A trial screening programme for type 1 diabetes that could transform the way the condition is identified and managed in its earliest stages, opens for recruitment today.
The first programme of its kind in the UK will identify children at high risk of type 1 diabetes, laying the groundwork for the development of any potential UK-wide screening programme.
Launching today on World Diabetes Day, ELSA (EarLy Surveillance for Autoimmune diabetes) will aim to recruit 20,000 children, aged 3-13 years, to assess their risk of developing type 1 diabetes.
Funded by Diabetes UK and JDRF, ELSA will provide crucial insights into practical and effective ways to screen large numbers of children in the UK, and support those at high risk and their families to ensure the earliest, safest diagnosis possible. Those identified as high risk could also gain access to clinical trials testing the newest innovations in type 1 diabetes treatment, which could prevent or delay the condition.
Type 1 diabetes is a serious and lifelong autoimmune condition affecting up to 400,0001 people in the UK. It is caused by an immune system attack on the insulin-producing cells of the pancreas, meaning they can no longer make insulin which results in high blood sugar levels. Rapid diagnosis of type 1 diabetes is essential to avoid life-threatening complications. However, over a quarter of children aren’t diagnosed with type 1 diabetes until they are in diabetic ketoacidosis (DKA)2, a potentially fatal condition that requires urgent hospital treatment.
The national research team, led by researchers at the University of Birmingham, will assess children’s risk of type 1 diabetes through a combination of finger prick and venous blood tests. The team will test for markers in the blood, called autoantibodies – tools used by the immune system to earmark insulin-producing cells for destruction. Autoantibodies are associated with the development of type 1 diabetes, and can appear in the blood years, or sometimes decades, before people begin to experience any symptoms.
Risk of type 1 diabetes increases with the number of different autoantibodies present in the blood. Those with two or more autoantibodies have an 85% chance of developing type 1 diabetes within 15 years, and it is almost certain that they will develop the condition in their lifetime.
Children found to be at risk and their families will be offered support and education – including information on symptoms and management – to help prepare them for the diagnosis of type 1 diabetes. Families will also be offered the opportunity to be followed up in the long-term to enable closer monitoring and potentially to start insulin treatment sooner. Research in Europe and the US has found that the extra support and monitoring screening programmes can offer dramatically reduces the risk of being diagnosed in DKA.
While type 1 diabetes is currently managed using insulin, there are new immunotherapy treatments on the horizon that could prevent or delay the condition. Children found to be at high risk could be invited to take part in research testing these treatments. One such treatment, teplizumab, which has been found to delay a diagnosis of type 1 diabetes by up to three years, is currently being reviewed for use in the UK and the US.
Through a series of interviews with families and healthcare professionals, the team aims to understand the most effective way to deliver a future screening programme. These insights will be critical in making the case for widespread routine screening for type 1 diabetes in the UK.
Clare Abbis’ daughter, Sophie, from Rugby, was diagnosed with type 1 diabetes during lockdown in 2020, aged 13, when she developed severe DKA. Clare says: “In the lead-up to Sophie’s diagnosis, she became very lethargic and napped in the afternoon, she lost her appetite and was incredibly thirsty, but it was very hot that day, so we didn’t think too much of it. But by 2am, Sophie had gone downhill rapidly and 111 sent an ambulance. Her glucose levels were found to be very high, so she was rushed to hospital. They worked very hard in A&E to bring her levels down and then she was transferred to a high dependency unit for monitoring. Our lives were turned upside down when Sophie was diagnosed with type 1 diabetes.
“Sophie’s now doing really well and is managing her diabetes herself. Looking back, the 4Ts were there, but type 1 diabetes just wasn’t something we’d ever considered. Had we known that Sophie was at risk, we might have known what to look out for and avoided her becoming so poorly. It’s scary to think what could’ve happened if we hadn’t got her to hospital in time. I hope that screening will help children have a safer diagnosis in future, so other families don’t have to go through the same thing we did.”
Parth Narendran, Professor of Diabetes Medicine, and Dr Lauren Quinn, Clinical Research Fellow at the University of Birmingham, said: “As general population screening programmes for type 1 diabetes emerge around the world, we need to explore how best to screen children here in the UK. The ELSA study will ask important questions about the best ways to recruit and will explore the experiences of families who take part.
“Screening children can reduce their risk of DKA at diagnosis around five-fold and can help them and their families settle into the type 1 diagnosis better. We know the value of identifying people at risk of type 1 diabetes and we have the tools to do so – now we need to understand how best to implement them in the UK.
“We are extremely grateful to our funders, Diabetes UK and JDRF. We hope ELSA will lead to the roll-out of a type 1 diabetes early detection programme for children in the UK and encourage families with children at a suitable age to consider taking part. To find out more about the ELSA study and to sign up, visit elsadiabetes.nhs.uk/take-part.”
Pete Shorrick, Head of Midlands and East at Diabetes UK, said: “We’re extremely proud to fund this pioneering research programme in partnership with JDRF, and we are delighted that this work is being led by researchers at the University of Birmingham, with the trial starting at a secondary school also in Birmingham.”
Identifying children at high risk of type 1 diabetes could put them and their families on the front foot, helping ensure a safe and soft landing into an eventual diagnosis, avoiding DKA and reducing the risk of life-altering complications.
“Every day without type 1 diabetes counts. Extra years without the condition means a childhood no longer lived on a knife-edge of blood sugar checks and insulin injections, free from the relentlessness and emotional burden of type 1 diabetes. ELSA will offer vital insights that could make screening for type 1 diabetes a reality in the UK, offering hope of a better future for people who are at risk of developing the condition in their lifetime”
Rachel Connor, Director of Research Partnerships at JDRF UK, which is co-funding the study, said: “We are in a hugely exciting period of type 1 diabetes research where we have a host of drugs that target the immune system progressing rapidly through clinical trials. We are demonstrating that it is possible to delay the need for intensive insulin treatment in those most at risk. When these drugs become available in the UK, we need to be ready to use them straight away.
“Until now, the best way to find people who might be starting to develop type 1 diabetes was through research with family members of people with type 1. But, as around four out of every five people diagnosed with type 1 diabetes have no family connection to the condition, this approach missed far too many people.
“The ELSA study will be pivotal in finding children who will benefit most from the latest immunotherapy drugs. It will also prepare families for the signs of type 1 diabetes, so that no child has to go through the trauma of being diagnosed in crisis with life-threatening DKA. This is why we are delighted to be building on the screening projects we have already supported around the world by joining with Diabetes UK to support research into screening for type 1 diabetes in the UK.” Find out how your child can take part in the ELSA study and sign up today: https://elsadiabetes.nhs.uk/take-part/
