A Multicenter Study to Evaluate the External Precision of the Aina HbA1c Monitoring System in Quantitative Measurement of Glycosylated Hemoglobin (HbA1c)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Precision (as measured by %CV) of HbA1c measurements
研究概览
简要总结
A three site study to evaluate the reproducibility of the Aina HbA1c Monitoring System in quantitative determination of glycosylated hemoglobin (HbA1c) took place at the following sites:
- Forsyth Institute in Cambridge, MA
- Orange County Research Center in Tustin, CA
- ActivMed Practices & Research in Methuen, MA
详细描述
Each site tested three identical samples of HbA1c, at three different levels of HbA1c measurement. Samples were drawn at the Forsyth Institute, received and blinded by the Sponsor, and returned to Forsyth Institute for testing. Samples were tested in triplicate, twice per day, over the course of five days, by three trained operators.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Agree to the terms of this consent form
- •Sign this consent form
- •Be 18 years or older
- •Have an HbA1c measured by a reference method within the last three months or based on medical history that is expected to fall in the range of 4 to 15%
- •Provide blood samples from your arm and finger
- •Come in in the morning of the study visit
排除标准
- •Not have a recent history of anemia or hemoglobin concentration above 20%
- •Not be pregnant
- •Not have previously given a blood sample to the Study Sponsor for a study
结局指标
主要结局
Precision (as measured by %CV) of HbA1c measurements
时间窗: Each sample was measured in triplicate, twice per day, over the course of five days
HbA1c measured on 3 samples on the Aina HbA1c Monitoring System by 3 operators at each site.
次要结局
未报告次要终点