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J Diabetes Sci Technol. 2017 Sep;11(5):953-965. doi: 10.1177/1932296817705143. Epub 2017 May 8.

Accuracy Evaluation of 19 Blood Glucose Monitoring Systems Manufactured in the Asia-Pacific Region: A Multicenter Study.

Author information

1
1 Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
2
2 Shanghai Clinical Medical Center of Diabetes, Shanghai, China.
3
3 Shanghai Key Clinical Center of Metabolic Disease, Shanghai, China.
4
4 Shanghai Institute for Diabetes, Shanghai, China.
5
5 Shanghai Key Laboratory of Diabetes, Shanghai, China.
6
6 Diabetes Research Laboratory, Shanghai Jiao Tong University Affiliated First People's Hospital, Shanghai, China.
7
7 Min-Sheng General Hospital, Taoyuan, Taiwan.
8
8 Clinical Laboratory, Chung Shan Medical University Hospital, Taichung, Taiwan.
9
9 School of Medical Laboratory and Biotechnology, Chung Shan Medical University, Taichung, Taiwan.

Abstract

BACKGROUND:

System accuracy of current blood glucose monitors (BGMs) in the market has already been evaluated extensively, yet mostly focused on European and North American manufacturers. Data on BGMs manufactured in the Asia-Pacific region remain to be established. In this study, we sought to assess the accuracy performance of 19 BGMs manufactured in the Asia-pacific region.

METHODS:

A total of 19 BGMs were obtained from local pharmacies in China. The study was conducted at three hospitals located in the Asia-Pacific region. Measurement results of each system were compared with results of the reference instrument (YSI 2300 PLUS Glucose Analyzer), and accuracy evaluation was performed in accordance to the ISO 15197:2003 and updated 2015 guidelines. Radar plots, which is a new method, are described herein to visualize the analytical performance of the 19 BGMs evaluated. Consensus error grid is a tool for evaluating the clinical significance of the results.

RESULTS:

The 19 BGMs resulted in a satisfaction rate between 83.5% and 100.0% within ISO 15197:2003 error limits, and between 71.3% and 100.0% within EN ISO 15197:2015 (ISO 15197:2013) error limits.

CONCLUSIONS:

Of the 19 BGMs evaluated, 12 met the minimal accuracy requirement of the ISO 15197:2003 standard, whereas only 4 met the tighter EN ISO 15197:2015 (ISO 15197:2013) requirements. Accuracy evaluation of BGMs should be performed regularly to maximize patient safety.

KEYWORDS:

Asia-Pacific region; EN ISO 15197:2015 (ISO 15197:2013); accuracy; blood glucose monitoring system

PMID:
28480733
PMCID:
PMC5950995
DOI:
10.1177/1932296817705143
[Indexed for MEDLINE]
Free PMC Article

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