N/A
Completed N=310
Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
Source: ClinicalTrials.gov NCT03130699 ↗Enrolled (actual)
310
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment — 8.17; 7.99; 8.44; 8.21 percentage — p=0.95
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment |
8.17; 7.99; 8.44; 8.21 | 0.95 |
| PRIMARY Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment |
8.29; 8.41; 8.83; 8.62 | 0.37 |
| PRIMARY Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment |
90.27; 88.20; 102.93; 95.69 | 0.26 |
| PRIMARY Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment |
97.85; 94.10; 92.04; 93.08 | 0.90 |
| PRIMARY Systolic Blood Pressure (SBP); 6 Months From Enrollment |
126.70; 124.84; 124.78; 124.81 | 0.21 |
| PRIMARY Systolic Blood Pressure (SBP); 12 Months From Enrollment |
125.10; 122.82; 124.13; 123.47 | 0.30 |
| SECONDARY Patient-Provider Communication; 6 Months From Enrollment |
4.18; 4.04; 4.28; 4.16 | 0.90 |
| SECONDARY Patient-Provider Communication; 12 Months From Enrollment |
4.09; 3.99; 4.16; 4.06 | 0.72 |
| SECONDARY Patient Blood Glucose Monitoring; 6 Months From Enrollment |
5.07; 5.62; 5.11; 5.37 | 0.61 |
| SECONDARY Patient Blood Glucose Monitoring; 12 Months From Enrollment |
5.08; 4.77; 5.15; 4.94 | 0.49 |
| SECONDARY Participated in Aerobic Exercise; 6 Months From Enrollment |
5.46; 5.29; 5.49; 5.41 | 0.96 |
| SECONDARY Participated in Aerobic Exercise; 12 Months From Enrollment |
5.11; 5.12; 4.72; 4.94 | 0.64 |
| SECONDARY Participated in Strength Exercise; 6 Months From Enrollment |
20; 11; 10; 21 | 0.87 |
| SECONDARY Participated in Strength Exercise; 12 Months From Enrollment |
12; 9; 8; 17 | 0.58 |
| SECONDARY Participated in Flexibility Exercise; 6 Months From Enrollment |
44; 39; 31; 70 | 0.25 |
| SECONDARY Participated in Flexibility Exercise; 12 Months From Enrollment |
29; 34; 15; 49 | 0.11 |
| SECONDARY Healthy Eating Behaviors; 6 Months From Enrollment |
50.12; 50.48; 49.41; 49.98 | 0.76 |
| SECONDARY Healthy Eating Behaviors; 12 Months From Enrollment |
51.04; 50.24; 50.67; 50.43 | 0.05 |
| SECONDARY Diabetes Distress; 6 Months From Enrollment |
2.16; 2.12; 2.16; 2.14 | 0.63 |
| SECONDARY Diabetes Distress; 12 Months From Enrollment |
1.96; 2.23; 2.07; 2.16 | 0.63 |
| SECONDARY Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment |
17.23; 16.31; 16.12; 16.22 | 0.002 sig |
| SECONDARY Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment |
16.68; 16.25; 15.85; 16.08 | 0.008 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03130699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.