System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method

Abstract

The accuracy of blood glucose (BG) measurement results obtained with systems for self-monitoring of blood glucose (SMBG) by people with diabetes is crucial for adequate therapeutic decisions. Requirements for SMBG systems, for example, acceptable system accuracy, are established in the International Organization for Standardization (ISO) standard 15197. Manufacturers often provide evidence of conformity with this standard to obtain the Conformité Européenne (CE) mark for their system; in the European Union this mark, is a minimum requirement for being marketed. Background: The standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek® Aviva, Contour®XT, GlucoCheck XL, GlucoMen® LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used.

Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197

“…7,8 The results presented here focused on MARD only and did not, for example, include system accuracy evaluation as defined in ISO 15197, which is a widely accepted ISO standard. 7,8 Such results generated from the data obtained in this study were presented in a recent publication by Link et al 35 Generating a large enough number of samples in the low glycemic range increases the complexity of study procedures, and it may threaten subject safety if not properly supervised, which is why studies often use altered blood samples. 11,13,14 Altering blood samples ex vivo, however, may introduce additional influence factors (e.g., interference from changes in oxygen partial pressure in GOD-based SMBG systems).…”

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

“…Several published studies have compared BGM brands and models by name during headto-head testing (56,57,136,(145)(146)(147)(148). For clinicians and consumers, MARD provides an excellent measure of accuracy and precision when evaluating a BGM (134).…”

Evidence From a Long-Term, Systematic Post-Market Surveillance Program: Clinical Performance of a Hematocrit-Insensitive Blood Glucose Test Strip

“…19,20 However, a counterpoint to this "sponsorship bias" would be that manufacturers are, for example, more aware of potential off-sets that exist between different reference instruments, which may contradict product labelling and therefore mitigate for factors impacting performance. 21,22 The nature of the applied blood sample also has a significant impact upon accuracy with a recent study demonstrating the impact of applying either capillary or venous blood samples to the same strip product under identical conditions. 23 Furthermore, even when design or reference methodology is common, interpretation of results between studies is not always straightforward.…”