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

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Diabetes Prevention

Treatment

Project Dulce Telehealth

Project Dulce Live

Dulce Digital Text-Based Education

Clinical Study ID

NCT05416060

MISP-60691

Ages > 18
All Genders

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.

Eligibility Criteria

Inclusion

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

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, orwhose 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 donationwithin 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

Study Design

Project Dulce Telehealth

March 23, 2023

November 30, 2024

Study Description

Diabetes self-management education using digital platforms including, telehealth group visits, text-based messages and live delivery will result in improvements in diabetes health behaviors, patient engagement, health literacy and HbA1c.

Diabetes disproportionately affects racial and ethnic communities. The investigator developed Project Dulce, an American Diabetes Association-recognized and Medicare-approved Diabetes Self-Management Education and Support (DSME/S) program addresses the needs of a racially and ethnically diverse San Diego population and includes a multi-disciplinary team with peer educators delivering DSME/S. Previous trials have shown Project Dulce team-care improves clinical management and reduces costs and that the peer education alone improves clinical outcomes in Hispanics with Type 2 Diabetes across 10 months.

Mobile health (mHealth) technologies represent a viable way to overcome many of these barriers and extend the reach of DSME/S to participants who need it most.

During the coronavirus disease (COVID-19) pandemic, Project Dulce was adapted for group telehealth settings and delivered via the electronic medical record (EMR) scheduling system. Additionally, a previously developed text messaging platform-Dulce Digital was offered to extend the reach of the care team through educational and motivational messaging, medication reminders, and blood glucose monitoring prompts. A previous randomized controlled trial of Dulce Digital demonstrated a significant reduction of HbA1c across 10 months versus usual care in Hispanics with diabetes. While live Project Dulce and Dulce Digital programs have demonstrated improvements in clinical and cost outcomes in Hispanic patients, a comparative analysis of live, group telehealth and text messaging programs has not been done. This study will assess a direct comparison of each of these modalities to explore the feasibility, acceptance, and effectiveness of each delivery modality across Hispanic communities living with type 2 diabetes.

Connect with a study center

Scripps Chula Vista Diabetes Center
Chula Vista, California 91910
United States
Active - Recruiting
Scripps Whittier Diabetes Institute
San Diego, California 92121
United States
Active - Recruiting

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