Control-IQ Observational (CLIO) Post-Approval Study
NCT04503174 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3157
Last updated 2023-12-08
Summary
Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).
Conditions
- Diabetes Mellitus, Type 1
Interventions
- DEVICE
-
t:slim X2 pump with Control-IQ technology
Real-world use
Sponsors & Collaborators
-
University of California, San Diego
collaborator OTHER -
Tandem Diabetes Care, Inc.
lead INDUSTRY
Principal Investigators
-
Jordan Pinsker, MD · Tandem Diabetes Care, Inc.
Eligibility
- Min Age
- 6 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-08-04
- Primary Completion
- 2023-06-02
- Completion
- 2023-06-26
- FDA Device
- Yes
Countries
- United States
Study Locations
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