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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Medical College of Wisconsin • ClinicalTrials.gov ID: NCT06031428

Registry updated: 2026-10-06
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Description

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.

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.
  • 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.

Eligibility criteria

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

Conditions

Diabetes Mellitus, Type 2

Locations

  • Center for Advancing Population Science, Medical College of Wisconsin — Milwaukee, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record