7. Diabetes Technology: Standards of Medical Care in Diabetes—2021

Standards of Care

Diabetes Care 2021 Jan; 44(Supplement 1): S85-S99. https://doi.org/10.2337/dc21-S007

Article Figures & Tables

Table 7.1

Comparison of ISO 15197:2013 and FDA blood glucose meter accuracy standards

Setting	FDA (206,207)	ISO 15197:2013 (208)
Home use	95% within 15% for all BG in the usable BG range^†	95% within 15% for BG ≥100 mg/dL
Home use	99% within 20% for all BG in the usable BG range^†	95% within 15 mg/dL for BG <100 mg/dL
Hospital use	95% within 12% for BG ≥75 mg/dL	99% in A or B region of consensus error grid^‡
	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; FDA, U.S. Food and Drug Administration; ISO, International Organization for Standardization. To convert mg/dL to mmol/L, see http://endmemo.com/medical/unitconvert/Glucose.php.
↵† The range of blood glucose 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 decisions (209).

Table 7.3

Continuous glucose monitoring (CGM) devices

Type of CGM	Description
Real-time CGM (rtCGM)	CGM systems that measure and display glucose levels continuously
Intermittently scanned CGM (isCGM)	CGM systems that measure glucose levels continuously but only display glucose values when swiped by a reader or a smartphone
Professional CGM	CGM devices that are placed on the patient in the provider’s office (or with remote instruction) and worn for a discrete period of time (generally 7–14 days). Data may be blinded or visible to the person wearing the device. The data are used to assess glycemic patterns and trends. These devices are not fully owned by the patient—they are a clinic-based device, as opposed to the patient-owned rtCGM/isCGM devices.