Speaker 1:

Welcome to AACE Podcasts. Thanks for tuning in as we elevate clinical endocrinology by taking deep dives into trends and topics that can help us improve our patient care and global health. Find the latest episodes on aace.com/podcasts. And now let's meet the endocrine experts who will be talking with us today.

Speaker 1:

Thanks for listening to another great AACE podcast. Join us for another episode at aace.com/podcasts and help us in our mission to elevate clinical endocrinology. Together we are AACE.

Dr. Lubaina Presswala:

Hi, and welcome to another ACE podcast. I'm Dr. Lube Pslo. I'm a clinical endocrinologist and assistant attending physician at Memorial Sloan Kettering Cancer Center and Assistant Professor of Medicine at Weill Cornell Medicine in New York. I am the online resource work group leader for the Diabetes Disease state network at ace, and my area of expertise is diabetes management and the use of advanced diabetes technologies in people with cancers. Today we will be discussing the practical applications of automated insulin delivery systems in the management of diabetes mellitus. Before we begin, I'd like to thank ACE and the combined effort of the diabetes disease state network in bringing this engaging podcast to our listeners. Joining me today are two leading experts in the field of diabetes technology, Dr. Diana Isaacs and Dr. Rocha. Welcome to the podcast. Please introduce yourself to our listeners.

Dr. Diana Isaacs:

Great. Well thank you so much for having us. My name is Diana Isaacs and I am an endocrine pharmacist and also a certified diabetes care and education specialist. And then I'm also on the leadership for the ACE Diabetes Disease State Network. And my role at Cleveland Clinic is that I am director of education and training in diabetes technology, also a certified insulin pump trainer and do a lot of the education and training with insulin pumps. And then I also lead our efforts with diabetes technology and pregnancy.

Dr. Viral Shah:

And thank you for having me. It's my pleasure to share this podcast with Dr. Pre and Dr. Isaacs. I am Dr. Vial Sha. I'm a professor of medicine and division of endocrinology at Indiana University. I also direct diabetes clinical research program within our Center for Diabetes and Metabolic Diseases, and my research is focused on diabetes technologies in people with type one and type two diabetes.

Dr. Lubaina Presswala:

Wonderful, thank you. Let's begin with some background information on continuous glucose monitors, also known as CGM and automated Insulin delivery systems, also known as a ID Systems. Dr. Shaw, can you please define continuous glucose monitors for our audience and the different types that are available in practice today?

Dr. Viral Shah:

Sure. I think the broadly continuous glucose monitors are categorized into two main types. I would say broadly number one is the professional CGM, which it means that you insert that CGM in a clinic. The patient will come back, you download, review the data and make some changes to improve outcome. Nowadays, we less often use those professional CGMs, but still available personal cgm, meaning by that people are using those CGMs every day for their diabetes management and those CGMs are now more commonly used. Now within that personal CG M, you can again say that there are some CGMs which are real time CGMs, meaning by that they provide you a continuous data on your phone without requiring it to scan or something like that. And then flash continuous glucose monitor, which nowadays we less often use but still being used are the ones that requires you to scan your sensor and then once you scan it gives you all the information that you need.

And the classical example of the flash continuous glucose monitor is Ebert Freestyle Libre, the previous generation one, two and two plus. Now in real time we have a four different manufacturers that makes different CGMs. For example, Dexcom, it's a Dexcom G six G seven ebit, freestyle Libre three and three plus, and I think three plus is going to replace the previous generation. So probably that is the most commonly going to be utilized in future the ever sense is the only implantable CGM, meaning by that it requires doctor to implant that in the office. But the good thing is that it lasts for a year so that the patient doesn't have to remove or replace that every 10 to 14 days. And then last but not the least, it's the Medtronic SIMERA standalone and they have a guardian for connect that goes along with the seven 80 G automated insulin delivery system.

Dr. Lubaina Presswala:

That's great. Thank you for that overview. Dr. Isaacs, can you please discuss the different types of insulin pumps and the various terminologies that may be used interchangeably to describe them?

