NCT06031428 MANAGe-DM: Novel Nurse Case Management to Improve Diabetes Outcomes in Formerly Incarcerated Black Men
| NCT ID | NCT06031428 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical College of Wisconsin |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-02-20 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Laura Hawks, MD
PRINCIPAL INVESTIGATOR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT06031428 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06031428 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06031428 currently recruiting?
Yes, NCT06031428 is actively recruiting participants. Contact the research team at lhawks@mcw.edu for enrollment information.
Where is the NCT06031428 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06031428 clinical trial?
NCT06031428 is sponsored by Medical College of Wisconsin. The principal investigator is Laura Hawks, MD at Medical College of Wisconsin. The trial plans to enroll 100 participants.
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