Evaluation of Blood Glucose Monitoring Systems
Research type
Research Study
Full title
Evaluation of Blood Glucose Monitoring Systems
IRAS ID
238945
Contact name
Sarah Dowrick
Contact email
Sponsor organisation
GlucoRx Ltd
Duration of Study in the UK
0 years, 5 months, 15 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.
Guidelines on determining system accuracy on blood glucose meters (BS EN ISO 1597:2015) state that it should be determined from at least 100 different subjects and that the evaluation should 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 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 pre and post measurement with the glucose meter.
In this study 4 blood glucose meters used in the UK will be compared across a wide range of blood glucose concentrations similar to that specified in Section 8 BS EN ISO 15197:2015.
The 4 meters will be a) HCT Meter (GlucoRx), b) Accu-Check Aviva Blood Glucose Meter (Roche), c) Dual Blood Glucose Monitoring System (CareSens), and d) Glucomen Areo 2K (Menarini). The reference laboratory analyser will be the YSI2300 (YSI Instruments). Only the glucose measurement functions of the devices will be tested. The reference laboratory analyser will be the YSI2300 (YSI Instruments).REC name
Wales REC 6
REC reference
18/WA/0023
Date of REC Opinion
23 Jan 2018
REC opinion
Favourable Opinion