Dr. Diana Isaacs:

Yeah, well it's been a really exciting time for insulin pump technology. So we have several different options of insulin pumps that work with the continuous glucose monitors and we call these automated insulin delivery or a ID systems. You may also hear it called a hybrid closed loop. And the reason we also call it a hybrid closed loop is because all of our existing systems still require the user to do some type of work of either announcing meals or at least entering in carbohydrates, but there's still something that needs to be done by the user usually around bolus doses to really maximize the time in range. And we have several systems that are available now. So we have for example, the Medtronic MiniMed seven 80 G, which is pairing with the Guardian four sensor or soon the simpl sensor to automate insulin delivery. We also have tandem's control IQ as well as the algorithm that works with the T Slim X two and the Moby Pump.

And there's just some differences between these in terms of, for example, the MiniMed pump that holds three units of insulin and you control the pump from the pump itself. Some of our pumps now can be controlled from smartphones and you don't actually, you have to wear the pump, but you don't have to interact with the pump that's on your body. And so in the case of what tandem's pump, the T slim X two is the one where it has a screen, you can interact with it, but then the mobi is a little smaller, it's 200 units and that there is one button to do a quick bolus, but typically everything is done from the smartphone. And then we also have Omnipod five. And what's unique about Omnipod five is it is a tubeless pump. So there is not the tubing and everything with the Omnipod five is controlled either from a smartphone app or the provided controller can be used if someone doesn't have the smartphone app and then the beta bionics eyelet.

So what's unique about this system, it does have tubing, but this actually is the only system that can use prefilled cartridges to fill it as opposed to filling from an insulin vial. And then this is the only pump that truly doesn't have any settings to put in. You put in the weight and connect to CGM and the settings are kind of determined by the algorithm. And then instead of entering in carbohydrates, a person would go ahead and enter in meals. They would enter in if they're eating a usual meal, a larger meal or a smaller meal. So it really kind of is designed to be more simplistic. And one thing I also want to call out is that the control IQ algorithm had a recent update where they have kind of a similar feature now where when you're starting the pump, there is this option now with entering in the weight and it can actually calculate the settings for you.

So that's we're seeing pumps trying to adapt with their algorithms to make it easier for the person and offer more options. And also I want to add that while eyelet is the only one that has this meal announcements, Omnipod five also has a feature where you can do presets and you can actually put in things like small, medium, large meal or set doses. So that can be an option with that system as well. And then the last one is the SQL twist, which is not available as of today but should be very, very soon. And this is actually an algorithm that's a little bit different in that it's based off of the open source DIY looping movement and the targets are a little bit different. So the target for this system actually goes all the way down to 87 compared to Omnipod five, it goes down to 110. ILIT is also 110. The Medtronic seven 80 G is 100. And then the control IQ algorithm, the tightest settings are in the sleep mode where it's one 12.5 to one 20. And then beyond that there's a lot more to say. There's certainly differences with settings that you can adjust within the algorithm, but that's kind of a high level view of what some of these differences are.

Dr. Lubaina Presswala:

Great, thank you for that excellent overview. To summarize for our audience, the CGMs we spoke about were the professional CGM, the continuous CGM with the flash CGM and the real time of which would be your freestyle Abbott Dexcom ever since implantable and the Medtronic guardian from the pumps that we already spoke about, the one to mention again would be your Tandem X two and mobi Medtronic MiniMed, Omnipod five beta bionics and the SQL twist soon to be coming. Alright, so let's talk about the approach of introducing these devices and their features to our patients by discussing some very interesting cases that we may encounter in everyday practice. So I have a 20-year-old Hispanic male who is a sophomore in college and a member of the college soccer team. He was diagnosed with type one diabetes approximately six months ago with diabetic ketoacidosis on presentation. His hemoglobin A1C is 7.7% on glargine 14 units daily and insulin spro one unit for 15 grams of carbs per meal. And he uses insulin pens and uses a glucometer and checking his finger sticks maybe two to three times most days of the week and he will check more in case of hypoglycemia symptoms that trigger when his glucose is 60 milligram per deciliter or lower. He is currently home for the summer and he presents for a follow-up visit for his diabetes management. Dr. Isaacs, please tell us about your approach for this patient at this visit.

Dr. Diana Isaacs:

Yeah, well I'm excited to let him know and offer him all of the different technology options really now our guidelines advocate that we should be offering technology early in the diagnosis. So I really want to encourage him to start CGM and also consider starting an automated insulin delivery system. So my approach would be first letting him know about these different options and really trying to educate and answer any questions about them. I really want the decision on what technology to use to be done through shared decision making and to be really well-informed. And so it's helpful to know if he plans to start an insulin pump because that could impact then which CGM may be preferred to use. Fortunately we are seeing expanded CGM compatibility with different pumps that now several of our pumps will work with multiple CGMs, but still there may be some cases like for example with the Medtronic seven 80 G right now, if I knew that he was leaning towards that system where it might make sense, okay, let's go ahead and start the sensor that's compatible with that, which currently right now is the guardian for.

And then in terms of just some things I'd probably point out to him is just with his active life with playing soccer that cause him to want to try perhaps a tubeless pump, but also it could be an option that he could disconnect the pump during soccer as long as he reconnects within an hour at least is checking his glucose. So it's not that he has to go on a tubeless pump and then I'd really want him to actually ideally be able to see the different pump options to lay hands on them to see how big they are. Same thing with the CGM devices to see the size of it, what it would look like on his body so he can make the most informed choice. Also some additional things to are how often he is bolusing or wanting to bolus if you prefer simplicity with more meal type of announcements versus entering in carbohydrates and those kind of features as well.

And then a big one of course is always going to be cost and contracts and many of our insulin pumps do go through the DME route, the durable medical equipment, which just means that you're often in a four year contract. So it's a really big decision. So there are some pumps that go through pharmacy. So for example, the Omnipod five, the SQL twist will be going through pharmacy and others are trying to actually have some contracts where they can go through the pharmacy route as well. So that may be a consideration because when it does go through pharmacy then you're not locked into this contract, although depending on the insurance he may have to pay more or less through pharmacy. So those of course are going to be considerations. I like for people to also do their own researching and so there's great websites like diabetes wise.org which are non-industry funded and really provide a nice overview of each different type of system so that ultimately he can really make an informed choice. And then once that choice is made, definitely counseling of course on the approach with different things like exercise, like his soccer, alcohol, intimacy with the pump, all of those would be provided through education and everything.

Dr. Lubaina Presswala:

Yeah, you bring up so many good points because this is not something that we can always tackle in one visit and requires multiple visits for them to feel comfortable for making that shared decision in choosing the device that suits their lifestyle. And it can be overwhelming to make that decision when you have so many other options available in front of you. So you bring up a great point Dr. Shah, can you please elaborate on the evidence that you would share with the patient about a ID systems versus insulin pens at the visit?

Dr. Viral Shah:

Sure. And I think first of all, I'm going to say I a hundred percent agree with what Dr. Diana Isaacs mentioned about the choices and I think I want to highlight a few things here. I think this case highlights that sometimes we as in provider have a checklist that which people are good for insulin pump or a ID system. But remember that those checklists were reasonably good in the past when we were using only insulin pump and not the a ID system With the A ID system, those checklists should not be applicable and a standard of care 2025 clearly recommends that all people with type one diabetes should be offered technologies that includes both CGM as well as the A ID system to optimize their diabetes care. So I think we should try to use the technologies as early as possible from their disease state.

In this case it's a type one diabetes. Now the evidence about a ID systems overwhelming, I would say the international consensus that was developed with the, I think there were about 40 plus experts at the A TTD about two years back highlighted all randomized control trial or randomized trial, but a single arm studies clearly documented improved A1C improved timing range with the use of automated insulin delivery system compared to their competitors. That includes either the pump sensor, augmented pump therapy or multiple daily injections. And that's why in a DS standard of care, it's a level A evidence, which is the highest level of evidence coming from randomized control trials or large studies for the use of automated insulin delivery systems in people with type one diabetes.

