Breakthrough T1D was on site in New Orleans, LA from June 5-8 for the American Diabetes Association’s (ADA) 86th Scientific Sessions. Check out all of our coverage below, including type 1 diabetes (T1D) advances across all our mission priority areas and several Breakthrough T1D-funded researchers and staff driving progress forward.
In case you missed it, see below for a recording our Mid-Year Mission Update, featuring key takeaways from ADA and other exciting developments that we’re looking forward to in 2026.
ADA 2026: Days 1 and 2
ADA 2026: Days 3 and 4
Check out coverage from days 3 and 4 at ADA, including an update on Eledon’s tegoprubart.
Mid-Year Mission Update with Breakthrough T1D leadership
For more ADA news and 2026 T1D progress updates, tune in below to hear Breakthrough T1D Chief Executive Officer Aaron Kowalski, Ph.D. cover the top advancements presented at ADA 2026 alongside updates from our mission pillar leads, Sanjoy Dutta, Ph.D. (Chief Scientific Officer), Lynn Starr (Chief Global Advocacy Officer), and Thomas Danne, M.D., Ph.D. (Chief Medical Officer, International).
Thanks for joining us throughout our coverage of the ADA 86th Scientific Sessions. We were encouraged by continued progress across our mission priority areas, including cures therapies, treatments, and devices. Breakthrough T1D staff and leadership were on-site hosting and participating in panel discussions, meeting with industry leaders, and engaging with researchers from around the world to accelerate T1D mission progress. Breakthrough T1D-funded research was front-and-center, showcasing the reach of our impact driven by supporters like you. That’s a wrap on ADA 2026, and we’re already looking forward to ADA 2027!
ADA’s 86th Scientific Sessions
This event is one of the largest diabetes conferences in the world, bringing together over 11,000 attendees to share and learn about cutting-edge research and advancements toward cures. Each year, Breakthrough T1D-funded researchers highlight their work, demonstrating the progress we’re making toward achieving our mission. Leading experts will present over 100 studies spanning cell therapies, disease-modifying therapies (DMTs), diabetes technology, treatments, and more!
ADA 2026 has officially come to a close! We’re excited to report on the final two days of the conference, with even more updates spanning Cures and Improving Lives. Read on to learn about Breakthrough T1D-funded research making an impact and highlights from our on-site staff, especially in cell therapies.
Check out the updates from days 3 and 4 across Cures and Improving Lives:
Quick Primer on T1D Immunology Terms
- Antigen: part of a beta cell that the immune system mistakenly recognizes as “non-self” and mounts an immune response against.
- Antigen-presenting cell (APC): Immune cell that “presents” beta cell antigens on their surface to T cells, which then learn to attack the beta cells.
- T cells: The destructive immune cells that directly attack beta cells.
- Regulatory T cells (Tregs): help control and resolve immune responses but are less functional and effective in T1D.
Cell Therapies
Cell Therapies Highlight: Breakthrough T1D-Funded Clinical Trial for Tegoprubart Continues to Hit Milestones
Piotr Witkowski, M.D. (University of Chicago) gave an update on the Breakthrough T1D-funded clinical trial for Eledon’s tegoprubart, an immune therapy being tested with donor-derived islet cell transplants. All 12 participants are off external insulin. They are not experiencing severe hypoglycemic events or unexpected adverse events, there are no signs of the body rejecting the transplanted cells, and there are no signs of kidney toxicity.
Islet Size Matters
- Presenter: Julia Panzer, Ph.D. (City of Hope)
- In humans, islets have a range of sizes.
- Older adults with T1D tend to have smaller islets, but we don’t know if islets are shrinking or if more small islets are being generated.
- Based on islets isolated from donor pancreases and sorted by size, smaller islets are less responsive to changes in glucose, and they are preferentially targeted by T cells (the immune cells that attack insulin-producing beta cells).
- This work provides insight into how T1D may progress differently with age based on changes in islet size.
Cell Therapies Highlight: Research Funded by Breakthrough T1D or the T1D Fund
Jessica Weaver, Ph.D. (Arizona State University) presented about how we can learn lessons from placental immunology to train the immune system to ignore beta cells in T1D. During pregnancy, specialized cells in the placenta (called trophoblasts) teach the mother’s immune system to ignore the developing baby. Dr. Weaver is testing if trophoblasts can be successfully transplanted in mice in an encapsulation device her team optimized through computational modeling to improve cell survival. The goal is to eventually see if trophoblasts can be co-implanted with islet cells so that they send signals to the immune system to ignore them.
Leonardo Ferreira, Ph.D. (Medical University of South Carolina) presented on a dual cell engineering strategy for T1D. In this approach, manufactured beta cells are engineered to display a unique protein fragment on their surface. Tregs are then engineered to recognize that same unique fragment. When implanted together, the Tregs can turn down the activity of any destructive immune cells that become activated against the protein fragment. In mouse models, this method has proven to be successful, and Dr. Ferreira is finding even more ways to modify these cell types to enhance their functions. The idea is to translate this into a new manufactured islet cell therapy approach that would also modify a person’s immune cells so that immunosuppression is not required.
Julie Sneddon, Ph.D. (University of California, San Francisco) studies how precursor cells turn into beta cells during development. Her work provides insights into how we can harness this knowledge to optimize beta cell manufacturing in the lab for large-scale islet cell therapies.
Quinn Peterson, Ph.D. (Mayo Clinic) focuses on manufacturing all the different cells of the islet, in addition to beta cells, for islet cell therapies. His work in T1D mouse models showed that implanting beta cells with alpha cells (which secrete glucagon) allows them to function better with fewer cells. This could have implications for how we optimize islet cell replacement therapies.
Peng Wang, Ph.D. (Mount Sinai Icahn School of Medicine) presented his work on a small molecule called harmine, which can promote the function and expansion of beta cells in T1D mouse models. The goal is to use harmine in the context of manufactured islet cell transplants to improve their maturation and function to make these therapies more effective.
Leonardo Velazco-Cruz, Ph.D. (Century Therapeutics, a T1D Fund portfolio company) presented on the company’s manufactured islet cell therapy product, CNTY-183, which is engineered with Allo-evasion 5.0 technology so that immunosuppression is not needed. Dr. Velazco-Cruz reported that Century Therapeutics has developed a scalable, bioreactor-enabled differentiation process that can produce consistent, functional manufactured islets. In mouse models, engineered islets were protected from the immune system and maintained insulin production as measured by C-peptide. The company will continue to develop its product for eventual translation into humans.

Advocacy Staff Making an Impact
Clem Cypra, Director of Health Policy, presented a poster from our Advocacy team on how well insurance claims capture hypoglycemia in people with T1D. This is especially important because an eligibility requirement for islet cell therapy clinical trials is severe hypoglycemia, and payers often use claims data to understand who may qualify for new therapies. The team found that claims capture significantly lower rates of hypoglycemia in people with T1D compared to rates reported in clinical studies and published reports. Therefore, relying on claims alone may result in coverage decisions that are not in line with real-world care for people with T1D, and additional research is needed to fully uncover the impact of hypoglycemia on the T1D community.

Key Takeaways
- Breakthrough T1D-funded cell therapy research is advancing on two fronts: helping transplanted islet cells survive and function without lifelong immunosuppression, and manufacturing better islet cells at scale.
- The clinical trial studying tegoprubart at the University of Chicago continues to impress, with all 12 participants off external insulin and no signs of rejection or kidney toxicity.
- Across the funded portfolio, researchers are engineering the immune system to tolerate beta cells while others refine how islet cells are created in a lab.
- Together, this work is moving the field toward manufactured islet cell therapies that could one day restore insulin production without immunosuppression.
Disease-Modifying Therapies
Cell engineering approaches to turn down autoimmunity
- Presenter: Justin Spanier, Ph.D. (University of Minnesota)
- The interaction between APCs and T cells is critical to the autoimmune process.
- Dr. Spanier presented on two different cell engineering strategies to disrupt this interaction.
- The first approach involves developing an antibody that binds to beta cell antigens on the surface of APCs, which physically blocks T cells from interacting with it.
- The second approach involves engineering Tregs to interact with beta cell antigens on the surface of APCs so that, again, T cells cannot interact.
- Dr. Spanier is further refining these approaches with the ultimate goal of finding new ways to suppress autoimmunity in T1D.
Disease-Modifying Therapies Highlight: Breakthrough T1D-Funded Research
Jacqueline Burke, Ph.D. (Northwestern University) spoke about the development of a “tolerozome,” a nanoparticle loaded with an immune-modulating agent (rapamycin) that can train the immune system to ignore beta cells. Her approach is unique in that tolerozomes are delivered specifically to immune cells, meaning that other surrounding cells are unchanged. Even more, this approach can be applied to islet cell transplants (to prevent attack on transplanted cells) or early-stage T1D (to preserve the body’s beta cells). Data from animal models of T1D support the potential for these approaches with limited toxicity, and ongoing studies will assess long-term tolerozome dosing and combination with manufactured islets.
Spotlight on Breakthrough T1D-Funded Research: Uncovering Biological Mechanisms in T1D
T1D Pancreases have Tissue-Wide Biological Alterations
- Presenter: Dirk Homman, M.D., Ph.D. (University of Miami)
- Dr. Homman presented his work on full-scale assessment of the entire pancreases of people with T1D (obtained through the Breakthrough T1D-sponsored nPOD program).
- Using histology and single-cell computational methods, he found that T1D pancreases have tissue-wide alterations that are not limited to islets.
- These findings will provide a better basis for our understanding of T1D pathology and help researchers adapt mouse models of T1D to better mimic biological changes that occur in humans.
Beta Cells are Stressed
- Presenter: Farooq Syed, Ph.D. (Arthur-Riggs Diabetes and Metabolism Research Institute)
- Beta cells have increased signaling through specific stress-response pathways, which may contribute to their ability to provoke an autoimmune response.
- Dr. Syed explored how stress pathways can influence large-scale changes in beta cell genes, further uncovering how molecular alterations in the beta cells themselves may contribute to autoimmunity.
Key Takeaways
- Disease-modifying therapy research is focused on retraining the immune system in a targeted way to ignore the beta cells so they can continue to produce insulin.
- These strategies include engineering various agents, including antibodies, modified Tregs, nanoparticles, and more that may protect transplanted islets or preserve beta cells in early-stage T1D.
- Foundational research is also deepening our understanding of the disease itself: T1D pancreases show tissue-wide alterations beyond the islets, and beta cells under stress may help provoke the autoimmune response.
- Together, we are going down the path to new ways to slow or stop the autoimmune attack at the heart of T1D.
Early Detection
Global Pediatric Screening Inequities
- Presenter: Jean Claude Katte, M.D., Ph.D. (University of Exeter)
- The Young Onset Diabetes in Sub-Saharan Africa study found that most people diagnosed with T1D in this geography did not have any autoantibodies detected.
- T1D screening tools based on autoantibody detection were developed using white populations with a European ancestry.
- This suggests that our current screening model and staging framework may not be suitable for people from all geographies since there appears to be biological variability.
- Dr. Katte also highlighted significant inequities in access to care in Africa and other geographies.
- Breakthrough T1D is committed to helping close these gaps through our Advocacy work around the globe, including our ALIGN-T1D initiative.
Monitoring Youth with One Persistent Autoantibody
- Presenter: Nicole Sheanon, M.D., M.S. (Cincinnati Children’s Hospital Medical Center). Dr. Sheanon is also a part of our Mission Impact Volunteer program.
- Around 15% of youth with a single autoantibody detected and no symptoms will go on to develop T1D.
- The first three years after autoantibody detection are the most critical monitoring window.
- Healthcare professionals (HCPs) should look out for any changes in health that may signal progression of T1D, including changes in HbA1c levels or the development of an additional autoantibody.
- Education is critically important so that families know to remain aware of the potential risk of T1D development, even if it’s low.
- For more, take a look at published consensus guidance for monitoring of early-stage T1D, which was published a few years ago and spearheaded by Vice President of Medical Affairs Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES.

