Disease-modifying therapies (DMTs) are treatments that prevent, slow, or reverse type 1 diabetes (T1D) by preserving or restoring insulin-producing beta cells. While there are several DMTs in clinical trials, there is only one that has been approved. A new Breakthrough T1D publication lays out how companies developing DMTs can incorporate strategic clinical trial design to evaluate the safety and efficacy of their products. The goal? More therapeutic options for more people—and sooner.

Why Do We Need this Roadmap?

DMTs can preserve beta cells, helping the body make its own insulin for longer. We know that more beta cells mean better health outcomes—improved blood sugar, reduced short- and long-term complications, and easier daily management. The best insulin for your body is the insulin it makes.

Teplizumab (Tzield) is the first approved DMT for stage 2 T1D and recently diagnosed stage 3 T1D. While this is a great achievement for the T1D community, we need more options that address the underlying cause of the disease so people can have a choice and select the therapy that best fits their needs. This has been challenging because DMT clinical trials have historically relied on outdated endpoints that make them require more time, money, and participants, which have slowed their movement through the drug development pipeline.

That’s why we need this roadmap: to get more DMTs to phase 3 trials—and eventually approved.

Accelerating DMTs Through the Pipeline

Thoughtful and targeted clinical trial design is key to moving DMTs through the drug development pipeline quickly and safely. Researchers and regulators need to carefully consider:

You read that right: we have clinical evidence that 10 DMTs can help the body make its own insulin for longer, and there are several others in early-phase trials that have shown promise in preclinical studies. To move these therapies to phase 3 studies, researchers and regulators need to work together so that clinical trials are designed and executed with the T1D community in mind.

Key Takeaways

• DMTs can preserve the body’s own insulin production, which is associated with better health outcomes.
• People with T1D need more options that address the underlying cause of the disease.
• Based on data from clinical trials, we know of several DMTs that show promise in T1D, but few have made it to phase 3 studies.
• Thoughtful clinical trial design, centered around mechanisms, target populations, combination approaches, repurposing of approved therapies, better endpoints, and the lived T1D experience, is the key to accelerating DMTs through the pipeline.

What’s Happening?

A new Breakthrough T1D-funded clinical trial investigating Eledon Pharmeceuticals’ immunotherapy, tegoprubart, with islet cell transplants in people with type 1 diabetes (T1D) and chronic kidney disease (CKD) just launched! This is the first time people with T1D and reduced kidney function are eligible for an islet cell therapy clinical trial—and the first person enrolled has received their transplant.

Tegoprubart and T1D: How We Got Here

Standard immunosuppressants can come with several side effects, including toxicity to the kidneys and damage to the transplanted islet cells themselves. Because of this, standard immunosuppression approaches, especially those that include tacrolimus, are not suitable for everyone who needs an islet transplant. Tegoprubart is a targeted immune therapy that offers a solution by acting as a milder, more targeted alternative—it can prevent rejection of transplanted islets with fewer side effects.

Eledon is currently running a Breakthrough T1D-funded clinical trial testing tegoprubart with deceased-donor islet cell transplants in people with severe hypoglycemic events or hypoglycemia unawareness. In this trial, all 12 participants are off injected insulin—with no side effects (and 3 additional people are enrolled). We know that this approach can be a functional cure for T1D. Now, Eledon is pursuing the next step: expanding access to people with T1D and CKD.

A New Clinical Trial and Another Step Forward

Immunosuppression is a barrier to eligibility for islet cell therapies. Because of the potential for kidney toxicity, people with T1D and CKD have been excluded from islet transplant studies if their kidney function is too low. Because CKD is common in people with T1D, this has been one of the biggest roadblocks for this population to access potential cures.

Until now, islet cell transplants were limited to people with T1D and healthy kidney function. Now that we have an option to replace toxic immunosuppression with milder tegoprubart, people with T1D and CKD are eligible for an islet cell therapy clinical trial for the first time ever. If this trial succeeds, islet cell transplants would be open to a larger portion of the T1D population.

Get Involved

This is a multi-center clinical trial that’s currently enrolling up to 10 participants at the University of Chicago and the University of Miami. Participants will receive tegoprubart in addition to a calcineurin inhibitor-free immunosuppression regimen (meaning no tacrolimus, which can be toxic to kidneys).

One year post-transplant, the investigators will measure the number of participants who have achieved insulin therapy independence, HbA1c levels less than 7%, and no severe hypoglycemic episodes, as assessed by continuous glucose monitoring (CGM).

Our Role and What’s Next

To make this new clinical trial possible, Breakthrough T1D awarded $8.5 million to the University of Chicago to fund the study, and Eledon is also a T1D Fund portfolio company. We are following this trial closely, and we look forward to seeing how the first person who received their transplant will progress.

“Advancing promising islet cell research that is a next step toward durable and scalable cures for type 1 diabetes is a key priority for Breakthrough T1D. We’re proud to support this trial that expands cell therapy research and access to people living with T1D and chronic kidney disease for the first time.” – Esther Latres, Ph.D., Senior Vice President of Research at Breakthrough T1D 

This trial is a key step forward in Breakthrough T1D’s Project ACT initiative and our larger goal of expanding access to islet cell therapies. The end game is little to no immunosuppression needed so that anyone with T1D, regardless of other complications, can get an islet cell transplant if they want to. We previously published a roadmap for how we can get islet cell therapies to more people—and this clinical trial will help us get there.

Breakthrough T1D’s first-ever Clinical & Research Congress (CRC 2026), focused entirely on type 1 diabetes (T1D), has come to a close! Check out all our coverage below from the exciting weekend in Philadelphia, PA, where researchers, clinicians, industry leaders, healthcare professionals (HCPs), and the T1D community united to share updates across our entire mission.

Check Out our CRC Recap Video!

Thanks for joining us throughout our coverage of our Clinical & Research Congress! And thank you to everyone who helped make this conference possible, including our sponsors, donors, supporters, and staff. We couldn’t do this without you.

