← Diabetes Core Update
Diabetes Core Update
James Gavin & Naunihal Virdi on CGM Use in Noninsulin-Treated Patients, Ivy Shi & Dhruv Kazi on GLP-1 RA Eligibility in Reproductive-Age US Women, and Eva Tseng on START Diabetes Prevention
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A
Foreign.
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Welcome to this second edition of the Points of Care, the official podcast of the journal Diabetes, Obesity and Cardiometabolic Care. This is the American Diabetes Association's new journal for clinicians, educators and advanced practice professionals. I'm Dr. Richard Beser, your podcast host. Joining us now for the second podcast is my co host, Dr. Jane Rusch. Welcome, Jane. Perhaps you can take a minute to tell us a little bit about yourself.
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C
Well, thanks, Rich. My name is Jane Roush and I am a professor and diabetologist at the University of Colorado and the Rocky Mountain Regional va. I have had the privilege to be past president of the American Diabetes association for Medicine and Science, the founder of the Women's Interprofessional Network, or winada, and I have been able to participate for three years on writing of the standards of care for diabetes. I came to the field of diabetes because my father's life was shortened by diabetes and I had a niece develop type 1 diabetes. And I just think everything about diabetes is interesting. So. So I am so interested in hearing from our authors on this podcast.
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B
Thank you, Jane. I'm really thrilled to be working with you on this podcast series. So welcome and I look forward to our future programs as well. With today's second podcast, we'll begin what will be our usual format for these programs. We'll be interviewing authors from maybe two or three articles from upcoming editions of Diabetes, Obesity and Cardiometabolic Care. We'll give each author an opportunity to discuss their work with a focus on its implications in the clinical and research arenas. These podcasts won't be a substitute for your reading the articles, far from it. Our goal is really to whet your appetite for some of the exciting topics that will be covered in the journal. The articles we discuss and many others, read them, think about them critically, and consider how they might help you in your clinical or research endeavors. So let's get started with today's program. It's with great pleasure that I introduce the authors of Our first article. Dr. James Gavins from Emory University School of Medicine and and Healing Our villages Incorporated, and Dr. Nonihal Verdi from Abbott Medical Affairs. Jim and Nonihal, welcome.
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A
Thank you.
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D
Thank you for having us.
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The title of their article is advancing type 2 diabetes care the Role of Continuous Glucose Monitoring in Non Insulin Treated Patients. Jim, let's start with your describing to our listeners what. What your goal was for the article. What is our knowledge gap that this article was trying to address?
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A
Thanks, Rich, and it's a pleasure to be here with you. And Jane, you know, there are numerous reasons why CGM has become a standard of care in the management of people with type 1 diabetes and in those persons with type 2 diabetes who are taking insulin. Now, this paradigm shifting technology, however, has made it possible for people with diabetes to reduce their glycemic variability, to improve their time and range. In other words, to really improve their outcomes for diabetes management across the board. And that includes lower glucose related hospitalizations and improvements in their overall quality of life. Now, these are the very outcomes that we desire for all people with diabetes, all 38 million or so of them in this country alone, whether they are on insulin or not. But what we know is that diabetes is a complex, progressive, chronic disease. It's associated with some of the most serious complications that we know of. And I don't need to belabor those for, for this audience, but the fact is that we have the ability to assess the quality of how we are managing this disease by monitoring levels of blood glucose or blood sugar. It's a surrogate that we use and I think quite effectively. Now, by monitoring these levels, we can assess a lot of things. The severity of the underlying diabetes, the stages that a person might be in, the effects of what we eat, drink, how we behave, the stresses that are acting on us, the effects of medication. So there are many influences on the status of a person's diabetes other than just being on insulin. And so CGM has become the only tool available to us that allows people with diabetes to accurately evaluate the level of their disease control anytime, any place. And it gives them the opportunity to make better and different decisions about how they live and behave. It really puts them in control. And we thought that it really was important to summarize for people, for the medical community, what the experience has been like for people who are not on insulin and for whom this technology offers a number of advantages. What I think about and what I try to teach Rich and Jane is that diabetes is a long, complex journey and it's really difficult sometimes to know the right road. But now CGM is kind of like the gps of diabetes management. And I think that's really what we are trying to provide people with.
