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

BACKGROUND: The 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. METHODS: A 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. RESULTS: The EGV1 self-monitoring blood glucose system with fingertip demonstrated an excellent correlation with venous blood (linear regression analysis: slope=1.01, intercept=-0.8972 mg/dl, r(2)=0.96), and with other brands of glucose systems (linear regression analysis: slope=0.99, intercept=+3.5632 mg/dl, r(2)=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. CONCLUSIONS: The 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.

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

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.

Clinical evaluation of the eBsensor hand-held blood glucose monitoring system.

BACKGROUND: Home glucose monitoring system is increasingly recognized as an important tool for glycemic control. We evaluated the clinical performance of the eBsensor glucose monitoring system. METHODS: Fingertip capillary blood glucose concentrations from 282 subjects were measured using eBsensor glucose monitoring system and compared against predicate devices and the Yellow Springs Instruments (YSI) 2300 blood glucose analyzer. Accuracy and precision of the eBsensor glucose monitoring system were assessed using several methods. The comparative study between the eBsensor and 2 currently marketed monitoring systems was performed. RESULTS: The 282 eBsensor readings covered a wide range from 2.6 to 24.4 mmol/l. Deming regression and Pearson correlation analyses showed a linear relationship between the eBsensor readings and the YSI reference method (eBsensor=0.9496 YSI+0.4127 mmol/l; r=0.98). Error Grid analysis demonstrated that 100% of the eBsensor readings in clinically acceptable zones A and B. The CVs for the 6 lots of strips were within the satisfactory interval (<6%). The comparative study showed that the eBsensor readings correlated well with the OneTouch Ultra values (r=0.97) and the Glucocard II values (r=0.97). CONCLUSIONS: eBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.