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.
Chen
Chien-Chih
CC
Wei-Gong Memorial Hospital, Miaoli, and The Institude of Biotechnology, College of Life Science, National Tsing Hua University, Hsinchu, Taiwan.
Tai
Der-Yan
DY
Ho
Ping
P
Lai
Yiu-Kay
YK
Lin
Jui-Jane
JJ
Mao
Simon J T
SJ
Lin
Chia-Chi
CC
Hsieh
Yu-Chen
YC
Chiang
Hsiang-Cheng
HC
Dai
Ken-Shwo
KS
D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male