Blood Glucose MonitoringSPARCNCT06973317
Self-Powered Photodetectors for Smarter Healthcare
An observational study of Blood Glucose Monitoring, run by Wrocław University of Science and Technology at 1 site in Poland.
Trial summary
The goal of this observational study is to evaluate the performance of a novel, non-invasive sensor device based on zirconium oxide photodetector designed to monitor key physiological parameters: blood glucose levels, heart rate, and blood oxygen saturation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blood Glucose Monitoring
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2027to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The populaiton studied will be patients at the Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower Silesian Specialist Hospital in Wrocław
Who may be able to join
- Adults aged 18-75 years
- Able to provide informed consent
Who cannot join
- Skin diseases or injuries on the fingers (e.g., psoriasis, open wounds, burns)
- Tattoos on the fingers
- Severe peripheral circulation disorders
- Pregnancy
- Presence of active implantable medical devices (e.g., pacemakers)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower Silesian Specialist Hospital in Wrocław
Wroclaw, Lower Silesian Voivodeship, 54-049
Tomasz Tomkalski, +48 71 306 47 85, tomasz.tomkalski@pwr.edu.pl
Katarzyna Gwóźdź
About this study
The goal of this observational study is to evaluate the performance of a novel, non-invasive sensor device based on zirconium oxide photodetector designed to monitor key physiological parameters: blood glucose levels, heart rate, and blood oxygen saturation. The study focuses on adult hospital patients aged 18 to 75, of all sexes, who are undergoing routine monitoring and treatment unrelated to the investigational device.
The main questions this study aims to answer are:
Read more
To what extent do the signals obtained from the newly developed device correlate with standard hospital-based methods for measuring blood glucose, heart rate, and blood oxygen saturation?
Is the device feasible, safe, and accurate for use in a real-world clinical setting?
How stable and reproducible are the sensor signals across a demographically diverse patient population?
Can advanced data analysis methods, such as machine learning techniques, be used effectively to interpret the device's output and provide accurate estimates of glucose concentration?
What is the user perception of comfort, safety, and practicality when the device is used in a routine hospital environment?
This study will not assign any interventions to participants; it is purely observational. The novel device is non-invasive, and its use will not interfere with standard clinical care. Measurements will be taken passively or concurrently with routine care procedures.
Participants will:
Continue to receive standard clinical care, including conventional monitoring of glucose, heart rate, and oxygen saturation.
Undergo additional measurements using the investigational device, which will be placed non-invasively on the skin (finger).
Answer a short usability questionnaire assessing their experience with the device, including any discomfort, perceived safety, or ease of use.
Data obtained from the device will be compared with routine clinical data from standard hospital devices (e.g., glucometers, pulse oximeters) to evaluate accuracy and reliability. No pharmacological, radiological, or invasive procedures will be involved.
- Conditions
- Blood Glucose Monitoring
- Keywords
- Non-invasive monitoring, Photoplethysmography (PPG), Machine learning, Medical devices, glucose
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of a Non-Invasive Device for Measuring Blood Glucose, Heart Rate, and Oxygen Saturation
To evaluate the correlation between the signals obtained from the newly developed non-invasive device and standard hospital-based methods for measuring blood glucose levels, heart rate, and blood oxygen saturation. The primary aim is to assess the feasibility, signal stability, and potential accuracy of the investigational device in a clinical setting.
Measured: 8 months
Secondary outcomes (3)
User-friendliness and Practical Usability of the Device in Routine Hospital Procedures
Usability of the device will be assessed using a standardized questionnaire (e.g., System Usability Scale, SUS) completed by clinical staff after performing routine procedures with the device. Additional measures will include the average time (in minutes) required to complete the procedure and the number of use-related errors observed per procedure, recorded by a trained observer.
Measured: 8 months
Variability of Device Readings Across a Demographically Diverse Adult Population
The device's output readings-heart rate (beats per minute), oxygen saturation (%SpO₂), and glucose levels (mg/dL)-will be collected from adult participants aged 18-75, balanced by sex. For each physiological parameter, variability will be assessed using standard deviation and coefficient of variation across repeated measurements. Device readings will be compared to reference standard measurements performed during the patients' routine hospital stay (e.g., laboratory tests) to evaluate consistency.
Measured: 8 months
Applying Machine Learning to Interpret Non-Invasive PPG Signals for Glucose Estimation
To apply and evaluate machine learning techniques for the interpretation of non-invasive PPG signals, in order to estimate glucose levels and benchmark the performance of the sensor platform
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study startJun 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose MonitoringStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wrocław University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- T. Marciniak Lower Silesian Specialist Hospital in Wrocław
- Responsible party
- Principal investigator, Katarzyna Gwozdz, Wrocław University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973317
- Sponsor's protocol ID
- SPARC
- Acronym
- SPARC
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) might not be shared for several reasons. Firstly, privacy and confidentiality concerns are significant, as even anonymized data could potentially lead to participant identification, especially in smaller datasets. Additionally, legal and regulatory restrictions, such as data protection laws like GDPR, may prevent sharing. Informed consent forms signed by participants might also include clauses that limit data sharing. Moreover, data quality and integrity issues could arise if the data is incomplete, inaccurate, or not yet validated for public use. There could also be commercial interests at play, where organizations may consider the data proprietary and choose to restrict access to maintain a competitive advantage. Finally, ethical considerations may arise, as sharing IPD might lead to misuse or misinterpretation of the data outside the intended research scope.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Powered Photodetectors for Smarter Healthcare
- ClinicalTrials.gov ID
- NCT06973317
- Acronym / sponsor ID
- SPARC / SPARC
- Conditions
- Blood Glucose Monitoring
- Keywords
- Non-invasive monitoring, Photoplethysmography (PPG), Machine learning, Medical devices, glucose
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wrocław University of Science and TechnologyUniversity, hospital or other
- Collaborators
- T. Marciniak Lower Silesian Specialist Hospital in Wrocław
- Study start
- Jun 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 May 2025 (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 observational study is to evaluate the performance of a novel, non-invasive sensor device based on zirconium oxide photodetector designed to monitor key physiological parameters: blood glucose levels, heart rate, and blood oxygen saturation. The study focuses on adult hospital patients aged 18 to 75, of all sexes, who are undergoing routine monitoring and treatment unrelated to the investigational device.
The main questions this study aims to answer are:
To what extent do the signals obtained from the newly developed device correlate with standard hospital-based methods for measuring blood glucose, heart rate, and blood oxygen saturation?
Is the device feasible, safe, and accurate for use in a real-world clinical setting?
How stable and reproducible are the sensor signals across a demographically diverse patient population?
Can advanced data analysis methods, such as machine learning techniques, be used effectively to interpret the device's output and provide accurate estimates of glucose concentration?
What is the user perception of comfort, safety, and practicality when the device is used in a routine hospital environment?
This study will not assign any interventions to participants; it is purely observational. The novel device is non-invasive, and its use will not interfere with standard clinical care. Measurements will be taken passively or concurrently with routine care procedures.
Participants will:
Continue to receive standard clinical care, including conventional monitoring of glucose, heart rate, and oxygen saturation.
Undergo additional measurements using the investigational device, which will be placed non-invasively on the skin (finger).
Answer a short usability questionnaire assessing their experience with the device, including any discomfort, perceived safety, or ease of use.
Data obtained from the device will be compared with routine clinical data from standard hospital devices (e.g., glucometers, pulse oximeters) to evaluate accuracy and reliability. No pharmacological, radiological, or invasive procedures will be involved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The populaiton studied will be patients at the Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower Silesian Specialist Hospital in Wrocław
Key inclusion criteria (2 listed)
- Adults aged 18-75 years
- Able to provide informed consent
Key exclusion criteria (5 listed)
- Skin diseases or injuries on the fingers (e.g., psoriasis, open wounds, burns)
- Tattoos on the fingers
- Severe peripheral circulation disorders
- Pregnancy
- Presence of active implantable medical devices (e.g., pacemakers)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of a Non-Invasive Device for Measuring Blood Glucose, Heart Rate, and Oxygen Saturation
Time frame: 8 months
To evaluate the correlation between the signals obtained from the newly developed non-invasive device and standard hospital-based methods for measuring blood glucose levels, heart rate, and blood oxygen saturation. The primary aim is to assess the feasibility, signal stability, and potential accuracy of the investigational device in a clinical setting.
3 secondary outcomes
User-friendliness and Practical Usability of the Device in Routine Hospital Procedures
Time frame: 8 months
Variability of Device Readings Across a Demographically Diverse Adult Population
Time frame: 8 months
Applying Machine Learning to Interpret Non-Invasive PPG Signals for Glucose Estimation
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) might not be shared for several reasons. Firstly, privacy and confidentiality concerns are significant, as even anonymized data could potentially lead to participant identification, especially in smaller datasets. Additionally, legal and regulatory restrictions, such as data protection laws like GDPR, may prevent sharing. Informed consent forms signed by participants might also include clauses that limit data sharing. Moreover, data quality and integrity issues could arise if the data is incomplete, inaccurate, or not yet validated for public use. There could also be commercial interests at play, where organizations may consider the data proprietary and choose to restrict access to maintain a competitive advantage. Finally, ethical considerations may arise, as sharing IPD might lead to misuse or misinterpretation of the data outside the intended research scope.
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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.
Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower Silesian Specialist Hospital in Wrocław
Wroclaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Glucose Monitoring, run by Wrocław University of Science and Technology at 1 site in Poland.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Jul 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of a Non-Invasive Device for Measuring Blood Glucose, Heart Rate, and Oxygen Saturation (time frame: 8 months). 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 10 Jul 2025.