Self-Powered Photodetectors for Smarter Healthcare

NCT ID: NCT06973317

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2027-06-30
• Study Completion Date: 2028-12-31

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.

Conditions

Blood Glucose Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

T. Marciniak Lower Silesian Specialist Hospital in Wrocław

UNKNOWN

Sponsor Role: collaborator

Wrocław University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Katarzyna Gwozdz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower Silesian Specialist Hospital in Wrocław

Wroclaw, Lower Silesian Voivodeship, Poland

Countries

Poland

Facility Contacts

Tomasz Tomkalski

Role: primary

tomasz.tomkalski@pwr.edu.pl

+48 71 306 47 85

Other Identifiers

SPARC

Identifier Type: -

Identifier Source: org_study_id