disparities. So, welcome. Welcome, everybody, for our second health disparities webinar. I'm Larissa Gomes. I'm an endocrinologist from University of Sao Paulo, Brazil, and a very recent member of the Committee of Diversity and Inclusion. So, it's a great pleasure to moderate this session about the use of diabetes technology to improve outcomes and advance equity. So, in this webinar, we're going to have two amazing speakers, Dr. Rocio Pereira and Dr. Estelle Everett. We're going to discuss about the clinical indication, the benefits of diabetes technology in the management of type 1 and type 2 diabetes. Then, they will discuss a difference in diabetes technology use in certain populations and lessening approach to promote more equitable use of diabetes technology across populations with diabetes. I'd like to remind you that live Q&A will occur at the end of the session. The chat is open. Be sure to submit or upvote your questions throughout the sessions. So, I'm delighted to introduce our first speaker, Dr. Estelle Everett. Dr. Everett is an endocrinologist and health service researcher at Gaffney School of Medicine at UCLA. She completed medical school at UCLA and her internal medicine residency and fellowship in endocrinology, diabetes, and metabolism at Johns Hopkins University. During her fellowship, she obtained a master's in health science and clinical investigation and a certificate in quality patient safety and outcomes research from the Blumman School of Public Health at Johns Hopkins University. Dr. Everett joined faculty at UCLA, the division of endocrinology, and general internal medicine health service research in 2019. Her research involved exploring and addressing barriers to care in vulnerable populations with type 1 diabetes. She has a particular interest in addressing inequities in access and use of diabetes technology. She has a K23 award from the NIH to evaluate the use of hybrid closed-loop insulin pump in those with type 1 diabetes. Dr. Everett is going to talk to us about addressing disparities in diabetes technology use in type 1 diabetes. Please, Dr. Everett. Microphone, please, Dr. Everett. Sorry about that. Hello, everyone. Thank you, Dr. Gomez, for that lovely introduction. I'm very excited to speak to you today about a topic that I'm very passionate about. The objectives of my talk today is to review the benefits of diabetes technology, describe some of the disparities that exist in diabetes technology and their potential drivers, and then talk about some approaches to address those disparities. I have no disclosures. So type 1 diabetes management is very challenging and burdensome. If you think about the traditional diabetes management, you have to inject insulin four plus times a day, monitor your blood sugars four plus times a day, know how to carb count, calculate your mealtime insulin, calculate your correctional insulin, time your insulin appropriately, manage hypoglycemia, the list goes on and on. When insulin pumps and CGMs came along, it really changed the game for type 1 diabetes management in terms of the burden of diabetes management and even for providers in terms of having better data available to make meaningful changes. Although many of you already know, I'll review briefly, insulin pumps are small devices that administer insulin in a more physiologic fashion. They use short-acting insulin that continuously provide a basal rate and then deliver large boluses when prompted to cover meals as well as hypoglycemia. They have many advanced features and advantages over multiple daily injections, including being able to have multiple daily rates, basal rates, temporary basal rates, they have a built-in bolus calculator, you're able to know how much insulin you have on board and have insulin flexible insulin bolus delivery. Continuous glucose monitors or CGMs are small devices, also placed under the skin, and they monitor blood glucose. I know more advanced devices now every one minute. It allows us to appreciate blood sugar trends, there's alarms for very high or very low blood sugars, and they give us the capability to be able to remote monitor. And when insulin pumps and CGM are used together, this is called sensor augmented pump therapy, or SAP. We now have hybrid closed-loop insulin pumps, and this is when the pump integrates with continuous glucose monitor and then the insulin pump modulates insulin delivery based on predicted hypoglycemia or hypoglycemia in order to maintain blood sugars in a targeted range. So diabetes technology has been associated with many benefits, including improved glycemic control. This is a study by Supal et al, published in 2016, that looked at 65 patients who are on multiple daily injections, or MDI, with no CGM. They then followed these patients over 12 months on different regimens, and we see that patients who had no change in the regimen, so continue on MDI and no CGM, had no change in their A1C over time. When we look at the group that was switched to insulin pump therapy with no CGM, we saw improvement in the A1C from 8.34 to 7.8. And then when we look at the group that used CGM, they had the greatest fall in A1C from 8.3 to 7.13. Studies also showed improvement in patient-reported outcomes. This study by Ruben et al. looked at differences in patient satisfaction using sensor-augmented pump therapy versus multiple daily injections a day. And they found those using sensor-augmented pump therapy reported higher rates of satisfaction with the convenience of their diabetes treatment regimen, greater satisfaction with efficacy, and really overall had a preference for sensor-augmented pump therapy. So CGM and insulin pumps have been found to have numerous benefits across many studies, and it's really now becoming the mainstay of type 1 diabetes management. The problem is that there's