T1D Plus - testing
and transforming
Type 1 Diabetes
(T1D) treatments
Primary Outcome
Finding more effective treatments that preserve pancreatic beta cells, reducing reliance on insulin injections.
One hundred years after its discovery, insulin remains the only available treatment for T1D. The T1D Plus trial is testing and developing therapies that sustain beta cell function and transform T1D treatment.
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
Principal Investigator: Professor Colin Dayan, Cardiff University
Senior Trial Manager: Julia Townson, Cardiff University
Key Trial Contact : Nigel Kirby, Cardiff University
“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 Product Owner for T1D Plus is Gosia Costar
Gosia Costar is one of our dedicated Product Owners here at Spiral. Gosia thrives on building strong relationships with clients and values collaboration at every stage of a project, ensuring solutions are both effective and meaningful.
