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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Scripps Whittier Diabetes Institute
Study ID
NCT05416060
Status
Recruiting
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Conditions

  • Diabetes Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dulce Digital Text-Based Education — BEHAVIORAL
    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.
  • Project Dulce Telehealth — BEHAVIORAL
    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.
  • Project Dulce Live — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Mar 23, 2023
Status verified
Jun 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dulce Digital
    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.
  • Experimental: Project Dulce Telehealth DSME/S
    Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.
  • Experimental: Project Dulce Live DSME/S
    Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Primary Outcome Measure

Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Scripps Chula Vista Diabetes CenterChula VistaCalifornia91910
Athena Philis-Tsimikas, MD
858-678-7046
Monica Ruiz, MA
619-813-6747
Scripps Whittier Diabetes InstituteSan DiegoCalifornia92121
Athena Philis-Tsimikas, MD
858-678-7046
Monica Ruiz, MA
619-813-6747

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By research site
Scripps Chula Vista Diabetes Center· Chula Vista, CAScripps Whittier Diabetes Institute· San Diego, CA

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