Development of a Comprehensive AP Training Curriculum for Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Human factors feedback
研究概览
简要总结
An e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs).
详细描述
This project will develop and test a comprehensive, web based training system for the artificial pancreas (AP) prototype identified as eDAPT (electronic Diabetes Artificial Pancreas Training). This e-learning training program is to prepare people with diabetes and their physicians on the use of UVA's Artificial Pancreas prototype -- Diabetes Assistant (DiAs), a software platform for the development and outpatient testing of smart phone based systems for Closed Loop Control of diabetes. The e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. It will be especially important as the number of clinical sites that use DiAs continue to grow both in the United States and internationally. It is also a critical step in moving the DiAs closer to a commercial product. A validated training program is required to proceed with the Food and Drug Administration (FDA) for both pivotal clinical trials and commercial approval of the AP.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endocrinologist, Certified Diabetes Educator, Nurse Practitioner actively managing patients with type 1 diabetes on insulin pumps and continuous glucose monitoring therapy
- •Actively managing patients using insulin pumps for at least one year
- •Former & Novice Study Subjects Inclusion Criteria:
- •Have Type 1 Diabetes Mellitus as defined by American Diabetes Association criteria or judgment of physician for at least 1 year
- •No previous experience with the artificial pancreas system in a clinical trial
- •Currently using insulin pump to manage their type 1 diabetes for at least one year
- •Actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target BG and active insulin
- •Knowledge of continuous glucose monitors
- •Former Study Subjects Inclusion Criteria:
- •Previous experience with the artificial pancreas system in a clinical trial
排除标准
- 未提供
结局指标
主要结局
Human factors feedback
时间窗: 2 hours
Administration of knowledge tests and focus groups
Validated eDAPT training tool
时间窗: 2 hours
Subjects learn how to properly operate \& configure DiAs.
次要结局
未报告次要终点
研究者
Sue Brown
Principal Investigator
University of Virginia
