PUGS (Paediatric Use of the AbbottSensorBasedGlucoseMonitoringSystem)
Research type
Research Study
Full title
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System for 21 days – an Accuracy Evaluation
IRAS ID
234355
Contact name
Nicola Trevelyan
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Duration of Study in the UK
0 years, 4 months, 31 days
Research summary
The Abbott Sensor Based Glucose Monitoring System was CE marked in August 2014 for adults as the “FreeStyle Libre Flash Glucose Monitoring System”, with a wear duration of up to 14 days in adults. Post market clinical activities have included evaluation of the System and extension of the CE mark to its use in the paediatric population and for pregnant women. The aim of this investigation is to support a potential label extension for up to 21 days wear duration for children with diabetes.\nIt is the intention of this Clinical Investigation to evaluate the point accuracy and safety of the system in a paediatric population with wear duration of up to 21 days. The study is a multi-centre, single arm, prospective evaluation of the system. The target enrolment is approximately 110 subjects. Participants will be aged between 4 and 17 years. During the study, the Reader will be “masked“ - this means it will not show a glucose reading when scanning the Sensor. However, participants will be required to do at least four finger prick blood glucose (BG) tests per day and will be able to see these BG results on the Reader and to use this data for self management. The study is expected to last for approximately 4 months from first patient first visit to last patient last visit.\nEach participant will be in the study for a maximum of 35 days.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
17/YH/0393
Date of REC Opinion
13 Dec 2017
REC opinion
Further Information Favourable Opinion