NCT01934842撤回不适用
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick Using the SAFE-T-FILL Capillary Blood Collection System
Seventh Sense Biosystems2 个研究点 分布在 1 个国家开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Non Inferiority of Analyte Levels
研究概览
简要总结
This study will compare blood collection from the forearm using an investigational device, TAP20-C to blood collection from the finger tip. The blood collected from the forearm and from the fingertip will then be analyzed for glucose, hemoglobin and hemoglobin A1c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •Healthy Subject Group
- •Male and female volunteers 18 years of age or older.
- •Voluntary written consent to participate in this study.
- •Diabetic Subject Group
- •Male and female volunteers 18 years of age or older.
- •Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.
- •Voluntary written consent to participate in this study.
排除标准
- •Subjects who are pregnant or nursing mothers by self-report.
- •Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins.
- •Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
- •Subjects with a missing index or middle finger on either hand or a missing forearm
- •Subjects who have known allergies to titanium.
结局指标
主要结局
Non Inferiority of Analyte Levels
时间窗: Day 1
The study will compare the concentrations of glucose, hemoglobin and hemoglobin A1c in blood samples collected with the two different blood collection methods in a single 2 1/2 hour session.
次要结局
未报告次要终点
研究者
研究点 (2)
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