The American Diabetes Association’s 85th Scientific Sessions were held from June 21- 24th, 2025. The research presented at ADA covers all areas of type 1 diabetes (T1D) developments, including devices, adjunct therapies and the latest in cell therapies.
Updates in cell therapies research
Dr. Andrew Pepper (Edmonton) presented on vascularization strategies to increase the survival and functionality of transplanted islets. The implantation of a biomaterial under the skin will trigger the immune system and initiate a foreign body reaction, which results in the formation of blood vessels and structural components around the foreign object. Removal of the object leaves a hollow pre-vascularized core suitable for islet transplantation. This process can be optimized by using a biodegradable material, so no removal is required, and by the addition of “accessory cells” such as stem cells that are programmed to form blood vessels to help maintain a vascularized environment for islets.
Most Pressing Challenge in Cell Therapy: When the panel of experts was asked about the biggest hurdle to bring cell therapies to people, the answer was unanimous – removing immunosuppressants while maintaining efficacy and safety.
This is a primary area of focus for Breakthrough T1D and the aim of many ongoing projects by Canadian researchers with Breakthrough T1D funding. One example is work led by Dr. Andras Nagy (Toronto) and Dr. Tim Kieffer (Vancouver) presented at ADA:
Dr. Nagy’s lab has identified eight immunomodulatory genes that, when modified, can cause transplanted cells to be ‘cloaked’ and evade immune rejection. The work presented at ADA demonstrates that Dr. Kieffer’s lab successfully incorporated these gene edits into human islets derived from human embryotic stem cells. When the cells were put into a petri dish with other immune cells, they survived the immune response that kills un-modified islets. This approach needs to be tested in an animal model before moving to human trials.
Updates on Vertex’s stem cell therapy, Zimislecel (VX-880)
Dr. Michael Rickels (Pennsylvania) presented on Zimislecel (VX-880) – a stem cell-derived islet therapy that requires immunosuppression, which is infused into a vein in the liver in people with T1D who have impaired hypoglycemic awareness and severe hypoglycemic events.
The phase 1/2 clinical trial, which is part of the ongoing pivotal phase 1/2/3 FORWARD-101 trial, is complete. Twelve participants received a single infusion of a full dose of cells and were followed for at least one year.
All 12 participants achieved the primary endpoint, which was elimination of severe hypoglycemic events and HbA1c levels less than 7%. 10/12 (83%) participants are insulin independent.
All 12 participants demonstrated sustained insulin production as measured by C-peptide, reduced external insulin therapy use, and achieved greater than 70% time in range. Mild to moderate adverse events were consistent with the immunosuppression regimen, infusion procedure, and complications from T1D.
These data were published in the New England Journal of Medicine and represent further evidence of the curative potential of manufactured islet transplantation for T1D. Breakthrough T1D’s support for Doug Melton, Ph.D.—whose proprietary lab-created islets are now being advanced by Vertex—goes back decades, both via research grants and an investment from the T1D Fund: A Breakthrough T1D Venture.
Read more about Vertex updates: https://breakthrought1d.ca/exciting-updates-from-vertex-stem-cell-based-therapy-clinical-trials/
6-month update on Sana Biotechnology’s immune-evasive islets
Dr. Per-Ola Carlsson (Sweden) presented data from Sana’s donor-derived islet therapy engineered with hypoimmune (HIP) technology showing that the cells can evade the immune system without immunosuppression. These cells were implanted intramuscularly in a first-in-human study into a person with T1D with no measurable insulin production.
Six months post-transplant, this person is consistently making their own insulin, as measured by C-peptide levels. A Mixed Meal Tolerance Test (MMTT) confirmed that these cells are not only surviving but also responding to changes in blood glucose levels. The person still requires external insulin therapy because they received a smaller dose of cells than the dose that would be required to achieve insulin independence. They did not experience any serious side effects, so the cells and procedure appear to be safe and well-tolerated.
This is a promising first step toward a functional cure for T1D that does not require immunosuppression. Sana Biotechnology is planning on applying this technology to manufactured islets. Sana has received support from the T1D Fund to advance their HIP technology in islets, and Breakthrough T1D continues to work closely with them.
Read more about Sana here: https://breakthrought1d.ca/cell-therapy-first-transplanted-islets-working-without-immunosuppressives/
Key Takeaways
Cell therapies are making significant headway in clinical trials, and some people receiving stem cell-derived islets become insulin independent. Researchers are tackling the biggest challenges for optimizing islet transplantation, including large-scale manufacturing, ensuring cell survival, and preventing detection by the immune system.
Updates on disease-modifying therapies
Dr. Heather Denroche (Integrated Nanotherapeutics) presented work on their lipid nanoparticle approach that can deliver antigen-specific immune therapy for T1D. This is done with a combination “vaccine-like” product that uses their proprietary multi-cargo lipid nanoparticles platform to co-deliver mRNA expressing certain islet-proteins (to enable antigen-specificity) and small molecule immunomodulators (to switch off the harmful autoimmune attack on islets). They have demonstrated that this therapy prevents and reverses diabetes in mice, which warrants further preclinical development as a promising treatment for T1D.
Laura Sanz Villanueva (Australia), who works in the lab of Breakthrough T1D-funded researcher Dr. Thomas Kay presented on a mechanistic follow-up study to the BANDIT clinical trial. The Breakthrough T1D-funded phase 2 BANDIT study in Australia showed that baricitinib, a JAK1/2 inhibitor that prevents immune cell communication, can increase insulin production as measured by C-peptide in people with recently diagnosed T1D. The present study found that baricitinib can reduce the number of natural killer (NK) cells in the pancreas, which are involved in the autoimmune destruction of beta cells. This data provides valuable insight into the mechanism of baricitinib-mediated protection of beta cells.
Key takeaways
Research that tackles a variety of approaches to disease-modifying therapies is showing true promise and potential to offer medications that will make T1D management easier and safer.
Updates on improving lives research
Adjunct-to-Insulin Therapies
There was significant focus on GLP-1 receptor agonists (GLP-1RAs) and SGLT inhibitors (SGLTi) in reducing long-term complications and improving glycemic control in people with T1D.
GLP-1 receptor agonists
Glucagon-like peptide 1 receptor agonists mimic the hormone GLP-1, which elevates insulin and regulates appetite. Examples include Ozempic® (semaglutide) and Mounjaro® (tirzepatide), which acts on both GLP-1 and a similar target, GIP.
SGLT inhibitors
Sodium-glucose cotransporter inhibitors target kidney cells to prevent them from reabsorbing glucose into the blood so it gets excreted as waste. Examples include Farxiga® (dapagliflozin) and Zynquista® (sotagliflozin).
Dr. David Cherney (Toronto) presented a review of SGLTi and GLP-1RAs in reducing chronic kidney disease (CKD) in T1D:
- In the EMPA-KIDNEY trial, empagliflozin (SGLTi) improved kidney health in people with T1D.
- In the ATTEMPT trial funded by Breakthrough T1D Canada and CIHR, dapagliflozin (SGLTi) improved time in range (TIR), reduced HbA1c levels, and had positive effects on kidneys in youth with T1D.
- The Breakthrough T1D-funded enrolling phase 3 SUGARNSALT trial is testing whether sotagliflozin (SGLTi) can prevent progression of moderate to severe kidney disease in people with T1D, and it includes careful diabetic ketoacidosis (DKA) risk mitigation strategies.
- The Breakthrough T1D-funded phase 2 REMODEL-T1D trial is testing if semaglutide (GLP-1RA) can improve kidney health in people with T1D.
Key takeaways
Breakthrough T1D is working toward a future where these drugs are an option for people with T1D to better manage their blood glucose levels and reduce the potential of long-term complications.
Canadian data was presented from the Breakthrough T1D-funded BETTER Registry which showed that of nearly 1,400 adults with T1D, approximately 14% (n=192) were using an adjunctive therapy. Amongst this group, the most common was Metformin (39% of the 192 adjunct therapy users), followed by GLP-1RAs (27%), SGLTi (21%), and a combination of these (13%).
While these therapies are not approved for use in adults with T1D in Canada, the Diabetes Canada Clinical Practice Guidelines were updated at the beginning of 2025 and are in the first in the world to recommend considering the (off-label) use of adjunct therapies for selected adults with T1D to help them meet their treatment goals.
Updates on diabetes device research
Dr. Alanna Weisman (Toronto) presented a review of barriers and enablers to diabetes technology in people with T1D. Across over 200 studies, the most common barriers included: racial or ethnic minority status, insurance concerns (e.g., coverage), and clinic- and provider-related factors (e.g., gatekeeping of information and/or prescriptions). The most common enablers included: patient education, patient support, and provider education. Dr. Weisman’s Breakthrough T1D-funded work is looking at barriers to technology use in socially disadvantaged Canadians.
Teams led by Dr. Anne-Sophie Brazeau and Dr. Rémi Rabasa-Lhoret (Montreal), who oversee the BETTER Registry, presented the following data from the Canadian registry on device use:
A comparison of technology use in adults over the age of 50 years of age from the BETTER Registry data (n=674), showed similar rates of insulin pump use in adults with T1D in their 50s (39%) and 60s (38%), but this was slightly lower for adults above the age of 70 (35%). More pronounced was the difference in rates of CGM use in adults in their 50s and 60s (85% for both groups) compared to the much lower rate in adults above the age of 70 (73%).
The BETTER Registry also has a significant wealth of patient-reported outcome measures that inform us of factors such as fear of hypoglycemia. In a sample of 115 adults with T1D, the introduction of automated insulin delivery (AID) reduced the number of hypoglycemia instances reported monthly, the number of nighttime symptomatic hypos, and perhaps most importantly, the average fear of hypoglycemia based on validated survey measurements. These findings support the potential of AID to reduce the burden of hypoglycemia in adults living with T1D.
Key takeaways
Breakthrough T1D-funded research into device access and development of next gen diabetes devices will enable improved daily management and reduce some of the mental and emotional burden of living with T1D.
To watch a video recap: https://www.breakthrought1d.org/news-and-updates/everything-you-need-to-know-about-ada-2025/
