Accu-Chek® Insight Insulin Pump EU Study: A European Multicenter Study to Evaluate the Accu-Chek® Insight Insulin Pump in Routine Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).
研究概览
简要总结
Accu-Chek® Insight Insulin Pump EU Study is a Multicenter Study to evaluate the Accu-Chek® Insight Insulin Pump in routine practice. This is an open-label, prospective, multinational, multicenter study evaluating the CSII therapy with the Accu-Chek Insight Insulin pump in routine practice in adult subjects with Type 1 or type 2 diabetes. Subjects must have been on intensive insulin therapy for at least six months i.e. either on CSII or MDI. All subjects will receive training in the preparation, programming and daily use of the Accu-Chek Insight Insulin pump. In addition, subjects previously on MDI may receive more training in order to be comfortable with the use of an insulin pump. The study will be conducted in 10-12 sites in Austria, France and the United Kingdom. A total of 80-95 subjects will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Male or female at least 18 years old
- •Diagnosed at least for 12 months with Type 1 or 2 Diabetes requiring insulin therapy
- •Intensive insulin therapy by MDI or CSII at least 6 months
- •Willing to self monitor blood glucose 4 times daily
排除标准
- •Significantly impaired awareness of hypoglycemia
- •Unstable chronic disease other than diabetes
- •Acute illness or inability to recognize pump signals or alarms as determined by the investigator
- •Pregnancy
结局指标
主要结局
The primary objective is to evaluate the Accu-Chek Insight Insulin Pump and associated pump devices in routine practice. This will be expressed by the rate of error messages per 100 patient years (confirmed by pump uploads).
时间窗: 6 months
次要结局
- Evaluate type and frequency of adverse events (serious/non-serious) possibly related or related to study devices and/or study procedures(6 months)
- Evaluate change in HbA1c from screening to month 3 and 6(3 weeks screening plus 6 months treatment period)
- Evaluate type and frequency of pump signals, i.e. reminders, errors, warnings, alarms, maintenance messages(6 months)
- Evaluate utilization of pump functions (e.g. basal rate profiles, temporary basal rates, bolus types)(6 months)
- Evaluate change in CGM-derived parameters from month 3 to month 6(6 months)
- Evaluate subject satisfaction based on surveys of important factors of health-related quality of life(6 months)