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- [00:00]
Aaron Lohr
Hello, I'm Aaron Lohr and this is the Endocrine News Podcast. Today we're talking about automated insulin delivery systems. There's a lot of interest in these systems and they were covered in depth at the endocrine Society's Type 1 Diabetes Fellows Program held earlier this year. We'll talk about them today, too. But first I'd like to say that Type 1 Diabetes Fellows program and this episode are made possible thanks to unrestricted educational grants by our supporters, including Abbott Diabetes Care Incorporated, Secure Corporation, Dexcom, Embekta, Insulet, JDRF Lilly usa llc, Mankind Corporation, Medtronic, Diabetes, Novo, Nordisk, Tamdem Diabetes Care and Vertex. Now, if you weren't at the Tund Fellows Program, you may be asking, how should automated insulin delivery systems be used? What are the challenges and limitations associated with these systems? Well, to help us answer these questions and more, our guest today is Dr. Grazia Aleppo. Dr. Aleppo is a professor of medicine at Northwestern University and was a presenter at the T1D fellows program. Thank you so much for being here today, Dr. Aleppo.
- [01:27]
Dr. Grazia Aleppo
Thank you so much, Aaron, for having me today.
- [01:30]
Aaron Lohr
Can you please tell us a bit more about available automated insulin delivery systems and what are their characteristics?
- [01:36]
Dr. Grazia Aleppo
The available aid systems today, short for automated insulin delivery systems, are basically a group of components. They have a pump or a pod, a container of insulin, an algorithm and a cgm. And these three connect together by modulating insulin delivery through the input from a cgm. And they go up on the insulin dose, go down, suspend, resume, give automation of correction. But these are still hybrid closed loops. So the user has to still take a dose of insulin. We call the meal announcement. They're not fully closed yet.
- [02:18]
Aaron Lohr
And are there any challenges associated with starting on an aid system?
- [02:24]
Dr. Grazia Aleppo
As for every new tool, you need to start working with the tool. I make this joke with my patients. I say, when you buy a new phone, you need to learn the phone. You need to have a class on the phone. You don't just use the phone as it is because you want to enjoy its features. So the challenges are, number one, to meet the patients where they are. Some people are coming from multiple daily injections. Some people are coming from a regular standard pump, Some are coming from another aid. So based on their level of understanding or expertise, fear of hypoglycemia, and many other components, the challenge is how do I start this patient? Making sure they get the best out of the system. Instead of doing that cookie cutter training, you need to adapt to the patient.
- [03:14]
Aaron Lohr
So I know a lot of people when they think about new tech, they think that this might be the answer to everything. Finally, this new technology is going to solve it all. But I imagine there may be some limitations. So can you tell us a little bit about the limitations associated with aid systems?
- [03:28]
Dr. Grazia Aleppo
I wish they could be set it and forget it. Not just yet. That would be my dream. We're getting there. So there are several limitations. Number one, the system per se, again I was mentioning before, this is not a fully automated system. The person who uses needs to take insulin for their meals. And knowing that I call this slow insulin, it's not really, they call it rapid, they're not rapid, they're actually pretty slow. So you need to very often pre bolus, pre dose insulin for the meal and to pay attention to that. If you can optimize the way you do the carbs is good. Some pumps of aid system do not require no carbs. So that's good. You can put usual carbs, more carbs, less carbs. But you gotta put something, you gotta do the pushing of the button to announce the meal, that's number one. So that requires the human to do something. The second thing is that the sensor still has some we call lag time. It doesn't really respond well to the setting of hypoglycemia. What I'm trying to say is when there is a low glucose, the sensors tells the pump to suspend. But then the resuming of the insulin fusion is always a bit delayed because of physiologic issue. You know, when we have low glucose, there is basal constriction, the vessels tighten up so the sensor has less flow and so the signal might be low for a longer time. So that exacerbates the duration of the suspension and that can cause rebound high glucose. We need to also train the patient on how to not overdo the low glucose correction. But then also are humans, we cannot tell take only 4 grams of carbs when they think they're going to die because they feel so low. We need to remember the many components. And then of course that is insulin. Insulin is one of the weak links together with the infusion site. So insulin, we call them rapid acting, ultra rapid acting. They're still not the same as physiologic insulin because there is this from the skin needs to go to the bloodstream. So the onset of action is somewhat delayed because of the insulin characteristics. And they really need to do this magic of optimizing the matching of the insulin action with the food digestion. So I have to really explain to the patient, all these things and they actually do a great job. But sometimes it's like to sort of optimize the timing, the dose and stuff like that. The last two things are exercise and infusion set. So just remember I tell my patient the difference between you being healthy and at home and you in the hospital with ketoacidosis, it's a 6 millimeter Teflon cannula. Do you really trust that? What I'm trying to say is that sometimes the cannula dislodges, lifts or can be partially removed, move. And so the insulin is not being absorbed correctly. There might be an occlusion alarm, there might not be. So people need to really pay attention to the glucose trends. If they stay high for a while, that really sounds like maybe it's a failed site. They need to change the site. Because remember, these systems try to bring the glucose down to a level that is either 100, 110, 120 around those numbers. So what would you be to 50? If you are persistent in the number, you need to think, okay, I have an automation now that increases the dose of insulin, increasing glucose. Why I'm not getting better, Perhaps I should change my sight. So exercise is a challenge because every aid system has sort of settings that do either activity mode, exercise, activity, temp, target, more gentle, whatever. All of these, however, need to be preset. In general, they actually have levels that go from, let's say 110 to 150, or we have a higher number to protect from hypoglycemia. But that also is not set it and forget it either. A, you need to remember to put it on before you do the exercise, then remember to time it until you're done. And even sometimes the level of glucose that is present for these systems might not be sufficient to prevent hypoglycemia. You might have to eat some glucose. That in turn can increase the insulin delivery. So a lot of little tricks you need to work on with the patient to try to optimize insulin delivery in the setting of exercise, which causes increase in insulin sensitivity. So this seems as challenges and we need to work around the challenges to optimize the results.
