New Publication Alert!

Breakthrough T1D spearheaded a paper titled “International consensus guidance for general population screening for islet autoantibodies to diagnose early-stage type 1 diabetes” that was published in Diabetologia. This is an important step toward integrating general population screening for type 1 diabetes (T1D) into clinical practice globally. Read on to learn more about why this is important, what experts think this should look like, and what it means for you and your family.

Making the Case for General Population 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, which lays out what clinicians should do when T1D autoantibodies are detected. But it does not touch on the bigger question: who should get screened?

There is an urgent need for population-level screening because:

• Global T1D incidence is increasing.
• Early detection has substantial benefits.
• Most T1D diagnoses occur in people without any family history of the disease.
• Evidence from ongoing, large-scale studies around the globe has shown that we have a screening method that works.

Breakthrough T1D convened a group of nearly 30 international experts to establish consensus that can act as a clinical roadmap to make general population screening a reality.

Key Recommendations for Clinical Adoption of General Population T1D Screening

So, who should get screened? Experts recommend that T1D screening begin in young children aged 2-4 years, with rescreening of children who test negative at ages 4-6 years and again at 10-15 years, aligned with other preventative healthcare visits. Every initial screening result should be confirmed with another test before diagnosis.

This may seem simple enough, but integrating screening into established clinical workflows will require collective effort. Healthcare systems must be fully prepared to deliver the entire screening, monitoring, and referral pathway before widespread integration. Policy and infrastructure must be in place, including established processes for confirming test results, education and monitoring of people with early-stage T1D, and referring people to specialists. In addition, healthcare professionals (HCPs) will need to effectively communicate with and provide psychosocial support to families at every step of the screening process.

The bottom line is that integrating general population T1D screening into clinics will require extensive cooperation across diverse medical settings to become a reality. But the payoff is clear: combined with Tzield and other emerging DMTs, general population screening should open the door to delaying—and eventually preventing—the onset of clinical, stage 3 T1D.

What this Means for You and Your Family

Right now, children and adults with or without a family history of T1D can participate in screening through free, research-based programs like TrialNet and ASK. Screening can be done in-person at certain locations, or screening kits can be sent straight to your home.

Based on the consensus guidance, families may consider starting to screen their children as early as ages 2-4. If the screening test detects autoantibodies, there are now concrete next steps that families can discuss with their physicians. You don’t have to wait until general population screening is integrated into clinics to take advantage of it.

Screening and Early Detection are Key to Breakthrough T1D’s Mission

General population T1D screening is a key part of our mission strategy, and more people screening means more people experiencing the benefits of early detection. To screen as many people as possible, clinicians need guidance—and this publication provides just that. We now have concrete recommendations for who to screen for T1D and when. Even more, this consensus has been signed off by almost every single one of our peer institutions, amounting to 20 global diabetes societies and organizations.

This publication is bringing conversations around general population T1D screening to the forefront. Breakthrough T1D is committed to expanding T1D early detection on a global scale, and widespread screening is one of our top priorities. We are mobilizing our resources, knowledge, and partnerships to make this a reality sooner so that more families around the world can benefit.

Many parents of children with type 1 diabetes (T1D) know the diagnosis story all too well. Your child is constantly thirsty. They’re not feeling well. Something seems off. Suddenly, you’re in a hospital, and they’re in diabetic ketoacidosis (DKA). You’re thrust into an unfamiliar world of 24/7 monitoring, managing blood sugars, and adopting a whole new way of living while trying to give your child some semblance of “normal.” 

Islet autoantibody screening for type 1 diabetes offers a chance to change this story. When parents and clinicians know which children are at higher risk of developing T1D, they can work together to catch the signs and symptoms of T1D onset, reduce the potential for serious complications, and be more prepared to effectively manage the condition if symptoms do appear. But even though this screening exists, families may not be aware of how they can access screening and the potential benefits.

