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

NCT05929196 | Completed

• 2 other identifiers: FBMI_MTM_sensor1/2023/LOK
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Sensor sensitivity

  After primary data acqiusition.

• Mathematical model of blood glucose dependence on blood dielectric parameters

  After primary data acqiusition.

Study Arms (1)

Blood sample donator

EXPERIMENTAL

The participant donates approximately 5 ml of blood sample.

Diagnostic Test: In vitro full blood diagnostic test.

Interventions

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.

Blood sample donator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• blood glucose can be measured with standard biochemical analyzer

You may not qualify if:

• minimum age limit 18 years

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Oblastní nemocnice Kladno, a.s.

Kladno, Central Bohemia, 27201, Czechia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: July 3, 2023
• Study Start: July 12, 2023
• Primary Completion: July 17, 2023
• Study Completion: September 1, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CZ (1)