FreeStyle Libre 3 Continuous Glucose Monitoring System

Status Terminated

Clinical Trial Summary

The purpose of this study is to characterize the FreeStyle Libre 3 Continuous Glucose Monitoring System performance with respect to YSI reference venous plasma sample measurements.

Clinical Trial Description

This is a pivotal, non-randomized, single arm, multi-center, prospective, nonsignificant risk study to evaluate the FreeStyle Libre 3 Continuous Glucose Monitoring System accuracy and safety. Up to 80 adult subjects (18 years of age or older) and up to 80 pediatric subjects (2-17 years of age) subjects will be enrolled at up to six (6) clinical research sites in the United States. Each subject will wear two sensors for 15 days. Interstitial glucose readings from each Sensor will be obtained with a corresponding smart phone. Subjects will do up to six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects' age and/or weight, subjects will have up to three (3) in- clinic visits during which intravenous blood draws and YSI reference testing will occur. ;

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus

Clinical Trial Details

NCT number	NCT05962710
Study type	Observational
Source	Abbott Diabetes Care
Contact
Status	Terminated
Phase
Start date	January 27, 2023
Completion date	January 31, 2023

View Details

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