Early Detection Highlight: Breakthrough T1D-Funded Researchers and Staff
Holly O’Donnell, Ph.D. (Barbara Davis Center) presented on the psychosocial impact of T1D diagnoses (early-stage and clinical) on families. Dr. O’Donnell found that communicating with families about the risk of T1D progression can be a challenge, and education efforts need to be individualized and repeated to be effective. Families with a greater understanding of T1D risk also tend to have more anxiety, especially for those who have a family history of the disease. Dr. O’Donnell is currently working on a Breakthrough T1D-funded study to adapt a cognitive behavioral therapy to reduce anxiety around risk of progression for families with children in early-stage T1D. For more, see Dr. O’Donnell’s o-demand seminar for HCPs.
Dr. Albanese-O’Neill spoke about recommendations for T1D screening and monitoring. She covered a range of topics, including the global T1D screening landscape, ICD-10 diagnosis codes for early-stage T1D, and the potential benefits and of screening, early detection, and follow-up monitoring. Dr. Albanese-O’Neill also discussed the importance of clinical trials, especially for DMTs targeted toward early-stage or newly diagnosed individuals, and she urged the HCPs in the audience to encourage research participation in their clinics. She closed with information about our early detection pilot clinics and international consensus guidelines for general population T1D screening, developed by Dr. Albanese-O’Neill with expert collaborators.

Key Takeaways
- Current screening methods may miss people elsewhere, so we must adapt our screening and staging frameworks need to ensure it works across the globe.
- Breakthrough T1D is working to close these gaps through Advocacy efforts around the world, including the ALIGN-T1D initiative.
- The first three years after detection are the most important monitoring window for youth who have a single autoantibody.
- Although it does have marked benefits, learning about T1D risk early can be emotionally difficult for families. Breakthrough T1D-funded research is developing tailored support to help them cope.
Improving Lives
The State of T1D in Adults
- Presenter: Marissa Hitchcock, BSN, RN, CDCES (Children with Diabetes)
- The global prevalence of T1D is increasing by 2-3% each year.
- 21% of adults with T1D are meeting HbA1c targets of less than 7%, and 64% are using diabetes technology.
- Cardiovascular events occur 10 to 15 years earlier in T1D adults, and 30-40% of adults develop kidney disease within 25 years of diagnosis.
- There are not enough options for adults with T1D to reduce their risk for heart and kidney disease; while GLP-1 receptor agonists and SGLT inhibitors are showing promise in clinical trials, they are still not approved and widely accessible.
- Major gaps in care for this population include healthcare access and affordability, psychosocial support, socioeconomic disparities, and representation in clinical trials.
- We need to do more for adults with T1D, and a major priority of Breakthrough T1D is funding research into devices and therapies that can improve blood sugar and weight management and reduce complications so T1D adults can do and feel better.
Improving Lives Highlight: Breakthrough T1D-Funded Researchers and Staff Making an Impact
Courtney Ackeifi, Ph.D., Senior Scientist, hosted a networking event for building partnerships with scientists and clinicians working on cardiometabolic therapies for T1D. In a short presentation, she highlighted the urgent need for cardiometabolic therapies for the T1D community and opportunities to partner with Breakthrough T1D to accelerate progress in this area. Anyone who is interested can check out our funding opportunities.
Key Takeaways
- It is critical that we continue to invest in complications research, especially as adults with T1D are encountering earlier and higher rates of heart disease and kidney disease. We need more options.
- There are still significant gaps that are preventing everyone from having access to the therapies that work best for them- Major gaps remain in access, affordability, mental health support, and clinical trial representation for adults with T1D.
- Breakthrough T1D is working to close these gaps so there are more options for people with T1D and they are accessible.
Advocating for Children with T1D
Lauren Figg (Stanford University) presented on how the medical community can advocate for children with T1D to get adequate access to care. Social needs, including basics like food, clothing, and shelter in addition to whether they can afford insulin or other supplies, should be document in electronic health records so HCPs can provide the appropriate support. Figg also suggested that HCPs be aware of local community resources, deliver information through multiple ways (verbal, printed, etc.), and follow up with families to ensure they are getting the T1D care they need.

That’s a wrap on ADA 2026! For more, tune in on Wednesday, June 10, at 6 PM Eastern Time on our social channels for a live Mid-Year Mission Update from our leadership—including highlights from ADA, recent advances, and what we can look forward to for the rest of 2026.
Coming soon: A full ADA 2026 recap with everything you need to know about the conference. Keep an eye on our News & Updates webpage!
ADA’s 86th Scientific Sessions
This event is one of the largest diabetes conferences in the world, bringing together over 11,000 attendees to share and learn about cutting-edge research and advancements toward cures. Each year, Breakthrough T1D-funded researchers highlight their work, demonstrating the progress we’re making toward achieving our mission. Leading experts will present over 100 studies spanning cell therapies, disease-modifying therapies (DMTs), diabetes technology, treatments, and more!
Reporting live from New Orleans, LA! Breakthrough T1D is on site at ADA 2026 with leading scientists, clinicians, healthcare professionals, industry partners, and more to hear about exciting updates in type 1 diabetes (T1D) research—including work supported by Breakthrough T1D.
Read on for everything you need to know from the first two days ADA 2026, including key takeaways from panels and sessions featuring Breakthrough T1D staff and noteworthy highlights from Breakthrough T1D-funded researchers—both past and present—whose work was front-and-center.
Check out the updates from days 1 and 2 across Cures and Improving Lives!
Cell Therapies: Breakthrough T1D Staff at the Forefront
Sanjoy Dutta. Ph.D., Chief Scientific Officer, participated in a panel discussion about advancing manufactured islet cell therapies for widespread clinical use. A major theme was that eligibility requirements for clinical trials are too narrow—which means that less people have the chance to benefit and trials don’t progress as quickly. Patient-reported outcomes will be important to demonstrate to regulators that many people with T1D can and want to benefit from islet cell replacement therapy, and we need established, systemic methods in place to take the T1D community’s opinions into account.
The panelists also discussed the current challenges surrounding immunosuppression, which is one of the barriers to clinical trial participation, and ongoing efforts to develop novel cell protection strategies. Immunotherapies in development for early-stage T1D may be applicable in islet cell transplant settings, including approaches that retrain the immune system to ignore beta cells—an area that Breakthrough T1D is invested in.
To accelerate progress in manufactured islet cell therapies, the panelists agreed that the top priorities are:
- More companies exploring novel approaches
- Expanding eligibility criteria for trials—and incoporating the perspectives of the T1D community into regulatory decisions—so we can build more evidence around the safety and efficacy of manufactured islet cell therapies
- Additional frameworks to help guide the field, like our cell therapies roadmap and upcoming publications from Breakthrough T1D staff around manufacturing and preclinical considerations
- Optimizing manufacturing processes to reduce costs and ensure access for people who want these therapies
- Optimizing cell therapy products by reducing or eliminating the need for immunosuppression and finding the best transplant site for survival

Brynn Marks, M.D., Senior Director of Medical Affairs, chaired a session about the promise and perspective of islet cell replacement therapies for kids with T1D. Notably, Melena Bellin, M.D. (University of Minnesota) spoke about insights from children with pancreatitis who require full pancreas removal and receive transplants of their own healthy islet cells into their livers. In comparison to adults, children who receive this type of dual transplant have higher rates of islet survival and function and are more likely to stop needing external insulin. Laura Jacobsen, M.D. (University of Florida) spoke about practical clinical expectations for cell therapies and DMTs based on the data we have in adults and what this might mean for kids. Finally, Jane Speight, Ph.D. (The Australian Center of Behavioral Research in Diabetes) closed out with a talk about psychosocial considerations for pediatric islet cell transplantation.

