A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes. Participants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or artificial pancreas with an ultra-rapid insulin called Lyumjev.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.

• Insulin pump use for at least 3 months.

• Individuals of childbearing potential must agree to use a highly effective method of birth control.

• Willing to switch to Lyumjev insulin for the duration of the study.

Locations
Other Locations
Canada
Research Institute of the McGill University Health Centre (RI-MUHC)
RECRUITING
Montreal
Contact Information
Primary
Carolyne Schumacher
carolyne.schumacher@mail.mcgill.ca
514-258-5431
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2024-12
Participants
Target number of participants: 12
Treatments
Active_comparator: AID-count
Experimental: AID-estimate
Experimental: AID-detect
Related Therapeutic Areas
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov