2025 Top T1D advances: Full speed ahead

First things first: cell therapies. One of the biggest breakthroughs that had the T1D community buzzing in the last year was Sana Biotechnology’s donor-derived islets that are genetically engineered to be invisible to the immune system. These cells are still making insulin 6+ months after the first person was treated—without immunosuppression! Sana—a portfolio company of the T1D Fund: A Breakthrough T1D Venture—published this accomplishment in The New England Journal of Medicine.

On the manufactured cell therapies front, Vertex Pharmaceuticals continues to hit milestones with zimislecel (formerly VX-880)—a therapy that Breakthrough T1D has had a hand in for decades. Promising results from the phase 1/2/3 clinical trial were published in The New England Journal of Medicine, revealing that 10 of 12 participants (83%) are insulin therapy independent. The study is ongoing.

Tegoprubart, an immunomodulatory drug made by the T1D Fund portfolio company Eledon, is being investigated as an alternative to standard immunosuppressants to help prevent transplanted islets from rejection. In a Breakthrough T1D-funded trial, six individuals who have received a donor islet transplant and tegoprubart are now insulin therapy independent. Preliminary data suggest that tegoprubart is more tolerable and has milder side effects compared to standard immunosuppressants—paving the way for easier post-transplant management. The study is ongoing, and nine people total are enrolled. The promising results from this trial opened the doors to another Breakthrough T1D-funded study that will include people with T1D and chronic kidney disease (CKD)—a population that was previously excluded from islet transplants due to side effects associated with standard immunosuppressants.

Cell Pouch is an implantable device that provides a livable environment for transplanted islets to help them survive. The ongoing phase 1/2 trial investigating Cell Pouch with donor-derived islets is on track to meet its endpoints for safety and tolerability, and people are achieving insulin therapy independence. The final cohort of this trial, which is expected to initiate before the end of this year, will use manufactured islets provided by Sernova’s partner Evotec. Even more, this cohort will receive Eledon’s tegoprubart instead of standard immunosuppressants—accelerating progress on two fronts at once. Breakthrough T1D has been supporting the development of Cell Pouch over many years, and we look forward to seeing data from the final cohort.

Building on results from a promising study funded by Breakthrough T1D, Eli Lilly launched two new pivotal clinical trials for baricitinib, a JAK inhibitor that is already approved for other autoimmune diseases. The trials will test whether baricitinib—which is taken as a once-daily oral pill—can delay the progression of stage 2 to stage 3 T1D (BARICADE-DELAY) or preserve beta cells in newly diagnosed stage 3 T1D (BARICADE-PRESERVE). Enrollment will open in 2026.

Another disease-modifying therapy is coming down the pike: ATG. Following from prior studies, the phase 2 MELD-ATG clinical trial found that low-dose ATG has the potential to preserve insulin-producing beta cells in children and young adults between five and 25 years old, and it was generally well-tolerated. In line with ATG’s potential, SAB Biotherapeutics—a company with funding support from the T1D Fund—is developing a next-generation ATG therapy.

Tzield, the first disease-modifying therapy approved to delay stage 3 T1D in people eight years and older in stage 2 T1D (before insulin therapy is required), has been accepted into the FDA Commissioner’s National Priority Voucher (CNPV) program for accelerated review. If approved, this could lead to expanded use of Tzield for people with newly diagnosed stage 3 T1D (when insulin therapy is required)—and this would be the first time people at this stage could have a therapy option besides insulin. We look forward to hearing more soon.

Right now, Tzield is only approved for use in delaying progression from stage 2 to stage 3 T1D for kids and adults eight years and older. The PETITE-T1D clinical trial is trying to change that. Interim results showed that Tzield is safe and well-tolerated in children under eight with stage 2 T1D, with no new safety issues reported. The study is ongoing and final results are expected in 2026.