A Coalition for Change

Ariadne Labs, a joint center for health systems innovation at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, convened the U.S. Coalition for Early T1D Action with the goal of developing actionable pathways and resources to expand access to screening to more children in primary care. This Coalition brings together 25 multidisciplinary stakeholders, including clinicians, researchers, advocates, policymakers, and families impacted by T1D.

As we launched our work to explore opportunities to expand screening, we knew that parents’ voices needed to guide our work. Their insights would be essential to creating tools that genuinely support families as they consider screening and navigate the steps that follow.

Centering the Parent Voice

We set out to gain a deeper understanding of what parents actually experience during early-stage T1D screening and monitoring. Through conversations with clinical colleagues, we were introduced to Breakthrough T1D’s Participant Advisory Council (PAC), which included parents who had personally navigated the process of screening and monitoring their children for T1D. We invited them to participate in early interviews to advise on the tools and resources that parents would need to navigate the screening process with their children. Their firsthand perspectives, shared candidly and in detail, were exactly what we needed as we began mapping out our ideas and resource concepts.

Throughout our process, we’ve relied heavily on the PAC members to describe their experiences. For example, one parent shared confusion in the results letter they received after screening. Their child had no antibodies, but they weren’t sure what that meant or what, if anything, should happen next. Their experience revealed an important gap between how screening information is delivered and how families actually understand it. This underscored a need to communicate results in a way that aligns with families’ real questions and concerns. The content, clarity, and delivery of the message deeply shaped this family’s experience. As the parent put it, “information can be transformative and helpful,” and it’s critical for that information to be tailored to support the people who need it most.

Expanding Family Engagement

After formally launching the Coalition at an in-person meeting in April 2025, we continued to expand our family and parent engagement. We included more parents with a broad range of experiences, including not just those whose children had been screened or diagnosed, but also those whose family history puts their children at greater risk for T1D but chose not to screen and those who are largely unfamiliar with T1D altogether. By bringing together such a broad parent community, we’ve been able to tailor our pathways and educational materials to be relevant, clear, and supportive for all families, regardless of where they are in the screening process.

Beyond ensuring our resources could resonate among parents with a wide range of experiences, our parent involvement had another unexpected benefit: clinicians gravitated more to the resources initially developed for families over the more clinically-focused tools. The clear language, step-by-step instructions, and approachable format helped healthcare clinicians communicate more effectively with parents to develop a shared understanding.

Why Lived Experience Matters

Direct engagement with families shaped our understanding of what matters most in T1D risk screening, diagnosis, and early care. Parents shared with us a strong desire to improve the process for others, whether or not their own children had been screened. By sharing their experiences, concerns, and hopes, they steered our work toward solutions that address both technical and emotional needs. Without this input, we risk missing the mark on creating something that families and clinicians find useful. Our approach recognizes parents and people with T1D as true partners in co-creating better care.

This work has shown that building tools around the lived experience of those affected leads to more effective, compassionate solutions that help families, clinicians, and systems alike. We strongly recommend including the PAC or local family voices in any T1D-related research or improvement initiative, from start to finish.

What to Know About Sana’s Gene-Edited Islets

Sana’s novel cell therapy approach is designed to help transplanted islet cells evade immune attack while continuing to produce insulin. The strategy uses gene editing to create hypoimmune islet cells, which are 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.

In this first-in-human study, deceased-donor islets were genetically modified to become immune-evasive and then transplanted into the forearm. Because this is a phase 1 trial, the primary goal is 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

The results so far are encouraging. After 60 weeks, there have been no severe 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. The islet cells were also visible in the participant through PET and MRI imaging.

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.

Importantly, the participant had no detectable immune response to the transplanted islet cells. While the levels of T1D autoantibodies remained unchanged, this had no impact on the survival and function of the gene-edited islets.

What’s Coming Next

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.

Excitingly, Sana plans to translate their hypoimmune gene-editing technology to manufactured islets in a new clinical trial, meaning that they are combining their unique immune protection strategy with a scalable approach. This is in line with our Project ACT initiative, which aims to dramatically speed development, access, and adoption of islet cell therapies for everyone with T1D who wants them.