Key Takeaways
The data surrounding islet cell therapies is very exciting, but we have more work to do until manufactured products are accessible to everyone with T1D who may want them. We are at the very beginning of considering what these therapies might look like in the pediatric T1D population.
Disease-Modifying Therapies
C-peptide
C-peptide is a biomarker of the body’s insulin production, which can be measured easily by a blood test. It’s formed when pro-insulin is cleaved into active insulin and C-peptide.
The Potential for a New and Improved C-Peptide
- Presenter: Samuel Sangqu Wu, Ph.D. (University of South Florida)
- C-peptide has the potential to be a validated endpoint for DMT clinical trials, and researchers like Dr. Wu are looking into new ways to help make this possible.
- Time to minimal residual C-peptide (TMRCP) is defined by how much longer people will have measurable C-peptide—meaning how long they will continue to make insulin.
- Dr. Wu applied this metric to six TrialNet studies and found that extrapolating TMRCP identified the same treatments as effective as each original analysis.
- TMRCP may be another metric to define the clinical meaningfulness of C-peptide, meaning it could be an alternative endpoint to consider for future DMT trials.
- Breakthrough T1D supported these efforts.
TEPLI-REAL: Evaluating Real-World Outcomes of People Treated with Tzield
- Presenter: Stephen Gitelman, M.D. (University of California, San Francisco)
- The purpose of this study was to understand populations who pursue treatment with Tzield and post-treatment outcomes through review of electronic health records.
- Diagnosis of T1D is heterogeneous, with people having either autoantibodies or dysglycemia (abnormal blood sugar) detected first, or others having both detected at the same time.
- These diagnostic pathways influence Tzield initiation. Those who had dysglycemia and autoantibodies detected at the same time had the shortest median time to start treatment.
- Most people who initiated Tzield were adolescents, and 94% of people who started treatment completed the full 14-day course.
- This study offers important considerations for healthcare professionals (HCPs) regarding how T1D diagnosis influences Tzield treatment in routine practice.
Decoding Immune Mechanisms and Engineering the Immune System in T1D
- Todd Brusko, Ph.D. (University of Florida) presented on spatial locations of different immune cells that contribute to the autoimmune process in T1D pancreases—and the underlying mechanisms that influence this.
- Kyle Gaulton, Ph.D. (University of California, San Diego) uncovered single-cell changes in pancreatic cells from T1D pancreases using advanced genomic methods.
- Mohammad Haj Dezfulian, Ph.D. (University of Pennsylvania) mapped T1D antigens contributing to autoimmunity by taking a closer look at T cells, which play a role in destroying insulin-producing beta cells.
- Remi Creusot, Ph.D. (Columbia University) presented on a different approach to retraining the immune system to ignore beta cells, starting with precursors to immune cells.
- Together, these studies are deepening our understanding of how and where the immune system attacks insulin-producing beta cells in T1D—and uncovering new ways to retrain it.
Disease-Modifying Therapies Highlight: Research Supported by Breakthrough T1D or the T1D Fund
Kenneth Brayman, M.D., Ph.D., FACS (University of Virginia) presented work on two Breakthrough T1D-funded projects. The first centered around the preclinical optimization of a potential immune therapy for T1D called IgM. Dr. Brayman and his team found that this therapy can retrain the immune system to ignore insulin-producing beta cells in mouse models of T1D, and he expanded on the mechanisms by which this happens. In humans, this could be another way to promote beta cell survival.
The second study that Dr. Brayman presented, which is funded by Breakthrough T1D in conjunction with his collaborator Gordon Laurie, Ph.D. (University of Virginia), focused on a new potential drug called N-104, which mimics a compound that was found to be decreased in people with T1D. The data presented show that, in mouse models, N-104 may suppress autoimmunity while simultaneously promoting beta cell regeneration—marking a new potential DMT worth exploring further.
Christoph Bausch, Ph.D. (SAB Biotherapeutics, a T1D Fund portfolio company) presented data from the phase 1 study of SAB-142, a humanized ATG. This potential DMT preserved C-peptide, improved time in range, and reduced insulin therapy use. Even more, it can be safely re-dosed with mild side effects related to the infusion procedure. Next up is the phase 2b SAFEGUARD study, which is currently enrolling and will further explore the safety and efficacy of SAB-142. The ultimate goal is to delay or halt T1D progression.
Alok Joglekar, Ph.D. (University of Pittsburgh) presented on a novel DMT approach that involves engineering different types of T cells in the body to suppress self-reactive T cells that are causing destruction of insulin-producing beta cells. His approach is designed to be antigen-specific, meaning selectively shutting down only the beta-cell-destroying T cells while leaving the rest of the immune system intact.

Key Takeaways
Understanding the key immune mechanisms underlying T1D pathogenesis is a major focus of T1D researchers, and they are turning this knowledge into novel strategies for potential DMTs. To expedite DMT clinical trials, time to minimal residual C-peptide may be a clinically meaningful measure of beta cell preservation. Real-world data about who is initiating Tzield treatment—and when—is providing HCPs with important information about the pathway to Tzield initiation in routine clinical practice.
Early Detection
Clinical Implementation of Pediatric T1D Screening and Monitoring
- Presenter: Sarah Lydia Holly, BSN, RN (Children’s National Hospital)
- Six pediatric endocrinology centers worked together to increase T1D screening and monitoring rates in kids through quality improvement and operational strategies.
- Between June 2024 to February 2026, the teams implemented patient and HCP education strategies, integration of screening and monitoring in clinical workflows, defined pathways for follow-up, and multidisciplinary coordination.
- The teams exceeded their goal and screened 1700+ people. No cases of diabetic ketoacidosis (DKA) reported, 85% engaged in long-term monitoring, and 73% were offered Tzield.
- This study demonstrates the feasibility of screening and monitoring in routine pediatric care, and this can facilitate early intervention and DKA prevention.
Early Detection Highlight: Breakthrough T1D Staff
Raquel Lopez Diez, Ph.D., Senior Scientist, hosted a Breakthrough T1D Reception for the T1D Genetic Risk Score (GRS) Consortium. The session brought together investigators and collaborators to discuss upcoming projects and future directions related to the T1D GRS Consortium, with dedicated conversations around genetics in non-European ancestry populations and adult-onset disease. The attendees exchanged ideas, identified areas for collaboration, and shaped priorities for the Consortium moving forward.
Key Takeaways
Screening and Early Detection has proven benefits, and the more people screened, the more people can avoid DKA at diagnosis, take advantage of a therapy to delay onset, and more. This is a major priority for Breakthrough T1D, and we support general population screening efforts.
Improving Lives
Discontinuation of Roche’s Dual GLP-1/GIP Receptor Agonist for T1D
- Presenter: Jeremy Pettus, M.D. (University of California, San Diego)
- Roche conducted a phase 2 clinical trial to evaluate changes in glycemic control in overweight or obese adults with T1D treated with their drug acmopatide (CT-868).
- People treated with acmopatide demonstrated reduced HbA1c levels, weight, insulin dose, and blood pressure compared to placebo.
- Despite these improvements, Roche decided to discontinue research into acmopatide and abandon plans for a phase 3 clinical trial.
- However, there are other companies studying GLP-1s in people with T1D. For example, Lilly has an ongoing clinical trial that is fully enrolled. Learn more below.
GLP-1/GIP Receptor Agonists: The Good News
Eli Lilly’s phase 3 trials for tirzepatide for glycemic control in adults with T1D and obesity or overweight (SURPASS-1-T1D and SURPASS-2-T1D) are fully enrolled, with results expected in the coming months. The Breakthrough T1D-funded ADJUST-T1D trial demonstrated glycemic and metabolic benefits for people with T1D and obesity or overweight using an AID system treated with semaglutide. A few days ago, top experts in the field published a consensus on safe use of this class of drugs in the T1D population—including authorship by Brynn Marks, M.D., Senior Director of Medical Affairs—which means that we are providing healthcare professionals (HCPs) with the education needed to bring these therapies safely to the T1D community (more to come on this later). We and others will continue to push for additional research solidifying the safety and efficacy of GLP-1/GIP receptor agonists and advocate for approval for the T1D community.
GLP-1 Receptor Agonists for Kids
- Presenter: Michelle Van Name, M.D. (Yale University)
- There is clear evidence in adults with T1D that GLP-1 receptor agonists can improve weight and glycemic control and reduce the risk of heart and kidney complications, and more clinical evidence is needed for the adolescent population.
- Adolescents with T1D could benefit from this class of drugs because they tend to have insulin resistance and live with overweight or obesity, and those who develop T1D earlier in life have a greater lifetime risk of long-term complications.
- Currently enrolling clinical trials (T1-DISCO and Obesity Complicating T1D: GLP-1 Analogue Anti-Obesity Treatment) in young adults living with T1D and obesity are investigating the impacts of GLP-1s on cardiovascular outcomes.
- Dr. Van Name’s mentor was Bill Tamborlane, M.D., a long-time champion for the T1D community and Breakthrough T1D supporter who recently passed away.

Improving Lives Highlight: Breakthrough T1D-Funded Researchers and Breakthrough T1D Staff
Richard Pratley, M.D. (Advent Health) presented on the unique needs of the heterogenous population of older people living with T1D. It can be especially challenging for HCPs to set glycemic targets because of variable life expectancies, lifestyle differences, presence of other health issues, and a lack of evidence surrounding blood glucose management for this population. Dr. Pratley recommends that goals for glycemic targets in older adults with T1D should be individualized, and T1D technology can significantly reduce hypoglycemic events. And he emphasized an important point—there aren’t enough therapies to reduce the risk of heart and kidney complications, which older adults are especially vulnerable for. Dr. Pratley is executing a Breakthrough T1D-funded clinical trial to repurpose cardiorenal drugs that work in T2D for T1D.
Viral Shah, M.D., a Breakthrough T1D-funded researcher, presented an evidence synthesis on ketone monitoring and treatment, which was co-authored by experts in the field including our Vice President of Medical Affairs, Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES. The team collected real-world or hypothetical clinical situations related to DKA to create a framework that HCPs can follow to determine the best course of action. This includes considering who is the intended population for ketone monitoring, when and how to check ketones, defining clinical parameters for elevated ketones, and follow-up steps for management. This effort is critically important because rates of DKA are increasing around the globe, as detailed in the preceding presentation by Guillermo Umpierrez, M.D. Ketone management is a Breakthrough T1D priority, and our Medical Affairs team previously spearheaded a publication outlining international expert recommendations on continuous ketone monitoring in T1D.
Dr. Albanese-O’Neill and Jonathan Rosen, Ph.D., Director of Research, were co-authors on two posters reporting on a multinational survey of adults using T1D technology with severe hypoglycemia exploring how they are doing in their daily lives. The participants reported sub-optimal health and significant impairments in productivity, highlighting the remaining unmet needs for the T1D community despite recent advances—showcasing why the work we do to improve the lives of those living with T1D is so critically important.

Key Takeaways
GLP-1s are top of mind for researchers—they have proven benefits for adults with T1D, and ongoing clinical trials will provide more evidence for their use in younger populations. We need to do more for older adults with T1D, from individualized approaches to glycemic targets to developing more therapies to prevent heart and kidney complications. Last but not least, DKA rates are increasing around the world, and Breakthrough T1D is actively involved in efforts to guide HCPs on ketone management—which is especially important with continuous ketone monitoring on the horizon.

