All right, I think we can start our webinar for today. Good afternoon. My name is Dr. Akturk. I am an Associate Professor of Medicine and Pediatrics at the Barbara Davis Center at the University of Colorado. I am also serving as the Communications Director for the ADA Diabetes Technology Interest Group, and I have two wonderful speakers today, and we are in the Technology Interest Group for the ADA, and Dr. Welch, he's an Assistant Professor of Clinical Medicine at the University of Cincinnati, and joining with Dr. Everett, and she's an Assistant Professor at the University of California in Los Angeles. Today we'll be reviewing the newest technologies in diabetes, and our title is Exploring Diabetes Technology Advancements in 2023, a Year in Review. Just to clarify, we'll be reviewing mostly the products that got FDA approval in 2023. So I would like to remind another webinar that will be next week, and this is an Hemsley Hands-On Tips to Improve Diabetes Care webinar, How to Make an AIDS System Work, Case-Based Review, and I will be moderating this session, and Dr. Benson and Wilson will be talking about some tips and case-based review for the AIDS systems, and this will be on December 12, Tuesday, 3 to 4 p.m. Eastern Time, and this is only for ADA members, and you can register. There will be a link in your chat box. And you can register now for the free Making Diabetes Technology Work CE program, and there will be another link in your chat box. You can earn free CE credits by staying up-to-date on diabetes technology, and that's a great educational program that we update every year, and then by ADA, and that you can just access to updated diabetes technology for AID systems and for the CGMs. And finishing my introductions, then I will be letting Dr. Welch to start for our webinar. Go ahead, Dr. Welch. Thank you. Hello. Thank you for the introduction. I'm excited to talk about updates in diabetes technology. We'll be talking about smart insulin pens, the Dexcom G7, and some anticipated products for next year with the Omnipod Go patch. I also just mentioned I'm an adult endocrinologist. I also am happy to share that I have type 1 diabetes, so I've been able to test out a few of these things and can speak from some experience. The first product is the Tempo Smart Pen. This was developed by Lilly and FDA-approved at the end of 2022. It consists of a specialized pen containing insulin with a smart button that goes on the top of the dial. There are three different versions of these pens, and you'll notice that each of these has the specific name Tempo Pen, so you can't just use any version of the insulin pen. It has to be prescribed separately, but the Tempo is able to fit on the end. The smart button can recognize which version of insulin it's being attached to, and it can also recognize how many units of insulin are given at a time. This communicates through Bluetooth to an app. It's called the Tempo Smart App, and this connects to Dexcom, CGM systems pretty seamlessly. It does not offer any insulin dosing recommendations, though you'll see that it does give suggestions based on what is prescribed. It does offer insulin reminders at mealtime or bedtime. It can take pictures of food and guess what the food is that you're eating. It can use barcodes to pull up nutritional information on products that are packaged to estimate how many carbs somebody is eating. It actually did a good job. I was trying this app out, and it can recognize everything in my lunch down to the Ritz crackers pretty well just by taking a picture of it. If somebody, say a patient, doesn't have CGM, the intro pack for the Tempo pens comes with a glucose meter that also communicates with the app by Bluetooth and can automatically log blood sugars that are tested with the glucometer. Like I was saying, I actually took the opportunity to download the app, and I tried to use it for a few weeks so that I could create this download. This is what a clinician would see if they had a patient who came and had the system set up. What I'll direct your attention to is up in the top left. It shows the programmed doses of insulin for Novolog. You can see there was fixed doses, an insulin to carb ratio, different carb ratios for breakfast and lunch, and a correction factor that's described with text. There's an ambulatory glucose profile that shows the time and target range, percent high, percent low, as I'm sure many of us are accustomed to seeing in downloads. There's also an insulin summary. You can see that for breakfast, I gave doses of insulin six times over 30 days. I actually wasn't using the pen for my own insulin delivery. I was just practicing, but you can also see that I made a small mistake, and I accidentally put in 55 units for lunch one day, so it was interesting to see how that worked. It shows you the total daily dose, estimates how many doses of insulin were given or missed, and then you can use that to hopefully help patients identify areas where they need to focus on. Farther down on these reports, you do get daily summaries, and you can see where a patient has given how many grams of carbohydrates for a meal, and it also documents the amount of insulin that was given for a bolus, and it provides detailed summaries below. My one issue with this was it was hard to tell exactly when, say, carbs were eaten or a bolus was given. The graph isn't very high resolution to where you could look for maybe gaps in the timing, as you might see in some more detailed reports that are more zoomed in. So, to summarize, some of the things that I liked were the meal reminders. It really will remind you every time it's a meal, and you have to acknowledge it. It will track your insulin, and you could also use this to track long and short-acting insulin, as I was showing earlier. We'll use the same button for both types of insulin, so you just switch it from the end of one to the end of another. The Dexcom integration was very seamless and easy to set up, and I thought the barcode scanner and the photo of food was a nice touch as well and could be helpful for some patients. Some things to keep in mind, it's not going to tell the patient exactly how much insulin to give based on their blood sugar or carb intake, although I am learning from Dr. Akhter that there was recent news on this, and there was an FDA approval that this app would be able to do that to give dosing recommendations. Overall, I found that the phone app was very busy. In addition to the basics of logging insulin, there was also a lot about, you know, try this new recipe that's, you know, good for patients with diabetes or restaurant suggestions. You know, you can almost scroll on endlessly with lots of kind of health tips and information, which I think is a good idea, but for some of my patients where I just need them to do the very basics, it could be distracting. This does require new prescriptions for the Tempo insulins, and clinically, one of the barriers that I'm running into is not all patients are covered for these types of insulin based on their insurance formulary, and so we've had to do prior authorizations a handful of times to get patients set up on this system successfully. This is just a very brief summary. What I want to emphasize is there are a lot of different types of smart insulin pens available. Each of them has different CGM integration capabilities. They have different dosing calculators, as well as battery life and other features that would be important to consider when you're working with the patient. I'd also like to talk about the Dexcom G7. This was also FDA approved at the end of 2022, and likely many clinicians have a lot of experience with this by now. I had the opportunity to wear both a Dexcom G6 and G7. This may or may not be a picture of my arm. It is actually a picture of my arm, but it just shows kind of a close-up view of the size differences of the G6 and the G7 systems. I also wanted to point out the adhesive surface area looks very different when you put them side by side. However, after I took this picture, I was going through some of the other instructions on the box, and I realized there was actually another adhesive patch that goes around the Dexcom G7 sensor and provides greater surface area of adhesive material. It helped me gain insight into why some of my patients come back and say, I tried the Dexcom G7, and as soon as I stepped in the shower, it just washed right off, or it didn't stick very well. I think it's because it may not be obvious that there's an additional adhesive patch in the box that should be placed over top of it to give added security. These are the different insertion devices comparing the Dexcom G7 on the left to the Dexcom G6 on the right. I found them comparable in ease of use and comfort. Some things that I would like to emphasize is it's indicated age is seven years and older for the back of the upper arm and the abdomen, but for pediatric patients between the age of two and six, it can also be used on the upper buttocks. In contrast to the Dexcom G6, the G7 system lasts up to 10 and a half days, which includes a 12-hour grace period where it's going to remind you to change the sensor, but it won't stop the use of the sensor. It has a shorter 30-minute warm-up time compared to the Dexcom G6, which had a two-hour warm-up time, and it actually allows for simultaneous start of the next sensor so that the warm-up time can be all done by the time you stop using the other sensor, and there's no gaps in data if you do this right. You can see here on the picture there's a Dexcom receiver, which is the black device, and that allows for uploading in a clinic if somebody didn't have the right kind of phone to integrate with the Dexcom G7. There's been a lot of exciting updates about the connectivity between the Dexcom G7 and insulin pumps, and indeed, this is a screenshot from the Tandem website showing a limited launch of integration between the Dexcom G7 and the Tandem insulin pumps. So specific clinics and geographic areas are getting access to this, and I'm hopeful that soon there will be a more widespread rollout available for everybody. I also was able to take the raw data from wearing both a Dexcom G6 and a Dexcom G7 placed at the exact same time, and I was able to make a graph of the outputs. So the G7 is in yellow and the G6 is in blue, and it kind of emphasizes the variability in concordance and accuracy at the very beginning of a Dexcom startup. They, you know, in some cases were 100 to 150 milligrams per deciliter different, but I found that as time went on, they really did agree quite well. This is about day three after they were inserted without any calibrations. So one thing I would say about the G7 is that there tends to be a tendency for some of these rapid kind of deviations from the trend. As you can see, kind of on this day, the Dexcom G7 kind of rapidly dropped and came back up, as well as later in the day, the spike seemed to be higher and come down faster than the G6. I don't know if this reflects something that's actually happening clinically, that the G6 isn't picking up, or it's a little more susceptible to some of these maybe pseudo trends, but that was an interesting feature and something that I've seen online of other people describing as they've been using it. And referring to the accuracy in terms of the mean average relative difference, which is comparing the values obtained from the CGM to the values obtained from a Yellow Springs instrument glucose reading device. So smaller is better. There was a MARD of 8.2% when used on the arm and a MARD of 8.8% when the arm and the abdomen were included together, and I just included the Dexcom G6 MARD of 9.2%. This is a plot from the publication that presented the accuracy and safety of the Dexcom G7. And mostly why I show it is because it shows quite a range of MARD values between sensors. So it gives the