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

被引:5
作者
Chen, Huizhen [1 ]
Yao, Qingtao [1 ]
Dong, Yang [1 ]
Tang, Zhimei [2 ]
Li, Ruiying [2 ]
Cai, Baochao [1 ,2 ]
Wang, Ruili [1 ]
Chen, Qiu [2 ]
机构
[1] Chengdu Univ Tradit Chinese Med, Sch Clin Med, Chengdu, Sichuan, Peoples R China
[2] Chengdu Univ Tradit Chinese Med, Affiliated Hosp, Dept Endocrinol, Chengdu, Sichuan, Peoples R China
关键词
Blood glucose monitoring system; Diabetes mellitus; Blood glucose;
D O I
10.1016/j.pcd.2018.12.010
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 (R) Glucose Hospital Meter, Freestyle Optium Neo H (R) 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. (C) 2019 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码:252 / 258
页数:7
相关论文
共 15 条
[1]  
[Anonymous], 2013, 151972013EN ISO
[2]  
Bedini Jose Luis, 2015, J Diabetes Sci Technol, V10, P85, DOI 10.1177/1932296815609368
[3]  
Bland JM, 1999, STAT METHODS MED RES, V8, P135, DOI 10.1177/096228029900800204
[4]   Self-Monitoring of Blood Glucose as Part of the Integral Care of Type 2 Diabetes [J].
Boutati, Eleni I. ;
Raptis, Sotirios A. .
DIABETES CARE, 2009, 32 :S205-S210
[5]  
Brazg Ronald L, 2013, J Diabetes Sci Technol, V7, P144
[6]   System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods [J].
Freckmann, Guido ;
Link, Manuela ;
Schmid, Christina ;
Pleus, Stefan ;
Baumstark, Annette ;
Haug, Cornelia .
DIABETES TECHNOLOGY & THERAPEUTICS, 2015, 17 (09) :635-648
[7]   Global estimates of diabetes prevalence for 2013 and projections for 2035 [J].
Guariguata, L. ;
Whiting, D. R. ;
Hambleton, I. ;
Beagley, J. ;
Linnenkamp, U. ;
Shaw, J. E. .
DIABETES RESEARCH AND CLINICAL PRACTICE, 2014, 103 (02) :137-149
[8]  
Hasslacher C., 2019, CLIN LAB, V201, P727
[9]  
International Organization for Standardization, 2003, 151972003E EN ISO
[10]  
Jendrike N., 2018, CURR MED RES OPIN, P1