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NCT05370781 · ClinicalTrials.gov registry record · NA
Michigan Men's Diabetes Project 2
A NA study of Diabetes Mellitus, Type 2, sponsored by University of Michigan.
- Active
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT05370781: Active NA study of Diabetes Mellitus, Type 2, sponsored by University of Michigan.
NCT05370781 is a NA study of Diabetes Mellitus, Type 2 that is active but no longer recruiting, run by University of Michigan. The registered enrollment target is 48 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05370781, a NA study of Diabetes Mellitus, Type 2, is active but no longer recruiting, sponsored by University of Michigan.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for their diabetes, have access to reliable transportation for study activities, and be willing to participate in 4 health assessments where they will get their A1C, blood pressure, height, and weight measured and they will complete a survey. All participants will receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist. Participants randomized to the intervention arm will also be offered 6 months of monthly diabetes self-management support (DSMS) sessions with trained Peer Leaders who are also Black men with type 2 diabetes. After the 6 months of support, this group will transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes related initiatives that are important to the group and chosen by the group. Due to the COVID-19 pandemic, DSME and DSMS sessions will likely be held via Zoom, ongoing support sessions have potential to be in person. The 4 health assessments will take place at baseline, 3-months, 9-months, and 15-months.
Primary Outcome
Anthropometric data/clinical data - Change in HbA1c. HbA1c was measured using the DCA 2000 point-of-care testing instrument. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Conditions Studied
Interventions
- BEHAVIORAL Peer Led Diabetes Self-Management Support
- BEHAVIORAL Diabetes Self-Management Education
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT05370781 still lists
NCT05370781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Peer Led Diabetes Self-Management Support is the first listed.
NCT05370781 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT05370781 about?
NCT05370781 is a clinical study titled "Michigan Men's Diabetes Project 2". The Michigan Men's Diabetes Project 2 (MenD 2) is an 18-month pilot randomized clinical trial. We are looking to recruit 60 Black men with type 2 diabetes (need to have diagnosis for at least 6 months) that are over the age of 21. Interested participants need to be under the care of a physician for ...
What is the current status of trial NCT05370781?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 48 participants. The study started on 2022-05-01. Estimated completion is 2026-06-30.
What conditions does trial NCT05370781 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05370781?
The interventions under investigation include: Peer Led Diabetes Self-Management Support (BEHAVIORAL), Diabetes Self-Management Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT05370781?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05370781 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05370781's enrollment target sits among peer trials
48 267th of 348 higher than 79 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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