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

Spotlight on Jessie Stover

Jessie Stover is the Development Manager at Breakthrough T1D’s Indiana Chapter. Stover was born and raised in Evansville, Indiana, and she now lives in Indianapolis with her two cats, Milo and Zuko. She enjoys reading, crafting, concerts, and “baking gluten-free desserts so good that no one can tell they’re gluten-free.”

Here, Stover tells her story: from type 1 diabetes (T1D) diagnosis as a toddler, to an insulin pump clinical trial, to learning how to manage her T1D as a teenager, to a new outlook on living with the condition as an adult. Breakthrough T1D thanks Stover for her bravery in sharing her story and her commitment to the T1D community.

Gummy Bears and Insulin Shots

Stover was diagnosed with type 1 diabetes when she was just 2 years old. While her family has a history of autoimmune disorders, “there is no one else in my family with T1D, so it was a big shock to my parents, and we all had so much to learn,” explains Stover.

The learning process started in the kitchen, with a container forever-full of gummy bears to treat lows, a new kitchen scale to measure and track carbs, and sugar-free versions of things Stover had always enjoyed, like Kool-Aid. Between her parents, grandparents, and school secretary, she had “quite the village.”

But, like any kid, Stover didn’t like shots, and she remembers running away from her parents when it was time for an insulin dose.

A Kiddo in a Clinical Trial

During one of Stover’s appointments with her endocrinologist in Indianapolis, she was referred to a clinical trial exploring whether young children could benefit from an insulin pump. “My mom is a very practical person, so it was almost a no-brainer for her since it meant the possibility of no more insulin shots, and it could help manage my blood sugars more smoothly,” explains Stover. No shots sounded pretty good.

By the age of 4, she was enrolled in the trial and using her first insulin pump. Stover noticed a difference immediately; the pump site insertion didn’t hurt at all because they had the option to use a numbing cream. The relief was tangible not just for Stover, but also for her primary caregiver: her mom. Using an insulin pump meant automatically calculated insulin doses, remote control of insulin dosing, and, most importantly, no more shots. Stover has been using an insulin pump ever since.

Being a Teenager is Hard Enough

As Stover grew into a teenager, she also grew into managing T1D on her own. This was when she first truly understood what her diagnosis meant. “It wasn’t new, but it was as if something finally clicked in my brain that it wasn’t going to go away, and now it was my turn to do all the work,” she explains. Coupled with stressful conversations around needing to “do better” to avoid future complications, it was a tough transition, and Stover struggled to find the resources to help her get through it. “Just because the textbook makes it look easy, and my mom made it look easy, it felt like I was expected to immediately do the same,” Stover recalls.

It all changed when someone on Stover’s diabetes care team said: “Being a teenager is hard enough. Adding T1D into the mix is like trying to stop a volcano from erupting!” For the first time, Stover felt that everything she was feeling about being a teen and managing T1D had been put perfectly into words. “I realized I was allowed to be angry, upset, and unhappy, and I didn’t have to just accept T1D and move on. Stepping back and allowing space to understand and grieve my diagnosis helped me,” she said.

This realization opened the door to more candid conversations and a stronger relationship with her parents. Stover was able to openly discuss her mental health needs and set boundaries around what she felt comfortable sharing with her parents about her T1D. “I let myself have space to have bad days and started celebrating the good. I started celebrating my diaversary and stopped trying to make other people comfortable with what I was going through, because I was the one going through it and I needed to do what I needed to do,” Stover explains.

A Fresh Outlook on Living With T1D

While Stover’s mindset around T1D evolved over the years, she also feels that mental health resources have improved dramatically since she was a teen. Now, she advocates for people living with T1D to take advantage of therapy or connect with others on social media who are experiencing the same thing.  “There’s an entire community of people who decided diabetes wasn’t going to be invisible, and in doing so, more honest conversations can happen,” Stover explains. “We know more about chronic illness fatigue, medical trauma, and the effect of societal pressure to be ‘normal.’ If you go looking, you can find someone talking about it. Validation is a very powerful thing.”

