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临床试验/NCT00923975
NCT00923975已完成不适用

Evaluation of Avatar Web Reports

Ascensia Diabetes Care2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
2
主要终点
Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks

研究概览

简要总结

The purpose of this study is to evaluate a Diabetes data management program in the hands of potential users, both lay persons and healthcare professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels.

详细描述

Diabetes data management programs upload glucose meter results to computers to provide information to lay persons and their health care professionals. With this data management system glucose results from the DIDGET TM meter can be uploaded to a secure website and used by adults with diabetes, by parents and guardians of children with diabetes, and by health care professionals to monitor diabetes by recognizing trends and patterns in blood sugar levels. During the study subjects performed specific tasks, such as uploading meter results and displaying reports. The study evaluates the subjects' success in using the software program, the program's ease of use, clarity and usefulness of user instructions, and user satisfaction with the diabetes data management program.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Lay users must be:
  • Be at least 18 years of age
  • Have diabetes or be the parent or legal guardian of a child with diabetes
  • Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
  • Be able to speak, read, and understand English
  • Have experience using a PC, navigating software programs, or browsing the internet
  • Healthcare professionals must:
  • Have experience using the internet
  • Have experience using diabetes data management software in the medical office

排除标准

  • Person working for a competitive medical device company
  • Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.

结局指标

主要结局

Number of Participants Who Rated Successful (<=3) by Healthcare Professionals When Participants Performed Specific Software Tasks

时间窗: 1-2 hours

Study staff rated participants on their success at performing specific tasks. The rating scale was: 1. = Successful ( no assistance) 2. = Successful after staff prompted to view user instructions 3. = Successful with verbal assistance or review of part of user instructions (as review a specific function during a Customer Service call) 4. = Unsuccessful (Subject could not perform the task) 5. = Subject could not perform task due to software or hardware failure after repeated attempt.

次要结局

  • Number of Participants Who Rated Ease of Performing Specific Tasks as Very Simple to Neither Simple Nor Difficult (<=3 Rating)(1-2 hours)
  • Number of Participants Who Rated Clarity and Usefulness of User Instructions as Good to Excellent (>=3)(1-2 hours)
  • Number of Participants Who Rated Their Satisfaction With The Following as Good to Excellent (>=3)(1-2 hours)

研究者

发起方
Ascensia Diabetes Care
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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