Diabetes Self-Management for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Cherlie Magny-Normilus, PhD, FNP-BC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Diabetes Self-Management Education and Support (DSMES) safe for humans?

The research does not specifically address safety concerns, but Diabetes Self-Management Education and Support (DSMES) is generally considered safe as it focuses on education and support to help people manage their diabetes effectively. ^{1 2 3 4 5}

How is the Diabetes Self-Management treatment unique for managing Type 2 Diabetes?

The Diabetes Self-Management treatment is unique because it focuses on empowering patients through education and support, using the ADCES7 Self-Care Behaviors framework to improve self-management and quality of life. This approach emphasizes behavior change and collaboration with healthcare teams, rather than relying solely on medication. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Diabetes Self-Management Education (DSME) and Support (DSMS) for managing Type 2 Diabetes?

Research shows that integrating Diabetes Self-Management Education and Support (DSMES) into primary care significantly improves blood sugar control and body mass index (BMI) in patients with Type 2 Diabetes. This approach helps patients better manage their condition and can lead to improved health outcomes. ^{2 3 4 7 9}

Who Is on the Research Team?

Cherlie Magny-Normilus, PhD, FNP-BC, FAAN

Principal Investigator

New York University

Are You a Good Fit for This Trial?

This trial is for adult Haitian immigrants, aged 21 or older, who have been living in the US for at least a year and have had type 2 diabetes diagnosed for over a year with an HbA1c level of 7.5% or higher. Participants must be willing to engage in an interview. Those with type 1 diabetes or unable to fully participate are excluded.

Inclusion Criteria

I am a Haitian immigrant and I am 21 years old or older.

Have lived in the US for at least one year

I have been diagnosed with type 2 diabetes for over a year.

Exclusion Criteria

I am able to understand and agree to participate in the study.

I have been diagnosed with type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the culturally tailored Diabetes Self-Management Education Program or standard care. The program includes an initial 45-minute consultation and six 2-hour weekly educational sessions.

6 weeks

1 initial consultation, 6 weekly sessions

Follow-up

Participants are monitored for changes in diabetes distress, physical activity, glucose variability, self-management behaviors, and self-efficacy.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Self-Management Behaviors
• Objective. data
• Physical activity

Trial Overview The study is testing the effectiveness of a new education program designed to help participants manage their type 2 diabetes better on their own. It's a pilot randomized study which means some people will receive the program while others may not, by chance.

How Is the Trial Designed?

Group I: Diabetes Self-Management Behaviors Experimental Treatment 1 Intervention

Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.

Group II: Usual Type 2 Diabetes Care Active Control 1 Intervention

The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study.

Diabetes Self-Management Behaviors is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Diabetes Self-Management Education for:

• Type 2 Diabetes Management
• Glycemic Control

Approved in European Union as Diabetes Self-Management Support for:

• Type 1 Diabetes Management
• Type 2 Diabetes Management
• Prediabetes Management

Approved in Canada as ADCES7 Self-Care Behaviors for:

• Diabetes Management
• Cardiometabolic Disease Management

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Boston College

Lead Sponsor

Trials

40

Recruited

49,300+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

The ADCES7 Self-Care Behaviors™ framework is essential for effective diabetes self-management education, promoting behavior change that leads to better health outcomes and quality of life for individuals with diabetes and related conditions.

The revised ADCES7 framework incorporates recent advances in diabetes management and digital health, emphasizing the importance of person-centered collaboration among healthcare teams to support individuals in achieving their health goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Effective Model of Diabetes Care and Education: The ADCES7 Self-Care Behaviors™. Kolb, L.[2021]

Integrating a diabetes self-management education and support (DSMES) program based on the ADCES7 Self-Care Behaviors in a primary care clinic significantly improved glycemic control, as evidenced by a reduction in hemoglobin A1c (A1c) levels from an average of 9.5 to 7.8 in 54 patients with type 2 diabetes.

