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The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France

Recruitingn/aAges 6 Years - anyAllTandem Diabetes Care, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. * Age ≥ 6 years at enrollment. * Using an insulin approved for use in the pump. * Ability for patient or parent/guardian to respond to alerts and alarms, and to provide basic diabetes self-management. * Reside full-time in mainland France. * Have an email address and mobile phone number * Participant or participant's parent/guardian has read and understood the information notice and has agreed to participate in the study. This includes agreeing to : 1. use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment. 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. 3. complete questionnaires per the study protocol. Exclusion Criteria: * 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. * Patients considered vulnerable under French law.
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What it tests

  • t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
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Where

25 sites
CH Agen-Nérac
Agen, France
CHU d'Angers
Angers, France
CHU Lyon HFME
Bron, France
CHU Dijon
Dijon, France
Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL)
Lyon, France
Institut de Diabétologie et de Nutrition du Centre (IDNC)
Mainvilliers, France
Hôpital Européen (APHM)
Marseille, France
GHEF Meaux
Meaux, France

…and 17 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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