Objective
The aim is to take the results of the ELSA study to create a fair and practical system that the NHS could use in to monitor and support children most at risk of developing T1D. The study focuses on two specific groups of children: those who tested negative in the first round of screening but still have a high genetic risk of developing T1D, and close relatives of people already living with the condition. The study will also collect evidence to help NHS leaders understand how effective and affordable such a programme could be. The work is organised into three connected “work packages”.
The first work package will explore how best to follow up children who tested negative for islet autoantibodies, but who may still be at high risk of developing T1D because of their genetics. These children may develop T1D later, and we want to avoid missing them. The research team will use extra drops of blood already collected through the ELSA programme to test for genetic markers that indicate a higher chance of developing T1D. Families of children with higher genetic risk will be offered annual re-screening to check whether they have started to develop autoantibodies. This will help us understand whether using genetics alongside antibody testing is a good way to keep track of children most likely to develop T1D. The study will also develop new educational materials and emotional support tailored to these families, to help them understand the results and what they mean. These materials will be created with input from parents and young people to make sure they are relevant and useful to all families, including those from underserved communities.
The second work package will explore how to offer screening to the siblings and children of people with T1D—known as first-degree relatives. These relatives are much more likely to develop T1D themselves, and a key group for early detection. The study will work with ten NHS clinics across the UK—chosen to reflect different locations, levels of deprivation, and ethnic diversity—to test how this family-based screening can be carried out within regular healthcare. Families will receive the same easy-to-use dried blood spot kits by post or during clinic appointments. They will be referred into the existing ELSA pathway for confirmatory testing and appropriate ongoing care. Within this part, we will identify what works well and what barriers need addressing, such as staff time, training, IT systems and communication with families. The goal is to build a shared learning network between sites and create a harmonised screening process that could be delivered consistently and fairly across the NHS.
The third work package will examine if overall this screening programme would offer the NHS good value-for-money. It will bring together data from the first two parts of the project—such as how many families take part, and how often the results lead to improved outcomes. The team will also collect information on the costs of running the programme, both for the health service and for families (such as time taken off work or travel expenses). This information will be used to build an economic model that shows the costs and benefits of screening, including how much it could save by preventing emergency hospital admissions. This model will be designed specifically for the NHS and will help commissioners decide whether to expand the programme more widely.
Taken together, this work will provide a strong foundation for a national screening and follow-up programme for early-stage T1D. The ultimate aim is to give every child the chance to be identified early, supported appropriately, and prepared in advance—reducing harm and improving lives.
Background Rationale
Type 1 diabetes (T1D) is a serious lifelong condition that affects thousands of children across the UK. It occurs when the immune system mistakenly attacks the insulin-producing cells in the pancreas. Insulin is needed to help sugar move from the bloodstream into the body’s cells for energy. Without enough insulin, sugar builds up in the blood, leading to major health problems.
A dangerous complication of undiagnosed T1D is diabetic ketoacidosis (DKA), which can occur when the body starts breaking down fat rapidly due to a lack of insulin. This can lead to a life-threatening emergency requiring urgent hospital treatment. Sadly, almost a third of children in the UK are still diagnosed with T1D only after they’ve developed DKA, often with no warning symptoms beforehand.
We now know that T1D does not appear overnight. It usually develops slowly over several years. The first sign is the presence of specific proteins in the blood called islet autoantibodies, which show that the immune system has started to attack the insulin producing cells of the pancreas. A child with two or more of these autoantibodies is very likely to develop T1D. This early, symptom-free phase is called early-stage T1D and is divided into Stage 1 (normal blood sugar) and Stage 2 (abnormal blood sugar). Being able to identify children in this early phase gives families time to prepare and opens the door to new treatments that could delay or even prevent the need for insulin.
To explore whether large-scale early detection is possible in the UK, the ELSA study (Early Surveillance of Autoimmune Diabetes) launched in November 2022. It uses a simple finger-prick blood test that can be done at home or school. Families collect a few drops of blood on a special card and post it to an NHS-certified lab. If the result is positive, a follow-up test at a local clinic confirms the findings and checks how far the condition has progressed.
The ELSA study has already screened over 30,000 children—well above its original target of 20,000. Families have responded positively to the easy and convenient testing approach. Children found to be in early-stage T1D are offered further tests and ongoing support through one of 20 NHS diabetes clinics across the UK. Feedback has shown high levels of trust in the study, and many parents say they would recommend the programme to others.
While ELSA has shown that early detection is both possible and acceptable, some gaps remain. Certain age groups, like toddlers and older teenagers, have been harder to reach. Some communities, especially in more deprived areas or among ethnic minority groups, may face barriers to participation. There is also currently no structured follow-up for children who test negative but have a high genetic risk of developing T1D in the future. And before a national screening programme can be introduced, the NHS needs strong evidence that it would be affordable and cost-effective.
The next phase of research will build on ELSA’s success and address these challenges. It will focus on reaching children at highest risk—especially those with a family history of T1D or a high genetic risk score—and offering them repeat testing and tailored support. It will also explore how best to deliver this kind of screening within everyday NHS services, gather input from families and healthcare staff, and provide clear, practical evidence for policymakers and commissioners.
Description of Project
Type 1 diabetes (T1D) usually starts quietly before any symptoms appear. During this early phase, the body shows signs through blood markers known as islet autoantibodies. Detecting T1D at this stage helps reduce the risk of a serious condition called diabetic ketoacidosis (DKA), which can occur at diagnosis, and leads to better long-term control of blood sugar levels.
In November 2022, the ELSA study was launched in the UK to screen children for early signs of T1D. It has quickly become the UK’s largest screening programme for T1D in children and an important part of a larger European initiative called EDENT1FI.
So far, ELSA has screened over 30,000 children, significantly exceeding its original goal of 20,000. The screening involves a simple dried blood spot test, which families usually collect at home or school. Across the UK, twenty specialist diabetes units help confirm positive screening results and manage early-stage disease. The ELSA team also provides wraparound support for families, has established an official medical code (SNOMED) for early-stage T1D, and created clear clinical guidelines to support children identified through screening before they become insulin-dependent.
Children involved in the study average around eight years old, with just over half being boys. Around one in five participants come from ethnic minority groups, closely matching the general UK population. Families have found out about the study mainly through social media, schools, and GP practices. Parents strongly prefer doing the test at home or school rather than going to clinics. Approximately 1% of children tested have early signs of T1D, with further testing confirming 126 cases so far. Any side effects from testing have been minor and short-lived. Parents trust the programme highly, are willing to recommend it, and are open to their children having repeat tests.
However, ELSA has identified some important areas for improvement. Currently, there is no structured plan to monitor children who test negative but still have a high genetic risk of developing T1D later, and there is not enough evidence yet to support widespread adoption by the NHS.
The next phase of the study aims to solve these issues by developing an equitable and scalable NHS plan that focuses on two key groups: children who test negative but have a higher genetic risk, and close relatives (siblings and children) of people already diagnosed with T1D. Researchers will also carry out a detailed economic assessment to show whether the new approach is cost-effective.
For children who have tested negative but still carry high genetic risk, previously collected blood samples will be analysed further. Annual repeat testing will be offered, particularly focusing on children at the highest risk. Educational materials and psychological support tailored to families' needs will be developed and evaluated, ensuring input from underserved groups. Screening will also be extended to close relatives of T1D patients through ten diverse NHS centres across the UK. Families will receive test kits either by mail or during routine appointments. Positive results will be confirmed through the existing ELSA pathway, while negative results will trigger the genetic-risk monitoring plan described above. Researchers will also identify what helps or hinders successful implementation at local sites, connecting NHS teams to share best practices. Finally, an economic analysis will clearly demonstrate the costs and benefits of screening family members versus current standard care. This will provide NHS commissioners with robust evidence to support a potential national rollout.
Overall, the next stage of ELSA aims to create a fair, and economically justified screening pathway, ensuring all children at risk of T1D across different backgrounds have equal access to early detection and care, significantly improving their health outcomes.
Anticipated Outcome
By the end of this project, we aim to have built and tested a full, practical system that the NHS can adopt to screen for early type 1 diabetes and support the children and families who are at the highest risk. The outcomes will be grouped into three areas of work, called work packages (WPs), each focusing on a key part of this future pathway.
WP1 – Following up children at high genetic risk
One of the major advances in this next phase is the use of genetic risk scoring. By analysing extra spots of blood already collected through the ELSA study, researchers will be able to identify children who, despite testing negative for diabetes-related antibodies, still carry a high genetic risk of developing T1D in the future.