impression that some sensors will be fairly accurate, and occasionally you may get one that is not as accurate. So clinically, this may mean if a patient is dealing with a sensor for more than 24 hours that's showing values that are likely not accurate, the solution may be to change the sensor. This shows the arm versus abdomen mean average relative difference. Slightly better on the arm at different ranges of glucose. But hard to say how clinically significant it is compared to the abdomen. I counsel my patients that they would be fine to use it in either place, whatever works best for them. I also like to highlight that sensor accuracy improves over time. This is day one compared to day 10 and 10 and a half, where the first day is getting a MARD of 11% or 12%. The final few days of the sensor are getting down into the 7% and 8% ranges on average. Just some practical tips. Make sure that the device is compatible for your patient. You can see the website for a list of compatible apps. Keep in mind the receiver doesn't connect to the internet or Wi-Fi, so you'll have to upload it directly by plugging it in in the clinic. It's not been evaluated in patients on dialysis or critically ill patients. There are ways to set up customized alerts so that the alarms are going off less for high blood sugar overnight for some patients who may be frustrated by that. I wish I had a little bit more information on this, but I just wanted to quote one part of the study that estimated about 16% of the sensors that were started failed to return glucose values. I like to think about it from the patient's perspective because oftentimes a sensor will fail for unclear reasons or fall off early, and it creates a lot of burden for patients to try and find new and additional supplies than what they were originally given. I just compare this to the Kaplan-Meier curve of sensor life from the Dexcom G6 in the first one showing adults and in the second one showing pediatrics. I imagine that it's something similar to this, but I would love to see more data about that. This is just a table showing, again, each type of modern CGM has a different length of use, warm-up time, accuracy, app, sharing, and connectivity with insulin pumps as well as calibrations. And finally, I just want to introduce the Omnipod Go. This was FDA approved in April of 2023. The idea that it delivers fixed doses of rapid acting insulin simulating what would be given by basal insulin. For example, it can deliver between 10 and 40 units per day at fixed doses. There are seven different varieties with differences in five unit per day increments. The user fills the pod with insulin and it's warm for 72 hours. You would have to change the prescription and pick up a different device if you wanted to have a different rate of delivery. There's no bolusing. This is waterproof and very similar in appearance and function to the other Omnipod systems. This does not have a PDM. So the user interacts with it and receives information through a system of flashing lights and beeping. So this is an example of the orange light, followed by the red light, and then you can see the green light. So, and then there's also beeping that happens when the pod is coming to the end of its life or running out of insulin. So it doesn't connect with any CGMs. There's no automatic mode or suspension for hypoglycemia. What I'm understanding is that it's for, it's ideal for those who are getting started with insulin or are likely to transition to a basal bolus insulin pump, likely an Omnipod, so that they can be used to the pod when it's time to make that type of a transition. It's to be commercialized in the coming year, and patients who are interested are welcome to sign up on the Omnipod website. Thank you very much for your attention, and I'm happy to take questions at the end of the webinar. I'm going to pass now to my colleague, Dr. Everett, and I'm very excited to learn as well about hybrid closed-loop systems. All right. Thank you, Dr. Walsh, for that great review on insulin, SmartPens, CGMs, as well as the new Omnipod Go. So in my talk, we're going to focus on automated insulin delivery system, and specifically, I'll highlight some of the new features that are in the new insulin pumps that were approved in 2029. I'm sorry, 2023. I'm ahead of myself. So in my talk today, I'll go over the updates, the new features in the Medtronic 780G, and compare that to the 670G. We'll review the new bionic pancreas system, as well as the new Tandemobi, and then at the end, I'll just do a brief overview of some of the key features in the algorithms of these different devices. So let's start with the MiniMed 780G system. So this system actually has been available in Europe since 2020, but was FDA-approved in April 2023 here in the U.S. And so this is Medtronic's most advanced hybrid closed-loop insulin pump system. So there are several new features with this system. So one of the big ones is that it uses the Guardian4 sensor that no longer requires calibration. So prior to this system, this was the only AID system that had a CGM that required calibration, which you imagine would be pretty burdensome for patients. So the fact that the system uses a CGM that doesn't require calibration is, I think, one of the biggest innovations in this system. Its auto mode is called SmartGuard technology, and it essentially uses current and past blood sugars to adjust insulin every five minutes. One of the other new features are these new autocorrections and then this meal detection feature. And so with this meal detection feature, if the patient underestimates their carbs or forgets to administer mealtime insulin, the system will detect a rapid rise in blood glucose and then automatically deliver stronger bolus doses up to every five minutes. So prior to this system, if the algorithm detects elevated blood sugars, it would increase the basal over time, but the basal will max out at a certain point. And