Diabetes Self-Management Program for Type 2 Diabetes

(MenD 2 Trial)

Overseen By Jaclynn Hawkins, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Black men with type 2 diabetes manage their condition better through education and support. Participants will receive diabetes self-management education and, if selected for the experimental group, additional support from peers with similar experiences. The researchers aim to determine if these peer-led sessions improve diabetes management. Men who have had type 2 diabetes for at least six months, are under a doctor's care, and can attend sessions might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance diabetes care for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diabetes self-management program is safe?

Research shows that peer-led diabetes self-management support (PLDSMS) is generally safe for people with type 2 diabetes. Studies have found that these programs help improve blood sugar control, often measured by HbA1c levels, without causing harm. Participants usually report a better quality of life and feel more confident in managing their diabetes. These support programs have not been linked to major negative effects, suggesting that PLDSMS is well-tolerated by most people.

These findings can reassure potential participants about the safety of joining such programs. Overall, the evidence supports that these educational and support sessions are beneficial and safe for those with type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Self-Management Program for Type 2 Diabetes because it emphasizes a peer-led support system that adds a unique layer to the standard diabetes care. Unlike typical treatments that mainly involve medication and dietary plans, this program includes ongoing support through trained peer leaders, which could enhance motivation and adherence to self-management practices. This peer support approach aims to empower participants by fostering community and shared experiences, potentially leading to better long-term management of diabetes.

What evidence suggests that this trial's diabetes self-management programs could be effective for type 2 diabetes?

Studies have shown that support from others can significantly help people with type 2 diabetes manage their condition and control blood sugar levels. In this trial, participants in the Peer Led Diabetes Self-Management Support (PLDSMS) arm will receive both diabetes self-management education and ongoing peer support. Research indicates that learning to manage diabetes, combined with peer support, leads to better habits, such as taking medications properly. Peer support has also been found to enhance quality of life and confidence in managing diabetes. Specifically, people with type 2 diabetes who joined peer-led programs experienced health improvements over time. These findings suggest that support from others could effectively manage type 2 diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Jaclynn Hawkins, PhD

Principal Investigator

University of Michigan, School of Social Work

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am being treated for diabetes by a doctor.

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

I am willing to participate in group sessions.

Exclusion Criteria

Your A1c level (a measure of blood sugar control) is less than 8%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diabetes Self-Management Education (DSME)

All participants receive 10 hours of diabetes self-management education with a Certified Diabetes Care and Education Specialist

Approximately 1 month

1 visit (in-person or virtual)

Diabetes Self-Management Support (DSMS)

Participants in the intervention arm receive monthly diabetes self-management support sessions with trained Peer Leaders for 6 months

6 months

6 visits (virtual)

Ongoing Support

Participants in the intervention arm transition into 6 months of ongoing support where they can continue DSMS and/or other diabetes-related initiatives

6 months

Potential for in-person visits

Follow-up

Participants are monitored for changes in health metrics such as A1C, blood pressure, and BMI at baseline, 3-months, 9-months, and 15-months

18 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Self-Management Education
• Peer Led Diabetes Self-Management Support

Trial Overview 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.

How Is the Trial Designed?

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

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

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Participation in a 6-week Diabetes Self-Management Education (DSME) program led to a significant reduction in hemoglobin A1c (HgbA1c) levels by 1.6% in overweight/obese patients, indicating improved glycemic control.

While BMI did not change significantly, participants showed marked improvements in diabetes knowledge and confidence, suggesting that DSME enhances self-management skills in community health center patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Diabetes Self-Management Education in Community Health. Brown, K., Lee, LT., Selleck, C.[2020]

Intensive glycaemic management through diabetes self-management education programs has been shown to improve health outcomes for both type 1 and type 2 diabetes patients, enhancing their knowledge, skills, and motivation.

These programs are effective and cost-efficient, but they need to be tailored to specific populations considering various factors like type of diabetes and cultural background to maximize access and uptake globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes structured self-management education programmes: a narrative review and current innovations. Chatterjee, S., Davies, MJ., Heller, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8920738/

The effect of peer support in diabetes self-management ... This study aimed to review the effectiveness of DSME interventions integrated with peer support on glycemic control in patients with type 2 diabetes. METHODS. A ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10885823/

Peer Support for Type 2 Diabetes Management in Low Studies have shown that different forms of peer support can help to improve self-management behaviours, including adherence to prescribed ...

3. diabetesresearchclinicalpractice.com diabetesresearchclinicalpractice.com/article/S0168-8227(24)00047-0/fulltext

Benefits of 12-month peer support for diabetes self ... Peer support (PS) is effective in diabetes management but sustained benefits have not been well documented. •. After active program support ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399124000399

Effect of peer support interventions in patients with type 2 ... A narrative synthesis of the results showed that peer support significantly improved QOL, self-management, self-efficacy, and HbA1c control in patients with ...

5. diabetesjournals.org diabetesjournals.org/care/article/48/5/807/158051/Community-Based-Peer-Support-for-Diabetes

Community-Based Peer Support for Diabetes Management For example, one study reported the effectiveness of a peer leader program in sustaining benefits of a 6-month community health worker diabetes ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39696177/

The Michigan men's diabetes project: perspectives on a peer ... Although there is ample evidence around the efficacy of peer-led diabetes self-management and support (PLDSMS) programs in improving diabetes ...

7. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Based on recent data (13,14,16), DSMES results in an average A1C reduction of 0.45–0.57% when compared with usual care for people with type 2 ...

8. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1622988/full

Impact of nurse-led self-management education on type 2 ... Nurse-led patient-centered self-management support improves HbA1c in patients with type 2 diabetes-a randomized study. Patient Educ Couns. (2016) 99:1821–9 ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0738399124000399/pdf

Effect of peer support interventions in patients with type 2 ... Peer support significantly improved QOL, self-management, self-efficacy, and HbA1c control in patients with T2DM, but had no significant effect on depression.

10. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11884-2

The Michigan men's diabetes project: perspectives on a peer ... Although there is ample evidence around the efficacy of peer-led diabetes self-management and support (PLDSMS) programs in improving diabetes ...