Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG

Study Overview
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Brief Summary
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The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

Detailed Description
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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:

Official Title
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Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Physical Logic Continuous Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signing an inform consent form Type 1 diabetes diagnosed at least 12 months prior to study inclusion Age > 18 years old Willing to perform all study related procedures Exclusion Criteria: Known or suspected allergy to the sensor or one of its components Psychiatric disorder Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease Patients who are not willing or are not capable of performing the protocol requirements Participating in another study that includes investigational drug or investigational equipment Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each | Device: Physical Logic Continuous Glucose Monitoring System<br>* Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between continuous glucose measurements using study device and YSI(yellow springs instrument) | Correlation between continuous glucose measurements using study device (Physical Logic) and YSI(yellow springs instrument)at variable glucose levels | up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous glucose monitoring system, Non invasive, Type 1 diabetes, Dielectric spectroscopy