a huge disparity of who has access to diabetes technology and the benefits associated with that versus those who have to use a traditional treatment like multiple daily injections a day. The Search for Diabetes and Youth study is a population-based longitudinal study. It was one of the early studies to show disparities in technology use. They described that insulin pump users were primarily a white race, had higher income, had a parental education that was a bachelor's degree or higher, and had private insurance. And so it's important to note that the groups that had reduced technology use, which are racial ethnic minorities, those of lower income, those of lower education, and those of public insurance, are also the groups that we know from many studies that have worse outcomes with type 1 diabetes, worse glycemic control, more diabetes complications. The Type 1 Diabetes Exchange, which is the largest U.S. type 1 diabetes registry, also looked at disparities but by race, and they found that disparities still existed even by race, even when we look at the highest income group. So looking at income greater than $100,000, only 45% of Black patients were insulin pump users versus 73% of white patients. And since this study, there has been dozens of studies showing disparities by race and ethnicity as well as socioeconomic status. So in the past 15 to 20 years, there has been a large increase in the uptake of diabetes technology use, and that's partially because there's been great advancements in the actual technology and some improvements in coverage. So in this study that I published earlier this year, we looked at a cross-sectional, a serial cross-sectional analysis of patients in the Search for Diabetes in Use study over four time periods between 2001 and 2019, and then we evaluated changes over time in insulin pump use by race, ethnicity, education, income, as well as insurance. And what we saw in the overall population, there was a large increase in uptake of insulin pump use. So in 2001 and 2005 period, pump use, the prevalence was only about 32%, and that almost doubled in the most recent time period of 2016 to 19. So when we looked at rates by our subgroups of interest, we see that despite there's an increase in pump use amongst all groups, the disparities that we saw in disadvantaged groups were no different in period one than there are in period four, the most recent period. And this is the case when we looked at race, education, income, as well as insurance type. So over 20 years, no change in the disparities. And so what are the potential contributors to disparities seen in diabetes technology? Unfortunately, there is not a large amount of studies to date that are exploring this. But in recent years, there have been more published in this area. And I'll review some of these findings through a framework that categorizes barriers to care by patient barriers, provider barriers, as well as system barriers. So let's start with patient barriers. So this is a study by Mentor and All published in 2022. They interviewed 42 Black adolescents and their parents regarding the decisions about using diabetes devices, and how their personal, familiar and cultural beliefs may influence their use. So in general, the study found many of the same barriers reported in the general population, but there were some unique themes that also emerge. And one thing I found really interesting about the study is that they asked patients, well, why do you think that there are differential uptake in diabetes devices in Black adolescents? And these are some of the things that they said. One mom said fear. Some people are just resistant to change because they don't understand. They prefer not to use. Second theme was surrounding lack of familiarity with type 1 diabetes and lack of exposure to devices. One teen said some people may not be comfortable with it because it's not what they're used to because no one else has experience with it. So many participants in the study reported not knowing not even one other person with type 1 diabetes, let alone anyone using a device. And so the lack of peers and lack of familiarity and exposure to these devices may lead to some stigmatization. They also reported that participants relied heavily on providers for knowledge surrounding diabetes technology and for the recommendation for its use. And so this becomes a little bit problematic when we look at some of the studies that follow. Patients also reported financial and insurance barriers and then potentially some issues with mistrust. So one mom said culturally you'll find beyond the fear of change, there's a fear of whether it's been tested enough. And then unwanted visibility. One teen said there are so many things that we worry about as people of color within society, meeting social normalities. We just don't want other attention. And so this highlights multiple identities and how the type 1 diabetes experience as someone who is a Black race may differ from those of other racial or social identities. So let's talk about provider barriers. Next I want to discuss a study that I conceptualized actually when I was a fellow, but was ultimately completed by one of the subsequent fellows, Dr. Cambor. And the goal of the study was to better understand how provider factors may impact racial disparities. It was a retrospective study that looked at adults presenting to clinic between April 2013 and then January 2020. And this study retrospectively followed patients who were CGM and pump naive at the start of the study period in 2013 and then followed them through 2020. And we reported what percentage of patients had discussions surrounding diabetes technology and what proportion of patients were prescribed diabetes technology. So we see overall in all the patients that presented to the clinic, technology