Community health worker coaches to support automated insulin delivery for Black children with type 1 diabetes
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)
This program will try having community health workers coach non-Hispanic Black children with type 1 diabetes who use automated insulin delivery to see if it helps their blood sugar control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 5 Years to 17 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07154251 on ClinicalTrials.gov |
What this trial studies
Non-Hispanic Black children with type 1 diabetes who are using an automated insulin delivery system will meet with a trained community health worker monthly for six months, with extra visits as needed. Participants and their parents or guardians will complete questionnaires at the start and end of the six-month coaching period and will take part in an interview at six months. After the coaching period, the team will continue to collect continuous glucose monitor and pump download data for an additional six months without extra CHW support. Care must be provided at University Hospitals Cleveland Medical Center and guardians must be English-speaking and willing to participate.
Who should consider this trial
Good fit: Ideal candidates are non-Hispanic Black children with type 1 diabetes who currently use or used an automated insulin delivery system within the past 3 months, have an HbA1c of about 8% or higher, receive care at University Hospitals Cleveland Medical Center, and have English-speaking guardians willing to participate.
Not a fit: Patients who are non-English-speaking, have type 2 or monogenic diabetes, have already worked with a community health worker for diabetes technology, are not using automated insulin delivery recently, or cannot attend visits at UH Cleveland are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could improve glucose control, increase confidence using diabetes technology, and help reduce outcome disparities for Black children with type 1 diabetes.
How similar studies have performed: Community health worker programs have improved diabetes care in other populations, but using CHWs specifically as coaches for automated insulin delivery in Black children is a relatively novel approach with limited direct evidence to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Sarah A MacLeish, DO — University Hospitals Cleveland Medical Center
- Study coordinator: Wendy Campbell, RN, CDCES
- Email: wendy.campbell@uhhospitals.org
- Phone: 216-844-3661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.