Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes

Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - Any
Start Date:June 22, 2017
End Date:August 2021
Contact:Athena Philis-Tsimikas, MD

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This study will compare Dulce Digital (i.e., the investigators' proven-effective combination
of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted
blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile
health) intervention that is tailored to individuals' needs and behavioral progress, in
improving diabetes clinical control, adherence, and patient-provider communication in
Hispanics - an at-risk, understudied population that experiences disparities in diabetes
prevalence and outcomes. These striking disparities in the growing and aging US Hispanic
population have taxed the US healthcare system, while significantly reducing quantity and
quality of life for millions of individuals. By offering an innovative, scalable, and
sustainable approach that seamlessly integrates several mHealth technologies into existing
primary care team processes to improve the health of Hispanics (and eventually, other
at-risk, underserved groups), DD-Me has strong potential to significantly impact public

Individuals of low socioeconomic (SES) and ethnic minority status, including Hispanics, the
largest U.S. ethnic minority group, are disproportionately affected by diabetes. Poor
healthcare access and cultural barriers prevent optimal care, adherence, and clinical
benefit, thus placing Hispanics at high risk for costly diabetes complications. The
investigators' established academic-healthcare-community partnership has unique experience in
developing and testing innovative, cost-effective, and sustainable chronic care interventions
to reduce disparities and improve health in underserved communities. The investigators
recently developed Dulce Digital (i.e., "one-size-fits-all" educational text messages, with
nurse monitoring of patient-transmitted blood glucose values), which improved glycemic
control across 6 months, relative to usual care in a recent randomized controlled trial (RCT)
of N=126 Hispanic patients with poorly controlled type 2 diabetes (T2DM). The process
evaluation for this trial indicated that Dulce Digital was both feasible and acceptable from
patient and provider perspectives; however, patients expressed a preference for a more
individualized intervention, and providers requested an even greater focus on health behavior
change. Thus, the proposed RCT will examine the comparative effectiveness of Dulce Digital
versus "Dulce Digital-Me" (DD-Me) in N=414 Hispanic adults of low SES with poorly controlled
T2DM from Neighborhood Healthcare, a San Diego Federally-Qualified Health Center. Guided by
patient and provider feedback, DD-Me includes Dulce Digital components plus personalized
goal-setting and feedback that is responsive to the individual's needs and preferences. The
DD-Me adaptive feedback component will be informed by the Resources and Support for
Self-Management Model and Operant Conditioning Theory, and based on the individual's progress
on intermediate behavioral targets (i.e., medication adherence assessed by wireless sensor;
brief mobile phone-based assessments of diet, physical activity, stress). Feedback will be
delivered via algorithm-driven automated messaging in 50% of DD-Me participants and by the
care team medical assistant in the remaining half to determine the feasibility and
acceptability (given the purported cultural relevance of interpersonal relationships in the
Hispanic culture), and the comparative effectiveness and cost of each delivery method.
Changes in indicators of diabetes clinical control [i.e., glycosylated hemoglobin (HbA1c) low
density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP)], patient-provider
communication, and patient adherence (i.e., to medication and other diabetes self-management
behaviors) will be evaluated across twelve months. Thorough process and cost-effectiveness
analyses will evaluate the scalability and sustainability potential of DD-Me. This
comparative evaluation of two mHealth approaches will elucidate how technology can be
integrated most effectively and efficiently within existing nurse-led chronic care approaches
to meet the complex needs of underserved individuals with poorly controlled T2DM.

Inclusion Criteria:

1. Self-identified Hispanic/Latino

2. 18 years or older

3. Registered patient of a Neighborhood Healthcare Clinic

4. Diagnosed with T2DM (Type 2 Diabetes Mellitus)

5. HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days

Exclusion Criteria:

1. Severe illness precluding regular clinic visits

2. Pregnant or lactating

3. Type 1 or gestational diabetes

4. Lack of minimal literacy

5. Plans to relocate

6. Severe auditory or visual problems

7. Primary language other than Spanish or English

8. Unwilling to carry a mobile phone
We found this trial at
La Jolla, California
Principal Investigator: Athena Philis-Tsimikas, MD
Phone: 858-678-7046
La Jolla, CA
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Chula Vista, California 91910
Chula Vista, CA
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