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

NCT07154251 | Recruiting

• 1 other identifier: STUDY20250042
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in capillary HbA1c

  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

  Baseline, 3 months, 6 months, 9 months, 12 months

Secondary Outcomes (18)

• Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring

  Baseline, 3 months, 6 months, 9 months, 12 months

• Change in time under 70 mg/dL as measured by continuous glucose monitoring

  Baseline, 3 months, 6 months, 9 months, 12 months

• Change in time over 250 mg/dL as measured by continuous glucose monitoring

  Baseline, 3 months, 6 months, 9 months, 12 months

• Change in continuous glucose monitor wear time as measured by continuous glucose monitoring

  Baseline, 3 months, 6 months, 9 months, 12 months

• Change in time in automated mode as measured by automated insulin delivery system

  Baseline, 3 months, 6 months, 9 months, 12 months

Other Outcomes (2)

• Number of meetings with community health worker

  Up to 6 months

• Duration in hours/minutes of meetings with community health worker

  Up to 6 months

Study Arms (1)

Community Health Worker

EXPERIMENTAL

Community Health Workers will meet with families monthly in the role of a diabetes technology coach, with additional visits as needed.

Other: Community Health Worker

Interventions

Community Health Worker OTHER

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

Community Health Worker

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Sarah A MacLeish, DO

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Campbell, RN, CDCES

CONTACT

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

Julie Hutter, RN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Single arm pilot intervention study with use of historic controls

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)