We couldn’t be more proud of how our inaugural conference turned out, and we’re already looking forward to next year. Mark your calendars: CRC 2027 will take place in Washington, D.C., from October 15-17, 2027!

It’s a rainy day in Philadelphia, but the mood at CRC 2026 could not be sunnier! The attendees are positively buzzing (seriously) with how timely and impactful this meeting is. It’s the right time for a meeting focused exclusively on type 1 diabetes (T1D), and the good news is we won’t have to wait years for the next one!

CRC 2027 will take place from October 15-17 in Washington, D.C., USA. Stay tuned for more information!

Islet Cell Therapies vs. Disease-Modifying Therapies: Which is Better?

Spoiler alert: There’s no right answer—there are pros and cons to both!

Peter Senior, MBBS, Ph.D. (University of Alberta) and Colin Dayan, MBBS, Ph.D. (University of Birmingham) debated the safety, costs, monitoring, potential long-term outcomes, and considerations for global access of disease-modifying therapies (DMTs) versus islet cell therapies.

Dr. Dayan made the case that islet cell therapies may be effective in the short-term, but in the long-term they might not be scalable, affordable, or deliverable globally. On the flip side, emerging DMTs may allow for a one-and-done treatment—meaning they could be far more affordable and easily accessible, especially in the pediatric population. DMTs also address the root cause of T1D from the start, rather than “putting a patch on it” later.

On the flip side, Dr. Senior argued that there are significantly more people living with established T1D compared to early-stage T1D or even within 100 days of a diagnosis—meaning that islet cell therapies, especially manufactured versions that are scalable, must be the solution since it is too late to preserve beta cells in most people. He also made the point that islet cell therapies can give patients more beta cells than a DMT would—and more beta cells meanings better outcomes, including freedom and flexibility.

Someone in the audience chimed in with an important point: Ideally, DMTs and islet cell therapies can one day be combined to maximize the benefits of each (e.g., restore insulin production and address autoimmunity against beta cells).

Islet Cell Therapies

The Burden of Immunosuppression

Sabarinathan Ramachandran, Ph.D. (University of Minnesota) gave an update on immunosuppression with islet transplants. The key challenge is these transplants work, but over the long term, 50-70% of recipients lose function. He outlined the approaches investigators are taking to reduce the burden of these necessary drugs, like gene-editing, encapsulation, and engineered microenvironments.

Cellular Reprogramming

Hongkui Deng, M.D. (Peking University) presented a talk on cellular reprogramming, which involves treating cells with specific factors that turns them into a different cell type. Dr. Deng and his team developed a new, non-traditional strategy—which he called “chemical reprogramming”—that uses small molecules (instead of proteins) to reprogram cells. This approach is more efficient and easier to accomplish in the lab than traditional cell reprogramming approaches.

Using chemical reprogramming, Dr. Deng’s team turned a person’s fat cells into islet cells. The team then transplanted these islet cells back into the same person under the anterior rectus sheath, a large, easily-accessible, and well-vascularized area (meaning transplanted islets have access to blood vessels carrying nutrients and oxygen).

This person achieved substantial improvements in time in range and blood-sugar management, and no safety issues were identified during continuous monitoring. They were also already on immunosuppressants for a liver transplant. Now, more than one person has received this treatment, and Dr. Deng and his team are monitoring them closely.

Dr. Deng’s lab is also working on artificial intelligence (AI)-based approaches to scale up chemical reprogramming for islet cell therapies in addition to researching new ways to remove the need for immunosuppression.

Disease-Modifying Therapies

Clinical Trial Design Post-Teplizumab

• Presenter: Jason Gaglia, M.D. (Joslin Diabetes Center, Harvard Medical School)
• We know that teplizumab (Tzield) works, but individual responses can be variable and there may be an optimal treatment window.
• Now that we have an approved DMT, the question becomes: Do we use teplizumab as a comparator in clinical trials instead of a placebo, so that everyone who participates has a chance to benefit?
• If we do, people may not want to participate if they can get teplizumab at their clinic and covered by insurance—or they may not want teplizumab at all because of the 14-day infusion, side effects, or other reasons.
• With this in mind, we do not have a clear answer yet about whether teplizumab should be used in place of a placebo in DMT clinical trials.

Early Detection

Advanced Screening Technologies

Katsiaryna Prystupa, M.D. (German Diabetes Center) presented a machine learning analysis to sort more than 600 newly diagnosed people with T1D into three groups based on shared features like autoantibodies and insulin resistance. One group is associated with diagnosis earlier in T1D progression, when more beta cells are remaining. This work could help identify who may benefit most from DMTs.  

Callie Zaborenko, Ph.D. (Indiana University School of Medicine) analyzed electronic health record (EHR) data and genetic information from adults to see whether a genetic risk score could help identify people at a higher risk of developing T1D. Adults with the highest scores were nearly ten times as likely to be diagnosed with T1D as adults with mid-range scores. This could one day help guide who is offered autoantibody testing, though more research is needed first.

Alice Carr, Ph.D. (University of Alberta) talked about the best way to assess if DMTs are working in early-stage T1D trials. Using data from TrialNet and TEDDY studies, she presented her work showing that oral glucose tolerance tests (OGTT) can estimate insulin secretion as a measure of beta cell responsiveness. This may better capture risk of T1D progression, which can help researchers choose the best participants for DMT clinical trials and understand if DMTs are working.

Kathleen Gillespie, Ph.D. (University of Bristol) and her team screened nearly 20,000 adults for islet autoantibodies and followed those with confirmed autoantibodies in the T1DRA study. The prevalence of adults who had multiple autoantibodies was similar to that in children, which supports screening in adults. The team is developing an approach to group people with a single autoantibody into tiers based on progression risk, which could help tailor individualized monitoring.

Brittany Bruggeman, M.D. (University of Florida) analyzed the TEDDY study to better understand the decline in function in the part of the pancreas that helps digest food (the exocrine pancreas) in children at risk for T1D. In kids who developed islet autoantibodies earlier, a biomarker of exocrine pancreatic function (FE-1) was lower in infancy, before autoimmunity against beta cells. Combined with other tests, this biomarker may one day help researchers better predict T1D progression.

Medical Affairs

Communication and Shared Decision-Making: Old and New Challenges in T1D

The diabetes care team is made up of many disciplines. This session was presented by three psychologists and a physician focusing on the behavioral and educational aspects of T1D.

The first speaker, Ellen O’Donnell, Ph.D. (MassGeneral Brigham and Harvard Medical School) discussed the best communication tactics for children and adults in early-stage T1D. Telling a person, and their family, about an early-stage T1D diagnosis is a life-changing conversation. Thankfully, we know the best ways to communicate this information: using metaphors, graphics, and pictures, and taking into account the full context of the family (e.g., their family structure, experience with T1D, and baseline mental health). Not only do we know the best ways to have these conversations, but there are tools and resources for clinicians and healthcare providers.

Next up, Jane Speight, Ph.D. (Deakin University, Australia) talked about a topic that we need to dedicate more time to: diabetes stigma. T1D is a chronic illness, and living with it is a deeply emotional experience. When HbA1c stops being information and starts being a measure of self-worth, it has negative results. It can cause teens, parents, and adults with T1D to feel dehumanized, which has a direct result on physical and mental health.

Some alarming stats:

Diabetes stigma is associated with lower well-being and less confidence (self-efficacy) in managing diabetes, in addition to other worse outcomes:

But there is something we can do. A positive, self-fulfilling feedback loop predicated on stigma-free communications can help people do better—and this needs to be considered in every conversation.

The final speaker, Carol Levy, M.D. (Icahn School of Medicine at Mt. Sinai) got into pregnancy and T1D. We know that women with diabetes require much tighter targets to reduce maternal and fetal health risks. These risks are real and difficult to manage for the mother and the physician—and they start pre-conception and continue post-partum. Insulin requirements change dramatically throughout gestation, and there is limited real estate on the body for continuous glucose monitors (CGMs) and insulin pumps. Even with the better tools that we have today, pregnancy outcomes remain suboptimal.

The main point: Flexibility, creativity, and understanding are needed. Pregnant women are thinking about lots of things—not just their T1D management. They don’t all want to wear a pump.

Centers of Reference

Breakthrough T1D Chief Medical Officer International, Thomas Danne, M.D., Ph.D. has a very clear way of describing our challenge for the future. Cures for T1D are planes, in the air. We’re still building the plane, but it’s in the air right now. We must ensure there is a runway so that when the plane is ready to land, it can.

Right now, we’re building that runway through our Centers of Reference program, which is explored in a presentation by James Shaw, M.D. (Newcastle University).

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.

Breakthrough T1D has created several working groups to help move these therapies forward now so they’re ready when cell therapies are (at scale). These include:

1. Training and education, including a clinician training program launched with ATTD in Europe and the American College of Diabetology in the US.
2. Clinical access, including reaching community clinicians, countering myths and fears, and peer review between Centers.
3. Harmonizing clinical care, including team composition, patient screening, monitoring, and follow-up.
4. Benchmarking and validation, including quality-assured registries and peer review.

Centers of Reference are a work in progress. They’re going to take time to get off the ground—but all the right people are working on it today.

That’s a wrap on CRC 2026! Keep an eye out for one more recap tomorrow with everything you need to know about this inaugural conference.

This article was written by Sandy Vogt, Ph.D. and Brian Herrick.

We are two days into the first ever Breakthrough T1D Clinical & Research Congress! Day 1 was full of optimism and excitement about the meeting—it’s really ALL type 1 diabetes (T1D), which is unique—and the future of treatments and therapies for this community.

Peter Senior, MBBS, Ph.D. (University of Alberta), a longtime Breakthrough T1D-funded collaborator, spoke at the beginning of the first session and his comments really set the tone for the day.

CRC is 100% Focused on the Lived Experience

A guiding principle of this meeting is that it is centered around the lived experience of people with the disease. To drive this home, all of the parallel sessions were introduced by community members, sharing a story about their lives with T1D.

One video focused on how artificial intelligence (AI) has the potential to transform diabetes technology—fewer calculations means less daily burden. Here’s another perspective from Daniel Newman:

That’s our whole goal: people doing better. And CRC was filled with nearly 1,000 people—all of whom are working toward that shared goal.

With that in mind, let’s hear about the solutions, innovations, and cutting-edge work shared on day 2! As a reminder, every session is not included here—and we encourage you to attend next year to get the full CRC experience!

Check out our video recap of CRC 2026 day 2!

Unmet Needs: Where We Are and What’s Still Needed for People with T1D

The day kicked off with a symposium sponsored by Vertex Pharmaceuticals that explored the unmet needs and emerging treatments in T1D. Vertex is developing a manufactured islet cell therapy for T1D, which is currently in a phase 1/2/3 clinical trial. Jennifer Sherr, M.D., Ph.D. (Yale School of Medicine) and Dr. Peter Senior shared a wealth of data showing that outcomes have been improving for people with T1D year by year with new technology, primarily automated insulin delivery (AID)—but people still aren’t doing well enough. Even with the best technology, a study showed that a significant percentage of people still aren’t achieving ideal glycemic control, and some are still experiencing severe hypoglycemic events.

In summation: Technology has absolutely improved care, but there are still unmet needs to be addressed.

Islet Cell Therapies

Protecting Transplanted Islets

The first islet cell therapy session of the day, chaired by Valeria Sordi, Ph.D. (IRCCS Ospedale San Raffaele), focused on how we can take manufactured islets and keep them safe from the immune system post-transplant without the need for immunosuppression. Islet cell therapy is a promising treatment for T1D but there are major barriers—one of which is the requirement for immunosuppression. This session tackled tactics for removing that barrier.

