NCT03607448

Freestyle Libre Flash Glucose Monitoring System

Freestyle Libre Flash Glucose Monitoring System Accuracy Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Up to 200 subjects will be enrolled in this study at a total of 6 clinical research sites in the United States. Subjects will wear a total of two (2) sensors, one on the back of each upper arm. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 8 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 six (6) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Subjects will have 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 Flash Glucose Monitoring System	Subjects will wear the Abbott Sensor based FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes

Timeline

• Start date: 2018-07-23
• Primary completion: 2018-11-21
• Completion: 2018-11-21
• First posted: 2018-07-31
• Last updated: 2018-11-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study