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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Diagnostic Test: In vitro full blood diagnostic test.

• Registration Number: NCT05929196
• Lead Sponsor: Czech Technical University in Prague

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.

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 Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-07-03
• Study Start: 2023-07-12
• Primary Completion: 2023-07-17
• Study Completion: 2023-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• blood glucose can be measured with standard biochemical analyzer

Exclusion Criteria

• minimum age limit 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample donator	In vitro full blood diagnostic test.	The participant donates approximately 5 ml of blood sample.

Primary Outcome Measures

Name	Time	Method
Blood sample relative permittivity	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.
Phase shift of scattering parameter S21	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.
Blood sample specific electrical conductivity	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.
Blood glucose concentration	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).

Secondary Outcome Measures

Name	Time	Method
Mathematical model of blood glucose dependence on blood dielectric parameters	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.
Sensor sensitivity	After primary data acqiusition.	Present the relation between the value of he Phase shift of scattering parameter S21 and Blood glucose concentration.

Trial Locations

Locations (1)

Oblastní nemocnice Kladno, a.s.; 🇨🇿 Kladno, Středočeský, Czechia