Evaluation of the User Performance of the Glucocard MX
Research type
Research Study
Full title
Evaluation of the User Performance of the Glucocard MX Blood Glucose Meter
IRAS ID
188244
Contact name
SD Luzio
Contact email
Sponsor organisation
Abertawe Bro Morgannwg University Health Board
Duration of Study in the UK
0 years, 3 months, 31 days
Research summary
Blood glucose monitoring systems are in vitro diagnostic medical devices used by individuals with diabetes. When used properly, the glucose monitoring system allows the user to monitor and take action to control the amount of glucose present in the blood.
New guidelines have recently been introduced (ISO15197:2013(E)) by the International Organization for Standardization (ISO) a worldwide federation of national standards bodies. The international standard is intended for blood glucose monitoring systems used by lay persons and the objectives are to establish acceptable performance and to specify procedures for demonstrating conformance to this international standard [1]. ISO 15197:2013(E) describes a series of studies which should be performed with blood glucose monitoring systems, many of which are related to overall usability of the product.
Specific to this study the standards describe requirement for user performance evaluation intended to demonstrate that intended users are able to obtain accurate measured glucose values when operating the blood-glucose monitoring system, given only the instructions and training materials routinely provided with the system. The accuracy of blood-glucose values measured by lay persons with diabetes will be compared to capillary blood glucose measure by a reference laboratory glucose analyser. User performance needs to be conducted by at least 100 different participants with diabetes representing different ages, genders and educational levels.REC name
Wales REC 6
REC reference
15/WA/0304
Date of REC Opinion
21 Sep 2015
REC opinion
Favourable Opinion