TY - JOUR
T1 - Accuracy of the EasyTouch blood glucose self-monitoring system
T2 - A study of 516 cases
AU - Dai, Ken Shwo
AU - Tai, Der Yan
AU - Ho, Ping
AU - Chen, Chien Chih
AU - Peng, Wen Chung
AU - Chen, Shih Te
AU - Hsu, Chun Chieh
AU - Liu, Yu Ping
AU - Hsieh, Hsiu Ching
AU - Yang, Chin Chang
AU - Tsai, Ming Chuan
AU - Mao, Simon J T
PY - 2004/11
Y1 - 2004/11
N2 - 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, r 2 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 (≤100, 101-200, and ≥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.
AB - 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, r 2 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 (≤100, 101-200, and ≥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.
KW - Clarke Error Grid analysis
KW - Diabetes mellitus
KW - Glucose self-monitoring system
KW - Home testing
KW - Point-of-care testing
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U2 - 10.1016/j.cccn.2004.06.010
DO - 10.1016/j.cccn.2004.06.010
M3 - Article
C2 - 15469866
AN - SCOPUS:4744341176
SN - 0009-8981
VL - 349
SP - 135
EP - 141
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
IS - 1-2
ER -