Abstract

This analytical comment discusses what standards are needed for the evaluation of the accuracy of glucose measurement systems continuously measuring glucose in the interstitial fluid. Since accuracy standards for continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) systems are currently based on modeling studies or consensus of experts, we raised the question whether non-inferiority trials evaluating the safety and efficacy of CGM/FGM measurements compared to capillary blood glucose measurement with point-of-care devices could help to establish clarity about the needed accuracy standards of CGM/FGM. Such trials could also support the replacement of capillary blood glucose measurements by modern CGM/FGM systems.