Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes (NCT03130699) | Clinical Trial Compass
CompletedNot Applicable
Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
United States310 participantsStarted 2017-10-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a mobile health app specifically designed for underserved Hispanic adults with Type 2 diabetes — since it's now completed, can you tell me what the results showed for HbA1c, blood pressure, and LDL cholesterol, and whether those improvements were meaningful enough to consider this kind of approach for me?
2The study tracked outcomes at both 6 and 12 months, which suggests the researchers wanted to see if benefits lasted over time — do the results show that any improvements in blood sugar or blood pressure held up at the 12-month mark, or did they fade?
3Since this was a digital, app-based intervention rather than a drug or procedure, how does using a mobile health tool like this compare to the standard diabetes management support you'd already recommend for me?
4This program was designed specifically for Hispanic adults who may face barriers to care — do you think the strategies used in this trial, like culturally tailored messaging or remote check-ins, would still be relevant and practical for my situation?
5Given that this trial is completed and not enrolling anyone, are there similar digital health programs or studies currently available that I could actually participate in or access right now to help manage my Type 2 diabetes?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment
Timeframe: 6 months from baseline
2
Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment
Timeframe: 12 months from baseline
3
Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment
Timeframe: 6 months from baseline
4
Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment
Timeframe: 12 months from baseline
5
Systolic Blood Pressure (SBP); 6 Months From Enrollment
Timeframe: 6 months from baseline
6
Systolic Blood Pressure (SBP); 12 Months From Enrollment