Diabetes Education and Support for Type 2 Diabetes

Overseen By Jennifer A Campbell, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Other diabetes trials, Substance abuse, Dementia, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a nurse-led phone-based program can help older African Americans better manage type 2 diabetes. Participants will receive diabetes education and support to address unmet social needs, aiming to improve health and well-being. One group will participate in monthly phone sessions as part of the DM Social Needs Intervention, which combines diabetes education, skills training, and social needs resolution. The other group will receive diabetes information by mail as part of Usual Care. Suitable candidates for this trial are individuals aged 50 or older, identifying as African American, with poorly controlled type 2 diabetes, often indicated by an A1C level of 8% or higher. As an unphased trial, this study provides a unique opportunity to contribute to innovative research aimed at improving diabetes management in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for older African Americans with poorly controlled type 2 diabetes?

Research has shown that the DM Social Needs intervention is being studied for its effectiveness in managing type 2 diabetes. This program combines diabetes education with skills training and addresses social needs. However, there is limited direct evidence about its safety from available sources.

This intervention is not a new drug or medical procedure. Instead, it is a structured support program delivered over the phone by a trained health educator. Programs like this are generally considered safe because they focus on education and support, not on introducing new medications or treatments. Typically, these programs have a very low risk of causing harm.

Since the trial tests an educational and support approach rather than a new drug or medical procedure, it is reasonable to expect that the intervention is well-tolerated. The goal is to help participants manage their diabetes better through education and addressing social needs, which can improve health outcomes without posing significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DM Social Needs intervention because it offers a personalized and holistic approach to managing Type 2 Diabetes. Unlike standard care, which typically involves medication and general educational materials, this intervention provides one-on-one support through monthly telephone sessions with a trained health educator. These sessions focus not only on diabetes education and skills training but also address social needs, helping to solve real-life challenges that can impact diabetes management. This tailored, supportive method could lead to more effective diabetes control and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that combining diabetes education with practical skills training and addressing social needs can improve diabetes management. In this trial, participants in the DM Social Needs Intervention arm will receive specific education and support, which studies have found often leads to better blood sugar control. The DM Social Needs program also addresses unmet social needs, which can significantly impact health. In similar programs, patients reported feeling more empowered and saw improvements in managing their diabetes. Early results suggest this approach could be especially beneficial for older African Americans with poorly controlled type 2 diabetes. Meanwhile, participants in the Usual Care arm will receive diabetes education materials recommended by the American Diabetes Association. ^{1 2 3 4 5}

Who Is on the Research Team?

Aprill Z Dawson, PhD, MPH

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for African Americans aged 50 or older with poorly controlled type 2 diabetes (HbA1C levels of at least 8%). Participants must self-identify as Black and have a diagnosis of T2DM. Those with significant dementia, involvement in other diabetes trials, substance abuse issues, or a life expectancy less than six months cannot join.

Inclusion Criteria

Self-identified as African American or Black

I have been diagnosed with type 2 diabetes.

I am 50 years old or older.

Exclusion Criteria

You are currently taking part in another diabetes research study.

You have a history of alcohol or drug abuse or dependency as assessed by the CAGE-AID questionnaire.

You are not expected to live for more than 6 months from the time of screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DM Social Needs intervention, including diabetes education and skills training, and resolution of social needs via telephone

6 months

6 monthly sessions (telephone)

Follow-up

Participants are monitored for changes in glycemic control and other outcomes after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DM Social Needs
• Usual Care

Trial Overview The study compares the effectiveness of two approaches: a nurse-led intervention providing education and skills training along with addressing social needs (DM Social Needs), versus usual care. It involves randomly placing participants into one of these two groups to see which method better improves clinical and patient-reported outcomes.

How Is the Trial Designed?

Group I: DM Social Needs Intervention Experimental Treatment 1 Intervention

A trained health educator will deliver the manualized DM Social Needs intervention. Participants will receive 6-monthly sessions of diabetes education and skills training, and problem solving and resolution of social needs via telephone.

Group II: Usual Care Active Control 1 Intervention

Participants in the usual care arm will receive mailed diabetes education materials in accordance with recommendations from the American Diabetes Association (ADA) monthly

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A systematic review of six controlled trials found that specific social support interventions, like group consultations and Internet-based peer support, can positively impact health outcomes for people with type 2 diabetes, improving measures like HbA1c and physical activity.

Traditional forms of social support, such as from family and friends, did not show significant improvements in diabetes control, suggesting that innovative support methods may be more effective in helping patients manage their condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social support in diabetes: a systematic review of controlled intervention studies. van Dam, HA., van der Horst, FG., Knoops, L., et al.[2022]

The diabetes self-management program, which included six weekly sessions focusing on self-efficacy and a participatory approach, significantly improved HbA1c levels in participants, with normal levels increasing from 4.5% to 28.6% over 28 weeks (p<0.001).

Participants in the experimental group also showed significant improvements in self-efficacy, body mass index (BMI), and dietary behaviors compared to the control group, indicating that integrating social work with general practice can enhance diabetes management outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General practice and social service partnership for better clinical outcomes, patient self efficacy and lifestyle behaviours of diabetic care: randomised control trial of a chronic care model. Lee, A., Siu, CF., Leung, KT., et al.[2011]

In a 9-month pilot program involving 7 dyads (individuals with type 2 diabetes and their support person), 6 out of 7 participants showed a reduction in hemoglobin A1c levels, indicating improved blood sugar control through community-based diabetes self-management education and support.