use was much lower in Black patients compared to non-Black patients. And that's for CGM and pump use. When we looked at the patients who are CGM naive, we found that 92% of non-Black patients had a discussion at some point surrounding CGM use versus only 80% of Black patients. And when it came to prescribing, 68% of patients were ultimately prescribed CGM versus only 50% of Black patients. When we look at insulin pump and the insulin pump naive patients, 80% of non-Black patients had a discussion surrounding pump use at some point versus only 72% of Black patients. And when we looked at prescribing, 42% were ultimately prescribed in the non-Black cohort versus only 23% amongst Black patients. We also looked at reasons that diabetes technology was not prescribed if a discussion in fact occurred surrounding technology. And one thing to note that in terms of patient preference being the reason why it was not prescribed, we saw Black patients was less likely to decline technology use based on patient preference. So this study demonstrates decreased discussions with Black patients and less refusal of technology use when offered. And so this infers that there may be some provider bias in terms of diabetes technology discussions of who providers discuss with and who they prescribe. Although one thing to note, this study did not adjust for factors such as self-management practices, which were a key component of guidelines at this time. So our study supported some of the findings that were reported in a qualitative study done completed by Agrawal et al, which interviewed 40 Black and Hispanic patients with type 1 diabetes in New York. And in this study, many patients reported that health care providers unilaterally decided on technology use for them, whether it was for or against it. And overall, there was a lack of detailed discussions about diabetes technology. Here are some quotes from that study. One patient said, yeah, I just got offered that recently when I went to my doctor on Wednesday, never before. And I've had it for a year and a half. I didn't know technology even existed. One patient, another patient said, I've heard about CGM, but it was never offered until I met my doctor. And then the last patient, I never had it referring to an insulin pump mentioned to me or even brought up. So when we combine this with the data from the previous study that stated that patients relied heavily on providers for information about technology and recommendations for its use, you can see how this can become problematic. This study also asked patients, well, why don't you have a diabetes device? One patient said he, the doctor just said, if I was a bit more responsible, if I'm, if I'm getting my numbers under control, then he would see if I should get the pump or not. But then in my mind, I'm like, well, why wouldn't you want me to get the pump anyway, so I can control my diabetes. And so my numbers can get better. And so endocrinologists for the better or worse were thought to be gatekeepers of diabetes technology. And so gatekeeping occurs when providers limit recommendation of diabetes technology to those who they perceive to, that will appropriately utilize them or benefit from them. But the issue is that this perception is subjective and subjective to bias and perception is not always congruent with reality. And so, and there are many studies that show that providers are actually not very good at predicting who will or will not do well on technology. And so this could be a potential barrier to technology for use in patients who may in fact benefit from technology, but are not our quote unquote perfect patients. And then in terms of systemic barriers, this study interviewed all comers with type one diabetes and families in the US and the UK, and asked them about systemic barriers. And some of the systemic barriers that reported were on the policy level, inadequate, they felt that there was inadequate support by the national government for support and technology use despite demonstrating benefits. On an organizational level, they felt that some hospitals and clinics didn't offer pumps or T-GEM because of the amount of work it was involved with and training patients and the paperwork, or they didn't have an appropriate staff. And now on an insurance level, they felt that insurance dictated coverage based on arbitrary criteria that didn't really align with patient preferences, provider recommendations, or the most up-to-date research. So the last study I'm going to talk about was a study that we published back in 2021 that looked at a method called structural equation modeling, and we looked at how adverse outcomes, adverse health outcomes in patients type one diabetes were impacted by technology use, insurance coverage, and social economic status. And so this is a, looks like a busy figure, but I'll walk through the key points. One, we found that CGM use and pump use were both directly associated with fewer adverse outcomes. Two, we saw that while socioeconomic status and insurance coverage directly were associated with adverse outcomes, there was much more significant indirect effect on adverse outcomes that operated through access of diabetes technology. So the conclusion we drew is that the disparities that we see in outcomes in type 1 diabetes may have the potential to be mitigated by addressing upstream issues in diabetes technology access. And so many people also say, in terms of the use of diabetes technology to address inequities and outcomes in patients with type 1 diabetes, they say, well, these devices are too expensive. But when we look at cost of diabetes care in the US, in 2007, it was estimated to be over $300 billion, and 55% of that was related to care for complications of diabetes. And so when we look at diabetes technology use, it only accounts