System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards

Comment

Maria Teodorczyk et al. J Diabetes Sci Technol. 2013.

. 2013 May 1;7(3):795-7.

doi: 10.1177/193229681300700325.

No abstract available

Comment in

In response to Teodorczyk and coauthors: System accuracy of blood glucose monitoring devices according to the current and proposed ISO 15197 standards.
Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. Freckmann G, et al. J Diabetes Sci Technol. 2013 Nov 1;7(6):1659-60. doi: 10.1177/193229681300700632. J Diabetes Sci Technol. 2013. PMID: 24351198 Free PMC article. No abstract available.

System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197.
Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. Freckmann G, et al. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. doi: 10.1177/193229681200600510. J Diabetes Sci Technol. 2012. PMID: 23063032 Free PMC article.
Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197.
Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Baumstark A, et al. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. J Diabetes Sci Technol. 2012. PMID: 23063033 Free PMC article.

1. Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy 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):1060–1075. - PMC - PubMed
1. 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):1076–1086. - PMC - PubMed
1. International Organization for Standardization (ISO). In vitro diagnostic test systems – requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. DIN EN ISO 15197:2003E.
1. International Organization for Standardization (ISO). In vitro diagnostic test systems – requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. (Draft.) ISO/DIS 15197:2012.
1. Bailey T, Chang A, Rosenblit PD, Jones L, Teft G, Setford S, Mahoney J. A comprehensive evaluation of the performance of the test strip technology for OneTouch Verio glucose meter systems. Diabetes Technol Ther. 2012;14(8):701–709. - PubMed