Recruiting

Diabetes Technology

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT07154251

Conditions

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Community Health Worker

Study Details

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.

Conditions

Type 1 Diabetes (T1D)

Study ID

NCT07154251

Start date

Nov 6, 2025

Status verified date

Nov, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Community Health Worker

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Wendy Campbell, RN, CDCES

216-844-3661wendy.campbell@uhhospitals.org

Julie Hutter, RN

216-844-3661julie.hutter@uhhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Wendy Campbell, RN, CDCES

216-844-3661wendy.campbell@uhhospitals.org

Julie Hutter, RN

216-844-3661julie.hutter@uhhospitals.org

Principal Investigator:

Sarah A MacLeish, DO

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Dec 4, 2025

Last verified

Nov, 2025

Keywords

  • Automated insulin delivery
  • Community Health Worker
  • Disparities
  • Type 1 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2025-12-04.