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NCT05416060: Dulce Digital
Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
NA trial testing Dulce Digital Text-Based Education in Diabetes Type 2 in 150 participants. Currently enrolling.
31 January 2026
Quick facts
| Lead sponsor | Scripps Whittier Diabetes Institute |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 150 |
| Start date | 23 March 2023 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 January 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Dulce Digital Text-Based Education
- Project Dulce Telehealth
- Project Dulce Live
Conditions studied
- Diabetes Type 2 — all drugs for Diabetes Type 2 →
Sponsor
Scripps Whittier Diabetes Institute
Who can join
18 and older, any sex, with Diabetes Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05416060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Scripps Whittier Diabetes Institute trials
Trials by the same sponsor.
- NCT06296550 — Enhancing Digitally Delivered Diabetes Education With Real-Time CGM · NA · recruiting
- NCT06501612 — Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App With Dexcom G7 · NA · completed
- NCT05580536 — Project Dulce for Arab Americans With Type 2 Diabetes · NA · recruiting
- NCT05378620 — Project Dulce for Filipino-Americans With Type 2 Diabetes · NA · completed
- NCT05307237 — Continuous Glucose Monitoring for High-Risk Type 2 Diabetes in the Hospital (Cyber GEMS) · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05416060 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Scripps Whittier Diabetes Institute
- Last refreshed: 22 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05416060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing