Observational Study on Advanced Diabetes Technologies for Children with Type 1 Diabetes

This study aims to understand how advanced artificial pancreas closed-loop technology helps children and teenagers (ages 6 to 17) with type 1 diabetes, especially those from lower-income backgrounds. These technologies use a continuous glucose monitor (CGM), which tracks blood sugar without finger-prick calibrations, to automatically deliver insulin. We want to see if using these devices improves blood sugar control, measured by how much time a person's blood sugar stays in a healthy range. You might be able to join if you have had type 1 diabetes for at least a year, are currently on insulin therapy, and have an HbA1C (a measure of average blood sugar over 2-3 months) of 8.0% or higher at least twice in the last year. The study is currently unclear about its recruitment status and plans to enroll 50 participants.

Study design
This is an observational study, meaning researchers will collect data before and after participants start using an FDA-approved closed-loop system. About 50 children and adolescents will be included.
What's involved
Participants will transition to a closed-loop system with assistance from an insurance navigator. They will receive diabetes care as usual, with periodic device downloads.
Compensation
Not stated in the trial record.
Follow-up
Blood sugar control will be measured at 3 months after starting the closed-loop system.

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NCT05849753

Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes

Recruiting
Not specifiedAges 6–17Observational
Nemours Children's Clinic
~50 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:Advanced artificial pancreas closed-loop technology

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent sensor glucose time-in-range
Measured over 3 months
Diabetes Mellitus, Type 1
Child
Delivery of Health Care
Equipment and Supplies
2 sites across 1 states
Florida2
  • Nelly Mauras, MD · PRINCIPAL_INVESTIGATOR · Nemours Children's Health Jacksonville

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Eligibility criteria

Inclusion

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

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
  • Percent sensor glucose time-in-range3 months

    70-180mg/dL