In this issue of Journal of Diabetes Science and Technology, Valgimigli and colleagues present promising data on the clinical accuracy of the new microdialysis-based continuous glucose monitoring device GlucoMen®Day. In this analysis, two issues are addressed: First, the established way data analyses may obscure interindividual variability in terms of a glucose monitoring system's accuracy; and second, to fully appreciate the future merits of the new system, data on accuracy, while a clearly necessary prerequisite, are not sufficient and need to be augmented by patient-reported outcome data as highlighted by recent U.S. Food and Drug Administration guidelines.
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2.
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U. S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for industry. Patient-reported outcome measures: Use in medical product development to support labeling claims. December 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
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