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- [00:00]
A
Hello, I'm Aaron Lohr and this is the Endocrine News podcast. Today we're talking about type 1 diabetes and we'll be spending a good amount of time on insulin delivery systems. This is a special episode and that it is supported by educational grants from Mankind and Insulet. Thank you. Furthermore, this episode is certified for up to 0.5American Medical Association Physicians Recognition Award. That's AMA PRA Category 1 credits and American Board of Internal Medicine Maintenance certification. That's ABIM MOC points. Now, if you'd like those credits and points, you'll need to take a pretest before listening to this episode. Then you'll listen to this episode on the Endocrine Society center for Learning. And then there'll be a post test and evaluation to claim your credits to make this process as simple as possible. Those activities are all on the Society center for Learning and we'll provide a link for them in today's episode description. All right, so the only people listening now should be those who are not interested in the credits or points or those who have taken the pretest on with the show. Our guests today are Drs. Graziel Leppo and Diana Isaacs. Dr. Aleppo is professor of medicine at Northwestern University Feinberg School of Medicine, and Dr. Isaacs is director of Education and training in diabetes and technology with the Cleveland Clinic. Thank you both for being here today.
- [01:40]
B
Thank you so much. It's a pleasure to be here today.
- [01:43]
C
Yeah, it's great to be here. Thanks for having us.
- [01:46]
A
Wonderful. Let's dive in. What are the biggest challenges and barriers to type 1 diabetes treatment?
- [01:53]
C
Yeah, I can start us off. So there are many. First of all, the way people come to their diagnosis of type 1 diabetes is often traumatic. Many people are diagnosed in DKA and are hospitalized. And that's kind of, it's like, all right, now you need to learn everything. You don't make insulin. On the flip side, there's actually several people now that are misdiagnosed think that they have type 2 diabetes for a period of time. And it takes much longer to figure out, hey, they actually have type 1 diabetes. And obviously the treatment is very different because the treatment is insulin. That poses a lot of challenges. Insulin, despite all of our advances, is a drug with a narrow therapeutic window. And what that means is you get a little too much and you experience hypoglycemia, which can also be life threatening. And of course, if you don't have enough, you can go into dka. And so it's always walking this fine line of well, you gotta get the right amount of insulin for what you're eating, for what your activity level is. And therefore, there's a lot we ask people to do in terms of how they're eating, as well as the monitoring of glucose so that we can get the right amounts of insulin. And as you can imagine, this takes a toll. I mean, this is a big mental and physical burden and it can be challenging. It's not an easy condition to take care of.
- [03:25]
A
Now, it seems like a few challenges are awareness. For example, adults with type 1 diabetes are frequently misdiagnosed at presentation, and therefore they miss a crucial window to enroll in clinical trials to preserve beta cell function. How important is this window and what can be done to better raise awareness and avoid misdiagnosis?
- [03:45]
B
I can take that one. It's one of my pet peeves in my practice, I always tell my fellows, think of type one, ask about the family history. If they have autoimmune diseases, you start to think about it. So the issue is many patients in the adult realm, which, what I take care of, they come to us with the diagnosis of type 2 just because they're an adult. But 50% of people today diagnosed with type 1 are over the age of 25. So we need to have a greater awareness. Just think about it. But also we have a lot of antibodies available, and so how many times do we check for blood tests, then they come back in their normal. So why can't we just check these antibodies? So what if they're negative? We know they don't have type one. We already figured out what we can do for this patient and go to a different channel of other medications. Now, the thing that is also important is that there are many clinical trials ongoing, and usually the window is about 90 days to maybe four months at most. Some studies actually even less, 45 days. So if you get a patient with potential early type 1 and they are given metformin because they think they have type two and they get to us an endo or even the primary care, that window is, I'm sorry, is often lost. And that is a shame, because then people with this diagnosis can get treatment. I have a patient of mine many years ago who actually was able to get into a study in Indianapolis. He drove there. You know, what happened to this patient actually required very little insulin for three or four years. And so this was great. But I don't want to call it inertia just because you're older. And actually even more important is because your BMI is high. That's even more important because the misnomer that people with type 1 should have a thin BMI, a low BMI being thin, it's no longer true. Think about the patient is. And the possible diagnosis is very, very important. And just a blood test can tell you very simply, I said at the.
