Accuracy validation and user performance analysis of two new self-monitoring blood glucose systems.

Abstract

Summary: Patients with diabetes require regular blood glucose monitoring. We evaluated the precision and user performance of two blood glucose monitoring systems, the accuracy results of GlucoTeq BGM200 and DiaRite BGM300, adhering to the EN_ISO 15197:2015 standards, which require blood glucose ≥100 mg/dL, >95% of the data within ±15% difference, and when blood glucose <100 mg/dL, >95% of the data within ±15 mg/dL. This study assessed their conformity with the YSI analyzer and other leading systems. Participants (n = 101), 18 years of age were included, covering a diverse demographic. Accuracy was determined using the YSI analyzer as the standard, employing linear regression, a consensus error grid and Bland-Altman analyses. The performance of both system users showed 100% conformity within zone A of the consensus error grid, high linear regression coefficients and minimal bias in the Bland-Altman analysis. Subjective satisfaction analyses showed average scores of 4.59 and 4.62 for BGM200 and BGM300, respectively. Comparison with other systems revealed high regression coefficients (CONTOUR®PLUS; R 2 = 0.9960, BGM200; R 2 = 0.9927, BGM300; R 2 = 0.9915, Accu-Chek® Guide; R 2 = 0.9910). Both systems demonstrated reasonable accuracy and user performance comparable to competitors' products and met international standards. Their reliability in real-world scenarios and high user satisfaction make them valuable tools for diabetes management.

Learning points: Reasonable accuracy: GlucoTeq BGM200 and DiaRite BGM300 complied with EN ISO 15197:2015 standards, achieving >95% accuracy validated against the reference method the YSI analyzer. High user satisfaction: both systems scored highly (4.59-4.62/5), reflecting ease of use, reliable operation and clear result interpretation. Competitive performance: comparable to leading devices such as CONTOUR®PLUS, with strong correlation coefficients (>0.99). Regulatory compliance: the trial met stringent international standards with a diverse participant group and robust methodology. Broad applicability: reliable for clinical and home use, supporting effective diabetes management.