Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
NCT07154251

Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery

Led by University Hospitals Cleveland Medical Center · Updated on 2025-12-04

16

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study uses community health workers (CHW) as diabetes technology coaches for African American children using automated insulin delivery systems but have an HbA1c of 8% or higher. Families will meet with the CHW monthly x 6 months with additional visits as needed. All participants and parents/guardians will fill out questionnaires at the beginning and end of the 6 month intervention in addition to an interview at 6 months. This will be followed by 6 months with no extra help from the CHW, but we will continue to follow CGM and pump download data.

CONDITIONS

Official Title

Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Self-reported as non-Hispanic Black
  • Clinical diagnosis of type 1 diabetes requiring insulin treatment at consent
  • Currently using or used within past 3 months an automated insulin delivery system
  • Receiving clinical care at UH Cleveland Medical Center
  • Has not previously worked with a community health worker for diabetes technology help
Not Eligible

You will not qualify if you...

  • Diagnosis of Type 2 or monogenic diabetes
  • Completed high school
  • At least one parent/guardian or family support person unwilling to participate
  • Non-English speaking guardians
  • Has not used automated insulin delivery within past 3 months
  • Has previously worked with a community health worker for diabetes technology
  • Custody issues involving children and family services

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

W

Wendy Campbell, RN, CDCES

CONTACT

J

Julie Hutter, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery | DecenTrialz