NCT04810780已完成不适用
Safety and Efficacy of DUO Extended Set: Combined Glucose Sensor and Infusion Set.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primery Effectivness Endpoint
研究概览
简要总结
The study will follow subjects for 28 days while using an DUO extended infusion set combined with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult patient with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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™ 670G or 640G Insulin pump with Guardian 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
- •Subject has Glycosylated hemoglobin (HbA1c) > 10 % at time of screening.
结局指标
主要结局
Primery Effectivness Endpoint
时间窗: 28 days
Precent of catheters reaching 7- day without set failure.
次要结局
未报告次要终点
研究者
Prof. Amir Tirosh
Director, Division of Endocrinology
Sheba Medical Center
研究点 (1)
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