Table 7.

Comparisons of the accuracy requirements for blood glucose meters, as dictated by the ISO 15197:2013, and iCGM, as required by the US FDA.

	ISO 15197:2013	FDA iCGM
Overall Accuracy	≥95% within ± 15 mg/dL for glucose concentrations <100 mg/dL ≥95% within ± 15% for glucose concentrations >100 mg/dL	>87% within ± 20%
ACCURACY REQUIREMENTS BY GLUCOSE CONCENTRATION
<70 mg/dL	n/a	>85% within ± 15 mg/dL >98% within ± 40 mg/dL
70–180/dL	n/a	>70% within ± 15% >99% within ± 40%
>180 mg/dL	n/a	>80% within ± 15% >99% within ± 40%
ADDITIONAL REQUIREMENTS
	≥99% within consensus error grid zones A and B	≤1% of glucose rates of change >1 mg/dL/min if true rate of change is < −2 mg/dl/min ≤ 1% of glucose rates of change < −1 mg/dL/min if true rate of change is >2 mg/dL/min

Adapted from Freckmann et al. (56).