Dulce Digital for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Scripps Whittier Diabetes Institute, San Diego, CA
Diabetes Mellitus, Type 2+2 More
Dulce Digital Text-Based Education - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 6 months

3 months
Change from Baseline Diabetes Distress (DDS-17) at 3 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
6 months
Change from Baseline Diabetes Distress (DDS-17) at 6 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 6 months
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Trial Design

3 Treatment Groups

Dulce Digital
1 of 3
Project Dulce Live DSME/S
1 of 3
Project Dulce Telehealth DSME/S
1 of 3
Experimental Treatment

150 Total Participants · 3 Treatment Groups

Primary Treatment: Dulce Digital · No Placebo Group · N/A

Dulce Digital
Behavioral
Experimental Group · 1 Intervention: Dulce Digital Text-Based Education · Intervention Types: Behavioral
Project Dulce Live DSME/S
Behavioral
Experimental Group · 1 Intervention: Project Dulce Live · Intervention Types: Behavioral
Project Dulce Telehealth DSME/S
Behavioral
Experimental Group · 1 Intervention: Project Dulce Telehealth · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Scripps Whittier Diabetes Institute · San Diego, CA
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2010First Recorded Clinical Trial
15 TrialsResearching Diabetes Mellitus, Type 2
18 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a Hispanic/Latino adult who is a registered patient of Scripps Health.
You have Type 2 diabetes.
You have a HbA1c level greater than or equal to 8% within the last 60 days.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.