- [05:44]
A
Beginning we're spending a lot of time talking about insulin delivery systems. I kind of want to get into that now. What options are out there in that regard and how do they differ from each other?
- [05:53]
C
Oh yeah. So it's exciting times. There's definitely a lot more ways to deliver insulin. So we have our traditional multiple daily injections where we've got multiple long acting insulins. Hopefully we have weekly insulin on the horizon in the US and then we have several rapid acting insulins so people can inject insulin. But now we're really in a new era of automated insulin delivery where we have several insulin pump systems that work with the different CGM sensors with different types of algorithms to provide automation. And it's been really exciting to see how this evolves. Initially we just had simple systems that could suspend insulin if it was either dropped too low or it was predicted to go too low. But now we have systems that not only can decrease insulin, but they also increase insulin if glucose is predicted to go too high. And then several of the systems can actually even give additional correction doses beyond that. So the systems that we have available, at least right now in the US is we have the MiniMed 780G system for automation. We have Control IQ plus we also have now the Omnipod 5, which is a tubeless insulin delivery system. So most of the pumps, they have some tubing to be able to connect to the body, but that's kind of the first fully tubeless. And then we also have the newest one is the twist, which is actually an algorithm that was based on the whole DIY looping movement that they were able to bring to the FDA for approval. And then we have the eyelet. And the eyelet is a little bit unique in the fact that it doesn't actually run off of the traditional settings that the other insulin pumps run off of. So with most insulin pumps, we're programming basal rates, we're programming an insulin to carbohydrate ratio, a correction factor. Even if the system doesn't actually use these settings, we still have to program them in with the islet. All you do actually is you put in a person's weight, you connect them to CGM and then you press go bionic and and it has an algorithm that delivers insulin based on those CGM levels. And all the person is asked to do is actually to announce their meals. So to announce that they're eating a usual meal less or more. All the systems where you're still supposed to do some type of meal announcement or carbohydrate counting. I think the hope for the future is to even be able to get rid of that. There's a few other unique ways of delivering insulin as well as. So we have some more simple pumps. You could think of them as wearable insulin. We have the secure simplicity device, which you can wear and you press the sides of it and you can do two unit boluses at a time. And there is also the VGO system, which delivers insulin in the background. 20, 30 or 40 unit daily basal dose and similar. It's got a button for two unit increments. So a little bit less customization, but an easy way of delivering insulin. Not everyone wants to wear a pump, right? Some people don't want to be attached to something all the time. Some people have skin sensitivities, some people just don't want to be on that. And so we do have connected pens, which are devices for insulin pen users that can track the insulin doses and also include some of those calculations with carbohydrate ratios and correction factors and keep track of active insulin. So to recommend doses to take. The other thing that we have now is actually inhaled insulin. Obviously it's a unique way of giving insulin compared to injectable, but the other thing about it is it works very fast. So it is actually more physiologic compared to all of the other insulins, which generally just take longer to start working and are in the body longer. So inhaled insulin works very quickly and is out of the body quickly. Much more like the insulin that comes from a healthy pancreas in a person without diabetes.
- [10:19]
A
So there are a lot of different modes and it seems to be there's always more that are coming here. As the future gets closer to now, what do the recent data tell us about the efficacy and safety of some of these new and emerging modes of insulin delivery?
- [10:34]
B
You know, era, there is so much data out there, it is so fantastic to see. There is no better time to be a person interested in diabetes care because it really is fantastic. I'll talk about inhaled insulin. Since Diana just mentioned it, we actually completed a clinical trial with inhaled insulin in people with type 1 diabetes, which was really interesting. I was so thrilled to do the study. I wanted to learn more about this Insulin because it was approved in 2014, but I didn't have much of understanding or much confidence on how to use it. So and so in this study we actually use a different conversion dose, which was the most important part. So we'd actually dose Afreza units, we could actually dose inhale units different than injected units. And that was very important. And so this group was a randomized control trial and they used the inhaled versus regular regimen was the insulin pump multiple daily injection initially for 17 weeks and then for 13 weeks where the control group went on the inhale insulin. And I'm telling you, these patients really enjoy doing the study. I learned a lot. The response post meal was dramatic. We did a mixed meal tolerance test to see, you know, if you inject regular insulin, in this case analogs, Aspert or Lisbo. And the group that was doing help took the dosamine help insulin for the post challenge glucose were much lower in the people who are using the inhale insulin. Not only that, at the end of the study we did again another mixed meal tolerance test, meal challenge. And the participant who started initially they inhaled insulin did even better because by the time 30 weeks had gone by, they became more comfortable dosing and increase the dose of insulin when they were just starting. So at the end it was about two and a half to three times the sort of equivalence of dose to the injected insulin. And there were no hypoglycemic episodes, people were just fine. And in fact 38% of the entire group of patients who were in the study stayed on inhale insulin plus long acting insulin. It just goes to show that some people really enjoy the method because you might be very active, this sort of unpredictable schedule, but don't want something attached to. Then you have your long acting insulin, which was Deglubec in this case, and this very rapid acting insulin that you can actually dose also postprandally and you can reduce the chance of what we call insulin stacking causing hypoglycemia. Now as far as the aid system, we have a ton of data, so many pivotal trials. And the beauty is that we also have real world numbers, 7,000, 8,000, 100,000 people using this system. It is so fantastic. What does the real world tell us that is even better than the randomized control or the for registration trials? It tells us that if the systems work well in the super controlled environment of a clinical trial, they work even better when the people can actually have them in their hands and just go in the real life. And that's the beauty of it and we have seen sort of reports with people with Medicare, Medicaid, insurance, old young, super old patients, super young people, they all do phenomenally because you know it, reduce hypoglycemia, you improve hyperglycemia, also reduce diabetes distress. The psychosocial is also very important and aspect of considering that in parents prefer it. Parents of kids with type one, it's very hard to give all this injection where you can just push a button and do much better with that. And the dosing is so much more flexible. So data are very strong for both inhaled insulin and for aid systems.
- [14:25]
A
And generally speaking, how well do healthcare providers understand all these different insulin delivery systems? Is there a need for more education and if so, where can they get it?
- [14:36]
C
I think there is a need for more education. I mean there's a lot to keep up with. There has been a lot of advances and I think it's hard to keep up with it all. And especially in primary care settings or any setting where a provider is taking care of multiple different disease states and not just diabetes, I respect that. It is a lot to keep up with. So while I think some people are definitely like they're in it, they're keeping up, I think there is a need for more education out there. And fortunately there are several good resources to go to get this education. So one of my favorite is actually a site called Diabetes Wise and they have Diabetes Wise for healthcare professionals. And so this is actually a site where you can see all of the different insulin delivery methods and you can do side by side comparisons on them. You can also hear from people that have used them and their kind of real world experiences. And one of the things that I especially appreciate about this is that it is, I think a very fair and balanced, it's a non industry funded site. I think it provides a lot of very good objective data on all of their respective systems. Another one that I particularly like a lot is actually the Panther tools which has been created by Barbara Davis. And these are incredible tools that go through every type of insulin pump, automated insulin delivery system to really outline their specific features. Because one of the questions that comes up is even if someone is familiar with the different options out there or when their patient comes back and they're trying to make changes to help improve their outcomes, their A1C, their time and range, what can they adjust with the pump to make a difference? And so these tools outline which settings can make meaningful differences and also provide information on how to interpret the data. Because each report from each system could look a little bit different as well. And then another site that I like a lot is something called Dana Tech. This is from adcs, the association of Diabetes Care and Education Specialists. This also has a lot of comprehensive resources on all of the different types of insulin delivery, including inhaled insulin. Inhaled insulin is also on the Diabetes Wise site as well. And I think going to these sites regularly, going to these resources is good. So it keeps these different options in someone's mind because it's easy to forget about something you may know, hey, oh yeah, there's inhaled insulin or there's this system, but if you're not using it, I think it's easy a couple months later to totally forget about it and then not offer it to your patients. So I think staying up to date on these is really important.