Bayer shared data from the phase 3 FINE-ONE clinical trial, which investigated finerenone (Kerendia®)—a drug that is already approved for type 2 diabetes—for CKD associated with T1D. The results showed that finerenone significantly reduces a marker of kidney damage, marking the first treatment in nearly 30 years to achieve positive outcomes for CKD in people with T1D. This data will be submitted for regulatory review to expand finerenone’s indication to include T1D.

The Breakthrough T1D-funded phase 2 ADJUST-T1D trial investigated whether the GLP-1 receptor agonist semaglutide (Ozempic®) could benefit people living with T1D and obesity or overweight who are using an automated insulin delivery (AID) system. Thirty-six percent of people in the trial treated with semaglutide met the primary endpoints for glycemic and weight control compared to 0% in the placebo group, and the drug was well-tolerated and safe. These data—which were published in The New England Journal of Medicine Evidence—show that GLP-1 receptor agonists have the potential to help people with T1D manage both blood sugar and weight.

Building on the growing interest in GLP-1s for T1D, Eli Lilly launched two pivotal clinical trials for tirzepatide (Mounjaro® or Zepbound®), a dual GLP-1/GIP receptor agonist. These trials—which are enrolling now—will investigate whether tirzepatide can reduce blood sugar levels in people living with T1D and obesity or overweight over a period of 40 weeks (SURPASS-T1D-1) or 20 months (SURPASS-T1D-2). Industry investment in GLP-1s for T1D is a promising avenue toward a future where this class of drugs may be approved for use in members of the T1D community.

AID systems are getting better each year, and approximately 10 such systems are now approved for use in the United States. Here are a few advances in diabetes technology that stood out:

• Dexcom’s G7 15-day sensor—the longest-lasting FDA-approved wearable continuous glucose monitor (CGM) on the market—is now available for people in the U.S. 18 and over.
• Sequel Med Tech’s twiist AID system, which uses FDA-cleared Tidepool Loop technology, is now available in the U.S.
• Tandem’s SteadiSet 7-day infusion set has been cleared by the FDA and is expected to launch in the U.S. in 2026.
• Abbott’s Freestyle Libre 3 Plus sensor has integrated with twiist and T:slim X2 insulin pumps.
• Medtronic unveiled the largest real-world dataset pulled from users of the MiniMed 780G AID system.

To better understand the mental health needs of the T1D community, Breakthrough T1D and the Helmsley Charitable Trust co-hosted a Psychosocial Roundtable, convening mental and behavioral health experts across the T1D care spectrum. The discussion revolved around challenges and gaps in psychosocial care for people with T1D and how we can work together to address them. Thanks to the expert opinions of the attendees, Breakthrough T1D has a clear path forward for tackling these issues and supporting the mental and emotional wellbeing of the T1D community through research and awareness.

Sanofi has entered into a licensing agreement with EVOQ Therapeutics, a company with support from Breakthrough T1D, to help develop and commercialize its NanoDisc technology. This technology has the potential to retrain the immune system to stop attacking beta cells. Industry partnerships like these are key to accelerating T1D research.

The Nobel Prize in Physiology or Medicine was awarded to three immunologists—Fred Ramsdell, Ph.D., Mary E. Brunkow, Ph.D., and Shimon Sakaguchim M.D., Ph.D.—for their discoveries in immune tolerance, meaning the immune system’s ability to distinguish between self and non-self. Building on these breakthroughs, Dr. Ramsdell co-founded Sonoma Biotherapeutics, a T1D Fund-backed company, to restore immune tolerance in autoimmune diseases like T1D. Another year, another researcher with ties to Breakthrough T1D winning the most prestigious award in science!

Breakthrough T1D, in partnership with the Helmsley Charitable Trust and Roche and Sanofi’s Global Health Unit, launched ALIGN-T1D. This is a new global alliance uniting philanthropic, industry, and community leaders to strengthen government-led T1D care networks in low-middle income countries, integrating diagnosis, insulin access, monitoring, and education.

