Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7

Last updated: January 31, 2025
Sponsor: Scripps Whittier Diabetes Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

Continuous Glucose Monitor and Undermyfork App

Continuous Glucose Monitor

Clinical Study ID

NCT06501612
24-8369
  • Ages 18-80
  • All Genders

Study Summary

This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications. Unlike standard care, which often involves periodic fingerstick glucose testing and limited dietary guidance, the proposed intervention offers continuous monitoring and tailored dietary insights, thus potentially improving overall diabetes management outcomes. The proposed intervention, therefore, deviates from standard care by integrating mobile health apps into the routine for CGM use, offering a novel avenue for enhanced glycemic monitoring and management.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have been diagnosed with type 2 diabetes

  • Are on any pills or injectable glucose lowering medication regimen except bolusinsulin

  • Speak, read, and write in English

  • Have A1c between 7.7% and 12.5% in the last 90 days

  • Have a cell phone that can download the Dexcom G7 and Undermyfork app

Exclusion

Exclusion Criteria:

  • Are on bolus insulin

  • Are pregnant

  • Are currently participating in another diabetes related study

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Continuous Glucose Monitor and Undermyfork App
Phase:
Study Start date:
October 09, 2024
Estimated Completion Date:
September 30, 2026

Study Description

The current research study seeks to determine the feasibility, acceptability, and effectiveness of using continuous glucose monitors (CGM) with and without a digital food diary (Undermyfork) for CGM naïve individuals with type 2 diabetes (T2D) in a real-world large community health setting. Undermyfork, as a novel digital tool, integrates CGM data with meal tracking, offering users insights into their dietary choices and glucose levels. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In addition, while the number of free health-related mobile applications continues to increase and underscores the growing interest in leveraging technology to improve health outcomes, there is a limited number of apps that are grounded in evidence. This highlights the importance for clinical testing to evaluate the efficiency and practicality of mobile apps aimed at enhancing health behaviors and outcomes, particularly with diabetes.

This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits, contributing to our understanding of the potential advantages and informing future diabetes care practices. The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications. Unlike standard care, which often involves periodic fingerstick glucose testing and limited dietary guidance, the proposed intervention offers continuous monitoring and tailored dietary insights, thus potentially improving overall diabetes management outcomes.

This need for new and effective treatments for T2D motivates the exploration of interventions like the proposed study to integrate easy-to-access mobile technology with CGM. Despite the availability of various diabetes management strategies, optimizing glycemic control remains a challenge. By evaluating the clinical and financial benefits of adding a mobile self-management apps to CGM technology, this study contributes to addressing the unmet needs of individuals who are interested in taking an active role in their health, aiming to advance our understanding of effective and patient-centered diabetes care. The potential outcomes of this research can influence future practices in diabetes management, benefiting individuals with T2D and contributing to the broader landscape of diabetes care.

Connect with a study center

  • Scripps Whittier Diabetes Institute

    La Jolla, California 92037
    United States

    Active - Recruiting

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