Innovative digital self-management for Type 2 diabetes
Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
This study is testing a new digital program to help underserved Hispanic and Latino adults with Type 2 diabetes manage their health better using mobile technology and group support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scripps Whittier Diabetes Institute Academic / other |
| Locations | 2 sites (Chula Vista, California and 1 other locations) |
| Trial ID | NCT05416060 on ClinicalTrials.gov |
What this trial studies
Dulce Digital 2.0 aims to enhance diabetes self-management among underserved Hispanic/Latino adults through mobile health (mHealth) technologies. The program includes telehealth group visits, text-based education, and live sessions to improve health literacy and clinical outcomes. By leveraging digital platforms, the initiative seeks to increase access to vital health information and support, ultimately addressing health disparities in diabetes care. The approach builds on previous successful interventions and is designed to be scalable for broader implementation.
Who should consider this trial
Good fit: Ideal candidates are Hispanic/Latino adults with Type 2 diabetes and an HbA1c of 8% or higher who are registered patients of Scripps Health.
Not a fit: Patients with severe illnesses, low literacy, or those not willing to use a mobile phone may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve diabetes management and health outcomes for underserved populations.
How similar studies have performed: Previous studies have shown success with similar telehealth and mHealth interventions in improving diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Severe illness precluding visits to clinic * Liver function tests (ALT and AST) \> 3 times the upper limit of normal * Body mass index ≤ 23 kg/cm * History of malignancy, except subjects who have been disease-free for \>2 years, or whose only malignancy has been basal or squamous cell skin carcinoma * Creatinine \>3.5 * History of drug or alcohol abuse within 12 months prior to randomization * Current enrollee in DSME/S * Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening * Anemia * Lack of minimal literacy needed to participate in the text intervention * Severe auditory or visual problems * Primary language other than Spanish or English * Not willing to carry a mobile phone * Pregnant * Plans to relocate
Where this trial is running
Chula Vista, California and 1 other locations
- Scripps Chula Vista Diabetes Center — Chula Vista, California, United States (Recruiting)
- Scripps Whittier Diabetes Institute — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Athena Philis-Tsimikas, MD — Scripps Health
- Study coordinator: Athena Philis-Tsimikas, MD
- Email: philis-tsimikas.athena@scrippshealth.org
- Phone: 858-678-7046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.