NICE recommends treatment that could delay development of type 1 diabetes in young people
National Institute for Health and Care Excellence (NICE) final draft guidance recommends NHS reimbursement for teplizumab.
NICE has recommended that teplizumab should be used for delaying the onset of stage 3 type 1 diabetes in adults and young people aged eight years and above, with stage 2 type 1 diabetes.
The move would recognise the treatment as the UK’s first licensed condition-modifying treatment to delay the onset of symptomatic type 1 diabetes.
Subject to NICE final guidance being published, the treatment is expected to be available to eligible patients within 60 days in Wales, and 90 days in England.
Type 1 diabetes is a progressive autoimmune condition that can begin with a “silent” pre-symptomatic stage.
Warning signs include symptoms known as the 4Ts – tiredness, thirst, thinning, toilet (urinating more often).
The condition is growing in prevalence in the UK and can lead to acute and long-term complications, including diabetic ketoacidosis (DKA), a potentially life-threatening condition.
Teplizumab is designed to target the immune system’s attack on insulin-producing beta cells in the pancreas. By modulating the immune response, it can delay the onset of clinical type 1 diabetes in people who are in stage 2.
Clinical trials showed that a single course of teplizumab, which is administered in hospital daily for 14 days, can halve the progression rates to symptomatic type 1 diabetes.
Following today’s announcement, NHS will need to develop new testing and treatment pathways to make teplizumab available in practice.
Until now, available treatment options have focused solely on managing the symptomatic disease. The latest recommendation from NICE paves the way for this treatment for type 1 diabetes to be made available to eligible patients in the UK, subject to final guidance.
This draft recommendation has been made possible by the UK Government’s decision to uplift the NICE QALY (Quality-Adjusted Life Years) cost effectiveness threshold in April 2026, to enable more innovative treatments to reach NHS patients in the UK.
The NICE decision was informed by a range of clinical data, including the TN-10 study, where a single 14-day course of teplizumab delayed the median onset of stage 3 type 1 diabetes by approximately two years compared to placebo.
There is estimated to be around 35,000 people under the age of 19 living with the condition in the UK.
A Sanofi-funded survey of 200 people with type 1 diabetes revealed that nearly 4 in 10 (38%) people living with type 1 diabetes have required an A&E (accident and emergency) visit in the past year.
“Early care intervention”
Ahmed Moussa, Sanofi Country Lead, UK and Ireland said: “Today NICE has recognised the value of a therapy that can delay the onset of symptomatic, stage 3 type 1 diabetes, representing a significant step towards a future care model that prioritises early intervention.
“Our vision is a future where traumatic diagnoses, often following life-threatening DKA events, become a rarity. By identifying at-risk individuals earlier, we can help prevent DKA through proactive glucose monitoring and timely intervention.
“Aligning to the NHS’s 10-year health plan, we are committed to working with the NHS and the entire type 1 diabetes community to not only ensure rapid access to this and future therapies but also to help build the vital infrastructure that will truly change the paradigm of care for type 1 diabetes in the UK.”
Dr Nick Thomas, Clinical Lecturer in Diabetes and Endocrinology, said: “The final draft guidance from NICE marks a step change in how we think about managing type 1 diabetes. In every clinic, I’m reminded by my patients just how much of a full-time job living with type 1 diabetes is.
“For the first time, we can now act to modify the condition. Through access to this innovation, eligible patients with early-stage type 1 diabetes will gain invaluable time to prepare for condition progression, helping to make a diagnosis a little more manageable and less traumatic.”
Treatment trialled at the University of Birmingham
Diabetes experts at the University of Birmingham welcomed news that teplizumab can delay the progression to insulin requiring type 1 diabetes in individuals with early-stages of the condition has been approved for use on the NHS, following the announcement by NICE.
At the University of Birmingham, Birmingham Women's and Children’s Hospitals and University Hospitals Birmingham NHS Foundation Trusts, ongoing research is looking at how a screening programme can help to identify young people at risk of the condition.
The ELSA (Early Surveillance for Autoimmune diabetes) study, led by Professor Parth Narendran, Professor of Diabetes Medicine at the University of Birmingham, has seen thousands of young people screened for antibodies that act as markers for whether type 1 diabetes will develop in later life (as evidenced in a publication in The Lancet Diabetes & Endocrinology).
The NICE announcement recognises the crucial role that screening programmes, including ELSA, will have for identifying young people who will benefit from teplizumab.
ELSA has also enabled patients to have early access to teplizumab, with the first young person in the UK, 14-year-old Sam from Kings Norton, receiving the drug at Birmingham Children’s Hospital under the care of Dr Renuka Dias and her specialist team at the Clinical Research Facility.
Now, with the approval for funded use on the NHS, it is estimated that around 1,100 people could be eligible for teplizumab in the first year-based data provided from the ELSA study.
Parth Narendran, said: “Today's NICE recommendation for teplizumab marks a significant milestone in the UK for people at the very earliest stages of type 1 diabetes.
“As the first disease-modifying therapy shown to delay progression to clinical, insulin-requiring type 1 diabetes, teplizumab has the potential to transform the treatment paradigm from reacting to disease onset to intervening earlier in the disease process. This means that patients identified early, for example through the ELSA study led by the University of Birmingham, will have benefit from treatment that can give valuable additional years free from the daily burden of managing type 1 diabetes.
“This decision will go a long way to help the development of screening, monitoring and prevention pathways that will underpin the future of type 1 diabetes care.”
Dr Renuka Dias, a Consultant Paediatric Endocrinologist working at Birmingham Women and Children’s Hospital is an Honorary Associate Clinical Professor at the University of Birmingham and the Lead Paediatrician for the ELSA study.
Dr Dias said: “The approval of teplizumab by NICE offers people with early-stage type 1 diabetes to delay the need for insulin potentially for several years and represents a genuine step-change in how we think about the management of this relentless condition and hope that in time we can move closer to managing type 1 diabetes without insulin as the first-line therapy.”
Preparing for type 1 diabetes
The announcement that teplizumab will be available on the NHS will give young people and adults more time to prepare for living with type 1 diabetes, with trial data suggesting that the drug can delay the onset of symptomatic diabetes by around two years.
In addition to teplizumab, academics at the University of Birmingham are researching other ways to preserve the cells that produce insulin in the pancreas, and which are lost in type 1 diabetes.
Colin Dayan, Professor of Clinical Diabetes and Metabolism is collaborating with colleagues across the UK in the Type 1 Diabetes Immunotherapy Consortium to conduct clinical trials in adults and children with new-onset type 1 diabetes, develop new approaches to beta cell preservation and, ultimately, to aim to find ways to manage type 1 diabetes without the need for insulin dependency.
Professor Dayan said: “This is such an exciting moment – it is the first step towards treating type 1 diabetes without insulin. Teplizumab delays the need for insulin by more than two years. Many other drugs have also shown promise in slowing the damage to insulin making cells by the immune system. As we pick up more cases early by screening and combine treatments to retain the body’s insulin making cells for longer and longer, we can foresee the day that insulin treatment in children becomes a thing of the past.”
Read more about type 1 diabetes
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