Accepted for/Published in: JMIR Formative Research
Date Submitted: May 12, 2020
Date Accepted: Jan 24, 2021
A Pilot Medical Food Study using a Smartphone Application with Continuous Glucose Monitoring Sensors
ABSTRACT
Background:
Novel wearable biosensors, ubiquitous smartphone ownership and telemedicine are converging to enable new paradigms of clinical research. A new generation of Continuous Glucose Monitoring (CGMs) provides access to clinical-grade measurements of interstitial glucose levels. Adoption of these sensors has become widespread for the management of type 1 diabetes and is accelerating in type 2 diabetes. In parallel, individuals are adopting health-related smartphone-based applications to monitor and manage care.
Objective:
We conducted a proof-of-concept study to investigate the potential of collecting robust, real-time clinical study measures of glucose levels.
Methods:
Using Abbott Freestyle Libre CGMs associated with a smartphone application, self-administered meal-tolerance tests were conducted to assess the impact of a synbiotic medical food on glucose control, in a 5-week, double-blind, placebo-controlled, 2x2 crossover pilot study (n=6), measured by incremental glucose AUCinc.
Results:
All subjects completed the study and mastered CGM usage. Approximately 3,000 data points per subject were collected across three sensors over 40 days. No adverse events were recorded and subjects reported general satisfaction with sensor management, study product and smartphone application. Despite a lack of sufficient power to achieve statistical significance, we detected meaningful changes in real-life settings justifying larger studies. We also demonstrated new capabilities of CGMs for compliance assessment.
Conclusions:
We have shown that CGMs can provide a comprehensive picture of glucose control without clinic visits. CGM usage in conjunction with our custom smartphone application can lower the participation burden for subjects while reducing study costs, and allows for robust integration of multiple valuable data types with the glucose levels remotely. Clinical Trial: This study was approved on March 13 2018 by the Aspire Institutional Review Board (IRB) with Protocol Number WB01-205. It is registered with ClinicalTrials.gov (Identifier: NCT04424888).
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