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NCT06321029 · ClinicalTrials.gov registry record · NA
Electronic Diabetes Tune-Up Group (eDTU) for African Americans
A NA study of Diabetes Mellitus, Type 2 and Diabetes Complications, sponsored by Indiana University.
- Active
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06321029 is a NA study of Diabetes Mellitus, Type 2 and Diabetes Complications that is active but no longer recruiting, run by Indiana University. The registered enrollment target is 60 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06321029, a NA study of Diabetes Mellitus, Type 2 and Diabetes Complications, is active but no longer recruiting, sponsored by Indiana University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Diabetes Tune-Up Group
Study Locations (1)
Indiana
- Indiana University School of Medicine - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-10-19 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06321029
The ClinicalTrials.gov registry entry for NCT06321029 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 1 intervention - of which Diabetes Tune-Up Group is the first listed.
NCT06321029 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT06321029 about?
NCT06321029 is a clinical study titled "Electronic Diabetes Tune-Up Group (eDTU) for African Americans". 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...
What is the current status of trial NCT06321029?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2023-10-19. Estimated completion is 2026-03-31.
What conditions does trial NCT06321029 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes Complications.
What interventions are being tested in trial NCT06321029?
The interventions under investigation include: Diabetes Tune-Up Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT06321029?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06321029 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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