Digital Diabetes Self-Management for Diabetes

(Dulce Digital Trial)

Recruiting at 1 trial location

Overseen By Monica Ruiz, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Whittier Diabetes Institute

Disqualifiers: Severe illness, Liver issues, Anemia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing three ways to help underserved adults with diabetes manage their condition: in-person classes, online group sessions, and text messages. The goal is to see which method works best for people who often face challenges like low income and limited access to healthcare. By teaching them how to manage their diabetes, the study aims to help them make healthier choices and control their blood sugar levels better.

Research Team

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Health

Eligibility Criteria

This trial is for Hispanic/Latino adults with Type 2 Diabetes, registered at Scripps Health, and an HbA1c level ≥8% in the last 60 days. It's not for those with recent substance abuse issues, severe health problems like anemia or liver dysfunction, minimal literacy, or who don't speak Spanish/English.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

Adults who are Hispanic/Latino and are patients at Scripps Health.

Your blood sugar level (HbA1c) has been higher than 8% in the last two months.

Exclusion Criteria

I am not willing to carry a mobile phone.

I am too ill to visit the clinic for treatments.

History of drug or alcohol abuse within 12 months prior to randomization

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in diabetes self-management education through digital platforms, including telehealth group visits, text-based messages, and live delivery

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Dulce Digital Text-Based Education
• Project Dulce Live
• Project Dulce Telehealth

Trial Overview Dulce Digital 2.0 evaluates two digital adaptations of Project Dulce aimed at improving diabetes self-management via text messages and telehealth platforms compared to traditional in-person education.

Participant Groups

Group I: Project Dulce Telehealth DSME/S Experimental Treatment 1 Intervention

Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Group II: Project Dulce Live DSME/S Experimental Treatment 1 Intervention

Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Group III: Dulce Digital Experimental Treatment 1 Intervention

Patients will participate in a text-based diabetes self-management educational and support (DSME/S) program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+