for less than 1%, 0.4% of diabetes technology. I'm sorry, 0.4% of the cost for diabetes care. So given that we know that better glycemic control is associated with less complications, it would be logical and beneficial for insurers and healthcare systems to encourage tools that are proven to improve glycemic outcomes, such as diabetes technology. And there's been several cost-benefit analysis that actually have shown that technology use is cost-effective in the long term. So I'll close with what can we do to improve diabetes disparities in racial ethnic minorities and in patients of lower socioeconomic status? One, we could consider providing more cultural specific support groups, as we saw in the first study that I discussed that the intersectionality between race and social identity may pose unique challenges for patients who have type 1 diabetes. Two, providing awareness to providers about unconscious bias and gatekeeping and how that may impact their practices. There's some suggestion that maybe there should be a standardized pathway to diabetes technology use to minimize the opportunity for bias in patients. Change the culture of how endocrinologists think about using diabetes technology. So instead of telling patients, well, you have to prove yourself or need to use this technology, you really should be thinking, does this patient have a barrier to care that can be addressed by diabetes technology? I also think that more studies in real world populations may encourage providers to prescribe technology to more vulnerable populations. One of the main focus of my research program is to really better understand technology use in underserved and understudies populations. I'm hoping that showing efficacy in this population will change prescribing practices. And then getting better sense of concerns from providers and addressing that as well. And then lastly, advocacy for policy change. There's been several commentaries that talk about criteria for approval for technology and how they're not always evidence-based. And some of this is changing more recently. And Dr. Pera will talk about that a little bit more, but advocating for policy change and better insurance coverage, I think will be very helpful. So in summary, diabetes technology is a powerful tool in diabetes management that can improve glycemic control, diabetes burden and quality of life. There is unequal access to diabetes technology, particularly in racial ethnic minoritized groups, lower income, and those with public insurance. And these groups also experience worse diabetes outcome and may have various diabetes management that can be addressed by diabetes devices. And so really further studies are needed to explore the specific barriers that these patients are experiencing technology access so that we can address that. Thank you. And these are acknowledgements of my collaborators. Thank you very much, Dr. Everett, for the great talk. And now I'd like to introduce our second speaker. I have a great pleasure to introduce Dr. Rocio Pereira, who is the Chief of Endocrinology at Denver Health, Associate Professor of Medicine at University of Colorado, and the Founder and Director of the Vuela for Health Lifestyle Intervention Program for Latinos. The primary focus of Dr. Pereira's work is addressing health disparities in diabetes and obesity. Dr. Pereira has been a member of the Endocrinal Society since 2001. She served as a Chair of the Society of Minority Affairs and CODI and contribute to a large number of other society efforts. Dr. Pereira is currently a member of the Board of Directors, Board Representative to CODI, and the Program Director of the Excel Excellence in Clinical Endocrinology and Leadership Program. Dr. Pereira is going to talk to us about the topic, Technology Use in Patients with Type 1 and Type 2 Diabetes, Clinical Indications and Access Issues. Please, Dr. Pereira. Thank you very much, Dr. Gomez, for that beautiful introduction. I want to make sure that everybody is able to see my screen here. Okay, so I'm going to focus us a little bit on the clinical indications for technology use in Type 2 Diabetes and our access issues and how we can expand access to this technology to improve care and to decrease disparities. I have no conflicts of interest. And I will go through the disparities in diabetes and again, the opportunities that technology provides for us to improve our services and decrease those disparities. I will discuss clinical indications and I will dig in a little bit on Medicare, specifically Medicare coverage, and I'll tell you why that is. So just a quick review of the disparities that we see in diabetes in our population here in the United States. We know that individuals from minoritized populations, including Black, Hispanic, and Asian-American, Native American populations have higher prevalence of diabetes. We know the prevalence of diabetes is also higher for people of low education levels and those with lower incomes. And these disparities in diabetes affect our minority youth. And we know that minorities with minority youth have higher incidence of Type 2 Diabetes. And so this issue is just going to increase for our minoritized communities. And we talked a little bit about diabetes complications and we see inequalities there, as well as disparities in diabetes mortality by group. So Dr. Everett discussed a little bit the benefits of continuous glucose monitoring and insulin pump use in all our patients, but primarily in our patients with Type 1 Diabetes. I'm gonna start discussing the benefits of continuous glucose monitor and then access to continuous glucose monitors. And as we all know, this technology allows our patients to see their blood sugars often in real time, to be able to connect their blood sugars to the foods that they have just eaten and understand