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

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 related to use of technology and diabetes distress will be also analyzed. All outcomes will also be collected at 6-months. Results could have important and fast applicability to the field and help better inform decision makers, including payers, clinicians, and patients and families and could serve to decrease health care disparities in this needy population.

NCT Number	NCT05849753
Lead Sponsor	Nemours Children's Clinic Collaborators: Jaeb Center for Health Research
Conditions	Diabetes Mellitus, Type 1, Child, Delivery of Health Care, Equipment and Supplies
Enrollment	50 participants
Start Date	2023-07-26
Primary Completion	2026-11-30 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-20