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Clinical Trial Details

Trial ID: L5529
Source ID: NCT06387199
Associated Drug: Semaglutide With 4 Meal Strategies
Title: Alleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide
Acronym: SEMA SMA
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 1 Diabetes|Diabetes Mellitus
Interventions: DRUG: Semaglutide with 4 meal strategies|DRUG: Placebo with 4 meal strategies
Outcome Measures: Primary: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo), Target range is defined to be between 3.9 and 10.0 mmol/L of plasma glucose for placebo vs semaglutide (at maximal tolerated dose) on closed-loop insulin therapy, 24 weeks | Secondary: Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L, % as per CGM data, 24 weeks|Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L, % as per CGM data, 24 weeks|Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L, % as per CGM data, 24 weeks|Mean glucose level, Defined as per CGM data, in mmol/L, 24 weeks|Standard deviation of glucose levels as a measure of glucose variability, Defined as per CGM data, in mmol/L, 24 weeks|Percentage coefficient of variation of glucose levels, % as per CGM data, 24 weeks|Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%, As per CGM data, 24 weeks|Glycated hemoglobin (HbA1c), Blood test to assess glucose control within 3-4 months, 24 weeks|Area under the curve 0-2h post meal, 0-3h post peal, As per CGM data, 24 weeks|Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire, 17-item questionnaire with a 6-point Likert scale from 1 (no stress) to 6 (high stress) for each item. Total score obtained from summing the scores of all items, 24 weeks|Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire, 8-item questionnaire with a 7-point Likert scale ranging from 0 (low satisfaction) to 6 (high satisfaction). Total score obtained from summing the scores of all items., 24 weeks|Average scores between interventions based on the Hypoglycemic Fear Survey - II, 33-item questionnaire with a 5-point Likert scale ranging from 1 (never) to 5 (almost always). Total score obtained from summing the scores of all items., 24 weeks|Heart rate, Beats per minute, 24 weeks|Blood pressure, mmHg, 24 weeks|Measure of body weight, Measurements done at visit - weight in kilograms, 24 weeks|Measure of body mass index, Measurements done at visit - body mass index as per kg/m\^2, 24 weeks|Measure of waist circumference and hip circumference, Measurements done at visit - circumference in cm, 24 weeks|Measure of waist-to-hip ratio, Measurements done at visit, 24 weeks|Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides, Blood tests, in mmol/L, 24 weeks|Urine albumin-creatinine ratio, Urine test, 24 weeks
Sponsor/Collaborators: Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12-01
Completion Date: 2027-01
Results First Posted:
Last Update Posted: 2024-12-18
Locations: Research Institute of the McGill University Health Centre, Montreal, Quebec, H4A 3J1, Canada
URL: https://clinicaltrials.gov/show/NCT06387199