The program successfully enhanced diabetes knowledge and self-care behaviors, demonstrating that leveraging social capital and technology can effectively support diabetes management in under-resourced rural communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating family and friend support, information technology, and diabetes education in community-centric diabetes self-management. Higa, C., Davidson, EJ., Loos, JR.[2021]

In a study involving 78 type II diabetic outpatients, both nutrition education programs led to significant improvements in dietary goals compared to a control group, indicating their effectiveness in managing diabetes through dietary changes.

However, the addition of a social learning component did not provide any additional benefits over the standard nutrition education program, and there were minimal differences in long-term outcomes like weight or blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition education and social learning interventions for type II diabetes. Glasgow, RE., Toobert, DJ., Mitchell, DL., et al.[2019]

Group-based education programs for managing Type 2 diabetes significantly reduce glycated hemoglobin (HbA1c) levels compared to individual interventions or usual care, with notable improvements observed at various follow-up periods up to 48 months.

These group interventions also positively impact other health metrics such as fasting blood glucose, body weight, and diabetes knowledge, suggesting they are more effective overall in promoting better self-management behaviors in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of group-based self-management education for individuals with Type 2 diabetes: a systematic review with meta-analyses and meta-regression. Odgers-Jewell, K., Ball, LE., Kelly, JT., et al.[2022]

The study found that patients with type 2 diabetes in socially and economically marginalized conditions primarily rely on their nuclear family for support, which includes economic assistance, help with treatment compliance, emotional support, and material aid.

While social support networks are crucial for helping patients manage their diabetes, they do not ensure high-quality medical care or effective self-management of treatment in marginalized settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support of Patients with Type 2 Diabetes in Marginalized Contexts in Mexico and Its Relation to Compliance with Treatment: A Sociocultural Approach. Juárez-Ramírez, C., Théodore, FL., Villalobos, A., et al.[2020]

Intensive glycaemic management through diabetes self-management education programs has been shown to improve health outcomes for both type 1 and type 2 diabetes patients, enhancing their knowledge, skills, and motivation.

These programs are effective and cost-efficient, but they need to be tailored to specific populations considering various factors like type of diabetes and cultural background to maximize access and uptake globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes structured self-management education programmes: a narrative review and current innovations. Chatterjee, S., Davies, MJ., Heller, S., et al.[2018]

A study involving 26,093 patients found that individuals diagnosed with type 2 diabetes (T2DM) reported higher levels of social needs, particularly in areas like prescription costs, transportation, and health literacy.

These associations suggest that addressing social determinants of health could be crucial in managing T2DM, highlighting the potential for partnerships between health systems and social service providers to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between a comprehensive social determinants of health screening and type 2 diabetes mellitus. Brady, E., Bridges, K., Murray, M., et al.[2021]

A study involving 110 patients with type 2 diabetes showed that both health system-based social care and a combined approach with behavioral intervention were feasible and acceptable for improving diabetes management.

Participants in both intervention groups experienced clinically significant reductions in hemoglobin A1C levels, with 33% of those receiving navigation alone and 34% of those receiving navigation plus diabetes self-management support achieving A1C levels below 8% after 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridge to Health/Puente a la Salud: a pilot randomized trial to address diabetes self-management and social needs among high-risk patients. Fitzpatrick, SL., Papajorgji-Taylor, D., Schneider, JL., et al.[2023]

Face-to-face and telephone-based peer support programs for diabetes self-management have shown the most promise in improving outcomes for individuals with type 2 diabetes, based on a review of 76 studies from 2007 to 2021.

Cultural competency is crucial for the success of peer support initiatives, and there is a need for careful recruitment and training of peer supporters to ensure sustainable and effective programs in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 2 diabetes peer support interventions as a complement to primary care settings in high-income nations: A scoping review. Lu, S., Leduc, N., Moullec, G.[2022]

The study aims to improve diabetes self-management education (DSME) specifically for socioeconomically deprived patients with type 2 diabetes (T2DM), who often face more complications and worse health outcomes.

Conducted as a prospective longitudinal study over 12 months, the research will analyze the effectiveness of structured diabetes education through standardized surveys and statistical methods, ensuring ethical standards are met throughout the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning types and learning success in a structured diabetes education programme for patients with type 2 diabetes: study protocol of a prospective, longitudinal study. Morro, T., Fink, A., Carmienke, S., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39408171/

Combined Diabetes Education/Skills Training and Social ... The results from this study will provide insights into the efficacy of a combined diabetes education and skills training and social needs ...

2. mdpi.com mdpi.com/2227-9032/12/19/1991

Combined Diabetes Education/Skills Training and Social ... This three-year randomized clinical trial will test the efficacy of the six-session nurse case-manager, telephone-delivered combined diabetes ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05935410

Diabetes Education/Skills Training and Social Needs ... The aims of this study are: Aim 1: Test the preliminary efficacy of the DM Social Needs intervention on clinical outcomes in older AAs with uncontrolled type 2 ...

4. researchgate.net researchgate.net/publication/384709312_Combined_Diabetes_EducationSkills_Training_and_Social_Needs_Resolution_Intervention_for_Older_African_Americans_with_Poorly_Controlled_Type_2_Diabetes_DM_Social_Needs_Study_Protocol_for_a_Randomized_C

Study Protocol for a Randomized Controlled Trial Conclusion: The results from this study will provide insights into the efficacy of a combined diabetes education and skills training and social ...

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-7-2023-413f3

Diabetes Education and Support for Type 2 Diabetes The DM Social Needs treatment is unique because it combines diabetes education and skills training with addressing social needs, which can impact diabetes ...