Measurement precision, accuracy and user performance evaluation in subjects with and without diabetes, a non-invasive blood glucose measurement device
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 1. The optical device developed will be useful in the non-invasive glucose monitoring.
研究概览
简要总结
Diabetes is the body’s inability to produce insulin. If undiagnosed or untreated it may lead to several health complications. Monitoring an individual’s glucose level is essential to managing it effectively. Present clinical methods are invasive. The optical approach is the most promising technology for non-invasive glucose monitoring. We have developed such an optical system with dual near-infrared wavelengths that have affinity for the glucose molecule. A clinical trial is required to validate the developed device against the gold standard.
At present, invasive blood glucose detection technology is mainstream, convenient, and practical, so both hospitals and household glucometers adopt the method of blood sampling first and then analyzing it in vitro for blood glucose measurement.
The non-invasive diagnosis of diabetes mellitus can be achieved by the optical system. The optical system consists of dual LEDs and a photodetector in a 3D enclosure. With the measurement site as the index finger, the change in the intensity of the reflected light from the finger is measured. The data is acquired from the patient with the finger placed on the optical system through a personal computer.
The device’s easy-to-use design and painless measurement method are intended to enhance the patient’s quality of life and increase compliance, which will improve diabetes management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Aged 21 years and above
- •Are able to walk to, take public transport to or drive to the testing site independently
- •Able to understand, read and write in English or Tamil.
- •All patients who are diagnosed with diabetes and healthy volunteers.
排除标准
- •Pregnant women and patients who are not interested in this research and who are not giving consent.
结局指标
主要结局
1. The optical device developed will be useful in the non-invasive glucose monitoring.
时间窗: Total time frame - 6 months | Calibration of optical device - 4 months | Validation of the optical Device - 2 months
2. The detector output correlated with the blood glucose, could provide instantaneous blood glucose level at the time of assessment.
时间窗: Total time frame - 6 months | Calibration of optical device - 4 months | Validation of the optical Device - 2 months
次要结局
- Random Blood glucose and HbA1c estimation(Total time frame - 6 months)
研究者
Angeline Kirubha S P
SRM Institute of Science and Technology