Stover’s fortitude shined through when she was diagnosed with Celiac disease right after she graduated college. This time, things went a little differently; Stover had learned to give herself grace, and she found that figuring out how to manage a second autoimmune disease was a bit easier this time around.

In the years since Stover first started using an insulin pump, diabetes technology rapidly advanced with the evolution of pumps and continuous glucose monitors (CGMs), which, when used together, are called an automated insulin delivery (AID) system. As she grew up, Stover was hesitant to put her trust in new systems. “There are so many nuances to T1D care, and it’s been hard to wrap my head around how technology could know me better than I know myself,” Stover explains.

Yet, she eventually decided to add a CGM to her T1D management toolkit. “It is nice to be able to see how your glucose levels are trending,” Stover said. Despite living with anxiety around technology failures and hypoglycemia, Stover found a way to make CGMs work for her. She has her low alarm set when her glucose levels reach 100 mg/dL—well before the typical threshold of 70 mg/dL—so she can execute a plan of action before her blood sugars drop further. “It’s a little extra peace of mind to know that I can catch a low before it becomes a big problem.”

From kid to adult and all the ups and downs in between, Stover found how to manage her T1D in the way that works best for her.

Breakthrough T1D was (and Still is) Along for the Ride

Stover and her family were connected with other T1D families and Breakthrough T1D from the very start. There was a “tiny but mighty” team of parents who started a Breakthrough T1D Walk in Southern Indiana during Stover’s childhood, which, over time, often included many of her friends and classmates. Over two decades later, the Holiday World Walk in Indiana is still alive and well (and organized by Stover herself!).

In addition to Walk, Stover was a Youth Ambassador. “Breakthrough T1D has been a part of my life almost as much as T1D has. And now, getting to be a part of sharing the Walk with other families is truly a gift,” she says.

Sign up for a breakthrough T1D walk today!

Word to the Wise

A word of advice from Stover: T1D is only invisible if you let it be. She encourages people living with the condition to take up space.

“Celebrate your diaversary, bedazzle your Omnipod, rock your fun patterned tapes, celebrate with diabesties. Find little ways to bring joy into it, but also take the time to feel the bad days. Take the time to learn how to let the good and bad coexist.”

Talk about T1D. Take advantage of resources. Connect with others online and in person. Give yourself grace. We can all learn a thing or two from Stover!

“We were never meant to do the job of the pancreas. Everyone carries the weight of T1D differently; everyone processes and grieves differently. There are going to be bad days, and the bad days should NEVER be punished. Grace, compassion, and a safe space to authentically be a person living with T1D will have a much better outcome. The only party at fault is the immune system that attacked the wrong thing.”

-Jessie Stover

They’re all over the news: Ozempic ®. Trulicity ®. Jardiance ®. Mounjaro ™. And more.

These drugs are all approved for glucose control in type 2 diabetes (T2D). Some of them also have additional indications reflecting their demonstrated benefits for cardiovascular disease, kidney health, and obesity.

None of these drugs are currently approved for glucose control in people with type 1 diabetes (T1D). However, a recent consensus report addressed the growing interest in GLP-1 receptor agonists as an adjunctive therapy for T1D and their “potential to improve glycemic and metabolic outcomes without increasing the risk of severe hypoglycemia or diabetic ketoacidosis.”

Let’s examine GLP-1 therapies and SGLT inhibitors and consider how drugs like Ozempic may one day help people with type 1 diabetes.

GLP-1 therapies

GLP-1 (glucagon-like peptide-1) receptor agonists work in multiple ways to control blood glucose and obesity. They block the release of glucagon, stimulate insulin production, slow the rate at which your stomach empties, and increase the sensation of feeling full. They are usually injected, but oral versions are available.

