think the key is here, so. So I think we are running out of time. So we can look at the next slide and then we have some tips and takeaways for the R program. So we can have a look at that. And then I can try to close the, before close the session, a couple other announcements I have to make, so. So before closing this session and you need to complete the post-test and claim your CE credit and so you will later today you will receive a post-test by email so you can just complete this one to claim your CE credit and it will be also recorded and it's it has been recorded so and you can access this one in the ADS Institute of Learning page in a few weeks and and it will be also you can watch that and claim the CE credit until the December 2024. So I would like to thank you for Dr. Benson and Dr. Wilson for their wonderful presentations and for all the attendees and I would encourage all of you to join the ADA Diabetes Technology Interest Group and we will be happy to answer your questions in the forum and then I will be closing this session and I would like to say thank you again and have a wonderful day. Thank you. Bye-bye. Thank you. It's been a pleasure.

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