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ACTIVE NOT RECRUITING

PS230005 Control-IQ 1.5 Post-Approval Study

NCT06717451 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DEVICE Control-IQ Technology v1.5

Study Locations (1)

California

  • Tandem Diabetes Care — San Diego

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2025-01-30
Est. Completion 2026-08-11

Sponsor

Tandem Diabetes Care

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06717451

The ClinicalTrials.gov registry entry for NCT06717451 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tandem Diabetes Care, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention — of which Control-IQ Technology v1.5 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06717451 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06717451 about?

NCT06717451 is a clinical study titled "PS230005 Control-IQ 1.5 Post-Approval Study". 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 ...

What is the current status of trial NCT06717451?

This trial is currently active not recruiting. The enrollment target is 144 participants. The study started on 2025-01-30. Estimated completion is 2026-08-11.

What conditions does trial NCT06717451 study?

This clinical trial studies the following conditions: Type 1 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06717451?

The interventions under investigation include: Control-IQ Technology v1.5 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06717451?

This trial is sponsored by Tandem Diabetes Care, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06717451 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial