[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614816":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":51,"centralContacts":58,"locations":68,"responsibleParty":142,"collaborators":145,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":154,"sex":160,"minAge":161,"maxAge":63,"enrollmentInfo":162,"targetDuration":63,"studyType":165,"phases":166,"briefSummary":169,"conditions":170,"keywords":176,"overallStatus":111,"whyStopped":63,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide group","EXPERIMENTAL","Participants randomized to this arm receive once-weekly subcutaneous tirzepatide in addition to use of the Tandem Control-IQ insulin pump and Dexcom G7 continuous glucose monitor. Tirzepatide is initiated at 2.5 mg weekly and increased by 2.5 mg every 4 weeks to a target dose of 10 mg weekly or the maximally tolerated dose. Dose escalation may be delayed or reduced if participants experience intolerable gastrointestinal symptoms. During Weeks 1-26, participants continue standard carbohydrate counting for all meals. Beginning in Week 27, participants stop entering carbohydrate amounts into the pump (no meal announcements) for six weeks while continuing tirzepatide at their maintenance dose. Throughout the intervention, participants undergo regular safety assessments, remote glucose data reviews, insulin-pump parameter adjustments as needed, and scheduled in-person visits to monitor metabolic, cardiovascular, and patient-reported outcomes.",[13,14,15,16],"Drug: Tirzepatide","Device: Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM)","Behavioral: Carbohydrate Counting","Behavioral: No Meal Announcement",{"label":18,"type":19,"description":20,"interventionNames":21},"Control group","ACTIVE_COMPARATOR","Participants randomized to the control arm use the Tandem Control-IQ automated insulin delivery system with the Dexcom G7 continuous glucose monitor, following standard-of-care diabetes management. They continue carbohydrate counting for all meals throughout the 32-week study and deliver prandial insulin boluses based on estimated carbohydrate intake, as is typical for users of hybrid closed-loop systems. No tirzepatide injections are administered. Participants receive the same device training, follow-up schedule, safety monitoring, glucose data reviews, and pump parameter adjustments as the tirzepatide arm. This arm serves as an active comparator, representing current standard therapy for type 1 diabetes with automated insulin delivery and meal announcements.",[14,15],[23,30,38,45],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Tirzepatide","Tirzepatide, administered as a once-weekly subcutaneous injection, initiated at 2.5 mg and escalated in 2.5-mg increments every 4 weeks to a target of 10 mg or the maximally tolerated dose, used as an adjunct therapy in adults with type 1 diabetes using the Tandem Control-IQ automated insulin delivery system.",[9],[29],"Mounjaro",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Tandem Control-IQ Automated Insulin Delivery System (with Dexcom G7 CGM)","This intervention uses the Tandem t:slim X2 insulin pump with the Control-IQ automated insulin delivery algorithm, integrated with the Dexcom G7 continuous glucose monitor. The system adjusts basal insulin and delivers automated correction boluses based on real-time glucose values. All participants receive standardized training and use this system for the full 32-week study. Rapid-acting insulin compatible with Control-IQ is required. This intervention is distinguished by its use under two different operational strategies: standard carbohydrate counting in the control arm and complete omission of meal announcements during the final 6 weeks in the tirzepatide arm.",[18,9],[36,37],"Control-IQ","Dexcom G7",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BEHAVIORAL","Carbohydrate Counting","Participants enter the estimated carbohydrate amount for every meal and snack into the Tandem Control-IQ insulin pump to calculate and deliver prandial insulin boluses. This reflects standard use of hybrid closed-loop systems. The procedure is maintained for the entire 32-week study in the control arm and during Weeks 1-26 in the tirzepatide arm.",[18,9],[44],"Meal Announcement",{"type":39,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"No Meal Announcement","Participants do not enter carbohydrate amounts or announce meals to the Tandem Control-IQ system. The pump operates without user-initiated prandial boluses, relying solely on automated basal adjustments and automated correction boluses. This intervention is implemented only in the tirzepatide arm during Weeks 27-32.",[9],[50],"Omission of Carbohydrate Counting",[52,55],{"name":53,"affiliation":5,"role":54},"Melissa-Rosina Pasqua, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":5,"role":57},"Ahmad Haidar, PhD","STUDY_DIRECTOR",[59,65],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},"Keddy Moise, MSc (candidate)","CONTACT","438-531-6896",null,"keddy.moise@mail.mcgill.ca",{"name":66,"role":61,"phone":63,"phoneExt":63,"email":67},"Rebecca Boyer-Hernandez, BSc","rebecca.boyer-hernandez@affiliate.mcgill.ca",[69,90,109,122],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Institut de Recherches Cliniques de Montréal","NOT_YET_RECRUITING","Montreal","Quebec","H2W 