4.4 Article

Landscape of Continuous Glucose Monitoring (CGM) and Integrated CGM: Accuracy Considerations

期刊

DIABETES TECHNOLOGY & THERAPEUTICS
卷 23, 期 -, 页码 S5-S11

出版社

MARY ANN LIEBERT, INC
DOI: 10.1089/dia.2021.0236

关键词

Integrated CGM; Accuracy; MARD; FDA; Class II; Class III devices

资金

  1. Abbott Diabetes Care

向作者/读者索取更多资源

Continuous glucose monitoring devices have been significantly improved with better sensor accuracy, leading to FDA approval of nonadjunctive use. This is important for informed clinical decision-making regarding current systems' performance characteristics and regulatory classifications.
Continuous glucose monitoring devices have significantly improved in many respects compared with earlier versions. As sensor accuracy improved, U.S. Food and Drug Administration approved a nonadjunctive indication for use that no longer required confirmatory blood glucose monitoring. This article discusses the performance characteristics and regulatory classifications for the current systems that are relevant to informed clinical decision-making.

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