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T1D-CATCH Program for Type 1 Diabetes in Young Adults (T1DTechCHW Trial)

N/A
Recruiting
Led By Shivani Agarwal, MD, MPH
Research Sponsored by Albert Einstein College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
T1D duration ≥6 months
Age between 18-35 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 month mark
Awards & highlights

T1DTechCHW Trial Summary

This trial is testing an enhanced community health worker model to help young adults from underrepresented minority groups with type 1 diabetes manage their disease using technology.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since T1D-CATCH is a support program rather than a medication, traditional side effects aren't expected. However, participants may experience stress or discomfort when adopting new technologies or changes in their routine due to the intervention.

T1DTechCHW Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had Type 1 Diabetes for at least 6 months.
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I am between 18 and 35 years old.

T1DTechCHW Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 month mark
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 month mark for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Glycosylated hemoglobin A
Quality of Life (Diabetes Distress
Quality of Life (Diabetes Distress)
+3 more
Other outcome measures
Adoption
Cost
Feasibility Check
+1 more

T1DTechCHW Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: T1D-CATCHExperimental Treatment1 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 ConditionActive Control1 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.

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Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
287 Previous Clinical Trials
11,857,078 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,377 Previous Clinical Trials
4,315,681 Total Patients Enrolled
Shivani Agarwal, MD, MPHPrincipal InvestigatorAlbert Einstein College of Medicine
1 Previous Clinical Trials
150 Total Patients Enrolled

Media Library

Community Health Worker Clinical Trial Eligibility Overview. Trial Name: NCT05211869 — N/A
Type 1 Diabetes Research Study Groups: T1D-CATCH, Usual Care Control Condition
Type 1 Diabetes Clinical Trial 2023: Community Health Worker Highlights & Side Effects. Trial Name: NCT05211869 — N/A
Community Health Worker 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211869 — N/A
~36 spots leftby Jan 2025
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