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French study tests smart insulin Pump's Real-World impact on diabetes control

NCT ID NCT07211126

Disease control Sponsor: Tandem Diabetes Care, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 350 people with type 1 diabetes in France who use the Control-IQ insulin pump system. Researchers want to see how safe and effective the system is over 12 months, focusing on blood sugar control and quality of life. Participants must be at least 6 years old and live in mainland France.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

All individuals with Type 1 Diabetes age 6+, who start therapy with the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 or Dexcom G7 and meet eligibility criteria.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

hypoglycemia type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH Agen-Nérac

    RECRUITING

    Agen, 47923, France

  • CH de Périgueux

    RECRUITING

    Périgueux, 24000, France

  • CHR Metz-Thionville

    RECRUITING

    Metz, 57000, France

  • CHU Lyon HFME

    RECRUITING

    Bron, 69677, France

  • CHU Nîmes

    RECRUITING

    Nîmes, 30029, France

  • CHU Toulouse

    RECRUITING

    Toulouse, 31403, France

  • CHU Tours

    RECRUITING

    Tours, 37000, France

  • CHU d'Angers

    RECRUITING

    Angers, 49100, France

  • CHU de Montpellier

    RECRUITING

    Montpellier, 34090, France

  • Centre du Diabète - Diab-e-Care Hospices Civils de Lyon (HCL)

    RECRUITING

    Lyon, 69003, France

  • Clinique Pasteur Toulouse

    RECRUITING

    Toulouse, 31300, France

  • Clinique Saint Jean de Védas

    RECRUITING

    Montpellier, 34430, France

  • GH Paris Saint-Joseph

    RECRUITING

    Paris, 75014, France

  • GHEF Meaux

    RECRUITING

    Meaux, 77100, France

  • Hôpital Européen (APHM)

    RECRUITING

    Marseille, 13003, France

  • Hôpital Européen Georges Pompidou (APHP)

    RECRUITING

    Paris, 75015, France

  • Hôpital Lariboisière

    RECRUITING

    Paris, 75010, France

  • Hôpital Robert Debré

    RECRUITING

    Paris, 75019, France

  • Hôpital St-Antoine (APHP)

    RECRUITING

    Paris, 75012, France

  • Institut St-Pierre

    RECRUITING

    Palavas-les-Flots, 34250, France

  • MSP Les Belles Fleurs

    RECRUITING

    Saint-Cyr-sur-Loire, 37540, France

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