The program also led to a significant decrease in body mass index (BMI), from an average of 33.2 to 32.2, indicating that structured diabetes education can effectively enhance both metabolic health and weight management in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Clinical Outcomes of Implementing Diabetes Self-Management Education and Support in a Primary Care Practice: A Quality Improvement Project. McGowen, CL., Appel, SJ.[2023]

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]

The AADE7 Self-Care Behaviors® framework is essential for effective diabetes self-management, promoting behavior change that leads to better health outcomes and quality of life for individuals with diabetes and related conditions.

The revised AADE7 framework incorporates recent advances in diabetes management and self-education, emphasizing a collaborative, person-centered approach among healthcare teams to support individuals at risk for or living with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors®. [2021]

A review of 13 studies involving 242 adults with type 2 diabetes revealed that both patients and healthcare professionals (HCPs) have mixed feelings about technology-assisted diabetes self-management education (DSME), with patients favoring easy-to-use platforms that provide reliable information.

Barriers to effective use included patients' technological competence and literacy, while HCPs struggled to integrate these interventions into their clinical workflows, highlighting the need for better technical support and training to enhance the adoption of these educational tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' and healthcare professionals' perspectives towards technology-assisted diabetes self-management education. A qualitative systematic review. Jain, SR., Sui, Y., Ng, CH., et al.[2020]

Diabetes Self-Management Education and Support (DSMES) is essential for equipping individuals with the knowledge and skills needed for effective diabetes self-care, and it is increasingly being enhanced by technology to improve access and outcomes.

Despite strong evidence supporting the benefits of DSMES, it remains underutilized, highlighting the need for individualized services that cater to the specific concerns and preferences of people with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2017 National Standards for Diabetes Self-Management Education and Support. Beck, J., Greenwood, DA., Blanton, L., et al.[2022]

Only 6.5% of patients with newly diagnosed type 2 diabetes mellitus (T2DM) utilized diabetes self-management education and support (DSME/S), indicating a significant gap in education for this group.

In contrast, 32.7% of patients with T2DM who were prescribed insulin used DSME/S, with demographic factors such as race and insurance type influencing usage rates, highlighting the need for targeted interventions to improve access and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-specific factors associated with use of diabetes self-management education and support programs in Louisiana. Yoshida, Y., Hong, D., Nauman, E., et al.[2022]

A study analyzed 173 diabetes self-management apps against the AADE7™ guidelines and found that while many apps support Healthy Eating (77%) and Monitoring (76%), very few address Problem Solving (31%), Healthy Coping (10%), and Reducing Risks (5%).

Interviews with diabetes professionals revealed that the lack of features related to Problem Solving, Healthy Coping, and Reducing Risks in apps may limit their effectiveness in supporting comprehensive diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of Diabetes Mobile Applications Features Compared to AADE7™: Addressing Self-Management Behaviors in People With Diabetes. Ye, Q., Khan, U., Boren, SA., et al.[2019]

Diabetes self-management education is crucial for empowering patients to effectively manage their condition and improve their quality of life.

The project aims to enhance the delivery and documentation of diabetes self-management education at a Cincinnati health center, focusing on the 7 essential self-care behaviors identified by the American Association of Diabetes Educators (AADE7).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Self-management Education Provision by an Interprofessional Collaborative Practice Team: A Quality Improvement Project. Harris, AN.[2019]

Citations

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

An Effective Model of Diabetes Care and Education: The ADCES7 Self-Care Behaviors™. [2021]

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

Exploring the Clinical Outcomes of Implementing Diabetes Self-Management Education and Support in a Primary Care Practice: A Quality Improvement Project. [2023]

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

An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors®. [2021]

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

Patients' and healthcare professionals' perspectives towards technology-assisted diabetes self-management education. A qualitative systematic review. [2020]

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

2017 National Standards for Diabetes Self-Management Education and Support. [2022]

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

Patient-specific factors associated with use of diabetes self-management education and support programs in Louisiana. [2022]

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

An Analysis of Diabetes Mobile Applications Features Compared to AADE7™: Addressing Self-Management Behaviors in People With Diabetes. [2019]

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

Diabetes Self-management Education Provision by an Interprofessional Collaborative Practice Team: A Quality Improvement Project. [2019]