MedTrace Logo

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

NCT05908448 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2024-12-03

No results posted yet for this 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.

Conditions

  • T1DM - Type 1 Diabetes Mellitus

Interventions

DEVICE

13 CGM (continuous glucose monitor)

The I3 CGM consists of three main components: a Sensor Pack (Applicator-Sensor assembly), a Transmitter Pack (with Bluetooth Low Energy (BLE)) and a mobile application (I3 CGM App). The user can view their glucose data on the I3 CGM App running on a compatible mobile device.

Sponsors & Collaborators

  • Atlanta Diabetes Associates

    collaborator OTHER

  • Sinocare

    lead INDUSTRY

Principal Investigators

  • Bruce Bode, MD · Atlanta Diabetes Associates

Eligibility

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

Timeline & Regulatory

Start
2024-02-07
Primary Completion
2024-10-18
Completion
2024-11-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05908448 on ClinicalTrials.gov