ADA Recap Series
This article is the last of our three-part ADA Recap Series. Breakthrough T1D was on site in Chicago, IL from June 20-23 for the American Diabetes Association’s (ADA) 85th Scientific Sessions. We’re here to report on the latest-and-greatest type 1 diabetes (T1D) advancements—including many driven by Breakthrough T1D funding.
Medical Affairs
Breakthrough T1D’s Medical Affairs program is bridging the gap between access to and adoption of therapies, treatments, drugs, and devices for T1D. To accomplish this goal, the Medical Affairs team is working on healthcare provider (HCP) education, development of clinical care guidelines, and clinical trial education and awareness.
Guidelines for T1D management
Guidelines for cardiovascular and kidney disease in T1D
- Presenter: Camila Manrique-Acevedo, M.D.; University of Missouri
- Cardiovascular disease (CVD) risk has decreased in people with T1D over time, but it is still the leading cause of death in people with T1D, representing a critical unmet need.
- Treatment recommendations and guidelines have largely relied on evidence from studies in T2D.
- Dr. Manrique-Acevedo recommends lipid-lowering medication (like statins such as Lipitor®) to reduce LDL to target levels. Based on an observational study, this class of drugs can reduce CVD risk by 22% in people with T1D.
- She also recommends lifestyle modifications, blood pressure management, weight management, and early and proactive screening for CKD.
- Development of clinical guidelines is a priority of Medical Affairs. The guidelines presented here are not published and do not necessarily represent the consensus of experts in the field. However, Dr. Manrique-Acevedo started the conversation to standardize CVD clinical care for people with T1D, which currently remains an unmet need.
Continuous ketone monitoring (CKM): Why does it matter?
CKM technology can have transformative benefits for intervening early when ketones are rising to prevent diabetic ketoacidosis (DKA), among other uses. Breakthrough T1D has been supporting the development of CKM technology, but it’s not quite a reality yet. However, we’re working hard to bring CKM to the T1D community, and we believe we’ll be there soon.
Consensus guidelines highlight: Breakthrough T1D staff making an impact
Clinical adoption of CKM
Development and clinical adoption of CKM will be a crucial step toward preventing DKA in people with T1D. Thomas Danne, M.D., Ph.D., Chief Medical Officer, Global, convened an International Breakthrough T1D Consensus Group to report on the application and utility of CKM for people with T1D. The report was submitted for publication just before ADA 2025. During the Symposium titled “Continuous Ketone Monitoring – Innovations and Clinical Applications,” five members of the Breakthrough T1D Consensus Group chaired and presented on how the initiative will impact the clinical adoption of CKM. The presentations covered the basics of ketones, self-monitoring of ketone levels with CKM, new data emphasizing the potential of CKM impact, and the importance of shared decision-making between HCPs and people with T1D—all of which were outlined in the consensus document. Development of CKM consensus guidelines is a critical first step toward clinical adoption of CKM so the T1D community can benefit.
Key takeaways
Guidelines for T1D management, especially clinical consensus guidelines that have been built by international experts, are key to advancing clinical adoption of the newest therapies, devices, and treatments for T1D and its complications. CKM consensus guidelines are coming soon!
Education and awareness
Precision medicine
Precision medicine refers to therapies and treatments that are targeted to a specific population of people based on genetics or other factors. This subpopulation is likely to respond more favorably to the precision medicine intervention compared to the general population.
Education and awareness highlight: Breakthrough T1D staff making an impact
Supporting the role of women in the T1D clinical care team
Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, Vice President of Medical Affairs, participated in a panel discussion about women in diabetes professions. She gave an overview of her personal career journey, providing valuable insight into the benefits of mentorship, training initiatives designed for career growth, fostering leadership for women, and developing supportive networks. The panel highlighted disparities such as lower numbers of women attending conferences and occupying leadership roles in diabetes professions. By understanding barriers and amplifying the achievements of women in the diabetes workforce, we can foster a culture of inclusion, provide women with opportunities for visibility and leadership, and ultimately create a stronger care team for people with diabetes.
Precision medicine for T1D
Joshua Vieth, Ph.D., Senior Director of Research, co-hosted a panel discussion with Ulf Hannelius, Ph.D., MBA, Chief Executive Officer of Diamyd Medical, titled “Precision in Diagnosis, Power in Treatment: The Future of Type 1 Diabetes.” Stephen Karpen, Pharm.D., Senior Director of Regulatory Affairs, was a panelist. The panel also included Laura Jacobson, M.D. (University of Florida), Emily Sims, M.D. (Indiana University), Jason Gaglia, M.D. (Harvard University), and Alecia Wesner (person with T1D).
The panelists discussed a range of topics, including how precision medicine can change the treatment landscape for disease-modifying therapies and practical challenges that people with T1D will face, such as coverage of screening to determine eligibility for precision medicine-based therapies.
A significant focus of the panel discussion was clinical trial education and awareness. Recruiting for trials that may only work for a portion of people with T1D may prove difficult—and it’s critical that HCPs communicate why a certain therapy may or may not be a great fit for an individual. Additionally, the panelists suggested that clinical trial education should be built into training for diabetes specialists and endocrinologists so they can appropriately talk with patients and share the most important information. As Dr. Sims put it, we need a “precision approach to talking about precision medicine.”
Speaking on behalf of the perspective of people with T1D, Ms. Wesner stressed the importance of educating not only HCPs but the T1D population about clinical trials, including those based on precision medicine. She discussed the impact of communicating the emotional side of clinical trial participation to people with T1D and how their decision to volunteer could benefit the T1D community as a whole.
DiabetesMine #DData ExChange event
This event brought together researchers, industry partners, clinicians, and regulatory specialists to discuss a range of diabetes topics. Esther Latres, Ph.D., Vice President of Research, hosted a panel discussion with industry titled “Headway and Hurdles: How can Diabetes Cell and Gene Therapy Succeed?” The panelists discussed the promise of cell therapies and role of Breakthrough T1D’s Project ACT (Accelerate Cell Therapies) in making these therapies a reality for people with T1D, especially those that do not require immunosuppression. Getting the word out about our work toward curative cell therapies—and discussing solutions to the challenges we’ll face bringing them from labs and into clinics—is a cornerstone of Breakthrough T1D’s Medical Affairs strategy.
Breakthrough T1D Advocacy shout-out
Marjana Marinac, Pharm.D., Associate Vice President of Regulatory Affairs, participated in a panel titled “Influencing Health Policy in 2025: A New World Order?” The discussion focused on the policy and regulatory environment surrounding funding for diabetes research, including the critical importance of continued renewal of the Special Diabetes Program. The panel also discussed the need to emphasize the voices of people with T1D in developing cures.
Key takeaways
Education and awareness—from HCPs, to people with T1D, to researchers—is essential for clinical adoption of new therapies that can benefit the T1D community. At multiple events that Breakthrough T1D staff led or participated in, diverse audiences learned about precision medicine, health policy, cell therapies, and supporting women on T1D care teams.
From T2D to T1D: Shortening the clinical trial timeline for repurposed drugs
Biomarker
A biomarker is a measurable change that is indicative of disease or response to a therapeutic intervention.
Bridging biomarker
A bridging biomarker can be used to extrapolate the effectiveness of a treatment from one indication or population to another. In this case, a bridging biomarker that was effective in measuring therapeutic benefit in type 2 diabetes (T2D) can be used to measure the same benefit in T1D.
Finerenone for T1D
- Presenter: Hiddo Heerspink, Ph.D.; University Medical Center Groningen
- Finerenone has proven effective in preventing progression of chronic kidney disease (CKD) in T2D.
- The phase 3 FINE-ONE clinical trial, which is testing whether finerenone can prevent progression of CKD in people with T1D, is nearly complete. The treatment period is only six months.
- The primary endpoint is change in urinary albumin-to-creatinine ratio (UACR), an indicator of kidney damage. UACR is being used as a bridging biomarker for this trial based on demonstrated effectiveness of predicting finerenone-driven kidney benefits in T2D.
- This has reduced the treatment time—and therefore clinical trial length—by a significant amount. Shorter clinical trials mean people may be more inclined to participate, and HCPs need to effectively communicate this to interested volunteers.
- This is also an important lesson in clinical trial design and the benefits of repurposing drugs for T1D that have already shown benefits in T2D.
Key takeaways
Shortening clinical trial timelines will be critical to getting groundbreaking therapies from clinical testing to people with T1D faster. We can learn lessons from treatments that work in T2D and repurpose them for T1D to make this possible. Encouraging HCPs to discuss shorter clinical trial options with interested trial participants will be essential to recruitment, which in turns moves trials along even faster.
The ADA 85th Scientific Sessions have officially come to a close—and we were inspired and energized by the incredible advancements we saw first-hand across cures therapies, treatments, devices, and Medical Affairs initiatives. Thanks to all the researchers, scientists, clinicians—including many who were funded by Breakthrough T1D—who joined the discussion and shared the exciting T1D research progress from labs and clinics around the world. See you next year!