Look out for another article soon wrapping up days 3 and 4 of ADA 2026!
Islet cell therapies for type 1 diabetes (T1D) replace destroyed insulin-producing beta cells with functional cells that allow the body to make insulin again. To ensure there are enough islet cells for everyone with T1D who wants them, Breakthrough T1D is prioritizing manufactured cell therapies, which can be made in large quantities in a laboratory, adhering to high levels of quality control.
These therapies are quickly advancing through the drug development pipeline. How are we making sure the clinical community is prepared for their arrival?
The answer: Centers of Reference.
Centers of Reference
Centers of Reference are expert multidisciplinary T1D care centers that are preparing healthcare professionals (HCPs) around the world to administer manufactured islet cell therapies to people with T1D. The goal is to make sure that expert clinical teams—who are already doing islet cell transplants at low scale—are ready to integrate these therapies into clinical practice at their institutions and train others, once they have regulatory approval.
The second annual Centers of Reference meeting was held at Breakthrough T1D HQ in early May by our Medical Affairs team. Read on to learn more about the attendees, what the meeting covered, and what we can expect next year.
Key Takeaways: Breakthrough T1D’s Second Annual Centers of Reference Meeting
- Seven international Centers are established, and four interprofessional working groups meet every month to keep progress moving.
- Attendees, which include the leading physicians and islet transplant support teams from the U.S., Canada, UK and Italy, continued the conversation around what kinds of education, training, resources, clinical care, and benchmarking are needed for Centers to be effective.
- A manuscript is underway to lay out a clinical implementation roadmap for Centers.
Assembling the team at Breakthrough T1D HQ
This meeting was hosted by Thomas Danne, M.D., Ph.D., Chief Medical Officer International, Brynn Marks, M.D., Senior Director of Medical Affairs, Alessandro Bisio, M.D., International Director of Medical Affairs, and Amara Ogbonnaya-Whittlesey, M.D., U.S. Director of Medical Affairs, who brought together the best and brightest minds who can make Centers of Reference a reality.
Physicians, transplant surgeons, nurses, scientists, and other HCPs from various global medical institutions were in attendance, coming from:
- University of Minnesota Medical Center
- University of Wisconsin Health Transplant Center
- The Penn Rodebaugh Diabetes Center
- University of Chicago Medicine
- IRCCS Ospedale San Raffaele (Italy)
- Institute of Transplantation, Newcastle upon Tyne (UK)
- Edmonton, University of Alberta (Canada)
Additional attendees from Breakthrough T1D included CEO Aaron Kowalski, Ph.D., Senior Vice President of Research Esther Latres, Ph.D., multiple members of our Medical Affairs and Advocacy teams, and two members of our Participant Advisory Council who are living with T1D.
What has changed since last year’s meeting?
- There are now seven global Centers of Reference: Edmonton, Canada; Newcastle, UK; Milan, Italy; Wisconsin, Chicago (IL), Minnesota, and Pennsylvania in the U.S.
- Steady progress has been made toward a clinical roadmap for the Centers of Reference model.
- Four interprofessional working groups were established, co-led by Melena Bellin, M.D. (Minnesota) and Jim Shaw, M.D., Ph.D. (Newcastle, UK), that meet virtually every month and in-person annually at Breakthrough T1D HQ.
- The four working groups are HCP Training and Education, Clinical Access to Cell Therapy, Harmonizing Clinical Care, and Benchmarking and Registries.
Convening experts with the power to make real change
The objective of this meeting was to build on the progress that the working groups have made over the past year. Each group focuses on a key aspect of the development of Centers of Reference, taking a divide-and-conquer approach to capitalize on experts’ strengths and workshop ideas with the larger team.
We have learned recently that when a first-of-its-kind therapy comes to market, it isn’t magically going to be adopted by physicians and administered to people. There is a significant amount of prep work that has to happen to ensure that every connection is made so that these therapies, and ultimately people with T1D, succeed.
This meeting is that work, led by the leaders in the field.

Working group #1: HCP Training and Education
The group identified which topics around islet cell therapies should be included in educational programs for aspiring T1D medical professionals, including eligibility for islet cell therapies, the transplant procedure itself, post-transplant care, and long-term monitoring. Importantly, the ultimate career path of the trainee should play a factor in which topics require further education versus a brief overview. For example, a psychologist working with the T1D community may not have the same educational needs as a transplant surgeon, but both should understand T1D cell therapy basics.
Working group #2: Clinical Access to Cell Therapies
This group focused on how to best educate HCPs and people with T1D about emerging islet cell therapies. The team found that most people who receive cell therapies self-refer, but misconceptions are a major barrier to pursuing them. Priority areas for increasing awareness in the T1D community are communicating through social media, creating an easy-to-use landing page or website with information and opportunities to connect with medical teams, and connecting people with peers who have received islet cell transplants. In terms of HCPs, the group is focused on creating referral pathways, using artificial intelligence to help establish clinical workflows for islet cell transplants, and utilizing professional organizations to connect with and educate the T1D medical community.
Working group #3: Harmonizing Clinical Care
This group has one of the most challenging tasks: creating a roadmap for the clinical implementation of islet cell therapies. This includes determining eligibility based on defined clinical measures, reaching consensus on the best way to approach care before, during, and immediately after islet cell therapy, and consistent long-term monitoring. To add to the challenge, this roadmap must be applied across diverse clinical settings in different countries. The experts in the room—some of the most prominent T1D physicians and transplant surgeons in the world—made significant progress in defining clinical measures and tools that should be used in islet cell transplants.
Working group #4: Benchmarking and Center Readiness
Centers of Reference will be held to the highest standards to ensure they are providing top-quality clinical care to people receiving islet cell transplants. To make this possible, this group created a framework for assessing Center readiness, collaborating with registries for data-sharing, and benchmarking to evaluate Center effectiveness. This includes development of specific criteria laying out what each Center needs, such as a complete islet cell therapy care team, established processes for quality and safety, research teams, and more.
One theme was clear throughout nearly all of the working groups: incorporating the perspectives of people with T1D is absolutely critical. The groups agreed that clinical decision-making around islet cell therapies is about more than just someone’s blood sugar—the way a person feels, their level of diabetes distress, and their individual circumstances are key factors to integrate into shared decisions between people and their care teams.
Over the next 12 months, each team will follow up on the challenges, solutions, and immediate next steps identified during the meeting to keep progress moving. Thanks to everyone’s hard work over a productive and exciting two days, we are accelerating faster than ever toward the development of expert Centers of Reference.
What the experts are saying

“Cell therapies are getting closer and closer to reality, and our partners in the clinic must be ready to implement them. This is a good problem to have! We know that new therapies will take far too long to reach the people that need them if we don’t have an established clinical infrastructure. We have the best people in the world in the room, working through the problem with us, to ensure that when these therapies do become an approved therapy option, the T1D community can benefit as soon as possible.”
-Thomas Danne, M.D., Ph.D., Chief Medical Officer International at Breakthrough T1D
“Our hope is that Centers of Reference enable preparedness and expedite the delivery of new cell therapies—as they are approved—to become immediately accessible to people with T1D most in need of a novel intervention for the treatment of their diabetes.”
-Michael Rickels, M.D., M.S., Medical Director, Pancreatic Islet Cell Transplant Program, Hospital of the University of Pennsylvania


“Breakthrough T1D is proactively working now to identify and remove current and future barriers to T1D cell therapy coverage. By working with payers and policymakers now, we will accelerate broader access to T1D cell therapies.”
-Aaron Turner-Phifer, Senior Director of Health Policy at Breakthrough T1D
“Centers of Reference can help prepare healthcare systems around the globe for future cell therapies in T1D by building the expertise and standards needed to deliver them safely. They also help share experiences and best practices so more hospitals are ready to adopt these treatments over time.”
-Carmen Hurtado del Pozo, Ph.D., Director of European Research at Breakthrough T1D

