Hello, everyone. Welcome to our webinar, Improving Access to T1D Clinical Trials. My name is Natalie Bellini. I'm an assistant professor of medicine at Case Western Reserve University and the program director for diabetes technology at University Hospitals in Cleveland, Ohio, where we follow approximately 100,000 people with type 1 and type 2, combined in type 1 and type 2 diabetes. Latest Innovations in Treatment in Type 1 Diabetes is a free continuing education series from the American Diabetes Association that provides the latest information and evidence-based guidelines from the ADA Standards of Care. This is a self-paced, excellently designed and executed 6.0 CE credit. The first module, Screening and Prevention, is available now. Please sign up. Five additional models will be released over the spring and summer. Finally, I'd like to introduce today's panelists. Dr. Anastasia Albanese is the Associate Vice President of Medical Affairs at Breakthrough T1D, where she and her team are focused on expanding access to early detection of type 1 diabetes and creating a culture of clinical trial participation in the type 1 diabetes community. Ashby Walker is an Assistant Professor and Director of Health Equity at the University of Florida Diabetes Institute. Her nationally recognized research as a medical sociologist focuses on reducing health disparities in diabetes. Additionally, Dr. Walker chairs ADA's National Health Disparities Committee. Sarah Weston is Director of Diabetes Behavioral Medicine and Psychology and is a Clinical Assistant Professor and Licensed Psychologist at the University of Florida. Dr. Weston is dedicated to improving the lives of people living with diabetes through research, clinical care and education, with a focus on behavioral science and mental health comorbidities. Hi, everyone. I hope you can hear me. It's great to see some of the names in the chat, many old friends, and lovely to be working today with the American Diabetes Association. There is a saying, if you want to go fast, go alone, but if you want to go far, go together, and there's nothing that brings me more pleasure than partnering with organizations like the American Diabetes Association. We're going to talk today about why clinical trials in type 1 diabetes are so important, and I'm going to give you some examples and I hope inspire you to think about how you can integrate talking about clinical trials in your clinical practice. I think you know the answer here, but what are clinical trials? These are processes that examine new and emerging or sometimes existing medical treatments to determine if they're safe and effective, and that could be a therapy or a device, and they are carefully designed and regulated by an ethics board, in the United States usually an IRB, and participation in clinical trials is completely voluntary. You can ask a lot of questions before you decide to enroll and sign the informed consent, and if for some reason you decide not to continue to participate, that is completely under the control of the person participating, so I think that voluntary aspect and becoming very informed about these trials is very, very important and we'll emphasize that as we move forward. Part of being informed is knowing about the phases of clinical trials, so there is actually a phase 0, which I'm not going to talk about, and there's a lot of work that happens before a drug is ever introduced to a human or a device that happens in animals and sort of off screen in labs, but the official phases from the National Institutes of Health start with phase 1, which are a safety study and to better understand what a safe dose and a dose that somebody might tolerate would be, and these studies in phase 1 often occur in people who have no diagnosis at all. These studies are early, we don't know much usually about the therapy, and so again, safety is key in phase 1. If the drug is determined to be safe at a specific dose, it moves on to a phase 2 trial where we're looking to see if it's effective. Does it work for the specific condition? In this case, it might be protecting the beta cells against the attack of the immune system in type 1 diabetes. If it's effective and continues to be safe, then we look at its comparative effectiveness against existing treatments, and this is what we see in phase 3, usually a pivotal trial, and if the pivotal trial is successful, and usually these are randomized control trials, then it will go in front of the regulators, the FDA, for approval. And then phase 4 are some studies that take place after the drug is approved, often called post-marketing studies and looking at long-term data. Why does this matter? When you're talking to people in your clinic, when you're talking to a family or an adult newly diagnosed with type 1 diabetes or in the early stages, you want to talk to them about the different phases of the trials because they may have their own risk-benefit calculus and may be concerned about safety in an early phase but may be more interested in a later phase trial. So good for you to share this information, and we've got some resources around it that we're going to share in an upcoming slide. What types of clinical trials are there in type 1 diabetes? All kinds of clinical trials. We have a really wonderful psychologist, clinical psychologist, on the webinar today. She's doing studies in behavioral health. We're looking at studies to delay or mitigate complications, both acute and chronic. Adjunctive therapies, like new drug classes that could be used in type 1 diabetes, like GLP-1s, semaglutide, things we hear a lot about in the news, or SGLT2 therapies that protect the heart and kidneys of people living with type 1 diabetes. Early detection, finding people early so they can benefit from therapies to delay the need for insulin in stage 3. And then diabetes technology. And then I'm going to talk a little bit more specifically today about protecting those insulin-producing beta cells and also some cell therapies that you may not have heard about yet, hopefully to build some excitement. Again, more than 300 type 1 diabetes clinical trials happening right now. What are the potential benefits? Well, you can contribute to science and help others in the future. Many of you know that I have a daughter with type 1 diabetes. She was diagnosed 23 years ago and 22 years ago she went on an insulin pump at the age of two years in a week. I and she often think about how thankful we are to the people who stepped forward and participated in device studies decades before she was born. Having an insulin pump at age two changed our lives because it allowed for micro doses. So there is the opportunity to help others and our family has been a beneficiary of that. Your participation may lead, evidence shows, to a more active role in your health. Researchers who conduct these studies are often leaders and experts in their field and you get a lot of time with them. So sometimes it feels like an upgrade to first class because you're spending hours and hours and