Labelling and Comprehension of IBL products-Rev 1
Research type
Research Study
Full title
Labelling and comprehension study of Inside Biometrics Products
IRAS ID
179265
Contact name
Selly Saini
Contact email
Sponsor organisation
Inside Biometrics Ltd
Duration of Study in the UK
0 years, 5 months, 12 days
Research summary
The aim of this research is to determine the comprehension of the Instructions for use of Inside Biometrics products specifically for ketone measurement by users who are both familiar and unfamiliar with blood glucose monitoring test systems.
This study will require 15 participants who have been diagnosed with Type 1 or Type 2 Diabetes 18 years or older who are familiar (already use) and unfamiliar (have never used) blood glucose monitoring test systems.
The study will be conducted at the Highland Diabetes Insititute, Inverness.
Participation in this study will last between 45-60minutes. Each participant will be given the user instructions for the device, perform a control solution test using the test system which will involve setting up a test system, applying control solution and obtaining a measurement. At the end of the procedure the participant will be asked to complete a questionnaire on using the device.
REC name
West of Scotland REC 4
REC reference
15/WS/0106
Date of REC Opinion
14 Jul 2015
REC opinion
Further Information Favourable Opinion