DiabetesNCT05929196
Feasibility Evaluation - Blood Glucose Level Monitoring by Microwave Metamaterial Sensor in Blood Samples.
A study testing In vitro full blood diagnostic test. in people with Diabetes, run by Czech Technical University in Prague at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- In vitro full blood diagnostic test.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCzechia
- Study dates
- 12 Jul 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- blood glucose can be measured with standard biochemical analyzer
Who cannot join
- minimum age limit 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- In vitro full blood diagnostic test.
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood sample donator | Experimental | The participant donates approximately 5 ml of blood sample. Receives: Diagnostic Test: In vitro full blood diagnostic test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: When blood sample is presented into the co-axial probe container within 24 hours from blood collection.
Secondary outcomes (2)
Sensor sensitivity
Present the relation between the value of he Phase shift of scattering parameter S21 and Blood glucose concentration.
Measured: 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.
Measured: After primary data acqiusition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start12 Jul 2023
- Primary completion17 Jul 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Czech Technical University in Prague
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luděk Šprongl, Ing., Principal investigator, Regional hospital in KladnoLukáš Malena, Ing., Principal investigator, Czech Technical University in PragueDavid Vrba, doc., Principal investigator, Czech Technical University in Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929196
- Sponsor's protocol ID
- FBMI_MTM_sensor
- Other IDs
- 1/2023/LOK
- Status last verified
- Feb 2024
- First submitted
- 5 May 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation - Blood Glucose Level Monitoring by Microwave Metamaterial Sensor in Blood Samples.
- ClinicalTrials.gov ID
- NCT05929196
- Acronym / sponsor ID
- FBMI_MTM_sensor
- Conditions
- Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Czech Technical University in PragueUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample donator | Experimental | Diagnostic Test: In vitro full blood diagnostic test.The participant donates approximately 5 ml of blood sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- blood glucose can be measured with standard biochemical analyzer
Key exclusion criteria (1 listed)
- minimum age limit 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Blood sample donator |
Primary outcome
Phase shift of scattering parameter S21
Time frame: 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 glucose concentration
Time frame: 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).
Blood sample specific electrical conductivity
Time frame: 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 sample relative permittivity
Time frame: 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.
2 secondary outcomes
Sensor sensitivity
Time frame: After primary data acqiusition.
Mathematical model of blood glucose dependence on blood dielectric parameters
Time frame: After primary data acqiusition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luděk Šprongl, Ing. principal investigator
Regional hospital in Kladno
Lukáš Malena, Ing. principal investigator
Czech Technical University in Prague
David Vrba, doc. principal investigator
Czech Technical University in Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In vitro full blood diagnostic test. in people with Diabetes, run by Czech Technical University in Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase shift of scattering parameter S21 (time frame: When blood sample is filled into sensor chamber within 24 hours from blood collection.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.