Evaluation of System Accuracy and Range of Error of the Blood Glucose Monitoring System Contour Plus Elite Against the ISO 15197 Requirements for Self-Testing

Introduction: Accuracy of blood glucose monitoring systems (BGMS) is critical to self-detection of dysglycemia by people with diabetes (PWD). Reliable BGMS are integral to diabetes care, contributing to continuous metabolic control and patient understanding of behaviors, allowing for flexible adjustment of therapy. Accuracy, availability, and acceptability of BGMS can impact clinical decisions and outcomes. Methods: Conducted in accordance with DIN EN ISO 15197:2015, this study evaluated the accuracy of the Contour Plus Elite BGMS in terms of agreement between test system measurements and reference system measurements across a predetermined range of blood glucose concentrations. A diverse group of 104 adults from a single center participated. Analysis included the production of consensus error grids (CEGs) to evaluate the clinical significance of deviations of results between the test and reference values. Results: All reference and test BGMS measurements were performed according to their specifications and requirements. A total of 600 of 600 (100%) Contour Plus Elite measurements across 3 lots showed deviations from the reference test of less than 15 mg/dL (0.83 mmol/L) for glucose concentrations <100 mg/dL (5.55 mmol/L) and less than 15% glucose concentrations ≥100 mg/dL (5.55 mmol/L), complying with the first DIN EN ISO 15197:2015 acceptance criterion. All Contour Plus Elite measurements (100%) resided within zone A of the CEG, thus exceeding the second criterion, which permits measurements in zone A or B. An ad hoc confidence analysis provided an additional metric, demonstrating that the smallest error range within which at least 95% of differences between test device and reference measurements fell was ±8.1 mg/dL or 8.1%. Conclusions: The evaluation revealed that the BGMS Contour Plus Elite fully complied with and exceeded DIN EN ISO 15197:2015 system accuracy requirements. The device displays a clinically acceptable level of accuracy for use by PWD. All measurements (100%) were well within acceptability levels.