Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05416060

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

Led by Scripps Whittier Diabetes Institute · Updated on 2025-06-22

150

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two digital health adaptations of Project Dulce aimed at improving diabetes self-management and digital health literacy among underserved Hispanic/Latino adults with Type 2 Diabetes. The study focuses on enhancing access to vital digital health information to help reduce health disparities and improve clinical and behavioral outcomes. The research compares the effectiveness of traditional in-person education, group telehealth sessions, and text-based messaging interventions in this population. Participants will be randomly assigned to one of three groups: a text-based diabetes self-management education and support program delivered via text messages over 6 months; a live peer-led telehealth group education program with a 5-week curriculum; or a live peer-led in-person group education program with the same 5-week curriculum. The telehealth and live programs cover diabetes management, medication, diet, exercise, and self-monitoring skills, available in English or Spanish. During the study, participants will be assessed at 3 and 6 months for changes in HbA1c levels, diabetes distress, and treatment satisfaction. Researchers will monitor clinical and behavioral outcomes, patient engagement, and health literacy improvements. The study participation includes regular follow-up and support through the assigned education program, with the total duration covering at least 6 months of intervention and assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hispanic/Latino adults who are registered patients of Scripps Health
  • Diagnosis of Type 2 Diabetes
  • HbA1c greater than or equal to 8% within the last 60 days
Not Eligible

You will not qualify if you...

  • Severe illness preventing visits to clinic
  • Liver function tests (ALT and AST) above 3 times the upper limit of normal
  • Body mass index 23 kg/cm or less
  • History of malignancy unless disease-free for more than 2 years or only basal/squamous cell skin carcinoma
  • Creatinine level greater than 3.5
  • History of drug or alcohol abuse within 12 months before randomization
  • Currently enrolled in diabetes self-management education or support
  • Blood donation of one pint or more in past 30 days, or plasma donation within 7 days before screening
  • Anemia
  • Insufficient literacy to participate in text-based intervention
  • Severe hearing or vision problems
  • Primary language other than Spanish or English
  • Unwillingness to carry a mobile phone
  • Pregnancy
  • Plans to relocate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 5 weeks to 6 months depending on program

Participants receive diabetes self-management education and support through one of three behavioral programs: text-based messages via Dulce Digital for ongoing support over 6 months; a 5-week group telehealth session delivered by a peer educator; or a 5-week live group session delivered by a peer educator. These programs provide skills and tools to manage diabetes and promote healthy behaviors.

Weekly group sessions for 5 weeks for telehealth and live programs; ongoing text messages for 6 months for Dulce Digital

Trial Site Locations

Total: 2 locations

1

Scripps Chula Vista Diabetes Center

Chula Vista, California, United States, 91910

Actively Recruiting

2

Scripps Whittier Diabetes Institute

San Diego, California, United States, 92121

Actively Recruiting

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Research Team

A

Athena Philis-Tsimikas, MD

M

Monica Ruiz, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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