Trial results for Dulce Digital-Me, an adaptive mHealth intervention for Type 2 Diabetes, were posted on 2025-06-25. The study enrolled 310 participants to compare different mobile health strategies for improving diabetes control in underserved Hispanic populations.

Background

Type 2 Diabetes is a chronic condition with significant health disparities, particularly among Hispanic populations who experience higher prevalence and poorer outcomes. Mobile health (mHealth) interventions, such as educational text messages and remote monitoring of patient-transmitted blood glucose values, are being explored as tools to improve diabetes clinical control, adherence, and patient-provider communication, especially in at-risk groups.

Trial design

This study, designated as Phase NA, enrolled 310 subjects with Diabetes Mellitus, Type 2. The trial compared Dulce Digital, an existing mHealth intervention, with Dulce Digital-Me (DD-Me), an adaptive and dynamic mHealth intervention tailored to individuals' needs and behavioral progress. The DD-Me intervention was delivered through different approaches: Automated Delivery and Medical Assistants, as well as a combined approach. While specific primary outcomes were not detailed in the posted results, key measurements included Glycosylated Hemoglobin (HbA1c) and Low-density Lipoprotein-cholesterol (LDL-C).

Key results

The study reported on Glycosylated Hemoglobin (HbA1c) and Low-density Lipoprotein-cholesterol (LDL-C) at various time points:

Key analyses using Logistic Regression, controlled for age, gender, employment, and language, showed p-values of 0.95, 0.37, 0.26, 0.9, 0.21, and 0.3, indicating no statistically significant differences between the intervention groups for the analyzed outcomes.

What this means

The results suggest that while mHealth interventions are a valuable tool for diabetes management, the adaptive tailoring strategies implemented in Dulce Digital-Me (Automated Delivery, Medical Assistants, or combined) did not demonstrate a statistically significant advantage over the standard Dulce Digital intervention in improving HbA1c or LDL-C levels in this population. The high p-values from the logistic regression analyses indicate that any observed differences in mean values across groups were not statistically significant, implying that these specific adaptive modifications may not have led to a distinct clinical benefit for these measured endpoints.

Source

The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03130699, titled "Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes", were posted on 2025-06-25 on clinicaltrials.gov.