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
Review
. 2015 Jul;9(4):895-910.
doi: 10.1177/1932296815584797. Epub 2015 Jun 8.

Performance of Cleared Blood Glucose Monitors

David C Klonoff  1 , Priya Prahalad  2
Affiliations
Review

Performance of Cleared Blood Glucose Monitors

David C Klonoff et al. J Diabetes Sci Technol. 2015 Jul.

Abstract

Cleared blood glucose monitor (BGM) systems do not always perform as accurately for users as they did to become cleared. We performed a literature review of recent publications between 2010 and 2014 that present data about the frequency of inaccurate performance using ISO 15197 2003 and ISO 15197 2013 as target standards. We performed an additional literature review of publications that present data about the clinical and economic risks of inaccurate BGMs for making treatment decisions or calibrating continuous glucose monitors (CGMs). We found 11 publications describing performance of 98 unique BGM systems. 53 of these 98 (54%) systems met ISO 15197 2003 and 31 of the 98 (32%) tested systems met ISO 15197 2013 analytical accuracy standards in all studies in which they were evaluated. Of the tested systems, 33 were identified by us as FDA-cleared. Among these FDA-cleared BGM systems, 24 out of 32 (75%) met ISO 15197 2003 and 15 out of 31 (48.3%) met ISO 15197 2013 in all studies in which they were evaluated. Among the non-FDA-cleared BGM systems, 29 of 65 (45%) met ISO 15197 2003 and 15 out of 65 (23%) met ISO 15197 2013 in all studies in which they were evaluated. It is more likely that an FDA-cleared BGM system, compared to a non-FDA-cleared BGM system, will perform according to ISO 15197 2003 (χ(2) = 6.2, df = 3, P = 0.04) and ISO 15197 2013 (χ(2) = 11.4, df = 3, P = 0.003). We identified 7 articles about clinical risks and 3 articles about economic risks of inaccurate BGMs. We conclude that a significant proportion of cleared BGMs do not perform at the level for which they were cleared or according to international standards of accuracy. Such poor performance leads to adverse clinical and economic consequences.

Keywords: BG monitor; FDA; ISO; accuracy; glucose; performance.

PubMed Disclaimer

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DCK is a consultant for Google, Insuline, Lifecare, Novartis, Roche, Sanofi, Tempramed, and Voluntis. He is also a stockholder in Tempramed. PP has no disclosures.

References

    1. Endocrine Today. Poor performance of blood glucose monitors prompts call to action. October 1, 2013. http://www.healio.com/endocrinology/diabetes/news/print/endocrine-today/.... Accessed April 8, 2015.
    1. PR Newswire. Diabetes Hands Foundation commends the Diabetes Technology Society (DTS), Food and Drug Administration (FDA) for first steps to protect diabetes patients. http://www.prnewswire.com/news-releases/diabetes-hands-foundation-commen.... Accessed April 8, 2015.
    1. Schnell O, Hinzmann R, Kulzer B, et al. Assessing the analytical performance of systems for self-monitoring of blood glucose: concepts of performance evaluation and definition of metrological key terms. J Diabetes Sci Technol. 2013;7(6):1585-1594. - PMC - PubMed
    1. Klonoff DC. The Food and Drug Administration is now preparing to establish tighter performance requirements for blood glucose monitors. J Diabetes Sci Technol. 2010;4(3):499-504. - PMC - PubMed
    1. US Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use: draft guidance for industry and Food and Drug Administration staff. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/.... Accessed April 8, 2014.