Comparing meal strategies for insulin delivery in type 1 diabetes
A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes
This study is testing three different ways to manage meals with a fast-acting insulin to see if simplifying how we count carbs can help people with type 1 diabetes better control their blood sugar.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montréal, Quebec) |
| Trial ID | NCT06021158 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate three different meal strategies using an ultra-rapid insulin called Lyumjev in conjunction with an automated insulin delivery system for patients with type 1 diabetes. Participants will engage in each meal strategy for 21 days, testing carbohydrate counting, qualitative meal size estimation, and meal detection in a randomized order. The goal is to determine if simplifying carbohydrate counting can improve insulin delivery and management for individuals with type 1 diabetes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 1 diabetes for at least 12 months who have been using an insulin pump for a minimum of 3 months.
Not a fit: Patients who are currently pregnant, breastfeeding, or have experienced severe hypoglycemia or diabetic ketoacidosis within the past month may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and simplified insulin management strategies for patients with type 1 diabetes.
How similar studies have performed: Other studies have explored automated insulin delivery systems, but this specific comparison of meal strategies with ultra-rapid insulin is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Montréal, Quebec
- Research Institute of the McGill University Health Centre (RI-MUHC) — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Michael Tsoukas, M.D. — Royal Victoria Hospital, Belfast
- Study coordinator: Carolyne Schumacher
- Email: carolyne.schumacher@mail.mcgill.ca
- Phone: 514-258-5431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.