In people with T2D, this class of drugs lowers blood sugar levels and, for most people, causes weight loss. GLP-1 therapies have also been shown to reduce the risk of long-term cardiovascular complications often experienced by people with T2D, such as heart attack and stroke.

GLP-1 drugs include Ozempic/Rybelsus/Wegovy (semaglutide), Trulicity (dulaglutide), Victoza (liraglutide), and Mounjaro (tirzepatide), among others.

When GLP-1 treatments hit the market in the early 2000s, Breakthrough T1D and others funded several clinical trials to test whether GLP-1 receptor agonists, in addition to insulin, improved outcomes for people with type 1 diabetes. While some of these studies showed that the addition of GLP-1 therapies to insulin led to improvements in HbA1c, total insulin dose, and weight, the benefits were relatively modest and accompanied by some side effects like hypoglycemia (low blood sugar). As a result, these studies did not lead to GLP-1 receptor agonists being highly adopted for use by people with T1D.

However, these trials were done with older GLP-1 drugs. We are investigating whether the newest, most advanced GLP-1 therapies (like Ozempic) will improve the health of people living with type 1 diabetes. (See below!)

SGLT inhibitors

SGLT (sodium-glucose co-transporter) inhibitors are oral medications for people with T2D that lower blood sugar by preventing the kidneys from reabsorbing glucose, leading to the excretion of sugar through the urine.

In addition to improving blood sugar for people with and without T2D, these drugs also provide benefits such as weight loss, blood pressure reduction, and transformative benefits to the heart and kidneys.

SGLT drugs include Jardiance (empagliflozin), Farxiga (dapagliflozin), and Invokana (canagliflozin), among others. The SGLT inhibitors empagliflozin and dapagliflozin are approved to treat chronic kidney disease and heart failure, regardless of diabetes status.

Yet, increased risk of diabetic ketoacidosis (DKA) in people with T1D limits the use of these therapies to improve blood sugar management or reduce the risk of complications. A key Breakthrough T1D priority is to find ways to mitigate this risk so people with T1D can also take advantage of the benefits of SGLT inhibitors.

Breakthrough T1D-funded research in GLP-1 and SGLT therapies

Breakthrough T1D has a long history with GLP-1 medications like Ozempic. In the 1980s, Breakthrough T1D-funded researcher Pauline Kay Lund, Ph.D., was the first to clone the hormone glucagon and discover two new hormones, one of which was GLP-1.

Today, there is real-world evidence of GLP-1 receptor agonists improving the lives of people with type 1 diabetes.

Evidence demonstrates that semaglutide (Ozempic) or tirzepatide (Mounjaro) have the potential to lower A1c, increase time-in-range, and reduce the amount of daily insulin needed in people with T1D. More research is needed in this area. That’s where Breakthrough T1D comes in!

Most recently, the Breakthrough T1D-funded ADJUST-T1D clinical trial showed that, in people with T1D and obesity or overweight using an automated insulin delivery system, Ozempic can help manage both weight and blood sugar.

Additional Breakthrough T1D-funded research on GLP-1 and SGLT therapies is investigating the benefits of these drugs for people with T1D, including reducing the risk of common complications of type 1 diabetes like cardiovascular disease and kidney disease.

Snapshot of active clinical trials in GLP-1 and SGLT therapies

Here are a few examples of Breakthrough T1D-funded clinical trials in GLP-1 and SGLT therapies that are currently underway:

Our commitment to improving lives

Breakthrough T1D strives to improve health outcomes in people living with type 1 diabetes. Insulin therapy alone is often not enough for people with T1D to achieve glucose and metabolic control. The use of adjunctive drugs that complement insulin therapy can help. Since the FDA has already approved these medications for treating other conditions, positive results from these clinical trials could speed up the adaptation of these therapies for people living with T1D.

Learn more about clinical trials and how they are advancing breakthroughs for the T1D community.

How Did This Happen?

