Title: Implementation of flash glucose monitoring in four paediatric diabetes clinics – before and after study to produce real world evidence of patient benefit
Funder: Department of Health and Social Care

Abstract: 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 &ldquo;information/innovation overload&rdquo; 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.

Lay abstract: Type 1 diabetes is the most common form of diabetes in children and occurs when the body does not produce insulin. People with type I diabetes need to inject insulin and monitor the levels of sugar in their blood. This is because high or low blood sugars can cause serious problems which happen quickly, like a hypo, when the blood sugar is too low, or a life-threatening coma when blood sugars are dangerously high or low. Keeping blood sugar within a healthy range is also important to avoid long-term health problems. For many young people monitoring blood sugar levels means frequent painful finger prick blood tests. We want to find out if a new sensor, worn on the upper arm, to monitor sugar levels works better. This is called flash monitoring and there is only one type of flash monitoring device called Freestyle Libre (Libre) currently available on the NHS. Libre is the size of a &pound;2 coin and has a tiny fine wire which senses the sugar levels in the fluid surrounding skin cells. A hand-held reader or Smartphone can be waved above the sensor to get an instant flash reading. This tells the young person/their parent if the sugar level is safe. All the readings from Libre can be sent to a computer and used to guide treatment decisions in clinics. We want to compare Libre with finger prick testing to see if it improves long-term blood sugar control and reduces hospital admissions in children. To do this we will use information collected from children s diabetes clinic appointments 12 months before and 12 months after starting Libre. We also want to find out what young people and parents, doctors and nurses think about Libre. We will see if it offers value for money to the NHS. This study will focus on four diabetes services in the South West: Bristol, Plymouth, Exeter and Swindon. Young people with type 1 diabetes and their parents tell us they are &ldquo;very interested&rdquo; in Libre and that the sensor may have benefits such as reducing finger prick tests and disruption to activities and sleep. We also want young people to work closely with us throughout the study, helping us to decide what is important to ask in our interviews and helping us to interpret and share our findings. We will work together to produce &ldquo;How to?&rdquo; tips for other young people using Libre. Our findings will be presented to patient groups and to local/national decision makers. We want to help young people with diabetes, their parents, and the people who provide NHS care.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: METABOLIC AND ENDOCRINE