In this episode of Dana Tech Talks, Dana Moreau speaks with Anastasia Albanese-O’Neill, Vice President of Medical Affairs at Breakthrough T1D, about the critical role clinical trials play in advancing type 1 diabetes care. They explore emerging therapies, growing screening efforts, and practical tools that help clinicians connect patients to research opportunities. Together, they highlight how building a culture of trial participation can accelerate progress toward T1D cures.
Dana Moreau
Welcome to Dana Tech Talks, a special series from ADCES's The Huddle, conversations with the diabetes care team powered by ADCES. I'm Dana Morrow of Dana Tech and in this series, we dive into the latest in diabetes technology, bringing you expert insights, clinical strategies, and the innovations shaping patient care. Whether you're new to diabetes tech or looking for the next level of expertise, Dana Tech Talks is your source for real world knowledge. So let's get started.
Today I'm joined by Anastasia Albanes-O'Neill, Vice President of Medical Affairs at Breakthrough T1D. She's here to talk about clinical trials and their importance in progress in T1D cures. Anastasia, welcome.
Anastasia Albanese-O'Neill
It's great to be here, Dana.
Dana Moreau
It's good to have you back. Before we go too deep on this topic, tell us about yourself and your role at Breakthrough T1D and more about the Medical Affairs team and why what they're doing is a priority.
Anastasia Albanese-O'Neill
Thank you so much. It's really lovely to be back, Dana. And indeed, my role here has changed since we talked last. Breakthrough T1D has added a new mission pillar, medical affairs. And we have been charged with thinking about the emerging care paradigm in type 1 diabetes. Here I'm talking about screening for early detection, monitoring and providing support for people in early stage type 1 diabetes immunotherapies to stop the immune system from attacking and destroying then some producing beta cells and looking ahead toward manufactured cell therapies to replace islet cells for people who can no longer produce their own insulin. Our team has been charged very strategically with thinking about adoption of these sort of emerging either care processes or therapies or devices, and I would just note that, you know, our organization had a huge role in getting automated insulin delivery, putting the evidentiary base behind it and working with regulators and health plans to get those devices covered. But I would note that only one in five Americans are using automated insulin delivery. So I think care teams are really thinking about how do I adapt to this really rapidly changing care paradigm? And we've developed this new mission pillar to think in partnership with care teams about how we can support those efforts.
Dana Moreau
Having known you for a few years now, you've led some really amazing efforts. And one of them, I think you either led or co-led was the development of an international consensus guide for monitoring people who are pre-stage T1D. Why was that guidance needed and what should clinicians know about applying it?
Anastasia Albanese-O'Neill
That's a great question, Dana. And I think it's a great example of where Breakthrough T1D can play a role in the ecosystem and why having a medical affairs pillar is so important. all of our staff on the medical affairs team joined Breakthrough T1D after spending years or even decades in clinical practice and type 1 diabetes. And I think that perspective is what provides those key insights. In the case of the monitoring guidance, when I first started at the organization and that's when we started working together, about three and a half years ago, I was asked to evaluate the barriers to the increased adoption of screening for type one diabetes auto antibodies in the clinical setting. And I took a hard look at the clinical literature and what I found, it was quickly apparent that we had a gap. The guidelines didn't say a word about what a provider should do in the event that a person's lab tests came back confirming that they had type one diabetes auto antibodies and were in early stage type one diabetes.
And I spent a lot of years, 14 years in clinical practice as a nurse practitioner and a diabetes educator. And we don't like to order lab tests when we don't have a clear plan of care grounded in the evidence about what we should do with the result. So the good news is the international clinical community agreed that we needed this guidance. We were lucky to recruit two terrific consensus builders to the project, Linda DiMeglio and Moshe Phillip. And in the end, we reached international consensus with folks, key opinion leaders from four continents. It was published in Diabetes Care and Diabetologia. And I would just flag here that this document is still the most popular manuscript at Diabetologia. It's still the most downloaded. I think showing a profound clinical need. I'll just end by saying that this document answers the question. If I order auto-antibody testing for somebody in clinic and the results come back indicating that auto-antibodies have been detected,
What is my plan of care? It's very clear in this document. It's a really important step for people in clinical practice that they can now build infrastructure around this evidence-based document. And we're just delighted about its reception and its contribution to the clinical sort of ecosystem.
