Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
Dulce Digital
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
March 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedJune 22, 2025
June 1, 2025
2.9 years
June 6, 2022
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.
3 months
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.
6 months
Secondary Outcomes (4)
Change from Baseline Diabetes Distress (DDS-17) at 3 months
3 months
Change from Baseline Diabetes Distress (DDS-17) at 6 months
6 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months
3 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 6 months
6 months
Study Arms (3)
Dulce Digital
EXPERIMENTALPatients will participate in a text-based diabetes self-management educational and support (DSME/S) program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.
Project Dulce Telehealth DSME/S
EXPERIMENTALPatients will participate in live a peer-led Telehealth diabetes self-management education and support program.
Project Dulce Live DSME/S
EXPERIMENTALPatients will participate in live a peer-led Telehealth diabetes self-management education and support program.
Interventions
Participants will be enrolled in the digital texting platform, Dulce Digital in which they will receive on-going support via text messages for 6 months, derived from the Project Dulce curriculum. Topics include medication reminders, motivational prompts, nutrition and stress reduction tips and request to submit weekly blood glucose numbers.
Project Dulce will consist of a group-based telehealth diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes.
Project Dulce will consist of a group-based diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Scripps Chula Vista Diabetes Center
Chula Vista, California, 91910, United States
Scripps Whittier Diabetes Institute
San Diego, California, 92121, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Athena Philis-Tsimikas, MD
Scripps Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This is a three-arm, non-blinded, randomized, controlled, parallel-groups, comparative effectiveness trial with N=150 participants.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2022
First Posted
June 13, 2022
Study Start
March 23, 2023
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
June 22, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share