Clinical trial NCT06973317: Self-Powered Photodetectors for Smarter Healthcare
Official title: Self-Powered Photodetectors for Smarter Healthcare
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Blood Glucose Monitoring
Keywords: Non-invasive monitoring
Photoplethysmography (PPG)
Machine learning
Medical devices
glucose
Lead sponsor: Wrocław University of Science and Technology
Sponsor class: OTHER
Collaborators: name: T. Marciniak Lower Silesian Specialist Hospital in Wrocław
First posted: 2025-05-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-75 years
* Able to provide informed consent

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Evaluation of a Non-Invasive Device for Measuring Blood Glucose, Heart Rate, and Oxygen Saturation
timeFrame: 8 months
Secondary outcomes:
measure: User-friendliness and Practical Usability of the Device in Routine Hospital Procedures
timeFrame: 8 months
measure: Variability of Device Readings Across a Demographically Diverse Adult Population
timeFrame: 8 months
measure: Applying Machine Learning to Interpret Non-Invasive PPG Signals for Glucose Estimation
timeFrame: 12 months
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower Silesian Specialist Hospital in Wrocław
state: Dolnośląskie
Study officials:
References: