Study of the Accuracy of the Glucocard SM Blood Glucose Meter
Research type
Research Study
Full title
Study of the Accuracy of the Glucocard SM Blood Glucose Meter
IRAS ID
187052
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 accuracy requirements for blood glucose meters. System accuracy needs to be determined from at least 100 different subjects. The evaluation has to be conducted in actual conditions of use, so that the effects of systematic error (measurement bias) and random error (measurement imprecision) normally experienced can be included. In practice the system accuracy evaluation needs to be performed with a minimum of 100 fresh blood samples each with sufficient volume to be measured by 3 reagent lots (strips) and at least in duplicate. In addition the individual measurements from the blood glucose meters also need to be compared to reference laboratory glucose concentrations.REC name
Wales REC 6
REC reference
15/WA/0279
Date of REC Opinion
25 Aug 2015
REC opinion
Favourable Opinion