Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

December 1, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions
Type 1 DiabetesDiabetes Mellitus
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

H4A 3J1

RECRUITING

Research Institute of the McGill University Health Centre, Montreal

All Listed Sponsors
lead

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER