title: How Much Accuracy of Interstitial Glucose Measurement Is Enough? Is There a Need for New Evidence?
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.
authors.affiliation: 1 Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|2 Diabetes Center Mergentheim, Bad Mergentheim, Germany.|3 Institute of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.
authors.forename: Norbert
authors.initials: N
authors.lastname: Hermanns
authors.affiliation: 1 Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|3 Institute of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.
authors.forename: Dominic
authors.initials: D
authors.lastname: Ehrmann
authors.affiliation: 1 Research Institute of the Diabetes Academy Mergentheim (FIDAM), Bad Mergentheim, Germany.|2 Diabetes Center Mergentheim, Bad Mergentheim, Germany.|3 Institute of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Kulzer
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods*; D045604:Extracellular Fluid / Q000737:chemistry*; D005947:Glucose / Q000032:analysis*; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods; D000067716:Point-of-Care Testing
chemical_list: D001786:Blood Glucose; D005947:Glucose
keywords: accuracy standards of continuous glucose monitoring systems; blood glucose monitoring; continuous glucose monitoring; flash glucose monitoring