Comparison of sensor glucose measurements with point-of-care glucose values and blood glucose values
Criteria | Blood glucose | Point of care | |
MARD | % difference between SG and reference (SG-reference)/reference × 100 | 11.2% | 9.7% |
ISO2003* | 84% | 90% | |
ISO2013† | 73% | 78% |
ISO2003, ISO2013.22 23
CGM systems have previously been reported to show MARD results between 10% and 20% in adults and paediatrics.
*System accuracy standards of 2003 (ISO: 15197:2003) states that 95% of blood glucose results should be within ±0.83 mmol/L of laboratory results at concentrations <4.2 mmol/L or within ±20% of laboratory results at concentrations of >4.2 mmol/L.
†System accuracy standards 2013 (ISO: 15197:2013) require that 95% of blood glucose results should be within ±0.83 mmol/L of laboratory results at concentrations of <5.6 mmol/L or within ±20% of laboratory results at concentrations of ≤5.6 mmol/L.
CGM, continuous glucose monitoring; MARD, mean absolute relative difference; SG, sensor glucose.