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Community Health Workers as Diabetes Technology Coaches for Children With Type 1 Diabetes

This study is looking at whether Community Health Workers (CHWs) can help African American children (ages 5-17) with type 1 diabetes better manage their condition using automated insulin delivery systems. You might be able to join if your child has type 1 diabetes, uses an automated insulin delivery system, and has an HbA1c (a measure of average blood sugar over time) of 8% or higher. The study will measure changes in HbA1c and how often children use their automated insulin delivery system in automated mode over 12 months. This study is currently unclear on its recruitment status and plans to enroll 16 participants.

Study design
This interventional study plans to enroll 16 participants. It will test the impact of Community Health Workers as diabetes technology coaches.
What's involved
You and your child would meet with a Community Health Worker monthly for 6 months, with additional visits if needed. You would also fill out questionnaires and participate in an interview.
Compensation
Not stated in the trial record.
Follow-up
After the 6-month intervention with the Community Health Worker, your child's data will continue to be followed for another 6 months, for a total of 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07154251

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

Recruiting
NAAges 5–17InterventionalHealth services
University Hospitals Cleveland Medical Center
~16 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Community Health Worker

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in capillary HbA1c
Measured over Baseline, 3 months, 6 months, 9 months, 12 months
+1 more outcome measured

Conditions

Type 1 Diabetes (T1D)

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Sarah A MacLeish, DO · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

Who to contact

Wendy Campbell, RN, CDCES
[email protected]
216-844-3661
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Change in capillary HbA1cBaseline, 3 months, 6 months, 9 months, 12 months
  • Change in number of participants who use an automated insulin delivery system with at least 80% time in automated mode over the past 30 days, as measured by download of data from the automated insulin delivery systemBaseline, 3 months, 6 months, 9 months, 12 months