Dr. Lubaina Presswala:

That's great. And can you also please share your expertise on use of a ID systems and perhaps type two diabetes and what do we know about that?

Dr. Viral Shah:

Yeah, that's a great question and I think with the use of GLP one analogs type two diabetes management has changed drastically is GD GLP one, I think we all recommend that in pretty much all type two diabetes patients because of multiple glycemic as well as the metabolic benefits. However, with the increasing duration of diabetes, a lot of people still going to require insulin and particularly those who have a lower eptide or lower beta cell mass or function would be very similar in terms of their insulin requirement as of type one diabetes. And the first system that was Omnipod five that could approved by the FDA for type two diabetes on insulin therapy. And it's very interesting the way that label is that it's an insulin therapy meaning by that people who are only on a basal or twice a day in PH or the basal bolus Omnipod five can be used in those individuals.

Tandem control iq, this was just like hard from a press got released at the A TTD last week in Amsterdam and it also got published simultaneously in New England General of Medicine clearly documenting superiority of tandem control IQ plus in management of type two compared to the competitors. So I think the evidence are coming in type two diabetes and that's what I do in my clinical practice as well, that people with type two diabetes who are already on GLP SGLT two, all other medications that we should be using for type two diabetes and then still requires insulin. Those are great individuals to get on the A ID system. I think a ID systems will offer them more quality of life, less work and better glycemic control and also reducing hypoglycemia because remember when we try to combine all these different medications, the risk of hypoglycemia may go up. And so using the A ID system, you are improving control without increasing the risk for hypoglycemia.

Dr. Lubaina Presswala:

Yes, that's great. And in my patients I see less glycemic variability when I have access to the CGM data report in front of me for patients who are on the A ID systems just because of the technology that prevents the hypoglycemia as well as the hyperglycemic excursions for many of these patients. And this is very overwhelming information, not just for patients but even for providers to share this with patients. So I think simple language, sensitively spoken language as well as offering multiple visits to provide this education is key to discussing insulin pumps in the office, whether it's for type one diabetes or type two diabetes. So let's move on to our next case. I have a 27-year-old patient with type one diabetes who has been using a ID system, Omnipod five for two years with good control. A1C is 6.7% without hypoglycemia and presents for a follow-up visit where she shares that she's six weeks pregnant at this visit. So Dr. Isaacs, please tell our listeners how would you approach this patient who's coming in and announcing that she's pregnant?

Dr. Diana Isaacs:

Yeah, it's a great, and this is a common scenario. So the challenge is that the algorithms that we currently have are not designed for pregnancy where we're aiming for these tighter targets outside of pregnancy. We're aiming for 70% between that 70 and 180 and the systems do a great job of getting there. In pregnancy though, we're aiming for at least 70% between 63 and 140. There is actually one system that is approved for use in pregnancy called the CAM a PS, but that system is not available in the US so therefore we don't have access to that. So what do we do in this situation? So the challenge is that the Omnipod five specifically, that lowest target is one 10. So we have a few options. So one option is we can certainly keep using the pump and we can use it in manual mode where when it's used as a manual pump, we're not having that automation, but then we can really fine tune it, we can adjust the basal rates and we can try to drive down the glucose levels.

I think the challenge is though there's a reason we use a ID, and that's because using a pump in manual can be really hard to reach those goals. And so sometimes it's a combination and I ask the person, I try to let them know about their options because another consideration also in pregnancy is that there can be a lot more insulin resistance in type one. Typically those insulin needs will rise by two to three times where they started. And for cases where it's type two or even some type one just have more insulin resistance than that and they get to a point where that 200 units, they are just going through it too quickly and they would benefit from having a pump that has a larger capacity. So we can try to use it and we're going to continue, let's say with the Omnipod five because the person just says, I can only wear a tubeless pump and I don't want to switch to anything else.

