Recruiting

Phase 2

Nurse Case ManagementMANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men

Sponsor:

Medical College of Wisconsin

Code:

NCT06031428

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MANAGe-DM - novel nurse case management

Monthly Educational Mailing

Study Details

Brief summary:

The study is a randomized control trial involving 100 participants (formerly incarcerated Black men with poorly controlled diabetes) to examine the effect of a tailored nurse case manager on glycemic control and other clinical outcomes, self-care behaviors, and quality of life at 6 months post-randomization.

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT06031428

Start date

Feb 20, 2024

Status verified date

Sep, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

age ≥18 years
identify as Black or African American
identify as male
formerly incarcerated in a state or federal prison system or county jail
clinical diagnosis of type 2 diabetes with HbA1c ≥8% at the screening visit
able to communicate in English.

Exclusion Criteria:

mental confusion on screening interview suggesting significant dementia
current participation in other diabetes clinical trials
active psychosis or acute mental disorder
life expectancy \<12 months
awaiting arraignment, trial, sentencing in the criminal legal system
on active surveillance by the criminal legal system, meaning on house arrest or subject to electronic monitoring

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control

experimental: MANAGe-DM

Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. MANAGe-DM will include NCM services tailored to the health needs of Black men with recent release from incarceration and T2DM. MANAGe-DM will include three components: 1) diabetes education and skills training; 2) healthcare navigation and 3) basic needs navigation. . Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.

Interventions

MANAGe-DM - novel nurse case management

Participants assigned to MANAGe-DM will receive the standard diabetes education mailing in addition to a novel nurse case management intervention. Each month of the study period, the NCM will conduct two phone call intervention sessions with individual participants.

Monthly Educational Mailing

All participants in the study will receive diabetes education mailers. This includes monthly mailings of diabetes education, based off the American Diabetes Association guidelines for Diabetes Education. Topics covered will include diabetes basics, monitoring and medications, healthy eating and exercise, overview of common comorbidities, basics of foot care, and strategies for overcoming common pitfalls.

Primary outcome measure

Hemoglobin A1C [ Time Frame: 6 months post-randomization ]

Central Contacts and Locations

Central contacts

Laura Hawks, MD

414-955-8020 lhawks@mcw.edu

Locations

Center for Advancing Population Science, Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Laura Hawks, MD

4149558020 lhawks@mcw.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-09-17.