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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-06

Study Completion Date

2027-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

T1DTechCHW: Enhancing the Community Health Worker Model to Promote Diabetes Technology Use in Young Adults From Underrepresented Minority Groups

NCT05211869

Diabetes Type 1 Diabetes Young Adult +1 more

COMPLETED NA

Acceptability of Virtual Educational Intervention for Adolescents and Young Adults With Type 1 Diabetes Mellitus

NCT04878419

Diabetes Mellitus, Type 1

COMPLETED NA

Group Visits for High Risk Type 1 Diabetes (T1D)

NCT05431686

Type 1 Diabetes

COMPLETED NA

Computerized Intervention of Parental Involvement in Diabetes Care of Their Child

NCT01515930

Diabetes

COMPLETED NA

Diabetes Management Personal Trainer

NCT00340093

Diabetes

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes (T1D)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm pilot intervention study with use of historic controls

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Community Health Worker

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

Group Type EXPERIMENTAL

Community Health Worker

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Community Health Worker

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No