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Completed

NCT Number: NCT05929196

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oblastní nemocnice Kladno, a.s.

Kladno, Central Bohemia, 27201, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • blood glucose can be measured with standard biochemical analyzer

Exclusion criteria

  • minimum age limit 18 years

Treatment and study plan

In vitro full blood diagnostic test.

Diagnostic Test

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.

Primary outcomes

  1. Phase shift of scattering parameter S21

    Time frame: When blood sample is filled into sensor chamber within 24 hours from blood collection.

    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.

  2. Blood glucose concentration

    Time frame: When blood sample is processed in biochemical analyzer within 24 hours from blood collection.

    Molar mass of glucose dissolved in liquid blood sample expressed as molar concentration (mmol/l).

  3. Blood sample specific electrical conductivity

    Time frame: When blood sample is presented into the co-axial probe container within 24 hours from blood collection.

    The specific electrical conductivity (S/m) of the blood samples will be measured using a coaxial probe.

  4. Blood sample relative permittivity

    Time frame: When blood sample is presented into the co-axial probe container within 24 hours from blood collection.

    The relative permittivity (-) of the blood samples will be measured using a coaxial probe.

Secondary outcomes

  1. Sensor sensitivity

    Time frame: After primary data acqiusition.

    Present the relation between the value of he Phase shift of scattering parameter S21 and Blood glucose concentration.

  2. Mathematical model of blood glucose dependence on blood dielectric parameters

    Time frame: After primary data acqiusition.

    The mathematical model describing which combination of dielectric parameter values (specific electrical conductivity and relative permittivity) corresponds to the certain blood glucose level.

Sponsors and collaborators

Lead sponsor

Czech Technical University in Prague

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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