This is what I'm comfortable with or this is what I can afford, we'll work with it. And we might do a combination of automated and manual settings. So for example, in the first trimester there's often more insulin sensitivity and actually a big risk of going low. And so we may use it in automated more often and just try to really intensify those carb ratios, those correction factors to make sure we're in that range as much as possible. Versus when you get into that second trimester, there is so much more insulin resistance that often at least using the pump in manual mode or at least a partial combination such as during the day automating it, but then in the evening doing manual. So we can really increase those basal rates to get it more into range. And then another consideration can be to switch to a different a ID system.

So for example, the seven 80 G that has a target that goes down to 100. It has been studied in pregnancy in the crystal trial. Granted it is not designed for pregnancy, so usually there's a lot of additional carbohydrate entries people need to put in to drive down to get more insulin, but it certainly can be a possibility. The control IQ algorithm has more things that we can adjust. So for example, in the control IQ algorithm, you can actually adjust the basal rates and the correction factors and that will increase the background insulin delivery. So even though the lowest target is one 12 to one 20 in sleep mode, we often can get glucose readings a little bit lower with that system. And then the other thing I'll add is I am excited to try the SQL twist in pregnancy just because knowing it has a target that goes down to 87 and there's also these pre-meal lower targets that you can do. And so of course it's not approved for use in that population, but I think we're going to probably try it and see if we can get better management in that with pregnancy.

Dr. Lubaina Presswala:

Great, thank you so much. That was very educational. And these patients particularly are sensitive for hypoglycemia and they may have hypoglycemia at blood glucoses of 80, so it gets particularly difficult during pregnancy to maintain that lower targets for a patient going through pregnancy. Dr. Shah, I'm going to change the scenario just a little bit. I'm going to present that this patient is coming in for a follow-up visit with you in her third trimester and she has been advised to go through a C-section. And what would be your approach in management of an insulin pump in the preoperative and postoperative settings?

Dr. Viral Shah:

That's a great question and also a difficult question. I think each institution does have their own protocol on how to manage this. What I do, I think it's also an individual decision. So we do work with the maternal fetal unit here. It's kind of a more coordinated care and some understanding between the OB and GY providers and us on how to manage people who are already on a ID systems. I am very comfortable to keep using the pump during delivery. Even sometimes if the insulin requirement changes are significant or for example, they are taking for a C-section. In those circumstances, the OB GY team may decide that they would probably take out the insulin pump for various reasons. In that case, they would probably give an IV insulin per institution protocol if it's just the delivery without let's say C-section or something. Most of the time we try to continue insulin pump.

Also, we have to remember that part. As soon as the placent is out, the insulin requirement drops significantly and people do require a significant change in their pump settings. Now it could be a trickier, and I do see often that people do experience some hypoglycemias after they are being delivered with baby. And again, simply because of that, there is a lot of insulin that has been pumped during that stressful delivery time and then suddenly that insulin is working and your insulin requirement also goes down. So those kind of time periods are critical and I think having a good understanding between that OB GY or MFM team and the endocrinologist and coordinated care would be the key. And I'm sure that a lot of institutions do come up with their kind of a written protocol making sure that we all are on the same page. But again, I think these kind of situations where things changes rapidly and you make those kind of an individualized decisions depending on different factors and circumstances.

Dr. Diana Isaacs:

I just want to add about the post delivery because depending on the algorithm, that could be a major issue because several of the algorithms rely on the total daily insulin dose for automation. And so if all of a sudden it was a very high dose and then it's dropping, that can lead to hypoglycemia even in automation. So with some systems, if we can reset the algorithm, we may do that. For example, Omnipod five, you can just reset the algorithm as long as a person knows their username and password. The other thing is it may be beneficial to actually use it in manual for a few days to have that total daily insulin dose reset and then use it in that way. It can be protective against hypoglycemia.

