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

February 26, 2024 updated by: Czech Technical University in Prague
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Středočeský
      • Kladno, Středočeský, Czechia, 27201
        • Oblastní nemocnice Kladno, a.s.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • blood glucose can be measured with standard biochemical analyzer

Exclusion Criteria:

  • minimum age limit 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood sample donator
The participant donates approximately 5 ml of blood sample.
Diagnostic test: In vitro full blood 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
When blood sample is filled into sensor chamber within 24 hours from blood collection.
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).
When blood sample is processed in biochemical analyzer within 24 hours from blood collection.
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.
When blood sample is presented into the co-axial probe container within 24 hours from blood collection.
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.
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
Time Frame: After primary data acqiusition.
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
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.
After primary data acqiusition.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Czech Technical University in Prague

Investigators

  • Principal Investigator: Luděk Šprongl, Ing., Regional hospital in Kladno
  • Principal Investigator: Lukáš Malena, Ing., Czech Technical University in Prague
  • Principal Investigator: David Vrba, doc., Czech Technical University in Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Actual)

July 17, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FBMI_MTM_sensor
  • 1/2023/LOK (Other Identifier: Oblastní nemocnice Kladno)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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