1R7","Canada","CA",{"type":78,"coordinates":79},"Point",[80,81],-73.58781,45.50884,{"lat":81,"lon":80},[84,88],{"name":85,"role":61,"phone":86,"phoneExt":63,"email":87},"Rémi Rabasa-Lhoret, MD-PhD","514-987-5762","remi.rabasa-lhoret@umontreal.ca",{"name":85,"role":89,"phone":63,"phoneExt":63,"email":63},"SUB_INVESTIGATOR",{"facility":91,"status":71,"city":72,"state":73,"zip":92,"country":75,"countryCode":76,"cosmosGeoPoint":93,"geoPoint":95,"contacts":96},"McGill University Health Centre","H4A 3J1",{"type":78,"coordinates":94},[80,81],{"lat":81,"lon":80},[97,98,101,102,104,106,108],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},{"name":99,"role":61,"phone":100,"phoneExt":63,"email":67},"Rebecca Boyer-Hernandez, BSc.","514-318-7298",{"name":53,"role":54,"phone":63,"phoneExt":63,"email":63},{"name":103,"role":89,"phone":63,"phoneExt":63,"email":63},"Michael A Tsoukas, MD",{"name":105,"role":89,"phone":63,"phoneExt":63,"email":63},"Abhinav Sharma, MD",{"name":107,"role":89,"phone":63,"phoneExt":63,"email":63},"Natasha Garfield, MD",{"name":56,"role":89,"phone":63,"phoneExt":63,"email":63},{"facility":110,"status":111,"city":72,"state":73,"zip":112,"country":75,"countryCode":76,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Hygea Medical Clinic","RECRUITING","H4A 3T2",{"type":78,"coordinates":114},[80,81],{"lat":81,"lon":80},[117,118,119,120],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},{"name":66,"role":61,"phone":63,"phoneExt":63,"email":67},{"name":53,"role":54,"phone":63,"phoneExt":63,"email":63},{"name":121,"role":89,"phone":63,"phoneExt":63,"email":63},"Michael Tsoukas, MD",{"facility":123,"status":71,"city":124,"state":63,"zip":125,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Insel Hospital, University Hospital Bern","Bern","3010","Switzerland","CH",{"type":78,"coordinates":129},[130,131],7.44744,46.94809,{"lat":131,"lon":130},[134,138,140],{"name":135,"role":61,"phone":136,"phoneExt":63,"email":137},"Tabea Schoenfeldt-Reichmann, PhD","+41 31 664 34 17","evatabea.schoenfeldt-reichmann@extern.insel.ch",{"name":139,"role":89,"phone":63,"phoneExt":63,"email":63},"Lia Bally, MD-PhD",{"name":141,"role":89,"phone":63,"phoneExt":63,"email":63},"Christoph Grani, MD",{"type":54,"investigatorFullName":143,"investigatorTitle":144,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Melissa-Rosina Pasqua","Assistant Professor, Division of Endocrinology and Metabolism",[146,148,150],{"name":147,"class":6},"Breakthrough T1D",{"name":149,"class":6},"Institut de Recherches Cliniques de Montreal",{"name":151,"class":6},"Insel Gruppe AG, University Hospital Bern","100614816","phase-2-a-clinical-trial-using-tirzepatide-to-help-adults-with-type-1-diabetes-automatically-control-their-blood-sugar-100614816",false,"NCT07284511","A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar","Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial","TZP","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required).\n* A BMI ≥ 27 kg\u002Fm2.\n* HbA1c \\> 6.5%, and \\\u003C 12%.\n* Current therapy: multiple daily injections or insulin pump.\n* Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible)\n* Active carbohydrate counting for prandial insulin dosing.\n* Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.\n\nExclusion Criteria:\n\n* Use of GLP1-RAs within the last four weeks.\n* Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.\n* Diabetic ketoacidosis within the last 2 months.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe renal impairment with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI), measured within the last four months.\n* Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.\n* Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.\n* History of bariatric surgery within the last 6 months.\n* Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.\n* Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.\n* Any safety concern that, in the investigator's judgment, precludes participation.","ALL","18 Years",{"count":163,"type":164},105,"ESTIMATED","INTERVENTIONAL",[167,168],"PHASE2","PHASE3","This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals.\n\nPeople with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose.\n\nTirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises.\n\nThis study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups:\n\nTirzepatide group:\n\nParticipants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals.\n\nControl group:\n\nParticipants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses.\n\nThe main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart\u002Ffitness, or body-composition tests.\n\nAs with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial.\n\nOverall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.",[171,172,173,174,175],"Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus",[171,177,178,179,180,25,29,181,182,183,184,185,186,37],"Overweight or obesity in type 1 diabetes","Automated insulin delivery","Insulin pump","Continuous glucose monitoring","GIP\u002FGLP-1 receptor agonist","Dual incretin therapy","Adjunctive tirzepatide therapy","Tandem Control-IQ","Hybrid closed-loop system","Closed-loop insulin delivery","2026-05-22",{"date":189,"type":190},"2026-05-27","ACTUAL",{"date":192,"type":190},"2026-05-19",{"date":194,"type":164},"2029-01",{"name":5,"class":6},4]