Dana Moreau
Okay, Anastasia, I love that. I love that this guidance exists and it makes such sense. So happy that your medical affairs team at Breakthrough T1D, formerly JDRF, exists and looking forward to all the other amazing things that you're working on. Which, among those, I know you guys have been looking more at and starting to build education for HCPs. So more modules, more CME resources and again, the Medical Affairs Unit is trying to close the gap between the new therapies and adoption. How do you envision that working? How can clinicians engage with it?
Anastasia Albanese-O'Neill
Thank you so much for that, Dana. what I'm really delighted about is ADCES has been our accrediting partner in this work. And I think the diabetes community is better when the diabetes organizations work together and pull on the same side of the rope in right direction, not against each other, but trying to get to the same place. So thank you to the team at ADCES for that. You're right. This work is already underway. Another strategic move on our part was to acknowledge that diabetes care has become more complex than it used to be and that our healthcare system is increasingly fragmented. And when we're in clinical practice, our FaceTime with people with diabetes is shrinking due to shorter clinic visits. There was a lot of terrific accredited education out there from our sister societies, including yours. So we've been, again, very strategic about the HCP facing materials that we are developing, and they're specifically targeted to that emerging care paradigm in type 1 diabetes that I mentioned earlier. So again, this is screening for early detection, follow-up monitoring et cetera. And we've got several offerings in place here in the United States. So the senior author of the monitoring guidance, Linda DeMailio offers an hour on how you can use that guidance in either pediatric or adult care for people in early stage type 1 diabetes. We've got a great offering on how people can get screened. What are the pathways and some considerations around cost? And we have, I think, probably one of our most popular is from a group of four psychologists on the needs of people in early stage type one diabetes and how you support them. I mean, I think a lot of diabetes care and education specialists and other clinicians in care right now are pretty used to providing support for people with type one diabetes who require insulin, but are a little out of their depth in terms of this new population of people in early stage type one diabetes. And kind of underlining the popularity of that offering, I've been going back and forth on LinkedIn with a psychologist in Brazil. She couldn't sign up to get continuing education credits, but she was able to sign up as other, meaning just an observer. And she's messaged to me that she's already thinking about how she can adapt their clinical approach using what she learned there. So I would just note that our education right now, we've got online, on demand, and then virtual live offerings. We will have up to 10 at the end of this fiscal year in the United States. But if you're out of the US, you can listen in on those as, again, not to get credit.
We've also got some education in six languages in Europe, and then we're testing out some new, what we call immersive accredited education, where we hear from people with type one diabetes and their experience, whether it's with early detection or immunotherapy or cell therapy, because we believe as an organization that is populated with people living with type one diabetes and their loved ones, that we want those voices to be involved at every stage of the clinical and research process. So that's something new we're trying, but.
Check out our website. We'd love to have people come over and it's all at no cost to you. It's free accredited education. So, we'd love for people to be involved and take part and give us some feedback.
That's terrific. And understanding how far you've come in just a few short years on all of the screening efforts is insane. So kudos to you and everybody working on this because I mean, three years ago, nobody was talking about it. And now it seems like everybody is and the percentage of people getting screened is insanely high for the amount of time that's passed in my opinion. it's been fantastic to watch.
That has been, think, the most exciting thing is seeing people's minds change. People who said, I may be hesitant to screen or I'm not sure, not just clinics, but people in the 1 diabetes community. And how exciting is that? And in the general population. So super thrilling. Thanks for noting that.
Dana Moreau
Yeah, most definitely. I don't know how you couldn't notice it. So not an easy lift, but yeah, thanks to you and so many other people who are working on efforts to keep everybody moving forward. But one of the things I know we definitely want to talk about today and get to are clinical trials. And T1D offers a tool, I believe, called Clinical Trial Connection that supports clinical trial education, volunteers, and so forth.
Can you talk a little bit about how providers or patients can practically use these tools and how you're expanding their reach?
Anastasia Albanese-O'Neill
Yeah, so there's sort of two pathways here. So the first is the clinical trial connect tool. This is on our website. You can easily access this tool at breakthrought1d.org forward slash clinical trials. We try to keep things simple. And if you click on this tool and provide some information, it will match you to clinical trials that you or your child is eligible for within the geography you specify. So I would encourage you to not put in, I want to participate in a trial within 10 miles of my home.
I would give it a little more room so it can match you to clinical trials in your area. This tool goes and pulls the information off of clinicaltrials.gov and will also give you the option to share your email with us where we can then provide you with additional updates. We noticed though, Dana, so first of all, use the match tool, let us know if you'd like to hear from us because we'll be in touch. But what we also noticed is sometimes when people follow the tool and they end up on clinicaltrials.gov,
They get a little overwhelmed by the language there. When you see a word like glutamic acid decarboxylase, that might be a bit overwhelming just for the average person out there trying to find a clinical trial.
Dana Moreau
It doesn't really roll off the tongue, does it?
Anastasia Albanese-O'Neill
It does not. It does not. really, thanks to a longtime volunteer, Dayton Coles, I'm going to say his name on this podcast. Dayton Coles, who is a partner of mine, but has always been a volunteer at our organization said, we need to develop a group of volunteers and where they live in their local community. These folks can be the trusted voice in that community, but affiliated with Breakthrough T1D to demystify clinical trials. So these folks, we've got 60 of them.
They are everything from aerospace engineers to MDs to elementary school teachers. We provide them all kinds of education on the currently recruiting clinical trials. And they are there in local communities to help educate, inspire, and then connect you to the clinical trial coordinators. These aren't recruiters. They're just there for you to have a one-on-one conversation. When you see those words on clinicaltrials.gov that you're struggling to decipher, these volunteers are dedicating their own time to again, help demystify the clinical trial process. They've all participated in clinical trials themselves, so they've got some experience that they can share. And they're so dedicated to this data that they listed their personal emails on our website. So you can actually go to our website, check by state and contact your local volunteer to just have a conversation about clinical research and what that feels like.
Dana Moreau
Anastasia, T1D trials often face recruitment challenges for a number of reasons. From your perspective, what are the biggest barriers that are unique to these trials and how can HCPs and diabetes care and education specialists help overcome them?
Anastasia Albanese-O'Neill
So we need to create, like we have in oncology and other diagnoses, a culture of research participation in type 1 diabetes. And healthcare professionals are a key component of making that happen. What we know from research is that healthcare professionals, including diabetes care and education specialists, are eager to talk about clinical trials. I will cite some evidence. There's a study from Tufts where they talked to about 600 non-oncology, because cancer does have a culture of research participation non-oncology physicians. And of these 600 or so physicians, 90 % said, I would be delighted to talk about clinical trials and my clinical practice. But then when they surveyed the people in that health system, one-tenth of 1 % of people were referred to clinical trials. So while 90 % of clinicians said, I want to refer, less than 1 % said that they had been referred. So we have got to give HCPs the tools that they need to talk about clinical trials in the healthcare setting and we're working on that. So I mentioned we've got accredited education. We have a really great offering. 30 minutes, if you give Dr. Laura Jacobson at the University of Florida, 30 minutes of your time, she will educate you on the currently recruiting clinical trials that stop the immune system from attacking and destroying the insulin-producing cells in the pancreas, the beta cells. And then we've also created a flyer of currently recruiting trials that you can review and you can share with people you see in clinic. So again, on the HCP side, we need partners to help integrate clinical trials into that clinical visit. So the first step is get educated on what clinical trials are available to people with type 1 diabetes or their loved ones. And the second step is to start talking about them when you meet these people in your clinical practice.
Dana Moreau
I have so many ideas and I want to talk to you offline about all of them, but we only have 15 minutes, so I'll move into the next question by hands really. So thinking about people listening to this podcast, what patients in a T1D clinic, I mean, should a clinician think, well, I should bring up clinical trial participation with this person? And how do you suggest that they might go about framing a conversation?
