The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
NCT07211126 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350
Last updated 2026-05-01
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.
Conditions
- Diabetes Mellitus, Type 1
Interventions
- DEVICE
-
t:slim X2 insulin pump with Control-IQ technology (Control-IQ System)
Participants enrolled in the study will start use of the t:slim X2 insulin pump with Control-IQ technology (Control-IQ System) with Dexcom G6 or Dexcom G7, and be followed for 12 months.
Sponsors & Collaborators
-
Tandem Diabetes Care, Inc.
lead INDUSTRY
Principal Investigators
-
Jean-Pierre Riveline, MD, PhD · Centre Universitaire du diabète et de ses complications, APHP, Hôpital Lariboisière, Paris, France
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-03
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- France
Study Locations
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