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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 a UK-wide screening programme.
Launched 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 effective and acceptable 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, that could prevent or delay the condition.
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.
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 and is currently being reviewed for use in the UK.
Through a series of interviews with families and healthcare professionals, the team aim 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.
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 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.”
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
Parth Narendran
Autoimmune condition
Type 1 diabetes is a serious and lifelong autoimmune condition affecting more than 300,000 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)1, a potentially fatal condition that requires urgent hospital treatment.
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.
Dr Elizabeth Robertson, Director of Research at Diabetes UK, which is co-funding the study, said:
“We’re extremely proud to fund this pioneering research programme in partnership with JDRF. 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.
“The era of being able to strike early to delay type 1 diabetes is within reach. The success of the next generation of preventative type 1 diabetes treatments depends on reaching as many people as possible who could benefit, and this can only be achieved through screening programmes. 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.”
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