26
Participants
Start Date
December 1, 2024
Primary Completion Date
January 31, 2027
Study Completion Date
January 31, 2027
Semaglutide with 4 meal strategies
The blinded drug will be used in addition to the participants routine closed-loop insulin pump therapy. It will be administered through subcutaneous injection on a weekly basis. The first 12 weeks will include progressively increasing doses of the drug whereby, the dose increases every 4 weeks. Once the maximum tolerated dose is achieved after 12 weeks, participants will undergo 4 meal strategies in a randomized order. These include (in no particular order); full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev. Each meal strategy will be 3 weeks in duration and will occur sequentially in the designated order.
Placebo with 4 meal strategies
The blinded drug will be used in addition to the participants routine closed-loop insulin pump therapy. It will be administered through subcutaneous injection on a weekly basis. The first 12 weeks will include progressively increasing doses of the drug whereby, the dose increases every 4 weeks. Once the maximum tolerated dose is achieved after 12 weeks, participants will undergo 4 meal strategies in a randomized order. These include (in no particular order); full carbohydrate counting with rapid-acting insulin, SMA with rapid-acting insulin, SMA with Lyumjev and fully closed-loop system with Lyumjev. Each meal strategy will be 3 weeks in duration and will occur sequentially in the designated order.
RECRUITING
Research Institute of the McGill University Health Centre, Montreal
McGill University Health Centre/Research Institute of the McGill University Health Centre
OTHER