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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05929196
• Other study ID #: FBMI_MTM_sensor
• Secondary ID: 1/2023/LOK
• Status: Completed
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: February 2024
• Source: Czech Technical University in Prague
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 1, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• blood glucose can be measured with standard biochemical analyzer

Exclusion Criteria:

• minimum age limit 18 years

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
Czechia	Oblastní nemocnice Kladno, a.s.	Kladno	Stredoceský

Sponsors (1)

Lead Sponsor	Collaborator
Czech Technical University in Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Sensor sensitivity	Present the relation between the value of he Phase shift of scattering parameter S21 and Blood glucose concentration.	After primary data acqiusition.
Secondary	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.