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

N/A

Recruiting

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

MenD 2 Trial 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.Check my eligibility

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.See study design

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.

MenD 2 Trial 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.

MenD 2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Hemoglobin A1c

Change in Regimen Adherence

Secondary outcome measures

Change in Adherence to gender norms

Change in Blood Pressure

Change in Body Mass Index

+4 more

MenD 2 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

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,796 Previous Clinical Trials

6,377,896 Total Patients Enrolled

Jaclynn Hawkins, PhDPrincipal InvestigatorUniversity of Michigan, School of Social Work

1 Previous Clinical Trials

80 Total Patients Enrolled

Media Library

Diabetes Self-Management Education (NA) Clinical Trial Eligibility Overview. Trial Name: NCT05370781 — N/A

Type 2 Diabetes Research Study Groups: Peer led diabetes self-management support (PLDSMS), Control Group

Type 2 Diabetes Clinical Trial 2023: Diabetes Self-Management Education Highlights & Side Effects. Trial Name: NCT05370781 — N/A

Diabetes Self-Management Education (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05370781 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current phase of this experiment actively seeking participants?

"Correct. Per the information on clinicaltrials.gov, this medical trial is currently recruiting potential participants. The initial posting was made on May 1st 2022 and most recently updated in October 20th 2022. A total of 60 candidates are needed from a single site for enrolment."

Answered by AI

What objectives is this trial hoping to accomplish?

"This clinical trial intends to measure Change in Regimen Adherence over a baseline, 3-month, 9-month and 15-month period. Secondary goals include assessing Change in Diabetes Quality of Life via survey data, Blood Pressure as Anthropometric/clinical data, and adherence with gender norms as indicated by survey results."

Answered by AI

What is the aggregate amount of individuals participating in this experiment?

"Affirmative. The details posted on clinicaltrials.gov confirm that this medical research, which was originally added to the database on May 1st 2022, is actively searching for test subjects. Approximately 60 individuals are required from a single study location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Michigan Men's Diabetes Project 2

Jaclynn Hawkins 2022. "Michigan Men's Diabetes Project 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05370781.

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