Diabetes Mellitus, Type 2MenD 2NCT05370781
Michigan Men's Diabetes Project 2
A study testing Peer Led Diabetes Self-Management Support and Diabetes Self-Management Education in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Peer Led Diabetes Self-Management Support and Diabetes Self-Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.
Who cannot join
- We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Peer Led Diabetes Self-Management Support, Diabetes Self-Management Education
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Led Diabetes Self-Management SupportBehavioural
While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
Diabetes Self-Management EducationBehavioural
Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom platform.
| Study group | Role | What they receive |
|---|---|---|
| Peer led diabetes self-management support (PLDSMS) | Experimental | 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. Receives: Behavioral: Peer Led Diabetes Self-Management Support; Behavioral: Diabetes Self-Management Education |
| Control Group | Active comparator | Participants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. Receives: Behavioral: Diabetes Self-Management Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Anthropometric data/clinical data - Change in HbA1c. HbA1c was measured using the DCA 2000 point-of-care testing instrument. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Measured: baseline, 3-months, 9-months, 15-months
Change in Diabetes Self-Management
Psychosocial survey data collection (self-reported). Diabetes self-management was measured using the 8-item Perceived Diabetes Self-Management Scale (PDSMS), with summed scores ranging from 8 to 40 and higher scores representing greater self-effectiveness. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Measured: baseline, 3-months, 9-months, 15-months
Secondary outcomes (7)
Change in BMI
Weight relative to height. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Measured: baseline, 3-months, 9-months, 15-months
Change in Depression
Psychosocial survey data collection (self-reported). Patient Health Questionnaire (PHQ-9)
- Sum Scores: The total score categorizes depression severity:
- 0-4: Minimal or none
- 5-9: Mild
- 10-14: Moderate
- 15-19: Moderately severe
- 20-27: Severe
A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Measured: baseline, 3-months, 9-months, 15-months
Change in Blood Pressure (Systolic)
Anthropometric data/clinical data - Change in Blood Pressure (systolic - mmHg). Blood pressure was measured using an automated machine that obtained three readings with 1 min between each reading. The readings were averaged and recorded. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Measured: baseline, 3-months, 9-months, 15-months
Change in Blood Pressure (Diastolic)
Anthropometric data/clinical data - Change in Blood Pressure (diastolic - mmHg). Blood pressure was measured using an automated machine that obtained three readings with 1 min between each reading. The readings were averaged and recorded. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Measured: baseline, 3-months, 9-months, 15-months
Change in Diabetes Social Support
To measure perceived social support, the 8-item Social Support Questionnaire (Duke-UNC Functional Social Support Questionnaire) was used. Responses are measured on a Likert scale from 1 ("Much less than I would like") to 5 ("As much as I would like"). The higher the score, the higher the level of perceived support. In the current study, response options ranged from 1 ("Much less than I would like") to 6 ("As much as I would like") across all eight items. Responses to the eight items were summed to produce a total score ranging from 8 to 48. Higher total scores indicate greater perceived social support.
Measured: baseline, 3-months, 9-months, 15-months
Change in Diabetes-Related Distress (Core)
To measure diabetes distress (emotional distress as a result of living with type 2 diabetes), the Type 2 Diabetes Distress Assessment System (T2-DDAS) was used. The Core Distress Score is the average of all eight items of the scale and is measured on a 1 to 5 Likert scale ("Not a Problem = 1" to "A Very Serious Problem = 5"). Higher scores indicate higher levels of distress. A mean score of <2.0 indicates little or no distress. A mean score ≥2.0 but not more than 2.9 indicates moderate distress. A mean score ≥3.0 indicates high distress. Any score >2.0 is considered clinically significant.
Measured: baseline, 3-months, 9-months, 15-months
Change in Conformity to Masculine Norms
The Short Form of the Conformity to Masculine Norms Inventory (CMNI-30) was used to assess conformity to traditional masculine norms. Participants rated the extent to which they agreed with 30 behavioral statements. Each item was scored on a 6-point scale ranging from 0 (strongly disagree) to 5 (strongly agree). Responses to all 30 items were summed to calculate a total score ranging from 0 to 150. Higher total scores indicate stronger adherence to traditional masculine norms.
