Recommendations on the Collection of Comparator Measurement Data in the Performance Evaluation of Continuous Glucose Monitoring Systems.

While current systems for continuous glucose monitoring (CGM) are safe and effective, there is a high degree of variability between readings within and across CGM systems. In current CGM performance studies, device readings are compared with glucose concentrations obtained with a comparator ("reference") measurement procedure (usually capillary or venous glucose). However, glucose concentrations from capillary and venous samples can systematically differ, often by as much as 5 to 10%. Different comparator methods have shown biases of up to 8%, and comparator devices of the same brand can systematically differ by more than 5%. To address these issues, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC WG-CGM) recommends standardizing study procedures and the comparator measurement process in CGM performance studies. The majority of IFCC WG-CGM members recommend the use of capillary samples as reference, mainly because CGM readings will then be aligned better with results from self-monitoring of blood glucose (SMBG). Even with factory-calibrated CGM systems, manufacturers require CGM users to perform SMBG in some situations, eg, manual calibration, confirmation of extreme readings, discordance between CGM readings and symptoms of hyper- or hypoglycemia, or intermittent signal loss. Comparator devices should meet defined analytical performance specifications for bias and imprecision. Comparator bias can be reduced by retrospective correction of comparator values based on measurements with a method or materials of higher metrological order. Once manufacturers align CGM readings of their systems with comparator results using standardized procedures, variability across CGM systems will be reduced.