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

Last updated: April 29, 2026
Sponsor: Tandem Diabetes Care, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Hormone Deficiencies

Diabetes (Pediatric)

Treatment

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

Clinical Study ID

NCT07211126
TP-0018999
  • Ages > 6
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinician-confirmed type 1 diabetes and for whom the site has initiated the t:slimX2 insulin pump with Control-IQ technology (Control-IQ System) with a Dexcom G6 orG7 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 toprovide 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 informationnotice 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 consecutivemonths after study enrollment.

  2. the reuse of their clinical data including HbA1c results, obtained at most 4months prior to enrollment, and as available according to the standard of careduring the next 12 months.

  3. complete questionnaires per the study protocol.

Exclusion

Exclusion Criteria:

  • A medical or other condition, or medications being taken that, in the investigator'sjudgement would be a safety concern for participation in the study.

  • Patients considered vulnerable under French law.

Study Design

Total Participants: 350
Treatment Group(s): 1
Primary Treatment: t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
Phase:
Study Start date:
March 03, 2026
Estimated Completion Date:
December 31, 2027

Study Description

This post-market surveillance study is a single-arm, prospective cohort study. It is designed to:

  1. Demonstrate, in the post-approval setting, the safety of the Control-IQ System for the management of type 1 diabetes by assessing the rate of severe metabolic complications (severe hypoglycemia and/or diabetic ketoacidosis).

  2. Determine glycemic outcomes during real-world use of the Control-IQ System over 12 months post-initiation.

  3. Demonstrate patient-reported satisfaction with the device, trust in the Control-IQ System, usability of the system, and improved quality of life.

  4. Describe the real-world use of the Control-IQ System.

Connect with a study center

  • CH Agen-Nérac

    Agen, 47923
    France

    Active - Recruiting

  • CHU d'Angers

    Angers, 49100
    France

    Active - Recruiting

  • CHU Lyon HFME

    Bron, 69677
    France

    Active - Recruiting

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

    Lyon, 69003
    France

    Active - Recruiting

  • Hôpital Européen (APHM)

    Marseille, 13003
    France

    Active - Recruiting

  • GHEF Meaux

    Meaux, 77100
    France

    Active - Recruiting

  • CHR Metz-Thionville

    Metz, 57000
    France

    Active - Recruiting

  • CHU de Montpellier

    Montpellier, 34090
    France

    Active - Recruiting

  • Clinique Saint Jean de Védas

    Montpellier, 34430
    France

    Active - Recruiting

  • CHU Nîmes

    Nîmes, 30029
    France

    Active - Recruiting

  • Institut St-Pierre

    Palavas-les-Flots, 34250
    France

    Active - Recruiting

  • GH Paris Saint-Joseph

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital Européen Georges Pompidou (APHP)

    Paris, 75015
    France

    Active - Recruiting

  • Hôpital Lariboisière

    Paris, 75010
    France

    Active - Recruiting

  • Hôpital Robert Debré

    Paris, 75019
    France

    Active - Recruiting

  • Hôpital St-Antoine (APHP)

    Paris, 75012
    France

    Active - Recruiting

  • CH de Périgueux

    Périgueux, 24000
    France

    Active - Recruiting

  • MSP Les Belles Fleurs

    Saint-Cyr-sur-Loire, 37540
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, 31403
    France

    Active - Recruiting

  • Clinique Pasteur Toulouse

    Toulouse, 31300
    France

    Active - Recruiting

  • CHU Tours

    Tours, 37000
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.