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

Study acronym: MANAGe-DM
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 1, 2027 → Dec 1, 2027
See other at-risk trials from Medical College of Wisconsin

Record History

  1. Primary completion pushed from Jun 1, 2027 to Dec 1, 2027 Completion pushed from Nov 1, 2027 to Dec 1, 2027 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 2 entries Show 3 more changesShow less
    • Completion pushed from Nov 1, 2027 to Dec 1, 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Primary completion date: Nov 1, 2026 to Jun 1, 2027 Site contact updatedv6 Show 1 more changeShow less
    • Site contact updated
  3. Start date changed from estimate of Dec 1, 2023 to Feb 20, 2024 Eligibility criteria shortened, about 3 words · Study description shortened, about 1 word · Study title shortened, about 2 wordsv5 Show 3 more changesShow less
    • Eligibility criteria shortened, about 3 words
    • Study description shortened, about 1 word
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Phase: Phase 3 to Phase 2v4
  5. Start date: Jun 28, 2023 to Dec 1, 2023v3
  6. Eligibility criteria shortened, about 13 wordsv2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06031428
Lead Sponsor Medical College of Wisconsin
Conditions Diabetes Mellitus, Type 2
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov