NCT03820050

FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Up to 250 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. 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 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 three (3), four (4) or five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects weight, subjects will have up to two (2) 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	System Performance will be characterized with respect to YSI reference venous plasma measurements

Timeline

• Start date: 2019-01-29
• Primary completion: 2019-06-14
• Completion: 2019-06-14
• First posted: 2019-01-29
• Last updated: 2019-06-18

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study