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

ClinicalTrials.gov ID

NCT07211126

Lead Sponsor

Tandem Diabetes Care, Inc.INDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

350Estimated

Last Update Posted

May 1, 2026Actual

Start Date

Mar 3, 2026Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

Official Title

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

Brief 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.

Detailed 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.

• Diabetes Mellitus, Type 1

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

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility 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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Tandem Diabetes Care, Inc.INDUSTRY

Hasna.ALLA@chu-nimes.fr+33 04 66 68 53 28

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