Clinical trial NCT06501612: Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7
Official title: Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7 in a Real-World Community Ambulatory Health Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes Technology
Diabetes Mobile Application
CGM Monitor
Lead sponsor: Scripps Whittier Diabetes Institute
Sponsor class: OTHER
First posted: 2024-07-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with type 2 diabetes
* Are on any pills or injectable glucose lowering medication regimen except bolus insulin
* 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 Criteria:

* Are on bolus insulin
* Are pregnant
* Are currently participating in another diabetes related study

Primary outcomes:
measure: Average Blood Glucose Level as Measured by HbA1c at Baseline, Day 20, and 4 Months
timeFrame: 4 months
Secondary outcomes:
measure: Time in Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent in Target Range at Day 20
timeFrame: 20 days
measure: Time Above Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Above Target Range at Day 20
timeFrame: 20 days
measure: Time Below Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Below Target Range at Day 20
timeFrame: 20 days
measure: Frequency of Compliance with Diabetes Self-Care Activities as Measured by the Summary of Diabetes Self Care Activities (SDSCA) Survey at Baseline, Day 20, and 4 Months
timeFrame: 4 months
measure: Severity of Diabetes Distress as Measured by the T2-Diabetes Distress Assessment System, Core Subscale at Baseline, Day 20, and 4 Months
timeFrame: 4 months
measure: Severity of Social Determinants of Health as Measured by the Scripps Social Determinants of Health Screening Tool at Baseline, Day 20, and 4 Months
timeFrame: 4 months
measure: Comfortability with Using Mobile Applications as a Health Resource as Measured by Two Likert-type Items at 4 Months
timeFrame: 4 months
Other outcomes:
measure: Process Indicators (Adoption): Perceptions of Undermyfork
timeFrame: Immediately following intervention completion
measure: Process Indicators (Adoption): Perceptions and Satisfaction of CGM
timeFrame: Immediately following intervention completion
Locations:
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
Study officials:
affiliation: Scripps Health
name: Athena Philis-Tsimikas, MD
role: PRINCIPAL_INVESTIGATOR
References: