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Diabetes Self-Management Program for Type 2 Diabetes (MenD 2 Trial)

N/A

Waitlist Available

Led By Jaclynn Hawkins, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Black/African American males, age 21 years or older with diagnosis of T2D for six months

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3-months, 9-months, 15-months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking to test the feasibility and acceptability of a diabetes self-management program for black men with type 2 diabetes.

Who is the study for?

The Michigan Men's Diabetes Project 2 is seeking Black men over the age of 21 with type 2 diabetes diagnosed for at least six months. Participants must be under a doctor's care, have reliable transportation, and an A1c level of 8% or higher. They should be willing to attend group sessions and complete health assessments throughout the study.

What is being tested?

This trial tests whether peer-led diabetes self-management support (DSMS) improves health outcomes in addition to standard diabetes education. Half will receive DSMS from trained peers for six months, followed by ongoing group-chosen support activities; all get ten hours of education from a specialist.

What are the potential side effects?

Since this trial involves educational interventions rather than medications, there are no direct medical side effects expected. However, participants may experience stress or time constraints due to regular attendance and engagement requirements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a Black/African American male, 21 or older, diagnosed with type 2 diabetes for six months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3-months, 9-months, 15-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3-months, 9-months, 15-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3-months, 9-months, 15-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hemoglobin A1c

Change in Regimen Adherence

Secondary study objectives

Change in Adherence to gender norms

Change in Blood Pressure

Change in Body Mass Index

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer led diabetes self-management support (PLDSMS)Experimental Treatment2 Interventions

Participants in the PLDSMS arm will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. This group will then transition into monthly 90-minute diabetes self-management support (DSMS) with trained peer leaders for 6 months. After the DSMS sessions, the group will transition into 6 months of ongoing support and will be encouraged to continue DSMS through initiatives that are important to them.

Group II: Control GroupActive Control1 Intervention

Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes Self-Management Education

2016

N/A

~520

0 / 1Eligibility criteria met