often with a diabetes educator who has a lot of expertise where you can learn about cutting-edge treatments and more participation means more progress. We can rule things in that work, we can rule things out that don't work, and this is very powerful but we have slow enrollment. We have a lack of clinical trial participants which leads to longer trials which means delayed results. Sometimes we spend time doing things that we should move on from and this of course requires more fundraising dollars for organizations like the ADA or others to complete these trials. So what is one of the roadblocks? Do physicians refer people to research or for those of you who are nurse practitioners or other allied health care professionals on the call? And I'm going to make an ask. I want to change what we're going to review here together on this slide and I want to see if we can move the needle. So this is a study from Tufts, the Tufts Center for the Study of Drug Development, and they interviewed almost 600 non-oncology physicians and non-oncology is important because in the field of cancer and oncology, research participation is the culture. Most people diagnosed with cancer participate in some form of research. In this study, 89% of the physicians they interviewed said, heck yeah, I'm happy to talk about research with people I see in my clinic. However, when you talked to the people in clinic, the patients, one-tenth, if we round down, one-tenth of one percent were referred to a clinical trial. And what did these doctors tell us? They said they don't have information on clinical trials, they don't know where to refer people, and they don't have time to learn about active trials. So we want to change that together starting today and we want to do it in a participatory way. I'm trying to move my slide. This is the same data from a different study. This one I'm including because it includes nurses. And when you include the nurses in this health system, 0.2, so two-tenths of a percent of people were referred to research. Is that enough? No. I think we can all agree. People can make their choice whether or not to participate, but if they never hear about the study, they will definitely never consider research participation in any of the areas available that we reviewed on an earlier slide. So my slide is moving. So I'm going to share with you a couple of what we would say sort of emerging areas in type 1 diabetes research that I think are terribly exciting. Just to review the natural history and the disease progression in type 1 diabetes, we know people who are diagnosed with type 1 diabetes stage 3 requiring insulin have a genetic risk, but 95 percent of those people do not progress to that diagnosis. What we believe, and we're still trying to sort this out, is that for some reason, whether it's the beta cells themselves or something in the environment, triggers the immune system and activates it to attack and destroy the insulin-producing beta cells in the pancreas, and we can pick up this immune response in the blood by testing for four type 1 diabetes autoantibodies, and I probably should have put them on this slide. Once you have two or more persistent autoantibodies, your likelihood of progressing to requiring insulin in stage 3 approaches 100 percent. So now we have stages in type 1 diabetes. Stage 1 is autoimmunity. So we pick up those persistent autoantibodies. Blood sugar is perfectly normal, and there are no symptoms. Once more of those beta cells are destroyed, the person progresses to stage 2 type 1 diabetes, where we start to see dysglycemia, usually high blood sugars, typically after meals, and stage 3 is that classic diagnosis of type 1 diabetes, where we have autoantibody. We can still see those autoantibodies. We have autoimmunity. We have hyperglycemia and symptoms like increased thirst, frequent urination, weight loss, blurred vision, etc. that vary. I'm going to talk about some studies in stage 3 type 1 diabetes that we're recruiting right now that are widely available in the United States and are quite exciting. You may ask, though, once somebody is already taking insulin in stage 3, how can we know if this therapy is working? How can we know that it's protecting the ability of the person to produce their own insulin? We use a measure called c-peptide, a lab value that you're probably familiar with, which measures the amount of endogenous insulin production. It can differentiate between if we just measured insulin in the blood, we would pick up both the insulin that was injected and the insulin the body made. But c-peptide is an endpoint that allows us to know if we are preserving that person's ability to produce their own insulin. That's what's going to be measured in these trials that I'm going to share with you right now. These are multi-site stage 3 clinical trials in type 1 diabetes. The reason I'm sharing them is no matter where you are in the United States, all of these studies will fly the individual and a care partner to the site and provide housing during the study activity. This increases access. You do not have to live next to the study site for any of these studies to participate if you decide to participate and qualify based on the inclusion criteria. The first one is on your left. It's a JAK inhibitor study. A JAK inhibitor is a pill, which we like. A lot of things in type 1 diabetes involve needles. This study is for individuals 12 to 35 years old. People are randomized 1, 1, and 1. Two get the therapy. Two out of three, the third person, every third person gets a placebo, which I know can be frustrating. We have a lot of safety data on JAK inhibitors in other conditions. We've got some great data that was published in the New England Journal of Medicine on a different JAK inhibitor, baricitinib, in an Australian trial that you can read about in the New England Journal of Medicine. Lots of safety data here. Here's the key. You have got to enroll in JAKPOT within the first three months, first 90 days. The next study is a trial nut study, which I'm not going to share more information about because it is full, but let's take a moment to celebrate that they filled this study examining rituximab and abatacept combination therapy. I'm going to move us along in the interest of time to talk about two more trials that are enrolling right now in type 1 diabetes. The next one is fraxalimab, which is an anti-CD40 ligand. There is not on this slide, but this has been studied in Sjogren's disease, and just a couple of months ago, an excellent publication in the New England Journal of Medicine on this drug in multiple sclerosis, which showed that 90% of people in that study responded. This is for folks 12 to 35 years old. You get randomized 2 to 1. Here's the enrollment timeline within 90 days of diagnosis. You need to enroll in this study, so you've got to make a decision very quickly, immediately following that type 1 diabetes diagnosis. The next study is Precision Medicine. This was designed specifically for people with type 1 diabetes. It's an intralymphatic