NCT03235492撤回不适用
Clinical Study of Salivary Glycated Albumin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)
研究概览
简要总结
(1) to determine whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood and (2) to investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure glycosylated hemoglobin (HbA1c).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •123 individuals with type 1 or type 2 diabetes
- •53 non diabetic controls
- •Age: 18 to 80
- •Body mass index >18.5kg / m2
排除标准
- •Acute illness (within 7 days) - respiratory infection, fever above 38 °C, sinusitis infection, severe allergies.
- •Individuals with known sickle cell, pregnancy, hemoglobinopathies, renal failure
- •Subjects unable to give voluntary informed consent
结局指标
主要结局
Salivary glycated albumin vs. glycosylated hemoglobin (HbA1c)
时间窗: 30 min
To investigate whether the non-invasive SmartAlbu portable salivary sensor is as accurate as standard tests that measure HbA1c.
Salivary glycated albumin vs. blood glycated albumin
时间窗: 30 min
Whether the ratio of glycated albumin and total albumin in saliva is equivalent to blood.
次要结局
未报告次要终点
研究者
Stephen N. Davis, MBBS
Chairman of Medicine
University of Maryland, Baltimore
研究点 (2)
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