Community Health Workers for Type 1 Diabetes

(CHWs AID Youth Trial)

Overseen By Julie Hutter, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must be taking: Insulin

Disqualifiers: Type 2 diabetes, Monogenic diabetes, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of community health workers (CHWs) in assisting African American children with type 1 diabetes in managing their condition through technology. It focuses on children using automated insulin delivery systems who still experience high blood sugar levels (HbA1c of 8% or higher). Families will meet with a CHW monthly for six months to receive additional guidance on using their diabetes devices. This trial suits children receiving care at UH Cleveland Medical Center who already use these insulin systems but have not previously worked with a CHW. As an unphased trial, it offers families a unique opportunity to receive personalized support and potentially improve diabetes management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using community health workers to help with diabetes technology, so it's likely you can continue your current treatment.

What prior data suggests that using community health workers as diabetes technology coaches is safe for African American children with Type 1 Diabetes?

Research has shown that community health workers (CHWs) are safe and very helpful in managing diabetes. Studies have found that patients working with CHWs often achieve better blood sugar control, even during challenging periods like the COVID-19 pandemic.

No reports indicate major negative effects when CHWs assist with diabetes care. In fact, CHWs have improved the health of higher-risk individuals, such as those from low-income backgrounds. This support can significantly impact those managing their diabetes.

Overall, CHWs are considered safe and effective in helping people manage diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Community Health Workers (CHWs) for managing Type 1 Diabetes because this approach offers a personalized and supportive method that current standard treatments might lack. Unlike traditional medical care that focuses primarily on insulin therapy and glucose monitoring, CHWs serve as diabetes technology coaches, meeting with families monthly and providing additional support as needed. This method aims to empower families with practical skills and emotional support, potentially improving adherence to diabetes management routines and enhancing overall quality of life for patients.

What evidence suggests that using community health workers is effective for managing Type 1 Diabetes?

Research has shown that community health workers (CHWs) can effectively improve diabetes management, particularly for individuals in low-income and minority groups. In previous studies, individuals with diabetes who collaborated with a CHW experienced significant reductions in their A1C levels, an important measure of blood sugar control. Specifically, one study found that CHW guidance lowered A1C by at least 1.0% for most participants, helping them maintain stable blood sugar levels. This improvement is crucial because lower A1C levels can reduce the risk of diabetes-related complications. Overall, involving CHWs in diabetes care has been linked to better health outcomes and a higher quality of life for those managing the condition. Participants in this trial will work with a Community Health Worker who will meet with families monthly as a diabetes technology coach, with additional visits as needed. ^{2 6 7 8 9}

Who Is on the Research Team?

Sarah A MacLeish, DO

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for African American children with Type 1 Diabetes who use automated insulin delivery systems but struggle to maintain their HbA1c below 8%. They must be willing to meet with a community health worker monthly for six months and participate in questionnaires and interviews.

Inclusion Criteria

Has not previously worked with a community health worker for help with diabetes technology

Self-reported as non-Hispanic Black

Currently using, or have used within the past 3 months, an automated insulin delivery system (consisting of a continuous glucose monitor and an insulin pump as well as an automated insulin delivery algorithm)

Exclusion Criteria

Completed high school

Non-English speaking guardians

I have been diagnosed with Type 2 or monogenic diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Families meet with community health workers monthly for 6 months, with additional visits as needed. Participants and parents/guardians fill out questionnaires at the beginning and end of the intervention.

6 months

6 visits (in-person), additional visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, with continued follow-up of CGM and pump download data.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker

Trial Overview The study tests if having a Community Health Worker as a diabetes technology coach can help manage Type 1 Diabetes better. Participants will receive guidance on using their insulin delivery systems effectively over six months, followed by another six without the extra support.

How Is the Trial Designed?

Group I: Community Health Worker Experimental Treatment 1 Intervention

Community Health Workers will meet with families monthly in the role of a diabetes technology coach, with additional visits as needed.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869924/

Impact of community health workers on diabetes ... We found that, among patients with diabetes, participation in the CHW program was associated with significant reductions in A1C and increased ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04238949

Community Health Workers in Pediatric Patients With ... ... outcomes in children with type 1 diabetes. These children have poorer glycemic control, lower quality of life, and increased healthcare utilization.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335520302254

Introduction of a community health worker diabetes coach ... CHW coaching reduced hemoglobin A1c by at least 1.0% for most participants. •. Most participants with diabetes working with the CHW met glycemic control.

4. withpower.com withpower.com/trial/community-health-worker-added-to-diabetes-team-for-type-1-diabetes-027fd

Community Health Worker added to diabetes team for Type ... Research shows that community health workers (CHWs) can effectively improve diabetes outcomes, especially in low-income and minority groups. While most studies ...

5. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-020-01377-8

The effectiveness of peer and community health worker-led ... COMP-DSMPs were inconsistently associated with improvements in clinical, behavioural, and psychological outcomes.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40302949/

A Potential Role for Community Health Workers Conclusions: There is a high prevalence of adverse SDOH in families from lower socioeconomic status at the time of diagnosis of pediatric T1D.

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

Impact of community health workers on diabetes ... Patients with CHWs were better able to manage their A1C levels than patients without CHWs, both before and after the onset of the COVID-19 pandemic. •. CHWs can ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2024/8810609

Adverse Social Determinants of Health in Children with ... Community health workers (CHWs) have been shown to improve outcomes in marginalized, high-risk populations. The purpose of this qualitative ...

9. 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.