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Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study.

Hector Roux de Bézieux1,2,3, James Bullard1, Orville Kolterman1

  • 1Pendulum Therapeutics, Inc, San Francisco, CA, United States.

JMIR Formative Research
|March 4, 2021
PubMed
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BMJ open diabetes research & care·2020

Continuous glucose monitoring (CGM) devices and smartphone apps enable remote collection of glucose data, reducing clinical study burdens. This pilot study demonstrates their potential for real-world glucose monitoring without clinic visits.

Area of Science:

  • Biomedical Engineering
  • Digital Health
  • Endocrinology

Background:

  • Wearable biosensors, smartphones, and telemedicine are transforming clinical research.
  • Continuous glucose monitoring (CGM) devices offer clinical-grade glucose measurements, widely adopted for diabetes management.
  • Health apps are increasingly used by individuals for self-care and monitoring.

Purpose of the Study:

  • To investigate the feasibility of collecting robust, real-time, annotated glucose data remotely for clinical studies.
  • To assess the impact of a proprietary synbiotic on glucose control using novel remote monitoring technologies.

Main Methods:

  • A 6-week, double-blind, placebo-controlled, 2x2 cross-over pilot study (n=6) using self-administered meal-tolerance tests.
  • Abbott Freestyle Libre CGM devices linked to a smartphone app with a visual diet log were used for primary endpoint measurement.
Keywords:
clinical trialscontinuous glucose monitoringdiabeteslifestyle modificationmobile apptelemedicine

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  • Data collection occurred over 40 days, averaging 3000 data points per subject.
  • Main Results:

    • All participants completed the study, successfully using CGM devices and the associated app.
    • No adverse events were reported; participants reported high satisfaction (8.25/10) with the study.
    • The study demonstrated the ability to detect meaningful changes in postprandial glucose response in real-world settings, despite limitations in statistical power.

    Conclusions:

    • CGM devices integrated with a smartphone app provide comprehensive glucose monitoring without requiring clinic visits.
    • This approach reduces participant burden and study costs while enabling remote integration of diverse data types.
    • The findings support the utility of CGM and digital health tools for future large-scale clinical research in diabetes.