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在 COVID-19 大流行期间使用和准确性的住院患者连续血糖监测:普通内科和 ICU 患者的观察性研究。

Use and Accuracy of Inpatient CGM During the COVID-19 Pandemic: An Observational Study of General Medicine and ICU Patients.

机构信息

Lahey Hospital and Medical Center, Burlington, MA, USA.

Weill Cornell Medicine, New York, NY, USA.

出版信息

J Diabetes Sci Technol. 2022 Sep;16(5):1136-1143. doi: 10.1177/19322968211008446. Epub 2021 May 10.

Abstract

BACKGROUND

Continuous glucose monitoring (CGM) is widely used in the outpatient setting for people with diabetes and has been limited to investigational use only for the inpatient population. In April 2020, the US FDA exercised enforcement discretion for the temporary use of inpatient CGM during the pandemic, thus hospitals were presented the opportunity to implement this technology.

METHODS

We sought to investigate the accuracy of CGM in hospitalized patients on general care floors and the intensive care unit (ICU) in attempts to decrease healthcare professional exposure to COVID-19 and ultimately improve glycemic management of patients affected by COVID-19. Point of care (POC) and laboratory (Lab) glucose values were matched with simultaneous CGM glucose values and measures of accuracy were performed to evaluate the safety and usability of CGM in this population. Our data are presented drawing a distinction between POC and Lab as reference glucose sources.

RESULTS

In 808 paired samples obtained from 28 patients (10 ICU, 18 general floor), overall mean absolute relative difference (MARD) for all patients using either POC or Lab as reference was 13.2%. When using POC as the reference glucose MARD was 13.9% and using Lab glucose as reference 10.9%. Using both POC and Lab reference glucose pairs the overall MARD for critical care patients was 12.1% and for general floor patients 14%.

CONCLUSION

We determined, with proper protocols and safeguards in place, use of CGM in the hospitalized patient is a reasonable alternative to standard of care to achieve the goal of reducing healthcare professional exposure. Further study is necessary to validate safety, accuracy, and efficacy of this technology. Investigation and analysis are necessary for the development of protocols to utilize CGM trend arrows, alerts, and alarms.

摘要

背景

连续血糖监测(CGM)在糖尿病患者的门诊环境中被广泛应用,仅限于住院患者的研究使用。2020 年 4 月,美国食品药品监督管理局(FDA)在大流行期间对住院患者 CGM 的临时使用行使了执法自由裁量权,从而为医院提供了实施这项技术的机会。

方法

我们试图研究 CGM 在普通病房和重症监护病房(ICU)住院患者中的准确性,以减少医护人员接触 COVID-19 的风险,并最终改善 COVID-19 患者的血糖管理。通过比较即时血糖值(POC)和实验室血糖值(Lab)与同时进行的 CGM 血糖值,我们评估了 CGM 在该人群中的安全性和可用性,并进行了准确性评估。我们的数据通过区分 POC 和 Lab 作为参考血糖来源来呈现。

结果

在从 28 名患者(10 名 ICU,18 名普通病房)中获得的 808 对配对样本中,所有患者的总体平均绝对相对差异(MARD),无论使用 POC 还是 Lab 作为参考,均为 13.2%。当使用 POC 作为参考血糖时,MARD 为 13.9%,而使用 Lab 血糖作为参考时,MARD 为 10.9%。使用 POC 和 Lab 参考血糖对的 ICU 患者总体 MARD 为 12.1%,普通病房患者为 14%。

结论

我们确定,在适当的协议和保障措施到位的情况下,在住院患者中使用 CGM 是实现减少医护人员接触目标的合理替代方案。需要进一步研究以验证该技术的安全性、准确性和有效性。有必要对 CGM 趋势箭头、警报和报警的使用协议进行调查和分析。

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