Self-Powered Photodetectors for Smarter Healthcare

NCT06973317 | Not Yet Recruiting

• 1 other identifier: SPARC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Non-invasive monitoring; Photoplethysmography (PPG); Machine learning; Medical devices; glucose

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Secondary Outcomes (3)

• User-friendliness and Practical Usability of the Device in Routine Hospital Procedures

  8 months

• Variability of Device Readings Across a Demographically Diverse Adult Population

  8 months

• Applying Machine Learning to Interpret Non-Invasive PPG Signals for Glucose Estimation

  12 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wrocław University of Science and Technology: lead
• T. Marciniak Lower Silesian Specialist Hospital in Wrocław: collaborator

Study Sites (1)

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

Wroclaw, Lower Silesian Voivodeship, 54-049, Poland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 15, 2025
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-05

Locations

PL (1)