Diabetes Self-Management Education for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MI
Diabetes Mellitus, Type 2+1 More
Diabetes Self-Management Education - Behavioral
Eligibility
18+
Male
What conditions do you have?
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Study Summary

This trial is looking to test the feasibility and acceptability of a diabetes self-management program for black men with type 2 diabetes. The purpose of this trial is to test the effectiveness of Diabetes Self-Management Education as a treatment for Diabetes Mellitus, Type 2. No patients in this trial will receive a placebo. Diabetes Self-Management Education has previously been approved by the FDA for a different condition, but this will be the first time it is being tested as a treatment for Diabetes Mellitus, Type 2.

Eligible Conditions

  • Diabetes Mellitus, Type 2

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: baseline, 3-months, 9-months, 15-months

baseline, 3-months, 9-months, 15-months
Change in Adherence to gender norms
Change in Blood Pressure
Change in Body Mass Index
Change in Depression
Change in Diabetes Quality of Life
Change in Diabetes Social Support
Change in Diabetes-Related Distress
Change in Hemoglobin A1c
Change in Regimen Adherence

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control Group
1 of 2
Peer led diabetes self-management support (PLDSMS)
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Diabetes Self-Management Education · No Placebo Group · N/A

Peer led diabetes self-management support (PLDSMS)Experimental Group · 2 Interventions: Peer Led Diabetes Self-Management Support, Diabetes Self-Management Education · Intervention Types: Behavioral, Behavioral
Control Group
Behavioral
ActiveComparator Group · 1 Intervention: Diabetes Self-Management Education · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes Self-Management Education
2016
N/A
~520

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3-months, 9-months, 15-months
Closest Location: University of Michigan · Ann Arbor, MI
Photo of university of michigan comprehensive cancer center 1Photo of university of michigan comprehensive cancer center 2Photo of university of michigan comprehensive cancer center 3
2022First Recorded Clinical Trial
24 TrialsResearching Diabetes Mellitus, Type 2
1012 CompletedClinical Trials

Who is running the clinical trial?

University of MichiganLead Sponsor
1,597 Previous Clinical Trials
6,328,281 Total Patients Enrolled
32 Trials studying Diabetes Mellitus, Type 2
4,673 Patients Enrolled for Diabetes Mellitus, Type 2
Jaclynn Hawkins, PhDPrincipal InvestigatorUniversity of Michigan, School of Social Work

Eligibility Criteria

Age 18+ · Male Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.