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

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 (CGM) devices provides access to clinical-grade measurement 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 apps to monitor and manage care. Objective We conducted a proof-of-concept study to investigate the potential of collecting robust, annotated, real-time clinical study measures of glucose levels without clinic visits. Methods Self-administered meal-tolerance tests were conducted to assess the impact of a proprietary synbiotic medical food on glucose control in a 6-week, double-blind, placebo-controlled, 2×2 cross-over pilot study (n=6). The primary endpoint was incremental glucose measured using Abbott Freestyle Libre CGM devices associated with a smartphone app that provided a visual diet log. Results All subjects completed the study and mastered CGM device usage. Over 40 days, 3000 data points on average per subject were collected across three sensors. No adverse events were recorded, and subjects reported general satisfaction with sensor management, the study product, and the smartphone app, with an average self-reported satisfaction score of 8.25/10. Despite a lack of sufficient power to achieve statistical significance, we demonstrated that we can detect meaningful changes in the postprandial glucose response in real-world settings, pointing to the merits of larger studies in the future. Conclusions We have shown that CGM devices can provide a comprehensive picture of glucose control without clinic visits. CGM device usage in conjunction with our custom smartphone app can lower the participation burden for subjects while reducing study costs, and allows for robust integration of multiple valuable data types with glucose levels remotely. Trial Registration ClinicalTrials.gov NCT04424888; http://clinicaltrials.gov/ct2/show/NCT04424888.

Applications of Cutting-Edge Biosensors in Healthcare and Biomedical Research

“…Participants expressed great satisfaction with the sensors, product, and app, and no negative incidents were noted. The need for larger research in the future is indicated by the considerable alterations in postprandial glucose response that were found in real-world settings, even though statistical Applications of Cutting-Edge Biosensors in Healthcare and Biomedical Research DOI: http://dx.doi.org/10.5772/intechopen.112693 significance could not be reached [41]. For noninvasive interstitial fluid (ISF) extraction and real-time glucose testing, a screen-printed iontophoretic biosensing system has been created.…”

Use of Continuous Glucose Monitors by People Without Diabetes: An Idea Whose Time Has Come?

“…It is well described that blood glucose levels change after a meal and that postprandial glucose responses (PPGR) depend on the macronutrients consumed, the time of day, and the individuals underlying beta-cell function. 14,15 Postprandial glucose responses are increasingly considered a major determinant of glycemic control, yet methods for predicting PPGR to food remain elusive and of limited efficacy. 16 CGMs can be utilized to evaluate the frequency with which individuals demonstrate elevations in postprandial glucose, the types of patterns, and how patterns vary between individuals given an identical nutrient challenge.…”