Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial Research Site Training Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 16
- 主要终点
- The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.
研究概览
简要总结
The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named inControl and the inControl Cloud and assess 24/7 in-home usability prior to initiating a large randomized controlled trial.
详细描述
Participation in this study will require 5 study visits over 2-4 weeks.
- Visit 1: screening/enrollment visit to assess study eligibility.
- Visit 2: continuous glucose monitor (CGM) training and initiation session based upon current or prior use of a CGM; if subject doesn't currently use a CGM, subject will be trained and may be asked to wear the CGM at home for 1 week.
- Visit 3: subjects will be taught how to use the study insulin pump.
- Visit 4: subjects will be trained on the use of inControl and wear it at home for 14 days.
- Visit 5: subjects will return study equipment and to complete questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Artificial Pancreas
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.
干预措施: Artificial Pancreas (Device)
结局指标
主要结局
The primary outcome is a qualitative assessment of the system's suitability for use in a large-scale in-home clinical trial based on the results of the Technology Acceptance questionnaire and feedback from clinical staff.
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
Stacey Anderson
Study Chair
University of Virginia