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Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
NA trial testing Dulce Digital in Diabetes Mellitus, Type 2 in 310 participants. Completed in 14 August 2021.
| Lead sponsor | Scripps Whittier Diabetes Institute |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 310 |
| Start date | 31 October 2017 |
| Primary completion | 14 August 2021 |
| Estimated completion | 14 August 2021 |
| Sites | 2 locations across United States |
Scripps Whittier Diabetes Institute
18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Glycosylated Hemoglobin (HbA1c) six months after enrollment
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 8.17 | ± 1.51 |
| Dulce Digital-Me (Automated Delivery) | 7.99 | ± 1.61 |
| Dulce Digital-Me (Medical Assistants) | 8.44 | ± 1.48 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 8.21 | ± 1.56 |
Glycosylated Hemoglobin (HbA1c) twelve months after enrollment
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 8.29 | ± 1.62 |
| Dulce Digital-Me (Automated Delivery) | 8.41 | ± 1.70 |
| Dulce Digital-Me (Medical Assistants) | 8.83 | ± 1.83 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 8.62 | ± 1.77 |
Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 90.27 | ± 33.66 |
| Dulce Digital-Me (Automated Delivery) | 88.20 | ± 36.38 |
| Dulce Digital-Me (Medical Assistants) | 102.93 | ± 47.96 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 95.69 | ± 43.12 |
Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 97.85 | ± 27.74 |
| Dulce Digital-Me (Automated Delivery) | 94.10 | ± 35.18 |
| Dulce Digital-Me (Medical Assistants) | 92.04 | ± 43.23 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 93.08 | ± 39.18 |
Systolic blood pressure (SBP); six months from enrollment
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 126.70 | ± 19.52 |
| Dulce Digital-Me (Automated Delivery) | 124.84 | ± 18.66 |
| Dulce Digital-Me (Medical Assistants) | 124.78 | ± 19.13 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 124.81 | ± 18.83 |
Systolic blood pressure (SBP); twelve months from enrollment
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 125.10 | ± 17.38 |
| Dulce Digital-Me (Automated Delivery) | 122.82 | ± 15.29 |
| Dulce Digital-Me (Medical Assistants) | 124.13 | ± 19.54 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 123.47 | ± 17.49 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 4.18 | ± 1.05 |
| Dulce Digital-Me (Automated Delivery) | 4.04 | ± 1.02 |
| Dulce Digital-Me (Medical Assistants) | 4.28 | ± 0.80 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 4.16 | ± 0.92 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 4.09 | ± 1.03 |
| Dulce Digital-Me (Automated Delivery) | 3.99 | ± 1.04 |
| Dulce Digital-Me (Medical Assistants) | 4.16 | ± 0.96 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 4.06 | ± 1.00 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 5.07 | ± 2.29 |
| Dulce Digital-Me (Automated Delivery) | 5.62 | ± 1.99 |
| Dulce Digital-Me (Medical Assistants) | 5.11 | ± 2.41 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 5.37 | ± 2.21 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 5.08 | ± 2.19 |
| Dulce Digital-Me (Automated Delivery) | 4.77 | ± 2.65 |
| Dulce Digital-Me (Medical Assistants) | 5.15 | ± 2.41 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 4.94 | ± 2.54 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 5.46 | ± 1.48 |
| Dulce Digital-Me (Automated Delivery) | 5.29 | ± 1.50 |
| Dulce Digital-Me (Medical Assistants) | 5.49 | ± 1.45 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 5.41 | ± 1.47 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Dulce Digital | 5.11 | ± 1.48 |
| Dulce Digital-Me (Automated Delivery) | 5.12 | ± 1.77 |
| Dulce Digital-Me (Medical Assistants) | 4.72 | ± 1.94 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | 4.94 | ± 1.85 |
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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