what kind of dietary changes they may be able to make to improve their management, their blood glucose, and to identify low blood sugar events, et cetera. So these are incredibly useful. And we have evidence that these show a decrease in A1c. They decrease hypoglycemia events. They increase the time during which our patients are in their glucose is in that desired range. And then they improve quality of life measures. So they decrease diabetes distress and increase confidence for our patients. So because of this data, our clinical guidelines now recommend that we use these continuous glucose monitors for our patients. Current clinical guidelines that you see here are for the American Diabetes Association and from the American Association for Clinical Endocrinology and they talk about including, providing this technology to our patients who are on multiple daily injections or continuous subcutaneous insulin infusions. This is an A and B category recommendation. Patients on, adult patients with diabetes on basal insulin should also be on this, should use this technology. And then youth with type 1 diabetes on multiple daily injections or youth with type 2 diabetes on multiple injections can also benefit from this technology. And the recommendations there, the evidence behind these recommendations is not as strong for those groups. I'm gonna talk about access now for a continuous glucose monitor, but I wanna first discuss the Medicare population. So in the United States, the Medicare formulary really, and benefits really determine what private insurance will cover and in turn determine what our Medicaid program will cover and really the medications and technology that our patients have access to. If we look at that population of Medicare recipients, we see that there is disparities there with a higher prevalence of diabetes among our minority populations who are on the Medicare, who receive Medicare services. So on the left panel, you see our Medicare fee-for-service beneficiaries by race and ethnicity, and you can see that the prevalence, again, is higher. Prevalence of diabetes is higher for those minority groups compared to our white population. At the same time, those minority groups also have less awareness of the benefits that the Medicare program can provide to them, including diabetes education and including supplies to monitor their blood sugars. And so we have a higher risk population here and a lower awareness of the resources they already have. The other thing we know about our diabetes or our Medicare population here in the United States is although currently 25% of the population identifies as being from a minority ethnic racial group, in 2060, it is predicted that almost half of the population will be from one of those groups. And so this population is growing. And again, to ensure that disparities in diabetes management, diabetes care do not grow, we need to pay close attention to this population. Looking at continuous glucose monitoring eligibility for the Medicare population, we know that there were disparities there. So in 2018, a majority of individuals, Medicare beneficiaries who were insulin treated did not qualify for continuous glucose monitoring coverage. However, in addition to that, the percentage of ineligible beneficiaries was higher among our black and Hispanic beneficiaries compared to white beneficiaries. So low access throughout, but lower access for those populations that most need it. Which led, and Dr. Everett mentioned this study, led Dr. Galindo and his group to publish this commentary titled, What's Wrong With This Picture? A Critical Review of Current Centers for Medicaid and Medicare Services Coverage Criteria for Continuous Glucose Monitoring. And they recommended that Medicare make a number of changes to increase access to services, particularly continuous glucose monitors. And they recommended eliminating this need for self-monitored blood glucose, which it was required for patients to be checking their blood sugars by finger stick four times daily, to eliminate the need for intensive insulin regimen requirements for patients with type two diabetes to have access to this technology, to eliminate the requirements for frequent insulin dosage adjustments based on glucose values. There was a requirement for this to be documented. To include telehealth services as an option for follow-up clinical consultations, to streamline these standardized documentations for obtaining coverage, and to provide clear guidance to our durable medical equipment suppliers who provide patients with this technology. So, and this year, Medicare did update their policy on continuous glucose monitoring use. And now individuals with type two diabetes no longer need to meet this three times daily insulin administration requirement. And so CGMs are available to everyone who is on insulin, who is using insulin. The coverage expanded to individuals who are not on insulin, if they have what they refer to as problematic hypoglycemia. And this would be at least two previous medication adjustments to, sorry, two events of low blood sugar of less than 54. And at least, or at least one level three event of blood sugar less than 54 associated with altered mental status or requiring a third party to assist. And then they also stated that the beneficiary, there was a need or still is a need for the beneficiary to have received appropriate training in the use of the device as evidenced by the prescription. So basically the provider has to give a prescription. And then you need to ensure that you are prescribing the CGM based on FDA approved indications of use. They also changed the six month follow-up requirement to include telehealth visits. And that was a huge change and clearly of benefit to our patients. So some improvement there in the Medicare