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

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is the Diabetes Self-Management Program safe for humans?

The research articles reviewed do not provide specific safety data for the Diabetes Self-Management Program, but they do not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is the Diabetes Self-Management Education treatment different from other treatments for type 2 diabetes?

Diabetes Self-Management Education is unique because it focuses on empowering patients to manage their own care through education, which can be delivered online, making it accessible and cost-effective. This approach is particularly beneficial for individuals with low literacy and numeracy skills, as it provides tailored support to help them understand and manage their condition effectively. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Diabetes Self-Management Education, Peer Led Diabetes Self-Management Support for Type 2 Diabetes?

Research shows that Diabetes Self-Management Education (DSME) helps people with diabetes control their blood sugar levels and improve their overall health. Studies have found that DSME can reduce complications and enhance the quality of life for those with type 2 diabetes. ^{2 7 10 11 12}

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. United States pubmed.ncbi.nlm.nih.gov

Integrating Undergraduate Patient Partners into Diabetes self-management education: Evaluating a free clinic pilot program for the Underserved. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of a self-management education program for people with type 2 diabetes: results of a 12 month trial. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Effectiveness of systematic self-management education on blood sugar level of patients in the community with type 2 diabetes]. [2012]

4. United States pubmed.ncbi.nlm.nih.gov

Assessing the value of the diabetes educator. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Diabetes self-management education improves quality of care and clinical outcomes determined by a diabetes bundle measure. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Mortality in an elderly type 2 diabetic patients' cohort who attended a self-management educational workshop. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

A Diabetes Self-Management Program: 12-Month Outcome Sustainability From a Nonreinforced Pragmatic Trial. [2019]

8. Canada pubmed.ncbi.nlm.nih.gov

Benefits of Diabetes Self-Management for Health Plan Members: A 6-Month Translation Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Diabetes Literacy and Numeracy Education Toolkit (DLNET): materials to facilitate diabetes education and management in patients with low literacy and numeracy skills. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Massive open online course for type 2 diabetes self-management: adapting education in the COVID-19 era. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Diabetes Self-Management Education in Community Health. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Diabetes structured self-management education programmes: a narrative review and current innovations. [2018]