Self-Powered Photodetectors for Smarter Healthcare

Обзор

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.

Первичные конечные точки

• Evaluation of a Non-Invasive Device for Measuring Blood Glucose, Heart Rate, and Oxygen Saturation [Срок оценки: 8 months]

Вторичные конечные точки (3)

• User-friendliness and Practical Usability of the Device in Routine Hospital Procedures [Срок оценки: 8 months]
• Variability of Device Readings Across a Demographically Diverse Adult Population [Срок оценки: 8 months]
• Applying Machine Learning to Interpret Non-Invasive PPG Signals for Glucose Estimation [Срок оценки: 12 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Польша · 1 центр

• Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower S — Wroclaw

Идентификаторы

NCT: NCT06973317 · SPARC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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