🏛️ Verified NIH Record • Updated 2025-11-08
PS230005 Control-IQ 1.5 Post-Approval Study (NCT06717451)
🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Tandem Diabetes Care, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Tandem Diabetes Care — San Diego, California
Age range: 2 Years to 5 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Tandem Diabetes Care — San Diego, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes — Cleveland, Ohio
- GO TEAM: Glucose Optimization Through Technology Assisted Management — Cleveland, Ohio
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Explore by condition: All Type 1 Diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.