policy. In terms of our state's Medicaid policies, these are state run. And so the policies there are highly, highly variable. Until July of 2021, there was a requirement for four blood glucose measurements via finger stick for most, if not all Medicaid programs. This fortunately was eliminated after people realized this was just not practical. And then Medicaid enrollees are the least likely of groups to use continuous glucose monitors, particularly those from black and Hispanic individuals. Again, the policies are very variable with the Southern states in the United States having the lowest rates of CGM use throughout the Medicaid program. CGMs were covered by 40 states in 2022, but again, based on very variable requirements. Some requiring that patients be followed by an endocrinologist, lots of requirements for pre-authorization and documentation, mostly lack of coverage for people with type two diabetes and this difficulty of where does the prescriptions be, where is this prescription sent? Is it sent as a DME product or is it sent to a local pharmacy? So a lot of difficulties in access for Medicaid recipients. We here in Colorado and in my institution, Denver Health, in addition to being a healthcare provider, we are a healthcare plan, Medicare or medical plan, and we offer Medicaid insurance to our population. And our Denver Health Medicaid insurance had on the formulary as of 2020, they included continuous glucose monitors. And the only requirement was for our patients to have diabetes. And so we were able to do this analysis of individuals who are eligible to receive CGM through our Medicaid program. We had 400, almost 450 individuals with type two diabetes who were prescribed these CGMs and 422 who filled them. And we saw a reduction in A1C in our patients. And if you look at the panel on the left, that reduction was really seen for our patients with type two diabetes, not so much for our patients with type one diabetes. And then we looked across the race, ethnicity groups, where a safety net hospital systems or hospital cares for about 55% of our patients identify as Latino, about 13% of our patients identify as black or African-American. And you can see that across those groups, we saw a reduction in A1C. Importantly, the only, shall we say, intervention here was allowing these individuals to have CGM covered through their insurance. There was little in terms of training our providers to use it, though there was support for our patients to learn how to use the device. So the last piece about CGMs that I'll discuss is virtual care considerations. So this technology allows us to look at our patients' blood sugars when they're not with us. And so that really allows us to increase our services, provide better services, is greatly beneficial to our patients. However, there is no billable process for those services currently for most patients or for most healthcare providers and services. And so figuring out how to make those services sustainable and increase the access of those services to our patients is going to be really an important piece of this conversation. I'm going to turn in the last few minutes to insulin pump therapy. So we heard about insulin pump therapy benefits for both patients with type 1 and type 2 diabetes. Of note, we have a variety of pumps, some very sophisticated with sensor augmentation and continuous loops which adjust their basal rates. And then we have some insulin pumps that may be of benefit to people who may not want to have such hands-on time and energy to manage a more sophisticated insulin pump. And so this is devices like the Vigo. It's a disposable mechanical pump. You have preset basal rates. The patient is able to do boluses by two-unit increments. There's this other mechanical pump patch. So there are different options. And a number of these have shown benefits in terms of A1C reduction as well as decreased total daily dose of insulin requirement and, importantly, in patient experience. Our clinical practice guidelines recommend use of insulin pump for our patients with type 1 diabetes. They recommend use of pumps alone or with sensor augmented features for patients who are on multiple daily injections and have type 1 diabetes. And also importantly, they mention that patients who, youth and adults, who are on multiple daily injections with type 2 diabetes can benefit from these devices. So in an ideal world, our Medicare coverage and other coverage would be parallel to these guidelines. Our Medicare eligibility criteria for insulin pump coverage is in front of you. And these are very complicated and very difficult to achieve. And so as it stands right now, our Medicare eligibility criteria includes having either a specified fasting C-peptide result or positive antibody test. People have to have documentation that they have completed a diabetes education program. They must be treated with at least three insulin injections or more a day for at least six months before using the pump. They must have documentation that they're monitoring their blood sugar at least four times a day. And then meeting some of the criteria that you see in front of you. So either A1C greater than seven or recurring hypoglycemia, white fluctuations, et cetera. There's a requirement that our patients are seeing their physician every three months with, again, documented visits and that they're managed by a physician who manages multiple patients on insulin pumps. So really takes away that management from primary care providers who in rural areas may be the only provider around for patients. So our Medicare coverage, again, not very practical and limits our access. And a similar group of physicians published this commentary, loss in translation, a disconnect between the science and Medicare coverage criteria for continuous subcutaneous insulin