- [07:52]
Aaron Lohr
Are aid systems for everyone with type 1 diabetes? Or are there certain folks who would benefit more than others?
- [07:59]
Dr. Grazia Aleppo
Aid should become or are going to become the standard of care for people with type 1, but the person has to be willing to use it. Remember, some people say, I don't want something attached to my body ball and chain because the pump is a tubing. So you need to also understand the psychology of the person with diabetes. Say, are you willing to wear this thing that's always on you? Right. So it's not just that the system works, of course, they work phenomenally. But first thing to ask for the patient is, are you willing to use these things on your body, the sensor, the infusion set or the pod, whatever. And so for people, might be they turn off or they feel uncomfortable, they might be in relationships and maybe, you know, uncomfortable just because of intimacy, whatever. So you need to think about that first. And then some systems have peculiarities that are good for some patients and not others. Some systems are very highly customizable. So the person who's totally ocd, they want to change a lot of things, they're good with that particular system. Some other people are hands off. So even something customizable, it's not going to work. So you need to work with the person to say what will work best for you. And so it's good for the patient to acknowledge what's available so they can actually decide what works better for their way of living, their attitudes towards their diabetes. And I tell my patient, I don't buy your shoes, I don't buy a car, I don't buy a phone. Why? Because you need to choose for yourself. I guide you for what I think will be better, but ultimately I can't choose for you. And so, yes, many systems can work for a lot of people, but some people might do better with one versus the other. And it's our job to say, discuss with the patient, show them what's available, and then see what they feel. And maybe point out that for this particular sickness, they do do ABC for they do the other thing and see if they feel comfortable one way or the other. So that's how we go about. But yes, if I could do everybody on pump. Oh, yeah, aid. But I'm not the person who has the diabetes, right?
- [10:03]
Aaron Lohr
Absolutely. One thing we said earlier to kind of likened some of these systems to, like when you get a new phone, you know, I know when I got a new upgraded phone, I waited a lot of years. There's been a lot of changes, and I needed someone to help me understand the new features and how to use it. What kind of training is necessary for optimal use of aid systems?
- [10:23]
Dr. Grazia Aleppo
I always tell my patients, you guys are so smart, you know how to use a lot of things. However you, this is still a medical tool. So I want you to understand the responsibility of using something safely because it delivers insulin. First of all, we need to make sure these are set up correctly. Now, some systems only want the way and they do their own thing. However, you still do some settings, we can just turn it on. There is some training done and in fact, for those particular system, training is pretty intense because you need to know how to use it when it doesn't work. So training means understand what to change, how to change, when to change particular setting, for example, when to or how to set up the activity mode. Some systems have different profiles, some system don't. What is your optimal target? Is it 100, 110, 120? And you have to really work with the patient to decide maybe we should start high and then go lower later. And then we need to also train the patient out to recognize failures, you know, site failures, the glucose are high. We need to have a backup pump plan in place because things can break when you go on vacation on Friday afternoon at 5 o'clock and so always remind patients of, you know, you need to have backup supplies. Understand what to do when this happens. For example, important things to remember is the system are driven by CGM data. Let's say the CGM is not received on time and there is no CGM available. So you can go into something called manual mode. For some systems there is no manual mode. You need to go back to check your glucose or go to multiple diary injections after three days. For some other system you can go in manual mode. But the challenge is if the manual mode settings are not matching the aid system delivered, you might have too little insulin or too much insulin, so you need to check those too. And this is done with training, you know, continuous monitoring to make sure that the things are set up safely. For example, you go from one aid to another, they're different beasts, they're not the same. So some things adjust differently. So we need to then retrain and readjust things to make sure they work well from one system to another. So it's not that the person is not intelligent, I'm not saying that, but this is insulin and insulin is a bit dangerous, can cause low blood glucose. So we need to make sure that the settings are placed and they're safe. That's all I'm trying to say.