Juan Alvarez-Dominguez, Ph.D. (University of Pennsylvania) presented how he and his team developed a method to watch the cells mature by placing electrodes inside the lab-grown islets. They have learned that the cells mature very quickly—like a switch being flipped on—versus gradually.

Audrey Parent, Ph.D. (University of California, San Francisco) and Sonja Schrepfer, M.D., Ph.D. (Cedars-Sinai Medical Center) both tackled gene editing using different approaches. Dr. Parent focused on modifying existing cells to protect them from the autoimmune response while Dr. Schrepfer’s work was centered on making the transplanted cells immune-evasive. These two tactics can potentially be used together in a complementary manner.

Zimislecel: Meaningful Benefits for Participants

Michael Rickels, M.D. (University of Pennsylvania) gave an update on the clinical trial for Vertex’s manufactured islet cell therapy zimislecel. All 12 participants have improved blood-sugar levels and no severe hypoglycemic events, and 10 of 12 people are off external insulin. Participants report significantly less diabetes distress and fear of hypoglycemia, demonstrating that islet cell therapies like this have a real impact on the day-to-day experiences of living with T1D.

Disease-Modifying Therapies

Research Supported by the T1D Fund

William Quinn, Ph.D. (SAB Bio) presented phase 1 clinical data from four people treated with SAB-142 (humanized ATG), a DMT designed to delay or prevent progression of T1D. The therapy targets immune cells responsible for the destruction of insulin-producing beta cells while also preserving those that help balance the immune system. SAB-142 has a favorable safety profile and preserved C-peptide in all participants—while actually enhancing C-peptide in 3 of 4 people. Enrollment is ongoing for the SAFEGUARD clinical trial for people within 100 days of a T1D diagnosis, and next up is the Breakthrough T1D-funded PRISE-ATG study, led by Dr. Haller, which will study SAB-142 in people within two years of a diagnosis.

Taylor Triolo, M.D. (Barbara Davis Center for Diabetes) presented safety data around CNP-103, a DMT in clinical trials developed by COUR Pharmaceuticals. CNP-103 works by restoring balance to the immune system by training it to stop recognizing beta cells as a threat. In a study with 32 participants, early data show favorable safety and tolerability, with no severe adverse events. The trial is expanding and efficacy data is expected in late 2026 or 2027.

Early Detection

A session chaired by Linda DiMeglio, M.D. (Indiana University School of Medicine) tackled early risk assessment for T1D. How do we find people earlier? How can we ensure they are able to take advantage of the myriad benefits of knowing they have early-stage T1D?

First up, Andrea Steck, M.D. (University of Colorado) talked about using continuous glucose monitoring (CGM) to assess T1D risk in addition to family history and autoantibody results. And there are some specific findings on how these can be used together:

• More time above 140 mg/dl is indicative of disease progression.
• Individuals who spend more than 15% of the day above 140 had about a 60% chance of progressing to stage 3 T1D within two years, versus about 15% for those below that level.
• Combined tools improve prediction validity. A risk score using CGM data, HbA1c, family history, and autoantibody results sorted people into low risk (about 5% chance in two years), medium (13%), and high (48%).
• For children in the middle stage, spending over 10% of the time above 140 signals risk of progression, and over 20% means it’s time to evaluate for stage 3 T1D.

Last up was Greg Lipak (HealthShare Exchange), who discussed how we can use AI to find individuals who may be misdiagnosed in electronic health records.

Improving Lives

Diabetic Ketoacidosis (DKA): Transforming Care with Continuous Ketone Monitoring

• Presenters: Richard Bergenstal, M.D. (HealthPartners Institute), Jennifer Sherr, M.D., Ph.D. (Yale School of Medicine), and Medha Munshi, M.D. (Harvard Medical School); supported by Abbott
• DKA is still a risk for people of all ages living with T1D because available ketone measurement methods are not widely used—and this drives up healthcare costs.
• Dual glucose-ketone monitoring will help guide care in real-time, warning people in advance so they can take action before an emergency happens.
• This technology could be particularly transformative for families, young adults transitioning to independence, people taking SGLT inhibitors, and older adults with other conditions or cognitive decline.

In a session chaired by Viral N. Shah, M.D. (Indiana University School of Medicine) that spanned multiple topics, Kalie L. Tommerdahl, M.D. (University of Washington) presented research on obesity and kidney disease in youth with T1D. Her data suggested that obesity and glycemic control affect T1D kidney health independently, which supports the notion that both need to be addressed in people with T1D for the best possible kidney outcomes.

Advocacy

Expanding Global Access to T1D Treatments and Care

• Professor Partha Kar (Portsmouth Hospitals NHS University Trust) talked about improvements in access to T1D care in India, ranging from education, to insulin, to glucose testing strips. Renza Scibilia (Senior Director of Global Responsibility) also mentioned the key role of Breakthrough T1D in advocating for better access, psychosocial health, and more.
• Carlos Antillón, M.D. (CEDYN, Mexico) presented on how global access and T1D innovations must advance together, and clinicians can help overcome barriers through advocacy, evidence generation, personalized treatment, HCP and patient education, and understanding what patients can realistically afford and sustain.
• Princess Padmaja K. Parmar (The Friends of Mewar) gave an inspiring talk on how global access to T1D supplies must be dependable and how lived experiences should guide all future work around T1D. She also highlighted the role of Breakthrough T1D in advancing research and access on a global scale.
• David Beran, Ph.D. (University of Geneva) gave a presentation around how barriers to access to T1D therapies and devices persist worldwide due to product shortages or discontinuations, with challenges in low- to middle-income countries largely driven by supply chain issues, technology costs, and more. Global advocacy and policy changes can help overcome these barriers.

Medical Affairs

Enrolling in Clinical Trials

Kimber Simmons, M.D. (University of Colorado) hit on a key point (and Breakthrough T1D organizational priority): clinical trial recruitment.

