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

Study acronym: RECORD-IQ
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Trial sites expanded: 21 → 25 locations
  2. Study sites: 21 to 23
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 5 of 10 entries
    • Study description expanded, about 4 words
  3. Trial sites expanded: 17 → 21 locationsv5
  4. Trial sites expanded: 13 → 17 locationsv4
  5. Trial sites expanded: 5 → 13 locationsv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of Dec 2025 to Mar 3, 2026
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07211126
Lead Sponsor Tandem Diabetes Care, Inc.
Conditions
(from sponsor)		 Diabetes Mellitus, Type 1
Related terms Diabetes Mellitus, Type 1, Hypoglycemia
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov