NCT07408141已完成不适用
Minimed Fit Payload Wear Study
Medtronic MiniMed, Inc.4 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2026年2月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 4
- 主要终点
- The MiniMed Fit Payload success rate at the end of Day 5.
研究概览
简要总结
The purpose of this study is to assess success/failure of the MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with insulin- requiring diabetes
- •Subjects 18 years of age or older
- •Subjects able and willing to sign informed consent
排除标准
- •Subjects who report known skin sensitivity or allergy to pressure-sensitive adhesives, e.g, medical device adhesives, band-aids, other acrylic-containing adhesives
- •Subjects with any skin condition in the area where device placement (e.g., irritation, rash, infection) could occur, per subject report.
- •Subjects who are pregnant (per self-report) at initial screening. If a subject becomes pregnant during the study, the site will follow procedures for study withdrawal.
研究组 & 干预措施
MiniMed Fit Payload adhesive components
Adult participants with insulin-requiring diabetes using the MiniMed Fit Payload adhesive components in different wear locations over a 7-day period.
干预措施: MiniMed Fit Payload adhesive components (Device)
结局指标
主要结局
The MiniMed Fit Payload success rate at the end of Day 5.
时间窗: 5 Days
The number of MiniMed Fit Payload that meet the success criteria divided by the total number of MiniMed Fit Payload devices applied at the end of Day 5.
次要结局
- The MiniMed Fit Payload success rate at the end of Day 7.(7 Days)
研究者
研究点 (4)
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