NCT07675161已完成不适用
CIP361: MiniMed Fit Payload Wear Pediatric Study
Medtronic MiniMed, Inc.10 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2026年6月25日最近更新:
适应症
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
- 59
- 试验地点
- 10
- 主要终点
- Summary of device survival
研究概览
简要总结
The purpose of this study is to assess MiniMed Fit Payload adhesive components in different wear locations over a 7-day period to support development of the future commercialized patch pump in participants 7-17 years of age.
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
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with insulin-requiring diabetes
- •Participants 7-17 years of age
- •Participant and parent/guardian/legally authorized representative are able and willing to sign informed consent/assent
排除标准
- •Participants who report known skin sensitivity or allergy to polycarbonate or pressure-sensitive adhesives, e.g., medical device adhesives, band-aids, other acrylic-containing adhesives.
- •Participants with any skin condition in the area where device placement (e.g., irritation, rash, infection) could occur, per participant report.
- •Participants who are pregnant (per self-report) at initial screening. If a participant 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
Pediatric 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
Summary of device survival
时间窗: 7 Days
The number of MiniMed Fit Payload that remain securely attached to the skin at the end of day 7. This is a descriptive endpoint.
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
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