Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age

NCT05416060 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-06-22

No results posted yet for this study

Summary

The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.

Conditions

  • Diabetes Type 2

Interventions

BEHAVIORAL

Dulce Digital Text-Based Education

Participants will be enrolled in the digital texting platform, Dulce Digital in which they will receive on-going support via text messages for 6 months, derived from the Project Dulce curriculum. Topics include medication reminders, motivational prompts, nutrition and stress reduction tips and request to submit weekly blood glucose numbers.

BEHAVIORAL

Project Dulce Telehealth

Project Dulce will consist of a group-based telehealth diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes.

BEHAVIORAL

Project Dulce Live

Project Dulce will consist of a group-based diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes.

Sponsors & Collaborators

  • Scripps Whittier Diabetes Institute

    lead OTHER

Principal Investigators

  • Athena Philis-Tsimikas, MD · Scripps Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-23
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416060 on ClinicalTrials.gov