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Comparative Study
. 2017 Nov;11(6):1240-1246.
doi: 10.1177/1932296817713220. Epub 2017 Jun 6.

Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?

Guido Freckmann  1 , Annette Baumstark  1 , Stefan Pleus  1
Affiliations
Comparative Study

Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?

Guido Freckmann et al. J Diabetes Sci Technol. 2017 Nov.

Abstract

Recently, the Food and Drug Administration (FDA) published guidance documents for point-of-care testing (POCT) and over-the-counter (OTC) blood glucose monitoring systems (BGMS). These are expected to improve weaknesses of the already established ISO 15197:2013 standard accuracy evaluation for OTC BGMS; however, the proposed criteria and procedures rather raise new questions. As an example, the OTC guidance stipulates tighter accuracy criteria in the low glycemic range than the POCT guidance for no obvious reason. Furthermore, a clear definition of requirements for the reference method is missing under consideration of the strict accuracy criteria. External surveillance of BGMS after introduction to the market is an issue that is addressed neither in the FDA documents, nor in ISO 15197, but in the Clinical and Laboratory Standards Institute (CLSI) guideline POCT12-A3.

Keywords: CLSI guideline; FDA guidance; ISO 15197; POCT; SMBG; blood glucose monitoring system.

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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: GF is general manager of the IDT (Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. GF/IDT have received speakers’ honoraria or consulting fees from Abbott, Ascensia, Bayer, Berlin-Chemie, Becton-Dickinson, Dexcom, LifeScan, Menarini Diagnostics, Novo Nordisk, Roche, Sanofi, Sensile, and Ypsomed. AB and SP are employees of the IDT.

Figures

Figure 1.
Figure 1.
Accuracy limits of the four standards at glucose concentrations from 0 to 200 mg/dl.
See this image and copyright information in PMC

References

    1. Food and Drug Administration. Blood glucose monitoring test systems for prescription point-of-care use—guidance for industry and food and drug administration staff. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/.... Accessed October 10, 2016.
    1. Food and Drug Administration. Self-monitoring blood glucose test systems for over-the-counter use—guidance for industry and food and drug administration staff. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/.... Accessed October 10, 2016.
    1. Krouwer JS. Why the new FDA glucose meter POCT guidance is disappointing [published online ahead of print December 5, 2016]. J Diabetes Sci Technol. doi:10.1177/1932296816682763. - DOI - PMC - PubMed
    1. International Organization for Standardization. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2013.
    1. Clinical and Laboratory Standards Institute (CLSI). POCT12-A3—Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities. 3rd ed. Wayne, PA: Clinical and Laboratory Standards Institute; 2013.

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