Regulators at the FDA thoroughly reviewed data from the PROTECT clinical trial to support Tzield’s approval. The PROTECT study demonstrated that Tzield could safely and effectively preserve insulin-producing beta cells in newly diagnosed children and adolescents with stage 3 T1D. Clinical data shows that individuals with more beta cell function also have better diabetes-related outcomes, like improved HbA1c, more time in range, less hypoglycemia, and less insulin use.

Tzield was approved through FDA’s accelerated approval pathway, demonstrating FDA’s recognition of the urgent needs faced by those living with T1D. This means that based on the available data, the FDA has determined the drug is safe and reasonably likely to provide a clinical benefit and can be available while an additional clinical study happens. Based on the experience with Tzield in stage 2 and the robust evidence in stage 3, input from an external advisory committee was not needed.

Tzield is the first drug approved for stage 3 T1D—a major milestone for the field. Many disease-modifying therapies for stage 3 T1D are currently in clinical trials and at various stages of the drug development pipeline. This also marks the first time a disease-modifying therapy has been granted approval based on C-peptide, a marker of beta cell function. Breakthrough T1D has supported efforts to advance C-peptide as a clinical trial endpoint for nearly 10 years.

Tzield is Addressing an Unmet Need

Tzield was granted accelerated approval because FDA recognizes there is a large unmet need in the T1D population—and the potential for Tzield to help meet these needs.

In 2022, Sanofi’s Tzield also became the first disease-modifying therapy approved to delay the onset of stage 3 T1D in people with stage 2 T1D. Tzield, which has been supported by Breakthrough T1D for decades, has been a game changer in T1D as it’s the first therapy for this disease that addresses the root cause of T1D, not the symptoms. It targets the T cells that are responsible for destroying insulin-producing beta cells, slowing down the autoimmune processes that cause T1D. In people with stage 2 who receive Tzield, a stage 3 diagnosis is delayed by an average of 2 years. In April 2026, FDA expanded Tzield’s indication in stage 2 to include children as young as 1 year of age and older.

The vast majority of people in stage 2 don’t even know they have early T1D because there are no external symptoms. The only way to know is to get screened for risk markers of T1D. While the number of individuals screened for T1D has dramatically risen in recent years, most people progress to stage 3 before they have the chance to reap the benefit of Tzield delaying onset. Now that Tzield is approved for stage 3 T1D, people will have more opportunities to preserve insulin-producing beta cells, even if they didn’t identify their T1D early.

“The approval of Tzield for individuals ages 8-17 with stage 3 type 1 diabetes is an exciting milestone that reinforces the importance of beta cell preservation and provides an opportunity to change the course of the disease for those living with T1D,” said Aaron J. Kowalski, Ph.D., Breakthrough T1D CEO. “For the first time, individuals diagnosed with type 1 diabetes in stage 3 will have the option to treat the disease rather than just the symptoms. Breakthrough T1D thanks the FDA for recognizing the urgent unmet need in T1D and granting Tzield accelerated approval in the U.S. We are also grateful for Sanofi’s continued study of Tzield, and we look forward to the results of the confirmatory clinical research.”

What Happens Next?

Sanofi is conducting a new clinical trial, called BETA PRESERVE, to support full approval of Tzield for stage 3 T1D. This study will provide additional safety and efficacy data from children and adults with T1D up to 25 years old with stage 3 T1D treated with Tzield or placebo.

There are two primary endpoints: HbA1c levels and days without mealtime insulin. If you or anyone you know may be interested in participating, contact a study site near you to learn more and see if you are eligible.

The Bottom Line

For the first time, individuals diagnosed with T1D have a therapy option besides insulin that addresses the root cause of the disease. This is a historic first, modifying the course of T1D and allowing people to benefit from preserved beta cell function, as the PROTECT study has demonstrated. 

This is incredibly exciting, but we are not done. We will continue to work to ensure individuals in stage 3 T1D all over the world, not just the U.S., have access to more therapies to help them do better.

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.

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!

The recent news about successful clinical trials in islet cell therapies for type 1 diabetes cures is very exciting. But the science behind it can be confusing. Breakthrough T1D is here to answer all of your questions about islet cells, from the research lab to real-world treatments.

What are islet cells?

Islet cells are a group of cells in the pancreas that release hormones to regulate blood sugar. Beta cells are a type of islet cell that make insulin. In people with type 1 diabetes (T1D), the autoimmune system destroys the beta cells in the pancreas, which produce insulin.

What is islet cell therapy?

Islet cell therapies replace destroyed islet cells with external insulin-producing cells and protect them so that they can function for a very long time.

Is islet cell therapy a cure for type 1 diabetes?

The answer is: It could be.

Adults around the world who have received islet cell transplants are coming off external insulin, lasting from months to years. But for newer, more advanced islet cell therapies, we are still doing clinical trials and don’t yet know how these cells will work long-term.

Right now, islet cell therapies as potential cures for type 1 diabetes are limited to adults with severe T1D who have a lot of trouble managing their condition. Even more, adults who are eligible to receive islet cell therapies need to take lifelong immunosuppressants, which, depending on other health considerations, may not be the right decision for everyone.

To make islet cell therapies available to everyone with T1D who may want them, Breakthrough T1D’s end goal is to manufacture islet cells on a large scale and safely put them inside the body of every person with T1D to replace the cells that were lost without the use of immunosuppressants. This would effectively cure type 1 diabetes.

Are there any islet cell therapies available right now?

In Europe and Canada, islet cell therapies using islet cells from deceased donors have been successfully used to treat people with T1D for years.

In the United States, there is currently one islet cell therapy approved for T1D as of 2023 called Lantidra®, which is also derived from deceased donors. Lantidra and other islet cell therapies used around the world are intended for adults with T1D who experience: 

• Severe hypoglycemia (dangerous low blood sugar) 
• Hypoglycemia unawareness (the inability to sense when blood sugar is dropping)

These individuals often cannot safely manage their blood glucose levels with the standard therapies used to manage T1D.

Other islet cell therapies are still in clinical trials. Adults with T1D who are interested in participating in these clinical trials generally must meet the same eligibility requirements: severe hypoglycemia and hypoglycemia unawareness.

What are deceased donor islet cells?

Deceased donor islet cells come from the pancreases of deceased donors. It can take up to three pancreases to get enough islet cells for one transplant. Deceased donor islet cells are in limited supply, and there aren’t enough for everyone with T1D who may want them. This is similar to a kidney or liver transplant—there aren’t enough organs for everyone who needs them.

What are manufactured islet cells?

Thanks to years of support from Breakthrough T1D and others, scientists can manufacture islet cells in a laboratory by using specific protocols to turn precursor cells into insulin-producing cells. Manufactured islet cells can be made in large quantities and are the only solution to making sure there are enough islet cells for everyone with T1D who may want them.

How are islet cells transplanted?

Islet cell transplantation is a procedure in which insulin-producing islet cells (from either deceased donors or a manufactured source) are transplanted into a person living with T1D. Once transplanted, these cells can begin producing insulin in response to blood glucose levels.

Lantidra, the only approved donor-derived islet cell therapy for T1D in the U.S., is transplanted as a single infusion into a vein in the liver. Other islet cell therapies in clinical trials are testing different transplantation sites around the body, such as in the forearm muscles, in a small device underneath the skin, or within the abdominal wall. The goal is to figure out which transplant sites allow the cells to have the greatest chance of survival.

Recipients of Lantidra—and most other donor-derived and manufactured islet cell therapies in clinical trials—must take immunosuppressives to prevent the body from rejecting the transplanted cells. However, researchers are testing new ways to protect islet cells without immunosuppressants.

What is immunosuppression?

Immunosuppression uses drugs to reduce the effectiveness of your immune system. It is required to prevent your body from rejecting a transplant.