infusion. And they recommended changing those guidelines, those eligibility guidelines to two items. One is that patients already treated with an insulin pump before enrolling in Medicare should just have access to them. And the second is that patients with any type of diabetes who require intensive insulin therapy based on the clinical judgment of a licensed healthcare provider should have access to these. So very straightforward and easy recommendations if they were implemented. We haven't gotten there yet. This year in 2023, the National Clinical Care Commission was requested by Congress to report on how to improve care for patients with diabetes. And one of their recommendations was that we should use existing processes to update and regularly reevaluate the eligibility criteria for these devices, that the eligibility should be clearly defined, consistently applied, that we should evaluate data, current data to revise these eligibility requirements. And just as a point of focus, these criteria were developed in 2004. So it's been a while. So opportunities for research in this area. We still need to learn more about diabetes technology use and how that affects our patient-centered outcomes, our patients' behaviors, our clinical outcomes. We need more information about perspectives of DM technologies from our patients, particularly our patients from these communities. And then we need to figure out how to really integrate diabetes technology to our virtual care services. I'm going to stop there so that we have some time for discussion and questions. And thank you very much, everyone, for your attention. Thank you very much, Dr. Pereira. I think we have content for hours of discussion, but we do have like 12 minutes. And I'm going to start with the Q&A questions. I think this first one could be for both. So the question is how this more flexible CGM criteria on the Medicare could diminish disparities. So we believe it's going to diminish these disparities since many of these new eligible patients are going to be seen in primary care. So Dr. Everett and then Dr. Pereira, please. I think I'll let Dr. Pereira answer this question since it related more to her talk. Okay. Yeah, I'm happy to do that. So I think more and more primary care providers are getting familiar with using this technology and looking at the data. And we endocrinologists are also working with our colleagues to increase their comfort level with using it. So I think now that these Medicare criteria are more relaxed and more patients are going to have access to the technology that I think that primary care providers will increase their use of the technology. I think it's also important for primary care doctors to know that even if you just prescribe it and let your patients give them a quick tutorial on, this is how you look at your blood sugar, that that really makes a difference for patients. So we have seen in our study that patients greatly benefited just from being able to see their blood sugars regardless of whether or not they had the discussion about blood sugars and medication with their providers. So even just giving that information to the patient in a way that they can use it is going to increase, improve care and decrease disparities for our patients. So continue, you can continue with the Medicare policy update. Is this only applicable for classic Medicare or is this also applicable for supplemental plans? Does this have to go through part B benefit? If you could explain a little bit for us what does it mean, the classic Medicare or supplemental plans? Yeah, this is now part of classic Medicare not needing to go through supplemental plans. So people on Medicare should have access to this technology through their part B benefits. And this is for CGM, not necessarily for pumps. Perfect. So Dr. Everett, the next question is some patients think that the technology will magically cure their diabetes. So the physician have to assess if they are ready or capable of using technology. So did you find that physicians don't make this assessment accurately when it comes to minorities? I think that's a really good question. And I agree some patients do have unrealistic expectations of diabetes technology. And I think a part of our job is to kind of have those discussions and make sure that they have a realistic view of how technology use can supplement their current regimen and benefit them. And I think in terms of whether, um, do I find that physicians are not making appropriate assessments? I can't say that. I think providers do the best that they can to assess their appropriateness of candidacy for patients to use and some pumps and CGM, but all providers will have biases that influence their decisions. And oftentimes these biases are unconscious. And so there's many studies throughout medicine, not just in diabetes, but, um, in cardiology and other fields that show how unconscious biases impact provider practices. And so there's a study that comes to mind, um, that was done in type one diabetes. Um, and it was a randomized controlled trial. They randomized patients to sensor augmented pump therapy versus a multiple daily injections. And so it was the random randomization process that decided who would be a technology user or not. And they interviewed the providers in that study. And many of them admitted that a lot of the patients that were randomized technologies were patients that they would think would not be a good candidate and they wouldn't actually start technology on, but those patients did equally as well, if not better. And so the providers admitted that, um, that, um, so I guess maybe their decisions were not on who would benefit were not maybe as spot on as they thought. And so I think all in all, I think providers do the best that they can, but I think a lot of, um, um, that