World-first type 1 diabetes risk screening study in adults opens for recruitment

A world-first research programme led by the University of Bristol that will identify adults at high risk of developing type 1 diabetes opens for recruitment. Launched on World Diabetes Day (14 November 2023), the Type 1 Diabetes Risk in Adults (T1DRA) study aims to recruit 20,000 UK adults, aged between 18 and 70, from the general population to assess their risk.

With a similar study for children – ELSA – launched last year, it means the UK is now the first country to offer general population type 1 diabetes screening for both children and adults, in a research setting.

Funded by The Leona M. and Harry B. Helmsley Charitable Trust and drawing on the UK's longest running study of type 1 diabetes, the Diabetes UK-funded Bart's Oxford Family study (BOX), T1DRA will answer critical questions about the development of adult-onset type 1 diabetes. It will also give those identified as high risk the opportunity for type 1 diabetes education and monitoring, and 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, lifelong autoimmune condition affecting up to 400,000 people in the UK. It occurs when the immune system destroys insulin-producing cells in the pancreas, meaning people can no longer make their own insulin and their blood sugar levels become dangerously high. More than half of type 1 diabetes diagnoses are in adults, but its development has mostly been studied in children and adult-onset type 1 is not well understood.

T1DRA will be open to those with no close family members with type 1 diabetes, who make up about 90% of those with the condition. The research team, led by Professor Kathleen Gillespie at the University of Bristol, will send participants test kits in the post, involving a finger prick blood test. They will examine the blood samples for markers of type 1 diabetes, called islet autoantibodies – proteins used by the immune system to earmark insulin-producing cells for destruction. Islet autoantibodies are linked with the development of type 1 diabetes, and can appear in the blood years, or sometimes decades, before people begin to experience any symptoms.

People identified as high risk will be followed up by the research team to examine how many develop type 1 diabetes, how quickly they progress to a clinical diagnosis and to identify which genetic, biological, and environmental factors can be linked with symptoms developing quickly. High risk participants will be offered access to information about the symptoms of type 1 diabetes, its management, and clinical trials testing new type 1 therapies.

While insulin therapy is required to manage type 1 diabetes, there are new immunotherapies on the horizon that could prevent or delay the condition. One such treatment, teplizumab, which has been found to delay a diagnosis of type 1 diabetes by on average three years, was approved for use in the US in 2022 and is currently being reviewed for approval in the UK. Several other immunotherapies for people at high risk of developing type 1 diabetes are currently being tested in clinical trials.

To sign up to the T1DRA study visit: t1dra.bristol.ac.uk.

T1DRA joins the ELSA (EarLy Surveillance for Autoimmune diabetes) study, a type 1 screening trial for children currently running nationwide. Funded by Diabetes UK and JDRF and led by Professor Parth Narendran at the University of Birmingham, ELSA is aiming to screen 20,000 children, aged 3-13 years.

One year since the launch of ELSA on World Diabetes Day 2022, 10,000 children have been recruited into the study and the team are aiming to recruit a further 10,000 over the coming 18 months. Interested families can find out more at elsadiabetes.nhs.uk.

This research will help us get a much clearer idea of how many adults in the UK are at risk of type 1 diabetes by screening for markers in blood samples. We will follow up those individuals with islet autoantibodies to better understand how type 1 diabetes occurs in adults and offer participants the opportunity to participate in clinical trials to prevent the condition."

Professor Kathleen Gillespie, lead researcher on T1DRA, University of Bristol

Maryaline Coffre, PhD, Program Officer at Helmsley Charitable Trust, said: "At Helmsley, we are committed to supporting people with and at risk of developing type 1 diabetes. This study will provide important insight into disease development in adults, potentially paving the way for new therapeutic strategies for the disease."

Dr Elizabeth Robertson, Director of Research at Diabetes UK, said: "We're delighted that the pioneering T1DRA programme is now recruiting and hope it will offer a better future for adults at high risk of developing type 1 diabetes. With the ELSA type 1 diabetes screening study actively recruiting children, the UK is at the forefront of research that will bring us closer to the day when risk of type 1 diabetes can be spotted early, and a diagnosis prevented."