- [17:29]
B
But also then I remember, as you were saying, if you think about all these many aid systems, there are so many out there now, they need to make sure. Is it possible? How many hours is the activity mode? For example, is it called activity mode? Is it called Attempt target? There's so many different nuances in these systems that we need to continuously refresh our memory and say, what is it called? How long does it last? So I actually like exactly the ones you use, Diabetes Wise and Panther program. And I'm going to look at the data that you told me now because I wasn't aware of that, because really we need to continuously keep up and this is a very fast growing field and it's getting faster by the minute. So there are going to be so many more systems out there. We need to, all of us, even the ones like us who do this every day, make sure we keep up.
- [18:19]
C
Another thing that the PANTHER program has is they have a table with like a side by side each system so you can quickly kind of look, oh yeah, this is activity mode, this is Temp target.
- [18:29]
B
Exactly.
- [18:30]
C
And so I think like, even for those that like to print things, like printing them out and having it up or having a PDF, you know, quickly available, that can really, really help in practice.
- [18:39]
B
I hang it in my office because I have residents, I have fellows, I have students. Look at the different ones so you can understand, you need to know all of them. But also you were mentioning before the way that they show the software, they're different from each other. You're going to get different password and id, but also understand which one are you going to look at. There are 30 reports for each system. You need to focus in your limited time with the patient so you can get the best out of it and make the right changes. He totally write about that.
- [19:11]
A
So we talked about healthcare providers, but patients need to keep up with this too. They need to know how these models are gonna work for them, what kind of education is available to them. Are there resources like diabetes wise for patients?
- [19:22]
C
There is actually. So the diabetes wise, there's a patient version and then there's a healthcare provider version. So that's actually one of the things I do. A lot of times people will meet with me and they want to kind of learn what's out there and I'll introduce the different options. But I actually tell them, I want you to go home and here's this website and I want you to take some time really going through it, learning about the different options. Come back to me if you've got, you know, with additional questions. But I don't want them to make a decision lightly because sometimes depending on what you're using, you might be in a contract for longer. And I just want people to feel really comfortable with what they choose. There's a couple other sites I think are really good for staying up to date on information. One of them is Diatribe. Diatribe.org that is fantastic. They are just really, I think, very cutting edge on everything new, like new data that comes out and they even started doing a daily drop email of like these top three clinical pearls based on like new things that have just come out. And even though it's geared toward people with diabetes, I, as a healthcare professional actually really enjoy those emails. Females as well, I mean, there's so many great resources, but another one that I really like is Diabetes Sisters. They are more geared toward the female community, but they are great in terms of just a lot of different issues and different updates for people with diabetes as well. And I was also going to say beyond Type one and beyond Type two are two other great sites as well that people can go to for really quality information.
- [21:03]
B
If you want to have a laughter, go to Tacoid Taking Control of diabetes with Dr. Adeline, Dr. Jeremy Pettis, who both live with type 1 and they had the most hilarious videos. But actually they're so educational. They really are fabulous. So there's so much that people can actually look at. But I agree with Diana. People need to understand. I make a joke, I say, I don't buy your shoes, I don't buy your phone. Why would I buy your pump? Or decide what you should choose because you're going to wear it, so it has to be something that resonates with you. It's very, very important to make the patient understand something that they wear 24 7.
