Feasibility for the use of a non-invasive wearable device for glucose monitoring.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Determining whether it is feasible
研究概览
简要总结
The study is designed to collect and evaluate the LUMOS biosensor data on subjects with varying blood sugar levels during fasting and post-prandial sessions.
The LUMOS device’s optical data collected from the finger non-invasively.
LUMOS is a non-invasive wearable spectroscopy device (25) with form factors that can be used for on-body sensing.
The device could accurately detect wavelengths or a combination of wavelengths within 13 nm with similar ratios of intensity to the ground truth spectrometer.
A fingertip version of the LUMOS device uses non-invasive optical spectroscopy to determine physiological responses of the fingertip.
Each device is powered by a lithium-ion battery that will last up to 10 days based on lab experiments. Data on the LUMOS Device is stored on the device which is encrypted to be FIPS (Federal Information Processing Standard) 140-24 compliant using AES encryption.
After the exit visit, physiological data will be downloaded off the device onto a password-protected and encrypted study computer via a USB connection. Then, it will be uploaded onto a HIPAA-compliant an encrypted web-platform.
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
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Age of 18 years or older.
- •Ability to provide informed consent.
- •Reports having a secure place to store an electronic device.
排除标准
- •Inability to consent.
- •Presence of hand tattoos or markings that could interfere with the optical sensor.
结局指标
主要结局
Determining whether it is feasible
时间窗: 2 months
次要结局
- Determining whether it is acceptable.(1 week)
研究者
Dr V Mohan
Madras Diabetes Research Foundation