Steady progress towards our goal
Manufactured islet cell therapies are coming. It is not a matter of if, but when. We are at a critical moment and need to ensure that HCPs are ready. Teamwork will get these therapies into clinics so people with T1D don’t have to wait years to get them.
This is why Breakthrough T1D is acting now: when the first manufactured islet cell therapy becomes commercially available, multidisciplinary care teams around the world will be prepared. This is essential to our Project ACT initiative, which is accelerating islet cell therapies that do not require immunosuppression for the T1D community.
Our goal is to advance islet cell transplants and establish Centers of Reference around the world, so that people anywhere can access these therapies as they become available. Centers of Reference are leading the way for safe and effective integration of manufactured cell therapies into clinics. These annual meetings provide a platform for international experts to connect and refine these Centers over two days of idea-sharing and collaboration. We’re already looking forward to seeing what the team will have accomplished by this time next year!
Karen Shishino Jordan, a long-time volunteer leader in the greater California Bay area, will serve as Breakthrough T1D (formerly JDRF) International Board of Directors (IBOD) Chair, succeeding current Chair Lisa Fishbone Wallack. Carlton McMillan, also a dedicated volunteer leader in the greater California Bay area, will serve as Vice Chair, succeeding current Vice Chair Matt Varey.
Karen’s and Carlton’s terms as Chair and Vice Chair, respectively, begin Wednesday, July 1, 2026.
Breakthrough T1D’s IBOD is the organization’s governing body. The IBOD is tasked with accelerating the organization’s mission progress toward life-changing breakthroughs to cure, prevent, and treat T1D and its complications. Learn more about Breakthrough T1D’s volunteer and staff leadership.
About the New Chair and Vice Chair
Karen Shishino Jordan became involved with Breakthrough T1D when her daughter Ali was diagnosed with type 1 diabetes (T1D) in 2008. In 2023, Karen was diagnosed with T1D which has added to her unique and deep understanding of what it means to live with the disease.
Karen has served on Breakthrough T1D’s IBOD and several Board Committees for more than a decade. Karen has lent her time and expertise across the entire organization having served as Chair of the Research Committee, a member of the Audit & Risk Committee, and as the current Chair of the Finance and Investment Committee through June 30, 2026. In years prior, she served as Chair of IBOD’s Funding Committee. Karen also serves on the Board of Directors of the T1D Fund: A Breakthrough T1D Venture, and on the Board for Breakthrough T1D’s Northern California Chapters. She is a member of the Joint Steering Committee for The Breakthrough T1D Center of Excellence in Northern California, which combines the expertise of Stanford University’s School of Medicine and the University of California, San Francisco. She is the inaugural recipient of Breakthrough T1D’s John Brady Award for Innovation.
Karen serves on the Board of Stanford Healthcare and is the recipient of the Stanford University Governor’s Award. She is also a Board member of Stroke Onward. Her previous nonprofit work includes service on various boards, committees, and councils, including the Stanford Athletics Board, Stanford Medicine Community Council, and the Portola Valley School District. Karen earned her Bachelor of Arts degree in Economics and Business from the University of California, Los Angeles; her Master of Business Administration degree from the Stanford Graduate School of Business; and a Genetics and Genomics Certificate from Stanford Medicine. She is a member of Forward Global and has worked as an investment banker.
Carlton McMillan joined the IBOD in 2023. He previously served on the Finance & Investment Committee and currently serves on the Nominating and Governance Committee. He was also the Chair of Board Development and Nominating and the Chair of Corporate Development on Breakthrough T1D’s Northern California Chapters Board, where he served for five years.
He became involved with Breakthrough T1D through his wife Ansley, who was diagnosed with T1D at age five. In prior years, Carlton spearheaded a corporate partnership between Airbnb and Breakthrough T1D and served as Team Captain of Airbnb’s Corporate Walk team. In addition, he and Ansley served as co-chairs of the San Francisco Walk committee in 2016 and 2017.
Carlton is Head of Finance & Operations at Watershed, an early-stage technology company focused on sustainability and carbon reduction for large global enterprises. Prior to Watershed, Carlton spent 10 years at Airbnb, where his time was split between scaling the company from its earliest stages through a public offering and building and launching Airbnb.org, a standalone 501c3 focused on emergency housing for the displaced. Prior to joining Airbnb, Carlton worked in public accounting and financial advisory services in Atlanta, GA. Carlton also serves on the Board of Directors and the Finance and Investment Committees of the San Francisco School in San Francisco, CA. Carlton received his Bachelor of Science degree in Business Management from the Georgia Institute of Technology (Georgia Tech).
An Era of Unprecedented Breakthroughs
This new leadership coincides with an era of unprecedented T1D breakthroughs championed by Breakthrough T1D.
“We are in a golden age of advanced medicine and are witnessing incredible progress in T1D cures research in all areas we support—especially cell therapies,” said Aaron J. Kowalski, Ph.D., Breakthrough T1D Chief Executive Officer.
“As the leaders of our International Board of Directors, Karen and Carlton will ensure we continue to drive cures and other life-changing breakthroughs forward through scientific advancements, advocacy, and clinical care,” he added.
“We thank Lisa and Matt, who were instrumental in helping us launch Project ACT (Accelerate Cell Therapies) among other accomplishments. Project ACT will dramatically help speed cell therapy products as cures through coordinated efforts to advance research, development, regulatory, access, and adoption,” he said.
“There has never been a more exciting time for our mission. People in clinical trials of cell therapies that we support are making insulin again, and many have been able to stop taking insulin therapy,” Kowalski said. “The potential for transformation is nothing short of electrifying and we look forward to the progress to come during Karen’s and Carlton’s time leading our International Board of Directors.”
Marilyn and Dr. Gerald Fishbone knew first-hand how incredible research changes the lives of people with type 1 diabetes (T1D). For more than 50 years, they were pillars in the T1D community, dedicating their lives to helping advance innovative research.
Marilyn and Gerald became deeply involved with Breakthrough T1D (then JDF and later, JDRF) in 1969 after their then-18-month-old son, Scott, was diagnosed with T1D.
“I had never heard of diabetes. No one in our family, before Scott, had diabetes,” Marilyn said in a 2021 interview with Breakthrough T1D.
Gerald passed away January 16, 2023. Marilyn, his beloved wife, passed away March 31, 2026.
After Scott’s diagnosis, Marilyn went on to found the New Haven, CT, Chapter, and remained an engaged volunteer and donor. Gerald served in many roles at Breakthrough T1D, including Chair of the Breakthrough T1D International Board of Directors (IBOD), Medical Advisor, Research Committee member, and donor.
The Fishbones created a legacy of service which is being carried forward by their children and grandchildren.
Their daughter, Lisa Fishbone Wallack, became Chair of IBOD in 2024 and had previously served as Vice Chair. She had also served as President of the Greater New England Chapter.
Their son, Scott, is a dedicated Breakthrough T1D volunteer leader who serves on the New Jersey Chapter Board and on the Chapter’s Executive Committee as Advocacy Co-chair.
“We believe in being involved and giving back,” said Marilyn. “Our kids joke that they never ate on a clean dining table because it was always covered in Breakthrough T1D fundraising envelopes. Most of the time, it was. We worked extremely hard and committed ourselves as a family to giving our time and energy to Breakthrough T1D and to inspiring others to join us.”
In 2001, the Fishbones’ then 5-year-old grandson, Harris Wallack, was diagnosed with T1D.
“His diagnosis, while still devastating, was so different. The technology available to make it safer and easier to manage T1D was drastically improved from when Scott was diagnosed,” explained Marilyn. “That is all thanks to the strategic leadership of Breakthrough T1D.”
The Fishbones are greatly missed. Their dedication and generosity to Breakthrough T1D will be felt by all members of the T1D community for decades to come.
Read more about Dr. Gerald Fishbone’s life.
Read more about Marilyn Klugman Fishbone’s life.
Breakthrough T1D is back from Barcelona! The final two days of ATTD were jam-packed with more incredible updates across all areas of our mission. Breakthrough T1D staff chaired and participated in many sessions—including Breakthrough T1D Senior Vice President of Research, Esther Latres, Ph.D.; Vice President of Medical Affairs Anastasia Albanese O’Neill, Ph.D., APRN, CDCES; Senior Director of Research, Jonathan Rosen, Ph.D.; and more.
Jump down to:
Screening
Screening is important! From preventing life-threatening diabetic ketoacidosis (DKA) at diagnosis, to giving people the opportunity to intervene with Tzield or disease-modifying therapies in clinical trials, to having more time to plan and prepare for type 1 diabetes (T1D) onset—screening and early detection are essential to our mission. And it must happen at a large scale if we’re going to achieve cures—which is why it was so heavily represented at ATTD 2026.
Vice President of Medical Affairs Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, chaired yet another panel where screening was again discussed. To repeat from our earlier recap, T1D Screening and Early Detection is a key mission priority for Breakthrough T1D. Multiple presentations illustrated how important it is, and why we need to screen more people to achieve our vision of a world without T1D.
One theme, and why it came up over and over again, is that we need more public education about screening, the benefits of early detection, and how mission-critical it is. It’s not an accident that there were many sessions that all hammered this home.
What can you do? Tell your community about screening!
Disease-modifying therapies
What are disease-modifying therapies?
Disease-modifying therapies are drugs that change the course of T1D. That means slowing or halting the progression of the disease, preventing it from ever occurring, and reversing it entirely.
There were several exciting presentations from some key Breakthrough T1D collaborators. This includes Jay Skyler M.D., MACP, FRCP, who outlined the challenges and obstacles that must be overcome at every stage in T1D in order to fulfill his personal mission to eradicate T1D before he retires. This includes disease-modifying therapies at different stages of T1D.
Another noteworthy lecture came from Chantal Mathieu, M.D., Ph.D. (who happens to be on the advisory committee for the Breakthrough T1D Clinical and Research Congress!). She focused on C-peptide, which is natural biomarker of insulin production.
Breakthrough T1D believes C-peptide should be a validated clinical trial endpoint. Dr. Mathieu agrees! Currently, metrics like HbA1c are used to evaluate the efficacy of therapies for early-stage T1D. In Dr. Mathieu’s opinion, HbA1c as a clinical trial endpoint will mean, simply, that it will be a very long time before another DMT joins Tzield as FDA an approved therapy for this disease.
And, most importantly, there are real benefits to maintaining beta cell mass and, therefore, having increased C-peptide function! We know this! And it’s up to Breakthrough T1D, academia, and others to persuade regulators that it’s time for it to be accepted as a clinical trial endpoint so there can be more options for people with T1D.
Cell therapies
Cell therapies, which place insulin-producing cells inside people with T1D, are a huge Breakthrough T1D priority, as exemplified by Project ACT.
Senior Vice President of Research, Esther Latres, Ph.D., chaired a session titled “Islet Cell Therapy: Cure for Type 1 Diabetes – How Far Are We?” This session highlighted Breakthrough T1D’s approach to cell therapies in pursuit of our ultimate goal: manufactured islets, produced at scale, transplanted without the need for chronic immunosuppression.

Cell therapies: Where are things now?
Islet transplants have been around for decades, but they require chronic immunosuppression. Additionally, deceased donor islets are in limited supply, meaning there are not enough islet cells for everyone with T1D who may want them.
Update on Eledon’s tegoprubart
Let’s start with the topic everyone is talking about: the use of Eledon’s tegoprubart with deceased donor islet cell transplants.
Breakthrough T1D is funding a trial at the University of Chicago evaluating the use of the targeted immunosuppressive therapy tegoprubart, instead of standard, broad immunosuppressants like tacrolimus, in islet cell transplants. The data so far has been very encouraging—and Principal Investigator, Piotr Witkowski, M.D., Ph.D., was at ATTD to share more.
What is Breakthrough T1D’s relationship with Eledon?
Breakthrough T1D has had a relationship with Eledon for several years, since Breakthrough T1D brought Eledon into the T1D space. Starting in 2023, Breakthrough T1D began funding a clinical trial that uses their drug, tegoprubart, with islet transplants in T1D, with initial additional support from The Cure Alliance and the Diabetes Research Institute. Additionally, the T1D Fund invested in Eledon in 2023.
All 12 recipients are off external insulin or on target to stop external insulin.
To date, 12 people with T1D have received deceased donor islet transplants and are receiving tegoprubart infusions every three weeks. All of the individuals are doing exceptionally.
Here’s some stats to back it up:
- All 12 subjects immediately experienced improved blood sugar levels and control.
- As of today, 10 of the 12 individuals are entirely off insulin therapy. The other two are on that trajectory.
- There have been zero unexpected adverse events, severe hypoglycemic episodes, thrombotic events, opportunistic infections, signs of rejection, or gastrointestinal symptoms.
- Crucially, there have been no signs of kidney and neurotoxicity, which is something that is observed in individuals who receive islet transplants and use tacrolimus.
The next step for this therapy is a study testing deceased donor islet cells in people with T1D and chronic kidney disease, funded by Breakthrough T1D.
The main takeaway? This remains a very promising alternative to current immunosuppression.
Sana’s gene-edited islets continue to make insulin
Per-Ola Carlsson, M.D., Ph.D., presented early results from a novel cell therapy approach designed to help transplanted islet cells evade immune attack while continuing to produce insulin.
The strategy uses gene editing to create hypoimmune islet cells—cells engineered to avoid detection by the immune system while maintaining their insulin-producing function. This approach is one of several next-generation cell therapy strategies being prioritized by Breakthrough T1D to help overcome one of the biggest barriers to cell replacement therapies: immune rejection.
Prior to this study, the concept had been demonstrated in non-human primates. Carlsson and his team have now taken the next step by testing the approach in a person living with T1D.
In this first-in-human study, deceased donor islets were genetically modified to become immune-evasive and then transplanted into the forearm. Because this was a phase 1 trial, the primary goal was to assess safety, while also monitoring islet function through C-peptide, a marker of the body’s own insulin production.
Importantly, the transplant included only about 5% of the number of cells typically needed to fully restore insulin production, reflecting the exploratory nature of the study.
The results so far are encouraging. After 60 weeks, there have been no severe or unexpected adverse events, meeting the trial’s primary safety endpoint. At 14 months after transplantation, the participant continued to produce detectable C-peptide, indicating that the transplanted cells remained alive and functional.
Researchers also observed that C-peptide levels temporarily declined after about one year, likely due to beta cell exhaustion, but subsequently recovered. This is an encouraging signal that the transplanted cells may be capable of regaining function.
While still very early, these findings provide important proof of concept that gene-edited, immune-evasive islet cells can survive and function in a person with T1D. If confirmed in larger studies, this approach could help move the field closer to cell therapies that work without long-term immune suppression—a major goal for the future of T1D cures.
Addressing challenges in cell therapies
Holger Russ, Ph.D. explored a key problem that must be overcome: manufacturing islets at a large scale is hard to do! He shared the processes that his team at the University of Florida uses and noted a secondary problem: we make all these cells, and a significant portion are lost post-transplantation. To solve that, he presented his work on different gene-editing strategies to keep these cells alive.
Katy Digovich, CEO of Minutia, discussed a different problem that needs to be solved: how do we monitor the transplanted islets? Minutia’s approach is to integrate gold (yes, gold) nanoparticles into the islet clusters, which allows them to safely monitor the cells and track graft survival and rejection.
All of this work is supported by Breakthrough T1D and/or the T1D Fund.
More to come soon for Vertex’s manufactured islets
Data from Vertex Pharmaceutical’s phase 1/2/3 clinical trial for zimislecel was presented by Trevor Reichman, M.D. This data is not new, but it reinforces the reasons for optimism around this manufactured islet cell therapy.
This therapy consists of fully differentiated, manufactured islet cells, infused into the portal vein using an approach similar to traditional donor islet transplantation. Participants are on immunosuppression, and the safety profile is consistent with the use of immunosuppressive medications.
Unfortunately for the T1D community, we’re not going to get new data for Vertex for some time because the data currently being collected will be used for their upcoming FDA submission. However, stay tuned for a Q&A with Vertex in the near future!
Improving Lives
Breakthrough T1D Director of Research, Jonathan Rosen, Ph.D., chaired the session “Bridging the Gap Between Academia and Industry in T1D.” This is an important priority area for us as we see ourselves as “gap fillers.” There is a pipeline from academia to industry to people with T1D, and Breakthrough T1D’s strategy is to identify these gaps and ensure that the pathway is as smooth—and complete—as possible.
This session featured several leaders from biotech illustrating how, ideally, everyone can work together to move products along. Some key points:

- Academia, startups, and big pharma companies all have strengths and weaknesses. All roles are important and it’s crucial to understand the limitations and capabilities of each player.
- Other key players: governments and non-profit organizations. Thanks to the Breakthrough T1D Advocacy team, there has been billions of funding to T1D research over the past few decades. All these products must undergo regulatory review. All play a part!
- What Breakthrough T1D can do is identify the shared objectives. Industry and Academia are not opposing forces, and it’s up to Breakthrough T1D to ensure everyone is bringing their strengths to the table and row in the same direction.
The use of adjunctive therapies, including GLP-1s, is a priority of the Breakthrough T1D’s Improving Lives Portfolio. The use of these drugs, which is often off-label and includes semaglutide and tirzepatide, is increasing in the T1D community.
The data backs this up. Satish Garg, M.D., presented research showing these medications may support weight loss, lower insulin requirements, and improved blood glucose, specifically including better time in range. We also heard again from Viral Shah, M.D., who gave a recap of the Breakthrough T1D-funded ADJUST-T1D study, which showed that the GLP-1 receptor agonist semaglutide (Ozempic) can improve weight and glycemic outcomes in people with T1D.
It’s true: GLP-1s are increasingly being used off-label in the T1D community, as demonstrated by the Breakthrough T1D-funded work of Francisco Pasquel, M.D., MPH. Using large-scale patient datasets from electronic health records, Dr. Pasquel found that rates of GLP-1 use are highest in people living with T1D and obesity in addition to those with cardiovascular disease (CVD) or kidney disease. While this class of drugs has potential to improve weight and blood sugar management, we need larger clinical trials to confirm safety, identify less-common side effects, and get a better idea of the non-glycemic benefits that GLP-1s may have for the T1D community.
To make some headway on the benefits of GLP-1s beyond glucose management, Janet Snell-Bergeon, Ph.D., MPH walked us through cardiovascular outcomes that were measured as a part of the ADJUST-T1D study. People treated with semaglutide had significant decreases in cholesterol and blood pressure. After plugging participant data into a cardiovascular risk prediction tool, Dr. Snell-Bergeon reported that people with T1D treated with semaglutide have a 20% reduced CVD event risk after five and ten years. We need more therapies to address CVD in T1D—while large-scale clinical trials are needed, this data demonstrates the potential for GLP-1s to improve cardiovascular outcomes in people with T1D.

One key thing to keep in mind when it comes to GLP-1s: safe implementation. Clinicians must work hard to avoid hypoglycemia while also preventing the onset of ketones and DKA. Breakthrough T1D has led this work for years, and is currently helping promote several clinical trials, including the SUPRASS-T1D study.
The risk of DKA also exists for a class of drugs known as SGLT inhibitors, which have proven to be effective for heart and kidney disease in type 2 diabetes (T2D) and people without diabetes, but are still being tested in T1D. Breakthrough T1D-funded researcher Ahmad Haidar, Ph.D., presented his work on changing ketone levels dependent on treatment with empagliflozin, an SGLT inhibitor, and lifestyle factors. Participants wore a continuous ketone monitor (CKM), and data showed that empagliflozin, in addition to lower-carbohydrate diets and greater physical activity, can increase ketone variability and the risk of ketosis. Dr. Haidar suggested that people with T1D may benefit from clinical time in range targets for ketones, and his studies demonstrate the potential of tracking ketone levels to predict and avoid DKA.

Thomas Danne wins an award

Breakthrough T1D Chief Medical Officer Thomas Danne, M.D., Ph.D., received the Children with Diabetes (CWD) President’s Award for Innovation. The award acknowledges a healthcare professional who exemplifies extraordinary leadership in using innovation and advancements in technology for devices that help people with diabetes thrive. An internationally recognized leader in endocrinology and pediatric diabetes, Dr. Danne has spent decades advancing research, clinical care, and global collaboration in the field.
“Breakthrough T1D is incredibly proud of Dr. Danne’s achievements and this well-deserved award for innovation and leadership in diabetes health care,” said Aaron Kowalski, Ph.D., Breakthrough T1D CEO. “Thomas’ many contributions to driving breakthroughs in type 1 diabetes therapy development and care have had a tremendous impact on the global T1D community and are instrumental in moving our mission forward, faster.”
Adios from Barcelona!
The next scientific conference we’ll be covering is the Annual American Diabetes Association (ADA) Scientific Session, which takes place from June 5-8 in New Orleans.
And, don’t forget, Breakthrough T1D will be hosting our first ever Clinical and Research Congress in Philadelphia in October! Over two and a half inspiring days, clinicians, researchers, scientists, healthcare professionals, industry leaders, and the T1D community will explore cutting-edge advances in T1D discovery science, immunotherapies, automated insulin delivery, islet cell therapies, psychosocial care, health equity, and more. Designed to foster collaboration and spark innovation, CRC 2026 will provide translational insights, interactive learning, and meaningful dialogue, all with one shared goal: improving lives and driving toward a world without T1D. Register today—and submit abstracts!
This article was written by Brian Herrick and Sandy Vogt, Ph.D.
Greetings from Barcelona, Spain! From March 11–14, 2026, the world’s leading type 1 diabetes (T1D) researchers, healthcare professionals, and industry partners gathered to share groundbreaking advances in T1D science—and Breakthrough T1D–supported work (and staff) were front and center.
Below is everything you need to know from the first two days of this remarkable conference, including key takeaways from panels and sessions chaired by Breakthrough T1D staff and supported researchers. Featured participants included Breakthrough T1D CEO Aaron Kowalski, Ph.D.; Chief Scientific Officer Sanjoy Dutta, Ph.D.; Thomas Danne, M.D., Ph.D., Chief Medical Officer; Vice President of Medical Affairs Anastasia Albanese O’Neill, Ph.D., APRN, CDCES; and many more.
Screening
T1D Screening and Early Detection is a key mission priority for Breakthrough T1D—and multiple presentations illustrated how important it is, and why we need to screen more people to achieve our vision of a world without T1D.
The landscape of T1D screening today is incredibly exciting—and has come a very, very long way in recent years. Across the globe, the number of people being screened, which includes kids and adults, is growing significantly. In addition to the U.S., screening numbers are on the rise across Europe, Australia, Qater, Israel, and now in Central America.
So—what are some big takeaways on screening?
Global screening programs
EDENT1FI, a European screening initiative supported by Breakthrough T1D, presented data from around the world on screening for early detection. One of the presenters was Breakthrough T1D VP of Medical Affairs, Anastasia Albanese-O’Neill, Ph.D., APRN, CDCES, who shared our screening strategy and underscored the importance of international consensus recommendations for screening and monitoring that can be used in clinical care. This session outlined the global scope of screening that Breakthrough T1D is supporting.

Breakthrough T1D is funding a truly global network of screening programs. From ELSA in the United Kingdom to ASK and TrialNet in the U.S. to FR1DA in Germany, all these centers are working together to build the case for general population screening. They’re doing this by improving outcomes for people with detected autoantibodies, providing follow-up monitoring, enrolling eligible individuals in clinical trials (including Breakthrough T1D-funded INNODIA), offering FDA-approved therapies like teplizumab (Tzield), and learning the best ways to educate and inform people of the benefits and logistics of screening and follow-up monitoring.
Education and communication are key. One incredible learning from Italy and the United Kingdom is how people learn about screening. For the majority of individuals, it’s through school and through social media. It’s up to all of us to help spread the word. Learn more about our screening programs here.
Another key takeaway from the ELSA study: no one who learns that they have T1D autoantibodies regrets having that knowledge. However, there are gaps around how we can help people with that information and how we can better support families who have detected T1D early.
Free, voluntary general population screening for T1D and Celiac Disease is now law in Italy. Francesca Ulivi from the Italian Diabetes Foundation shared what Italy is learning about how they are increasing the number of people screening—and to add to an earlier note, education is key.
Clinical adoption of T1D screening
In 2024, Breakthrough T1D led the way with the publication of Consensus Guidance for Monitoring Persons with Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes. This report contains guidelines for what to do when T1D autoantibodies are detected—but it does not touch on the bigger question: who to screen?