injection, which sounds scary, but people are tolerating it well. 2 to 1 randomization. Again, it's antigen specific, looking at the effect of the drug on glutamic acid decarboxylase or GAD. Again, you have to enroll pretty quickly within six months of diagnosis for this study. The final study I want to show you, and I hope you will be excited to talk about, is called Tadpole. This goes all the way down to age four months and up to the age of 40 years, so a lot of people eligible for this study. The abbreviation of the drug here is DFMO. It's a difluoromethyl ornithine. For those of you who like the full drug name, I prefer the abbreviation. The goal here is really to reduce beta cell stress so it doesn't involve the immune system, but this study has six sites. You can be flown in, and there's some good safety data in the field of oncology, but again, you have to enroll and be randomized in the first 100 days following diagnosis. We've got to start talking about these studies if we're going to delay and prevent type 1 diabetes. What if, though, you've had type 1 diabetes for a long time and you no longer have any C-peptide, meaning you have no insulin-producing beta cells to protect? There is a burgeoning group of studies taking place in replacement cell therapy, and I want to share the results from one of those studies with you. This is the forward study studying an agent called VX880. They completed a phase 1-2 safety study, and these are some of the early results. I will just draw your attention to Doug Melton, who developed the drug in partnership with others at Harvard, and Brian Shelton, who is wearing the first inhuman sweatshirt at the bottom. When Brian Shelton, these are his results. Before he enrolled in the study, he took 34 units of insulin a day. His time and range was 40 percent because he experienced significant lows, and so he kept his blood sugars high, and his A1c was 8.6 percent. As he approached a year on the drug, his time and range was reduced to 99.9 percent, and his A1c was 5.2 percent. This is a cell therapy. These are stem cells grown from a cell line in the laboratory and infused through the hepatic portal vein. I will draw your attention that this is a safety study, so we do not know long-term data on this therapy, and that's why he's wearing that first inhuman sweatshirt. I will quickly note that there is some preliminary data from the first 12 individuals in this study. All achieved a reduction in A1c to less than 7 percent. Twelve eliminated severe hypoglycemic events, which were creating significant burden, and the FDA has moved this forward and given the drug a name, Zamylacell, and now it will be available in a phase 1, 2, 3 pivotal trial, enrolling approximately 50 people, and you can learn more at the link below. I hope I've inspired you to think about research. I'm going to move it on to my colleague, Ashby Walker, who will move us to our second learning objective. Well, hi, everybody. We're so thrilled to have you here today to be part of this webinar series on how we can really think about the importance of clinical trials, and in particular, what I'm going to talk about is recognizing the current scope and importance of representative participation in clinical trial research. We know that type 1 and type 2 diabetes is increasing everywhere in the world at really astounding rates. There was a seminal publication in The Lancet that documented and predicted where we're headed with the global burden of diabetes, and a really important part of this Lancet publication was pointing out that everywhere in the world, when we look at risk for type 2 diabetes and risk for complications from type 1 diabetes, historically marginalized communities face some of the greatest risk everywhere you look at this. When we think about type 1 diabetes in the United States in particular, we have very well-documented health disparities and outcomes, and this is based on sociodemographic variables like socioeconomic status, race, ethnicity, age, and someone's geographic location. And these sociodemographic variables have profound impacts on people's health outcomes that live with type 1 diabetes. We have studies that show that A1c is impacted by many of these sociodemographic variables. And important to some of the discussions we're having today, we also know that there are well-documented disparities in the use of technologies like CGM and insulin pumps according to race and ethnicity. So we know in type 1 diabetes, these health disparities exist and persist. So it's really important when we start talking about clinical trials to consider representation and to ensure that when we design and implement clinical trials, we are very intentional about ensuring that we have a broad range of representation to include everyone living with type 1 diabetes. When you look at existing trials right now, you look at the FDA Drug Trial Summary Snapshot Report that you can find that's available online. When we look at some of the drug trials that are going on and we look at the reports of who is participating in those trials, we do see that there tends to be an over-representation of people who are non-Hispanic white in many of our clinical trials. This is especially true when we look at type 1 diabetes. When we look at our national registries that we have available to us in the United States, like the Type 1 Diabetes Exchange and the Type 1 Diabetes QI Project. So our largest national registries that we have over-represent people who are non-Hispanic white that live with type 1 diabetes. And they also tend to over-represent people who are covered by private health insurance. This is also the case when we look at clinical trials in type 1 diabetes that we just heard about from Dr. Albanese O'Neill. And in particular, when we look at studies related to technology and type 1 diabetes and AID studies, again, there tends to be an over-representation of people who are non-Hispanic white and also people who have very high levels of education and who are covered by private health insurance. So why is diversity important when we talk about clinical trial registry? Number one, all people living with type 1 diabetes should be represented in our trials to ensure that we can generalize the findings across populations. Number two, clinical trials represent opportunities for interventions to address some of these disparate outcomes that we see in type 1 diabetes. And number three, greater diversity in type 1 diabetes clinical trials aids in the understanding of epigenetic and potential biocultural influences on disease etiology. Increasing diversity in type 1 diabetes clinical trials is gonna require very intentional efforts to develop long-term and strategic community partnership with stakeholders from a range of non-endocrinology settings. When we think about T1D clinical trials, we often see recruitment efforts that are focused in endocrinology and in clinical care settings. But what we have to remember is there are other ways to engage participants in research that