Implementation of flash glucose monitoring in four paediatric diabetes clinics – controlled before and after study to produce real world evidence of patient benefit. Statistical and health economic analysis plan

Abstract This study seeks to answer two key questions: Does flash glucose monitoring improve outcomes in children with Type 1 diabetes compared to finger prick testing? What are the healthcare implications associated with flash monitoring when compared to finger prick testing in terms of staff time, experience and healthcare costs? We report our combined Statistical and Health Economic Plan (SHEAP) for a controlled before and after study using routinely collected health record data on children who are eligible for flash glucose monitoring (Abbott FreeStyle Libre™) and a control population of children who continue to finger prick test in South West England. Our main analysis includes comparison of glucose control in terms of glycated haemoglobin (HbA1c) and UK health service costs relating to prescribing and loss of control (via record of diabetes related complications).