T1D-CATCH Program for Type 1 Diabetes in Young Adults

(T1DTechCHW Trial)

Not currently recruiting at 1 trial location

Overseen By Shivani Agarwal, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Developmental disability, Sensory disability, Pregnancy, others

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

Compensation: Varies

Number of Visits: 6

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adults from underrepresented minority groups manage type 1 diabetes more effectively. It tests a new approach where community health workers (CHWs) support and encourage the use of diabetes technology. Participants will either receive this support or continue with their usual care. Ideal candidates are 18-35 years old, identify as non-Hispanic Black or Hispanic, have had type 1 diabetes for at least six months, and are not currently using connected diabetes technology. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care strategies and potentially improve personal health management.

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 focuses on encouraging the use of diabetes technology, so it's best to ask the study team for more details.

What prior data suggests that the T1D-CATCH model is safe for young adults with type 1 diabetes?

Research has shown that programs like T1D-CATCH, which use community health workers (CHWs), are generally safe for participants. Studies have found that CHWs help people manage their health better without causing harm. Similar programs have reported no serious side effects. CHWs receive training to support people, especially those at higher risk, by providing education and guidance. This approach has been well-received and may improve health without introducing new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the T1D-CATCH Program because it offers a fresh approach by using Community Health Workers (CHWs) to provide personalized and peer-supported care for young adults with Type 1 Diabetes. Unlike the usual care, which primarily involves routine visits to healthcare providers for monitoring and treatment adjustments, this program emphasizes technology education and social support through both individual and group sessions. The flexibility of videoconferencing or in-person meetings, depending on participant preference and COVID-19 guidelines, adds a modern twist that could improve engagement and outcomes for young adults managing their diabetes.

What evidence suggests that the T1D-CATCH program is effective for young adults with type 1 diabetes?

Research shows that community health workers (CHWs) can help young adults from minority groups with type 1 diabetes (T1D) overcome challenges in using diabetes technology. Studies have found that CHWs provide essential education and support, facilitating the adoption and continued use of these tools. This approach is cost-effective and scalable to assist more individuals. Previous research has demonstrated that CHWs have successfully increased technology use, which is crucial for managing T1D. In this trial, the T1D-CATCH program, which participants may receive, specifically aims to boost technology use in these groups, showing promise in improving diabetes care. ^{1 2 3 4 6}

Who Is on the Research Team?

Shivani Agarwal, MD

Principal Investigator

Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-30 with type 1 diabetes who are not currently using a connected diabetes technology system. Participants must be from underrepresented minority groups, specifically non-Hispanic Black or Hispanic, and speak English or Spanish. Those who are pregnant, have disabilities that interfere with participation, or have been in another related study recently cannot join.

Inclusion Criteria

I have had Type 1 Diabetes for at least 6 months.

Not currently on a connected diabetes technology system (includes never offered, prescribed but not started within 3 months of receiving the device, discontinued, or previously refused technology)

Self-identified URM status: non-Hispanic Black or Hispanic

Exclusion Criteria

Developmental or sensory disability interfering with study participation

Current pregnancy

Participation in another behavioral or diabetes technology intervention study in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the T1D-CATCH intervention or usual care over a 9-month period, with weekly individual sessions and optional monthly group sessions for the intervention group.

9 months

Weekly individual sessions, optional monthly group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of autonomy, competence, social support, and quality of life.

6 months

Follow-up assessments at 6 and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker
• T1D-CATCH

Trial Overview The T1D-CATCH program is being tested to see if it helps young adults from minority groups start and continue using diabetes technology over six months. The study will compare the effects of this enhanced community health worker model against usual care in a randomized controlled trial lasting nine months.

How Is the Trial Designed?

Group I: T1D-CATCH Experimental Treatment 1 Intervention

The CHW intervention will consist of both individual and optional group sessions with YA-URMs with T1D. In individual sessions, CHWs will provide T1D technology education, peer support, and social needs management. Over the 9-month study period, session frequency will involve weekly individual sessions based on participant technology milestones and an optional monthly CHW-led peer group support session. CHW individual and group sessions will be held via videoconferencing or in person, per participant preference and institutional COVID-19 rules.

Group II: Usual Care Control Condition Active Control 1 Intervention

Control arm participants will receive usual primary or endocrine care at Montefiore. Usual care consists of a physician or nurse practitioner visit with review of blood sugars and treatment decisions based on provider experience. Physicians in endocrinology practices are nested within a diabetes center with access to diabetes nurse practitioners/educators, dieticians, a psychologist, and nurses. In all practices, patients are recommended to see their physician or nurse practitioner every 3 months and attend individual or group sessions.

Community Health Worker is already approved in United States for the following indications:

Approved in United States as Community Health Worker for:

• Support for diabetes technology use in type 1 diabetes

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Community Health Worker (CHW) interventions can lead to a modest reduction in hemoglobin A1c (A1c) levels in people with diabetes, with a standardized mean difference of 0.21 based on a meta-analysis of nine randomized controlled trials with at least 12 months of follow-up.

