Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT05288452
- Lead Sponsor
- University of Alabama at Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
<br><br> 1. Self-identified as Black/African American<br><br> 2. ICD diagnosis of T2DM<br><br> 3. =18 years of age<br><br> 4. Ongoing insulin treatment<br><br> 5. HbA1c =8% within 6 weeks of study screening<br><br> 6. has the ability to converse in and read English<br><br> 7. must provide written informed consent prior to enrollment<br><br>Exclusion criteria:<br><br> 1. Current enrollment in any diabetes-related interventional study<br><br> 2. Cognitive impairment<br><br> 3. End-stage kidney disease (CKD-5)<br><br> 4. Pregnant or plans to become pregnant within 12 months<br><br> 5. Currently enrolled in a structured lifestyle change program<br><br> 6. Enrolled in remote patient monitoring or health coaching within 60 days of the study<br> or intervention<br><br>HIV Cohort Criteria<br><br>Inclusion Criteria<br><br> 1. = 18 years of age<br><br> 2. ICD diagnosis of T2DM<br><br> 3. HbA1c = 7%<br><br> 4. Confirmed HIV+ diagnosis<br><br> 5. Prescribed HIV ART therapy as part of care<br><br>Exclusion Criteria<br><br> 1. Current enrollment in any diabetes-related interventional study or structured<br> lifestyle change program<br><br> 2. Enrolled in RPM or health coaching (except for coaching on smoking cessation) within<br> 60 days of the intervention<br><br> 3. Cognitive impairment<br><br> 4. End-stage kidney disease (CKD-5)<br><br> 5. Pregnant or plans to become pregnant within 12 months
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FREEDOM Study: Change in HbA1c level between baseline and 12 month;Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
- Secondary Outcome Measures
Name Time Method