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PS230005 Control-IQ 1.5 Post-Approval Study

NCT06717451 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2025-11-12

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Jordan Pinsker, MD · Chief Medical Officer, Tandem Diabetes Care

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2026-08-11
Completion
2026-08-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06717451 on ClinicalTrials.gov