The Most Exciting and Impactful Advances in Diabetes in 2025!

Let’s dive in!

10 People with T1D Become Insulin-Independent in Vertex Clinical Trial

The big news from Vertex Pharmaceuticals this year was that their stem cell–based treatment for type 1 diabetes, zimislecel (formerly VX-880), is showing promise. In early trials, 10 out of 12 people with severe T1D became insulin-independent within a year – a huge step toward what could be a functional cure for type 1 diabetes.

The main requirement of zimislecel is that you have to take low-dose immunosuppressants for life to make sure your body doesn’t reject the new cells, but Vertex is working on genetically edited “hypoimmune” islet cell therapies that hope to solve that problem.​ If it has continued success, zimislecel could be the first scalable cell therapy that fundamentally changes type 1 diabetes treatment.

Sanofi’s Tzield Gets Fast-Track FDA Review for Stage 3 T1D

In October, Tzield was accepted for expedited FDA review under the Commissioner’s National Priority Voucher pilot program for Stage 3 T1D.

If approved, Tzield would become the first therapy to preserve beta-cell function in adults and kids 8 years and older who are newly diagnosed with type 1 diabetes. Until now, there have been no therapies that could change the course of type 1 diabetes after diagnosis.

Tzield works by modulating the immune system, aiming to preserve the insulin-producing beta cells in the pancreas and delay their destruction.​ In clinical trials, one treatment course of Tzield delayed the clinical diagnosis of type 1 diabetes for an average of two years.

Lilly to Start Phase 3 Trials to Delay T1D & Preserve Beta Cell Function

Two phase 3 studies from Lilly are moving forward to see if a medication called baricitinib could delay and/or prevent type 1 diabetes.

• The BARICADE-DELAY study will test whether baricitinib can delay or prevent the progression to clinical T1D (stage 3) in adults and children currently in stage 1 or stage 2 T1D.
• The BARICADE-PRESERVE study will explore whether baricitinib can help preserve pancreatic beta cell function in adults and kids who are newly diagnosed with stage 3a T1D.

These new trials are being launched because an earlier study called BANDIT reported preservation of C-peptide levels in new-onset stage 3 T1D participants following treatment with baricitinib. Lilly plans to begin these new studies in late 2025 and early 2026.

Kriya Preps for Human Gene Therapy Trials in Type 1 Diabetes

Kriya Therapeutics is working on a new gene therapy for type 1 diabetes called KRIYA-839. The treatment involves delivering insulin and glucokinase genes right into the muscle to help the body control blood sugar on its own, so no external insulin or immune-suppressing drugs would be needed. 

In animal studies, it’s shown some pretty exciting results – better blood sugar levels, lower A1c, and reduced triglycerides, all without causing lows. Kriya recently received funding to take the next big step to start testing it in people.

Sana’s Engineered Islet Cells Avoid Immune System Destruction and Make Insulin

In August, Sana Biotechnology announced that they hit a major milestone with genetically engineered insulin-producing islet cells created to work without immunosuppressants. The first person to receive a small test dose of these cells did well, and the transplanted cells were still making insulin after 12 weeks. This first patient only received a small test dose so they still need external insulin, but the study shows that genetically modified cells can survive without immune-suppressing drugs. Sana expects to start Phase 1 clinical trials in 2026. We’re cautiously optimistic that this will work well in more than one patient. 

New Medications & Indications

New drug approvals and expanded indications for many common medications are helping to change the landscape of diabetes treatment, offering broader protection for heart, kidney, and metabolic health.

Kidney and Heart Health

• KERENDIA (finerenone) was approved to treat patients with heart failure and kidney disease in type 2 diabetes. It also recently showed positive results in treating chronic kidney disease in adults with type 1 diabetes.
• The FDA approved Ozempic (semaglutide), a GLP-1 RA, to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease.
• Wegovy (semaglutide) was approved by the FDA for the treatment of adults with MASH with moderate to advanced liver fibrosis.
• Mounjaro demonstrated cardiovascular protection in a landmark head-to-head trial against Trulicity (an older GLP-1 RA), reinforcing its benefit for people with type 2 diabetes and heart disease.
• Rybelsus, Novo Nordisk’s oral semaglutide, was approved for cardiovascular risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior cardiovascular event.

Diabetes & Weight Loss

• Multiple studies in 2025 showed that Lilly’s once-daily oral GLP-1 medication orforglipron demonstrated superior glycemic control, meaningful weight loss, and cardiometabolic improvements in adults with type 2 diabetes and obesity or overweight.

 Hypercortisolism

• Corcept’s new drug application for Relacorilant to treat hypercortisolism was accepted by the FDA and assigned a target action date of December 30, 2025. Hypercortisolism is a serious condition that’s often missed by healthcare providers.

 Hypothyroidism

• Xeris Pharmaceuticals announced positive topline Phase 2 results for XP‑8121, their once‑weekly subcutaneous levothyroxine formulation using the XeriSol™ platform to treat hypothyroidism.

 Weekly Basal Insulin and Inhaled Insulin 

• Novo Nordisk resubmitted Awiqli to the FDA with the potential to be the first once-weekly basal insulin treatment for adults with type 2 diabetes.
• MannKind announced that the FDA agreed to review its application to allow Afrezza inhaled insulin to be used in kids and teens ages 4 to 17 who have diabetes (type 1 or type 2). The FDA is expected to make a decision by May 29, 2026.

Technology News: New Partnerships and Device Updates

Pumps and sensors are teaming up like never before, giving people with diabetes more connected, customizable choices..

• Abbott’s Libre technology is the first CGM associated with reduced hospitalizations for heart complications in people with type 1 and type 2 diabetes and hypoglycemia.
• Dexcom’s G7 CGM received 15-day approval from the FDA, and launches December 1st. Dexcom’s Smart Basal, an integrated basal‐insulin titration module for type 2 diabetes in the G7 app, also received FDA clearance. Dexcom’s over-the-counter CGM Stelo now syncs with the OURA ring.
• Medtronic announced they’re going back to their old name, MiniMed, for their diabetes company. Their Simplera Sync sensor for the MiniMed 780G System was FDA approved, and the 780G system was also approved for adults 18 and over with type 2 diabetes on insulin.
• The newest insulin pump on the market, Sequel’s twiist automated insulin delivery (AID) system, had a limited launch in the U.S. on July 7. It will integrate with the FreeStyle Libre 3 Plus and the Eversense 365 CGMs.
• Tandem received FDA approval for Control IQ Plus for use in type 2 diabetes. Tandem’s t:slim X2 insulin pump was also approved for use with Lyumjev ultra-rapid acting insulin.
• Biolinq Shine was granted De Novo Classification by the FDA for the first fully autonomous, needle-free glucose sensor.