It is well established that clinical trials take far too long to enroll. It is also true that a new T1D diagnosis is an incredibly difficult situation for families to navigate. They must weigh placebo, randomization, side effects, and more. Then, the family has to make a decision quickly to successfully enroll within the clinical trial window.

Dr. Simmons and her team in Colorado rolled out a program to educate families about beta cell preservation in their one-week follow-ups. The results were striking. Among interested families, 24% of families enrolled in a clinical trial within 8 weeks.

Healthcare Professionals with T1D: A Unique Perspective on T1D Care

• Andrew Welch, M.D. (University of Cincinnati) talked about disruptions in diabetes supplies, including two calls to action: 1) diabetes tech companies should give people the quantity of supplies they actually need, taking into account early failures and 2) we need transparent real-world data about supply interruptions and their consequences.
• Sarah Westen, Ph.D. (University of Florida) and Marissa Hitchcock, BSN, RN, CDCES (Children with Diabetes) discussed how language matters when talking to people with T1D, especially when it comes to communicating the risk of complications and reducing diabetes stigma. Dr. Westen also told her own T1D story, including how Breakthrough T1D has supported her personally—and professionally!
• Kathryn Nagel, M.D. (Maine Medical Center) presented on how we need more data and better care for women with T1D who are pregnant, especially through psychosocial support and technologies for pregnancy-specific glycemic goals.

Look out for another article coming soon covering day 3 of CRC 2026. Keep an eye on our News & Updates webpage!

This article was written by Sandy Vogt, Ph.D., and Brian Herrick.

Hello from Philadelphia, PA! We could not be more thrilled that, after years and years, we have finally kicked off our inaugural Breakthrough T1D Clinical & Research Congress (CRC). This groundbreaking event is focused entirely on type 1 diabetes (T1D), and it’s happening right now!

For the next three days, we’ll provide you with everything you need to know about this conference, the top takeaways, and what the path forward looks like so that people with T1D can live better, healthier lives. And in case you missed it, check out our precap on what we plan to cover.

Check out our video recap of CRC 2026 day 1!

Islet Cell Therapies: Research Supported by Breakthrough T1D or the T1D Fund

Piotr Witkowski, M.D., Ph.D. (University of Chicago) presented on the Breakthrough T1D-funded clinical trial for tegoprubart, an alternative to standard immunosuppressants, developed by T1D Fund company Eledon. Tegoprubart is maintaining its success: All 12 participants who have received an islet cell transplant are off external insulin (7 after one transplant; 5 after two) with stable blood-sugar levels, no side effects, and no toxicity in the kidneys. An upcoming clinical trial will test tegoprubart in people with T1D and chronic kidney disease (CKD)—the first time this population is eligible for an islet cell therapy.

Per-Ola Carlsson, M.D., Ph.D. (Uppsala University) provided an update on the first person treated with a partial dose of immune-evasive islet cells developed by Sana, another T1D Fund company. There were no serious side effects, and the cells continue to survive and make insulin over a year post-transplant.

Leonardo Velazco-Cruz, Ph.D. (Century Therapeutics, a T1D Fund company) presented on a manufactured immune-evasive islet cell therapy that has shown promise in animal models of T1D, advancing towards first-in-human studies and clinical-grade, scalable manufacturing. Unlike other therapies currently in clinical trials, Century’s product is both scalable and does not require immunosuppression.

Disease-Modifying Therapies

C-peptide: Why it Matters for Clinical Outcomes

• Presenter: Justin Gregory, M.D. (Sanofi)
• Based on several datasets, we know that more C-peptide means better glycemic control and fewer short- and long-term complications (especially severe hypoglycemia, diabetic ketoacidosis, and retinopathy).
• This relationship is foundational to why we are so focused on C-peptide: it matters!
• For years, Breakthrough T1D has advocated for the use of C-peptide as a validated surrogate endpoint, which would make DMT clinical trials smaller, faster, and less expensive—without cutting corners on safety.

Early Detection

The benefits of screening for T1D are well established. Combined with follow-up and monitoring, early detection can reduce the risk of diabetic ketoacidosis (DKA) at diagnosis, connect people to clinical trials and specialists, open the door to FDA-approved therapies that can delay the need for insulin therapy, and give families time to plan and prepare.

The question now is how to increase access to screening, and how to ensure people with early-stage T1D are connected to next steps and options. That was the focus of a panel chaired by Chantal Mathieu, M.D., Ph.D. (KU Leuven, Belgium).

Improving Lives

Kerendia (Finerenone): First New Therapy in 30 Years for Kidney Disease and T1D

• Presenter: Sergio Chang Figueroa, M.D. (University of Louisville), speaking on behalf of Bayer
• The FDA recently approved finerenone (brand name Kerendia), a once-daily pill already approved for type 2 diabetes, for people with T1D and CKD—the first advance in nearly 30 years for this population.
• CKD is one of the most common complications of T1D: nearly a third of people with T1D will develop it, increasing their risk of kidney failure and heart complications.
• As part of our Improving Lives program, Breakthrough T1D strategically collaborated with Bayer to support the FINE-ONE clinical trial that led to this approval.

Making Sure Your Insulin is Still Potent

• Presenter: Maren Schinz, Ph.D. (Beyond Diagnostics AG)
• People living with T1D may wonder if their insulin is still good to use after temperature changes—and this company is developing a way to fix that.
• Studies in animal models of T1D have shown that injecting insulin that has lost some of its potency doesn’t lower blood-sugar levels as well.
• This team developed an assay that can be paired with a smartphone to check the potency of insulin in real-time.

Automated Insulin Delivery (AID) in the Era of Artificial Intelligence (AI)

• Tadej Battelino, M.D., Ph.D. (University Medical Center Ljubljana) talked through use of AI in continuous glucose monitor (CGM) data, MRIs, and other clinical metrics to predict progression or monitor the impacts of T1D.
• Todd Brusko, Ph.D. (University of Florida) highlighted complex data types generated from human samples that can be analyzed with AI to help us learn even more about what causes T1D.
• Juan Espinoza, M.D. (Northwestern University) highlighted how to best integrate AI into T1D care in clinical settings.
• Boris Kovatchev, Ph.D. (University of Virginia) presented about how digital twins—a computational model for blood-sugar changes—fueled by AI can speed clinical development of next-generation AID systems.

Medical Affairs

As early detection, disease-modifying therapies, and islet cell therapies move forward and treatment options expand, Tandy Aye, M.D. (Stanford School of Medicine), Brynn Marks, M.D. (Senior Director of Medical Affairs at Breakthrough T1D), and Katelyn O’Brien, Pharm.D. (Boston Medical Center) participated in a session chaired by Bobby Gabbay, M.D., Ph.D. (Joslin Diabetes Center) about how the medical community needs to effectively adapt to the current and future state of T1D care.

Some high-level takeaways:

• The field is moving faster than the care system. The world of T1D is rapidly changing. The paradigm is changing, including the proliferation of screening and early detection and novel disease-modifying therapies and islet cell therapies. Clinical teams must be ready to keep pace with the current and future landscape.
• Islet cell therapies are coming—and they depend on workforce as much as science. There are severe limits to the supply of deceased donor islets (for now!) but there also aren’t enough care teams to administer them. Learn more about how we’re trying to solve this problem through Centers of Reference and Breakthrough T1D’s Interventional Diabetology program.
• Diabetes care and education specialists are an underused bridge. Fewer than 5% of Medicare beneficiaries and fewer than 7% of privately insured people get education in the first year after diagnosis. These specialists have longer visits, can close technology gaps (CGM, automated insulin delivery), and relay real-world challenges back to clinicians.
• The workforce pipeline is a concern. We need more endocrinologists.

Kick-off

Dr. Mathieu closed the Congress’s opening day by describing the future of T1D as “two paths.” One is technology, and one is disease-modifying therapies plus islet cell therapies. These are not two disparate paths—technology has the capability to keep people healthy so that when DMTs and islet cell therapies arrive at scale, people with T1D can make the most of it.

Where we are

• Technology works in the real world. Dr. Mathieu presented data from her homeland of Belgium showing HbA1c falling year over year, first with sensors (around 2017) and further with hybrid closed-loop systems. In addition to glycemic improvements, people with T1D are seeing lower risk of complications, including retinopathy and kidney disease.  
• Disease-modifying therapies are here. Teplizumab, approved in November 2022, is the first therapy to delay the immune attack on beta cells. It has since expanded to children as young as one and to many countries.
• Screening is rapidly ramping up. Dr. Mathieu’s European consortium has screened about 140,000 children—and this is only increasing in Europe and across the world.

Our vision for the future

• Treat earlier in stages 1 and 2, to delay insulin therapy dependence by months, years, or decades.
• Personalize treatment using immune biomarkers that predict who will respond.
• Run more trials and build more integrated networks, like TrialNet.
• Islet cell therapies are next.

The last thing she said, and a key theme of this meeting, is the need for collaboration. We all need to set our egos aside and work together. The people in this room are responsible for the current state—and the myriad revolutions that have directly led to people with T1D doing better today. The people in the room are going to be the ones that make cures possible—but only if we work together.

Look out for articles coming soon covering days 2 and 3 of CRC 2026. Keep an eye on our News & Updates webpage!

This article was written by Sandy Vogt, Ph.D., and Brian Herrick.

Heart and kidney complications remain a major concern for people living with type 1 diabetes (T1D). While there are some therapies available to reduce the risk of these complications, the T1D community urgently needs more options. SGLT inhibitors (SGLTi), which have proven effective in people with type 2 diabetes (T2D) and people without diabetes, are a potential solution, but there have been several roadblocks in their development. To overcome these challenges and accelerate SGLTi for people with T1D, Breakthrough T1D spearheaded a publication laying out the path forward.

Key Takeaways

• People with T1D urgently need more heart and kidney therapies.
• SGLTi works in people with T2D and people without diabetes, and we expect people with T1D to experience similar heart and kidney benefits; however, these benefits have not been demonstrated yet.
• DKA is a real risk of SGLTi, but strategies to reduce this risk—including continuous ketone monitoring—have the potential to enable safer use of these therapies in the T1D population.
• Smart design of pivotal clinical trials for SGLTi will make them smaller, less expensive, and quicker without cutting corners on safety.

Heart and Kidney Complications: An Unsolved Problem in T1D

People living with T1D are at a heightened risk of developing both heart and kidney disease in their lifetimes. Chronic kidney disease (CKD) can progress to kidney failure, in which a transplant or dialysis is needed to survive. Kidney disease also amplifies the risk of heart disease, which includes heart failure, atherosclerotic cardiovascular disease, and more.

While some therapies exist to help slow the progression of heart and kidney disease, there are simply not enough available—and no treatments exist to prevent them altogether.

What are SGLT Inhibitors?

SGLTi, or sodium-glucose cotransporter inhibitors, are a class of medications that block glucose transport in the kidneys. This allows for excretion of excess sugar through the urine, which ultimately lowers pressure inside the kidney’s filtration system. These drugs also ease strain on the heart.

SGLTi were originally developed for blood-sugar management in people with T1D, but they were not approved due to an increased risk for DKA (more on that later). Yet, SGLTi have shown tremendous benefits for heart and kidney protection in people with T2D and without diabetes, independent of their effects on lowering blood sugar. People with T1D were not included in these clinical trials, even though we expect similar benefits. That’s why Breakthrough T1D is taking the lead to advance SGLTi to treat heart and kidney disease in the T1D community.

What We Know about SGLTi from Clinical Trials

We have extensive data on the benefits of SGLTi in people with T2D and people without diabetes. In fact, these medications are the frontline therapy for treating heart failure and kidney disease. Based on an analysis of several clinical trials in these populations treated with SGLTi:

People with T1D have historically been excluded from larger SGLTi clinical trials studying heart and kidney benefits, which explains why we don’t have as much information on its effectiveness in T1D. Yet, we can extrapolate some of the expected benefits based on available data from smaller trials.