A person who receives a transplant of any kind will almost always need to take immunosuppressants for the rest of their lives. Immunosuppressants help keep transplanted organs, tissues, and cells alive. However, they can come with side effects and may make individuals more susceptible to infections and cancers. For those who are eligible to receive an islet cell transplant, it is up to individuals and their care teams to determine if the benefits of receiving a transplant outweigh the risks of lifelong immunosuppression.

Why do current cell therapies require immunosuppression?

Most islet cell therapies—including Lantidra and those in clinical trials—require immunosuppression. This is because the source of the islet cells comes from somewhere other than your own body. Your body views the transplanted cells as “foreign,” meaning the immune system will activate and reject the transplant, and the islet cells will die. To prevent this from happening, immunosuppressants can dampen your immune system so that it doesn’t attack the transplanted cells.

Researchers are finding new ways to make immunosuppression milder or remove the need for immunosuppression altogether. Some of these approaches are already in clinical trials.

Why is there so much talk about clinical trials and T1D?

Without clinical trials, we would never know if new therapies developed by scientists in the lab could make a difference in people’s lives. This is where the T1D community comes in! By volunteering to participate in clinical trials, you become uniquely positioned to help drive biomedical research forward. Moreover, by participating, you help not only yourself, but everyone with T1D.

Why are there such specific eligibility requirements for cell therapy clinical trials?

Clinical trials can come with both risks and benefits. The potential benefit would be the islet cell therapy working, meaning the transplanted islets survive and make insulin. The potential risks include side effects from the transplant procedure, chronic immunosuppression, and more.

Right now, these trials are limited to adults with the most difficultly managing their T1D because the potential benefits outweigh the risks. The adults eligible to participate in these trials will help researchers gather more evidence about the safety and efficacy of islet cell replacement therapies.

Until researchers have more data on the safety and efficacy of islet cell therapies, children are not yet eligible for these trials to protect them from the potential risks. Future clinical trials may be available to children and other populations of adults with T1D, but we are not there yet.

Where can I find cell therapy clinical trials I’m eligible for?

Breakthrough T1D  has an easy-to-use tool called the Clinical Trials Connection, which asks users simple questions—about where they live, the distance they can travel, and other characteristics—to match them with trials for which they are eligible.

Here are some currently recruiting trials in cell therapies in the U.S.:

Everyone says a cure is 5-10 years away. Why does progress seem to be so slow for T1D advancements?

First, clinical trials can take quite a long time. It can be difficult to find people with T1D who are eligible and willing to participate. Also, people who are receiving a new therapy or treatment often need to be monitored for years to understand long-term safety and efficacy.

Second, science is often complex and unpredictable. Research and clinical trials don’t always turn out the way we hope they will. And we can’t always predict how long research will take. But, all data is good data! Researchers learn from clinical trials to help think about the best way to approach future studies.

Does fundraising for Breakthrough T1D helping fund research in cell therapies?

As the leading global T1D research and advocacy organization, Breakthrough T1D is currently funding over $450 million in research in 24 countries. Everything we do is focused on making cures happen for everyone facing T1D, sooner.

Without continuous support from the T1D community, we would never have gotten this far.

Breakthrough T1D looks forward to a future where manufactured islet therapies are a reality for everyone with T1D, and we will not stop until we get there.

Will cell therapies ever become available for everyone living with T1D?

In the coming years, it’s likely that first-generation manufactured islet therapies will be available to people with T1D with severe hypoglycemia unawareness and will require broad immunosuppression. Later, advancements in cell survival and immune protection—combined with the discovery of more tolerable immune suppression approaches—will open the doors for more people with T1D to access these life-changing therapies.

By Sandy Vogt, Ph.D. and Kara Sweet

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:

Cell Therapies

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.

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.

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.

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.

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.

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.

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!

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.

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.

Disease-Modifying Therapies

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.

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.

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 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.

Look out for another article soon wrapping up days 3 and 4 of ADA 2026!