Call goes out for type 1 diabetes screening in UK

Researchers behind a large-scale feasibility trial of a finger-prick blood test for type 1 diabetes (T1D) have said it can identify children with the disease earlier and allow prompt treatment.

They say the ELSA trial – published in The Lancet Diabetes & Endocrinology journal and funded by charities Diabetes UK and Breakthrough T1D – lays the groundwork for a national screening programme that could pick up the 25% of children with T1D who are not diagnosed until they develop diabetic ketoacidosis (DKA), a life-threatening condition that requires urgent hospital treatment.

Earlier diagnosis means that they can receive drugs to control blood sugar sooner, helping to reduce the risk of long-term complications. In time, they could also benefit from new medicines like Sanofi's first-in-class Teizeild (teplizumab), which was approved in the UK last year and has been shown to delay the progression of the autoimmune disease and the need for insulin injections by around three years.

Led by researchers at the University of Birmingham, ELSA enrolled around 17,000 children aged three to 13 who had finger-prick testing for autoantibodies that attack the insulin-producing beta cells in the pancreas, which can be present years before symptoms develop.

From that cohort, 75 had one autoantibody, placing them at increased risk of T1D, while 160 had two or more, meaning they were in early-stage T1D, but did not yet need insulin. Seven children with undiagnosed T1D were identified and had to start insulin therapy straight away.

At the moment, Teizeild is indicated only for use in patients aged eight and over, but Sanofi has already filed for approval to extend its label to include children aged one or over with diagnosed stage 2 T1D, when blood glucose levels start to become abnormal, but patients still have no symptoms.

Scaled up, a screening programme could make T1D a condition that can be anticipated and monitored, reducing the risk of complications, said diabetes specialists.

One of the children who participated in ELSA, 11-year-old Imogen Norman of the West Midlands, was diagnosed with T1D as a result of the study and was the second child in the UK to be treated with Teizeild.

Her mother, Amy, said the trial "has helped us as a family to prepare for the future in a way we never expected. Knowing what's coming – rather than being taken by surprise – has made an enormous difference to our confidence and peace of mind."

The team behind ELSA are now expanding the study to include children aged two to 17, and are also running a second trial, ELSA 2, that will assess how paediatric screening can be scaled across the NHS and evaluate the cost-effectiveness of such a programme. There are around 400,000 people living with T1D in the UK.

Prof Shareen Forbes, professor of diabetic medicine at the University of Edinburgh, said one crucial part of ELSA was the insights it revealed on recruitment strategies for screening, with social media and schools found to be effective channels.

"Crucially, the findings also highlight the importance of home-based screening for families living in more socioeconomically deprived areas based on postcode," she said. "Recruitment and testing in non-home settings – such as schools – significantly increased participation among minority ethnic groups."