一项试点随机对照并行手臂试验,评估与澳大利亚1型糖尿病成年人常规护理相比,Omnipod DASH®胰岛素管理系统的治疗满意度:理由,研究设计和方法
Yee Wen Kong1,2,3, Cheng Yi Yuan1,2,3, Katerina Kiburg1,2
1Diabetes Technology Research Group, The University of Melbourne, Melbourne, VIC, Australia.
Pilot and feasibility studies
|October 9, 2023
概括
本试点研究评估了Omnipod DASH胰岛素补丁系统在澳大利亚1型糖尿病成年人的可行性和用户接受度. 这些发现将为更大规模的补丁治疗试验提供信息.
科学领域:
- 糖尿病 技术 技术
- 内分泌学 在内分泌学.
- 临床试验 临床试验
背景情况:
- 胰岛素疗法 (IPT) 通过每天多次注射 (MDI) 改善了1型糖尿病 (T1D) 的葡萄糖控制.
- 传统的胰岛素有其局限性,包括尺寸,绑定的输液套,以及淋浴等活动的断开要求,影响用户接受.
- 奥姆尼波德DASH胰岛素管理系统是一个无线控制的无管,防水补丁,提供了一个潜在的更可接受的替代方案.
研究的目的:
- 评估胰岛素补丁治疗的可行性和可接受性,与澳大利亚成年T1D患者的通常护理相比.
- 收集数据,为更大规模的多站点随机对照研究提供设计和功率计算的信息.
- 评估用户对补丁技术作为传统胰岛素输送方法的替代品的看法.
主要方法:
- 一项试点多站点并行随机受控研究,涉及64名T1D成年人.
- 参与者被随机分配到Omnipod DASH系统或他们通常的护理12周,然后使用Omnipod DASH系统进行12周的延长阶段.
- 通过研究完成率 (目标≥0.80) 确定可行性,并使用糖尿病技术问卷 (DTQ-current) 评分来衡量可接受性.
主要成果:
- 该研究旨在根据完成率确定可行性,目标为0.80.
- 通过将随机化后12周的DTQ当前得分与基线进行比较来评估可接受性.
- 二次结果包括其他用户接受度,流程,资源,以参与者为中心,医疗保健专业人员和血糖结果.
结论:
- 这项试点研究预计将提供初步见解,了解研究设计的可行性,用于补丁治疗研究.
- 它将产生关于澳大利亚成年T1D患者接受胰岛素贴片技术的首批数据.
- 结果将指导开发一项更大规模的研究,调查贴片对T1D患者主观结果的影响,这对T1D患者至关重要.
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