Breakthroughs in type 1 diabetes research in 2025

The year was off to an incredible start with a huge step forward for cell therapies that aim to cure T1D. Sana Biotechnology published data from their clinical trial that transplanted insulin-making cells from organ donors, which had been engineered to hide from the immune system, into a person with T1D. The results showed that the recipient of these cells is now producing insulin without needing dangerous immunosuppressive drugs.

Breakthrough T1D contributed to this research by investing in Sana Biotechnology through the T1D Fund.

Another exciting development in cell therapies for T1D came in February. Transplants of islets (which contain insulin-making beta cells) are typically placed in the liver, but lots of the new cells die because they don’t have a good enough blood supply. Breakthrough T1D-funded researchers have developed a method of enclosing donor islets inside a network of blood vessels, enabling them to be inserted under the skin instead. This method could make islet transplants more successful and less invasive for people with T1D.

In March, Breakthrough T1D-funded researchers in Australia announced a new blood test, BASTA, that can detect T1D earlier than ever before by directly measuring the immune activity involved during T1D development. Current early diagnostic tests detect proteins that indicate that the immune system has already started attacking beta cells. But BASTA can track the immune cells responsible for causing the damage, allowing more opportunity to intervene before too much harm is done.

April saw Breakthrough T1D-funded researchers discover that products released by the gut microbiome (viruses and bacteria that live in our digestive system) could help delay the onset of T1D. An Australian clinical trial found that an oral supplement boosted the gut microbiome and immune response in people with T1D. When samples of the participants’ microbiome were given to mice at risk of T1D, they developed T1D more slowly – a world-first finding.

The largest and most in-depth study examining human pancreas samples for signs of viral infection was published in May. The analysis found that people without T1D had no signs of viruses in their pancreas, but over 80% of those with T1D did. While viruses don’t directly cause T1D, they may trigger the immune system attack in people at high genetic risk. This may mean that therapies to target viral triggers, like antiviral drugs and/or vaccines, may be effective in preventing or delaying the onset of T1D.

At the world's largest diabetes conference in June, Vertex Pharmaceuticals announced the latest results from the FORWARD-101 trial. This trial tested a therapy called zimislecel that infuses lab-grown beta cells into the liver of people with T1D. A year after receiving the therapy, all participants were free of severe low blood glucose (hypoglycaemia), and 10 out of 12 participants no longer needed to take insulin. This is a promising step towards giving people with T1D the ability to make insulin again.

In July, a new subtype of T1D was identified in African populations. The findings showed that 65% of children tested across Cameroon, Uganda and South Africa didn't have the protein markers in their blood that are typically associated with T1D. They also had no genetic pre-disposition to T1D, or features consistent with other types of diabetes (such as type 2 diabetes or malnutrition-related diabetes). The researchers think they have discovered a new non-autoimmune form of T1D.

A paper outlining a roadmap for beta cell replacement therapies that can cure T1D was published in August. Written by a team of Breakthrough T1D leaders and staff, the paper establishes guidelines on how to accelerate the availability of beta cell replacement therapies for people with T1D by designing clinical trials that speed up their development, regulatory approval, access, and adoption. It also recommends that more people with T1D should be included in designing clinical trials and in evaluating the benefits of beta cell therapies.

The results from several clinical trials were released at Europe’s biggest diabetes conference in September, including:

• The MELD-ATG trial found that low-dose anti-thymocyte globulin (ATG) lowers HbA1c and preserves insulin production in young people recently diagnosed with T1D.
• The Ver-A-T1D trial results suggested verapamil could slightly help preserve insulin release in people newly diagnosed with T1D, so could be tested with other therapies to improve its effectiveness.
• The LENS trial showed that fenofibrate can reduce the progression of diabetic retinopathy in people with T1D.

In October, Eli Lilly announced the launch of 2 new clinical trials to investigate the effect of baricitinib on the onset and progression of T1D. BARICADE-DELAY will test whether baricitinib can delay onset of T1D in children and adults with stage 2 T1D, while BARICADE-PRESERVE will test whether baricitinib can preserve insulin production in people recently diagnosed with T1D. These trials follow the BANDIT trial, a landmark Australian clinical trial, which found that baricitinib protects beta cell function in young people newly diagnosed with T1D.

November was another bumper month for clinical trials results! Researchers leading clinical trials around the world shared the following results:

• The FINE-ONE study found that finerenone significantly reduced signs of kidney damage in people with T1D and chronic kidney disease.
• The INTIMET study found that while metformin doesn’t improve insulin resistance in people with T1D, it does reduce insulin needs.
• The TIRTLE1 study showed that tirzepatide can significantly and safely reduce the amount of insulin needed in people with T1D and obesity.
• The PETITE-T1D study suggested that teplizumab (Tzield) is as safe and tolerable in children under 8 who have stage 2 T1D as it is in older individuals.

As the year draws to a close, we’re looking to the future of T1D research by investing over $1m in 7 of the most promising early career researchers in Australia. Through the Breakthrough T1D Australia Type 1 Diabetes Clinical Research Network (T1DCRN), we have awarded 7 bright researchers fellowships that offer funding and bespoke mentorship. Over 2 years, the fellows will develop their skills, helping them to become future leaders in the field and achieve more breakthroughs for people living with T1D.