Clinical Study of Salivary Glycated Albumin
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Salivary glycated albumin vs. blood glycated albumin
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
研究组 & 干预措施
SmartAlbu
If a participant agrees, after obtaining informed consent, the investigator will measure and record temperature, blood pressure, heart rate, height and weight. The participant will be given detailed instruction on how to hold the container and will be asked to spit (or deposit) their saliva up to the indicated line. The procedure will be performed twice to study the reproducibility of the test. The participant will then be asked to have a standard blood draw of 2-3 mls of blood into a vacutainer tube for analysis of HbA1c at the central lab and 1-2 mls of blood for glycated albumin for assay analysis, and a finger stick for point of care HbA1c measurement.
干预措施: SmartAlbu (Device)
结局指标
主要结局
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.
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.
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