Improving Access to Advanced Closed-Loop Insulin Delivery Technology for Children and Adolescents with Type 1 Diabetes in Lower Socioeconomic Groups

What this Trial Is About

Researchers are investigating the use of advanced closed-loop insulin delivery technology in 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 racial and ethnic minority groups, including African American, HispanicLatino, and non-Hispanic white children, to address disparities in diabetes management and technology access. The goal is to see if using these FDA-approved devices can improve diabetes control and reduce health disparities in a real-life clinical setting. Participants will be offered advanced artificial pancreas closed-loop systems that automatically deliver insulin based on continuous glucose monitoring CGM without fingerstick calibrations. Families will receive help with insurance approvals and device access through a clinical insurance navigator. All patients will be prescribed a CGM if they do not already have one. Diabetes care will continue as usual with routine clinic visits and periodic device data downloads. Data will be collected before device use and at 3- and 6-month intervals while using the devices. During the study, children will be monitored through standard diabetes care visits, with assessments including glucose time-in-range, HbA1c levels, and questionnaires about technology use and diabetes-related distress. The main measure is the percent of time their blood sugar stays within a target range after 3 months. Secondary measures and patient-reported outcomes will be evaluated at 3 and 6 months. The results aim to inform healthcare providers, payers, and families to help improve access and outcomes for underserved populations over a total study period of up to 6 months.

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