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提高连续血糖监测系统的临床价值和实用性:问题与建议——欧洲糖尿病研究协会与美国糖尿病协会糖尿病技术工作组联合声明。

Improving the Clinical Value and Utility of CGM Systems: Issues and Recommendations: A Joint Statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group.

机构信息

Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, U.K.

Keck School of Medicine of the University of Southern California, Los Angeles, CA.

出版信息

Diabetes Care. 2017 Dec;40(12):1614-1621. doi: 10.2337/dci17-0043. Epub 2017 Oct 25.

Abstract

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes.

摘要

最初的连续血糖监测 (CGM) 系统问世已有 15 年以上。当时许多人认为 CGM 将彻底改变糖尿病强化胰岛素治疗的应用;然而,朝着这一愿景的进展一直较为缓慢。尽管有所增加,但在世界大多数地区,每天使用 CGM 而不是传统血糖仪进行自我血糖监测的人数比例仍然很低。采用 CGM 的障碍包括费用、测量可靠性(特别是在早期一代系统中)、人为因素问题、缺乏显示结果的标准化格式以及对如何最好地使用 CGM 数据来做出治疗决策的不确定性。本科学声明就改善 CGM 设备的临床使用和监管(上市前和上市后)处理提出了建议。其目的是提高安全性和有效性,以支持该技术的进步,从而使更多糖尿病患者从中受益,提高生活质量和健康结果。

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