Status:
RECRUITING
A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Diabetes Mellitus, Type 1
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 carbohydrat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin…); 1 month for GLP1-RA.
- Use of glucocorticoids (except low, stable doses and inhaled steroids).
- Use of hydroxyurea.
- Planned or ongoing pregnancy.
- Breastfeeding.
- Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.
- Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.
- Recent (\<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
- Known hypersensitivity to the study drug or its excipients.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06021158
Start Date
December 20 2023
End Date
December 1 2024
Last Update
March 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Institute of the McGill University Health Centre (RI-MUHC)
Montreal, Quebec, Canada, H4A 3J1