NCT05962710

FreeStyle Libre 3 Continuous Glucose Monitoring System

FreeStyle Libre 3 Continuous Glucose Monitoring System Confirmation Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre 3	FreeStyle Libre 3 Continuous Glucose Monitoring System

Timeline

• Start date: 2023-01-27
• Primary completion: 2023-01-31
• Completion: 2023-01-31
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study