Implementation of flash glucose monitoring in four paediatric diabetes clinics – before and after study to produce real world evidence of patient benefit

Research 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? Background Type 1 diabetes is the most common form of diabetes in children. Management requires monitoring commonly by finger prick testing and injection of insulin multiple times a day.

Flash monitoring is a relatively new method of monitoring that offers an alternative to painful finger prick testing. The only flash monitoring device currently available on the NHS is FreeStyle Libre (Libre).

Libre measures glucose levels in the interstitial fluid via a sensor, worn on the upper arm, containing a glucose sensing filament that sits under the skin.

Readings are taken by scanning the sensor which provides instant feedback; additionally, past readings can be downloaded in the 3-monthly diabetes clinics and used to optimise treatment/dietary choices.

While Libre was initially left to local CCGs to commission, NHS England recently intervened (April 2019) to make Libre freely available on prescription to eligible children and adults, so ending the postcode lottery.

This intervention was announced as a temporary measure, which provides time for real world evaluation of both the patient benefit and resource implications of Libre on prescription.

Design We plan a 16-month controlled before and after study using routinely collected health record data on children who are eligible for Libre and a control population of children who continue to finger prick test in the South West of England. We will employ a multi-method approach to draw together health outcome, economic and qualitative evidence.

Aims To assess whether the introduction of Libre on prescription is associated with improved long-term blood glucose control in a paediatric population with type 1 diabetes To evaluate the resource and cost implications associated with the introduction of Libre To explore views and experiences of NHS staff in implementing Libre to understand the impact on care provision To explore views and experiences of young people and their parents to inform guidance on the use of Libre To identify lessons about the use of Libre and possible “information/innovation overload” that might have more general relevance for wearable technologies in healthcare Objectives To compare long-term blood glucose control (HbA1c) and acute diabetic complications in paediatric patients before and after they start using Libre, and with a contemporaneous comparator group who continue to finger prick test To compare the NHS secondary care healthcare resource and costs in paediatric patients before and after they start using Libre To identify the benefits, challenges and burden to NHS staff of using Libre in their care provision To ask young people and parents about their experiences of using Libre To produce guidance on the use of Libre which we can disseminate regionally and nationally Dissemination We will work with our research partners (including our young people/ parent contributors) to co-produce guidance based on our study results for sharing with local and national audiences.