The clinical performance of the EGV1 self-monitoring blood glucose system

Abstract

BackgroundThe novel technique of blood volume detection can improve the reliability and accuracy of a self-monitoring blood glucose system. Self-management of diabetes can be improved, and the glycemic range can be efficiently controlled. MethodsA total of 153 patients with diabetes mellitus participated in the clinical study. The accuracy, blood volume detection, interference, and altitude effect of the EGV1 self-monitoring blood glucose system were evaluated and compared among the fingerstick, alternative site testing, and venous blood. ResultsThe EGV1 self-monitoring blood glucose system with fingertip demonstrated an excellent correlation with venous blood (linear regression analysis: slope=1.01, intercept=−0.8972mg/dl, r2=0.96), and with other brands of glucose systems (linear regression analysis: slope=0.99, intercept=+3.5632mg/dl, r2=0.94). The Clarke error grid analysis indicated that the results of fingertip and alternative sites were in the acceptable zones, A and B. The system required 0.6 ul of a blood sample to obtain an accurate reading, and was unaffected by several interferents and altitude. ConclusionsThe EGV1 self-monitoring blood glucose system using various blood samples demonstrated acceptable accuracy and reliability compared to the laboratory reference and other self-monitoring blood glucose systems.