The ELG Analysis of Glucose a Correlational to Blood Glucose Assa
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event
研究概览
简要总结
This study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have been diagnosed with type 1 or 2 diabetes
- •Be 25 - 65 years of age
- •Male or female
- •Various ethnicities are desired
- •Must be available for 2 visits within a 2-4 week period and willing to spend up to 1-2 hours/visit
- •Must have daytime availability for visits
- •Able to have 1 venous blood draw & up to 4 fingersticks for complete blood testing at each visit
- •Must be willing and able to fast (for at least 6 hours) prior to first visit
排除标准
- •Taking drugs of abuse (illegal and/or prescription)
- •Have been in another research study in the last 30 days
- •Have had a blood transfusion or severe blood loss in the last 14 days
- •Have Sickle Cell Anemia
结局指标
主要结局
Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Fasting Event
时间窗: Visit will last for up to 1-2 hours. This outcome will measure overnight fasting results.
Measuring precision and accuracy of ELG (glucose/A1C %) without blood samples, by performance evaluation to 3 different standard OTC fingerstick, A1C Now (or equivalent OTC brand) and NGSP-certified lab, using whole blood comparative tests with use of venous blood draw/fingersticks and NGSP-certified lab, and assess confidence limits to Bland-Altman plot, after overnight fasting for a minimum of 6 hours.
Standard OTC Glucose, A1C & Laboratory Results in Comparison to ELG Device During Non-Fasting Event
时间窗: This visit will be measured within a 4 week time frame, following the 1st visit. This visit will last for up to 1-2 hours. This outcome will measure non-fasting results.
Measuring precision and accuracy of ELG (glucose/A1C %) without blood samples, by performance evaluation to 3 different standard OTC fingerstick, A1C Now (or equivalent OTC brand) and NGSP-certified lab, using whole blood comparative tests with use of venous blood draw/fingersticks and NGSP-certified lab, and assess confidence limits to Bland-Altman plot, during non-fasting.
次要结局
未报告次要终点