School-partnered collaborative care intervention for young children with type 1 diabetes: A pilot and feasibility protocol

BACKGROUND: Despite advances in treatments, children with type 1 diabetes struggle to achieve glycemic targets. Though school-based programs may help support families to achieve targets, challenges remain with coordinating care between health systems and schools, where students spend much of their day. Monthly, virtual meetings between a parent, school nurse, and a diabetes specialist may bridge this gap by using a shared treatment plan to meet goals. METHODS: This is a pilot cluster-randomized trial to test a school-partnered collaborative care model (SPACE for T1D) for children aged 5-12 years with type 1 diabetes for ≥6 months. School districts were randomized in a 2:1 allocation ratio to the intervention (SPACE for T1D) or enhanced usual care. Participants complete the study over four consecutive months. Parents and school nurses evaluate the feasibility, acceptability, appropriateness, and usability of SPACE using valid questionnaires. The study team monitors retention, fidelity, and practicality. Exploratory outcomes assess change in glycemia, care utilization, type 1 diabetes-related quality of life, self-efficacy skills, and missed class time due to diabetes interventions. RESULTS: Twelve school districts were randomized. One dropped out due to no eligible students, leaving 11 participating districts. We approached 46 students; 30 provided consent for a recruitment rate of 65%. CONCLUSIONS: This study will evaluate the feasibility and acceptability of the SPACE for T1D intervention in varied school districts. Findings will facilitate a fully-powered trial to evaluate the impact on health and academic outcomes, adding to the evidence base of school-based interventions to support youth with chronic disease. NCT: NCT06420661.