Researchers at UCSF are testing innovative new approaches to type 1 diabetes that go far beyond insulin injections, including cell therapies made from patients' own blood cells and immunotherapies designed to stop the disease before it progresses. With 42 active diabetes clinical trials currently underway at the institution, 26 of which are open to eligible participants, the San Francisco Bay Area has become a hub for cutting-edge diabetes research that could fundamentally change how the condition is managed and potentially reversed .

What New Treatments Are Being Tested for Type 1 Diabetes?

Type 1 diabetes occurs when the immune system mistakenly attacks the insulin-producing cells in the pancreas, leaving the body unable to regulate blood sugar naturally. Current treatments rely on insulin therapy, but several UCSF trials are exploring ways to either restore the body's own insulin production or prevent the disease from developing in the first place .

One of the most promising approaches involves GNTI-122, an investigational cell therapy that uses a patient's own blood cells to potentially restore insulin production. In this 78-week study, researchers are enrolling adults ages 18 to 45 who were recently diagnosed with type 1 diabetes. Participants receive either a low dose of the therapy, a high dose, or a high dose combined with rapamycin, a medication that helps regulate the immune system. Researchers monitor disease markers like C-peptide levels, which indicate how much insulin the pancreas is still producing, along with hemoglobin A1C (HbA1c), a measure of average blood sugar control over three months .

Another trial is testing VX-880, an infusion treatment specifically designed for people with type 1 diabetes who experience impaired awareness of hypoglycemia, a dangerous condition where patients don't recognize when their blood sugar drops dangerously low. This study enrolls participants ages 18 to 65 and evaluates the safety, tolerability, and effectiveness of the treatment .

For younger patients, UCSF is also testing teplizumab, an immunotherapy drug that aims to slow or halt the progression of type 1 diabetes in its early stages. This multicenter trial enrolls children and young adults ages 1 to 25 with recently diagnosed stage 3 type 1 diabetes and measures changes in blood sugar control and insulin independence over 52 weeks compared to a placebo .

How Are Automated Systems Changing Diabetes Management During Pregnancy and Daily Life?

Managing blood sugar during pregnancy is particularly challenging for people with type 1 diabetes, as hormonal changes make glucose control more difficult and errors can affect both mother and baby. UCSF is testing whether automated insulin delivery (AID) systems, which use continuous glucose monitors (CGMs) and smart insulin pumps to automatically adjust insulin doses, can improve outcomes during labor and delivery. Researchers are comparing these systems to intravenous insulin, the current standard of care, and measuring neonatal blood sugar outcomes, patient satisfaction with birth experience, and time-in-range metrics, which show how much of the day blood sugar stays in the target zone .

For children with type 1 diabetes, another trial called AIDANET Pediatrics is testing a smartphone-based control system paired with a modified Tandem insulin pump and Dexcom G6 continuous glucose monitor in participants ages 6 to 13. This approach allows parents and caregivers to monitor and adjust insulin delivery remotely, reducing the burden of constant manual management .

Steps to Determine If You Qualify for a Diabetes Clinical Trial

• Check Your Age and Type: UCSF trials serve different age groups and diabetes types. Some trials enroll children as young as 1 year old, while others target adults up to age 65 or older. Identify which trials match your age and whether you have type 1 diabetes, type 2 diabetes, gestational diabetes, or prediabetes.
• Review Specific Eligibility Criteria: Each trial has unique requirements. Some focus on recently diagnosed patients, others on people with specific complications like impaired hypoglycemia awareness or diabetic macular edema (eye damage from diabetes). Visit the UCSF clinical trials website or the specific trial's information page to confirm you meet all criteria.
• Contact the Research Team: Reach out to UCSF's diabetes research coordinators through the clinical trials portal at clinicaltrials.ucsf.edu/diabetes or visit trial-specific websites like polarisstudy.com for GNTI-122. Research staff can answer questions about what participation involves, including time commitments, procedures, and potential risks and benefits.

What About Type 2 Diabetes and Gestational Diabetes Trials?

UCSF's diabetes research extends beyond type 1 diabetes. The AWARD-PEDS PLUS trial is testing higher doses of dulaglutide, a GLP-1 receptor agonist (a class of medications that helps the pancreas release insulin and reduces appetite), in children ages 10 to 17 with type 2 diabetes. This eight-month study evaluates whether additional dosing options can improve blood sugar control in younger patients .

For pregnant people with gestational diabetes, the DECIDE trial is comparing metformin, an oral medication, against injectable insulin to determine if metformin is equally effective at preventing pregnancy complications. This pragmatic trial enrolls 1,572 pregnant individuals with gestational diabetes across 20 U.S. sites and follows participants and their children through delivery and up to two years postpartum, measuring both safety and patient-reported factors like barriers to medication use .

UCSF is also testing treatments for diabetic macular edema, a serious eye complication where fluid accumulates in the macula, the part of the retina responsible for sharp vision. The RO7446603 trial evaluates a new drug administered alone or in combination with existing treatments like aflibercept or faricimab, measuring both eye safety and vision outcomes in participants ages 18 and older .

Why Should Patients Consider Participating in Clinical Trials?

Clinical trials offer several potential benefits. Participants gain access to cutting-edge treatments years before they become available to the general public, receive close medical monitoring, and contribute to research that could help millions of people with diabetes. Many trials provide compensation for time and travel, and participants work with experienced diabetes research teams who understand the complexities of blood sugar management .

However, trials also involve risks, including potential side effects from experimental treatments, time commitments for visits and monitoring, and the possibility that the new treatment may not work better than current options. It's important to discuss the specific risks and benefits of any trial with the research team and your personal diabetes care provider before enrolling .

With 42 active trials and 26 open to new participants, UCSF represents one of the largest concentrations of diabetes research in the country. Whether you have type 1 diabetes, type 2 diabetes, gestational diabetes, or are at risk for developing diabetes, exploring clinical trial options could connect you with treatments that may transform your health and contribute to breakthroughs that benefit future generations.