NCT01775059Unknown不适用
Collection of Performance Data From the Integrated Sensor and Infusion Set. TRIAL 4
Medtronic Diabetes R&D Denmark3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Accuracy endpoint
研究概览
简要总结
This is a multi-center, non-randomized, and interventional study in which subjects will use the Integrated sensor and infusion set with MiniLink Transmitter and the Medtronic Paradigm® VEO™ insulin pump (Sensor augmented pump) for 15 days.
The purpose of this study is to collect performance data on the Integrated sensor and infusion set for approximately 15 days, with the intention for each subject to wear 5 sets for 3 days each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is 18 years of age or older at time of screening
- •Subject has a clinical diagnosis of insulin requiring diabetes, as determined by investigator.
- •Subject is currently using a Medtronic Paradigm Sensor Augmented insulin pump and has been so for a minimum of 3 months at time of enrollment.
- •Subject has Continuous Glucose Monitoring experience (min 30% of CGM use within the month prior to enrollment).
- •Subject has an average of 3 SMBG per day (verified via CareLink) during the month prior to enrollment.
- •Subject is willing to wear the study devices for the duration of the study
- •Subject is willing to perform frequent (min 7 per day) SMBGs during study device wear
- •Subject is willing to keep a short diary during the device wear.
排除标准
- •Female subject is pregnant, per urine pregnancy test performed at time of enrollment in women of child bearing age.
- •Female subject plans to become pregnant during the course of the study.
- •Subject is unable to tolerate tape adhesive in the area of the placement of the study device.
- •Subject has any unresolved adverse skin condition in the area of the placement of the study device (e.g. psoriasis, rash, Staphylococcus infection).
- •The subject is not deemed to be an appropriate candidate for the study by the investigator for any reason.
研究组 & 干预措施
Integrated sensor and infusion set.
Experimental
干预措施: Integrated sensor and infusion set. (Device)
结局指标
主要结局
Accuracy endpoint
时间窗: 5 months
Agreement Rate (% within 20%) using VEO Pump
Safety endpoint
时间窗: 5 months
Descriptive summary of SAE, Adverse events and Device complaints
次要结局
- Accuracy endpoint(5 months)
研究者
研究点 (3)
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