T1D+ - testing and transforming Type 1 Diabetes (T1D) treatments.

T1D+

One hundred years after its discovery, insulin remains the only available treatment for T1D. The T1D+ trial is testing and developing therapies that sustain beta cell function and transform T1D treatment.

Primary Outcome:

Finding more effective treatments that preserve pancreatic beta cells, reducing reliance on insulin injections.

Background

  • Type One Diabetes is a condition where the body's immune system destroys insulin-producing cells in the pancreas. 

  • Insulin injections can't fully replicate the body's natural insulin production. An alternative approach is to slow or halt the autoimmune process that destroys the beta cells of the pancreas. 

  • Several such treatments (immune therapies) have been developed, but each one individually is not enough to stop the destructive process altogether.  

Trial design

  • This trial involves 40 sites across Europe, including the UK, Austria, France, Belgium, Germany, and Italy. 

  • An additional network, ATIC, will contribute 5-10 sites with a goal to recruit about one-third of all participants. The trial might expand to other regions depending on funding and regulatory approval.

  • Participants will be checked every three months for a year using a Mixed Meal Tolerance Test (MMTT). This test involves drinking a liquid meal and measuring the insulin their body produces over the next two hours.

  • The T1D-Plus trial uses an "adaptive platform trial" format. This means they can test multiple treatments in a flexible and efficient way—inviting adults recently diagnosed with stage 3 T1D to participate. 

  • These participants will either receive Verapamil SR alone or combined with other treatments. Verapamil SR is a drug primarily used for high blood pressure, but it's also been found to protect beta cells. 

  • The trial is set up so that new treatments can be added over time.

Key connections

“My systematic thinking approach is focused on delivering platform solutions that improve process efficiencies for Spiral's clients and contribute to their trial's success.”

Spiral’s contribution

Our Spiral Project Lead for T1D+ is Gosia Costar

Gosia Costar is one of our dedicated Project Managers here at Spiral. Her passion for enhancing health outcomes through innovative technology makes her the perfect addition to our team.