so in this new system, after the background basal is maxed out, the system will then give autocorrections that can bolus up to every five minutes. And so these autocorrections would be given if you're maxed out on your basal or if the system detects a rise greater than 120 milligrams per deciliter. This system also has personalized glucose targets rates and has the lowest target being 100, which is the lowest target for all the AID systems currently available. And then the last thing I'll mention is that the infusion sets associated with the system can be worn up to seven days. So this is longer than what was previously. So in this table, I just wanted to highlight some of the new features compared to the previous models that I've been trying. And I reviewed most of them already, but you can see the autocorrections, the personalized target rates as low as 100. As previously, they built in the capability to have updates to the system as they kind of innovate the algorithm and additional features. We talked about the Guardian 4 sensor and not requiring calibration. And then this system also allows you to track your glucose levels on the Apple Watch, which was previously not the case. One thing I think it's really important to highlight, in previous models, especially in the 670G, there were a lot of patient complaints about how often the system knocks you out of auto mode. And so this was very frustrating for patients. And one of the reasons when it was initially launched that many patients decided to opt out using it. But one thing you'll notice is that with the new system, patients are staying in auto mode much at a higher rate. And so up to 95% of the time, patients are in the auto mode, which is a significant improvement and something that would improve usability of the device. So next, I want to talk about the islet bionic pancreas. So this system uses the Dexcom G6 algorithm. And this system is very unique because I think it's the closest that we have to a fully automated system. And so the only programmable feature that it requires to start auto mode is the patient's weight and obviously an active CGM. And there, the algorithm decides basically all the insulin requirements for the patient. There's also no carb counting, which is also a new unique feature, although patients must be carb aware. So have a sense of what is a lot of carbs or a little bit of carbs, but they don't have to know the specifics and do the calculations for carb counting. There's no correctional boluses. The system adjusts it on its own. And again, all you need is weight. So there's no preset basal rates. So I kind of talked about many of these features, but I wanted to show some of the screenshots of the system. So I mentioned to start the system, you'll need to enter body weight. You'll obviously need a CGM. The targets are usual, higher, and lower. And they associate these targets with blood glucose values. So usual being 120, lower 110, higher being 130. Although the eyelid folks mentioned that these are kind of ballparks and you should not necessarily expect your patient to reach 120 if that's the usual goal or reach 110. But that is what it's targeting, but it's usually a little bit higher than that. And so you'll see here, the CGM target will be higher than usual or lower. It's usually when you first initiate the system, it's recommended that you start at usual, and then you can adjust from there. When it comes to meals, so although you don't have the carb count and ultimately the system will determine how much insulin the patient needs, the patients must announce their meals. And so the way that it works, so in the first screen, you'll see the fork and a knife. So you'll click that button to get to the announce carbs screen. You'll choose whether it's breakfast, lunch, or dinner. And then you'll enter whether it's a usual meal for me, it's more than usual meal or less than usual meal. And so when patients start the system, it's recommended that they eat what's typical for the most part so that the system can understand what a usual meal is for the patient. And then that'll better allow the system to learn how to adjust when they're eating more or less. There's often also a common question about what do you do for snacks? And so the answer that I've got from Beta Bionics is, well, if it's the snack is near breakfast, you can consider it breakfast and then say maybe less than usual meal since there's not really a snack function. So since the system is so automated, there's really limited capabilities for physicians to adjust. But one thing you can adjust is the glucose target. And so Beta Bionics has given us some suggestions on how we can adjust the model or parameters when we should consider adjusting. And so again, most patients should start at the usual target. And then they should consider increasing it if the percentage of time within glucose, I'm sorry, they should consider decreasing the goal if the percentage of time is less than 54, about more than 1% of the time, or if they're consuming carbs to prevent them treating lows at least twice a day. So I'm sorry. So they should increase the target if they have basically these parameters regarding hypoglycemia. And then they should lower the target if their average glucose is above 180 or if it's greater than 160 and they have a low rate of hypoglycemia, so less than 0.5, and they have minimal needs to consume carbs to prevent hypoglycemia. All right, so now we'll talk about the Tandem Mobi. So this system was approved this summer in July 2023. And the big thing with the system is its size. So it's the world's smallest insulin delivery system. So it's about 50% smaller than the Tandem X2. And as you can see, it's small enough to fit in the coin pocket of someone's jeans. The cartridge holds less insulin than the T-Slim X2, about 200 units, where the Tandem T-Slim X2 holds about 300 units. It also has the ability to have smaller tubing, so at