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临床试验/NCT07408141
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

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

发起方
Medtronic MiniMed, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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