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C
So given that lofty goal, Dr. Verdi, how did you guys go about trying to summarize the data that was available?
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D
Yeah, and thank you so much, Jane, for having us here. We reviewed the evidence from meta analyses, clinical trials and real world studies to understand how CGM impacts clinical outcomes. And what we saw was, across the board, people using CGM saw better, a 1C, more time in range Less time running high. And in the real world data, we saw fewer hospitalizations and ER visits among people with type 2 diabetes who are not on insulin.
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C
And so this is a pretty exciting development. And I will tell you that this article, which I want all of our listeners to read, has an incredible table that summarizes the data that are available. And Dr. Verdi, I'd love you to walk us through, through those tables and how to make sure that we don't get lost, because there is a lot of information there.
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Yeah.
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With Table 1, the goal was for people to understand the study design, the populations and the outcomes, primary outcome being listed first, and to give everybody an understanding so that when they start reviewing the results, they can see what are the differences between the different studies. And that was the big goal with the first table.
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C
I will say that because there were such divergent results, you made an innovation in the way you set your table up to just put an asterisk to say these are the outcomes that are significant in each of these studies. And by and large, it looks like you got some A1C at lowering some time and range improvements. So what do you think this is really going to do for providers and people with type 2 diabetes going forward? How can we use this in practice?
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Jim Jane, for people with diabetes who are not in good glycemic control, we know that they're at risk for progression of their disease and for development of many of those complications and acute events that we worry about. It doesn't matter what type of treatment you're on, it doesn't matter what if they're not at the level of glucose control that avoids complications and acute events, they're at risk for serious trouble. The studies that we've summarized show that the use of CGM is beneficial in such persons no matter what their treatment, no matter what their stage of diabetes. Now, for any person with diabetes that is not at the desired level of control, what our paper is really trying to present is to show that the broad based evidence from a variety, a large variety of studies and study populations that CGM is a beneficial tool that can dramatically improve outcomes and will very likely save lives, improve the quality of life and save health care dollars. Now, it's clear that we need more people with diabetes and uncontrolled diabetes who are not on insulin to have the benefit of CGM use. And we need to gather more outcomes data under a wide variety of social, economic and environmental conditions. That's clear. Policymakers, payers, health systems, all need to build on the evidence base that We've tried to summarize here, that's been demonstrated already that shows the power of CGM to change outcomes in diabetes. And we're hoping that people will use this as a kind of a launchpad to look into it further and deeper.
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Yeah, you know, I think you've hit the nail on the head. But as you think about cgm, people's mindset tended to be you get the CGM data and you adjust an insulin dose. And, and I think we have to get away from that glucose centric approach and particularly with type 2 diabetes, which we're recognizing is not necessarily a glucose centric condition, but the glucose probably is a reasonable surrogate for the overall control and helps people keep their focus on it. Having said that, how would you recommend from what you've learned from this, that people with type 2 diabetes not using insulin in use the CGM information to transfer or translate into specific actions?
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Yeah, I mean, one thing that we have seen in some of the studies that have been run, one of the studies that we cited with Dr. Polanski is that, you know, people were changing behaviors, that, you know, it drives them to be more engaged with their career. People use the CGM data in different ways. So some people may use it to guide diet choices. There are new features within CGM that provide tools that give feedback on how food can impact their glucose. Some people use it to guide exercise and then other people also use it to reinforce behaviors such as medication adherence.
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If I could just add, you know, when you have real time, moment to moment information about what your behavior, what your, what the decision is that you've just made, how that has affected your glucose level, ergo your diabetes control, it makes a huge difference in terms of your ability to participate in shared decision making in conjunction with your healthcare provider team.
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Jane, do you have any last comments?
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I just wanted to say that I really think it is a very fascinating article that I hope that our readers are able to look to and then probably the next step will be to consider how to really take this to third party payers and how to make sure that people with diabetes not taking insulin understand how to interpret the results and don't get discouraged with sugars going up and down. But I'd like to thank you both very much for your time and I think you have definitely given an enticement to the readers to pull up this article and learn a little more as they try to optimize care for type 2 diabetes.
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Thank you so much.
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Thank you.
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Thank you both.
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For our next article. I'M really thrilled to introduce Dr. Ivy Shih and Dhruv Kazi with their article GLP1 eligibility in reproductive age us females. I wanted to see Kazi what it was that motivated you and your team to do this research project.
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Thank you, Jane. We have previously shown that about 137 million U.S. adults are eligible for GLP1s, more than half of whom. And we were interested in quantifying the number of reproductive age women because there are special implications, clinical and policy implications for this population, both with regard to safety during pregnancy as well as during lactation and therefore understanding how many women are eligible, what happens when they discontinue therapy is a long term goal of our group.
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C
And how did you set out to do this investigation?
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To answer that, I'll say that we use the National Health and Nutrition Examination Survey. This is a data set provided by the CDC. It's also called NHANES. It's a nationally representative survey of the U.S. population that combines interviews, physical exams and lab data. This data set allows us to estimate what's happening at a population level, not just within a specific health system or a specific clinical trial. We identified non pregnant women that were aged 18 to 44 that met eligibility criteria for the major GLP1 clinical trials across three specific indications for diabetes, for weight management and for secondary cardiovascular prevention. Our findings were actually very striking. About 45% of these reproductive age women, or about 25 million people in the US were eligible for GLP1 therapy. And really importantly, I think the vast majority of those eligible that we found, about 24 of the 25 million, were driven by weight management rather than diabetes or cardiovascular disease. This is also specifically a population that has a substantial cardiometabolic burden. They have really high rates of obviously obesity, but also high rates of hypertension and hyperlipidemia compared to their peers, despite being relatively young.
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So what is it that you think that you learned from this investigation that is truly news to the general population?
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I'll start by saying I think that my first major takeaway from this is just simply the scale of it. So nearly one in two reproductive women in the US or reproductive age women in the US are eligible for these medications. So this isn't really a niche issue anymore. It's something that's going to come up in primary care clinics, cardiology clinics, endocrinology clinics and ob GYN practices. I think on a daily basis. I think more broadly reflects a shift in population health that cardiometabolic diseases are increasingly affecting young adults. Our study puts those numbers in terms of treatment eligibility and emphasizing the importance of clarifying guidance around those clinical visits for this specific population.
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So what do you think the clinical implications are going to be for young women taking these agents in a preconception setting?
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One of the important features of these therapies is that we don't exactly know the safety during pregnancy. There are animal studies that suggest some delayed fetal development, and therefore the current recommendation is that the therapy should be discontinued two months before conception. Now, here's the challenge. Half the pregnancies in the US are unplanned. So in general, half the women don't know when conception happens. And so they haven't been wouldn't be able to switch off the medication or discontinue the medication two months before then. The other piece is that GLP1s, because of their effect on weight loss, tends to regularize ovulation. So women who weren't expecting to conceive may be able to conceive what's called in the popular media ozempic bab. We're going to see a fairly large number of fetuses who were exposed to GLP1s during the early phases of development. And so we've got to be cognizant of the safety concerns, but also do more research on what this means for the mother and child. On the flip side, if they discontinue therapy before pregnancy, there's an anticipated substantial weight gain. We know that two thirds or more of the weight loss comes back in the first year. Weight regain from GLP1 discontinuation will overlap with the weight gain of pregnancy, and that has implications for mother and child. So there's a lot of clinical implications here we have to think about and that we hope to study in future years.
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To that point, what I'm thinking here is that this really is a start of potentially a lot of other research work looking into things. So perhaps you could give us your thoughts as to where you think you need to go from here.
