Actions & Insights Evaluating a Novel Diabetes Management Solution.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 3
- 主要终点
- Scaled preference questionnaires on new blood glucose monitoring digital tool.
研究概览
简要总结
Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.
详细描述
During ASCEND, patients will complete a single visit clinical study divided into two distinct parts. Part 1 involves each subject completing a number of simple quantitative exercises to gauge their level of comprehension of diabetes related information. Subjects will then continue during the same visit to complete part 2 which involves gathering qualitative feedback from each subject on the new Blood glucose monitoring system.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with T1DM or T2DM
- •Performs SMBG
- •Male or female, at least 16 years old.
- •Able to communicate (speak, read and write) in English
- •Willing to sign an informed consent.
排除标准
- •Unlikely to be compliant with the study in the opinion of study staff.
- •Conflict of Interest - Prospective Participants are currently working for, previously worked for, or have an immediate family member currently working for a company that manufactures or markets the products tested under this procedure
结局指标
主要结局
Scaled preference questionnaires on new blood glucose monitoring digital tool.
时间窗: 1 hour
Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive.
次要结局
- Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects.(1 hour)
- Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 1 subjects.(1 hour)
- Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c.(1 hour)
- Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy.(1 hour)
- Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects(1 hour)