To make the case for general population screening, Breakthrough T1D convened a group of international experts to establish guidance for the clinical adoption of screening for early detection. This paper is expected to be published later this year and will be a clinical roadmap for general population screening—so more people can realize the benefits.
Breakthrough T1D Chief Scientific Officer, Sanjoy Dutta, Ph.D., also spoke to our organization’s vision for expanding general population screening.
Breakthrough T1D is funding a series of pilot screening programs across the country. These centers aim to develop and test diabetes center workflows for screening and monitoring for T1D. We are learning a lot from these, as presented by Carla Demeterco-Berggren, M.D., who runs a Breakthrough T1D-funded screening pilot in San Diego. Some key takeaways:

- With proper monitoring, DKA is almost completely preventable. Her center has had 0 people who had autoantibodies detected present with DKA at diagnosis.
- Successful T1D screening takes an integrated approach within the hospital setting, from hospital leadership to the nurses running the diabetes clinics.
- More importantly—it takes a team! Screening is just one step. Monitoring is where DKA prevention happens. And it takes a team to do that.
- The more people we screen, the more people can benefit!
Disease-modifying therapies
Disease-modifying therapies (DMTs) have the potential to change the course of T1D by slowing, halting, or reserving its progression. Teplizumab (called Tzield in the U.S.) was the first DMT approved by the FDA in November 2022 for individuals with early-stage T1D, delaying the onset of clinical, symptomatic T1D and the need for insulin therapy by a median of two years. Since its approval, and thanks to increased education and awareness around screening, hundreds of people have had the opportunity to benefit from teplizumab.
Breakthrough T1D and Tzield
Learn more about the first disease-modifying therapy for T1D and how Breakthrough T1D helped guide it through every stage of therapy development.
The changing landscape of available T1D therapies requires healthcare professionals (HCPs) to consider how to best work within existing care structures to support their patients who are using therapies like teplizumab. In an informative session led by Breakthrough T1D-funded researchers Prof. Colin Dayan, BSc, MBChB, Ph.D., FRCP from Cardiff University, Michael Haller, M.D. from the University of Florida, and Prof. Olga Kordonouri from Children’s Hospital Auf der Bult in Hannover, Germany, these superstar endocrinologists walk us through practical considerations for use of teplizumab in clinics and real-world experiences from the perspective of both teplizumab recipients and caregivers.

- People considering teplizumab should work with their diabetes care team to ensure they meet pre-assessment, vaccination, and other requirements and are able to tolerate intravenous access for the duration of the infusion.
- Teplizumab requires 14 consecutive infusion days, and people may have the opportunity to finish the infusion process at home with a home healthcare aide after the first five days in an infusion clinic. Everyone is consistently monitored for safety both during and after the infusion process.
- Multidisciplinary staff, diverse training, and specific infrastructure are required for successful teplizumab infusion, monitoring, and follow-up. This includes infusion nurses, on-call clinicians, pharmacy coordination, thorough documentation, after-hours care, support for travel and lodging for families coming from afar, and centers that have the capacity to deliver teplizumab for 14 days straight.
- In a survey of 47 people who received teplizumab in the U.S., 49% had a family history of T1D, 47% were initially misdiagnosed with type 2 diabetes, and 36% had other autoimmune conditions.
- In the same survey, 98% of people reported that their rationale for choosing teplizumab was to delay T1D onset. While most respondents were grateful to receive the therapy and would recommend it to others, people still check blood sugars often and worry about what to eat.
Cell therapies
While the current standard of care for T1D has taken immense strides in the recent past, one thing is abundantly clear: people with T1D are not doing well enough. Per data presented by Breakthrough T1D-funded researchers Jason Gaglia, M.D., Trevor Reichman, M.D., Jennifer Sherr, M.D., and Jay Skyler, M.D. at Vertex Pharmaceuticals’ Industry Session, globally, about 25% of people with T1D are hitting their ideal HbA1c target of under 7%. Automated insulin delivery (AID) systems—which have been transformative for T1D care—are improving outcomes, but the majority of people are not achieving their ideal goals. This means that most people with T1D are more at risk for the most common complications of the condition, including heart disease, kidney disease, and diabetic eye disease.
Among the individuals who are achieving ideal HbA1c goals, an acute complication begins to emerge: severe hypoglycemic events.
This paints a pretty clear picture: we need better therapies to help people do better, and cell therapies have the potential to fill the gaps between how people are currently doing and where they need to be to prevent long-term and acute complications.
Currently, deceased-donor islet transplants are an option, but they are not an option for the majority of people with T1D due to a scarcity of deceased-donor islet cells (it can take 4 donor pancreases to get enough cells for one person) and the drawbacks of chronic immunosuppression.

The future Vertex and the field at large is driving toward is one where manufactured islets are mass produced at scale, which solves the scarcity problem, and are used with novel techniques to keep them safe from the immune system—including gene-edited cells and alternatives to modern immunosuppression (like Eledon’s tegoprubart).
One other note: someone in the audience inquired as to why more people in the U.S. do not receive islet transplants. The panelists were in agreement that it is due to the current regulatory environment for deceased-donor islet cells, which classifies them as biologics, not organs. This reinforces Breakthrough T1D’s efforts to urge the Department of Health and Human Services to reclassify deceased-donor islet cells as organs—which it has the legal authority to do now.
Improving Lives
All the major T1D tech companies were present and accounted for at ATTD. Omnipod, Abbott, Tandem, Minimed, Dexcom, and more highlighted their current devices and how they can improve diabetes management.
We’re not going to cover the specifics of these devices, but one theme was consistent throughout the presentations: people utilizing AID systems and continuous glucose monitors (CGM) have better outcomes.
But there were some exciting developments around adjunctive therapies, the use of artificial intelligence, and a new approach: gene therapy.
The use of Artificial intelligence (AI) is a hot topic at ATTD. This topic was presented by longtime Breakthrough T1D collaborator Boris Kovatchev, Ph.D., in the opening lecture and Giacomo Cappon, M.D., Marc Breton, Ph.D., and others in a plenary session chaired by Breakthrough T1D CEO Aaron Kowalski, Ph.D.

One of the more interesting areas discussed was the use of digital twins—virtual models of a person with T1D. These models allow researchers and clinicians to test potential changes in diabetes management in a simulated environment before talking through and implementing those adjustments in real life. The potential is big, but there are still risks. AI-generated “hallucinations,” e.g. 2 + 2 = 7, can occur, and any therapeutic recommendations need human review. Even so, the promise of these tools for T1D is significant.
Dr. Kovatchev and Dr. Breton also highlighted how AI is already being used in clinical trials. Their talks focused on AID As a Network (AIDANET), an AI-based AID system. This fully closed-loop setup—using a Dexcom G6, a Tandem t:slim insulin pump, and a smartphone—first learns from insulin pump and CGM data. Once it understands a person’s patterns, it takes over and fully automates insulin delivery. No mealtime announcements required.

Dr. Breton shared data from a Breakthrough T1D–funded study using AIDANET, and the results were striking. People who already had lower HbA1c levels saw modest improvements, while those starting with higher HbA1cs experienced significant gains. In this fully closed-loop, no-bolus approach, AIDANET was better than standard use across nearly every outcome for the 34 people in the clinical trial—and overall, it delivered superior glycemic control.
How does it achieve this? Essentially, AIDANET performs about as well as usual care during the day and then outperforms it at night.
Breakthrough T1D continues to fund this work, including the AIDANET clinical trial in adolescents and young adults that Dr. Breton presented. The takeaway so far: AIDANET delivers equivalent control for people who are already well managed—and even better outcomes for those with higher HbA1c levels.
And here’s something to look out for: there is an ongoing clinical trial testing AIDANET at home in over 50 people with T1D. The data should come out soon—and should be another proof point in support of the use of AI in T1D.
Gene therapy in T1D
Longtime Breakthrough T1D collaborator Jeremy Pettus, M.D., was in attendance to share information from Kriya Therapeutics, a T1D Fund portfolio company. Kriya is pursuing a gene therapy for T1D, and it’s an exciting new approach to achieving glycemic control.
Gene therapies explained
Gene therapies are still fairly new—there are 7 approved today, and they primarily are used for rare diseases. They work by using a safe, non-pathogenic virus to deliver genetic information into the nucleus of a cell. This process does not alter the individual’s chromosomes or genetic makeup but can correct genetic abnormalities or change the behavior of cells to treat disease.
Applications in T1D
Kriya’s approach is to modify muscle cells to secrete insulin. This is very different from, for example, beta cell therapies, which place insulin producing beta cells into people with T1D. In Kriya’s therapy, there are no new beta cells or transplanted cells that require immunosuppression—it’s just enabling muscle cells to make insulin.
The administration of this therapy is fairly straightforward. For 2-3 months in advance of the procedure, the recipient takes immunomodulatory drugs. Then, they undergo a procedure where they receive intramuscular injections in both thigh muscles. Then, the person goes home. After 2-3 months, the cells are fully up to speed and making insulin, which has the potential to help control blood sugar levels and reduce insulin therapy requirements.
Clinical trials
In large animal models, the data is very encouraging—after receiving the therapy, blood glucose levels were normalized on the order of years. Based on this data, clinical trials are expected to begin in people this year.
This phase 1 clinical trial, called the Progress Study, will assess dosage and safety, and the phase 2 trial will expand to assess broader safety and efficacy.
This is a new and innovative approach supported by the T1D Fund. If you’re interested in participating in the clinical trial, stay tuned to our clinical trials page, which is regularly updated with opportunities like this.
Medical Affairs
Breakthrough T1D Chief Medical Office Thomas Danne, M.D., Ph.D. ,outlined the goals of our Medical Affairs team—which is to improve the world’s ability to accelerate implementation of current and future breakthroughs so that, ultimately, people with T1D can have better quality of life.

The current state of endocrinology globally is a growing concern. For example, we don’t have enough endocrinologists and diabetes educators to take on of the growing and aging population of people with T1D. Clinical adoption for teplizumab, the first approved DMT for T1D, has been slow. We must build the infrastructure today to ensure that in the future, there isn’t a gap between the breakthroughs in the lab becoming breakthroughs for people with T1D.
Dr. Danne outlined the vision for a training program that will entice a new generation of endocrinologists as the field evolves and new methods of treating T1D are available. Breakthrough T1D and ATTD are supporting a certificate program for an interventional diabetologist, which includes training in immunology, using immune therapies to treat individuals in stage 1 and stage 2, education on cell therapies for those in stage 3 and stage 4, and the other advancements in the pipeline. He also spoke about other work the Medical Affairs team is involved in including the Centers of Reference, an international collaboration creating a roadmap for implementing manufactured cell therapies into clinics once they become available.
More to come!
We have even more exciting updates to share with you. Keep an eye out for our recap of days 3 & 4 of ATTD, coming next week!
This article was written by Brian Herrick and Sandy Vogt, Ph.D.
This article was written by Alecia Wesner (pictured above, right), a Participant Advisory Council (PAC) member, a Clinical Trial Education Volunteer, and long-time Breakthrough T1D supporter. Alecia’s story details her lived experiences with type 1 diabetes, participation in clinical trials, and her journey to joining the PAC. The views expressed by the author are her own and are not necessarily representative of Breakthrough T1D or our leadership, employees, or supporters.
Where it all began

