Feasibility Study of the Solo™ Insulin Pump
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Medingo Ltd
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Device-related adverse outcome
研究概览
简要总结
The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.
详细描述
This is a multi center, one arm, open label and prospective study to assess the safety and usability of the Solo™ MicroPump Insulin Delivery System .
The study will include a 30 days treatment period with the Solo MicroPump with no special care required for maintaining glycemic control and with an optional extension period of up to six month.
The study will consist of up to 5 visits and one follow up phone call one week after termination of the study. In case of participating the extension period, additional visits will consist once a month.
Visit 1 includes eligibility, baseline evaluation and training in handling of the Solo™ System. If no additional practice is required patients will be enrolled. Visit 2 will commence and Solo pump will be filled with insulin. If additional practice is required subject will be sent home for an additional training period of a few days practice using saline and then return for visit 2.
Treatment visits will take place at 3, 14 and 30 days after the enrolment. Additional visits will take place at 60, 90 and 180 days depending on the extension period.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of:
- •18 to 60 years in Israel
- •16 to 60 years in Austria
- •Type I diabetes and pump treatment duration of more than 6 months.
- •Subjects who are using Humalog®, NovoRapid®, and Apidra® 100U/ml insulin
- •Measures glucose at least four times per day.
- •No more than one severe hypoglycemic or ketoacidosis episode within one year
- •Willing to sign an informed consent.
- •Cooperative, willing to attend all study visits.
排除标准
- •A1c >= 10.0%
- •Two or more documented events of severe hypoglycemia within the previous 12 months
- •Diabetes related hospitalization over the past 12 months
- •Current significant diabetes-related complications
- •Pregnant, lactating or planning to become pregnant during the course of the study
- •Substance or alcohol abuse
- •Uncontrolled hypertension
- •Known dermal hypersensitivity to medical adhesive
- •Recurrent episodes of skin infections or dermatological allergies
- •Serious or unstable medical or psychological conditions
- •Current participation in other clinical studies.
- •Working for a competitor company
结局指标
主要结局
Device-related adverse outcome
时间窗: During treatment period
次要结局
- Mechanical dysfunction and diabetes-related adverse outcome(During treatment period)