Blood Glucose Monitoring Based on Imaging of the Eye
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Data Acquisition for Continued Algorithm Development Using Photographic Images of the Iris Compared to Fingerstick Glucose Concentration
研究概览
简要总结
Previous animal studies done by Dr. Brent Cameron in 2013 at the Univ. of Toledo have shown that glucose present in the fluid in the front of the eye, called the aqueous humor, correlates well with blood glucose. As blood glucose changes, the optical properties of the aqueous humor change, causing a change in the appearance of the iris of the eye.. The data collected in this study will be shared with IRISense to assist in validating the algorithm being used to develop the database needed. The data collected so far is in a narrow band of the normal glycemic range (healthy volunteers). We will collect standard digital photographic images of the eyes of subjects with diabetes along with corresponding blood glucose concentrations using the finger stick glucose monitoring method. In order to do this we will use standard digital photography techniques that is embedded in our benchtop prototype device
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Diabetes Type 1 and 2 and can be verified by the principal investigator
排除标准
- •Patients with any disease or abnormality of the eye
- •Patients who are mentally incapacitated, cognitively impaired or with severe psychological disorders and cannot sign consent on their own
结局指标
主要结局
Data Acquisition for Continued Algorithm Development Using Photographic Images of the Iris Compared to Fingerstick Glucose Concentration
时间窗: 60 day period
Eight digital photographic image of the subject's iris will be obtained at various times during each visit under standard illumination using the developed instrumentation. A point-of-care fingerstick blood glucose reading will be taken with an FDA approved blood glucose measurement device (i.e., Contour, Bayer Healthcare, LLC) as close to simultaneously as possible with the photograph.
次要结局
未报告次要终点