This work package will show whether it’s possible to carry out genetic analysis reliably using these simple blood samples and whether families are willing to take part in re-screening based on genetic risk. The project will offer annual testing to children at higher risk, helping to spot the very earliest changes in their immune system before symptoms begin.
Alongside this, the team will co-design a range of new educational and psychological resources with families, including clear explanations of what genetic risk means, how to look out for signs of diabetes, and where to go for support. These tools will be evaluated to make sure they are helpful, understandable, and meet the needs of different families, particularly those from communities who have traditionally been underrepresented in research.
WP2 – Screening first-degree relatives
First-degree relatives (FDRs)—siblings, children and parents of people with T1D—have a much higher chance of developing the condition than the general population. This work package will explore how best to offer T1D screening to this important group within routine NHS care.
Ten NHS centres across the UK, chosen to reflect a wide range of locations and populations, will invite FDRs aged 2 to 17 to take part. They will receive blood-spot kits by post or in person during clinic visits, making it easy for families to participate. The process for following up both positive and negative results will be clearly mapped and tested in real-world settings.
Importantly, this package will also study the practical aspects of delivering the screening—such as staff time, family communication, IT systems, and local adaptations—to build a “playbook” for future NHS use. Each site will share its experience through webinars and shared learning events, helping to create a national “community of practice” among professionals working on early diabetes care.
Work Package 3 – Cost-effectiveness and value for the NHS
This part of the project will create a detailed cost-effectiveness model that is specific to the UK. It will use real-life data collected from the first two work packages to estimate how much it would cost the NHS to run this kind of screening programme, and how much health benefit it would deliver in return.
This model will include a wide range of factors: the cost of the blood tests, time spent by health professionals, hospital costs avoided (like emergency care for diabetic ketoacidosis), and the quality of life for children and their families. It will also include travel costs and time taken by parents, to reflect the real-world impact of the programme on families.
The goal is to produce clear, reliable evidence that can be used by NHS commissioners and decision-makers. This will help them decide whether and how to scale up the programme nationally. If the approach proves cost-effective, it could pave the way for the UK to introduce national T1D screening for the first time.
Relevance to T1D
Roughly 30,000 young people in the UK live with T1D, and incidence is rising. Nearly half still present in diabetic ketoacidosis (DKA), a frightening experience for families and a costly emergency to the NHS. Early identification shifts that balance. Children diagnosed before symptoms can be prepared to start insulin calmly, avoiding intensive-care stays and the shock of a crisis. Families gain time to learn, practise finger-pricks and adjust emotionally.
Equity is central. Children from deprived areas and some ethnic minorities are more likely to reach hospital in DKA and less likely to access insulin pumps and sensors. By using home testing, community engagement and targeted interviews, the project aims to design a pathway that serves everyone, not just the well-resourced.
For families already affected by T1D, cascade screening of close relatives offers a concrete way to screen siblings and offspring. Instead of vague worry, relatives receive clear results and personalised follow-up, opening doors to prevention trials.
Clinicians benefit from structured, evidence-based protocols that slot into routine care, reducing uncertainty and workload. The NHS benefits financially: each avoided DKA admission saves thousands of pounds. Detailed cost analysis will show whether the pathway delivers health gains at an acceptable cost per quality-adjusted life-year, the benchmark for many NHS investments.
Reliable early-stage detection is also a gateway to new treatments. Disease modifying drugs like Teplizumab work when given before insulin is needed. A nationally derived pathway provides a ready pool of participants for future preventive trials, accelerating research and improving health outcomes.
At a societal level, the project meets public expectations: conditions should be caught early, care personalised and information easy to grasp. Parents in ELSA already report feeling more in control once they know their child’s risk. Scaling that reassurance to tens of thousands more families is a direct public-health gain.
Finally, the pathway can act as a template for other conditions—such as coeliac disease or familial high cholesterol—where early markers exist but screening logistics are unresolved. Demonstrating that genetic risk scores and home sampling can be woven into routine paediatrics helps pave the way for broader preventive medicine.
In short, this project offers a practical, equitable and cost-conscious route to earlier T1D detection, better health outcomes, reduced inequalities and lower NHS bills—benefits that resonate across the entire T1D community.