Accuracy of Sensor Based Glucose Monitoring Systems (ADC-UK-PMS-18039)
Research type
Research Study
Full title
Accuracy of Sensor Based Glucose Monitoring Systems
IRAS ID
253930
Contact name
Dileep Dasyam
Contact email
Duration of Study in the UK
0 years, 1 months, 27 days
Research summary
The purpose of this study is to test a medical device called the “FreeStyle Libre Flash Glucose Monitoring System’ (the ‘study device’) that has been developed by the Sponsor to help monitor glucose levels in people with diabetes. \n\nThe study device is a sensor-based monitoring system that has been designed to replace the need for regular fingerpricks, except under certain conditions explained in the labelling. The study device has been approved for use since 2014. \n\nThe aim of this study is to determine the accuracy of the study device and of another glucose monitoring device called the ‘Dexcom G6 Continuous Glucose Monitoring System’ (referred to as ‘Dexcom G6 device’; approved for use in the United States since 2018) against venous blood glucose analysed with a standard device (Yellow Springs Instrument analyser) and fingerprick capillary blood glucose measurements.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1838
Date of REC Opinion
16 Oct 2018
REC opinion
Further Information Favourable Opinion