Menu
Recruiting NCT07154251

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

No phase Interventional Type 1 Diabetes (T1D)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Community Health Worker.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D). Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Interventions

  • Other 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 measures

  • 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]
Secondary outcome measures (12)
  • Change in time in range (70-180 mg/dL) as measured by continuous glucose monitoring [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
  • Change in time under 70 mg/dL as measured by continuous glucose monitoring [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
  • Change in time over 250 mg/dL as measured by continuous glucose monitoring [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
  • Change in continuous glucose monitor wear time as measured by continuous glucose monitoring [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
  • Change in time in automated mode as measured by automated insulin delivery system [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months]
  • Change in psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents/guardians [Time frame: Baseline, 6 months]
  • Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale [Time frame: Baseline, 6 months]
  • Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy [Time frame: Baseline, 6 months]
  • Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version [Time frame: Baseline, 6 months]
  • Change in medical distrust, as measured by the Group Based Medical Distrust Scale [Time frame: Baseline, 6 months]
  • Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index [Time frame: Baseline, 6 months]
  • Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index [Time frame: Baseline, 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • University Hospitals Cleveland Medical Center — Cleveland

Identifiers

NCT: NCT07154251 · STUDY20250042

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