Status:
ACTIVE_NOT_RECRUITING
Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
University of Mississippi Medical Center
Cooper Green Mercy Health Services
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Brief Summary: The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social dete...
Detailed Description
Detailed Description: 1. FREEDOM Study (Type 2 Diabetes Mellitus): The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Self-identified as Black/African American
- ICD diagnosis of T2DM
- ≥18 years of age
- Ongoing insulin treatment
- HbA1c ≥8% within 6 weeks of study screening
- has the ability to converse in and read English
- must provide written informed consent prior to enrollment
- Exclusion criteria:
- Current enrollment in any diabetes-related interventional study
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
- Currently enrolled in a structured lifestyle change program
- Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
- HIV Cohort Criteria
- Inclusion Criteria
- ≥ 18 years of age
- ICD diagnosis of T2DM
- HbA1c ≥ 7%
- Confirmed HIV+ diagnosis
- Prescribed HIV ART therapy as part of care
- Exclusion Criteria
- Current enrollment in any diabetes-related interventional study or structured lifestyle change program
- Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
Exclusion
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT05288452
Start Date
January 1 2023
End Date
June 30 2026
Last Update
May 30 2025
Active Locations (1)
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1
UAB Hospital and UMMC Cardiology Clinics
Birmingham, Alabama, United States, 35205