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

Area of Science:

• Medical Devices
• Clinical Diagnostics
• Diabetes Technology

Background:

• Regular blood glucose monitoring is essential for effective diabetes management.
• Existing monitoring systems require evaluation for precision, accuracy, and user performance.
• International standards like EN ISO 15197:2015 provide benchmarks for blood glucose meter accuracy.

Purpose of the Study:

• To evaluate the accuracy and user performance of the GlucoTeq BGM200 and DiaRite BGM300 blood glucose monitoring systems.
• To assess the conformity of these systems with EN ISO 15197:2015 standards.
• To compare the performance of BGM200 and BGM300 against a reference method (YSI analyzer) and other leading systems.

Main Methods:

• Accuracy assessment using the YSI analyzer as the reference standard.
• Statistical analyses including linear regression, consensus error grid, and Bland-Altman analysis.
• User performance evaluation with 101 diverse participants (≥18 years) and subjective satisfaction surveys.

Main Results:

• Both GlucoTeq BGM200 and DiaRite BGM300 met EN ISO 15197:2015 accuracy requirements (>95% conformity).
• User performance showed 100% conformity within Zone A of the consensus error grid, with high correlation coefficients and minimal bias.
• High user satisfaction scores (4.59-4.62/5) were reported for both systems, indicating ease of use and clear results.

Conclusions:

• GlucoTeq BGM200 and DiaRite BGM300 demonstrate reliable accuracy and user performance, meeting international standards.
• These systems offer competitive performance comparable to established market leaders.
• Their accuracy, reliability, and user satisfaction make them valuable tools for diabetes self-management in clinical and home settings.