Feasibility Evaluation - Blood Glucose Level Monitoring by Microwave Metamaterial Sensor in Blood Samples.

Study Overview
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Brief Summary
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The goal of this clinical trial is to test microwave metamaterial glucose sensor on blood samples. It means to compare the results of glucose values obtained by microwave metamaterial sensor and by standard biochemical analyzer.

Detailed Description
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Participants will include physiological and pathological populations. Participants donate approximately 5 ml of blood sample. Three sample tubes will be collected from ten adult participants. In the first test tube, the blood glucose content will be determined by a validated biochemical analyzer (Roche, Switzerland). In the remaining volume of the blood sample, the dielectric parameters (relative permittivity and conductivity) will be estimated using a coaxial probe (Keysight, USA). Microwave metamaterial sensors with 5, 7 and 9 unit cells will be loaded with blood samples and the specific scattering matrices will be obtained using a vector network analyzer. The main monitored outcome measure will be the phase of parameter S21.

Official Title
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Feasibility Evaluation - Blood Glucose Level Monitoring by Microwave Metamaterial Sensor in Blood Samples.

Conditions
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Diabetes

Intervention / Treatment
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* Diagnostic Test: In vitro full blood diagnostic test.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: blood glucose can be measured with standard biochemical analyzer Exclusion Criteria: minimum age limit 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood sample donator<br>The participant donates approximately 5 ml of blood sample. | Diagnostic Test: In vitro full blood diagnostic test.<br>* Participant will donate approximately 5 ml blood sample. Later in a laboratory the sample will be processed in the microwave metamaterial sensor for non invasive blood glucose monitoring and standard biochemical analyzer. Specific dielectric properties and scattering parameters will be measured for blood glucose level determination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase shift of scattering parameter S21 | The proposed microwave sensor uses a section of planar metamaterial transmission line operating at GHz frequencies. The speed of electromagnetic wave propagation through the sample is affected by the concentration of glucose. The delay can be expressed in degrees (°) as the phase of the complex S21 parameter. | When blood sample is filled into sensor chamber within 24 hours from blood collection. | 
| Blood glucose concentration | Molar mass of glucose dissolved in liquid blood sample expressed as molar concentration (mmol/l). | When blood sample is processed in biochemical analyzer within 24 hours from blood collection. | 
| Blood sample specific electrical conductivity | The specific electrical conductivity (S/m) of the blood samples will be measured using a coaxial probe. | When blood sample is presented into the co-axial probe container within 24 hours from blood collection. | 
| Blood sample relative permittivity | The relative permittivity (-) of the blood samples will be measured using a coaxial probe. | When blood sample is presented into the co-axial probe container within 24 hours from blood collection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensor sensitivity | Present the relation between the value of he Phase shift of scattering parameter S21 and Blood glucose concentration. | After primary data acqiusition. | 
| Mathematical model of blood glucose dependence on blood dielectric parameters | The mathematical model describing which combination of dielectric parameter values (specific electrical conductivity and relative permittivity) corresponds to the certain blood glucose level. | After primary data acqiusition. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes