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糖尿病儿童吸入的技术层胰岛素:INHALE-1扩展研究
Roy W Beck1, Lauren Kanapka1, Roshanak Monzavi2
1JAEB Center for Health Research, Tampa, Florida, USA.
Diabetes technology & therapeutics
|February 5, 2026
概括
在INHALE-1扩展研究中发现,在52周的时间里,科技界胰岛素 (TI) 对患有糖尿病的儿童是安全的. 虽然HbA1c略有增加,但TI为儿科患者提供了一个可行的选择,特别是那些避免使用AID系统的人.
科学领域:
- 儿科内分泌学 儿科内分泌学
- 糖尿病管理 糖尿病管理
- 药理学 药理学是指药理学的学科.
背景情况:
- 在INHALE-1试验中,对患有糖尿病的儿童进行了技术层胰岛素 (TI) 的评估.
- 进行了扩展阶段,以收集TI的长期安全数据.
研究的目的:
- 评估技术层胰岛素 (TI) 在糖尿病儿科患者的长期安全性和有效性.
- 在最初的INHALE-1随机对照试验后提供扩展的安全数据.
主要方法:
- 患有1型或2型糖尿病的4-17岁儿童被随机分配给TI或快速起作用模拟剂 (RAA) 加上基础胰岛素和CGM.
- 参与者可以进入52周的延长阶段,在两组中都使用TI.
主要成果:
- 在使用TI时,没有报告严重的肺部不良事件.
- 从26周到52周,HbA1c水平略有恶化 (TI组的0.38%,RAA交叉组的0.31%)
- 在TI使用期间,持续的葡萄糖监测显示在54 mg/dL以下的时间是最小的.
结论:
- 在INHALE-1扩展阶段,儿童糖尿病患者的TI没有证实任何安全问题.
- 对于患有糖尿病的儿童来说,TI可能是一个有益的治疗选择,特别是那些无法或不愿意使用自动化胰岛素输送系统 (AID) 的儿童.
- 尽管HbA1c略有增加,但TI的安全概况和报告的患者满意度表明其有用.
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