Enhanced Diabetes Management Program for Type 2 Diabetes

(FREEDOM Trial)

Recruiting at 1 trial location

Overseen By Aseel El Zein, MS, PhD, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Insulin, HIV ART

Disqualifiers: Cognitive impairment, End-stage kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

304 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, ongoing insulin treatment is required, and if you are part of the HIV cohort, you must continue your prescribed HIV ART therapy.

Is the Enhanced Diabetes Management Program for Type 2 Diabetes safe for humans?

The Diabetes Self-Management Education and Support (DSMES) programs, which are part of the Enhanced Diabetes Management Program, have been shown to improve health outcomes and reduce emergency visits, indicating they are generally safe for humans. ^{1 2 3 4 5}

How is the Enhanced Diabetes Management Program for Type 2 Diabetes different from other treatments?

The Enhanced Diabetes Management Program is unique because it combines Diabetes Self-Management Education and Support (DSMES) with digital health coaching, food box delivery, and remote patient monitoring (RPM), offering a comprehensive approach that integrates education, nutrition, and technology to support patients in managing their diabetes more effectively. ^{1 3 6 7 8}

What data supports the effectiveness of this treatment for managing Type 2 Diabetes?

Research shows that diabetes self-management education and support (DSMES) programs can improve health outcomes, such as reducing weight and blood sugar levels, and decrease emergency visits. Digital tools and community-based programs have been effective in extending these benefits and supporting lifestyle changes. ^{1 5 7 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am on HIV medication as part of my treatment.

I have been diagnosed with HIV.

Self-identified as Black/African American

Exclusion Criteria

I am not currently enrolled in any diabetes-related study or lifestyle program.

I joined a remote patient monitoring or health coaching program, excluding smoking cessation, within the last 60 days.

Current enrollment in any diabetes-related interventional study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital health coaching, food box delivery, and remote patient monitoring for diabetes management

12 months

3 in-person visits (baseline, month 6, month 12), 2 telephone check-ins (month 3, month 9)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program
• Digital Health Coaching
• Food Box Delivery
• Remote Patient Monitoring (RPM)

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 4 Interventions

Digital coaching+ Food delivery+ RPM

Group II: Arm 4 Active Control 3 Interventions

Digital coaching+ RPM

Group III: Arm 5 Active Control 3 Interventions

Food delivery+ RPM

Group IV: Arm 6 Active Control 1 Intervention

The participant's will not receive any Intervention

Group V: Arm 8 Active Control 2 Interventions

RPM

Group VI: Arm 2 Active Control 2 Interventions

Digital coaching

Group VII: Arm 3 Active Control 3 Interventions

Digital coaching+ Food delivery

Group VIII: Arm 7 Active Control 2 Interventions

Food delivery

Core Intervention: Diabetes Self-Management Education and Support (DSMES) Program is already approved in United States for the following indications:

Approved in United States as Diabetes Self-Management Education and Support (DSMES) Program for:

• Type 2 Diabetes Mellitus Management

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Cooper Green Mercy Health Services

Collaborator

Trials

1

Recruited

300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Pack Health

Industry Sponsor

Trials

6

Recruited

1,100+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Cooper Green Mercy Health Systems

Collaborator

Trials

1

Recruited

300+

Published Research Related to This Trial

Implementing diabetes self-management education (DSME) in primary care clinics (PCCs) significantly increased enrollment in classes and led to notable reductions in A1C levels and weight among participants, particularly those newly diagnosed with diabetes.

The study demonstrated that translating an accredited DSME program from an academic medical center to PCCs effectively improved access to diabetes education, benefiting patients who may not have access to hospital-based programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Access to Diabetes Self-management Education in Primary Care. Chomko, ME., Odegard, PS., Evert, AB.[2022]

A digital diabetes self-management education and support (DSMES) program significantly reduced hemoglobin A1c (HbA1c) levels by an average of 0.8% over 4 months in a study of 195 participants, indicating improved blood sugar control.

Participants with higher baseline HbA1c levels (>9.0%) experienced an even greater reduction of 1.4%, along with significant improvements in diabetes distress and medication adherence, suggesting the program's effectiveness in enhancing overall diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial. Wilson-Anumudu, F., Quan, R., Castro Sweet, C., et al.[2021]

Diabetes self-management education and support (DSMES) is crucial for people with diabetes, as it equips them with the necessary skills and knowledge to manage their condition effectively, leading to improved health outcomes.

