Comprehensive Diabetes Management for Diabetes

(IDEA Trial)

Overseen By Helen Margellos-Anast, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sinai Health System

Disqualifiers: Gestational diabetes, Stage-V renal, severe cardiovascular, others

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

Compensation: Varies

Number of Visits: 12

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this randomized trial is to determine the optimal combination and sequence of three enhancements for a team-based care model for patients living with diabetes in Chicago. The study aim is to determine optimization of intervention components. Participants will be randomly assigned to diabetes self-management training or remote glucose monitoring. After 6 months, participants will be rerandomized to a subsequent study arm (including a CHW support program) depending on a tailoring variable of change in A1c. Researchers will compare the final 6 study arms to see which combination and sequence of enhancements produces the most improvement in A1c.

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's best to discuss this with the trial coordinators or your doctor.

Is the Comprehensive Diabetes Management treatment safe for humans?

The available research on diabetes self-management education and community health worker programs does not specifically address safety concerns, but these programs are generally focused on education and support, which are considered safe approaches for managing diabetes. ^{1 2 3 4 5}

How is the Comprehensive Diabetes Management treatment different from other diabetes treatments?

This treatment is unique because it combines community health worker support, diabetes self-management education, and remote glucose monitoring, offering a comprehensive approach that empowers patients to actively manage their diabetes with personalized support and real-time data. ^{1 2 3 4 6}

What data supports the effectiveness of this treatment for diabetes management?

Research shows that programs led by community health workers (CHWs) for diabetes self-management education (DSME) help improve blood sugar control and other health outcomes. These programs empower people with diabetes to make better self-care choices and work effectively with healthcare providers. ^{1 2 7 8 9}

Are You a Good Fit for This Trial?

This trial is for African American/Black or Latinx adults with Type 1 or Type 2 diabetes, an HbA1c level over 7%, and access to a smartphone. They must be current patients who've completed at least one Center appointment and not already using remote glucose monitoring or working with a community health worker.

Inclusion Criteria

Able to provide consent

Identify as African American/Black or Latinx

Your most recent HbA1c level is higher than 7%.

Exclusion Criteria

I have severe heart disease that limits my daily activities.

I have advanced kidney disease or am on dialysis.

I have been diagnosed with diabetes during pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to either Remote Glucose Monitoring or Diabetes Self-Management Training for the first 6 months

6 months

Monthly data collection and monitoring

Rerandomization and Subsequent Treatment

Participants are rerandomized based on A1c response to continue with or switch to different interventions, including potential addition of Community Health Worker support

6 months

Monthly data collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Data collection at 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker tailored support
• Diabetes Self-Management Training (DSMT)
• Remote Glucose Monitoring (RGM)

Trial Overview The study tests how well different combinations of diabetes care enhancements work together. It starts with either self-management training or remote glucose monitoring, then adds tailored support after six months based on A1c changes. The goal is to find the best sequence for improving blood sugar control.

How Is the Trial Designed?

Group I: Remote Glucose Monitoring > Remote Glucose Monitoring+Community Health Worker (RGM->RGM+CHW) Experimental Treatment 2 Interventions

Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a continuation of RGM, with the addition of a CHW to provide tailored support.

Group II: Remote Glucose Monitoring > Remote Glucose Monitoring (RGM->RGM) Experimental Treatment 1 Intervention

Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will remain in the RGM group.

Group III: Remote Glucose Monitoring > Diabetes Self-Management Training (RGM->DSMT) Experimental Treatment 2 Interventions

Participant will be randomized into the RGM study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being diabetes self-management training (DSMT).

Group IV: Diabetes Self-Management Training > Standard of Care (DSMT->SOC) Experimental Treatment 1 Intervention

Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a responder (A1c improved by at least 1 percentage point), patient will be directed back to standard of care.

Group V: Diabetes Self-Management Training > Remote Glucose Monitoring (DSMT->RGM) Experimental Treatment 2 Interventions

Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being RGM.

Group VI: Diabetes Self-Management Training > Community Health Worker (DSMT->CHW) Experimental Treatment 2 Interventions

Participant will be randomized into the DSMT study arm for the first 6 months. At the 6-month rerandomization point, if the patient is a non-responder (A1c has not improved by at least 1 percentage point), patient will be randomized again with one arm being a CHW to provide tailored support.

Who Is Running the Clinical Trial?

Sinai Health System

Lead Sponsor

Trials

26

Recruited

11,900+

Published Research Related to This Trial

A community health worker (CHW) diabetes self-management education program significantly reduced HbA1c levels and diabetes distress in Latino adults with type 2 diabetes over 6 months compared to enhanced usual care, indicating its effectiveness in managing diabetes.

Participants who continued with a peer leader (PL) program maintained their HbA1c improvements and reported fewer depressive symptoms at 18 months, suggesting that ongoing support is crucial for sustaining diabetes management gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Spencer, MS., Kieffer, EC., Sinco, B., et al.[2022]

Patients in a Community Health Worker (CHW)-led diabetes self-management education program showed significant improvements in their blood glucose levels (A1C) and blood pressure after one year, indicating the program's effectiveness.

