Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App with Dexcom G7
NCT Number: NCT06501612
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Type 2 Diabetes
Sponsor: Scripps Whittier Diabetes Institute
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-30
Completion Date: 2026-09-30

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.

Primary Outcome Measures: Average Blood Glucose Level as Measured by HbA1c at Baseline, Day 20, and 4 Months, HbA1c is a person's average blood glucose level over the past three months. This measurement will be collected using lab results provided from healthcare provider. Scores below 7% indicate a healthy HbA1c. Scores above 7% indicate increased risk of diabetes-related complications., 4 months
Secondary Outcome Measures: Time in Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent in Target Range at Day 20, Measures the percentage of time a participant's blood glucose levels stay within the target range using a CGM device throughout the 20-day intervention. Target range is defined as having a blood glucose level between 70 and 180 mg/dL. Thus, percent Time in Range = 100 (Number readings in range (70-180mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time., 20 days|Time Above Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Above Target Range at Day 20, Measures the percentage of time a participant's blood glucose levels exceed the target range using a CGM device throughout the 20-day intervention. Above range is defined as having a blood glucose level above 180 mg/dL. Thus, percent Time Above Range = 100 (Number readings above range (\>140mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time., 20 days|Time Below Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Below Target Range at Day 20, Measures the percentage of time a participant's blood glucose levels fall below the target range (usually less than 70 mg/dL) using a CGM device throughout the 20-day intervention. Below range is defined as having a blood glucose level below 70 mg/dL. Thus, percent Time Below Range = 100 (Number readings below range (\<70mg/dL)/Total number of readings from CGM). Number of readings will be used in calculation, which scale directly with time., 20 days|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, The Summary of Diabetes Self Care Activities Survey measures frequency and consistency of diabetes self-care activities during the past 7 days. Possible scores range from 0 (0 Days) to 7 (7 Days). Higher scores indicate better compliance with diabetes self-care., 4 months|Severity of Diabetes Distress as Measured by the T2-Diabetes Distress Assessment System, Core Subscale at Baseline, Day 20, and 4 Months, The T2-Diabetes Distress Assessment System, Core Subscale produces a total score to reflect overall emotional distress related to diabetes for individuals with type 2 diabetes. Possible scores range from 1 (Not a Problem) to 5 (A Very Serious Problem) with higher scores indicating higher reported levels of diabetes-related distress., 4 months|Severity of Social Determinants of Health as Measured by the Scripps Social Determinants of Health Screening Tool at Baseline, Day 20, and 4 Months, The Social Determinants of Health (SDOH) Screening tool measures the environmental conditions where people are born, live, learn, work, and age that affect a wide range of health and quality-of-life outcomes using 12 items. Possible responses include: Yes, No, Decline to Answer, or Unable to Assess. More "yes" responses indicate more severe environmental conditions affecting health., 4 months|Comfortability with Using Mobile Applications as a Health Resource as Measured by Two Likert-type Items at 4 Months, The 2 brief items of this measure examine participants' comfort and perceived skills at using mobile health applications for their health on a scale ranging from (1) not comfortable to (5) very comfortable. Higher scores indicate that participant is more comfortable with using mobile health applications as a health resource. This helps identifying patients with adequate mobile health technology literacy., 4 months
Other Outcome Measures: Process Indicators (Adoption): Perceptions of Undermyfork, Results of semi-structured interviews will be qualitatively, descriptively analyzed to reveal perceptions of Undermyfork mobile app, implementation efficacy, challenges, satisfaction, and benefits., Immediately following intervention completion|Process Indicators (Adoption): Perceptions and Satisfaction of CGM, Results of brief CGM Satisfaction questionnaire analyzed to reveal perceptions and satisfaction of CGM. Higher scores indicate more satisfaction with CGM use., Immediately following intervention completion