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

NCT06031428 | Recruiting Phase 2

• 1 other identifier: PRO00044942
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  Venous draw will be use to obtain HbA1C

  6 months post-randomization

Secondary Outcomes (2)

• Blood Pressure

  6 months post-randomization

• Quality of Life (Short Form Health Survey, SF-12)

  6 months post-randomization

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

Behavioral: Monthly Educational Mailing

MANAGe-DM

EXPERIMENTAL

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.

Behavioral: MANAGe-DM - novel nurse case management

Interventions

MANAGe-DM - novel nurse case management BEHAVIORAL

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.

MANAGe-DM

Monthly Educational Mailing BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Center for Advancing Population Science, Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laura Hawks, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Hawks, MD

CONTACT

414-955-8020; lhawks@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 11, 2023
• Study Start: February 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)