NCT07154251 Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery
| NCT ID | NCT07154251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals Cleveland Medical Center |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2025-11-06 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Sarah A MacLeish, DO
PRINCIPAL INVESTIGATOR
University Hospitals Cleveland Medical Center
Frequently Asked Questions
Who can join the NCT07154251 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07154251 currently recruiting?
Yes, NCT07154251 is actively recruiting participants. Contact the research team at wendy.campbell@uhhospitals.org for enrollment information.
Where is the NCT07154251 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT07154251 clinical trial?
NCT07154251 is sponsored by University Hospitals Cleveland Medical Center. The principal investigator is Sarah A MacLeish, DO at University Hospitals Cleveland Medical Center. The trial plans to enroll 16 participants.
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