The article highlights recent findings from the National Diabetes Education Program National Diabetes Survey, which identifies gaps in self-management behaviors and DSMES delivery, suggesting areas for improvement to enhance diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. Piccinino, LJ., Devchand, R., Gallivan, J., et al.[2020]

A 12-month community-based diabetes self-management education and support program significantly improved health outcomes for 115 participants, including reductions in weight, BMI, and A1C levels, which were sustained over time.

The program also led to a decrease in medication intake and diabetes-related emergency department visits, indicating not only improved health but also potential cost savings in healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Engagement in Type 2 Diabetes: A Collaborative Community Health Initiative. Freeman, K., Hanlon, M., Denslow, S., et al.[2022]

The BDTM Diabetes Care App significantly improved patient satisfaction, hemoglobin A1c (HbA1c) levels, and reduced diabetes distress among 32 adults with type 2 diabetes over a three-month period.

Diabetes providers recognize the potential of DSMES apps as valuable tools for patient education, with 100% willing to recommend them, highlighting the importance of features like evidence-based content and data tracking for effective self-management support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Applications to Support Diabetes Self-Management Education: Patient Experiences and Provider Perspectives. Krall, JS., Childs, B., Mehrotra, N.[2023]

The study aims to adapt the Diabetes One-Day (D1D) program for rural communities, creating a culturally appropriate virtual diabetes self-management education and support (DSMES) program called rural D1D (R-D1D).

This pilot trial will be the first to evaluate both the effectiveness and implementation of a virtually delivered DSMES tailored for rural populations, potentially improving access to diabetes care in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial. Litchman, ML., Kwan, BM., Zittleman, L., et al.[2022]

A digital health intervention (DHI) for diabetes self-management education and support (DSMES) should be integrated into routine care and provide structured, high-quality information to effectively meet the needs of patients with type 2 diabetes mellitus (T2DM) and diabetes specialist nurses (DSN).

Key elements for success include suggesting tasks to encourage behavioral changes and offering feedback from DSNs to patients, as identified through focus group discussions with 14 T2DM patients and 4 DSNs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overcoming the struggle of living with type 2 diabetes - diabetes specialist nurses' and patients' perspectives on digital interventions. Jarl, F., Davelid, A., Hedin, K., et al.[2023]

Diabetes self-management education (DSME) programs combined with peer support significantly reduce glycated hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes, with a notable effect size of -0.41 based on a systematic review of 12 studies.

Programs that are smaller in size, last for 6 months or less, and involve frequent group meetings are particularly effective in improving glycemic control, suggesting that these factors enhance the benefits of DSME with peer support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of peer support in diabetes self-management education on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis. Azmiardi, A., Murti, B., Febrinasari, RP., et al.[2022]

A survey of 30 diabetes self-management education (DSME) programs in Montana revealed that 77% of urban and 50% of rural programs can provide services to more patients with diagnosed diabetes, indicating a strong capacity for diabetes management.

Both urban (84%) and rural (60%) programs reported the ability to offer lifestyle services to individuals at high risk for diabetes, but major barriers include lack of reimbursement (80%) and insufficient staff (60%), highlighting the need for better funding to enhance diabetes prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capacity of diabetes education programs to provide both diabetes self-management education and to implement diabetes prevention services. Butcher, MK., Vanderwood, KK., Hall, TO., et al.[2019]

The implementation of Diabetes Self-Management Education and Support (DSME/S) for Medicare patients aged 65 and older with type 2 diabetes led to a 15% increase in its usage, significantly improving patient engagement in their care.

After 4 weeks of DSME/S, participants showed a statistically significant decrease in fasting blood glucose levels and an improvement in quality of life, demonstrating the effectiveness of this intervention in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Glycemic Control and Quality of Life With Diabetes Self-Management Education: A Pilot Project. Andrich, D., Foronda, C.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Enhancing Access to Diabetes Self-management Education in Primary Care. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Early Insights From a Digitally Enhanced Diabetes Self-Management Education and Support Program: Single-Arm Nonrandomized Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Patient Engagement in Type 2 Diabetes: A Collaborative Community Health Initiative. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mobile Applications to Support Diabetes Self-Management Education: Patient Experiences and Provider Perspectives. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Overcoming the struggle of living with type 2 diabetes - diabetes specialist nurses' and patients' perspectives on digital interventions. [2023]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of peer support in diabetes self-management education on glycemic control in patients with type 2 diabetes: a systematic review and meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Capacity of diabetes education programs to provide both diabetes self-management education and to implement diabetes prevention services. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Improving Glycemic Control and Quality of Life With Diabetes Self-Management Education: A Pilot Project. [2021]