Evaluation of IFU for StatStrip A monitoring system
Research type
Research Study
Full title
An evaluation of the comprehensibility and clarity of instructions for use (IFU) for a patient self-testing device used to measure glucose and creatinine.
IRAS ID
244313
Contact name
Maurice O'Kane
Contact email
Sponsor organisation
Nova Biomedical
Duration of Study in the UK
0 years, 8 months, 16 days
Research summary
A new monitoring system to test glucose and creatinine has been developed. It is intended for use by people with diabetes at home and point-of-care use by healthcare professionals as an aid to evaluate the effectiveness of diabetes control, the treatment of renal diseases and in monitoring renal dialysis. This study will evaluate the comprehensibility and clarity of instructions for use of the Nova StatStrip A monitoring system.
REC name
Wales REC 7
REC reference
18/WA/0169
Date of REC Opinion
9 May 2018
REC opinion
Favourable Opinion