Libre Performance Check, version 1.0
Research type
Research Study
Full title
Performance Check and Safety Data collection for Abbott Sensor-based Glucose Monitoring systems
IRAS ID
161804
Contact name
Alistair Lumb
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Research summary
This study is conducted at multiple sites with the purpose of monitoring the continuing performance and safety of the FreeStyle Libre glucose monitoring systems approved for use. Anyone aged 18 or over with type 1 or type 2 diabetes may be able to participate. Participants will be asked to wear up to four sensors at a time, for the period stated in the device labelling instructions. During this period participants will be asked to scan their sensor/s when required and perform a minimum of four blood glucose fingerprick readings per day for each day of sensor wear to allow evaluation of Sensor accuracy. Before starting to use the sensor/s participants will be trained in the use of the glucose monitoring system(s) and will be asked to provide demographic data, diabetes and medication history and have their height and weight recorded. At the end of the sensor wear, participants’ sensor and blood glucose data are uploaded for analysis by the Sponsor.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/1136
Date of REC Opinion
17 Nov 2014
REC opinion
Further Information Favourable Opinion