BEAGLE-Abbott Sensor Based Glucose Monitoring System Paediatric Study
Research type
Research Study
Full title
Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System – Paediatric Label Extension Study (CE)
IRAS ID
166399
Contact name
Julie Edge
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
The Abbott Sensor Based Glucose Monitoring System is currently indicated for measuring glucose levels in adults with diabetes. This investigation will assess the use of the System children with diabetes.
Successful diabetes management is dependent upon effective self-management; children and adolescents with diabetes and their families need help and support to achieve this. The advantage of the Abbott Sensor Based Glucose Monitoring System is it significantly increases the amount and availability of detailed glucose data, while significantly reducing the time and pain issues of glucose monitoring. The on-body Sensor that scan be 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 Abbott Sensor Based Glucose Monitoring System in a paediatric 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 90 subjects. Participants will be aged between 4 and 17 years using insulin by either injection (MDI) or by insulin pump therapy (CSII).
For this study, the Reader is “masked” until the final visit; this means it will not show a number when scanning the sensor this is because we have not yet proved that the system is accurate in children. However they will be able to see blood glucose results when they do a finger prick test using the Reader as a glucose meter.
The study is estimated to last approximately 18 weeks and study participation will be a maximum of 28 days.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1228
Date of REC Opinion
18 Dec 2014
REC opinion
Further Information Favourable Opinion