7. Diabetes Technology: Standards of Medical Care in Diabetes—2019
Article Figures & Tables
Tables
- Table 7.1
Comparison of ISO 15197 and FDA blood glucose meter accuracy standards
Setting FDA125,126 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‡
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.
- Table 7.2
Interfering substances
Glucose oxidase monitors Uric acid Galactose Xylose Acetaminophen L-dopa Ascorbic acid Glucose dehydrogenase monitors Icodextrin (used in peritoneal dialysis)