Type 1 Diabetes Breakthrough: New Clinical Trials Offer Hope for Protecting Insulin-Producing Cells

Several groundbreaking clinical trials are actively recruiting participants with type 1 diabetes, offering access to investigational medications designed to protect the insulin-producing cells that the immune system attacks. These studies represent a significant shift in diabetes research, moving beyond managing blood sugar to potentially preventing or slowing the disease itself. If you or a loved one has been recently diagnosed with type 1 diabetes, these trials could offer a chance to access cutting-edge treatments before they're widely available.

What Are These New Trials Testing?

The clinical trials currently enrolling focus on a novel approach: stopping the immune system from destroying the beta cells in the pancreas that produce insulin. One major trial is investigating an investigational drug called teplizumab, which works by affecting the immune cells that attack insulin-producing cells. This represents a fundamentally different strategy than traditional diabetes management, which focuses on controlling blood sugar levels after the damage has already occurred.

Another study, called SAFEGUARD, is evaluating a medication called SAB-142 in people newly diagnosed with type 1 diabetes. The goal is to delay disease progression in the critical early months after diagnosis, when the immune system is most actively destroying beta cells. Additionally, researchers are testing the FABULINUS trial, which examines how an investigational drug can preserve pancreatic beta cell function while participants continue their insulin therapy and have their glucose monitored throughout the study.

Who Can Participate in These Studies?

Eligibility varies by trial, but most focus on people recently diagnosed with type 1 diabetes. Here are the key enrollment criteria across the major studies:

• Age Range: Studies accept participants from as young as 1 year old up to 85 years old, depending on the specific trial. The teplizumab trial accepts ages 1 to 25, while SAFEGUARD enrolls ages 5 to 40, and the Medtronic closed-loop system study accepts ages 7 to 85.
• Time Since Diagnosis: Most trials prioritize people newly diagnosed with type 1 diabetes, typically within the past month to 100 days. This timing is critical because the immune attack on beta cells is most active in the early stages.
• Insulin Therapy Status: Some trials require participants to be on insulin therapy for 90 days or less, while others accept people who have been managing type 1 diabetes for at least one year with specific A1C (a measure of average blood sugar control) levels between 7.0% and 10.0%.
• Additional Requirements: Certain studies, like the artificial pancreas trial, require participants to live within 40 miles of the research center, have been using a hybrid closed-loop system for at least three months, and have another adult household member available to assist with the technology.

What Do Participants Receive?

One of the most appealing aspects of these trials is that participants receive comprehensive support and advanced diabetes technology at no cost. In the FABULINUS trial, for example, participants receive the study medication or placebo, a continuous glucose monitor (CGM), an electronic diary, a blood glucose meter, and all study visits and procedures covered by the research team. A continuous glucose monitor is a small device that tracks blood sugar levels throughout the day and night, providing real-time data that helps with diabetes management.

The Medtronic study offers particularly innovative technology: participants will use a next-generation closed-loop system that pairs the NMX8 screenless insulin pump with the DS5 disposable CGM. This system uses an investigational algorithm called Vivera, designed to automate more of daily diabetes care, including basal insulin delivery, correction doses, and even meal boluses. Participants can choose from different meal-handling approaches, ranging from no meal announcements to full flexibility in how they manage food intake.

How to Determine If a Clinical Trial Is Right for You

• Contact the Research Centers: Reach out directly to the clinical trial coordinators at Benaroya Research Institute (diabetes@benaroyaresearch.org or 1-800-888-4187), Rocky Mountain Clinical Research in Idaho Falls (rockymountainclinicalresearch@idahomed.com or 208-522-6005), or Oregon Health and Science University (OHSU) for trials focused on kidney disease protection or artificial pancreas systems.
• Join a Registry First: If you're interested in future research opportunities, consider joining the Benaroya Research Institute Autoimmune Registry (BRIAR), which is open to people with autoimmune conditions like type 1 diabetes, those with a family history of autoimmune disease, or healthy volunteers. Registry members provide basic health information that helps researchers match them to current and future studies.
• Speak with Clinical Trial Education Volunteers: The Greater Northwest Chapter of Breakthrough T1D has Clinical Trial Education Volunteers who can answer specific questions about which trials might be appropriate for your situation. You can reach out to Laura Tremblay, Jude Restis, or Mark Smith for personalized guidance.
• Review Time Commitment: Different trials require different levels of participation. Some involve approximately four months of commitment with both clinic and virtual visits, while others may have longer or shorter timeframes. Make sure the time commitment fits your schedule.

Why Does Timing Matter for Type 1 Diabetes Trials?

The reason many of these trials focus on people recently diagnosed with type 1 diabetes is that the disease progresses most rapidly in the early months after diagnosis. During this window, the immune system is actively attacking the beta cells that produce insulin. By intervening early with medications that can protect these cells or slow the immune attack, researchers hope to preserve the body's remaining insulin-producing capacity. This could mean better blood sugar control, less insulin needed, and potentially fewer complications down the road.

Some trials also investigate whether these interventions can help people who have lived with type 1 diabetes longer. For instance, one study is examining whether an oral medication called Sotagliflozin can slow kidney function decline in people with type 1 diabetes who have had the disease for at least eight years and have been continuously treated with insulin. Diabetic kidney disease is a serious complication, so this research addresses a critical need for people with long-standing type 1 diabetes.

What Happens After the Trial Ends?

Many trials offer extended access options, meaning participants may be able to continue using the investigational medication or technology even after the formal study period concludes. This is particularly important for trials testing new insulin delivery systems or medications that show promise. Be sure to ask about post-trial access when you inquire about enrollment.

Participating in a clinical trial is a way to access potentially life-changing treatments while contributing to research that could help millions of people with type 1 diabetes. If you've been recently diagnosed or have lived with type 1 diabetes for years, exploring these opportunities could be a meaningful next step in your diabetes management journey.