Usability and HbA1c Method Comparison Study Using Lay Person Micro-Blood Specimens
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
研究概览
简要总结
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
详细描述
This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein). The information and data obtained will be used to finish development of a convenience kit that allows doctors to provide their patients a method to have their blood tested for clinical laboratory tests in the convenience of their home without having to visit the doctor's office or clinic.
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
- 是
入选标准
- •Ability to understand and follow verbal and written instructions in English
- •Demonstrate a willingness to participate by providing a written informed consent
- •Aged between 18 to 80 years of age with no obvious signs of illness (e.g. fever, vomiting)
- •Diabetics who were diagnosed 6 months ago or longer are preferred. However, non-diabetics will be accepted into the study.
排除标准
- •Withdrawn informed consent
- •Mental or physical impairment which would preclude participation
- •Any condition which, in the opinion of the Principle Investigator or site or study coordinator, makes the participant unsuitable for this study. This includes but is not limited to any mental or physical impairment, which would preclude provision of adequate and knowledgeable consent.
结局指标
主要结局
Usability and HbA1c Method Comparison Study Using Lay-Person Micro-Blood Specimens
时间窗: Outpoint measured within 3 months
To establish that when using capillary blood collected in the Home Access Collection Cassette, lay-users can obtain HbA1c results equivalent to results from professionally-collected samples
次要结局
未报告次要终点