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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
University Hospitals Cleveland Medical Center
Study ID
NCT07154251
Status
Recruiting
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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Community Health Worker — OTHER
    Community Health Worker will meet with families monthly (and more often as needed) in the role of a diabetes technology coach

Study Details

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.

Key Dates

Start date
Nov 6, 2025
Status verified
Nov 2025
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Community Health Worker
    Community Health Workers will meet with families monthly in the role of a diabetes technology coach, with additional visits as needed.

Primary Outcome Measure

Change in capillary HbA1c [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106
Wendy Campbell, RN, CDCES
[email protected]
216-844-3661
Julie Hutter, RN
[email protected]
216-844-3661
Sarah A MacLeish, DO (PRINCIPAL_INVESTIGATOR)

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By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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