protocolSection identificationModule nctId: NCT06387199, orgStudyIdInfo id: 2024-10227, briefTitle: Alleviating Carbohydrate Counting for Patients With Type-1 Diabetes Using a Closed Loop System With Weekly Subcutaneous Semaglutide, acronym: SEMA SMA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2026-07, completionDateStruct date: 2026-07, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: McGill University Health Centre/Research Institute of the McGill University Health Centre, class: OTHER, descriptionModule briefSummary: A closed-loop insulin system, often labelled the "artificial pancreas" (AP), consists of an insulin pump, a continuous glucose monitor, and an interface coordinating between them to regulate insulin dosage based on glucose levels. Primarily designed for managing type 1 diabetes, this system has demonstrated significant benefits in previous studies. Yet, despite these advantages, certain challenges persist.Semaglutide, utilized in treating type 2 diabetes and obesity, is a once-weekly injectable medication that elevates levels of a gastrointestinal hormone known as Glucagon-Like Peptide-1 (GLP-1). This hormone alters gastric emptying, inhibits glucagon release, and reduces appetite. While not officially sanctioned for type 1 diabetes treatment in North America, studies have explored its efficacy as an adjunctive therapy alongside insulin, yielding favorable outcomes in blood glucose regulation. Comparable drugs like liraglutide and exenatide have been employed in type 1 diabetes treatment as well, albeit with less pronounced glucose-regulating effects compared to semaglutide, even in type 2 diabetes.The goal of this 50-week randomized placebo-controlled crossover 2x4 factorial designed trial is to assess whether commercial automated insulin delivery (AID) systems using rapid-acting insulin with adjunct weekly injections of semaglutide (at the maximally tolerated dose) can replace carbohydrate counting with simple meal announcements (SMA) without degrading glucose control., conditionsModule conditions: Type 1 Diabetes, conditions: Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE2, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: randomized placebo-controlled crossover 2x3 factorial designed trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 26, type: ESTIMATED, armsInterventionsModule interventions name: Semaglutide with 4 meal strategies, interventions name: Placebo with 4 meal strategies, outcomesModule primaryOutcomes measure: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo), secondaryOutcomes measure: Percentage of time spent in the range of glucose levels between 3.9 and 7.8 mmol/L, secondaryOutcomes measure: Percentage of time spent in glucose levels below 3.9 and 3.0 mmol/L, secondaryOutcomes measure: Percentage of time spent in glucose levels above 7.8, 10 and 13.9 mmol/L, secondaryOutcomes measure: Mean glucose level, secondaryOutcomes measure: Standard deviation of glucose levels as a measure of glucose variability, secondaryOutcomes measure: Percentage coefficient of variation of glucose levels, secondaryOutcomes measure: Proportions of participants with time in range between 3.9 - 10.0 mmol/L≥ 70%, secondaryOutcomes measure: Glycated hemoglobin (HbA1c), secondaryOutcomes measure: Area under the curve 0-2h post meal, 0-3h post peal, secondaryOutcomes measure: Average scores between interventions on the Type 1 Diabetes Distress Scale questionnaire, secondaryOutcomes measure: Average scores between interventions on the Diabetes Treatment Satisfaction questionnaire, secondaryOutcomes measure: Average scores between interventions based on the Hypoglycemic Fear Survey - II, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Measure of body weight, secondaryOutcomes measure: Measure of body mass index, secondaryOutcomes measure: Measure of waist circumference and hip circumference, secondaryOutcomes measure: Measure of waist-to-hip ratio, secondaryOutcomes measure: Lipid profile, specifically: LDL-cholesterol, HDL-cholesterol, triglycerides, secondaryOutcomes measure: Urine albumin-creatinine ratio, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Research Institute of the McGill University Health Centre, city: Montreal, state: Quebec, zip: H4A 3J1, country: Canada, contacts name: Nicholas Sabelli, BSc, role: CONTACT, phone: (514) 377-9455, email: nicholas.sabelli@mail.mcgill.ca, contacts name: Michael Tsoukas, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ahmad Haidar, Ph.D, role: SUB_INVESTIGATOR, contacts name: Vanessa Tardio, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False