Status:

RECRUITING

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

Lead Sponsor:

University Hospitals Cleveland Medical Center

Conditions:

Type 1 Diabetes (T1D)

Eligibility:

All Genders

5-17 years

Phase:

NA

Brief Summary

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 me...

Eligibility Criteria

Inclusion

  • Self-reported as non-Hispanic Black
  • Clinical diagnosis of type 1 diabetes, requiring treatment with insulin at the time of consent
  • 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)
  • Clinical care provided at UH Cleveland Medical Center
  • Has not previously worked with a community health worker for help with diabetes technology

Exclusion

  • Clinical diagnosis of Type 2 or monogenic diabetes
  • Completed high school
  • At least 1 parent/guardian or family support person not willing to participate
  • Non-English speaking guardians
  • Has not used automated insulin delivery within the past 3 months
  • Has previously worked with a CHW for help with diabetes technology
  • Custody of children and family services

Key Trial Info

Start Date :

November 6 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2027

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT07154251

Start Date

November 6 2025

End Date

March 1 2027

Last Update

December 4 2025

Active Locations (1)

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1

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106