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NCT05908448 · ClinicalTrials.gov registry record

The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus

A clinical trial, sponsored by Sinocare.

Completed
Registry status
134
Enrollment target

NCT05908448: Completed study, sponsored by Sinocare.

NCT05908448 is a clinical trial that has completed, run by Sinocare. The registered enrollment target is 134 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05908448 has completed, sponsored by Sinocare.

COMPLETED
Registry status
134 participants
Enrollment target

Study Summary

The purpose of the investigation is to evaluate the performance of the I3 CGM in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM.

Primary Outcome

percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the YSI control

Interventions

  • DEVICE 13 CGM (continuous glucose monitor)

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2024-02-07
Est. Completion 2024-11-13
Sinocare

2 total trials

What the finished NCT05908448 record still lists

NCT05908448 is an observational study that tracks outcomes without assigning an intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which 13 CGM (continuous glucose monitor) is the first listed.

NCT05908448 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05908448 about?

NCT05908448 is a clinical study titled "The True Vie I3 Continuous Glucose Monitoring System in Pediatric Patients With Type 1 Diabetes Mellitus". The purpose of the investigation is to evaluate the performance of the I3 CGM in Pediatric Patients with Type 1 Diabetes Mellitus (T1DM) according to the FDA's special controls for iCGM.

What is the current status of trial NCT05908448?

This trial is currently completed. The enrollment target is 134 participants. The study started on 2024-02-07. Estimated completion is 2024-11-13.

What interventions are being tested in trial NCT05908448?

The interventions under investigation include: 13 CGM (continuous glucose monitor) (DEVICE).

Who is sponsoring clinical trial NCT05908448?

This trial is sponsored by Sinocare, which has 2 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05908448, the US trial registry maintained by the National Library of Medicine. NCT05908448 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.