Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 D
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 t
| Condition(s) | Diabetes Mellitus, Type 1, Child, Delivery of Health Care, Equipment and Supplies |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 participan |
| Who can participate | 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 t |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Lead sponsor | Nemours Children's Clinic |
| Locations | Jacksonville, Florida, United States; Orlando, Florida, United States |
| Start date | 2023-07-26 |
| NCT ID | NCT05849753 |
| Official listing | https://clinicaltrials.gov/study/NCT05849753 |