Based on the proven heart and kidney benefits of SGLTi, researchers think that SGLTi will work in T1D, too. But we haven’t proven that yet. The bottom line is that we need more data around use of SGLTi in T1D—and thoughtfully designed clinical trials will help us achieve that sooner.

The Path to Approval: Surrogate Endpoints

For clinical trials looking at heart and kidney outcomes, traditional endpoints are often progression to kidney failure or death from heart or kidney complications. These endpoints are difficult to study, especially in T1D, because these trials require lots of participants and may take a very long time.

One solution: surrogate endpoints. These are biomarkers, or biological markers, that serve as a proxy for how an individual feels, functions, or survives and can be used in place of traditional endpoints in a clinical trial if they are recognized by regulatory agencies as clinically meaningful. One example is HbA1c, which can assess the risk of complications, or C-peptide, which is often used to assess whether disease-modifying therapies can preserve insulin-producing beta cells. There are also bridging biomarkers, which are endpoints that can be used to extrapolate the effectiveness of a treatment from one indication or population to another, like from T2D to T1D. Clinical trials in T1D that use these kinds of endpoints can often be smaller, less expensive, and quicker, while still providing critical information on safety.

Because the benefits of SGLTi are already so well understood in other populations, large scale clinical trials with traditional endpoints may not be needed to establish their benefit in T1D, especially for kidney disease. In cases like this, bridging biomarkers can be a more strategic approach to clinical trial design that can accelerate SGLTi therapies for the T1D community.

Enabling Safe SGLTi Use with DKA Risk Mitigation

The major drawback of SGLTi use in T1D is that there is about a 3-fold increase in DKA risk. DKA is a life-threatening complication that occurs when the body doesn’t have enough insulin, leading to the breakdown of fat for energy instead of sugar and eventually ketone buildup in the blood. In people with T1D, SGLTi increases DKA risk partly because it reduces blood-sugar levels, which may lower insulin doses.

Ongoing SGLTi trials in T1D have protocols in place to monitor ketones and empower participants to act when levels start rising. Recently, the first continuous ketone monitor (CKM) for T1D was approved, and CKM has tremendous promise to be another tool that can help people with T1D safely achieve the benefits of SGLTi. Breakthrough T1D is funding several studies to uncover how CKM can most effectively reduce DKA risk, so we’ll continue amassing important safety data as SGLTi move through the clinical pipeline.

SGLTi Clinical Trials in T1D

The Future of SGLTi in T1D

Technically speaking, there have been no SGLTi approved specifically for use in T1D in the U.S. Yet, multiple SGLTi are approved for adults with heart failure or CKD with or without diabetes, and this does not exclude people with T1D—but clinical use remains low. More trials and more data are needed to aid in the clinical adoption of SGLTi in T1D, and decisions around SGLTi use ultimately lie with individuals and their care teams.

The phase 3 SUGARNSALT trial (which includes DKA risk mitigation) will provide critical evidence around the SGLTi sotagliflozin in people with T1D and CKD and, if favorable, could lead to consideration for regulatory approval. Going forward, thoughtfully designed clinical trials will help get the data needed for future regulatory decisions and clinical adoption of SGLTi. Along with current strategies to prevent DKA, continuous advancements in CKM promise to improve the benefit-to-risk ratio of SGLTi for people with T1D.

In collaboration with researchers, clinicians, regulators, and companies around the world, Breakthrough T1D will keep advancing safe, effective use of SGLTi so that people with T1D will have another tool for healthier hearts and kidneys—and longer, healthier lives.

After months and months of preparation, it’s finally here! Breakthrough T1D’s very first Clinical & Research Congress (CRC), a groundbreaking event focused entirely on type 1 diabetes (T1D), is happening this week from October 9-11 in Philadelphia, PA.

Bringing Together People United in Our Shared Goal

This scientific meeting is a groundbreaking event, uniting T1D researchers, scientists, healthcare professionals (HCPs), industry leaders, and community members from all parts of the globe, whose lives have been shaped by T1D in one way or another. Attendees will have the chance to discuss cutting-edge advancements in T1D discovery science, technology, treatments, and more. Our agenda is shaped by the voices of the T1D community, ensuring that the lived experience of T1D is at the center of the ongoing work toward our shared goal: improve the lives of people with T1D as we drive toward cures.

The CRC will be hosted in Philadelphia, where Breakthrough T1D was founded 50+ years ago. Philadelphia is a hub of medical innovation and scientific advancements, making it an ideal location for experts from across the world to convene and share T1D research, clinical progress, and milestones.

What We’re Looking Forward To

Cures

• Progress in several islet cell therapy studies we’re watching closely
• Novel strategies to protect transplanted islets
• New approaches in disease-modifying therapies (DMTs) and developments in ongoing clinical studies
• Expert perspectives on general population screening for T1D
• The role of genetic risk and other advanced technologies for T1D early detection

Improving Lives

• Recent exciting progress in T1D complications, including chronic kidney disease
• Progress in automated insulin delivery and the role of artificial intelligence
• Advancements in ketone monitoring and management
• Innovations in adjunctive therapies

Advocacy and Medical Affairs

• Developments in expanding global access to life-changing treatments
• Insights into gaps in T1D clinical care—and how we can fill them
• Strategies for clinical trial education and awareness
• Perspectives on clinical trials, pregnancy, technology, and more from HCPs living with T1D
• Discussions around scaling up islet cell therapies from a clinical perspective

CRC: A Place to Come Together to Share T1D Breakthroughs

We envision this event as the go-to forum for translational updates, collaborative dialogue, and cross-sector collaboration. Our leadership and staff have worked tirelessly for months on end to bring this vision to life, and many will be in attendance participating in sessions, sharing ideas, and making sure the event runs smoothly from start to finish.

