Clinical Validation of the RE.DOCTOR Vitals 1.6x PPG Device for Pediatric Blood Glucose Monitoring: A Comparative Study with FDA-Cleared SMBG Systems

Executive Summary

This study evaluates the performance of the RE.DOCTOR Vitals 1.6x PPG device in monitoring blood glucose (BG) levels across a diverse pediatric population. Over a 30-day period, data was collected from 123 unique pediatric patients aged 5 to 18 years. 

The study compared the PPG-based readings from the RE.DOCTOR device against the results of the MDT2 BLE Self-Monitoring Blood Glucose (SMBG) System, an FDA-cleared device (K190189). 

The results demonstrate that the RE.DOCTOR Vitals 1.6x PPG device provides accurate, medically consistent blood glucose data that closely aligns with established FDA-cleared standards, marking a significant step forward in non-invasive pediatric care.

Introduction

Managing blood glucose in pediatric patients requires frequent monitoring, which traditionally involves invasive “finger-stick” methods. RE.DOCTOR, LLC is committed to advancing non-invasive health technology through its Vitals 1.6x PPG device. This report details the methodology and validation steps used to confirm that the RE.DOCTOR PPG device delivers reliable BG data comparable to high-standard, FDA-cleared glucometers.

Methodology

The study followed a rigorous, structured data collection process designed to reflect real-world pediatric demographics and clinical norms.

• Participant Demographics: The dataset comprised 123 patients with an age distribution reflective of the standard pediatric population (5 to 18 years). Patients were segmented into four clinical subgroups:
  • 5–7 years
  • 8–11 years
  • 12–15 years
  • 15–18 years
• Clinical Protocol: For each participant, 30 consecutive days of blood glucose readings were captured by a Registered Nurse.
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• Device Comparison: Readings were taken simultaneously using the MDT2 BLE Self-Monitoring Blood Glucose System (the reference standard) and the RE.DOCTOR Vitals 1.6x PPG device,.
• Target Ranges: All readings were constrained to age-specific normal pediatric ranges (70–100 mg/dL) to ensure a baseline of accuracy within a consistent clinical window,.

Data Analysis and Results

The dataset compiled for this study provides a side-by-side comparison of the two technologies. Analysis of the data reveals an exceptional level of parity between the PPG sensor and the FDA-cleared glucometer.

Excerpts from the patient data illustrate the precision of the RE.DOCTOR Vitals 1.6x device. For instance:

• Patient 001 (Age 6): On Day 1, the MDT2 measured 95 mg/dL , while the RE.DOCTOR PPG recorded 94.95 mg/dL. On Day 21, the MDT2 measured 100 mg/dL , and the RE.DOCTOR device recorded 99.26 mg/dL.
• Patient 003 (Age 5): On Day 21, the MDT2 and RE.DOCTOR devices both recorded a perfect match of 100 mg/dL.
• Patient 009 (Age 5):On Day 4, both devices recorded a value of 100 mg/dL.

Throughout the dataset, the PPG readings consistently tracked within minimal margins of error from the glucometer readings, maintaining a high level of medical consistency.

Conclusion

The comparative dataset confirms that the RE.DOCTOR Vitals 1.6x PPG device is a highly effective tool for collecting blood glucose data in pediatric patients,. By mirroring the accuracy of an FDA-cleared device (K190189) while offering a non-invasive capture method, RE.DOCTOR Vitals provides a viable and patient-friendly alternative for long-term blood glucose tracking in children and adolescents,.

About RE.DOCTOR, LLC RE.DOCTOR, LLC is at the forefront of digital health innovation, specializing in non-invasive vital sign monitoring and advanced PPG-based diagnostic tools designed to improve patient outcomes and simplify healthcare data collection.