A world-first research program led by the University of Bristol to identify adults at high risk of developing type 1 diabetes has opened 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 the population to assess their risk.
With a similar study for children – ELSA – launched last year, this means that the UK is now the first country to offer general population type 1 diabetes screening for 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 Oxford Family Study (BOX) (BOX) of Diabetes UK funded by Diabetes UK, the T1DRA answers critical questions about the development of adult-onset type 1 diabetes. It will also give those identified as high risk the opportunity for education and monitoring of type 1 diabetes, and access to clinical trials testing the latest innovations in the treatment of type 1 diabetes, which prevent or delay the condition.
Type 1 diabetes is a serious, lifelong autoimmune condition that affects 400,000 people in the UK. This happens when the immune system destroys the insulin-producing cells of the pancreas, meaning that people can no longer make their own insulin and their blood sugar levels can become dangerously high. More than half of type 1 diabetes diagnoses are in adults, but its development is often studied in children and adult-onset type 1 is poorly understood.
T1DRA is open to those who do not have a close family member with type 1 diabetes, which makes up about 90% of those with the condition. The research team, led by Professor Kathleen Gillespie of the University of Bristol, will send participants post test kits, which involve a finger prick blood test. They will check blood samples for markers of type 1 diabetes, called islet autoantibodies – proteins used by the immune system to mark insulin-producing cells for destruction. Islet 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.
People identified as high risk will be followed by the research team to assess how many develop type 1 diabetes, how quickly they progress to a clinical diagnosis and to determine whether what genetic, biological, and environmental factors may be linked to symptoms that develop quickly. High-risk participants will be given access to information about the symptoms of type 1 diabetes, its management, and clinical trials testing new type 1 therapies.
While insulin therapy is necessary to manage type 1 diabetes, there are new immunotherapies on the horizon that can prevent or delay the condition. One such treatment, teplizumab, which has been found to delay the diagnosis of type 1 diabetes by an average of 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 enroll in the T1DRA study visit: t1dra.bristol.ac.uk.
T1DRA participated in 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 of the University of Birmingham, ELSA aims to screen 20,000 children, aged 3-13 years.
One year since ELSA’s launch on World Diabetes Day 2022, 10,000 children have been recruited into the study and the team aims to recruit an additional 10,000 over the next 18 months. Interested families can find out more at elsadiabetes.nhs.uk.
This research will help us get a 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 develops in adults and give participants the opportunity to participate in clinical trials to prevent the condition.
Professor Kathleen Gillespie, lead researcher at 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. for new treatment strategies for the disease .”
Dr Elizabeth Robertson, Director of Research at Diabetes UK, said: “We are delighted that the pioneering T1DRA program is now recruiting and hope it will provide 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 the risk of type 1 diabetes can be detected early, and prevent a diagnosis.”