are beyond endocrinology settings that will ensure a more broad range of participation in our trials. And I'm gonna talk in a minute more about how we can ensure community-based participation. Everyone, I'm gonna now switch over to talking about common roadblocks to clinical trial participation. So in a multi-site study funded by Breakthrough T1D conducted at the University of Florida, Lurie Children's Hospital and UMass Memorial Medical Center, we aimed to collect provider feedback about current and best practices related to clinical trial recruitment. We also aimed to examine factors impacting clinical trial research participation in the individual, family, and systemic level. And we also aimed to describe youth and young adults living with diabetes and their parents and assessed for knowledge of clinical trial participation, rates of past participation, and also expectations for an interest in participation to better understand why people are or are not engaging in clinical trial research. So we used three cohorts of four key stakeholder groups that were recruited both online and in person. And that was in order to increase the diversity of the participant sample. And we had folks complete self-report surveys of research participation, roadblocks, and their interests in clinical trial research. And so we assessed providers at UMass, and then we assessed parents of young children, adolescents and their parents, and then young adults living with type 1 diabetes, both via in-clinic settings at locations such as UF and Lurie, and then also online via an anonymous survey that was more of a nationwide sample. And this slide briefly covers our overall demographics. We did have quite a range of diversity in participant A1c and whether or not they were using Pump and CGM, and a rather representative sample of race and ethnicity. So some common roadblocks to clinical trial participation. So a positive thing is that providers did identify key recruitment strategies within their clinic. So they mentioned at most, they're using direct provider patient support, or direct provider patient recruitment strategies. So talking one-on-one to the patient. Also using flyers. So key information, data handouts that could be given to patients or potential participants. And then less so, they used study or staff recruitment, websites or social media, and also things like mail, email, phone contacts outside of the clinic visit. So although there are these useful strategies in the clinic setting, unfortunately, 60% of providers noted that they almost never talk about clinical trials with their patients during diabetes clinic visits. And what we see here with the green bars are various reasons why providers are noting that they didn't have these conversations. And so that included the psychosocial complexity of the patient. Also limited time during clinic visits. Limited knowledge of active studies. And then some just said, I didn't intend, I had no ill intentions here, but I just didn't talk about it, right? And so our hope today is that we can alleviate some of these burdens, some of these roadblocks by providing you this education around clinical trials. And also noting that things like psychosocial complexity may not actually be a roadblock, right? It may be that patients who are struggling with psychosocial complexity are the ones we need to study more in clinical trials so that we can best learn how to help a diverse patient population. So then we asked participants to rate roadblocks to engaging in clinical trial research. And so on a rating scale of one to six, where one is not a barrier and six is a significant barrier, we asked both the in-clinic and online cohorts, and remember this included a mix of young adults, adolescents, and caregivers, what are the roadblocks that they are struggling with? And you see across the board in the in-clinic and online cohorts, the most common reported roadblock was possible side effects. And so educating patients and participants on potential side effects when they are or are not a risk is really critical to reducing this roadblock. Something interesting here is that the online cohort did endorse missing school or work and also location restraints, a little bit more than the in-clinic cohort. And this could symbolize that patients who maybe are not close to large medical centers are maybe struggling more with access to the places that are doing clinical trials, right? And so thinking about educating people on the fact that a lot of these trials will pay for transportation, as Dr. Albanese-O'Neill noted, and will pay for resources to help the participant engage is really, really critical and important to enrollment. Other reported roadblocks that came up, things like uncertainty or fear around researchers, costs of this study, the study impacting their relationship with the healthcare provider. So concerns that it may mean that the patient no longer works with their medical provider, which usually is not the case, right? Thinking about not having enough information about the trials, worried about continuity of care, interference with daily life, and things like time constraints came up. And then patients and caregivers also reported a limited prior participation in clinical trials in addition to limited knowledge. And so we actually gave our in-clinic cohort a knowledge quiz about what is a clinical trial and asked some common questions about defining a clinical trial, whether or not the trial is voluntary, for example. And participants endorsed a mean score of 50% on that quiz, which tells us that people are not informed and that we need to do better about our education as healthcare providers. Participants also rated how often their healthcare provider discussed clinical trials during diabetes clinic visits. And we noted here over half of the online participants reported lack of discussion altogether about clinical trial research. So on a positive note, we also asked about reported interests in clinical trial participation. And here the scale is one, is I'm not interested at all in this topic, and a six is I'm very interested in clinical trial participation in this topic. And you'll see across the board in several categories of clinical trial research, people are endorsing that they want to participate and that there is interest. By and large, we never saw lack of interest as a roadblock to clinical trial participation. So here you see, of course, finding a cure for diabetes was our number one interest area across the board in our clinic online cohort. But we also are seeing plentiful interest in other domains, such as thinking about testing closed-loop technology, thinking about new diabetes technology trials, thinking about ways to prevent diabetes. And also as a psychologist who specializes in type 1 diabetes, I'll point out a category such as ways to decrease diabetes burnout had very high interest. And so we do have studies going on in behavioral medicine and in psychology that are clinical trials related to improving coping mechanisms, reducing