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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

FREEDOM Trial 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.Check my eligibility

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.See study design

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.

FREEDOM Trial 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.

FREEDOM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FREEDOM Study: Change in HbA1c level between baseline and 12 month

for the HIV Cohort: Change in HbA1c level between baseline and 6 months

FREEDOM 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cooper Green Mercy Health ServicesUNKNOWN

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,215,907 Total Patients Enrolled

Pack HealthIndustry Sponsor

5 Previous Clinical Trials

864 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been accepted to take part in the trial?

"Affirmative. Information on clinicaltrials.gov demonstrates that this medical trial, initially posted January 1st 2023 and most recently amended November 29th 2022, is still recruiting patients - 304 to be exact - from a single site."

Answered by AI

Is this project currently recruiting participants?

"As per clinicaltrials.gov, this trial remains open to applicants. The study was initially published on January 1st 2023 and the most recent edit occurred November 29th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)

Tapan Shirish Mehta 2023. "Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05288452.

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