Updates Coming Your Way – Stay in the Know

This is the first time in history Breakthrough T1D is hosting an event like this (and it won’t be the last!). We are thrilled to create a one-of-a-kind space where researchers and T1D community members from around the globe can connect, collaborate, share ideas, and ultimately contribute to our shared mission of a world without T1D. We can’t wait to share the exciting updates we’ll hear at CRC with our community. Thank you to our supporters for helping make this event possible. We wouldn’t be able to do this without you!

Islet cell therapies for type 1 diabetes (T1D) are in the works. In clinical trials, people are coming off external insulin—and experiencing healthy blood sugar levels. Researchers and clinicians are working hard behind the scenes to advance next-generation manufactured islet cell therapies as scalable cures. The momentum is real—and it’s more important than ever to double down, bring all the key players together, and make them a reality.

The Workshop: Bringing Together Key Voices

To keep the momentum going, Breakthrough T1D co-hosted a public workshop with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) titled “Accelerating the Translation of Cell Therapy for Type 1 Diabetes.” This workshop convened researchers, clinicians, industry leaders, representatives from the U.S. Food and Drug Administration (FDA), individuals with T1D, and more to discuss best practices and recommendations for accelerating islet cell therapies for the T1D community as newer generations become available.

The planning committee included several Breakthrough T1D staff:

• Esther Latres, Ph.D. (Senior Vice President, Research)
• Nicholas Mamrak, Ph.D. (Senior Scientist, Research)
• Marjana Marinac, Pharm.D. (Associate Vice President, Regulatory Affairs)
• Chanel Press, Ph.D. (Director, Regulatory Affairs)
• Brianna Greeno (Senior Manager, Regulatory Affairs)

The Conversation: Advancing Islet Cell Therapies from the Lab to Humans

The workshop broadly focused on considerations for advancing manufactured islet cell therapies, including lab-based work, large-scale manufacturing, and clinical trial design. Read on to learn more about the discussion around each topic.

Why this Matters

Islet cell therapy science is advancing on three fronts at once: nonclinical research in the lab, clinical trials in humans, and large-scale manufacturing. While researchers, scientists, and clinicians are working hard pushing these efforts forward, Breakthrough T1D is helping to keep the conversation open around what’s working, how to overcome challenges, how to engage with regulators, and new partnerships and collaborations. Even more, keeping the voices of people with T1D in the mix is key to advancing islet cell therapies in a way that’s meaningful for our community. Breakthrough T1D thanks the NIDDK for co-hosting a successful event and all presenters, panelists, and attendees for contributing to critical conversations that will ultimately help accelerate next-generation islet cell therapies for type 1 diabetes.

Finerenone is the First Therapy Approved in 30 Years for Kidney Disease and T1D

Today, the U.S. Food and Drug Administration (FDA) approved finerenone (brand name Kerendia) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). UACR is a measure of kidney damage, and reducing it is expected to slow kidney disease progression in adults with CKD and T1D. This is a major win for the T1D community—finerenone is the first therapeutic advance in 30 years for people living with the burden of T1D and kidney disease.

Finerenone

Finerenone is a once-daily pill that has been approved since 2021 for the treatment of CKD in type 2 diabetes and, since July 2025, for certain adults with heart failure. In CKD, the hormone aldolsterone is overactive, leading to kidney damage. Finerenone blocks this hormone’s activity to protect the kidneys from further damage.

Data from the FINE-ONE Study that Led to this Approval

Bayer’s global, phase 3 FINE-ONE clinical trial investigated the use of finerenone in people with CKD associated with T1D. This trial achieved its primary outcome: finerenone significantly reduced UACR—a measure of kidney damage—compared to placebo.

So, what does this mean? Previous clinical trials with people who have type 2 diabetes and CKD have shown that reductions in UACR from finerenone are associated with positive long-term health outcomes. In people with T1D, reductions in UACR caused by finerenone are likely indicative of lower risk of kidney disease progression, kidney failure, and cardiovascular events. These data were published in The New England Journal of Medicine.

Finerenone was well-tolerated, with no new safety issues reported and few serious adverse events. Based on these results, Bayer submitted the data for regulatory review, with the goal of expanding finerenone’s indication to include treatment of CKD in people living with T1D. Finerenone’s approval represents an incredible step forward for people living with the burden of both kidney disease and T1D.

A Win for T1D and Kidney Disease

CKD is one of the most common complications of T1D. Nearly a third of people living with T1D will develop CKD, increasing the risk of both kidney failure and cardiovascular disease. Right now, the treatment options for people with T1D and CKD are limited—and there is a major need for therapies that can address this.

Finerenone is the first therapy in three decades to achieve positive outcomes for CKD in people with T1D. This is a huge step forward in the right direction, and this exciting data has the potential to transform the lives of people living with T1D with CKD now that finerenone is approved for this population.

The Bigger Picture

Breakthrough T1D strategically collaborated with Bayer to support the FINE-ONE clinical trial, and we are committed to further collaboration with Bayer to advance therapies for people with T1D. Working together with Bayer and other companies will allow us to deliver more treatments to people with T1D to address complications like kidney disease.

“Today, there are few treatments available for chronic kidney disease, a common complication of type 1 diabetes. The approval of finerenone (brand name Kerendia) is a huge win for the T1D community. Breakthrough T1D thanks the FDA for its review and approval and Bayer for their commitment to giving people with T1D a new therapeutic option for chronic kidney disease.”

Jonathan Rosen, Ph.D., Research Director at Breakthrough T1D

As a part of our Improving Lives portfolio, we aim to identify and support treatments and therapies that can address complications that arise from T1D, like CKD. The approval of finerenone opens the door for more treatments to come that could transform the landscape of available therapies for people with T1D, and industry investment in this space helps drive progress forward faster than ever. The T1D community needs more options, and our strategic industry partnerships will help make this possible.

Breakthrough T1D thanks the FDA for approving finerenone and Bayer for their commitment to improving the lives of people living with CKD associated with T1D.