Undermyfork App + CGM for Type 2 Diabetes

Overseen By Kallie Brown, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Whittier Diabetes Institute

Must be taking: Glucose lowering

Must not be taking: Bolus insulin

Disqualifiers: Pregnancy, Other diabetes study

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 20 days

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Health

Eligibility Criteria

This trial is for adults with type 2 diabetes who haven't used a Continuous Glucose Monitor (CGM) in the last 6 months, have an HbA1c level between 7.7% and 12.5%, use a smartphone regularly, and are on stable glucose-lowering medication except bolus insulin.

Inclusion Criteria

My HbA1c level is between 7.7% and 12.5%.

I haven't used a CGM device in the last 6 months.

I use a smartphone regularly and can download apps.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use continuous glucose monitors (Dexcom G7) with or without the Undermyfork mobile app for real-time glucose monitoring and dietary tracking

20 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of diabetes distress and self-care activities

4 months

3 visits (in-person)

Treatment Details

Interventions

• Undermyfork Mobile App with Dexcom G7

Trial Overview The study tests if using the Undermyfork mobile app alongside a Dexcom G7 CGM device improves diabetes management compared to just using the CGM alone. It evaluates how real-time monitoring combined with dietary tracking affects glycemic control.

Participant Groups

Group I: CGM plus Undermyfork group Experimental Treatment 1 Intervention

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.

Group II: CGM Only group Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+