System accuracy evaluation of the new blood glucose monitoring meter “GLUCOCARD S onyx” beyond ISO 15197:2013/EN ISO 15197:2015 requirements and with new patient safety features

GLUCOCARD S onyx shows clinically satisfactory accuracy and reliability, even exceeding the ISO 15197:2013 criteria, for hypoglycemic cases with glucose critically low as <3.9 mmol/L (<70 mg/dL) and hyperglycemic cases with glucose ≥10.0 mmol/L (≥180 mg/dL). Healthcare organizations as well as manufacturers are aiming to offer new BGM systems that go beyond the ISO criteria and offer systems that can be consulted instead or besides CGM (Continuous Glucose Monitoring) in case of e.g. severe hypo- and/or hyperglycemic episodes. A MARD factor of 4.15% revealed an excellent system accuracy over the total clinically relevant glucose range. With additional user-friendly features, this BGM can be seen as a useful tool for efficient diabetes therapy, especially in the event of severe blood glucose fluctuations.