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Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
NCT05416060 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BEHAVIORAL Dulce Digital Text-Based Education
- BEHAVIORAL Project Dulce Telehealth
- BEHAVIORAL Project Dulce Live
Study Locations (2)
California
- Scripps Chula Vista Diabetes Center — Chula Vista
- Scripps Whittier Diabetes Institute — San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2026-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05416060
The ClinicalTrials.gov registry entry for NCT05416060 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Scripps Whittier Diabetes Institute, which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetes Type 2 appearing as the primary indexed condition, and to 3 interventions — of which Dulce Digital Text-Based Education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05416060 reports 2 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05416060 about?
NCT05416060 is a clinical study titled "Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age". 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 o...
What is the current status of trial NCT05416060?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2023-03-23. Estimated completion is 2026-01-31.
What conditions does trial NCT05416060 study?
This clinical trial studies the following conditions: Diabetes Type 2. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05416060?
The interventions under investigation include: Dulce Digital Text-Based Education (BEHAVIORAL), Project Dulce Telehealth (BEHAVIORAL), Project Dulce Live (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05416060?
This trial is sponsored by Scripps Whittier Diabetes Institute, which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05416060 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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