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
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 involve an investigational device, the Seventh Sense Biosystems TAP20-C. The TAP20-C device collects small amounts of blood from the forearm which can then be used for blood testing. The study will also involve collecting blood by fingerstick which is a common way of collecting blood. The SAFE-T-FILL Capillary Blood Collection system and the Terumo Capiject 1.5 mm Blade Safety Lancet will be used for this. The study will compare the concentrations of glucose, hemoglobin, and HbA1C in blood samples collected with the two different blood collection methods. Additional information will be collected about how the TAP20-C device performs.
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
- •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
排除标准
- •1.Subjects who are pregnant or nursing mothers by self report 2.Subjects who have eaten or consumed sugar-containing drinks in the 2 hours before blood sample collection begins 3.Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested 4.Subjects with a missing index or middle finger on either hand or a missing forearm 5.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 HbA1C in blood samples collected with the two different blood collection methods in a single two hour session.
次要结局
未报告次要终点