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

Overview

Journal J Diabetes Sci Technol

Specialty Endocrinology

Date 2017 May 9

PMID 28480733

Citations 8

Authors

Wang Yu-Fei

Jia Wei-Ping

Wu Ming-Hsun

Chien Miao-O

Hsieh Ming-Chang

Wang Chi-Pin

Lee Ming-Shih

Affiliations

Soon will be listed here.

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.

Citing Articles

Comparative Study Between Blood Glucose Meters in a Maternity Center.

Ayadi R, Tlig M, Jdida I, Zribi K, Khefacha L, Sassi M Womens Health Rep (New Rochelle). 2024; 5(1):572-578.

PMID: 39206021 PMC: 11347866. DOI: 10.1089/whr.2024.0030.

Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.

Luppa P, Zeller M, Pieper M, Kaiser P, Weiss N, Vierbaum L Front Mol Biosci. 2024; 11:1371426.

PMID: 38572446 PMC: 10987728. DOI: 10.3389/fmolb.2024.1371426.

Blood glucose monitoring devices: current considerations.

Sly B, Taylor J Aust Prescr. 2023; 46(3):54-59.

PMID: 38053807 PMC: 10665089. DOI: 10.18773/austprescr.2023.013.

Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.

Sacks D, Arnold M, Bakris G, Bruns D, Horvath A, Lernmark A Diabetes Care. 2023; 46(10):e151-e199.

PMID: 37471273 PMC: 10516260. DOI: 10.2337/dci23-0036.

A Nanotechnology-Based Approach to Biosensor Application in Current Diabetes Management Practices.

Shoaib A, Darraj A, Khan M, Azmi L, Alalwan A, Alamri O Nanomaterials (Basel). 2023; 13(5).

PMID: 36903746 PMC: 10005622. DOI: 10.3390/nano13050867.

References

Simmons D . How Should Blood Glucose Meter System Analytical Performance Be Assessed?. J Diabetes Sci Technol. 2015; 10(1):178-84. PMC: 4738212. DOI: 10.1177/1932296815598599. View

CLARK Jr L, Lyons C . Electrode systems for continuous monitoring in cardiovascular surgery. Ann N Y Acad Sci. 1962; 102:29-45. DOI: 10.1111/j.1749-6632.1962.tb13623.x. View

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T . Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2011; 14(4):330-7. PMC: 3317395. DOI: 10.1089/dia.2011.0170. View

. Consensus statement on self-monitoring of blood glucose. Diabetes Care. 1987; 10(1):95-9. View

Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G . Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012; 6(5):1076-86. PMC: 3570841. DOI: 10.1177/193229681200600511. View

Hasslacher C, Kulozik F, Platten I . Accuracy of self monitoring blood glucose systems in a clinical setting: application of new planned ISO- standards. Clin Lab. 2013; 59(7-8):727-33. DOI: 10.7754/clin.lab.2012.120710. View

Blonde L, Karter A . Current evidence regarding the value of self-monitored blood glucose testing. Am J Med. 2005; 118(Suppl 9A):20S-26S. DOI: 10.1016/j.amjmed.2005.07.053. View

Nathan D, Genuth S, Lachin J, Cleary P, Crofford O, Davis M . The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329(14):977-86. DOI: 10.1056/NEJM199309303291401. View

Parkes J, Slatin S, Pardo S, Ginsberg B . A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000; 23(8):1143-8. DOI: 10.2337/diacare.23.8.1143. View

10.

Hasslacher C, Kulozik F, Platten I . Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014; 8(3):466-72. PMC: 4455429. DOI: 10.1177/1932296814522804. View

11.

Polonsky W, Fisher L, Schikman C, Hinnen D, Parkin C, Jelsovsky Z . Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011; 34(2):262-7. PMC: 3024331. DOI: 10.2337/dc10-1732. View

12.

Kristensen G, Monsen G, Skeie S, Sandberg S . Standardized evaluation of nine instruments for self-monitoring of blood glucose. Diabetes Technol Ther. 2008; 10(6):467-77. DOI: 10.1089/dia.2008.0034. View

13.

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C . System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012; 6(5):1060-75. PMC: 3570840. DOI: 10.1177/193229681200600510. View

14.

Miller K, Beck R, Bergenstal R, Goland R, Haller M, McGill J . Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013; 36(7):2009-14. PMC: 3687326. DOI: 10.2337/dc12-1770. View

15.

Brazg R, Klaff L, Parkin C . Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013; 7(1):144-52. PMC: 3692226. DOI: 10.1177/193229681300700117. View

16.

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C . Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2013; 16(2):113-22. DOI: 10.1089/dia.2013.0208. View

17.

Breton M, Kovatchev B . Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diabetes Sci Technol. 2010; 4(3):562-70. PMC: 2901032. DOI: 10.1177/193229681000400309. View

18.

Sacks D, Arnold M, Bakris G, Bruns D, Horvath A, Kirkman M . Position statement executive summary: guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Diabetes Care. 2011; 34(6):1419-23. PMC: 3114347. DOI: 10.2337/dc11-9997. View

19.

Pardo S, Dunne N, Simmons D . Using Radar Plots to Demonstrate the Accuracy and Precision of 6 Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2017; 11(5):966-969. PMC: 5950999. DOI: 10.1177/1932296817713026. View

20.

. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005; 28(5):1245-9. DOI: 10.2337/diacare.28.5.1245. View