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

Recruitingn/aAges 6 Years - 17 YearsAllNemours Children's Clinic
NCT05849753 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

50 children/adolescents (ages 6 to \<18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours \~ 1/3 each AA, Hispanic/Latino, non-Hispanic whites. All families that qualify and agree to transition to closed-loop technologies will be recruited to allow data to be gathered before and after use of devices. They will go through the process of approval with the assistance of an insurance navigator in clinic. Those not a CGM will be prescribed one as well. Diabetes care will be 'real life', devices will be prescribed, and care per clinic routine with periodic device downloads. Principal outcome, time-in-range, will be analyzed at 3-months compared to baseline, each participant their own control. Secondary outcomes including HbA1c, other glucose metrics and questionnaires re

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📋 Eligibility rules (as published)
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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What it tests

  • Advanced artificial pancreas closed-loop technology
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Where

2 sites
Nemours Children's Health
Jacksonville, United States
Nemours Children's Health
Orlando, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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