Bias Source of Signal in SCOUT DS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Determine Device Bias
研究概览
简要总结
The primary objective is to identify device characteristics, components or subsystems that manifest as screening score bias in SCOUT DS.
详细描述
In the process of calibrating multiple SCOUT DS units, consistent inter-device score differences were found. These differences could create a bias in the measurement of Diabetes Risk scores (DRS) in human subjects. This study is intended to examine two of the various subsystems of the SCOUT DS to determine whether either of them might be capable of introducing bias into the measurements, with the ultimate aim of eliminating inter-device measurement variation.
The testing of human subjects in this trial is necessary to determine whether variability in the performance of these device subsystems actually affect DRS scores in a real world setting.
The trial will be a prospective, single site, investigational trial. The trial will utilize four SCOUT DS devices. Subjects will report to the investigative site for multiple visits. The number of visits will vary between three to seven visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and/ or females greater than or equal to 18 years of age
排除标准
- •Have received investigational treatments in the past 14 days
- •Have psychosocial issues that interfere with an ability to follow study procedures
- •Are known to be pregnant
- •Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
- •Have been treated in the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
- •Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
- •Are known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
结局指标
主要结局
Determine Device Bias
时间窗: Up to 1 year
The primary objective of this study is to identify device characteristics, components, or subsystems that manifest as screening score bias in SCOUT DS. The study will switch subsystems between devices and if the bias differs by more than 3.5 Diabetes Risk Score units compared to the baseline score, we would conclude that the bias was contained within that particular subsystem
次要结局
未报告次要终点