Actively Recruiting
Breaking Health Care Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Led by Nemours Children's Clinic · Updated on 2026-02-23
50
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
N
Nemours Children's Clinic
Lead Sponsor
J
Jaeb Center for Health Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children and adolescents aged 6 to under 18 years with type 1 diabetes (T1D) who have suboptimal blood sugar control and come from lower socioeconomic backgrounds. The study focuses on whether offering advanced closed-loop insulin delivery systems, also known as artificial pancreas technology, can reduce health care disparities and improve diabetes management in this group, including minority populations. The study aims to evaluate real-life use of these devices and their effects on health outcomes and quality of life. Participants will be prescribed FDA-approved closed-loop insulin delivery devices that automatically adjust insulin based on continuous glucose monitoring (CGM) without fingerstick calibrations. These devices will be provided through their insurance, including Medicaid. All families agreeing to use these closed-loop systems will have data collected before and after device use, with support from an insurance navigator. For those not already using a CGM, one will be prescribed. Diabetes care will continue as usual with periodic data downloads from the devices. Throughout the study, researchers will track blood sugar control, focusing on the time glucose levels stay within the target range at 3 and 6 months compared to baseline. Other measures include HbA1c levels and patient-reported outcomes like diabetes distress and attitudes towards technology. The study involves regular clinic visits and data collection to assess both clinical markers and quality of life, aiming to inform better care strategies and reduce disparities in diabetes treatment.
CONDITIONS
Brief Title
Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of type 1 diabetes for at least 1 year based on clinical presentation or positive diabetes autoantibodies
- On insulin therapy, including injections or open-loop pumps
- HbA1C of 8.0% or higher at least twice in the last 12 months, with an upper limit less than 14%
- Lower socioeconomic status defined as below 200% of the federal poverty level or exceptional needs
- Approximately one-third African American, one-third Hispanic/Latino, one-third non-Hispanic white; other ethnic groups allowed
- History of hypothyroidism on adequate replacement therapy with normal thyroid function allowed
You will not qualify if you...
- Severe eczema or skin conditions preventing use of devices
- Chronic medications or conditions interfering with diabetes management (except ADHD medications)
- Chronic seizures or severe neurodevelopmental delay
- Current use of hybrid closed-loop insulin delivery systems
- Significant mental health disorders that may hinder device use
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants who undergo routine care with advanced artificial pancreas closed-loop technology are observed to capture data on diabetes control and technology use.
Assessments at baseline, 3 months, and 6 months
Trial Site Locations
Total: 2 locations
1
Nemours Children's Health
Jacksonville, Florida, United States, 32207
Actively Recruiting
2
Nemours Children's Health
Orlando, Florida, United States, 32827
Not Yet Recruiting
Research Team
N
Nelly Mauras, MD
K
Kelly Hildebrandt, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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