least as little as five-inch tubing. And so it gives a little bit of flexibility where you can wear the insulin pump. And so you can attach it to your clothes, but they also have an adhesive sleeve that would allow for wear on the body. So it will kind of function more like a patch, like similar to the Omnipotor. It could be attached to the skin if you don't want to hold the clothes. So it gives some flexibility. It's also compatible with all the Tandem infusion sets and all the various sizes of tubing. And so there's up to 300 different combinations of infusion sets and tubing that you can use. So again, they're really trying to provide flexibility in its wear. So as you saw on the picture of the device, there is no screen on the insulin pump. And so everything is controlled through an app. And so at this point, it's only functional with an iPhone. And so there is an application on the iPhone that will allow patients to bolus and use all the functions of their insulin pump. There hasn't been any discussions on when, if and when it will be Android capable, but I imagine that is in the future. Similar to their previous models, they have the capability to do remote updates. And then the algorithm is unchanged. And so the Tandem will be used as control IQ, which is the same automated insulin delivery algorithm as the T-Slim. There's no ports on this system. And so charging is wireless and it's also water resistant as well. So Tandem kind of has laid out their future plans for their insulin pump. And so the Mobi was just approved, but in the future, they plan to have a tubeless version. They recently acquired a company that creates tubeless insulin pumps, and that is on their plan in the future. They also plan to release the T-Slim X3. And their plans for that system is really to just modernize the interface to improve usability. They plan to increase the battery life of the device and then increase the processing power so it's capable to operate some of the advanced algorithms they have planned in the future. So lastly, I just wanted to go over some of the differences in the algorithms because now we have several different insulin pumps or automated delivery systems, and they all operate a little bit differently. And so it's sometimes very difficult to keep track of what system does what. And so I just wanted to review some of the key features. So we have the Islet, and their auto mode is just called the bionic pancreas. The 780G's auto mode is called SmartGuard. Control IQ is the auto mode for Tandem. And then automated mode is what the Omnipod 5 is called. So for the basal automation, as I mentioned before, for the Islet, all we need is the user's weight. And then the system adjusts the insulin every five minutes based on the CGM trends. And then it adapts the algorithm based on the daily glucose patterns. So essentially what's occurring now and what has occurred in the past. For the 780G, the auto basal is calculated using the total daily dose of insulin, which is updated every midnight. And then the system adjusts the basal insulin every five minutes based on the CGM trends and the target glucose range of value, I should say. So for Control IQ, so this device has, for those who are used to using this device, you program the background basal rates. And then this system essentially increases and decreases the programmed basal rates based on the predicted CGM glucose in 30 minutes, and always aiming for that target glucose. And then the Omnipod 5 also uses total daily dose, which is updated every time there's a pod change. And then this adaptive system adjusts the insulin every five minutes based on the 60-minute predictive glucose value, and then aiming for the target. And so as I mentioned for the Islet, all the mealtime boluses, all the correctional boluses are automated. For the 780G, we have auto-corrections at max every five minutes if the glucose is above 120. And then the auto-corrections can be turned on and off as needed. And then for Control IQ, you have auto-correction boluses, but they're at a maximum once every hour. And it's based on the predicted blood glucose greater than 180 and 30 minutes. And then for Omnipod 5, there are no automated boluses. So each system has a different range of target glucoses. Again, the Islet is just usual lower or higher. The MiniMed has three targets as low as 100. And then Control IQ, you have a range between 112.5 to 160. And then the Omnipod 5 has five options ranging from 110 and 150. And then other than for the Bionic Pancreas, we know there's no carb counting. You just have to announce your meal and whether it's greater than usual or lower than usual. And then for all the other systems are more traditional where you have to enter the grams of carbs. And then it uses a bolus calculator to determine what dose is on the given. All right. So that's my final slide. And I guess we're moving on to our question today where I'm happy to take any questions. Okay, perfect. Thank you so much, both of you for this wonderful presentation. So, and if there are any questions and I'm just looking in the chat box. And so there is a question, do you have any patients in the clinic for the Islet? And I can just ask you for both of you, maybe we can start with Dr. Everett, any Islet patients, do you have any in the clinic? So I have not personally used Islet on any of my patients. Most of my clinical care is at the VA and they have not yet, I guess, come to an agreement. And so I personally have not used the Islet, although I know I have several colleagues outside the system that have. I am in the process of using it. I have a handful who are in the process of obtaining the Islet. The kind of ideal patient that I've been identifying so far is the burnt out patient with diabetes who is kind of done counting and being quite so precise all the time with their diabetes. So I'm hopeful to have more experience with it. And we have some patients started Islet. And