Accuracy of the EasyTouch blood glucose self-monitoring system: a study of 516 cases.
BACKGROUND
Self-monitoring blood glucose device is an important tool for diabetes patients to efficiently control their blood glucose concentrations. We evaluated the accuracy of EasyTouch glucose monitoring system.


METHODS
Capillary blood glucose concentrations measured using EasyTouch and the reference values obtained from Yellow Springs Instruments (YSI) 2300 STAT were performed in the Department of Laboratory Medicine, Wei-Gong Memorial Hospital. Results were evaluated using (1) linear regression analysis, (2) Clarke Error Grid analysis, (3) percentage of readings within a defined range of deviation from the reference value, (4) bias plots, and (5) coefficients of variation (CVs) calculated from 60 measurements in series.


RESULTS
The window of the 516 EasyTouch readings covered a range from 42 to 555 mg/dl. Linear regression analysis yielded a regression slope 0.9972, intercept 1.899 mg/dl, r2 0.9571, and Syx 14.89 mg/dl. A Clarke Error Grid analysis showed 100% of the EasyTouch readings in clinically acceptable zones A and B. Of the EasyTouch readings, 98.3%, 91.9%, 78.3% and 46.9% were found within +/-20%, +/-15%, +/-10%, and +/-5%, respectively, of the reference values. Further analysis showed that the percentage of EasyTouch readings within the defined intervals was similar in three glucose ranges (< or =100, 101-200, and > or =201 mg/dl). The CVs for the four lots of strips (lot 1 to lot 4) ranged from 3.5 to 5.5%, 2.1 to 4.8%, 1.8 to 3.6%, and 3.0 to 5.7%, respectively.


CONCLUSIONS
EasyTouch provides high accurate and precise glucose readings over a wide range of glucose concentrations.
Bioptik Technology Inc., 1F, No. 9 Industry E. Rd. IV, Science-Based Industrial Park Hsinchu, Hsinchu 300, Taiwan. Dai@bioptik.com.tw
Ken-Shwo
KS
Dai
Der-Yan
DY
Tai
Ping
P
Ho
Chien-Chih
CC
Chen
Wen-Chung
WC
Peng
Shih-Te
ST
Chen
Chun-Chieh
CC
Hsu
Yu-Ping
YP
Liu
Hsiu-Ching
HC
Hsieh
Chin-Chang
CC
Yang
Ming-Chuan
MC
Tsai
Simon J T
SJ
Mao
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood; D006400:Hematocrit; D006801:Humans; D015203:Reproducibility of Results; D014527:Uric Acid / Q000097:blood
D001786:Blood Glucose; D014527:Uric Acid