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. 2010 Sep 1;4(5):1265-8.
doi: 10.1177/193229681000400528.

We need tighter regulatory standards for blood glucose monitoring, but they should be for accuracy disclosure

Barry H Ginsberg  1
Affiliations

We need tighter regulatory standards for blood glucose monitoring, but they should be for accuracy disclosure

Barry H Ginsberg. J Diabetes Sci Technol. .

Abstract

Regulatory interest has focused on the accuracy of blood glucose monitoring systems. Currently, almost all systems meet the International Organization for Standardization (ISO) 15197 clinical standard (≥95% of the values within 20% of the reference for values above 75 mg/dl and within 15 mg/dl below that level). Should the systems have to meet one of the extended ISO standards of 15%, 10%, or even 5%? There is a wide variety of people with diabetes doing glucose monitoring, and the majority do not need better accuracy. Indeed, when selecting an insulin dose, the inaccuracy of the glucose reading has little effect compared with the inaccuracy in counting carbohydrates and the variability in insulin absorption. It might be far better to evaluate the accuracy in a standard method and provide the accuracy values on a standard label. Patients and health care providers could then select the monitoring system that best meets their needs.

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Figures

Figure 1.
Figure 1.
The extended ISO 15197 standard. The 20% standard is shown in orange, the 15% in yellow, the 10% in light green, and the 5% in dark green.
Figure 2.
Figure 2.
Documented outliers. In this illustration of clinical data, about 0.1% of the values had serious errors.
See this image and copyright information in PMC

References

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    1. International Organization for Standardization In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197:2003. http://www.iso.org/iso/catalogue_detail.htm?csnumber=26309

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