The effectiveness of CHW interventions appears to be greater in individuals with higher baseline A1c levels, suggesting that these interventions may be particularly beneficial for those with more severe diabetes management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. Palmas, W., March, D., Darakjy, S., et al.[2022]

Community health workers play a valuable role in diabetes care, with studies showing increased participant knowledge and satisfaction, particularly among minority populations in the USA.

Some interventions involving community health workers led to improvements in physiological measures and positive lifestyle changes, although more research is needed to fully understand their impact and optimal roles in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of persons with diabetes. Norris, SL., Chowdhury, FM., Van Le, K., 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]

The diabetes education program for community health workers led to significant improvements in patients' lipid profiles, with reductions in total cholesterol and triglycerides, indicating potential benefits beyond just blood sugar control.

While both the intervention and control groups showed a decrease in HbA1c levels, the changes were not statistically different between the two groups, suggesting that the education program did not have a unique impact on blood sugar levels compared to standard health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. de Souza, CF., Dalzochio, MB., Zucatti, ATN., et al.[2022]

Integrating Community Health Workers (CHWs) into diabetes group visits for low-income Hispanic adults led to significantly better clinical outcomes, including improved A1C levels and adherence to preventive care guidelines over a 6-month period with 50 participants.

Participants in the intervention group not only lost weight but also reported high satisfaction with the group visits, indicating that this approach is both effective and well-received by the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. Vaughan, EM., Johnston, CA., Cardenas, VJ., et al.[2023]

The REACH for Control (RFC) intervention, delivered by community health workers, showed significant improvements in hemoglobin A1c (HbA1c) levels and quality of life for adolescents with poorly controlled type 1 diabetes, compared to standard care.

Caregivers found the RFC intervention to be acceptable, although the frequency of follow-up sessions for skills practice was lower than intended, indicating a need for adjustments in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of an Evidence-Based Diabetes Management Intervention for Delivery in Community Settings: Findings From a Pilot Randomized Effectiveness Trial. Ellis, DA., Carcone, AI., Naar-King, S., et al.[2022]

The Peer-AID trial is evaluating a home-based intervention delivered by community health workers to help low-income individuals with poorly controlled type 2 diabetes, with a focus on improving A1c levels over 12 months.

The study successfully enrolled 287 diverse participants from disadvantaged backgrounds, highlighting the potential for community-based programs to address diabetes management in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support. Nelson, K., Drain, N., Robinson, J., et al.[2022]

The Home Health Parties (HHP) intervention effectively improved diabetes self-management among Hispanics in rural Washington by emphasizing family involvement and social support, as reported by 40 participants through qualitative interviews.

Key strategies included the role of trained community health workers (promotores) in fostering trust and cultural understanding, and the use of practical tools like cookbooks and monitoring devices to enhance participants' skills and confidence in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The Promotora Explained Everything": Participant Experiences During a Household-Level Diabetes Education Program. Shepherd-Banigan, M., Hohl, SD., Vaughan, C., et al.[2021]

The study analyzed 16 community health worker (CHW) programs focused on diabetes management, revealing that CHWs primarily served as educators and were often informally recruited, with most programs targeting minority populations.

Key challenges identified included retaining CHWs, maintaining intervention fidelity, and ensuring sustainability, highlighting the importance of community support and addressing broader social issues for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the community health worker model within diabetes management: challenges and lessons learned from programs across the United States. Cherrington, A., Ayala, GX., Amick, H., et al.[2022]

Citations

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T1DTechCHW: Enhancing the Community Health Worker ... The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages ...

2. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/10811580

T1DTechCHW: Enhancing the Community Health Worker (CHW ... CHWs are an evidence-based, cost-effective, scalable work force that can address multi-level barriers to diabetes technology use in YA-URMs with T1D, but have ...

3. chwcentral.org chwcentral.org/resources/come-to-a-conclusion-together-feedback-on-the-collaboration-around-technology-using-community-health-workers-in-type-1-diabetes-t1d-catch-study/

“Come to a Conclusion Together”—Feedback on the ... This study explores the T1D-CATCH intervention, aiming to enhance diabetes technology adoption among minoritized young adults with type 1 diabetes (T1D).

4. diabetes.jmir.org diabetes.jmir.org/2025/1/e76387

A Web-Based Qualitative Study Using Human-Centered ... A community health worker (CHW) model is a potential community-based intervention that can address inequity associated with diabetes technology ...

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-4-2022-e8ffe

T1D-CATCH Program for Type 1 Diabetes in Young Adults · Info ... This trial tests a program called T1D-CATCH where community health workers help young adults from minority groups with type 1 diabetes use diabetes ...

6. 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 ...