Clinical evaluation and alternative site blood glucose testing of the EasyPlus mini R2N blood glucose monitoring system.

ABSTRACT

BACKGROUND: The complications of diabetes are preventable by exact glycemic control, which can be provided by an accurate self-monitoring blood glucose system to promote self-care in the management of diabetes. METHODS: We evaluated the accuracy and reliability of the EasyPlus mini R2N blood glucose self-monitoring system and compare glucose measurements between the fingertip, thenar, hypothenar and forearm. Over a 1-month period, 165 patients with Types 1 and 2 diabetes mellitus participated in this study. RESULTS: EasyPlus mini R2N blood glucose results obtained from the fingertip correlated well with the laboratory reference (linear regression analysis: slope=1.03, intercept=-1.63 mg/dl, r(2)=0.970) and were comparable to the results generated from 2 other blood glucose meters. Clarke error grid analysis showed all EasyPlus mini R2N glucose results in clinically acceptable zones A and B (96.79% in zone A and 3.21% in zone B). The CVs of the within-run and total precision testing were within the acceptance criteria (<6%). As compared to the alternate site, the fingertip correlated well with the thenar and hypothenar values and the forearm value. CONCLUSIONS: The EasyPlus mini R2N showed clinically acceptable accuracy and reliability as compared to the laboratory reference, and no significant or detectable glucose differences between alternate sites were observed.