FreeStyle Libre Pro Use in Primary and Secondary Care; Revision A
Research type
Research Study
Full title
Evaluation of FreeStyle Libre Pro for Individuals with Insulin Managed Type 2 Diabetes in Primary and Secondary Care
IRAS ID
170230
Contact name
Ramzi Ajjan
Contact email
Sponsor organisation
Abbott Diabetes Care
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
The FreeStyle Libre Pro Flash Glucose Monitoring System is indicated for use by Health Care Professionals for detecting trends and tracking glucose patterns in adults with diabetes to help facilitate therapy adjustments.
The advantage of the FreeStyle Libre Pro Flash Glucose Monitoring System is that it significantly increases the amount and availability of detailed glucose data, by wearing a sensor on the back of the arm without the burden of collecting additional blood glucose measurements via a finger prick. The on-body sensor can be worn for up to 14 days. Health Care Professionals (HCPs) can observe the glucose trend data and glucose patterns for the previous 14 days with minimal inconvenience by scanning the sensor.
This study will assess the impact of varying amounts of FreeStyle Libre Pro wear on time within glucose target range. It is an open-label, multi-centre, 3 arm, pilot, randomised, non-significant risk evaluation of the System on adults with Type2 Diabetes.
The target enrolment is approximately 170 subjects (approximately 150 to be randomised) with glycated haemoglobin (HbA1c) level of 58 to 108 mmol/mol.
The study is estimated to last approximately 47 weeks. Each participant is anticipated to be in the study for between 20 and up to a maximum of 35 weeks depending on which arm of the study participants are randomised to.
For this study, the reader remains with the HCP and data retrieval is performed at specific points in the study. The reports generated by the System can be used by the HCP to review glucose management and therapies with the participant.REC name
North West - Preston Research Ethics Committee
REC reference
15/NW/0087
Date of REC Opinion
26 Jan 2015
REC opinion
Favourable Opinion