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医疗服务提供者对妊娠期自动胰岛素设备的看法及临床实践中的实施考量

Provider Perspective on Automated Insulin Devices in Pregnancy and Considerations for Implementation in Clinical Practice.

作者信息

Hand Jane, Levy Carol J

机构信息

Division of Endocrinology, Diabetes, and Metabolism, Icahn School of Medicine at Mount Sinai, New York, NY, USA.

出版信息

J Diabetes Sci Technol. 2025 May 8:19322968251334397. doi: 10.1177/19322968251334397.

Abstract

Pregnancy in people with type 1 diabetes mellitus (T1D) is well-known to be linked to adverse maternal and neonatal outcomes. Although advancements in diabetes technology, especially hybrid closed-loop (HCL) and advanced hybrid closed-loop (AHCL) systems, have greatly enhanced management for nonpregnant individuals with T1D, pregnant patients still represent a high-risk group that requires further research. Existing trials have shown mixed data in terms of clinically meaningful benefits in glycemic control, but these may be specific to the closed-loop system. Currently, there is one AHCL system approved and available for use in pregnancies complicated by diabetes in the United Kingdom, Europe, and Australia. However, there are no Food and Drug Administration (FDA)-approved closed-loop systems for use during pregnancy in the United States. Existing HCL/AHCL system use is off-label for pregnancy in the United States and often requires assistive techniques to target the tighter glucose levels needed during pregnancy. For patients struggling on multiple daily injections (MDIs) or sensor-augmented pump therapy (SAPT), studies have shown that HCL/AHCLs can reduce the burden of care and enable some people to achieve tighter glucose levels. This review aims to provide an overview of the existing evidence of closed-loop systems in pregnancies complicated by T1D and to discuss their implications and considerations with system use.

摘要

1型糖尿病(T1D)患者怀孕与不良的母婴结局相关,这是众所周知的。尽管糖尿病技术取得了进展,特别是混合闭环(HCL)和高级混合闭环(AHCL)系统,极大地改善了非妊娠T1D患者的管理,但妊娠患者仍然是一个需要进一步研究的高危群体。现有试验在血糖控制的临床意义上的益处方面显示出参差不齐的数据,但这些可能特定于闭环系统。目前,在英国、欧洲和澳大利亚,有一种AHCL系统被批准用于糖尿病合并妊娠。然而,在美国没有食品药品监督管理局(FDA)批准的用于妊娠期间的闭环系统。在美国,现有的HCL/AHCL系统用于妊娠属于标签外使用,并且通常需要辅助技术来针对妊娠期间所需的更严格的血糖水平。对于在每日多次注射(MDI)或传感器增强泵治疗(SAPT)中挣扎的患者,研究表明HCL/AHCL可以减轻护理负担,并使一些人能够实现更严格的血糖水平。本综述旨在概述T1D合并妊娠中闭环系统的现有证据,并讨论其使用的影响和注意事项。

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