Safety and Efficacy of 7-day Wear Infusion Set vs. Control Infusion Set.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary
研究概览
简要总结
The purpose of this study is to evaluate the Extended Wear (EW) infusion set seven day functioning in patients with Type 1 diabetes compared to the Quick-set infusion set. The study will be carried out in adults with type 1 diabetes.
详细描述
This is a 1-center, prospective, open label randomized, crossover controlled study.
40 patients will be using 4 infusion sets (a total of 160 sets) that will serve as an exploratory pilot study to assess the SD of 7 day use for future study design.
Eligible patients meeting the enrollment and randomization criteria will be randomized into 2 arms, each arm will undergo 2 phases. In each phase a different type of infusion set will be evaluated. Each evaluation will be for4 sets (up to 28 days). The order will be determined by the randomization process:
- Arm 1: Quick-EWIS. First phase Quickset, second phase EWIS.
- Arm 2: EWIS-Quick. First phase EWIS, second phase Quickset.
Following screening and informed consenting to the trial, a randomized procedure will define the subject trial arm:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes for at least one year
- •Using a MiniMed™ VEO pump or 640G Insulin pump with or without using an Enlite™ Sensor .
- •Age 18 to 80 years
- •Hemoglobin A1c level less than or equal to 10%
- •Not currently known to be pregnant, nor planning pregnancy during the study.
- •Willingness to follow the protocol and sign the informed consent
排除标准
- •A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- •Pregnant or lactating females
结局指标
主要结局
Primary
时间窗: 8 weeks
• Percent of catheters reaching 4, 5, 6, 7 days use without set failure.
次要结局
- Exploratory outcomes(8 weeks)
研究者
Dr. Jacob Ilany MD
M.D.
Sheba Medical Center