Clinical Trial

PS230005 Control-IQ 1.5 Post-Approval Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated November 12, 2025 (before its estimated August 11, 2026 completion). Its status may not reflect the trial's current state.
Summary
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to \<6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-12-02; most recent amendment 2025-11-08.
Status change: Recruiting → Active, Not Recruiting 2025-08-11
Status change: Not Yet Recruiting → Recruiting 2024-12-14
Trial Details
NCT Number NCT06717451
Lead Sponsor Tandem Diabetes Care, Inc.
Collaborators: University of California, San Diego
Conditions Type 1 Diabetes
Enrollment 144 participants
Start Date 2025-01-30
Primary Completion 2026-08-11 (estimated)
Study Completion 2026-08-11 (estimated)
Updated on ClinicalTrials.gov 2025-11-12