Automated delivery system for insulin and pramlintide in adults with type 1 diabetes
A Randomized, Controlled, Crossover Trial to Assess a Fully Automated, Dual-hormone (Insulin-and-pramlintide) Delivery System Without Carbohydrate Counting in Regulating Glucose Levels in Adults With Type 1 Diabetes.
PHASE2; PHASE3 · McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06046417
This study is testing a new automated system for delivering insulin and pramlintide to see if it helps adults with type 1 diabetes manage their blood sugar better than a system that requires counting carbs.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre (other) |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT06046417 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a fully automated delivery system for Lyumjev insulin and pramlintide in improving glycemic control in adults with type 1 diabetes. Participants will undergo three different interventions in a randomized order, comparing the fully automated system to a hybrid system that includes carbohydrate counting. The study aims to determine the optimal insulin to pramlintide ratio for better glycemic outcomes. Participants will use advanced devices, including continuous glucose monitors and insulin pumps, throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of type 1 diabetes who have been using insulin pump therapy for at least three months.
Not a fit: Patients currently using certain antihyperglycemic agents or those with confirmed gastroparesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and quality of life for adults with type 1 diabetes.
How similar studies have performed: Other studies have shown promise with automated insulin delivery systems, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals ≥ 18 years of age. * A clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes relies on the investigator's judgment; C peptide level and antibody determinations are unnecessary. * Using insulin pump therapy for at least three months. * Individuals of childbearing potential using an effective birth-control method. An individual of childbearing potential must agree to use a highly effective method of birth control. Exclusion Criteria: * Current or recent use of antihyperglycemic agents other than insulin (≤ 2-week use of sodium-glucose cotransporter-2 inhibitor (SGLT2I), Metformin, etc.; ≤ 1-month for glucagon-like peptide-1 receptor agonists (GLP1-RA)). * Current use of glucocorticoid medication (except low, stable doses and inhaled steroids). * Individuals with confirmed gastroparesis. * Use of medication that alters gastrointestinal motility (ex: domperidone). * Use of hydroxyurea. * Planned or ongoing pregnancy. * Breastfeeding individuals. * Severe hypoglycemia requiring hospitalization in the past month. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions. * Diabetic ketoacidosis episode in the past month. * Clinically significant nephropathy, neuropathy, or retinopathy as judged by the investigator. * Recent (\< 6 months) acute macrovascular event, e.g., acute coronary syndrome. * Other serious medical illnesses which are likely to interfere with study participation or the ability to complete the trial by the investigator's judgment. * Known hypersensitivity to the study drugs or their excipients.
Where this trial is running
Montreal, Quebec
- Research Institute of the McGill University Health Center — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Michael Tsoukas, M.D. — Research Institute of the McGill University Health Center
- Study coordinator: Joelle Doumat, BSc.
- Email: joelle.doumat@mail.mcgill.ca
- Phone: 832-798-3648
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.
Conditions: type1diabetes, Diabetes Mellitus, Type 1, Pramlintide, fully automated delivery system, artificial pancreas, Insulin, Lyumjev, fully closed loop