- [21:42]
A
I'm going to shift gears a little bit and talk a little bit about access. We know that access to treatment is challenging, particularly for patients on Medicare and Medicaid. Can you walk us through those challenges?
- [21:51]
B
Yes, I'll be happy to do that because I deal with this every day. So I'll give you a little bit of scenario. He's a patient of mine who's 64 and a half, has had type 1 diabetes for 54 years, has lived very well with type 1 for 54 years. He's wearing an AIED system. Now he's going to turn 65 and now he has to explain to Medicare that yes, he still has type one, that yes, he still needs to take the insulin, then yes, instead this applies. But Medicare is so many outdated and sort of clinically irrelevant rules that make the patient really go through a major change and they need to be adjusted to that. So if you need to get a pump or get supplies and you go into Medicare, you need to have either antibodies which by the way turn negative after 50 years, so you're not going to have positive or a very low C peptide which shows you don't have any sort of endogenous insulin production. However, you can have C peptide measurable, you still can dwell on a pump. And clinical trials have shown that it doesn't matter if it's positive or negative, it doesn't make you more insulin, less insulin requiring. Right. The other thing that is important is how it is structured. So tubed pump with the two part B and the tubeless goes to part D or so pharmacy. This is not easy for people to understand the supplies. So people can get their pump supplies and their CGM supplies through a mail and order supply like a pharmacy, not yet to go to a DME, which is durable medical equipment. And they want every three months an A1C, a chart note before they release the supplies. So think about a person who's done well for 55 years now has to come to see me every three months just in case diabetes goes away and prove that they continuously need. This is a very, very tiring process, especially because they might miss an appointment for whatever reason, they get no supplies, the insulin is not paid for. So all this becomes very stressful. The same applies to Medicaid. Of course, it's a state regulated agency, but still in Illinois. Yes, they cover pumps, but they're very strict. You need to come in every so many months and show you have an improvement, otherwise they might deny. So all of these things become very burdensome for somebody who's lived with that condition for so many decades. So can you imagine the added burden to now I cannot get my supplies because I missed my appointment about four days and so that is very stressful. People really have to understand all these have to be done, otherwise they won't get their supplies. So very many major in my opinion is redundant. It doesn't make the patient do better. Sometimes they have to ration their supplies because they might run out of them and they might be in a different state. In Florida, let's say winter in there, it's get another doctor. So complicated. Really should be less complicated. But also there is no evidence that it's better. None whatsoever.
- [24:56]
C
I agree with that. I just want to add there has been a trend toward more pumps starting to go through pharmacy. It's a good thing because then a person's not locked into that long term contract and also when they go through pharmacy then they're not asking for that C peptide. And so it has been a little easier for pumps that don't go through DME to be able to get them. So I hope that continues. But I definitely agree with the supply issue. And usually people can only get enough for exactly the number of days. So it's like if anything happens, they just end up without. Which is just so unfortunate because we know the outcomes are better with these systems.
- [25:35]
B
Yes, the pharmacy is a much better way to go. So I'm hoping that other manufacturers will hear and because you know you have to have a warranty for five years, not four. Four years is for any insurance, commercial insurance, you go to Medicare, it's 5. So in technology a 5 year old pump is really obsolete because they go so fast. I know there's a lot of software updates, I understand that. But the method is too heavy to get through all these steps, whereas pharmacy will be easier for patients.
- [26:10]
A
And what do healthcare providers need to consider when they're looking at all these different systems that are available and how they choose one?