Breakthrough T1D helped organize an event at the European Parliament to highlight unmet needs for the T1D community and discuss how to accelerate cures—especially cell therapies—in the European Union. In a similar vein, an event co-hosted by Breakthrough T1D in Brussels, Belgium sparked conversation about overcoming challenges surrounding cardiovascular disease in T1D. Building long-term partnerships with EU Institutions and international diabetes organizations will allow us to work together towards global T1D breakthroughs.

Breakthrough T1D, in partnership with Friends of Mewar and UNICEF, participated in the Udaipur Type 1 Diabetes Summit: Advancing Access, Equity, and Action, in Udaipur, Rajasthan, India. The event gathered government leaders, health experts, community advocates, and international partners to develop a collaborative roadmap for strengthening T1D care across India.

Breakthrough T1D, Breakthrough T1D Canada, and the Stem Cell Network partnered to support four new projects led by Canadian researchers to drive high-impact research into manufactured cells and next-generation cell replacement therapies. This partnership is a novel and meaningful part of Breakthrough T1D’s global Project ACT effort to power high-impact cell therapies research.

The Australian government committed $50M over five years to the T1D Clinical Research Network (T1DCRN), a highly impactful research network driven by Breakthrough T1D Australia. This funding will support T1D research in prevention, precision medicine, and cures.

The Grand Challenge, a partnership between Breakthrough T1D UK, the Steve Morgan Foundation, and Diabetes UK, is funding 23 research projects to advance new treatments and cures for T1D. Their funding is supporting 189 researchers and collaborators across 49 institutions in eight countries. Recent breakthroughs from the past year include uncovering why T1D could be more aggressive in young children and developing a new insulin-glucagon molecule that could reduce dangerous hypoglycemic events.

Breakthrough T1D Research and Advocacy staff, in collaboration with other leading experts in the field, authored a paper titled “Future Directions and Clinical Trial Considerations for Novel Islet Beta Cell Replacement Therapies for Type 1 Diabetes” in the journal Diabetes. This publication outlines what the future of beta cell replacement therapies looks like—and how we can make these therapies a reality for everyone with T1D who wants them through innovative clinical trial design and expanding the pool of eligible trial participants.

“The Urgent Need for Breakthrough Therapies and a World Without Type 1 Diabetes” was authored by Breakthrough T1D staff and leadership and published in Diabetes Therapy. This commentary exposes the many persistent challenges of living with T1D, despite incredible progress in recent years. The publication is a call to action for the entire T1D community—researchers, clinicians, advocates, people with T1D, regulators, and all other stakeholders—to work together to overcome barriers at all levels to make cures for T1D a reality sooner rather than later.

Breakthrough T1D Advocacy staff and collaborators published a paper titled “Perceptions of the Benefits and Risks of Novel Therapies for Type 1 Diabetes: A Qualitative Study” in the journal Diabetes Therapy. This Breakthrough T1D-funded study found that people with T1D and their caregivers are largely willing to try next-generation therapies, drawn by the promise of reduced reliance on insulin and freedom from constant disease management. These findings highlight the importance of ensuring that the perspectives of people with T1D and their caregivers are used to guide regulatory decisions around the benefits and risks of a new therapy.

Breakthrough T1D Advocacy staff and collaborators published an article called “We Are on the Verge of Breakthrough Cures for Type 1 Diabetes, but Who Are the 2 Million Americans Who Have It?” in The Journal of Health Economics and Outcomes Research. This study identifies key T1D demographics in the U.S. and predicts how these demographics may change over the next decade. These data will help inform elected officials and payers about how healthcare policies may ultimately affect the T1D community—ensuring that the policies in place are having the greatest impact they can.

An analysis by Avalere Health, which was supported by Breakthrough T1D, found that research funded by the Special Diabetes Program (SDP) has yielded more than $50 billion in federal healthcare savings. This study supports the fact that the SDP has a strong return on investment, both clinically and economically, and demonstrates its ever-important role in bringing advanced therapies to the T1D community and improving health outcomes. Even more, SDP funding was recently extended through January 30, 2026, with retroactive funding back to October 1, 2025.