Clinical Research Directory
Browse clinical research sites, groups, and studies.
PS230005 Control-IQ 1.5 Post-Approval Study
Sponsor: Tandem Diabetes Care, Inc.
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.
Key Details
Gender
All
Age Range
2 Years - 5 Years
Study Type
OBSERVATIONAL
Enrollment
144
Start Date
2025-01-30
Completion Date
2026-08-11
Last Updated
2025-11-12
Healthy Volunteers
No
Conditions
Interventions
Control-IQ Technology v1.5
Tandem t:slim X2 insulin pump or Tandem Mobi insulin pump with Control-IQ technology v1.5. Every month participants will receive a survey to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment. Participants will also complete surveys related to patient reported outcomes at baseline, 6 months, and 12 months.
Locations (1)
Tandem Diabetes Care
San Diego, California, United States