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临床试验/NCT02434094
NCT02434094已完成不适用

Development of a Comprehensive AP Training Curriculum for Adults

University of Virginia1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2015年4月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sue Brown

Principal Investigator

University of Virginia

研究点 (1)

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