burnout, navigating barriers to care, such as executive function deficits or comorbid medical conditions with mental health conditions, right? So there are clinical trials going on in the psychological realm as well. So making sure that patients' participants have access to the knowledge, the understanding that these trials are available is our goal today and to get you these resources later on in today's presentation. So now I will shift it back to Dr. Walker. For this section of our module, we're gonna talk about strategies for trying to build long-term relationships with community partners in an effort to increase representation in clinical trials. In terms of strategies and resources to encourage clinical trial participation, we really have to think about community partnerships as well as the funding we have to build the community partnerships. And why it's important to focus on this is because the community partners really are not only important in terms of being sites of diverse populations that we might wanna have representation, they have expertise that they can bring to us that will help make our trials better. Oftentimes you'll hear this as stakeholder engagement, but truly being able to see your community partner as an equal collaborator in clinical trials is really important from the outset. So considering building community partnerships beyond the endocrinology setting and clinical settings is really important for enrollment. A lot of our clinical trials in type 1 diabetes understandably recruit within endocrinology settings. But what we have to remember is many people living with diabetes, this is especially true for type 2 diabetes, but also true for adults with type 1 diabetes, they exclusively receive their care within primary care settings. So we have to think outside of the traditional endocrinology setting and to where we can look for communities to increase representation of people that may be underrepresented in endocrinology settings. The relationship with community partners and research participants should be symbiotic. We are not simply airdropping in a community trying to get our numbers filled for trials and making sure those numbers are representative. We want to engage in research in a meaningful way with communities that also meets their needs and draws on their historical political context in terms of participation in the research. Many times when we talk about the lack of diversity in clinical trials, what is cited as a barrier is historic mistrust. Mistrust that has come from many inequities in terms of how research has been conducted. But what I want to point out, while this is a really important barrier, research has also demonstrated that people from historically marginalized communities are very interested in participating in clinical trials. However, they are seldomly asked. And that is a different barrier than mistrust that we need to address. When you think about building a community partnership, this is where your colleagues in public health will be very helpful to you on your research teams. Being able to do what we call community engaged research and building these long-term partnerships really is the cornerstone for ideal partnerships. And when you look at what community engaged research is, the CDC has a lot of models for this. In particular, I've drawn from a Penn State toolkit that's available online for how do we actually go through this process of building community partnerships. But this is not a short-term relationship. This starts before research even begins with doing clear needs assessment. So your research can be informed by the needs of the actual community that you wanna work with. This also involves a lot of collaboration and consulting about the study design and what would be ideal for study implementation. And ideally, what you want through really strong clinical trial participation is community capacity building. So empowering communities through participation in research to be able to better address some of the complex challenges in our case of living with diabetes. I'm gonna give you an example. It's one thing to hear about a community-based research and building community partnerships. I think it is helpful to use an applied example. So one large trial that I was part of and Dr. Weston was part of is the Extension for Community Health Outcomes or ECHO diabetes trial. If you're not familiar with the ECHO model, this is a provider-to-provider empowerment model where in our case, diabetes experts train primary care providers through tele-education and how to better deliver diabetes care within the primary care setting. We implemented a very large, what's called stepped wedge trial across the state of California and Florida where we sought out federally qualified health centers to be our participants in this trial and to really rigorously measure patient level, provider level and health center level outcomes to see if this type of educational intervention actually improved outcomes for people living with type 1 diabetes within the FQHC setting. So we strategically focused on what are called FQHCs or federally qualified health centers because within the United States, over 30 million people receive all of their comprehensive primary care at FQHCs. They're located in medically underserved areas. They don't turn anyone away based on their ability to pay or health insurance status. So again, thinking outside of a traditional endocrinology setting, the FQHC is a really important locus of care delivery that is embedded within medically underserved areas. We strategically targeted FQHCs and we used a lot of very intentional enrollment efforts with patients within the FQHCs that draw on those public health community-based research principles that I'll give you the examples of here. So we really worked to build a study team through the echo diabetes intervention trial that were within the FQHC setting and that had long term relationships with the communities that we wanted to represent. It was also really important before we did the trial to do a very careful needs assessment. So we best understood the needs of the FQHC setting. When you look at how we did recruitment for patient level participants in the echo diabetes program, Dr. Ananta Adala has published a wonderful article on this if you wanna look in terms of our methodologies of how we really work to ensure representative communities were in our echo trial. But first of all, we had to obtain buy-in and support from the FQHC leadership. There were multiple levels of buy-in but we really had to work on relationship building with the FQHC to demonstrate value of participating in this for their health center and then to make sure we were being responsive to the FQHC's need. We also hired study staff from within the FQHC setting to recruit participants. We use what we call diabetes support coaches which were a combination of a community health worker and a peer support coach. And in many cases, those diabetes support coaches were then able to do