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ACTIVE NOT RECRUITING
NCT06717451

PS230005 Control-IQ 1.5 Post-Approval Study

Sponsor: Tandem Diabetes Care, Inc.

View on ClinicalTrials.gov

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

DEVICE

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