Type2 DiabetesMANUPNCT03208686
The Men Are Now United Program
A study testing Intervention Group in people with Type2 Diabetes, run by Michigan State University at 1 site in United States.
Trial summary
The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 19 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male
- Tyep 2 Diabetes
- 21 years old or older
- Owns cell or smart (mobile) phone or willing to use one if provided
Who cannot join
- Non-ambulatory
- Serious physical illness
- Psychiatric diagnosis of serious mental illness
- Serious diabetes complications impeding meaningful participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Management of Diabetes in Black Men
The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.
Read the detailed description
The investigators propose a single-subject, repeated measures intervention where each participant will serve their own control. Participants will serve as their own controls for a period of three months prior to the start of the four-month intervention. The study will conclude with an assessment 7-months from baseline. Single-subject designs are most often used in applied research. The design allows the participant to serve as the control, rather than using another individual/group. The design is sensitive to individual differences whereas group designs are sensitive to averages of groups. Year 1 is dedicated to the development of the text messages and the content for the 10 group meeting sessions. Year 2 focuses on the Time-1 control period assessment (pre-baseline at 3 months before the intervention), the Time-2 assessment (baseline), implementation of the 10-week intervention, a post-intervention assessment (Time-3), and 3-month follow up at Time-4, and analysis. Specifically, in Year 2, the primary outcome of A1c will be assessed at Time-1, 3 months later at the start of the intervention, at the end of the intervention, and at 7-months. The investigators will also include secondary assessments of glucose readings, waist circumference, and blood pressure.
- Conditions
- Type2 Diabetes
- Being tested
- Intervention Group
- Keywords
- Gender, Men, Black/African American, Self-management
- Medical subject headings
- Coitus, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
A single-arm intervention comprised of (a) 10 weekly discussion groups; (b) motivational text messages; (c) a remote sensing persuasive health technology - a cloud-based cellular glucometer connected to a dedicated web site to reduce A1c by 0.5% by improving diabetes self-management behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Other | A single-arm intervention comprised of discussion groups, text messages, and a cloud-based cellular glucometer. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels
A1c
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start1 Apr 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Claremont Graduate University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208686
- Sponsor's protocol ID
- CGA#149084
- Acronym
- MANUP
- Status last verified
- Mar 2025
- First submitted
- 3 Jul 2017
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management of Diabetes in Black Men
- ClinicalTrials.gov ID
- NCT03208686
- Acronym / sponsor ID
- MANUP / CGA#149084
- Conditions
- Type2 Diabetes
- Keywords
- Gender, Men, Black/African American, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, Claremont Graduate University
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 5 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.
Detailed description
The investigators propose a single-subject, repeated measures intervention where each participant will serve their own control. Participants will serve as their own controls for a period of three months prior to the start of the four-month intervention. The study will conclude with an assessment 7-months from baseline. Single-subject designs are most often used in applied research. The design allows the participant to serve as the control, rather than using another individual/group. The design is sensitive to individual differences whereas group designs are sensitive to averages of groups. Year 1 is dedicated to the development of the text messages and the content for the 10 group meeting sessions. Year 2 focuses on the Time-1 control period assessment (pre-baseline at 3 months before the intervention), the Time-2 assessment (baseline), implementation of the 10-week intervention, a post-intervention assessment (Time-3), and 3-month follow up at Time-4, and analysis. Specifically, in Year 2, the primary outcome of A1c will be assessed at Time-1, 3 months later at the start of the intervention, at the end of the intervention, and at 7-months. The investigators will also include secondary assessments of glucose readings, waist circumference, and blood pressure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Behavioral: Intervention GroupA single-arm intervention comprised of discussion groups, text messages, and a cloud-based cellular glucometer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Black/African American
- Male
- Tyep 2 Diabetes
- 21 years old or older
- Owns cell or smart (mobile) phone or willing to use one if provided
Key exclusion criteria (4 listed)
- Non-ambulatory
- Serious physical illness
- Psychiatric diagnosis of serious mental illness
- Serious diabetes complications impeding meaningful participation
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 |
|---|---|---|
| Intervention GroupA single-arm intervention comprised of (a) 10 weekly discussion groups; (b) motivational text messages; (c) a remote sensing persuasive health technology - a cloud-based cellular glucometer connected to a dedicated web site to reduce A1c by 0.5% by improving diabetes self-management behaviors. | Behavioural | Intervention Group |
Primary outcome
Blood glucose levels
Time frame: 4 Months
A1c
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Type2 Diabetes, run by Michigan State University 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 5 inclusion and 4 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 6 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood glucose levels (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2025.