Human Factors and Home Use Study of the Vigilant Diabetes Management Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale)
研究概览
简要总结
A human factors and home use study to assess whether subjects with diabetes and their caregivers can understand feedback received from the Vigilant Diabetes Management Application about their blood glucose patterns and whether the decisions made in response to device feedback are made in accordance with the intended use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with diabetes mellitus testing blood glucose 3 or more times per day
- •Clinicians who see diabetes patients
排除标准
- •Admission for diabetic ketoacidosis in the 6 months prior to enrollment
- •A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol
- •Patients who are not willing to share their glucose meter data, or do not perform the tasks asked of them and follow instructions for the study will be excluded
- •Pregnancy
结局指标
主要结局
Adequate understanding of algorithmic feedback based on surveyed responses (Measure: units on a scale)
时间窗: 1 month home use
An exit questionnaire will survey participants about comprehension of algorithmic feedback. Across all 5-point rating scales, the average rating will be determined.
Successful completion of frequent and risk-related tasks (Measure: Percent of tasks successfully completed)
时间窗: Controlled in-office testing for up to 2 hours
Percent successful initial or reattempt task completion across the range of usability tasks. Example: One task is to access the "Trends" screen to review and interpret weekly and monthly trend data for blood glucose variability and average glucose values.
次要结局
未报告次要终点