Performance Study of the SOLO 2.0 Insulin Pump
试验速览
- 阶段
- 不适用
- 发起方
- Medingo Ltd
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Device related safety issues
研究概览
简要总结
The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment.
详细描述
This is a multi center, one arm, open label and prospective study to assess the safety and quality of the SOLO 2.0 MicroPump Insulin Delivery System, following changes that were done to the SOLO previous version which was validated in 54 subjects.
SOLO 2.0 has the same intended use and core technology as previous SOLO with addition of safety measures, GUI changes and design changes for manufacturability.
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 three month in Israel and up to six month in Austria.
The study includes 3 scheduled treatment 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.
The study includes 3 scheduled treatment visits and one scheduled telephone call
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range:
- •16 to 65 years (Graz)
- •18 to 65 years (Israel)
- •Diabetic insulin pump user with diagnosis duration of more than 6 months.
- •Subjects who are using Humalog®, NovoRapid®/NovoLog or Apidra® 100U/ml in- - 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 safety issues
时间窗: with in the first month of use
Subject complaints documented in the R\&D questionnaire and Complaint Report Forms which were assessed and found to be device related safety issues.
SOLO use errors
时间窗: within the first month of use
Use errors or potential use errors reported in Subject Diary which may be related to SOLO safety.
Device-related adverse outcome
时间窗: within the first month of use
Device-related adverse outcome, such as significant skin irritation or infection at the attachment site
次要结局
- Diabetes-related adverse outcome(with in first month of use)
- Satisfaction iwth SOLO(within the first month of use)
- Product quality (MTBF)(within the first month of use)