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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best combination and sequence of treatments for managing diabetes. Participants will receive either diabetes self-management training (DSMT) or remote glucose monitoring (RGM) for six months. Based on changes in their blood sugar levels, they may then switch to a different treatment plan that includes tailored support from a community health worker. The study seeks individuals with type 1 or type 2 diabetes who identify as African American/Black or Latinx, have a recent HbA1c over 7%, and use a smartphone compatible with the Glooko app. As an unphased trial, it offers a unique opportunity to explore personalized diabetes management strategies.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the three treatment options in this trial—Remote Glucose Monitoring (RGM), Diabetes Self-Management Training (DSMT), and Community Health Worker (CHW) support—are generally safe and well-tolerated for people with diabetes.

For Remote Glucose Monitoring, studies have found that continuous glucose monitors are both effective and safe. These devices help manage blood sugar levels by providing real-time feedback and are widely used without major safety concerns.

Diabetes Self-Management Training is a well-known program that teaches diabetes management. Research has shown that this training can prevent serious complications like heart disease and kidney problems. It is a standard method of care and is considered safe for most patients.

Community Health Worker support programs have also been studied and found to improve health outcomes. These workers provide personalized support and help patients manage their conditions better. No major safety issues have been reported with this type of assistance.

Overall, these treatments have been used safely in other settings and studies. Participants in this trial can expect them to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for diabetes management because they combine innovative technology and personalized support. Unlike traditional methods like medication and lifestyle changes alone, Remote Glucose Monitoring (RGM) allows for continuous tracking of blood sugar levels, providing real-time data to patients and healthcare providers. Additionally, the integration of Community Health Workers (CHWs) offers tailored support, which can enhance patient engagement and adherence to treatment plans. Diabetes Self-Management Training (DSMT) empowers patients with the skills needed to manage their condition effectively. This approach aims to improve outcomes by personalizing care and utilizing technology to keep patients informed and engaged.

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

Research has shown that Remote Glucose Monitoring (RGM), one of the treatment options in this trial, can significantly aid in controlling blood sugar levels. Studies indicate that continuous glucose monitoring provides real-time information, enabling more personalized diabetes care. Diabetes Self-Management Training (DSMT), another treatment option in this trial, has proven effective in helping individuals make healthier lifestyle choices and manage their care, resulting in improved blood sugar levels and a better quality of life. Additionally, support from Community Health Workers (CHWs), also under study in this trial, has improved diabetes outcomes, particularly in areas with high diabetes rates. These methods offer promising ways to manage diabetes effectively. ^{6 7 8 9 10}

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

Completed at least 3 months of their assigned study condition

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

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3929361/

The Role of Community Health Workers in Diabetes Community health worker (CHW) interventions have been found to be a promising strategy for improving diabetes outcomes, especially among low-income and racial ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265813/

Evaluating the effectiveness of community health worker ... Community health worker (CHW) interventions in control of HbA1c levels in diabetes have shown varied effects in randomised controlled trials ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000603

Impact of community health workers on diabetes ... This program was effective in improving diabetes management among patients living in diabetes-burdened communities, and the effects were persistent throughout ...

4. researchprotocols.org researchprotocols.org/2024/1/e57313/

Training of Community Health Workers in Diabetes Lead to ... This study outlines a systematic review aiming to evaluate the impact of training programs for CHWs in diabetes management in LMICs.

5. diabetesjournals.org diabetesjournals.org/care/article/41/7/1414/36448/Outcomes-at-18-Months-From-a-Community-Health

Outcomes at 18 Months From a Community Health Worker ... The primary outcome was HbA1c. Secondary outcomes were blood pressure, lipid levels, diabetes distress, depressive symptoms, understanding of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6469661/

Effect of Community Health Worker Support on Clinical ... We hypothesized that, compared with patients who did not receive CHW support, those enrolled in the IMPaCT program would have improved self-rated health, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5607679/

Community Health Worker Support for Disadvantaged ... Objectives. To determine whether a community health worker (CHW) intervention improved outcomes in a low-income population with multiple chronic conditions.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06040463

Improving Diabetes Equity and Advancing Care Study 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 ...

9. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2816057

Barriers and Facilitators to Implementing an Evidence ... Importance Community health worker (CHW) programs may improve health outcomes, increase quality of life, and reduce hospitalizations and cost of ...

10. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2019.00981

Evidence-Based Community Health Worker Program ... IMPaCT is a theory-based intervention in which specially hired and trained community health workers provide tailored social support for high-risk patients.