Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1/2023/LOK | Other Identifier | Oblastní nemocnice Kladno |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood sample donator | Experimental | The participant donates approximately 5 ml of blood sample. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oblastní nemocnice Kladno, a.s. | Kladno | Central Bohemia | 27201 | Czechia |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |