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

Recruiting now

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT07211126

Run by

Tandem Diabetes Care, Inc.

People needed

350

Starts

2026-03-03

Expected to finish

2027-12-01

Last updated by the study team

2026-05-01

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 :
• use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
• 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.
• complete questionnaires per the study protocol.

You may not qualify if…

• 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.

Where it is running

• CH Agen-Nérac — Agen, France (enrolling)
• CHU d'Angers — Angers, France (enrolling)
• CHU Lyon HFME — Bron, France (enrolling)
• Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL) — Lyon, France (enrolling)
• Hôpital Européen (APHM) — Marseille, France (enrolling)
• GHEF Meaux — Meaux, France (enrolling)
• CHR Metz-Thionville — Metz, France (enrolling)
• CHU de Montpellier — Montpellier, France (enrolling)
• Clinique Saint Jean de Védas — Montpellier, France (enrolling)
• CHU Nîmes — Nîmes, France (enrolling)
• Institut St-Pierre — Palavas-les-Flots, France (enrolling)
• Hôpital Lariboisière — Paris, France (enrolling)
• Hôpital St-Antoine (APHP) — Paris, France (enrolling)
• GH Paris Saint-Joseph — Paris, France (enrolling)
• Hôpital Européen Georges Pompidou (APHP) — Paris, France (enrolling)
• Hôpital Robert Debré — Paris, France (enrolling)
• CH de Périgueux — Périgueux, France (enrolling)
• MSP Les Belles Fleurs — Saint-Cyr-sur-Loire, France (enrolling)
• Clinique Pasteur Toulouse — Toulouse, France (enrolling)
• CHU Toulouse — Toulouse, France (enrolling)
• CHU Tours — Tours, France (enrolling)

Full record on ClinicalTrials.gov

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