Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Comment
. 2019 May;13(3):559-560.
doi: 10.1177/1932296818803113. Epub 2018 Oct 17.

Why the Details of Glucose Meter Evaluations Matters

Affiliations
Comment

Why the Details of Glucose Meter Evaluations Matters

Jan S Krouwer. J Diabetes Sci Technol. 2019 May.

Abstract

In an article in the Journal of Diabetes Science and Technology, Macleod and coworkers describe an evaluation of LifeScan glucose meters that focus on the effects of sample types and comparison methods. They make a valid point that these factors influence the accuracy observed in evaluations and recommend the comparison method be the one recommended by the manufacturer for the sample type in the intended use statement. Yet, the recommended comparison method is not a reference method. The accuracy hierarchy of definitive, reference, and field methods originally described by Tietz should remind one that virtually all glucose meter evaluations use commercially available field methods as the comparison method. Finally, one should not neglect the FDA adverse event database as a way to assess glucose meter performance.

Keywords: MAUDE; YSI; definitive method; evaluation; glucose meter; reference method.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Comment on

References

    1. Macleod K, Katz LB, Cameron H. Capillary and venous blood glucose accuracy in blood glucose meters versus reference standards: the impact of study design on accuracy evaluations [published online ahead of print August 7, 2018]. J Diabetes Sci Technol. doi:10.1177/1932296818790228. - DOI - PMC - PubMed
    1. Tietz NW. A model for a comprehensive measurement system in clinical chemistry. Clin Chem. 1979;25:833-839. - PubMed
    1. BIPM, IEC, IFCC, ILAC, IUPAC, IUPAP, ISO, OIML. The International Vocabulary of Metrology—Basic and General Concepts and Associated Terms (VIM). 3rd ed. Joint Committee for Guides in Metrology; 2012. https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf. Accessed August 27, 2018.
    1. US Department of Health, Education, and Welfare, Food and Drug Administration. In vitro diagnostic products for human use, proposed establishment of product class standards for detection or measurement of glucose. Fed Regist. 1974;39:24136-24147. https://cdn.loc.gov/service/ll/fedreg/fr039/fr039126/fr039126.pdf. Accessed August 27, 2018.
    1. Skeie S, Thue G, Nerhus K, Sandberg S. Instruments for self-monitoring of blood glucose: comparisons of testing quality achieved by patients and a technician. Clin Chem. 2002;48:994-1003. - PubMed