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I'll jump in and say there's some emerging observational data that suggests that there's no major increase in congenital malformations. But this data is still really limited and we're kind of observing it from observational data sets. So there's still really limited safety data around early pregnancy exposure and kind of, as Kazi mentioned, this concern around rebound weight gain and metabolic changes after discontinuation that might actually worsen the cardiometabolic health right around the time of either conception or delivery. It brings into a lot of questions about when or how to stop these GLP medications safely around the time of pregnancy. And I think we just don't have very clear guidance on that yet.
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And the priority for our group is to specifically answer that question of GLP1 discontinuation pre pregnancy and what happens to maternal health and fetal health after GLP1 discontinuation in this context, and what the optimal timing of discontinuation should be for the women who are able to plan conception and pregnancy.
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I just want to say you certainly have piqued our interest because this is a very important and contemporary issue that will be facing primary care docs, cardiologists, endocrinologists alike, and the need for preconception counseling.
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Yes, we agree, and we're excited to continue on this research. Thank you.
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B
Thank you both for joining us today. Next we have Dr. Eva Chen. Her article is Diabetes Prevention A Multi Level Strategy for Primary Care Clinics. Eva comes from the Johns Hopkins School of Medicine, Division of General Internal Medicine. Eva, we know that prediabetes is becoming increasingly common in the adult population, and because of that, preventive strategies are becoming much more important. Tell us about the strategies that you examined in this study and what you were hoping to learn.
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E
Yeah, thank you for having me. So, as you alluded to, prediabetes is growing. We know that 1 in 3 US adults have prediabetes, and it increases your risk of a whole host of other issues like type 2 diabetes, stroke, and heart attack. So what we wanted to do is build on these gaps and learn what we can do to address prediabetes. So our earlier work at our local institution, we use some EHR data to look at how clinicians manage prediabetes. And we found that in general, people are really good about ordering labs to, you know, monitor blood sugar changes. But things such as coding a pre diabetes diagnosis code, which we use as a proxy for measuring someone as being recognized as having prediabetes, was really low. And very few patients were started on metformin or referred to nutrition therapy, which are some of the recommended treatments for prediabetes. So then added to that, we conducted some qualitative interviews with our patients and clinicians to understand what might be some common barriers. This is very common to other literature. We found that patients talked about limited time, lack of motivation, and really limited access to programs for lifestyle change or weight loss. And then on the flip side, clinicians talked about not being as familiar with the diabetes prevention program and having some uncertainty about how to dose metformin. For example, for Prevention. So then using these findings, we developed what we called the START Diabetes prevention clinical pathway. And this focuses on multiple steps, so includes so the START stands for screen test, act, refer and treat. And then we packaged it with a workflow, some shared decision making tools and EHR based decision support tools to help clinicians and patients discuss prevention options.
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So can you tell us exactly how you laid out this strategy and what precisely this article is telling the reader about?
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Exactly. So what we did is we tested this practical real world start diabetes prevention clinical pathway. It rolled it out over 12 months at a suburban primary care clinic near Baltimore. And we compared it with a nearby control clinic. And our main measure was to see over that 12 month period whether patients with prediabetes received preventive treatment. This we included as a referral to the diabetes prevention program and or prescription for metformin within 30 days of their primary care visit. And we compared that between the intervention and control clinic to see if there are any differences over time.
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And what were your take home messages? What did you learn from this?
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Yeah, so our results we showed that both clinics actually saw an increase in preventive treatment uptake among patients with prediabetes and that the overall difference between sites was not significant. That said, patients at the intervention clinic were more likely to say that they talked about prediabetes with their doctor. They felt better informed, felt that their views were respected and also PCPs in the intervention clinic felt that the START diabetes prevention approach was acceptable and useful for engaging patients about pre diabetes treatment. So in general, we felt that our study showed that a straightforward and low cost tools for preventing diabetes in regular care is doable, but also highlights that there's rare rules constraints. So busy PCPs competing priorities and they had variable use of the tools limit how much these interventions can change treatment behavior. So I would say the big takeaways was that these simple EHR integrated workflows ensured decision making resources can improve patient engagement and the quality of their conversations about pre diabetes. But to truly boost treatment uptake, clinics need more than just tools alone. We need workflow supports, we need protected time, we need team based roles where nurses and health coaches can also be involved to ensure that the intervention is not just between the patient and the pcp. And then the other was that we realized that pragmatic implementation is also affected by practice realities and system changes. So at the same time that we were conducting our study, we had a number of health system initiatives around diabetes prevention and we were actually expanding the diabetes prevention program and being able to offer it to patients. So more and more clinicians were hearing about it and growing awareness about it. So we think that also affected that both the intervention and control clinics had increased uptake of referrals to the diabetes Prevention program.
