Status:
NOT_YET_RECRUITING
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
Lead Sponsor:
Tandem Diabetes Care, Inc.
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6+ years
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 sy...
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 ...
Eligibility Criteria
Inclusion
- 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 :
- use Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
- 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.
- complete questionnaires per the study protocol.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07211126
Start Date
December 1 2025
End Date
December 1 2027
Last Update
October 7 2025
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