Abstract
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.
Highlights
Diabetes mellitus (DM) is unanimously recognised as one of the principal healthcare epidemics of the 21st century [1,2,3,4]
The principle areas of expenditure are predominantly in the management of diabetic complications and diabetic medications, another area with significant investment is in glucose monitoring systems that aid in the self-monitoring of blood glucose (SMBG) [9, 10]
With an average age of 63 years, samples from 57 men and 48 women were tested over the course of the study and had their blood glucose analysed by both the BG meter and the reference method
Summary
Diabetes mellitus (DM) is unanimously recognised as one of the principal healthcare epidemics of the 21st century [1,2,3,4]. Such remarks stem from epidemiological data highlighting the rising burden of DM as shown by the prevalence of DM increasing from 285 million to 382 million between the years 2011 and 2013 [3, 5, 6]. Recognised as an integral component in the management of DM, numerous studies have shown that SMBG provides an effective means of controlling blood glucose (BG) levels [11,12,13,14].
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