监管跟上现实。
Regulation Catches Up to Reality.
作者信息
Edelman Steven V
机构信息
1 University of California San Diego, San Diego, CA, USA.
出版信息
J Diabetes Sci Technol. 2017 Jan;11(1):160-164. doi: 10.1177/1932296816667749. Epub 2016 Sep 25.
Abstract
The FDA recently conducted an Advisory Panel meeting to evaluate the safety, efficacy, and benefits of granting a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system. If approved, this claim will allow users to make day-to-day treatment decisions, including insulin dosing directly from the glucose values and rate of changes arrows generated by the CGM device, without the requirement of a confirmatory measurement with a self-monitoring blood glucose (SMBG) meter. Sporadic SMBG testing gives limited data, while CGM gives a value every 5 minutes and has alerts, alarms, trending information and allows caregivers to follow the user in real time 24/7. This indication will lead to more wide spread use of CGM and improve overall care with protection of hypoglycemia.
摘要
美国食品药品监督管理局（FDA）最近召开了一次咨询小组会议，以评估授予德康G5移动连续血糖监测（CGM）系统非辅助标签声明的安全性、有效性和益处。如果获批，这一声明将允许用户做出日常治疗决策，包括直接根据CGM设备生成的血糖值和变化率箭头来调整胰岛素剂量，而无需使用自我监测血糖仪进行确认测量。偶尔进行的自我监测血糖（SMBG）测试提供的数据有限，而CGM每5分钟提供一个值，并具备警报、提醒、趋势信息，还允许护理人员全天候实时跟踪用户情况。这一适应症将促使CGM得到更广泛的应用，并通过预防低血糖来改善整体护理。
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