Diabetes Clinical Trial
— RE-VITALOfficial title:
An Observational Study Comparing RE.DOCTOR Vitals® Software Accuracy
Verified date | February 2024 |
Source | RE.DOCTOR LLC |
Contact | Simon Halliday |
Phone | +1-307-278-9811 |
simon[@]re.doctor | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this observational trial is to advance digital health monitoring through the analysis of Photoplethysmography (PPG) waveforms collected via RE.DOCTOR Vitals software. The study aims to collect a diverse and extensive dataset of PPG waveforms, alongside traditional physiological measurements, for the purpose of enhancing existing algorithms and machine learning models used in health monitoring. The primary focus is on improving the accuracy and reliability of algorithms in interpreting PPG data to derive meaningful insights into physiological parameters. The main questions it aims to answer are: - How can extensive datasets of PPG waveforms be utilized to enhance existing algorithms and machine learning models? - How do correlations between PPG waveforms and key physiological parameters (such as glucose levels, blood pressure, heart rate, respiration rate) contribute to refining algorithms for more accurate and reliable health predictions? Participants will be asked to: - Continuously monitor their health using smartphone applications. - Allow the collection of PPG waveforms in diverse settings. - Engage in tasks related to monitor health parameters using medically approved devices
Status | Not yet recruiting |
Enrollment | 1000 |
Est. completion date | March 1, 2025 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age between 13-80 years. - Ownership of a smartphone compatible with the designated data collection application. - Willingness to use the smartphone application for continuous PPG data collection. - Ability to provide informed consent for participation in the study. - No known history of conditions or medications that significantly affect PPG waveforms (e.g., severe arrhythmias, use of beta-blockers). - Healthy individuals and individuals with diagnosed CVD diseases, individuals with diagnosed pre-diabetes, diabetes I, diabetes II Exclusion Criteria: - Age outside the specified range of 13-80 years. - Lack of ownership of a compatible smartphone. - Inability or unwillingness to use the designated smartphone application for data collection. - Known history of severe arrhythmias or use of medications affecting cardiovascular function. - Any condition that, in the judgment of the investigator, may compromise the participant's ability to complete the study. |
Country | Name | City | State |
---|---|---|---|
United States | Re.Doctor | Albuquerque | New Mexico |
Lead Sponsor | Collaborator |
---|---|
RE.DOCTOR LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software | Systolic and Diastolic Blood Pressure Measurement taken with RE.DOCTOR Vitals Software | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Systolic and Diastolic Blood Pressure Measurement taken with medical device | Systolic and Diastolic Blood Pressure Measurement taken with medical device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Systolic and Diastolic Blood Pressure Measurement taken with alternate PPG software device | Systolic and Diastolic Blood Pressure Measurement taken with alternate PPG software device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Heart Rate Measurement taken with RE.DOCTOR Vitals Software | Heart Rate Measurement taken with RE.DOCTOR Vitals Software | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Heart Rate Measurement taken with medical device | Heart Rate Measurement taken with medical device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Heart Rate Measurement taken with alternate PPG software device | Heart Rate Measurement taken with alternate PPG software device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Respiration Rate Measurement taken with RE.DOCTOR Vitals Software | Respiration Rate Measurement taken with RE.DOCTOR Vitals Software | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Respiration Rate Measurement taken with medical device | Respiration Rate Measurement taken with medical device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Respiration Rate Measurement taken with alternate PPG software device | Respiration Rate Measurement taken with alternate PPG software device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Blood Oxygen Measurement taken with RE.DOCTOR Vitals Software | Blood Oxygen Measurement taken with RE.DOCTOR Vitals Software | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Blood Oxygen Measurement taken with medical device | Blood Oxygen Measurement taken with medical device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Blood Oxygen Measurement taken with alternate PPG software device | Blood Oxygen Measurement taken with alternate PPG software device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Blood Glucose Measurement taken with RE.DOCTOR Vitals Software | Blood Glucose Measurement taken with RE.DOCTOR Vitals Software | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Blood Glucose Measurement taken with medical device | Blood Glucose Measurement taken with medical device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. | |
Primary | Blood Glucose Measurement taken with alternate PPG software device | Blood Glucose Measurement taken with alternate PPG software device | Measurements will be taken at three specific times: In the morning after 6-8 hours of sleep. 2 hours after the first meal of the day. Before bedtime. |
Status | Clinical Trial | Phase | |
---|---|---|---|
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