Evaluating clinical outcomes of using Undermyfork mobile app with Dexcom G7: Protocol for CGM-Undermyfork randomized controlled trial.

BACKGROUND: Mobile health apps have the potential to enhance education for glycemic management in individuals with type 2 diabetes (T2D). The growing desire to use diabetes-related mobile applications indicates the industry's broad effort in leveraging technology to improve health outcomes in diabetes patients. However, many available applications still lack evidence-based features, and applications that go through clinical validation often do not include an active control in their studies. The purpose of this in-progress trial is to evaluate the effectiveness of a novel photo-based food diary smartphone app (Undermyfork) that visually connects meals to glucose excursions to promote behavior change.

METHODS: This is a randomized, controlled, prospective, parallel-group trial with an active comparator, enrolling N = 90 adults with T2D, elevated HbA1c, and continuous glucose monitoring (CGM) naivety in a real-world community-based health system. Participants complete a run-in/screening period, and if eligible, are randomized into the intervention to use CGM alone (Group 1) or to use the Undermyfork mobile app in addition to CGM (Group 2). The trial will examine comparative effectiveness in improving CGM metrics, HbA1c, and diabetes self-care behaviors over 4 months.

DISCUSSION: We hypothesize that Group 2 will have more evident improvements in CGM metrics and HbA1c given Undermyfork's focus on utilizing CGM data to understand meal-related decisions that may allow participants to gain insights into the relationship between their dietary choices and glucose fluctuations throughout the day. This trial may have implications for improved glycemic management, reduced risk of diabetes-related complications, and enhanced well-being for individuals with T2D.

CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT06501612https://clinicaltrials.gov/study/NCT06501612.