NCT06321029Completed
Electronic Diabetes Tune-Up Group (eDTU) for African Americans
Electronic Diabetes Tune-Up Group (eDTU) for African Americans: A Pragmatic Trial Phase 2
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
The primary aims of this study are: 1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates). 2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control. Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 4 Jan 2024
- Start date
- 19 Oct 2023
- Primary completion date
- 31 Mar 2026
- Lead sponsor
- Indiana University
- Diseases
- Type 2 diabetes
- NCT number
- NCT06321029
What you commit to
- Study type: Interventional
- Participants enrolled: 63
- From 19 Oct 2023 to the primary completion date, 31 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation of new medical treatment regimens (e.g., chemotherapy) for acute medical diagnoses that would require the patient's primary attention
Other illness
- Presence of serious mental health disorder (e.g., psychotic disorders or severe mood disorders with suicidal ideation)
- Diagnosis of a major acute medical condition (e.g., myocardial infarction, stroke, cardiac rehabilitation, stage 3 or stage 4 cancer diagnoses) within the last three months
Other
- Limited English language proficiency
Who the study is looking for
- Age ≥ 21 years
- Self-identified Black or African American female
- Type 2 diabetes diagnosis ≥ 1 year
- A1c ≥ 7.0% in the past year per medical record or patient report
- DDS-17 score ≥ 2.0 at screening
- Active email address
Age in the registry: 21 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.