Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting
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 Rated Successful (<=3) at Performing Specific Tasks
研究概览
简要总结
The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.
详细描述
Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.
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
- 否
入选标准
- •Lay users must:
- •Be at least 18 years of age (at least 80% must be 55 years or less)
- •Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home
- •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 PC programs or browsing the internet
- •Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software
- •Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software
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 Rated Successful (<=3) at Performing Specific Tasks
时间窗: 1-2 hours
Study staff rated participants on their success at perfoming specific tasks. The rating scale was: 1. = Successful 2. = Successful after being referred to user instructions 3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) 5. = Problem encountered with software
次要结局
- Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3(1-2 hours)
- Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3(1-2 hours)