INHALE-1:在患有1型糖尿病的儿童中进行了多中心随机试验,对吸入的技术层胰岛素进行了随机试验
Michael J Haller1, Lauren Kanapka2, Roshanak Monzavi3
1Department of Pediatrics, University of Florida, Gainesville, FL.
Diabetes care
|November 12, 2025
概括
吸入的技术层胰岛素 (TI) 在患有糖尿病的儿童中没有满足HbA1c的非劣质性. 然而,与快速起作用的模拟胰岛素相比,TI是安全的,改善了治疗满意度,减少了体重增加.
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:
- 1型糖尿病是一种慢性疾病,需要终身胰岛素治疗.
- 优化胰岛素输送方法对于改善血糖控制和患者生活质量至关重要.
- 吸入胰岛素为可注射胰岛素配方提供了潜在的替代方案.
研究的目的:
- 评估吸入技术圈胰岛素 (TI) 与快速起作用模拟胰岛素 (RAA) 的疗效和安全性,用于糖尿病儿科患者.
- 评估TI对血糖控制的影响,特别是HbA1c水平和范围内的时间 (TIR).
- 确定TI的安全性,包括肺功能和不良事件.
主要方法:
- 一项随机对照试验,涉及230名患有1型糖尿病的年轻人 (4-17岁).
- 参与者被分配给接受TI或RAA胰岛素26周,与基础胰岛素和持续血糖监测 (CGM) 一起.
- 主要结局是HbA1c的变化,对0.4%的差距进行非劣质性测试.
主要成果:
- 主要分析没有实现TI和RAA组之间的HbA1c变化非劣质性 (P = 0.091).
- 在CGM测量的时间范围 (70-180 mg/dL) 中,两组之间没有显著差异 (P = 0.38).
- 试管婴儿组报告了更高的治疗满意度 (P = 0.004),并经历了更少的体重和BMI百分比增长 (P = 0.009).
结论:
- 在患有糖尿病的儿科患者中,吸入的技术圈胰岛素不符合HbA1c的非劣质性标准.
- 在26周的时间里,TI表现出良好的安全性,没有对肺功能产生不良影响.
- 对于一些患有1型糖尿病的儿科患者来说,TI提供了一个潜在的有价值的治疗选择,提高了他们的满意度并减轻了体重增加.
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