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性能和患者对A7+TouchCare胰岛素补丁系统的满意度:一个随机对照的非劣势性研究

Coralie Amadou^1,2, Vincent Melki³, Jennifer Allain⁴

¹Service d'Endocrinologie, Diabétologie et Maladies Métaboliques, Centre Hospitalier Sud-Francilien de Corbeil-Essonnes, Corbeil-Essonnes, France.

|August 24, 2023

概括

在患有糖尿病的成年人中,A7+TouchCare胰岛素补丁的性能和患者满意度与Omnipod系统相当. 这两种系统都提供了有效的葡萄糖管理,患者对这两种设备表示满意.

科学领域:

内分泌学在内分泌学.
医疗器械医疗器械
糖尿病管理糖尿病管理

背景情况:

一种新的胰岛素补丁,A7+TouchCare (Medtrum),与已建立的Omnipod系统进行了评估.
评估表现和患者满意度是新的糖尿病管理技术的关键.

研究的目的:

为了比较A7+TouchCare胰岛素补丁与Omnipod系统的疗效和患者满意度.
为了确定两种胰岛素系统之间的葡萄糖管理中的非劣势.

主要方法:

一项多中心,随机,开放的,受控的研究,涉及100名患有1型或2型糖尿病的成年患者.
患者使用了Omnipod或A7+TouchCare3个月,主要结果是持续血糖监测 (CGM) 的葡萄糖管理指标 (GMI).

主要成果:

在GMI中证明了非劣势性,A7+TouchCare和Omnipod组之间的平均差异为0.002%.
两种胰岛素系统之间在CGM参数中没有发现显著差异.
两种系统的患者满意度都很高,尽管对特定功能 (如补丁交付和控制接口) 的偏好有所不同.

结论:

在血糖控制和患者满意度方面,A7+TouchCare胰岛素与Omnipod一样有效.
这两种胰岛素补丁系统都为糖尿病管理提供了可行的选择,用户界面偏好影响了设备选择.

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