- [12:49]
Aaron Lohr
Oh no, that makes a lot of sense. People want to have some level of confidence that what they're using is going to help them in the way that it's meant to. And in fact, I'd like to ask even that there's some strategies to optimize the outcomes when using aid systems. How do we make the Most of it.
- [13:03]
Dr. Grazia Aleppo
I always believe that things can be tweaked. Even with the most sort of simple systems, you can still adjust and ask questions to the patient. So we look at the reports, which is our daily job sort of thing, and we try to find places where the patient is having a challenge and say uncontrolled, it's a challenge. For example, a particular time of the day with a high glucose after eating. So we say, okay, is it the timing of the insulin, Is it the carb ratio? What is it? What are we doing? So we talk and we say, let me show this particular day. And we look at this particular time. Okay, why do you think could be different? Especially because when we look at these reports, we can see things might be happening every day at the same time. And so we try to say, okay, if this happens, trending every day and there's a pattern of this, what could we do? Or the person has a behavior that doesn't use the pump optimally because the system needs specific things. So we need to guide them and say, okay, let's look at this together. See what you're doing. Is this. The system doesn't like it because it does this other thing. And so by just teaching and showing the patient what is happening, tells them how to coexist. This is a symbiotic experience with the system because there is the intelligence of the patient and the machine they need to live together is co pilot. One is not better than the other because if they fight each other, they don't get the best. And that's what I find to be important to say, okay, the system is doing this for you. Can we optimize it so you can get to the max timing range? You can get to. So you do better overall?
- [14:36]
Aaron Lohr
A lot of this is wonderful and there's a lot of people listening, you know, who are probably thinking, well then maybe everybody should have one that needs one. But does everyone have access to that? So I guess my question is, what are the barriers, you know, to access to the use of these aid systems?
- [14:52]
Dr. Grazia Aleppo
This is a great question. So there are many barriers to them. Fortunately, these systems are covered by all insurances, but they are not inexpensive. For example, if the system is covered by something we call DME Turbo medical equipment, then there might be a deductible that the patient has to incur every year. And if patients have these high deductible premiums and they have to spend $5,000 before the insurance takes over, they spend half of the year paying out of pocket for supplies that's very expensive. The other thing is that very often there is these warranties. For example, if you are on Medicare, the warranty for a pump that goes through DME is five years, not four. So they might extend the life of the system, but in four years the system becomes a bit obsolete. So they don't have access to the newer ones because they have to wait five years. Other challenges are, for example, for patients who are on Medicaid they do fantastic, but they need to be seen very often. Specifically every three months we have to have char notes sent to the suppliers for Medicaid, Medicare especially. And so we need to always have all this paper with so much stuff to make the patient, you know, consider to use these systems. And then, you know, they don't get the supplies on time because of all this bureaucracy of paperwork. So some companies have done a great job by doing pharmacy benefits for supplies which of course is much more affordable because it's more a co payment. But not all the insurance companies have the same policies, even the same companies, different groups with different sort of policies. So we need to be aware that some people might afford one system better than the other. Not because it's better or worse. It's because their insurance company has a special policy. They might be able to cover one system more than another with a different way make sense. So it depends on the situation. And then we need to understand a couple more things. One is literacy. You want to make sure the patient is able to understand how to use. So again, training and repeated reinforcement. Older adults might have difficulty with touching the button sometimes or having poor vision. So we need to then either go to a different system that may allow that or involve the family. And then of course for children the barrier is somebody else has to also be able to push these buttons in the school system. So it's not just one barrier. There are many barriers. And we have an obligation not only try to overcome, but especially to also minimize health disparities. We need to offer this system to everyone. There is nobody that needs to wait to go on an aid. Even the ONC is 10. That is the best time because that's when they'll do better. Because automation will take care of so much stuff, right? So much more than just or you got to be in better shape. That's actually such a bad. I think it's obsolete way to look at people with going to this AED system because the automation does so much for the patient and so there will be the perfect patient. But we need to also be open and offer this system to everybody who is able to access it and push for it.
- [18:07]
Aaron Lohr
We're just about out of time. This is fantastic. I feel like we've learned a lot about these aid systems and I'm so thankful that you could be on the podcast today and share your thoughts. Thank you so much for being here.
- [18:17]
Dr. Grazia Aleppo
It's been such a pleasure. Thank you so much for having me.
- [18:21]
Aaron Lohr
If you enjoyed hearing about automated insulin delivery systems and wish you could have attended the type 1 diabetes fellow series, I have some good news for you. The program is now accessible on the Society center for Learning, and you can head over there right now. See the link in today's episode description and get ready to learn about current and emerging therapies for the treatment of preclinical type 1 diabetes, various strategies for exercise and minimizing hypoglycemia, the latest individualized treatment strategies and emerging insulin therapies, and so much more. Until next time, thanks for listening. Endocrine News Podcasts are a free service of the Endocrine Society. To learn more or to become a member, visit the society's website at www.endocrine.org.