標題: Clinical evaluation of the eBsensor hand-held blood glucose monitoring system
作者: Chen, Chien-Chih
Tai, Der-Yan
Ho, Ping
Lai, Yiu-Kay
Lin, Jui-Jane
Mao, Simon J. T.
Lin, Chia-Chi
Hsieh, Yu-Chen
Chiang, Hsiang-Cheng
Dai, Ken-Shwo
生物科技學系
Department of Biological Science and Technology
關鍵字: diabetes;glucose monitoring system;Clarke error grid analysis;glucose meter;strip;self-monitoring;accuracy;precision;electrochemical
公開日期: 1-Feb-2007
摘要: 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. (c) 2006 Elsevier B.V. All rights reserved.
URI: http://dx.doi.org/10.1016/j.cca.2006.09.023
http://hdl.handle.net/11536/11167
ISSN: 0009-8981
DOI: 10.1016/j.cca.2006.09.023
期刊: CLINICA CHIMICA ACTA
Volume: 377
Issue: 1-2
起始頁: 170
結束頁: 173
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