Type 1 Diabetes Clinical Trial
Official title:
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG
The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.
The non invasive continuous glucose sensing system of Physical Logic is based on a vector
network analyzer (VNA), which monitor blood glucose through propriety sensors.Dielectric
spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by
the electric dipole moment of the sample it interacts with. This method utilizes the change
in the impedance of the antenna to measure the change in the relaxation processes of the
interrogated medium.
The VNA (vector network analyzer) , which emits non irradiating electromagnetic waves in
very low power emission, is connected via standard coaxial cables to propriety sensors that
are attached to the patient skin without direct contact.
Study objective:
To evaluate the feasibility of a new noninvasive method to measure continuous glucose values
using electromagnetic radiation.The glucose values generated by the investigational non
invasive devise will be compared to glucose reading of a reference devise, which measure
blood glucose levels at the subcutaneous tissue.
During the study we will evaluate the reliability of the study device under the conditions
of alter blood glucose values in the range of 50-400 mg/dl:
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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