Behind the Screens: Innovations in Type 1 Diabetes Clinical Trials—From Immunomodulation to Screening Strategies and Advanced Cell Therapies

Announcer:
Welcome to DataPulse from EASD 2025 on ReachMD. This activity, titled “Behind the Screens: Innovations in Type 1 Diabetes Clinical Trials—From Immunomodulation to Screening Strategies and Advanced Cell Therapies” is provided by Medcon International.  

Dr. Caruso 
Hello from EASD 2025 here in Vienna. I am Dr. Irene Caruso, and today I’m reviewing new insights coming from the oral session entitled Behind the Screens: New Adventures in Type 1 Diabetes Clinical Trials.

During this session, we covered the broad spectrum of type 1 diabetes research, spanning from prevention and screening to immunomodulation and cell therapy. We began with SAB-142, which is a fully human anti-thymocyte globulin which was developed to overcome the limitations of rabbit ATGs. 

Preliminary data on healthy volunteers show that human ATG comes with only transient lymphopenia, avoiding permanent lymphopenia and serum sickness. These results are indeed encouraging and are likely to be expanded in future clinical trials.

Then two large studies covering screening followed. The first one, the ELSA study, was conducted in the UK and showed that on a population level, screening for islet autoantibodies was both acceptable and feasible using dried blood spots, although with some concerns regarding the inclusion of underserved groups of people. 

From Germany, the Fr1da study provided long-term data on children with a single autoantibody positivity. Discussion was lively and focused on the need of risk screening these patients and also on choosing the right threshold for autoantibody levels.

Another presentation focused on risk stratification for progression to clinically overt type 1 diabetes. The analysis of the TrialNet data showed that HbA1c thresholds should be different for children and adults due to the fact that physiologically HbA1c increases with aging. Adults will require higher HbA1c levels to match their younger counterparts in terms of risk for clinically overt type 1 diabetes progression, and this will likely be included in future clinical consensus and guidelines.

Finally, the FORWARD study reported impressive results with zimislecel, which is a stem cell–derived islet transplantation. Participants no longer required insulin after 1 year of follow-up, while exhibiting excellent HbA1c and CGM metrics. While immunosuppression remains a concern, these findings highlight the extremely powerful potential of stem cell–derived islet transplantation.

Altogether, this session highlighted how much progress is being made in type 1 diabetes research, and probably the combination of these approaches will ultimately lead to a radical change in how we detect, prevent, and treat type 1 diabetes in the next few years.

From EASD 2025, that’s all. Thank you for listening. 

Announcer:
Thank you for listening to this DataPulse from EASD 2025 on ReachMD. This activity is provided by Medcon International. Thank you for listening.