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Comparative Study
. 2019 Jun;13(3):252-258.
doi: 10.1016/j.pcd.2018.12.010. Epub 2019 Feb 13.

The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria

Huizhen Chen  1 , Qingtao Yao  1 , Yang Dong  1 , Zhimei Tang  2 , Ruiying Li  2 , Baochao Cai  3 , Ruili Wang  1 , Qiu Chen  4
Affiliations
Comparative Study

The accuracy evaluation of four blood glucose monitoring systems according to ISO 15197:2003 and ISO 15197:2013 criteria

Huizhen Chen et al. Prim Care Diabetes. 2019 Jun.

Abstract

Self-monitoring of blood glucose is recommended to monitor glycaemic levels for the prevention and treatment of diabetes mellitus.The accuracy of blood glucose monitoring systems (BGMS) directly affects the health of the patients. In this study, we evaluated the accuracy of four different blood glucose monitoring systems, including Gold-Accu Meter, Nova StatStrip Xpress® Glucose Hospital Meter, Freestyle Optium Neo H® and Accu-Chek Performa according to ISO15197:2003 and ISO15197:2013 criteria. We found that four brands of BGMS (eight BGMS) all met the minimum requirements for system accuracy performance of ISO 15197:2003 and the accuracy criteria of ISO 15197:2013. All results of BGMS lie within zones A and B of the Consensus Error Grid (CEG). In conclusion, all BGMS met the accuracy criteria of ISO 15197:2003 and the accuracy criteria of ISO 15197:2013.

Keywords: Blood glucose; Blood glucose monitoring system; Diabetes mellitus.

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