First Gene Therapy Trial for Type 1 Diabetes to Launch in 2026

KRIYA-839 represents a new direction in type 1 diabetes research: gene therapy. Unlike insulin injections or pumps that replace missing insulin, this approach aims to train the body's own cells to make insulin.

The therapy delivers two genes—one for glucokinase and one for insulin—directly into muscle cells in the quadriceps using an adeno-associated virus (AAV) vector. The AAV is a modified virus chosen specifically because it does not cause disease. Once inside muscle cells, these genes remain in the cell nucleus and continue to produce genetic material throughout the patient's life.

An important distinction: KRIYA-839 is not gene editing. The therapy does not integrate with a person's chromosomes or alter their genetic makeup. Instead, the genes sit within muscle cell nuclei and work independently, similar to how other gene therapy products already approved by regulators operate.

Dr. Jeremy Pettus, an endocrinologist at UC San Diego, explained the approach at the 2026 International Conference on Advanced Technologies and Treatments for Diabetes: "It doesn't integrate with the host genome. It's not changing the chromosomes."

The PROGRESS study will be the first clinical trial testing this gene therapy approach in type 1 diabetes. Adults with type 1 diabetes will receive a single intramuscular injection of KRIYA-839 and be followed for one year, with researchers tracking both safety and whether the therapy works.

For the type 1 diabetes community, this represents a shift from the long timelines often associated with experimental treatments. As Dr. Pettus noted: "In the type 1 community, we're used to [hearing] this will happen in 10 to 15 years and maybe will come one day. It's very exciting to stand here and say that this is actually something that's in the works and happening now."

Gene therapy itself is not new. Several gene therapy products have already been approved by regulators, primarily for rare, single-gene diseases. What has changed is manufacturing: scientists can now produce these therapies at scales and costs that make it possible to test them in more common conditions like type 1 diabetes.

Preclinical data—studies done in the laboratory before human testing—demonstrated that both the glucokinase and insulin genes worked safely and effectively, paving the way for human trials.

Origin: medscape.com (News report). Evidence: News report, corroborated with 3 indexed studies. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.