I think we're just not as good as we think at deciding who would be the best candidates. Perfect. One more question. I think Dr. Everett can answer. Do you think can device what they call manufactured reduce disparities? For example, multilingual device, talk device for visually impaired, um, people do you think like this kind of device or wider access, wider access would be, would help? Sure. I think, um, I think as time goes on, they, the manufacturers have been trying to do so. I know the CGMs definitely have multiple languages, English or Spanish. Um, I know the Dexcom I think can connect to like watches or certain devices where they will report verbally what the patient's blood sugars are. And so I think there are trying, um, and there was a session actually at one of the conferences focused on like patients who are visually impaired or, and how these devices are, um, addressing those needs. And I think they're trying, especially for some pumps have interfaces for people, um, that can't see in low lighting or have bigger wording. And so I think they're, they're trying to address some of those, um, some of those issues. And then I know even with the technology, some of the companies are starting to think about how to reduce disparities in technology use by trying to broaden their inclusion criteria, um, or, um, um, you know, partnering with researchers that, um, like have an interest in addressing disparities. So I think, uh, we're moving towards the right direction. Thank you. The next question, they congratulate you both. And they, they say for patients who are reluctant to take on a personal unit of CGM, there is a professional unit that clinic providers could loan to patients for a 10 to 14 days trial for data retrieval. So what peers of wisdom do you have from these clinics to obtain such professional units? Dr. Pereira. Yeah. Yeah. I'll start with that one because I've, I've actually tried to implement this in our own clinic services and have not been successful. I think, you know, the, the issue or the barrier is that this is a, an upfront investment. Um, and so the clinic typically has to, um, purchase these devices. They have to set up the workflow to, um, uh, place them and get them back from their patients. Um, but really, uh, you know, there's potential for great, um, a great, uh, advantage for our patients and our providers. In terms of our patients, just there's a lot of reluctance sometimes from patients to try something new and, you know, things that I hear my patients saying is, oh, I'm worried about the, the needle that's going to be in my arm. And so we have to clarify it's actually, there is no needle. It's just a little teeny tiny tube that will, will stay there. Um, and this is not going to harm the people around you. Um, or, you know, they say it's going to be painful. And so, um, you know, just doing that two week trial could help patients understand what it really is like and to, to, to look at the data and to see what the benefit is for them. As far as providers, having more glucose data is just, it's, it's, it's a night and day difference. You know, right now with point of care glucose, we are looking at blood sugars at, at the maximum six times maybe per day for some of our patients with type one diabetes, but we don't know what's happening in between that time. Um, and so to be able to see what's happening in between those periods of time, to be able to look at trends, to be able to look at, um, all the data over a two week, week period or a three month period, uh, is just incredible and very useful in terms of helping our patients, um, uh, adjust their medications, um, and, uh, getting their blood sugar under better control. So I think there's a lot of potential for that. And there is reimbursement by the way, for this professional CGM use to the clinics. Um, I think the last question here is, I think maybe Dr. Everett can, can answer. Can you speak on the ongoing costs associated with CGM and muscumin pump use and how that can limit access to use? Sure. So I think when we think about, I think across all studies that have looked at barriers to CGM and insulin pump use cost is usually on the top of what, um, is the major barrier. So I think, um, that is by far one of the things that I think most strongly limits access to CGM use and whether that cost associated with the insurance providers or, or not, I think that, um, is a big thing. And so, um, and, you know, and even some of, I think there's, um, you know, costs not only in terms of, well, my insurance cover, uh, like cover this device, but sometimes they do cover it, but the co-pays for the materials and things are so high that patients are unable, um, uh, to continue that. And, you know, with the type one diabetes population, that's younger and changes in insurance, like losing of jobs, going to school, I think, um, continue use is a problem. And so, um, I think, um, you know, with like the freestyle Libre that came out that significantly reduced the cost of, of, um, of insulin, um, CGMs. And so I'm hoping really as time goes on and as really the market for technology is actually increasing, we're seeing more types of insulin pumps, uh, more types of CGM over time. I'm really hoping that that will reduce the cost, especially as technology use is becoming more prevalent. Um, but I guess time will tell, but I, I agree that is the, by far the biggest barrier and is something that, that needs to be addressed. Perfect. So thank you very much. Both of you, this concludes our session. Thank you for joining us today and please keep an eye out for future health disparity webinar. Thank you very much.

diabetes technology

equity

disparities

continuous glucose monitors

insulin pumps

glycemic control

complications

barriers to access

Medicare coverage

healthcare providers