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Control‑IQ automated insulin delivery for people with type 1 diabetes in France

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

Observational Tandem Diabetes Care, Inc. · NCT07211126

This project will try the Control‑IQ automated insulin pump (t:slim X2 with Dexcom G6/G7) in people with type 1 diabetes aged 6 and up in France to track safety, blood sugar control, and quality of life for 12 months.

Quick facts

Study typeObservational
Enrollment350 (estimated)
Ages6 Years and up
SexAll
SponsorTandem Diabetes Care, Inc. Industry-sponsored
Locations21 sites (Agen and 20 other locations)
Trial IDNCT07211126 on ClinicalTrials.gov

What this trial studies

This is a single‑arm, prospective post‑market cohort of people with clinician‑confirmed type 1 diabetes who start the t:slim X2 pump with Control‑IQ and a Dexcom G6 or G7 sensor. Participants will be followed for 12 months to capture severe metabolic complications (severe hypoglycemia and diabetic ketoacidosis), glycemic outcomes from CGM and routine HbA1c results, device usage patterns, and patient‑reported satisfaction, trust, usability, and quality of life. Data are collected from routine care and scheduled questionnaires, and enrollment is limited to residents of mainland France aged six years and older. The study is designed to describe real‑world safety, performance, and patterns of use across all approved populations.

Who should consider this trial

Good fit: Ideal candidates are people age ≥6 with clinician‑confirmed type 1 diabetes who have had the t:slim X2 pump with Control‑IQ initiated with a Dexcom G6 or G7 sensor, live in mainland France, can respond to alarms and perform basic diabetes self‑care, and agree to 12 months of follow‑up and questionnaires.

Not a fit: Patients unlikely to benefit include those under age six, those who do not use or who discontinue the Control‑IQ system or Dexcom CGM, people unable to respond to alarms or manage basic diabetes tasks, and those living outside mainland France.

Why it matters

Potential benefit: If successful, the study could reassure patients and clinicians about the safety and everyday effectiveness of Control‑IQ and support more confident use in routine care.

How similar studies have performed: Previous randomized trials and real‑world and post‑market data for Control‑IQ have demonstrated improved time‑in‑range and reductions in hypoglycemia, so this study extends an existing evidence base into broader real‑world use.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Agen and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 1Control-IQt:slim X2 insulin pumpControl-IQ technologyDKAsevere hypoglycemiaautomated insulin dosingautomated insulin delivery
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.