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New study aims to close the gap in diabetes tech for underserved kids

NCT ID NCT05849753

Disease control Sponsor: Nemours Children's Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study enrolls 50 children and teens (ages 6 to under 18) with type 1 diabetes who have high blood sugar levels and come from low-income families. Participants will receive help from an insurance navigator to get a closed-loop insulin pump and continuous glucose monitor. The main goal is to see if using these devices improves their time-in-range blood sugar levels after 3 months.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

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.

Who is studied

A target of 50 children and adolescents (ages 6 to \<18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and of lower SES (below 200% of state-specific poverty line by family size and income), with no other chronic illnesses will be recruited from the Pediatric Endocrine clinics at Nemours Children's Health Clinics in Jacksonville and Orlando, FL. Cohort will be \~ 1/3 each AA, Hispanic/Latino, and non-Hispanic White (NHW).

Ages

6 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: Diagnosis of T1D for at least 1 year based on clinical presentation (polyuria, polydipsia, weight loss, and/or ketoacidosis, or with positive diabetes autoantibodies) on insulin, including injections or open-loop pumps * HbA1C ≥ 8.0% at least twice within the last 12 months before study initiation, upper limit of HbA1C \<14% * Be of lower SES, defined based on \< 200% above published US levels of poverty by family size and income, or based on exceptional circumstantial needs in the opinion of the investigators * Approximately 1/3 AA, 1/3 Hispanic/Latinos, 1/3 non-Hispanic whites. Asians, Pacific Islanders and other ethnic groups however will not be excluded from participation if other criteria met * History of hypothyroidism on adequate replacement therapy with normal thyroid function will be allowed Exclusion Criteria: * Severe eczema or any other skin condition that would limit availability of healthy skin to wear devices * Chronic medications/medical conditions that could interfere with diabetes management (ADHD medications allowed) * Chronic seizures, or severe neurodevelopmental delay * Current use of hybrid closed-loop, automated insulin delivery system * Significant mental health disorder that in opinion of the investigator would hinder device use

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Conditions

The condition(s) this trial relates to.

primary interstitial lung disease specific to childhood type 1 diabetes mellitus type 1 diabetes mellitus 1

As listed by the trial registrant

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

Child Delivery of health care Diabetes mellitus, type 1 Equipment and supplies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nemours Children's Health

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Health

    NOT_YET_RECRUITING

    Orlando, Florida, 32827, United States

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