CHWs effectively bridged the gap between patients and primary care providers by offering support in diabetes management, education, and access to resources, demonstrating their valuable role in enhancing diabetes care coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community health worker-led diabetes self-management education program and implications for CHW involvement in care coordination strategies. Collinsworth, AW., Vulimiri, M., Schmidt, KL., et al.[2022]

Community health workers (CHWs) played a crucial role in diabetes self-management by providing encouragement and motivation during 1859 individual patient contacts, which helped patients incorporate diabetes management into their daily lives.

Patients reported that the personal connection and support from CHWs were distinct from that provided by family or healthcare teams, highlighting the importance of integrating CHWs into standard diabetes care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching how, not what: the contributions of community health workers to diabetes self-management. Davis, KL., O'Toole, ML., Brownson, CA., et al.[2018]

Participation in a 6-week Diabetes Self-Management Education (DSME) program led to a significant reduction in hemoglobin A1c (HgbA1c) levels by 1.6% in overweight/obese patients, indicating improved glycemic control.

While BMI did not change significantly, participants showed marked improvements in diabetes knowledge and confidence, suggesting that DSME enhances self-management skills in community health center patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Diabetes Self-Management Education in Community Health. Brown, K., Lee, LT., Selleck, C.[2020]

This pilot study aims to implement Diabetes Self-Management Education (DSME) in clinics in Liberia, focusing on improving the knowledge and self-management skills of people living with insulin-dependent diabetes, with a structured approach involving training for healthcare providers.

The study will assess the feasibility and acceptability of DSME, measuring outcomes such as changes in self-management behaviors, glycaemic control (measured by hemoglobin A1c), and psychosocial well-being, which are crucial for improving diabetes care in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating implementation of Diabetes Self-Management Education in Maryland County, Liberia: protocol for a pilot prospective cohort study. Trujillo, C., Ferrari, G., Ngoga, G., et al.[2022]

Only 6.8% of privately insured adults aged 18-64 with newly diagnosed diabetes participated in diabetes self-management education and training (DSMT) during the first year after diagnosis, highlighting a significant gap in adherence to recommended guidelines.

The American Diabetes Association emphasizes the importance of DSMT for newly diagnosed patients, as they are most receptive to learning about diabetes management, indicating a critical opportunity to improve participation rates in this essential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes self-management education and training among privately insured persons with newly diagnosed diabetes--United States, 2011-2012. Li, R., Shrestha, SS., Lipman, R., et al.[2022]

A study involving 120 primary care physicians found that more than half provided inadequate quality of diabetes self-management education (DSME) across various areas, indicating a need for improvement in training.

The highest scores were in the 'drug intake' domain, while lower scores in 'problem-solving' and 'being active' suggest that physicians may not be effectively equipping patients with the skills needed for comprehensive diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management Education in Type 2 Diabetes in Primary Care. Korzh, O.[2021]

A 2.5-month diabetes education training for community health workers (CHWs) significantly improved their diabetes knowledge, as evidenced by pre- and post-test results from the Diabetes Knowledge Questionnaire (DKQ).

The training utilized diverse methods, including case studies and role-playing, highlighting the need for standardized diabetes competencies and evaluative tools tailored specifically for CHWs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Training for Community Health Workers. Aponte, J.[2020]

A 6-week group-based diabetes self-management education (DSME) program tailored for New Zealand improved participants' confidence in managing diabetes, physical activity levels, and glycaemic control, with HbA1C levels decreasing significantly from 8.07% to 7.62% at 6 months.

While the program showed effectiveness at 6 months, improvements in glycaemic control and blood pressure were not sustained by 9 months, indicating that a refresher course may be necessary to maintain these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured, group-based diabetes self-management education (DSME) programme for people, families and whanau with type 2 diabetes (T2DM) in New Zealand: an observational study. Krebs, JD., Parry-Strong, A., Gamble, E., et al.[2022]

Citations

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

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. [2022]

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

Effectiveness of a community health worker-led diabetes self-management education program and implications for CHW involvement in care coordination strategies. [2022]

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

Teaching how, not what: the contributions of community health workers to diabetes self-management. [2018]

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

Effectiveness of Diabetes Self-Management Education in Community Health. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating implementation of Diabetes Self-Management Education in Maryland County, Liberia: protocol for a pilot prospective cohort study. [2022]

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

Diabetes self-management education and training among privately insured persons with newly diagnosed diabetes--United States, 2011-2012. [2022]

7. Bulgaria pubmed.ncbi.nlm.nih.gov

Self-management Education in Type 2 Diabetes in Primary Care. [2021]

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

Diabetes Training for Community Health Workers. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A structured, group-based diabetes self-management education (DSME) programme for people, families and whanau with type 2 diabetes (T2DM) in New Zealand: an observational study. [2022]