Anastasia Albanese-O'Neill
That's a really important question. So first of all, everyone should hear about clinical trials. On our website, we have a list of virtual clinical trials. And Dana, these are clinical trials that people can literally participate in from their couch if they want or go to a local lab. So there's one on that list that picks up everybody. I think people should also be talking to families who come along to the clinic visit about screening for early detection. And then we have an urgent need in people who are newly diagnosed with type 1 diabetes or in stage 3 type 1 diabetes. This is the population of people who still have some ability to produce insulin and they can enroll in a clinical trial of a type that we call the disease modifying therapy. These are clinical trials to help us understand how we stop the immune system from attacking and destroying those insulin producing cells in the pancreas, the beta cells.
What's key to know here for people listening is most of these studies require enrollment within the first two to six months of diagnosis. So there's an urgency here. And I realize we get hesitant about talking to somebody about research when they're underwater with this new diagnosis of type one diabetes. But these studies are essential to our understanding of how to slow down and eventually stop the immune system from destroying the body's ability to produce insulin from destroying those beta cells in the pancreas. And we have studies right now that are recruiting all the way down to one year of age. The majority of the currently recruiting studies have travel support for the individual and for a care partner. So every single person who is newly diagnosed with type one diabetes in stage three, which is insulin requiring should be introduced to these studies. I mentioned earlier, Laura Jacobson is providing a 30 minute free accredited offering on these studies specifically. If you give us 30 minutes of your time and download our flyer, you should be comfortable talking with your patients about these studies, help us move the science forward. And we've got our clinical trial education volunteers who can also help if you want to connect them with somebody in your clinical practice.
Dana Moreau
Thinking about Laura and her 30 minutes. If you had 30 seconds with a busy DCS who's never referred a patient to a T1 trial before, how would you tell them to get started?
Anastasia Albanese-O'Neill
I want to first acknowledge how busy the DCES is in clinical practice and that you see a lot of different people with diabetes, type 1, type 2, monogenic, gestational diabetes. So thank you. That's number one. Number two, how do you get started? Attend our free HCP education for this specific group of clinical trials, protecting the beta cell. We want 30 minutes of your time. And then you can access our free flyers for the currently recruiting studies. We update these frequently. And then the third step, and this is important, think about how you're gonna integrate this into your clinical narrative. I will say, you are the people in practice right now. So if you have ideas on how we can better support you and you're listening to this podcast, we wanna be your partner in this work. We know you're on the ground in clinic. Share your insights with us so that together we can build that culture of research participation in the type one diabetes community.
Help us be your partner, a better partner in this work.
Dana Moreau
And I think that's probably a good final thought to end on, but is there anything else that we haven't touched on that you think is critical?
Anastasia Albanese-O'Neill
I would just say, Dana, and thank you for that opportunity. This is an exciting time in type 1 diabetes. 20 years ago in the clinical guidance, there was no continuous glucose monitoring. There was no automated insulin delivery. There was no screening for early detection and no approved immunotherapies to delay type 1 diabetes progression and halt the immune system in its tracks. Participation in clinical trials is what has made all of these breakthroughs possible, but we are not done.
If we do nothing today, we will be in the same place tomorrow. So my call to action to anybody listening is join us and let's work together to create that culture of clinical trial participation in the T1D community and let's safely get additional breakthroughs across the finish line. And one day, my hope, and I don't know when, but one day let's create a world without type 1 diabetes that.
Dana Moreau
As I always say, I love your LinkedIn profile that says you're on the hunt for a cure for T1D. At Godspeed, Anastasia. If anyone's going to do it, it's you. So thank you so much for joining us today. That's a wrap for this episode of Data Tech Talks, a special series from the huddle. I hope you found today's discussion valuable. Stay ahead of the curve with more expert-led conversations on diabetes technology and innovations. Explore even more at danatech.org for in-depth resources, training, and the latest in diabetes tech. And don't forget to subscribe to The Huddle so you never miss an episode. Thanks for joining us and we'll see you next time. The information in this podcast is for informational purposes only and may not be appropriate or applicable for individual circumstances. This podcast does not provide medical or professional advice and is not a substitute for consultation with a healthcare professional. Please consult your healthcare professional for any medical questions.