recruitment for surveys because there were much higher levels of trust working with somebody within the FQHC than somebody from an outside academic medical center coming in and trying to do recruitment for research. We also ensured that we have staff that spoke the languages of the communities that were served in the FQHC setting. And we had study materials that were leveled in terms of literacy and translated accordingly. When you look at the cohort that we were able to recruit for the echo diabetes program through the FQHCs, there are a lot of differences demographically in our cohort than the large cohorts that I was mentioning before from the type one diabetes exchange. So when you look at our cohort, the majority of participants were not non-Hispanic white and also only 19% of our participants in echo diabetes were covered by private health insurance. The majority of people in the echo diabetes cohort were covered either by public health insurance or they had no health insurance. So this represents a really important group of people that we want to represent in clinical trials. The good news is when you look at the outcomes of the echo diabetes stepped wedge trial, and you can read this in an article that's available now in diabetes care, we saw statistically significant improvement in the use of technologies like CGM and insulin pumps from this provider education intervention. And we also saw a reduction in the proportion of people that were greater than 9% HbA1c. So I highlight the echo diabetes trial as an example of an effort that really worked intentionally to ensure representation from different groups. And then importantly, we saw improved outcomes among groups that face disproportionate risk for negative health outcomes in type 1 diabetes. Back to you, Dr. Weston. Thank you so much. I am going to now transition to talking about navigating a patient provider communication around behavior change and also discussing clinical trial research participation. So to do this, I am going to first start by identifying patient provider dynamics that may impair shared decision-making and effective patient care. And we can do this by then talking about alternative approaches. So there are some traditional dynamics in medicine that may impair shared decision-making. And the traditional approach may view the provider as the expert, right? And so thinking about a hierarchical distribution of power where there's directive communication, such as, I think this could be a good trial for you to participate in. I want you to participate in this clinical trial. What we want to do is remove the word I in that hierarchical distribution and instead shift to patient-centered language and a patient-centered approach where there's partnership and there's a shared decision-making. And so very slight tweaks to your language can really promote patient empowerment. So let's sit down together and look at available clinical trials. Let's learn what trials may be options for you. Let's talk together about those options and problem solve if there's any roadblocks to participation. So thinking about some common communication traps to avoid. So avoiding the expert trap. So as your provider, I am concerned about, or as your provider, I think that this is a good, a clinical trial, right, for you to participate in. And instead, again, shifting to that shared decision-making language. Also avoiding the question and answer trap. So commonly, we may ask things like, have you been checking your blood glucose, right, which we know can sometimes put patients into a bit of a corner and puts them on the defense. If they haven't, the conversation ends there. So instead, how many times a week have you been checking your blood glucose, right? We can apply these same language shifts to discussion around clinical trials. So tell me what you know about a clinical trial. Talk to me about what might be your interests in clinical trial participation. Also avoiding the confrontation trap. So a common thing that I hear providers often say is you've been canceling a lot of appointments, right? And we mean this with really good intentions. We want to understand what the roadblocks are to coming to clinic visits. But a slight shift in language here, I am so happy that you came to your visit today. What helped you get here can lead to the same problem-solving that we're looking to achieve. So by that slight shift, I'm so happy you came. What helped you get here? The patient may say, hey, I had transportation today. My sister or my brother was able to take me to the visit. Then you can use that to problem-solve maybe a roadblock of transportation. Same thing can apply when talking about clinical trials, right? So I'm so excited that you're interested in this. Is transportation a barrier? How can we help you overcome that barrier? Also thinking about negotiation versus empowerment. And so negotiation does not lead to effective behavior change. And so we say things like, if you lower your A1c by X, then we'll prescribe a pump. If you lose X pounds, then we can talk about this clinical trial, right? If you come to more frequent appointments, then we can do this clinical trial, or then I'll prescribe X. And we don't find that this is effective in the behavioral science literature. So instead, we want to switch that language to patient empowerment. What is important to you? Let's work as a team. What helped you get here today? And these slight shifts can really improve inclusivity and reduce that judgmental tone that may stop us in our tracks. So formulating strategies to activate patient behavior change and to get patients thinking more about clinical trial participation. Some strategies, decision balance. So weighing the pros and cons of making or not making a change, or deciding to participate in a clinical trial. What are the pros? What are the cons? These kinds of decisional balance conversations can help you identify what the patient perceives as those potential roadblocks. And some of them may be able to be overcome, right? If maybe say that they're concerned about maintaining their relationship with you as a healthcare provider, you can talk about them that that's not the case and that there will be that continuity of care. If they're concerned they can't afford to travel to the site of the trial, you can problem solve if maybe that trial will pay for transportation costs. Also providing support. So acknowledging that those limitations are difficult, identifying the roadblocks, validating the difficulty, and also ensuring that there's never pressure, right? That it is always the patient's individual lived experience and choice in participating in these trials. Then engaging in collaborative problem solving. So if appropriate, modifying expectations, using teamwork, presenting options, right? So maybe this trial, maybe this trial. These are different things that maybe have different pros and cons for you. Identifying facilitators of success, and then really importantly, reviewing progress. So something that we know about change or making decisions in psychology is that decisions are not often made overnight. So if you're introducing a clinical trial or multiple trials for the first time during a clinic visit, that patient may need to hear about that trial multiple times. And I know some of the trials have a short window of enrollment, but you can still kind of have the person sleep on it, right, maybe call them in a couple of days to get their thoughts, maybe have them come back into an earlier clinic visit if possible to think about the pros and cons of decisional balance. What I would strongly advise though is don't have the conversation and then not bring it up again, right? Because this may be something very actively on the patient's mind. And if you meet them at their next visit, hey, what do you think about that? Let's engage in teamwork in this conversation. It will show them that you care, that you remembered the conversation and that you're eager to understand their interests and also maybe validate their roadblocks. And then of course, having an inclusive clinic environment. So promoting access for all. And real quick, I just wanted to show what I think is a pretty powerful slide about provider intent versus impact. And so all of our intent as a healthcare provider is positive, right? We want to promote patient self-efficacy. We want to reduce distress. We want to engage in positive relationships with the people that we work with. But our impact can either match that intent or be separate from that intent. And oftentimes our language and how we're interacting with the patient has a profound impact on whether our impact matches our intent. So when we're using suboptimal language that is more of that expert role or maybe has a judgmental or a rushed tone, we achieve the opposite of what we intend and then vice versa with our optimal language choices. Also behavior adjustments are really key here. And so instead of rushing through information, really trying as much as possible to patiently provide that information and the rationale for why you're delivering that information. If patients don't understand why you're talking to them about something, sometimes it can be perceived in a way that maybe is not your intent. And then also instead of assuming a person is maybe not interested or unable, engage in that collaborative decision-making. Maybe they would be able if they understood how to overcome the roadblocks. Instead of choosing a trial yourself, offer education options. Instead of focusing on one-sided benefits, engage in that intentional collaboration. And also just the tone of voice that we use as providers can be really powerful. So instead of a rushed or judgmental tone, taking a deep breath yourself kind of before you go into the clinic visit, making sure that you're using a calm and inclusive tone in displaying those behavior tendencies. And I will wrap up here with a QR code, which will also be available at the end in our resources for a video vignette series that we developed with the Youth Strategies Committee here with ADA, where we recorded eight video vignettes of mock clinic visits where we use inclusive language to promote behavior change and decision-making in the clinic setting. So these are available completely free of cost. I've had our clinics here just meet for lunch, grab some popcorn, watch the vignette series, and we found it to be a really good educational tool for how to tweak language just ever so slightly to make it more inclusive and to help promote decisional balance in all aspects of diabetes care. So I will switch it back to Dr. Albanese-O'Neill. Thank you, Dr. Weston. I'm gonna do something Dr. Weston told us not to do and I'm going to move quickly, but this is recorded and there will be links in the chat. You heard from Dr. Weston that people are eager to participate in research. You heard from Dr. Walker that people don't always hear, are not invited to participate in research. And we know that you are very busy in your clinical setting and you may not have time to develop your own resources or are not sure where to go to get more information. I think it's really important what we heard from Dr. Weston about shared decision-making. And I will note, and I didn't do this earlier, that in the standards of care 2025 in the United States, screening for type 1 diabetes, autoantibodies in family members is the standard of care. It is recommended in the guidelines and in the country of Italy, it is the law of the land, meaning every child in the country of Italy, ages one to 17, will be screened for type 1 diabetes, autoantibodies. Knowing that you have early stage type 1 diabetes allows you time to think about your next steps and talk with your care team in a meaningful way about what you're going to do next. Are you going to intervene early with an improved therapy in stage 2 type 1 diabetes? Are you going to wait till a diagnosis of stage 3 diabetes and participate in a clinical trial? What are you going to do to avoid DKA at diagnosis? Please talk about screening. Two free ways to do it through a research pathway, through TrialNet if you're a family member or through the ASK study, which is screening anyone in the United States ages one year or older for both type 1 diabetes and celiac disease. And because it is now in the standards of care, you as a clinician, a physician, a provider can order autoantibody screening in your clinical setting. And again, this allows time to plan and prepare. We have on our website, and I know our colleague, Joe is dropping these into the chat, but we have a wayfinding document on our website. You can simply scan the QR code to take you to information about how to either guide people you meet in your clinic to participate in screening in a research study or and have a conversation about that or prescribe them clinically. In addition, there's a lot of ways you can connect to clinical trials and you can learn more and people that you see in your clinical setting can learn more. On our website, we have a clinical trial connect tool. It takes one minute or less to complete and it will connect the person who uses the tool to clinical trials that are appropriate for them based on their age and other criteria that they include. There's a QR code on the screen and I know it's gonna be in the chat and this will allow you to connect with us so you can receive more information about clinical trials. In addition, TrialNet is a great place to go for currently recruiting clinical trials in the United States and of course, also screening. You can also look locally. I hate to say Google, but you can Google. Type in Type 1 Diabetes Clinical Trials and your local university and academic trials will come up and of course, clinicaltrials.gov is another excellent resource where you can refine your search. I recommend checking the box recruiting, not yet recruiting and look for those currently recruiting clinical trials and you can also join the T1D Exchange Registry where they will also send you information specific to