Northwestern University
This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.
Background: Type 1 diabetes (T1D) is the most common form of diabetes in children and adolescents, affecting approximately 1 in 300 young people in the United States. The disease results from autoimmune destruction of pancreatic β-cells and often progresses silently over months to years before clinical symptoms emerge. Although first-degree relatives have a substantially higher risk of developing T1D, most children diagnosed with T1D do not have a family history of the disease. The presence of multiple islet autoantibodies is associated with an almost certain lifetime risk of insulin-requirin…
Inclusion Criteria: Children \- Clinics will be encouraged to select screening ages or visits that align with international consensus statements for screening during early childhood, mid-childhood, and preadolescence and routine U.S. well-child visit schedules, and that minimize workflow disruption and maximize screening completion, such as visits that already include blood draws for other routine tests (e.g., lead screening at age 2). Children who have visits at their clinic's selected ages will be eligible to have their data extracted from the electronic health record (EHR) Parents/Caregi…
This is an observational implementation study. The research team does not assign or deliver any clinical interventions. T1D screening orders and blood draws occur as part of routine care at clinician discretion, and the study observes EHR outcomes and collects surveys/interviews. The research team will deliver a set of implementation strategies (clinician education, clinician ordering reminders, and facilitation) to all participating clinics to enable routine screening adoption. These are clinic-wide activities and are not research 'interventions' assigned to participants, and clinical decisions remain at clinician discretion. These strategies will not be randomly assigned.