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C
So one of the big things that you stress in the introduction to this paper, which I hope everyone reads, is that only 5% of all people living with prediabetes are introduced to either a virtual or face to face diabetes prevention program. What did you learn from what you did in this specific study about some next steps to expand that?
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E
Yeah, so that's a great question. So uptake is still low. So as you mentioned, 5% of eligible individuals report participating in a diabetes prevention program. And there's a number of different factors. There's insurance coverage issues, there's access issues, but there's also patients in general may not want to join a program that is a year long. They might not be ready for it. So our next study, which is funded by the American Diabetes association, we're actually going to integrate a proven diabetes risk model into our EHR so that clinicians can estimate their patients future risk of diabetes and how that changes with joining the Diabetes Prevention Program and or starting metformin. And so the idea is that this tool can help clinicians quickly prioritize those who need immediate attention and also provide information to patients that is informative to them in making that decision about whether to join a program or, for example, take a medication.
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B
All right, Eva, well, that was an excellent summary. Thank you very much for your commentary and for joining us today.
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E
Thank you for having me.
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C
Yes, lovely paper. And we need to get people enrolled and we need to be looking to a future where both clinicians and people at risk for diabetes are on top
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B
of it and start the process early. So, Jane, we're almost at the end of this episode of our podcast, the Points of Care. We've certainly heard from three very interesting authors from this current edition of Diabetes, Obesity and Cardiometabolic Care. Perhaps you can summarize some of your thoughts about what we've heard.
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C
Thank you so much, Rich. I think this has been a very exciting review of a few of the articles that will get the readers to read this journal because we have really gone the gambit. We have started with looking at the strategies to manage type 2 diabetes using continuous glucose monitoring and whether or not people with type 2 diabetes will benefit. Looking like they will benefit from this therapy. We have had the opportunity to learn about innovative strategies to increase the likelihood of people with prediabetes to be engaged in diabetes prevention. And we have learned about this important contemporary issue of GLP1 use in women who are in reproductive age with the risk of a pregnancy on an agent that is not yet approved in pregnancy. Very exciting articles. And they're just a few of the articles in this next issue.
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B
Yeah, you know, I agree with you. And the CGM thing to me strikes a chord because CGM typically had been for people using insulin with a specifically glucose centric focus. Now in type 2 diabetes, where there are a lot of other conditions other than glycemia that we're focusing on, we're no longer glucose centric. And the implications that CGM can impact behaviors and other considerations so that it can impact a lot of other parameters that we're looking at is very exciting. So I'm excited to see where this is going to go. Well, thank you, Jane. I think this is very useful to think about and I want to encourage our readers and listeners to read into the next edition of Diabetes, Obesity and Cardiometabolic Care. There are a lot of articles in there. We highlighted some today, but dig deeper into the details of their design, methods and results and look over some of the other articles that are there, the author's conclusions, and I think it'll be a very valuable experience for all of our listeners. The full contents of Diabetes, Obesity and Cardiometabolic Care can be found at diabetesjournals1word.org forward/docm car. And there's a link in there to the episode notes, so be sure to look for our next journal issue and the next episode of this podcast, both of which will drop in mid June 2026. And do subscribe to the Points of Care on your favorite podcast app so you won't miss what's next in Diabetes, Obesity and Cardiometabolic Care. The Points of Care is made possible by our dedicated donors, listeners and partners. Thanks to your support, we're changing the future of diabetes. I'm Dr. Richard Beser on behalf of my co host, Dr. Jane Roush. Thank you very much for joining us.