Self-Powered Photodetectors for Smarter Healthcare
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Blood Glucose Monitoring. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Evaluation of a Non-Invasive Device for Measuring Blood Glucose, Heart Rate, and Oxygen Saturation [Time frame: 8 months]
Secondary outcome measures (3)
- User-friendliness and Practical Usability of the Device in Routine Hospital Procedures [Time frame: 8 months]
- Variability of Device Readings Across a Demographically Diverse Adult Population [Time frame: 8 months]
- Applying Machine Learning to Interpret Non-Invasive PPG Signals for Glucose Estimation [Time frame: 12 months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Department of Endocrinology, Diabetology and Internal Medicine at the T. Marciniak Lower S — Wroclaw
Identifiers
NCT: NCT06973317 · SPARC