SWIIM study protocol: a pre-post study evaluating the implementation of an established pediatric diabetes management program to improve glycemic outcomes for children and young people with type 1 diabetes

Background Most young people with type 1 diabetes (T1D) fail to achieve internationally recommended glycemic targets despite recent advances in diabetes technology and education. There is significant variability in management practices and glycemic outcomes across diabetes services, and the need for a more unified approach has been recognized. The Success with Individualized Insulin Management (SWIIM) program, developed at John Hunter Children’s Hospital (JHCH) in New South Wales (NSW), Australia, has demonstrated glycemic outcomes among the best reported nationally for pediatric diabetes. However, its feasibility and effectiveness have not been tested. Objective This study aimed to evaluate the implementation of SWIIM across metropolitan and non-metropolitan healthcare settings in NSW, assessing its feasibility, cost-effectiveness, and impact on clinical outcomes. Methods A pre–post-implementation study will be conducted in three hospitals: two non-metropolitan sites in the Mid-North Coast Local Health District (MNCLHD) and one metropolitan site in the Nepean Blue Mountains Local Health District (NBMLHD). An education program will be delivered to clinicians with written resources and clinical support. All children and young people aged 0–18 years with T1D receiving care at these sites receive SWIIM for diabetes management. Data will be collected over an 18-month implementation period with retrospective pre-intervention data for comparison. The primary outcome was the change in HbA1c levels over the implementation period. Secondary outcomes included continuous glucose monitoring (CGM) metrics, insulin therapy modality, adherence to complication screening, hospitalization rates, and program feasibility indicators. Acceptability will be assessed using validated patient- and clinician-reported measures. A cost-effectiveness analysis will be performed to determine the financial impact of implementing the SWIIM over standard care. Discussion This study aims to evaluate the implementation of a structured, evidence-based pediatric diabetes management program in diverse Australian health service contexts. If successful, SWIIM could provide a scalable and sustainable model of care that improves outcomes and healthcare delivery for pediatric T1D.