you about clinical trials that you may be eligible for and want to learn more about. I would also note the five studies that I shared with you that are recruiting right now at stage three to stop the immune attack or protect the ability of the beta cells to produce insulin. We have a free continuing education credit from Laura Jacobson, Dr. Jacobson at the University of Florida. It's on demand and she will be offering some live virtual webinars. It's 30 minutes of your time, but we saw that you need information about these studies to be able to answer questions and engage in that shared decision-making. This is your opportunity. In addition, on our website, we have very simple flyers. This one is on therapies that delay, aim at delaying and preventing type 1 diabetes by changing the process of the disease. These are studies in cell therapy, that ability to replace or to infuse cells that can react to glucose and produce insulin. And these are virtual studies. You can participate in these studies from your couch and they are, or you may need to go to a local lab, but you can do it right there in your home. This is a great opportunity to think about participating in research if you're in a remote or rural area. We also have volunteers at Breakthrough T1D in every community across the United States. They're listed on our website and their goal is to educate, inspire and connect people to research and really share that lived experience. They've all participated in research. You can learn more about them. And I'm gonna highlight one of our volunteers, Marjorie Lazare, who's up in New England. She is very passionate about research and has worked with us to develop some videos in English and Spanish that you can play in your waiting room. They're unbranded, but talking about the phases of clinical trials, what it feels like to participate and of course, early detection for type 1 diabetes. So we can think about, again, trying to figure out how to delay the diagnosis. The ADA has created this wonderful resource list for you that you can download and link to all of these resources. What an amazing discussion with the three of you. I've been taking notes. I'm excited about what we can do in the future. So our first question is early type 1 detection is considered a clinical trial? Thanks. I think that question came from a colleague of ours in Italy where early detection is again, law of the land. But I wanna specify that some type 1 diabetes screening is still in the research space. There are two pathways to identifying people in early stages of type 1 diabetes and introducing them to approved therapies or research opportunities. The first is what we're doing now and talked about on this call. That's auto antibody screening. And again, if you have two persistent auto antibodies, your likelihood of progressing to a stage three diagnosis of type 1 diabetes requiring insulin is 100% over your lifetime. That's one pathway. And that is, we've funded research in that space for 40 years. It's now in the clinical guidelines in many places and in the United States for family members. The other approach is genetic screening. And as I mentioned, even people with the highest genetic risk do not progress to a diagnosis of type 1 diabetes because we don't entirely understand why the immune system is activated. But screening for genetics has a very compelling story because if we identify people at the highest risk, we can reduce the number of people that we need to screen for auto antibodies, reduce some stress and anxiety and probably reduce costs. So, but that is not ready for prime time yet. That is not in clinical practice. And so we are funding at Breakthrough T1D with our partners elsewhere, research around genetic screening followed by auto antibody screening for early detection. So I hope that answers the question. Auto antibodies are in the clinical practice now and moving into clinical practice in the population screening space, genetic screening is still in research. And we do have a bit, a lot to learn still about auto antibody screening in adults. Most of the data we have is in pediatrics and I wanna underline that. Thanks for the question, Natalie. Excellent, we have one more question. A random question speaking about screening for genetics, 23andMe screens for celiac has Breakthrough T1D spoke to them perhaps? Interesting question. Yes. That is a great question. Where we are funding research is the ASK study, which I highlighted on the slide. That study will screen, and I wanna underline this again, thanks for the opportunity, whoever asked this question, anyone ages one or older in the United States for both type one diabetes and celiac disease. So if you are curious, remember, same genetic risks, it's confirmed on the six chromosome genetic risk for both conditions and also autoimmune thyroid disease. So if you want to be screened, you do not need to have a family connection. It is free. It is a research study. You will need to fill out an informed consent. The ASK study, it's in your materials that Joe and the team at ADA have provided. So for any of you who said, wow, there's so much going on. I have so many, what do I do? How do I even get started? The one thing I would tell you is last week, I saw someone with newly diagnosed type one diabetes in my office. And I said, look, this is what we do. Let's go to the website. Let's go to Breakthrough T1D. Let's look for the opportunities for someone three weeks in, knowing that there were studies available, but not knowing how far away she might have to travel. So we opened it up and said, let's just look and see what's in the US. We typed in type one, we typed in how many weeks she'd had it, a diagnosis date. And it came up that actually she's going away to college in a city that's about seven hours from me in Cincinnati. And she has since that time interacting with me in my room enrolled in a study. And I don't know if we would have gotten her there any other way. That to me means everything right now. So where do we go from here? I guess is the question, right? That's all the time we have for today. We've answered the questions that have been posted. I wanna thank you for your commitment to this important topic. This is very new, isn't it? We weren't talking about screening. We weren't talking about staging. We weren't talking about enrolling in trials for people with pre type one, right? With a stage one or stage two, or even stage zero type one diabetes 10 years ago event. So this is an important commitment that you've made with us today. I wanna thank our presenters for sharing their expertise with us so we can all work together to advance research and improve care for individuals living with type one diabetes. Please remember to watch for the survey from the ADA insights team. Thank you and have a wonderful day. Thank you.

Type 1 Diabetes

clinical trials

informed consent

trial participation barriers

diverse representation

patient empowerment

shared decision-making

healthcare providers

treatment advancements