NCT04238949Active, not recruiting
Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes
The Impact of Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes - A Pilot Study
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
The primary aim of this pilot randomized controlled trial is to determine if the integration of a Community Health Worker (CHW) into the healthcare team of children with newly diagnosed type 1 diabetes is associated with an improvement in diabetes control. The secondary objectives are to determine if utilization of CHWs is also associated with improvements in psychosocial outcomes, healthcare utilization, and decreased costs.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 21 Jan 2020
- Start date
- 6 Dec 2019
- Primary completion date
- Jan 2027
- Lead sponsor
- Children's Hospital of Philadelphia
- Diseases
- Type 1 diabetes
- NCT number
- NCT04238949
What you commit to
- Study type: Interventional
- Participants enrolled: 28
- From 6 Dec 2019 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diabetes autoantibody negative
Other
- Children in custody of the State where there is no identified caretaker who can complete study procedures
- Non English speaking primary caregiver and patient
- Medicare insurance
- Tricare insurance
- Move to a zip code greater than a 60-minute drive from CHOP Buerger Center for Advanced Pediatric Care during the course of the study
- Move to a zip code not in Pennsylvania during the course of the study
Who the study is looking for
- Males or females aged \< 17 years old
- Within 31 days of clinical diagnosis of Type 1 Diabetes (T1D)
- Government insurance at time of enrollment
- Patient lives in a zip code in Pennsylvania within a 30-minute drive of Children's Hospital of Philadelphia (CHOP) Buerger Center for Advanced Pediatric Care at time of enrollment
- Plans on completing the "Type 1 Year 1" program at CHOP, an intensive T1D education program that is standard of care for all newly diagnosed patients with T1D at CHOP
- Diabetes autoantibody positive
- English speaking caregiver and patient
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.