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. 2021 Sep;23(S3):S5-S11.
doi: 10.1089/dia.2021.0236.

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

Timothy S Bailey  1 , Shridhara Alva  2
Affiliations

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

Timothy S Bailey et al. Diabetes Technol Ther. 2021 Sep.

Abstract

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.

Keywords: Accuracy; Class II; Class III devices; FDA; Integrated CGM; MARD.

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