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Extra home support may help kids manage new diabetes diagnosis

NCT ID NCT04238949

Disease control Sponsor: Children's Hospital of Philadelphia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study looks at whether adding a community health worker to the diabetes care team helps children recently diagnosed with type 1 diabetes. The health worker will visit the child's home, help set health goals, and address social needs like food or housing. The study will track blood sugar control, hospital visits, and missed appointments over one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Community health worker support (home visits, goal setting, social needs screening)
What this could lead to
If it works, this could show that adding a community health worker helps children with type 1 diabetes manage their blood sugar better and reduces hospital visits.
What could go wrong
This is a very small pilot study with only 28 children, so results may not apply to everyone. It tests a support service, not a new drug, so any benefits are likely modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

28 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Diabetes autoantibody negative * 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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Health Behavior Patient Compliance type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Compliance, patient Diabetes mellitus Health behavior Psychosocial problem Type 1 diabetes

Contacts and locations

Locations

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.