NCT06237322

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

January 23, 2024

Last Update Submit

February 1, 2024

Conditions

Respiratory DisorderCardiovascular DiseasesDiabetesPre-DiabetesPrimary Care

Outcome Measures

Primary Outcomes (15)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (5)

Healthy

Blood Pressure, Heart Rate and Respiration Rate Measurements: Observations will be made using a medically approved blood pressure monitor, Heart Rate Monitor, Respiration Rate Monitor. 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. Measurement: 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. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately.

Cardio vascular diseases

Blood Pressure, Heart Rate and Respiration Rate Measurements: Observations will be made using a medically approved blood pressure monitor, Heart Rate Monitor, Respiration Rate Monitor. 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. Measurement: 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. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately.

Pre-Diabetes

Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. 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. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately.

Diabetes I

Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. 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. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately.

Diabetes II

Blood Glucose Measurement: Participants will use a medically approved glucometer to measure their blood glucose levels. 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. PPG Data Collection with Mobile App: Before each blood glucose measurement, participants will use the RE.DOCTOR Vitals mobile app to collect raw PPG signals. Then without closing the app, they use medical device and enter blood glucose data from the glucometer into the app after each measurement. Data collection will be initiated by participants clicking the "collect data" button on the mobile app. Observations: Participants will be guided on the correct use of the glucometer and instructed to note down readings accurately.

Eligibility Criteria

Age13 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The inclusion criteria are designed to ensure that participants are within a target age range, have access to the required technology, and are willing and able to actively participate in the study. The criteria also aim to exclude individuals with conditions or medications that could potentially confound the relationship between PPG waveforms and physiological parameters. Exclusion criteria are defined to ensure the safety and feasibility of participants in the study. Excluding individuals with specific health conditions or medications that could significantly affect PPG waveforms helps maintain the integrity of the data and the validity of the study outcomes.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Re.Doctor

Albuquerque, New Mexico, 87110, United States

Location

Related Links

MeSH Terms

Conditions

Respiration DisordersCardiovascular DiseasesDiabetes MellitusGlucose Intolerance

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemia

Central Study Contacts

Simon Halliday

CONTACT

+1-307-278-9811simon@re.doctor

Daniel Lantape

CONTACT

+37441200356daniel@re.doctor

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 1, 2024

Study Start

March 1, 2024

Primary Completion

December 15, 2024

Study Completion

March 1, 2025

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)