System accuracy evaluation of the GlucoRx nexus voice TD-4280 blood glucose monitoring system.
Use of blood glucose (BG) meters in the self-monitoring of blood glucose (SMBG) significantly lowers the risk of diabetic complications. With several BG meters now commercially available, the International Organization for Standardization (ISO) ensures that each BG meter conforms to a set degree of accuracy. Although adherence to ISO guidelines is a prerequisite for commercialization in Europe, several BG meters claim to meet the ISO guidelines yet fail to do so on internal validation. We conducted a study to determine whether the accuracy of the GlucoRx Nexus TD-4280 meter, utilized by our department for its cost-effectiveness, complied with ISO guidelines. 105 patients requiring laboratory blood glucose analysis were randomly selected and reference measurements were determined by the UniCel DxC 800 clinical system. Overall the BG meter failed to adhere to the ≥95% accuracy criterion required by both the 15197:2003 (overall accuracy 92.4%) and 15197:2013 protocol (overall accuracy 86.7%). Inaccurate meters have an inherent risk of over- and/or underestimating the true BG concentration, thereby risking patients to incorrect therapeutic interventions. Our study demonstrates the importance of internally validating the accuracy of BG meters to ensure that its accuracy is accepted by standardized guidelines.
Department of Diabetes & Endocrinology, Countess of Chester Hospital NHS Foundation Trust, Chester CH2 1UL, UK.
Muhammad
0000-0001-8807-2970
M
Khan
Department of Diabetes & Endocrinology, Countess of Chester Hospital NHS Foundation Trust, Chester CH2 1UL, UK.
Keith
0000-0001-9203-028X
K
Broadbent
Department of Clinical Sciences & Nutrition, University of Chester, Chester CH1 4BJ, UK.
Mike
0000-0002-5390-7453
M
Morris
Department of Diabetes & Endocrinology, Countess of Chester Hospital NHS Foundation Trust, Chester CH2 1UL, UK.
David
0000-0001-5507-2149
D
Ewins
Department of Diabetes & Endocrinology, Countess of Chester Hospital NHS Foundation Trust, Chester CH2 1UL, UK.
Franklin
F
Joseph
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D015203:Reproducibility of Results