FreeStyle Libre In Pregnancy Study (FLIPS), Revision A
Research type
Research Study
Full title
Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System – Use in Pregnancy Label Extension Study (CE)
IRAS ID
190003
Contact name
Rudolf Bilous
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Duration of Study in the UK
0 years, 4 months, 30 days
Research summary
The FreeStyle Libre Flash Glucose Monitoring System is currently indicated for measuring glucose levels in adults with diabetes. This investigation will assess the use of the System in pregnant women with diabetes.
Women with any kind of diabetes are at increased risk of morbidity and mortality during pregnancy. Pregnancy has a substantial effect on diabetes management and optimisation of glycaemic control is vital for the mother and developing foetus. Women with type 1, 2 or gestational diabetes mellitus (GDM) are advised to self-monitor their glucose levels throughout their pregnancy.
The advantage of the FreeStyle Libre Flash Glucose Monitoring System is it significantly increases the amount and availability of glucose data. The on-body Sensor is worn for up to 14 days. Users can observe the current glucose level, glucose trend data and glucose patterns with minimal inconvenience by scanning a sensor worn on the back of the arm rather than conventional blood glucose monitoring test that requires a finger prick.
It is the intention of this Clinical Investigation to establish the accuracy of the FreeStyle Libre Flash Glucose Monitoring System in a pregnant population so that it might be used by them in the future to help achieve and maintain glycaemic control.
This Study is a multi-centre, prospective, single arm, non-significant risk evaluation of the System.
The target enrolment is approximately 80 subjects. For this study, the Reader is “masked” until the final visit; this means it will not show a glucose reading when scanning the sensor this is because we have not yet proved that the system is accurate in pregnancy. However they will be able to see blood glucose results when they do a fingerprick test using the test strip port on the Reader.
The study is estimated to last approximately 18 weeks and study participation will be a maximum of 28 days.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0436
Date of REC Opinion
9 Nov 2015
REC opinion
Further Information Favourable Opinion