N/A
Completed N=12
Online Diabetes Education Project (ODEP)
Source: ClinicalTrials.gov NCT04743778 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Metabolic Control of A1c (Mean Change in A1C) — -0.02 percent
Summary
This pilot randomized control trial will be testing an empowerment-based virtual group diabetes self-management education and support (DSME/S) for African American/Black adults with type 2 diabetes living in Detroit. Participants will be randomized to either a control group or the virtual DSME/S group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Control of A1c (Mean Change in A1C) |
-0.02 | — |
| PRIMARY Depression |
-0.79 | — |
| PRIMARY Regimen Adherence |
1.12 | — |
| SECONDARY Body Mass Index (BMI) |
-0.54 | — |
| SECONDARY Blood Pressure |
7.75; 5.33 | — |
| SECONDARY Diabetes Social Support |
0.48 | — |
| SECONDARY Diabetes-Related Distress |
-5.72 | — |
| SECONDARY Diabetes Quality of Life |
0.14 | — |
Eligibility Criteria
Inclusion Criteria
- Agee 18 or older, Black, a diagnosis of T2D for one year duration or longer, ambulatory status.
Exclusion Criteria
- Non-ambulatory, serious health conditions (morbid obesity and severe symptomatic heart disease, visual impairment, renal failure, and peripheral neuropathy), psychiatric illness (severity requiring hospitalization) or cognitive deficit (illness determined using the Montreal Cognitive Assessment tool) and serious diabetes complications (e.g. blindness) that would impede meaningful participation
Data sourced from ClinicalTrials.gov (NCT04743778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.