Collecting vital signs using the Comestai app

Vital Signs Data Collection Using "Comestai" Application

This study is testing if the Comestai app can accurately measure vital signs like blood pressure and heart rate using your phone's camera, especially for people who are overweight, obese, or have diabetes.

Quick facts

• Study type: Observational
• Enrollment: 3000 (estimated)
• Ages: 16 Years to 65 Years
• Sex: All
• Sponsor: Buzzi Children's Hospital (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT06427564 on ClinicalTrials.gov

What this trial studies

This study aims to verify and validate the collection of vital parameters such as Blood Pressure, Heart Rate, Respiratory Rate, and Oxygen Saturation using the Comestai mobile application. Participants will use the app to measure these parameters non-invasively through their mobile device's front camera, and results will be compared with standard clinical devices. The study will involve 3000 subjects and seeks to enhance self-monitoring of health status, particularly for individuals with overweight, obesity, or diabetes. Consent will also be obtained for collecting relevant blood test results.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 16 to 65 who can provide informed consent and comply with study procedures.

Not a fit: Patients with compromised circulation, physical malformations, or severe allergies to medical sensors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enable early detection of health changes and improve patient care through enhanced self-monitoring.

How similar studies have performed: While the use of mobile apps for health monitoring is gaining traction, this specific approach using the Comestai app is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

Prior to enrollment in this study, subjects must meet all the following inclusion criteria:

1. Subject must have the ability to understand and provide written informed consent.
2. Male or Female subject ≥16 and ≤65 of age.
3. Subject must be willing and able to comply with study procedures.

Exclusion Criteria:

Subjects will be excluded from the study if any of the following conditions are present:

1. Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study.
2. Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.
3. Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs.
4. Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.
5. Subject unfit to participate in the study to the judgment of the investigator.

In addition to the Inclusion/Exclusion criteria, the 70% of target population should include adult subjects with at least one of the following:

* Pre-diabetes or diabetes HbA1C 5.7-13%
* \>30% of subjects with HbA1C 5.7-6.4%
* \>30% of subjects with HbA1C \>6.4%
* Hypertension with systolic measurements above 130 mmHg
* \>40% of subjects with systolic BP \>130 mmHg
* \>20% of subjects with systolic BP \>160 mmHg
* Total cholesterol: \>40% of subjects with \>200 mg/dl and/or LDL above 130 mg/dl
* Atrial fibrillation 1%
* Smokers \~ 20-30% of all subjects in the study

Note: the same subject can have more than one of the above medical conditions. It is preferred that subjects will be treatment- naive for the medical condition they suffer from or are not under treatment at the time of participation (e.g. a subject who suffers from hypertension has not started his treatment to lower his blood pressure).

Where this trial is running

Milan

• ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital — Milan, Italy (Recruiting)

Study contacts

• Principal investigator: Gianvincenzo Zuccotti, MD, Prof — Buzzi Children's Hospital
• Study coordinator: Gianvincenzo Zuccotti, MD, Prof

Conditions Vital Signs