Accuracy of the SofTouch Device Measuring Blood Glucose and Other Parameters Clinical Trial
Official title:
A Comparative Clinical Trial to Assess the Accuracy of the SoftTouch. A Novel Non-invasive Device for Measuring Peripheral Blood Glucose, Carbon Dioxide, pH, Hemoglobin, Hematocrit, SpO2, Peripheral Pulse and Blood Pressure.
1. Aim:
SoftTouch is a non-invasive device intending for use in the temporarily quantitative
measurement of peripheral blood biomarkers. The aim of the clinical trial is to study
the accuracy of the SoftTouch device compared with registered (FDA-approved) invasive
and non-invasive devices.
2. Hypothesis:
Human physiological biomarkers may be measured from the color distribution of the internal or
external (skin) tissue. The technology of the SoftTouch finger-mounted device is based on the
color distribution of the peripheral blood tissue, which enables the measurement of certain
biomarkers and vital signs under consideration.
Description of the Method:
1. The method of measuring non-invasive peripheral physiological parameters such as Pulse,
Blood Pressure, Blood pH, SpO2, CO2, Hemoglobin, Blood Glucose, Hematocrit and
additional physiological parameters is based on the color distribution of a human
tissue. SoftTouch is a finger-mounted device incorporated a dedicated light source and a
color image sensor similar to a digital camera. The light transverses and is reflected
from the tissue under consideration. Analyzing the tissue color distribution of the
sampled real-time video in the frequency color space time domain may provide certain
information about the biomarkers and vital-signs under consideration. The current
study's goal is to find out if the results accuracy are satisfactory compared with
regulatory cleared devices by the FDA and other notified bodies.
2. The Patient signals shall be recorded as is for algorithm improvement, future research
of additional bio parameters and calibration.
3. the device is declared calibrated if executed successfully on the entire recorded data.
4. for non invasive blood glucose the device shall be provided to selected diabetic
patients for the own use at home.
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