NCT04464772

FreeStyle Libre Continuous Glucose Monitoring System Accuracy Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the Freestyle Libre Glucose Monitoring System in pediatric and adult subjects with respect to YSI reference venous plasma sample measurements.

Detailed description

Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make 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: 2020-07-10
• Primary completion: 2020-09-14
• Completion: 2020-09-22
• First posted: 2020-07-09
• Last updated: 2020-11-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study