University of Exeter research 'could transform type 1 diabetes
A world first ‘test at home’ kit has today been released- which can tell if you’re at risk
Last updated 7th Mar 2024
Scientists at the University of Exeter admit it's ‘like science fiction’ as they today help release a new test for a treatment before someone is even confirmed to have the disease.
Diabetes clinician Professor Richard Oram from the University of Exeter spent a decade researching the genetic markers for type 1 diabetes - and says at the moment there’s treatments which only work for those at the early stages of developing the autoimmune disease.
Professor Oram developed the genetic risk score based on a decade of research, and has worked with Randox on developing the new biochip.
He said: “It's almost a bit like science fiction this idea that before you develop or are clinically diagnosed with the disease you could be identified as having it - you could start a treatment before you have any symptoms. That's the place we're headed. "Nearly 50 per cent of people who present with type 1 diabetes can be life threateningly unwell, often requiring intensive care.
"There are now new drugs emerging that are effective in modifying the disease but they only work before symptoms develop."
"The world is waking up to the value of screening programmes for type 1 diabetes because of new drugs which must be given at the earliest stages of disease.
"Our new biochip is a pioneering example of how understanding a person’s background genetic risk can help identify those at highest risk, ensuring they have further antibody screening so we can efficiently identify type 1 diabetes early enough for treatment to be effective.
"The Randox biochip could aid in speeding up decisions around who should be monitored and tested further, making public health screening cost effective and improving lives by increasing access to treatment.”
A spokesperson for the university added: "The test is available to buy, and could help develop new screening programmes for type 1 diabetes, as new drugs emerge which must be prescribed at early stages to be effective. The new test will also help determine type 1 from type 2 diabetes, further improving clinical decision making and treatment.
"The test, developed by UK diagnostics company Randox using research from the University of Exeter, could help introduce public health screening in the UK and across the world.
"Now, the test has received UK regulatory approval – the first such approval issued globally. This means it will be available to consumers in the UK, through Randox Health clinics, and can be ordered online for sample collection at home and returned to Randox’s laboratories for testing.
"Type 1 diabetes has a significant inherited risk. The new test is conducted on a Randox biochip which can simultaneously identify up to 10 genetic variants linked to risk for type 1 diabetes. An algorithm is then applied to assess the risk associated with the identified variants for each individual, to calculate a genetic risk score. Previous trials have shown that genetic risk scores are particularly effective in predicting risk for type 1 diabetes. This score will help identify people who don’t have diabetes but are at high risk of developing the disease in the future and can be referred for autoantibody testing to give a definitive diagnosis. The biochip can also be used after diagnosis, to help identify what type of diabetes a person has, which is crucial to ensuring they get the best possible treatment and care.
"Identifying those at high risk is particularly topical, as new drugs emerge that can reduce the impact of type 1 diabetes – and they can only be given at the earliest stages, before a clinical diagnosis is given. In November 2022, the US Food and Drug Administration (FDA) approved the use of teplizumab – the first disease-modifying treatment for type 1 diabetes. It can only be prescribed pre diagnosis, yet there is currently no screening programme anywhere in the world to identify early pre-clinical type 1 diabetes. The drug is not yet approved for use in the UK, however, health services globally are now considering how best to introduce public health screening programmes.
"Type 1 diabetes affects more than eight million people worldwide, and numbers are projected to rise significantly. The disease causes the body’s own immune system to attack the beta cells which regulate blood sugar. Although the disease is primarily caused by genetics, only around one in ten people with type 1 diabetes have a family member affected, making the other nine in ten difficult to identify. Currently, they are often referred for autoantibody tests when symptoms start to show – but that can be too late to mean they are eligible for treatment.
"The new fingernail-sized biochip works by applying DNA extracted from a patient’s blood sample to the biochip surface, upon which copies of the high-risk type 1 diabetes genetic variants are fixed. If a match occurs, the patient’s DNA will bind to the fixed risk variants and emit light. The pattern of positive genetic variants indicates genetic risk and an algorithm is then applied, factoring the significance of each gene variant. The higher the genetic score, the greater the risk that the individual will develop the disease. Those at high risk can then be monitored and put forward for autoantibody screening, while those at low risk need not be screened, which saves money."
Dr Lucy Chambers, Head of Research Communications at Diabetes UK, said: “We’re delighted to see that research supported by Diabetes UK has informed the development of an innovative new tool to find people at high risk of type 1 diabetes. "New treatments to prevent or delay type 1 are on the horizon, and their success hinges on establishing effective screening methods to pinpoint those at higher risk. We are continuing to fund research into type 1 screening and are pleased to see new innovations that have the potential to improve lives.”