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
- Abbott Diabetes Care
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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