FLUIDS - FreeStyle Libre Use In Patients Undergoing Dialysis
Research type
Research Study
Full title
FreeStyle Libre Flash Glucose Monitoring System use in Insulin Treated Patients Undergoing Dialysis
IRAS ID
251963
Contact name
Thomas Connor
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
This purpose of this study is to assess the use of the FreeStyle Libre Flash Glucose Monitoring System in adults with diabetes undergoing haemodialysis.
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. In typical use, 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 specific intention of this study to determine the accuracy of the FreeStyle Libre Flash Glucose Monitoring System in a population with diabetes undergoing haemodialysis.
This Study is a multi-centre, prospective, single arm, non-significant risk evaluation of the System.
The target enrolment is approximately 27 subjects. For this study, the Reader will be “masked” until the final visit; this means it will not show a glucose reading when scanning the sensor and this is because we have not previously assessed the accuracy of the system in persons with diabetes undergoing dialysis.
However, participants 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 12 weeks and study participation will be a maximum of 28 days.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0398
Date of REC Opinion
11 Oct 2018
REC opinion
Favourable Opinion