NCT07154251Recruiting
Utilizing Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes Using Automated Insulin Delivery
Utilizing a Community Health Worker in the Role of a Diabetes Technology Coach for Black Children Using Automated Insulin Delivery and Not Meeting Glycemic Targets (CHWs AID Youth)
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 16 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 6 Nov 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Diseases
- Type 1 diabetes
- NCT number
- NCT07154251
What you commit to
- Study type: Interventional
- Planned participants: 16
- From 6 Nov 2025 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has previously worked with a CHW for help with diabetes technology
Other illness
- Clinical diagnosis of Type 2 or monogenic diabetes
Other
- 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
- Custody of children and family services
Who the study is looking for
- 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
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.