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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CH Agen-Nérac
  Agen, France Recruiting
• CHU d'Angers
  Angers, France Recruiting
• CHU Lyon HFME
  Bron, France Recruiting
• CHU Dijon
  Dijon, France Recruiting
• Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL)
  Lyon, France Recruiting
• Institut de Diabétologie et de Nutrition du Centre (IDNC)
  Mainvilliers, France Recruiting

Study contacts

• Principal investigator: Jean-Pierre Riveline, MD, PhD — Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, France
• Study coordinator: Arthur Senigout
• Email: record-iq@sanoia.com
• Phone: +33 6 85 98 40 44

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.