Measured: baseline, 3-months, 9-months, 15-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start1 May 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaclynn Hawkins, University of Michigan
- Investigators
- Jaclynn Hawkins, PhD, Principal investigator, University of Michigan, School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370781
- Sponsor's protocol ID
- HUM00200469
- Other IDs
- 1R21DK117339-01A1
- Acronym
- MenD 2
- Status last verified
- Apr 2026
- First submitted
- 3 May 2022
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hawkins J, Sengupta S, Kloss K, Kurnick K, Ewen A, Nwawkwo R, Funnell M, Mitchell J, Jones L, Piatt G. Michigan men's diabetes project II: Protocol for peer-led diabetes self-management education and long-term support in Black men. PLoS One. 2023 Mar 2;18(3):e0277733. doi: 10.1371/journal.pone.0277733. eCollection 2023.
PubMed 36862648
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Michigan Men's Diabetes Project 2
- ClinicalTrials.gov ID
- NCT05370781
- Acronym / sponsor ID
- MenD 2 / HUM00200469
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Posted 7 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer led diabetes self-management support (PLDSMS) | Experimental | Behavioral: Peer Led Diabetes Self-Management Support, Behavioral: Diabetes Self-Management EducationParticipants 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. |
| Control Group | Active comparator | Behavioral: Diabetes Self-Management EducationParticipants in the control group will receive 10 hours of diabetes self-management education (DSME) with a certified diabetes care and education specialist. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Black/African American males, age 21 years or older with diagnosis of T2D for six months, transportation to attend program activities, under the care of a physician for diabetes, and willing to attend group delivered sessions.
Key exclusion criteria (1 listed)
- We considered restricting eligibility to a higher-risk population of participants with A1c ≥ 8%. Preliminary data suggest that over 50% of the proposed study sample will have an A1c ≥ 8%. Focusing on all older Black men with T2D allows us to cast a wide net for secondary prevention and public health impact.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Led Diabetes Self-Management SupportWhile the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population. | Behavioural | Peer led diabetes self-management support (PLDSMS) |
| Diabetes Self-Management EducationParticipants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom platform. | Behavioural | Control Group, Peer led diabetes self-management support (PLDSMS) |
Primary outcome
Hemoglobin A1c
Time frame: baseline, 3-months, 9-months, 15-months
Anthropometric data/clinical data - Change in HbA1c. HbA1c was measured using the DCA 2000 point-of-care testing instrument. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
Change in Diabetes Self-Management
Time frame: baseline, 3-months, 9-months, 15-months
Psychosocial survey data collection (self-reported). Diabetes self-management was measured using the 8-item Perceived Diabetes Self-Management Scale (PDSMS), with summed scores ranging from 8 to 40 and higher scores representing greater self-effectiveness. A longitudinal mixed-effects linear regression model was used to examine changes in primary and secondary outcomes over time between the intervention (PLDSMS) and control (EUC) groups. The reference/comparison group was the PLDSMS group.
7 secondary outcomes
Change in BMI
Time frame: baseline, 3-months, 9-months, 15-months
Change in Depression
Time frame: baseline, 3-months, 9-months, 15-months
Change in Blood Pressure (Systolic)
Time frame: baseline, 3-months, 9-months, 15-months
Change in Blood Pressure (Diastolic)
Time frame: baseline, 3-months, 9-months, 15-months
Change in Diabetes Social Support
Time frame: baseline, 3-months, 9-months, 15-months
Change in Diabetes-Related Distress (Core)
Time frame: baseline, 3-months, 9-months, 15-months
Change in Conformity to Masculine Norms
Time frame: baseline, 3-months, 9-months, 15-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36862648Hawkins J, Sengupta S, Kloss K, Kurnick K, Ewen A, Nwawkwo R, Funnell M, Mitchell J, Jones L, Piatt G. Michigan men's diabetes project II: Protocol for peer-led diabetes self-management education and long-term support in Black men. PLoS One. 2023 Mar 2;18(3):e0277733. doi: 10.1371/journal.pone.0277733. eCollection 2023.
Related trials for Diabetes Mellitus, Type 2
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaclynn Hawkins, PhD principal investigator
University of Michigan, School of Social Work
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Led Diabetes Self-Management Support and Diabetes Self-Management Education in people with Diabetes Mellitus, Type 2, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: baseline, 3-months, 9-months, 15-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.