AMCR Institute, Escondido, California, USA.
Abbott Diabetes Care, Alameda, California.
Diabetes Technol Ther. 2021 Sep;23(S3):S5-S11. doi: 10.1089/dia.2021.0236.
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 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.
与早期版本相比,连续血糖监测设备在许多方面都有了显著的改进。随着传感器准确性的提高,美国食品和药物管理局批准了一种新的适应证,不再需要确认性血糖监测。本文讨论了与知情临床决策相关的当前系统的性能特征和监管分类。