NCT05288452Completed
Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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 determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 304 (actual)
- First submitted
- 17 Feb 2022
- Start date
- 5 Jan 2023
- Primary completion date
- 21 Jul 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Type 2 diabetes
- NCT number
- NCT05288452
What you commit to
- Study type: Interventional
- Participants enrolled: 304
- From 5 Jan 2023 to the primary completion date, 21 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Current enrollment in any diabetes-related interventional study
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
- HIV Cohort Criteria
- Current enrollment in any diabetes-related interventional study or structured lifestyle change program
- Cognitive impairment
- End-stage kidney disease (CKD-5)
Other
- Pregnant or plans to become pregnant within 12 months
- Currently enrolled in a structured lifestyle change program
- Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
- Pregnant or plans to become pregnant within 12 months
Who the study is looking for
- 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
- ≥ 18 years of age
- ICD diagnosis of T2DM
- HbA1c ≥ 7%
- Confirmed HIV+ diagnosis
- Prescribed HIV ART therapy as part of care
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAB Hospital and UMMC Cardiology Clinics Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
Related publications
- Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care.Contemp Clin Trials · 2026 · PMID 41354173
This page is information, not medical advice. Discuss any trial with your doctor.