Self-Powered Photodetectors for Smarter Healthcare (SPARC)

Wrocław University of Science and Technology

Status: Begins enrollment in a year or more

Conditions: Blood Glucose Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06973317

SPARC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)