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

NCT06501612 | Completed

• 1 other identifier: 24-8369
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes Technology; Diabetes Mobile Application; CGM Monitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time in Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent in Target Range at Day 20

  20 days

• Time Above Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Above Target Range at Day 20

  20 days

• Time Below Range (CGM Metric) as Measured by Percentage of Blood Glucose Levels Spent Below Target Range at Day 20

  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

  4 months

• Severity of Diabetes Distress as Measured by the T2-Diabetes Distress Assessment System, Core Subscale at Baseline, Day 20, and 4 Months

  4 months

Other Outcomes (2)

• Process Indicators (Adoption): Perceptions of Undermyfork

  Immediately following intervention completion

• Process Indicators (Adoption): Perceptions and Satisfaction of CGM

  Immediately following intervention completion

Study Arms (2)

CGM plus Undermyfork group

EXPERIMENTAL

Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 2 devices) and will be instructed to use the mobile food diary application. A post-Undermyfork satisfaction qualitative interview will be administered and compensation provided when the CGM is removed and survey completed.

Other: Continuous Glucose Monitor and Undermyfork App

CGM Only group

ACTIVE COMPARATOR

Participants will be provided continuous glucose monitors (Dexcom G7) to monitor blood glucose for the entire duration of this study (i.e., one new device every 10 days for a total of 2 devices).

Other: Continuous Glucose Monitor

Interventions

Continuous Glucose Monitor and Undermyfork App OTHER

Participants will be provided two Dexcom G7 sensors to wear during the 20-day intervention period (two 10-day devices). Participants will also be instructed to download and use Undermyfork mobile application where they will have access to their history of their blood glucose responses to their meals in Undermyfork. A randomly selected number of participants in this group will be requested to complete a semi-structured qualitative interview to assess satisfaction with using Undermyfork application immediately following the intervention.

CGM plus Undermyfork group

Continuous Glucose Monitor OTHER

Participants will be provided two Dexcom G7 sensors to wear during the 20-day intervention period (two 10-day devices).

CGM Only group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Scripps Whittier Diabetes Institute: lead

Study Sites (1)

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Athena Philis-Tsimikas, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: October 9, 2024
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)