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Enhanced Diabetes Management Program for Type 2 Diabetes (FREEDOM Trial)

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescribed HIV ART therapy as part of care
Confirmed HIV+ diagnosis
Must not have
Current enrollment in any diabetes-related interventional study or structured lifestyle change program
Cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trialwill use an optimized intervention to improve type 2 diabetes among Black Americans with cardiovascular and kidney disease in Alabama/Mississippi. It includes digital coaching, food delivery, and remote monitoring.

Who is the study for?
The FREEDOM study is for low-income Black adults in the Deep South with type 2 diabetes, aged 18 or older, who are HIV positive and on insulin treatment. Participants must have a high HbA1c level indicating poor blood sugar control and face social challenges like poverty. They can't join if they're pregnant, planning to become pregnant soon, have severe kidney disease or cognitive issues, or are already in another diabetes study.
What is being tested?
This trial tests a comprehensive approach to manage type 2 diabetes by providing participants with food deliveries tailored to their dietary needs, digital health coaching sessions for better disease understanding and management strategies, remote patient monitoring tools to track health metrics regularly from home, and specialized education classes about diabetes care.
What are the potential side effects?
Since this trial focuses on educational support rather than medication changes or new drugs being introduced into the regimen of participants, there aren't direct side effects related to medications. However, lifestyle adjustments may cause temporary discomfort as habits change.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on HIV medication as part of my treatment.
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I have been diagnosed with HIV.
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I am currently being treated with insulin.
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently enrolled in any diabetes-related study or lifestyle program.
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I have difficulty with memory or thinking clearly.
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I have advanced kidney disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
FREEDOM Study: Change in HbA1c level between baseline and 12 month
for the HIV Cohort: Change in HbA1c level between baseline and 6 months

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment4 Interventions
Digital coaching+ Food delivery+ RPM
Group II: Arm 4Active Control3 Interventions
Digital coaching+ RPM
Group III: Arm 5Active Control3 Interventions
Food delivery+ RPM
Group IV: Arm 6Active Control1 Intervention
The participant's will not receive any Intervention
Group V: Arm 8Active Control2 Interventions
RPM
Group VI: Arm 2Active Control2 Interventions
Digital coaching
Group VII: Arm 3Active Control3 Interventions
Digital coaching+ Food delivery
Group VIII: Arm 7Active Control2 Interventions
Food delivery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Health Coaching
2022
N/A
~50
Remote Patient Monitoring (RPM)
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Cooper Green Mercy Health ServicesUNKNOWN
National Institute on Minority Health and Health Disparities (NIMHD)NIH
444 Previous Clinical Trials
1,413,204 Total Patients Enrolled
Pack HealthIndustry Sponsor
5 Previous Clinical Trials
824 Total Patients Enrolled
University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,069 Total Patients Enrolled
University of Mississippi Medical CenterOTHER
182 Previous Clinical Trials
196,800 Total Patients Enrolled
Cooper Green Mercy Health SystemsUNKNOWN

Media Library

Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program Clinical Trial Eligibility Overview. Trial Name: NCT05288452 — N/A
Type 2 Diabetes Research Study Groups: Arm 4, Arm 5, Arm 6, Arm 8, Arm 1, Arm 2, Arm 3, Arm 7
Type 2 Diabetes Clinical Trial 2023: Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program Highlights & Side Effects. Trial Name: NCT05288452 — N/A
Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288452 — N/A
~133 spots leftby Jun 2026
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