I mean, I think that's, you know, the patients should be chosen accordingly for the features for this pump. So that brings a point of how are you choosing your patients in the clinic for the AIDS system? So there are so many AIDS systems and then apparently, you know, one fit doesn't fit for all. So how do you choose for your patients? So I can start with that. I think it's, I think like, you know, most, you know, the way that we approach medicine, it's kind of like shared decision-making. And so, you know, we have these different options and I think there's not one that fits every person in their lifestyle. And so there are certain, I often just review all the options that are available and then figure out what works best with patients. There are patients, I remember there was a patient who was a security guard and who was like, I can't have a tube pump because it might get dislodged or, you know, for the patients who may have issues with numeracy or really are, you know, don't have the capability to be very involved in a care, maybe something like the bionic pancreas will be better because it really doesn't require much from the patients. And so I think, you know, as a provider, you'll always make suggestions from what's your standpoint you think may be the best, but I think really the patients, they know themselves better, what they're capable of. And so kind of giving them that option and what works best with their lifestyle, I think is really important. How about you, Dr. Roush? Interesting question. So probably the very first question that I'm asking patients, if they've decided this is where they wanna go is how they feel about having a tubed versus a non-tubed insulin delivery system. And some people that kind of makes the decision, but now there's, you know, increasing more options with the MOBI coming out. The other kind of spectrum that we have to consider is precision. You know, some patients may have a unique, something clinically that kind of a one size fits all basal program will have a hard time adapting to. So the Omnipod is calculating or the basal insulin based on total daily dose. You know, patients who are having a frequent change in total daily dose, this can be kind of frustrating. Sometimes I have patients who are wanting to really target say the Don phenomenon. And you just don't get as many tools with some of the other pumps, say compared to the tandem platform where you can adjust the basal rate. So if somebody is kind of medically complicated and we have to keep that in mind, something like peritoneal dialysis, you wanna discuss with the patient what you can adjust in the background of the pump. Okay. We have a question from our dear friend, colleague, Jean Wright. Do you think AID has a place in primary care? Should primary care clinicians be prescribing AID systems? I think that's an excellent question. And I think it depends. So I know the bionic pancreas, which is a very, you know, there's not much that you can adjust. It's very simple. And I think definitely primary care doctors can be trained to use it. And I know beta bionics is actually, they're planning a trial or it's currently doing a trial with its use in primary care. So I think it will be very interesting to see the outcomes of their study, but I think it can be done with proper training. But, you know, this discussion has come up with CGMs in the past and like, and the question is like, does primary care wanna manage this given all that they do? And then I guess, do they have the time and then the knowledge to be able to do so? But I think with appropriate training and infrastructure, it can be done. But the question is like, is that in place in, you know, the particular clinic to support that? I would say absolutely, especially with the bionic pancreas. I think this was designed with primary care clinicians in mind to have kind of so few variables that it can just pick up and go. I think you would want to be very familiar with it. I think you would wanna talk specifically to your patient about what to do if something were to happen to the pump. You know, it doesn't really have a backup mode that it goes to. So you would have to have a very clear backup plan if something were to happen. But I think if there's interest and enthusiasm from a primary care provider, I think this would be a great way to go. And I would like to answer this question too. I mean, as we are endocrinologists, we cannot see all patients with typhoid diabetes. There are not enough endocrinologists in the US to see all patients with typhoid diabetes. So primary care is a great resource to see these patients and provide some help. So I think it's not only limited to ILET, but also the other systems. As long as they are comfortable, they have a team and support and they can just use the systems. And, you know, in 10 years ago, what we were doing for the AIDS systems are we were looking for the patients, handpicking the patients, even in our guidelines that, who is a really great, you know, A1C candidate and who is doing finger stick and who is doing this and who is doing that. But in the recent years, in the ACE and ADA updated their guidelines to include all patients with typhoid diabetes to use the AIDS systems. So, and I think we shouldn't be excluding people as long as there is a motivation, enough support system, and there's a follow-up plan. And I think the primary care is will be a great resource to help the endocrinologist to take care of the patients for the in-type of diabetes scene. So- I definitely agree with that. And I kind of want to second that point. And a lot of my research is around like, you know, how do we basically expand and use of insulin pump systems, especially in patients that traditionally were higher risk and thought to be not good candidates. Because I think now there are many studies that show, you know, patients with really high A1Cs who are not necessarily adherent with blood sugars, checking their blood sugars or getting the insulin dose, they can benefit a lot for some of these technologies. And so I think moving away from that thought, like you have to prove yourself, like worthy to use technology, I think is a good, you know, a good change in thought in the field of endocrinology. And there is a question about, how about using these systems in the inpatient settings? Just to remind that none of these devices are FDA approved to be used for inpatient management, but I just would like to hear your institutional, you know, approach and your personal approach. I think I'll let Andrew start on this because I know you've had, we've kind of talked about this before. Yeah. And even just going back earlier in some of the slides I was showing, you know, the CGM states in the insert, this is not for patients who are critically ill or, you know, in certain clinical circumstances, this has not been tested. And I'm sure those studies are ongoing. I don't have the data on the tip of my fingertips to share with you, but I'll tell you what our institution does. And that is patients who are capable of managing their pump and CGM, as in they're not receiving, you know, like sedating medications, certain types of pain medicines, or are critically ill and have the supplies to do so, we let them continue the AID system of their choice with finger stick glucose checks for verification of the CGM when they're making dosing decisions. And I'm probably biased as I share my perspective, but I think it has worked pretty well from what I see. I can't think of any examples where it went terribly wrong. And I can say that for the small procedures that not requiring general anesthesia, like endoscopy, colonoscopy, most of the time people can use the exercise mode or increasing the target for a temporary higher target, and they can use the pumps. But for the general anesthesia, and then most of the company prospectus also, you know, suggest turning off the pump and giving the management to the surgery team. So I think there are institutional differences on how to manage things and overall. So, but that's kind of a great answer. And another question, how do you manage settings, customized alerts on CGM from nearly diagnosed type 1 diabetes and beyond when they move forward? Do you have different targets or how do you manage that? I'm sorry, I missed the first part of the question. You said, how do we what? How do you manage settings, customized alerts on CGM from nearly diagnosed type 1 diabetes and beyond as they move forward? I think I'll just start here, but I think it's something I should do more of. Honestly, when somebody is newly diagnosed with type 1 diabetes, there's so many things that are going on that it's often in the follow-up that I think I realized, oh, maybe I had an opportunity to raise the target glucose value upward so that there were fewer alarms and less anxiety about it. I'm fortunate to benefit from working with a great team in the diabetes technology space of, you know, educators and nurses who are often more attuned to this than I am as a provider. And they'd make those adjustments to typically raise the glucose threshold. I agree. I think this is something I should ask more. I think it's for the patients who are having trouble or mentioned any issues with the alarms. I think I usually take the time to delve a little bit deeper. How often are they alarming and what settings and figure out whether we should adjust accordingly. But our diabetes educators also are excellent and they help a lot with that. Okay. So how do you approach to patients that are resistant to use the technology? You know, if somebody is not achieving goals for time in range or A1C or somebody is having a lot of hypoglycemic episodes and how do you introduce the CGM and or AID? So which one is your priority first and how do you approach to this patient? So I can start with that question. I think when I have patients that are struggling to manage their diabetes, I usually, I guess in general, try to understand like what barriers they're having. Like, what are the things that they're struggling with? Why is it difficult, for example, to check your blood sugar? Or, and I think when we just ask those questions and kind of get a sense of how patients are operating in the real world outside of the clinic, you're gonna get a better sense of like what challenges are happening. I am, and so what I often do is introduce technology in the sense of like, can we, well, I'm pretty liberal. I offer technology to anyone who wants to use it that can use it safely. But I guess the, but the question for me is like, can, will this technology help address some of the challenges that you're having? And so sometimes that answer is yes. Sometimes that answer is no or sometimes the answer is yes and the patients are not at the point where they want to use it or feel like they are comfortable going to that point. But I usually try to, you know, discuss the pros and the cons and see really can this help some of the challenges you're having? And because I think oftentimes it can help really reduce some of the burden, but there are particular patients where like a CGM would actually increase their anxiety even more and actually cause more trouble than not. And so I think it's really understanding the challenges that the patient have and seeing how technology can or cannot help. I find that most of the time, if there's somebody who's very resistant to adopting some automated insulin delivery, there's usually a story behind that. And usually it goes something like, I used, I tried an earlier version of a CGM and it was always wrong and I don't want to put my life in the hands of technology. Or I tried an earlier version of an insulin pump and I had a lot of issues. I didn't feel like it was helping me. And so I switched away from that. So I think that's the first step is figure out what's really going on inside of this person and what their experience was. The other thing I usually try to highlight because I think this is really clear in different studies using AID is the benefits of overnight control. When you're not eating anything, the pump just takes you down to the target and rarely are there any interruptions or complications in doing so. And so trying to emphasize that, a lot of people really perk up because they realize they go to sleep every night worrying, what's going to be my blood sugar in the morning? Am I going to have a low? And to give somebody the opportunity to worry less about something that's hard can usually get them interested. I find this is often a long discussion and multiple visits. And I often give people names of devices and systems to look up and learn more about and to come back with questions. And in the end, I don't think that everyone requires technology to succeed in diabetes, but there are people who could benefit who probably misunderstand the benefits. Perfect. So we have another question from Dr. Wright. Is there a place for, or do you see gemming pre-diabetes? So obviously this is not currently an FDA-approved approach but so do you use anything for the, just to see a pattern or any helping you for diagnosis in pre-diabetes? And I mean, I think we should answer this in two ways for type 1 and type 2 diabetes separately. And I will be happy to talk about that too but I just would like to hear you first. And if you want to answer for type 1 or type 2 diabetes or before both of them, please go ahead. So I personally have not used CGMs in type and pre-diabetes. I guess I often don't see patients for pre-diabetes also but I'm not sure. Yeah, I actually, I'm not sure whether, I mean, I think there is some helpfulness in terms of understanding how different things impact your blood sugar. So how different foods impact your blood sugar, how exercise can affect your blood sugar. I think those are helpful and can spark behavioral change. And I think there's some studies that have looked at that but that's not something I have incorporated in my practice. I'll just speak about type 2 diabetes. I think there is a role for it. Specifically somebody who's glycemic status is a little bit uncertain. You know, something isn't adding up with the A1C or their fasting glucose. And so we have a system in our clinic where patients can receive a trial version of a modern CGM and they wear it for the duration and then it comes back and gets interpreted. And, you know, these are kind of billable procedures that are covered even in patients who have pre-diabetes for diagnostic purposes. And oftentimes we find, you know, surprises, blood sugar going higher. I really like it when the patient can see when it's not a blinded study because that feedback is really important. I also use these occasionally for diagnostic purposes in patients who have other conditions like PCOS where determining kind of precise diagnosis of diabetes versus pre-diabetes beyond A1C and fasting blood sugar can, I think, have a role. And so that someone may have access to certain types of medications for type 2 diabetes that wouldn't have access otherwise. I was gonna ask, Kathy, so at the, at least at the VA, they, I guess, are pretty strict on our criteria and it would not even consider giving a person with pre-diabetes like a CGM. And I wonder in the outside world, do private insurance companies, will they approve a personal CGM or have you had any experience with that for patients with pre-diabetes? Andrew? For a diagnostic session, yes. For continuous use, no. No. So I can answer this question for pre-type 1 diabetes, for stage 2 type 1 diabetes. So there is a study in publishing diabetes care was also presented before in ADA meetings by the Pediatric Barbara Davis Center. So I can answer this question for pre-type 1 diabetes. So there is a study in publishing diabetes care was also presented before in ADA meetings by the Pediatric Barbara Davis Center. So what they did is they use the CGM to see if they can predict to use for the going to the stage 3 type 1 diabetes and then staging wise. And average glucose and the time about 140 was higher in some patients. So, you know, when they predict that. I think there will be some new recommendations are coming up and in probably in the next six months to a year for the, by the consensus updates and for the ATTD. And so let me tell you that much and I don't want to be, you know, speculate more on that. So, but I think there'll be more use on this ones. And also there is a one study by Dr. Shah that, you know, using the CGMs before COVID times, you know, this was published many years ago that using that in the people with non-diabetes and healthy volunteers to, you know, seeing that how the CGM is, you know, it can be, you know, interpreted that. But the main thing is I think that we should be customizing the CGMs for this populations. And, you know, all the CGMs are working based on an algorithm and that algorithms are not tested on people with the prediabetes or the diabetes. It doesn't mean that it cannot be used on anything. I think we just have more research on that to see, you know, what can we do on that? So I think our time is up. So I'm just checking if you don't have any other questions. So I don't see anything else. So you can always reach us by the ADA forums and from the ADA Diabetes Technology Interest Group. So we are the members in that group and we encourage you to be a member and join us. So I would like to thank Dr. Welch and Dr. Everett for this great presentation and for ADA giving us the platform. So, and I will be seeing you for a different webinar on December 12th. And then thank you so much for everybody for attending. So thank you so much. Have a wonderful week. Bye.

diabetes technology

Tempo Smart Pen

insulin pen

Dexcom G7

continuous glucose monitoring

CGM

Medtronic 780G

hybrid closed-loop insulin pump

Ilet Bionic Pancreas

Tandem MOBI