Skip to main content
OpenTrials
Completed

NCT Number: NCT03130699

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

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 health.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Mercy Chula Vista, Chula Vista, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified Hispanic/Latino
  • 18 years or older
  • Registered patient of a Neighborhood Healthcare Clinic
  • Diagnosed with T2DM (Type 2 Diabetes Mellitus)
  • HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days

Exclusion criteria

  • Severe illness precluding regular clinic visits
  • Pregnant or lactating
  • Type 1 or gestational diabetes
  • Lack of minimal literacy
  • Plans to relocate
  • Severe auditory or visual problems
  • Primary language other than Spanish or English
  • Unwilling to carry a mobile phone

Treatment and study plan

Dulce Digital

Behavioral

One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.

Dulce Digital-Me (Automated Delivery)

Behavioral

Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.

Dulce Digital-Me (Medical Assistant)

Behavioral

Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.

Primary outcomes

  1. Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment

    Time frame: 6 months from baseline

    Glycosylated Hemoglobin (HbA1c) six months after enrollment

  2. Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment

    Time frame: 12 months from baseline

    Glycosylated Hemoglobin (HbA1c) twelve months after enrollment

  3. Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment

    Time frame: 6 months from baseline

    Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment

  4. Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment

    Time frame: 12 months from baseline

    Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment

  5. Systolic Blood Pressure (SBP); 6 Months From Enrollment

    Time frame: 6 months from baseline

    Systolic blood pressure (SBP); six months from enrollment

  6. Systolic Blood Pressure (SBP); 12 Months From Enrollment

    Time frame: 12 months from baseline

    Systolic blood pressure (SBP); twelve months from enrollment

Secondary outcomes

  1. Patient-Provider Communication; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Patient-Provider Communication as reported by patient; six months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome.

  2. Patient-Provider Communication; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Patient-Provider Communication as reported by patient; twelve months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome.

  3. Patient Blood Glucose Monitoring; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Patient Blood Glucose Monitoring as reported by patient; six months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week.

    A higher value on this scale is a better outcome.

  4. Patient Blood Glucose Monitoring; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Patient Blood Glucose Monitoring as reported by patient; twelve months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week.

    A higher value on this scale is a better outcome.

  5. Participated in Aerobic Exercise; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Participated in Aerobic Exercise as reported by patient, six months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome.

  6. Participated in Aerobic Exercise; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Participated in Aerobic Exercise as reported by patient, twelve months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome.

  7. Participated in Strength Exercise; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Participated in Strength Exercise as reported by patient; six months from enrollment

  8. Participated in Strength Exercise; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Participated in Strength Exercise as reported by patient; twelve months from enrollment

  9. Participated in Flexibility Exercise; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Participated in Flexibility Exercise as reported by patient; six months from enrollment

  10. Participated in Flexibility Exercise; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Participated in Flexibility Exercise as reported by patient; twelve months from enrollment

  11. Healthy Eating Behaviors; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Healthy Eating Behaviors as reported by patient; six months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome.

  12. Healthy Eating Behaviors; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Healthy Eating Behaviors as reported by patient; twelve months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome.

  13. Diabetes Distress; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Diabetes Distress as reported by patient; six months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome.

  14. Diabetes Distress; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Diabetes Distress as reported by patient; twelve months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome.

  15. Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment

    Time frame: 6 months from baseline

    Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; six months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome.

  16. Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment

    Time frame: 12 months from baseline

    Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; twelve months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome.

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Collaborators

  • San Diego State University
  • University of California, San Diego

Registry information

Acronym: DD-Me

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2017
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.