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Tours","Tours","37000",{"type":39,"coordinates":304},[305,306],0.70398,47.39484,{"lat":306,"lon":305},[309],{"name":310,"role":28,"phone":311,"phoneExt":10,"email":312},"Sophie Gounin","+33 2 47 47 75 43","S.GOUNIN@chu-tours.fr",{"type":314,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100609174",false,"NCT07211126","The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France","RECORD-IQ","Inclusion Criteria:\n\n* Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or G7 CGM sensor.\n* Age ≥ 6 years at enrollment.\n* Using an insulin approved for use in the pump.\n* Ability for patient or parent\u002Fguardian to respond to alerts and alarms, and to provide basic diabetes self-management.\n* Reside full-time in mainland France.\n* Have an email address and mobile phone number\n* Participant or participant's parent\u002Fguardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to :\n\n  1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.\n  2. the reuse of their clinical data including HbA1c results, obtained at most 4 months prior to enrollment, and as available according to the standard of care during the next 12 months.\n  3. complete questionnaires per the study protocol.\n\nExclusion Criteria:\n\n* A medical or other condition, or medications being taken that, in the investigator's judgement would be a safety concern for participation in the study.\n* Patients considered vulnerable under French law.","ALL","6 Years",{"count":324,"type":325},350,"ESTIMATED","OBSERVATIONAL","This post-market surveillance study is primarily designed to demonstrate the ongoing safety of the Control-IQ system, the ongoing performance of glycemic control and quality of life with Control-IQ system use, and the rate of use of the Control-IQ system. The system will be assessed in all approved populations during the first 12 months of use.",[329],"Diabetes Mellitus, Type 1",[331,332,333,334,335,336,337,338,339],"Control-IQ","t:slim X2 insulin pump","Control-IQ technology","DKA","severe hypoglycemia","automated insulin dosing","automated insulin delivery","quality of life","type 1 diabetes","2026-04-29",{"date":342,"type":343},"2026-05-01","ACTUAL",{"date":345,"type":343},"2026-03-03",{"date":347,"type":325},"2027-12",{"name":5,"class":6},21]