NCT02821117

FreeStyle Libre Glucose Monitoring System Paediatric Study

An Evaluation of Self-Management of Diabetes Using FreeStyle Libre Flash Glucose Monitoring System in Young People

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for the self-management of diabetes.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre Flash Glucose Monitoring System	Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear. During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase. Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management.

Timeline

• Start date: 2016-06-30
• Primary completion: 2016-11-30
• Completion: 2017-02-22
• First posted: 2016-07-01
• Last updated: 2017-04-21

Locations

10 sites across 3 countries: Germany, Ireland, United Kingdom