Dr. Lubaina Presswala:

Yeah, I think you bring up a good point, and it may even be at the discretion of the provider to consider removing the pump in the post-op setting for 24 hours, give them a day to recuperate with long-acting insulin to DKA at a much lower dose and then resume the pump in manual mode until you realize what the requirements have been in the post-op setting for that patient. I know in my institution at Memorial Sloan Kettering, I have patients not pregnant, but they are going through surgery and specifically cancer related surgery, which tends to be a very urgent nature. And as long as the CGM and the pump site are out of the surgical field, our institution is in favor of using the a ID system to keep their glucoses in control during surgery and in the post-op period. But then the impetus is really on our anesthesiologist to monitor glucoses per protocol using the hospital device and be at the discretion if the sugars are too high to consider removing the pump if that's appropriate, to prevent EKA and then be in close communication with the entire team at the hospital system. So it's a very tricky situation and close communication with all the teams is certainly highly valuable. Well, this has been a very fascinating discussion. Thank you both. I would like to request you to share maybe three main key takeaway points from this discussion today, Dr. Isaacs.

Dr. Diana Isaacs:

Oh, sure. So I guess one is that technology is here, offer it to our patients. Really it should be offered earlier definitely with type one diabetes early in the diagnosis, but also there's so much evidence for type two diabetes, especially insulin users. So we should stay up to date and make sure that we can offer these technologies to our patients. I think second point is shared decision making. There are so many great options and yes, there's certain factors that may guide us and say, Hey, this may be a good option for you based on how active you are or based on your preferences. But really I think we want to offer choice because it's the person that's going to be using this all of the time and has to feel really comfortable with it. And then I think the third thing is that there are some really unique intricacies with each algorithm now, and it it's really important to stay up to date to figure out, well, what can you adjust if someone's not meeting their goals, what types of things can you adjust? And depending on the system, that could be, I mean most of 'em, with the exception of eyelet, you can at least adjust the carbohydrate ratios. But then depending on the system, you may be able to go much beyond that and adjust correction factors or basal rates. But understanding what you can adjust is really important. Otherwise you could end up going up and up and up on basal rates and unfortunately it's going to have no impact for the person.

Dr. Viral Shah:

I agree with Dr. Reiks, and I think my three take home message here in this podcast would be number one, initiating diabetes technologies, CGM and a ID systems as early as in type one diabetes has been shown to improve outcome. So I would recommend all endocrinologists and diabetologists who are listening to this podcast to be diabetes technology champions. Individualization is the key. That's my second message, and I think Dr. Isaac has really emphasized that throughout her conversations. And number three is that I do agree that it's an overwhelming with four system. The fifth one is in the line, and then probably that may be a sixth and seventh, I don't know. And so each one works differently. And so it becomes very difficult for providers, particularly in a primary care space where hard to keep up with the pace that we are moving in this diabetes technology field.

And so my recommendation would be that if you really are interested in learning about that part, you have to be updated because people are going to use that part. They're going to come to your clinic. And so it would be good that you get updated into diabetes technologies. And to do that part, I would recommend that you listen to this kind of an ACE forecast. And number two is that the ACE annual meeting does have a diabetes technology bootcamp, which is like and a half a day, pretty nice compact overview on all diabetes technology and hands of workshop. I think attending those kind of a workshop would be really give you a confidence on what these technologies offer for your patients with diabetes.

Dr. Lubaina Presswala:

Thank you, Dr. Sean, Dr. Isaacs, for your invaluable time and expertise. I think I would echo your points and tell our listeners to please attend our ACE Diabetes workshop at the national meeting and remember to just learn about all the features that might be available on the pumps activity mode. Just reduces the burden of hypoglycemia as well, I've noticed in my patients. And so just being educated on the features of the pump gives you the confidence to share that information with your patients. I want to thank ACE and the Diabetes Disease Network for their support in bringing this engaging podcast To our audience, to our listeners, thank you for tuning in.