NCT05416060 Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age

Eligibility & Interventions

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This trial targets 150 participants in total. It began in 2023-03-23 with a primary completion date of 2026-12-31.

Brief 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.

Eligibility 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

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