7. Diabetes Technology: Standards of Medical Care in Diabetes—2019

Position Statements

Diabetes Care 2019 Jan; 42(Supplement 1): S71-S80. https://doi.org/10.2337/dc19-S007

Article Figures & Tables

Table 7.1

Comparison of ISO 15197 and FDA blood glucose meter accuracy standards

Setting	FDA^125,126	ISO 15197-2013¹²⁷
Home use	95% within 15% for all BG in the usable BG range^†	95% within 15% for BG ≥100 mg/dL 95% within 15 mg/dL for BG <100 mg/dL 99% in A or B region of Consensus Error Grid^‡
Home use	99% within 20% for all BG in the usable BG range^†
Hospital use	95% within 12% for BG ≥75 mg/dL
	95% within 12 mg/dL for BG <75 mg/dL
	98% within 15% for BG ≥75 mg/dL
	98% within 15 mg/dL for BG <75 mg/dL

BG, blood glucose. To convert mg/dL to mmol/L, see http://www.endmemo.com/medical/unitconvert/Glucose.php.
↵†The range of BG values for which the meter has been proven accurate and will provide readings (other than low, high, or error).
↵‡Values outside of the “clinically acceptable” A and B regions are considered “outlier” readings and may be dangerous to use for therapeutic decisions¹²⁸.