- [26:18]
B
You need to look at the patient and say, are you the kind of a person want to customize everything? So some patient of ours are really so engaged they want to change everything in their pump that they can sort of adjust and customize. If you give them a system where you can customize nothing, they might be frustrated and not use the system for what it can do for them. On the other hand, I have patients of mine who would not handle a customizable aid. They need to go something very simple like the eyelet and you just let it Forget it. Or Omnipod 5 that you have no tubing, you just put it on the arm. People can have less dexterity. Right. And therefore using something that is simple to apply can also help them. At the same time, you want to explain to the patient, you need to sort of understand how to relate to these two. And so there are simulation apps people can look at. But I agree with Diana. Go home and look at this website. It's very important. People think so much about when they buy a phone. Oh my gosh, the camera is this much big. So whatever. Which is something sort of useless. Right. But for a pump or aid that it just makes them healthier. They might not take you so intensive. And they should. And so we want to make sure that the provider understands the patient need. They cannot just say use this for whatever reason. They might not be able to handle it or might be dissatisfied. And you don't want somebody to fail on aid because a very depressing thought. These systems are phenomenal. There are so many out there, one for each need. Truly little big, small reservoir, bigger reservoir, tube, no tube. Help the patient understand. And this way. Diana really was so instrumental explaining the training, the teaching, the talking about it. You're going to have to decide tomorrow when you decide, you know you're going to be okay with this system. But also remember, if you choose a system that is not with the contract for whatever many years, you might go to a pharmacy based system if you really do not like the system or back and forth. So there are many options for commercial insurance so far. Important thing is to understand what the patient wants to get out of this. But also explain to the patient what the system can and cannot do. These are not yet set it and forget it. They're getting there for many things. They really are simple. But from other. They need the patient to fill the reservoir. They keep it empty. There is no insulin. Right. It detaches from their body the glucose at 350 they might go in DKA. So they need to be aware. It sort of coexist and symbiosis with the aid system.
- [28:52]
C
Those are such great points. And I completely agree. I think ultimately we shouldn't be deciding for the person they should decide. But we can certainly guide them based on what we know. And so I think some important questions are definitely does somebody want a tubeless system versus the tubing Grazia brought up about I think the reservoir size. So some holds 160 units, other hold 300 units. So that's gonna be an important consideration based on how much insulin going through. And I think definitely there's differences in terms of customizations as well as targets. And so there's going to be so many things a person's going to think about. And then also, even outside of aid, is a person want to use a pump or does a person feel more comfortable using a connected pen device? Sometimes a connected pen is a bridge. Actually, someone starts out with injections, they don't feel quite ready to go to a pump, so they go to a connected pen. And then I think we always have to be thinking, also we've got inhaled insulin and not forget that that can be a great, great option for our rapid acting insulin. So we just got to keep it all together. And based on what we learn about the person, we can make some suggestions and help them determine their best technology.
- [30:13]
B
That's right. But important we think about one thing only when we need to sort of think about the person. And one particular patient of mine was in the study with inhaled insulin. This particular person says, I don't want to go on a pump. I'm going my inhale. And he's doing phenomenal. So I never thought about that. So, okay, maybe they say, no, I don't want to have anything attached. And I needed to respect his choice. And I have nothing to add because he's got great timing, range, great outcome. So who am I to say, you got to do this again? But it behooves me to think outside. Just think, there are many things out there that can help a patient. So thank you, Diana, for bringing this up. We need to think about every single tool available to the patients.
- [30:55]
A
Well, this has been an absolutely fascinating conversation and unfortunately we have run out of time. So big thank you to doctors Grazia Aleppo and doctor Diana Isaacs. Thank you so much for being our guest today.
- [31:07]
B
Thank you so much for having us.
- [31:08]
C
Yeah, thanks so much for having us.
- [31:12]
A
That's all for this episode. I hope you enjoyed hearing more about insulin delivery systems. Remember, if you want those credits and points mentioned earlier and you took the pretest, you still need to go to the Endocrine Society center for learning to take the post test and evaluation. We'll have a link to those in today's episode description. We'll be back soon with another fascinating dive into the world of endocrinology. Until then, 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.