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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Diagnostic test: In vitro full blood diagnostic test.

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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.

Collaborators and Investigators

• 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

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: Diabetes
• 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