T1D-CATCH Program for Type 1 Diabetes in Young Adults

(T1DTechCHW Trial)

Overseen by Shivani Agarwal, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Albert Einstein College of Medicine

Disqualifiers: Developmental disability, Sensory disability, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a program called T1D-CATCH where community health workers help young adults from minority groups with type 1 diabetes use diabetes technology better. The program includes education, goal-setting, peer support, and help with insurance paperwork. The aim is to see if this support improves their use of diabetes tools and overall care.

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 data supports the effectiveness of the T1D-CATCH treatment for young adults with type 1 diabetes?

Research shows that community health workers can effectively help manage diabetes by providing education and support, as seen in studies where they improved health outcomes for people with diabetes. This suggests that using community health workers in the T1D-CATCH program could be beneficial for young adults with type 1 diabetes. ^{1 2 3 4 5}

Is the T1D-CATCH Program safe for young adults with type 1 diabetes?

The research on Community Health Workers (CHWs) in diabetes care shows that integrating CHWs into diabetes management programs is generally well-accepted by participants and does not report any safety concerns. This suggests that the T1D-CATCH Program, which uses CHWs, is likely safe for young adults with type 1 diabetes. ^{4 6 7 8 9}

What makes the T1D-CATCH treatment unique for young adults with type 1 diabetes?

The T1D-CATCH treatment is unique because it uses community health workers (CHWs) to provide personalized support and education in community settings, which is different from traditional medical care that typically occurs in clinical settings. This approach aims to improve diabetes management by leveraging the close connection CHWs have with the community, potentially leading to better adherence and health outcomes. ^{1 2 3 4 8}

Research Team

Shivani Agarwal, MD

Principal Investigator

Albert Einstein College of Medicine

Eligibility Criteria

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 am between 18 and 35 years old.

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)

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.

Trial Timeline

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

Treatment Details

Interventions

• Community Health Worker (Behavioral Intervention)
• T1D-CATCH (Behavioral Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Dr. Philip Ozuah

Albert Einstein College of Medicine

Chief Medical Officer since 2019

MD from University of Ibadan, Nigeria

Dr. Yaron Tomer

Albert Einstein College of Medicine

Chief Executive Officer since 2021

MD from Sackler School of Medicine, Tel Aviv University

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Sarah E. Paul

The Leona M. and Harry B. Helmsley Charitable Trust

Chief Executive Officer since 2021

Harvard summa cum laude, J.D. from Harvard Law School

Walter Panzirer

The Leona M. and Harry B. Helmsley Charitable Trust

Chief Medical Officer since 2021

MD

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

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

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

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

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. [2022]

2. United States 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. [2022]

3. United States 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. [2022]

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

Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. [2022]

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

"The Promotora Explained Everything": Participant Experiences During a Household-Level Diabetes Education Program. [2021]

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

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of persons with diabetes. [2022]

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

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

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

Implementing the community health worker model within diabetes management: challenges and lessons learned from programs across the United States. [2022]