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孕期1型糖尿病的自动胰岛素输注:行动呼吁

Automated Insulin Delivery for Pregnancy With Type 1 Diabetes: A Call to Action

Diabetes Care · 2026 年 9 月 24 日 · T1D Pregnancy & Me Study Group*

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评论呼吁将孕妇纳入自动胰岛素输注系统临床试验,并开发适合孕期血糖目标的设备。

1型糖尿病孕妇需要强化血糖管理以达到孕期更严格的血糖目标,避免严重母婴并发症,但这些目标极难实现,给孕妇带来巨大负担和心理困扰。自动胰岛素输注(AID)已成为非孕期1型糖尿病的推荐输注方式,但孕妇被落在后面:美国食品药品监督管理局批准的AID系统并非为孕期血糖目标设计,多数未标注孕期适用;孕妇被广泛排除在临床试验之外,导致数据极其有限;此外多数设备在血糖处于胎儿最佳范围时会减少胰岛素输注。作者呼吁各方将孕妇纳入新AID技术试验,设计能满足孕期独特血糖管理需求的系统,并支持现有获批系统的真实世界研究。

为什么推荐给您:评论指出孕期人群被排除于新技术试验的伦理与公平问题,属值得关注的伦理议题。

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摘要Abstract

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Type 1 diabetes (T1D) requires intensive glycemic management in pregnancy with insulin to achieve pregnancy-specific glycemic targets and avoid serious maternal and perinatal morbidity. Glycemic targets for pregnancy, which are lower than those outside pregnancy, are extremely challenging to achieve, resulting in considerable burden and psychosocial distress for pregnant women living with T1D. While automated insulin delivery (AID) is now the recommended mode of insulin delivery for T1D, pregnant women with T1D have been left behind. AID systems approved by the U.S. Food and Drug Administration for use in the U.S. are not designed to meet pregnancy glycemic targets, and most are not labeled for pregnancy. Broad exclusion of pregnant participants from clinical trials, including those of AID systems, has resulted in extremely limited data to guide the use of these devices in pregnancy. Furthermore, for most devices insulin delivery is reduced when continuous glucose monitoring (CGM) sensor values are in the optimal range for fetal well-being. We call on stakeholders to deliver AID systems that meet the needs of pregnant women with T1D so that they can use AID at a time in life when they stand to benefit the most. Specifically, we should include pregnant women in clinical trials of new AID technologies, design AID systems that can meet the unique glycemic management challenges of pregnancy, and support real-world studies of currently approved AID systems while we await pregnancy-specific innovations.

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