I was diagnosed with type 1 diabetes (T1D) in 1979 in suburban Philadelphia. I had just finished kindergarten, learned to ride a bike, and spent summer days pedaling the block. I was thirsty all the time. I was a new little cyclist and it was summer, of course I was thirsty! One day I drank an entire quart of iced tea, within mere minutes, at a neighbor’s house. That was the red flag. My pediatrician sent us to the local hospital, and multiple nurses and a doctor held me down as they repeatedly struggled to find a vein for a blood draw. My Dad took me for pancakes afterwards—definitely not ideal without insulin. Later, there was a phone call and my Dad left the house. I saw him sitting outside with his head in his hands. It was the first time I saw him cry. My Mom pulled me away from the window.
I spent the next week and a half in a children’s ward of a Philadelphia hospital. My parents were trained to care for me, and I practiced giving insulin shots on an orange while arts and crafts kept me busy. I spoke to my parents every night on a pay phone, whispering, while crying that I wanted to come home. My parents would say the other children in the ward needed me to be brave. This was long before continuous glucose monitors (CGMs) or even portable blood glucose meters. My parents learned to check my glucose by testing my urine with chemicals in test tubes, a non-exact way to measure glucose range. When I came home, neighbors were anxious because many believed diabetes was contagious.
A designer’s perspective on T1D clinical trials

Clinical trials and research have been central to my life. Clinical trials are essential to proving a concept, where ideas are tested rigorously and then refined.
My training as an industrial designer has always been about the intersection of people and systems. Whether designing a lighting fixture, a user interface, or an educational program, I think first about human needs, usability, and empathy.
That design lens informs how I view research. A study protocol is not just a list of procedures. It is a system that has users, interfaces, and outcomes. Participants are the users. Devices and consent forms are the interfaces. The data is the outcome. When design thinking is applied to research, studies become more accessible, clearer, and better aligned with the realities of daily life.
A defining experience
For those of us living with type 1 diabetes, research is not just academic—it is the path to a better quality of life. I have participated in nine clinical trials and numerous studies. I tested early automated insulin delivery (AID) systems over many years, assessing software and hardware which led to commercially available AID systems. I tested an implantable continuous glucose monitor, and I took part in studies that examined complications and diabetes biomarkers. Each trial taught me about technology, the human body (specifically mine), and how research truly impacts lives.

The experience that defined my clinical trial pathway was in my mid-20’s. I developed retinopathy. Due to a great macular specialist, I received aggressive laser treatments for years. It was scary, especially as a young professional starting a career in product development and visual design. The treatments that preserved my vision were possible because others had volunteered for research for years, even decades, before me. That reality gave me enormous gratitude, and it also gave me a sense of responsibility. Participating in research is how I have been able to embrace a life philosophy of “Do good, feel good” and ultimately pay it forward. Clinical trials and research studies are how we learn and design better solutions for everyone who follows.
Joining the Participant Advisory Council

My designer’s perspective led me to join the Breakthrough T1D Participant Advisory Council (PAC). I had been involved with Breakthrough T1D for many years as a Clinical Trial Education Volunteer, an advocate, and former board member. The PAC offered a new opportunity to bring lived experience directly into the research process.
On the council, we review trial designs, advise on participant burden, critique consent language, and recommend practical changes in the hope of lowering barriers to participation. My concern initially was that I’d be a token voice, but we are not. We are advisors who help researchers see the experience through the eyes of the people who will take part in the studies—people who may ultimately benefit from the data gained.
One of the most meaningful ways I contributed as a PAC member was in June 2025, when I spoke on a panel about disease-modifying therapies (DMTs) at the American Diabetes Association Scientific Sessions in Chicago. The panel focused on disease-modifying therapies designed to preserve C-peptide (a biomarker for insulin production) and slow or stop the progression of T1D. I represented the lived experience, and I brought the perspective of a long-term clinical trial participant and an educator who helps others understand and navigate research opportunities.
Using my voice to spread awareness about clinical trials

There were numerous questions to be addressed. One question asked how patients view trials targeted at specific subsets of the T1D population compared to all open trials. My answer was that subsets are still part of the whole community, and a win in one group can expand to broader benefits. At the same time, being excluded from any study can feel deeply personal. People who have made the decision to participate and then hear they do not qualify may feel a sense of loss and frustration. That is where clear communication and education matter. Explaining why inclusion and exclusion criteria exist, offering information about other potential trials, and keeping lines of communication open helps people stay engaged rather than feeling shut out.

Recruitment, especially for new onset trials, is another challenge the panel addressed. Speed matters because opportunities for early intervention are time-sensitive. Effective recruitment requires a network approach. Endocrinologists and clinicians are critical, but so are community organizations, advocacy groups, and peer networks. Many newly diagnosed people search for help and connect with the T1D community to find resources. When trusted peers share information about trials, it not only demystifies the process and reduces the emotional burden for families facing a new diagnosis—it opens doors.
We also discussed patient-relevant endpoints in DMT trials. Clinical metrics matter, but they do not capture everything people live with. Participants prioritize outcomes that reduce daily burden, delay disease progression, improve long-term health, lower the risk of severe hypoglycemia, preserve endogenous insulin, enhance glycemic control, potentially reduce lifetime treatment costs, and sustain hope. These are the practical changes that matter in everyday life.
Education and implementation were the final themes I emphasized. Clinicians and patients alike need clear information about DMTs and about how early interventions would be implemented in real-world settings. Linking DMTs to screening efforts ensures that people in the early stages of T1D are identified and connected with options. Volunteers, advocacy groups, and community programs are essential for amplifying success stories and helping clinicians and patients understand how to access emerging therapies.

“Research is deeply personal”
All of this ties back to design. When we include lived experience in research design, the results are more humane, relevant, and practical. We reduce friction that prevents people from participating, and we improve outcomes by focusing on the needs of real users. My perspective as both a person who lives with T1D and an industrial designer helps me see where small design decisions have large effects.
Looking forward, I remain committed to this work because research is deeply personal. It saved my vision. It offers better tools and brighter possibilities. It is also a way to honor those who volunteered before me and to give others the chance to benefit. Whether I am advising on study protocols, speaking on national panels, or teaching people how to find trials, I see it as part of the same lifelong commitment: to make life with T1D easier, to improve the design of treatments and systems, and to help guide us toward the ultimate goal: cures.

If you or someone you know may be interested in joining the Participant Advisory Council, please reach out to Michelle Simes-Kennedy at [email protected].
Learn more about clinical trials
Visit Breakthrough T1D’s clinical trials web page to learn more about how you can get involved in clinical trials. Use our clinical trial matching tool to find recruiting trials near you that you may be eligible for. Connect with a Clinical Trial Education Volunteer in your area to better understand the process and get your questions answered.
What’s happening?
Today, Breakthrough T1D co-hosted an event with leading international diabetes organizations to discuss cardiovascular disease (CVD) and type 1 diabetes (T1D)—where we are, challenges that remain, and how we can work together in Europe and beyond to address this need for the T1D community.
The focus of the event: Doing more for CVD and T1D

This event, titled “Type 1 Diabetes & Cardiovascular Disease: From Data to Solutions,” took place today on November 14, 2025, in Brussels, Belgium. Breakthrough T1D co-hosted this event in conjunction with the International Diabetes Federation (IDF) Europe and the International Society for Pediatric and Adolescent Diabetes (ISPAD). The goal was to bring together different stakeholders to address a critical concern: the lack of therapies for cardiovascular disease for people living with T1D.
The speakers at the event covered a range of topics. Jonathan Rosen, Ph.D., Director of Research at Breakthrough T1D spoke about the often-overlooked link between CVD and T1D. Others touched upon lessons we can learn from (T2D) diabetes and CVD, the gaps in evidence that still exist, new frontiers in CVD care for people living with autoimmune diseases, and the inclusion of T1D in CVD therapy development.
Attendees
From Breakthrough T1D:
- Sanjoy Dutta, Ph.D., Chief Scientific Officer
- Jonathan Rosen, Ph.D., Director of Research
- Carmen Hurtado del Pozo, Director of European Research
- Hilda Ahnstedt, Program Officer of European Research
- Alessandro Bisio, M.D., Director of Medical Affairs, International
Other attendees:
- Speakers from the European Medicines Agency
- Member of the European Parliament: Elena Nevado del Campo (EPP, Spain)
- People living with T1D
- Researchers
- Industry leaders
Why this matters

People living with T1D have a high risk of developing heart complications, despite advances in T1D care. At this time, there are only a few options available to lower this risk. In the United States and Europe, people with T1D have access to blood pressure medications and lipid-lowering medications (for example, statins) that can reduce the risk of developing CVD.
Other therapies, like the SLGT inhibitors empagliflozin or dapagliflozin, are the standard of care in the U.S. to treat heart failure in people without diabetes or with T2D. This class of drugs has revolutionized treatment and significantly reduced the rates of heart failure in these populations. However, people with T1D were excluded from these clinical trials—despite the fact that heart disease remains a critical concern for the T1D community. While not strictly approved, these drugs are occasionally prescribed off-label to reduce the risk of heart failure in people with T1D. Greater accessibility will require regulatory approval, and these options are not currently available for people living in Europe.
Despite the availability of some treatments that can reduce the risk of heart complications, there are no available cardioprotective therapies in the U.S. or Europe that can prevent CVD in people with T1D. More targeted, innovative therapies and treatment strategies are needed to further reduce the risk of—or ideally prevent altogether—cardiovascular complications in the T1D population.
There is a clear unmet need for the T1D community: the risk of CVD is high, and there are not enough options to treat or prevent it. That’s where events like these come in. They are a call to action for collaborative research efforts, better data integration, new and innovative ideas, and global cooperation towards a shared goal of better heart health for people living with T1D. The growing prioritization of CVD is evidenced by the European Commission’s cardiovascular health plan—which includes the Joint Action on Cardiovascular Diseases and Diabetes—showcasing how stakeholders in Europe are taking charge to accelerate breakthroughs for CVD and T1D.
What we’re saying
“Cardiovascular disease remains the leading cause of death for people with type 1 diabetes, yet targeted therapies and guidelines are still lacking. In collaboration with IDF Europe, ISPAD, and aligned with the European Commission’s cardiovascular plan, this event brings together researchers, clinicians, patient advocates, regulators, and industry partners to drive collaborative solutions and accelerate progress toward better prevention and treatment strategies.”
Addressing the challenge of cardiovascular complications is a cornerstone of our Improving Lives strategy. Breakthrough T1D is actively supporting clinical trials for therapies that can reduce or prevent CVD in people with T1D, and we are working on identifying new projects and researchers to fund to further accelerate these efforts.
We are committed—on a global scale—to making sure people with T1D live the best lives possible, which includes having accessible therapies that reduce the risk of heart complications. Events like these bring together the right people that can make this happen in Europe and beyond.

