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ObservationalRecruitingISRCTN97974414

ELSA: EarLy Surveillance for Autoimmune diabetes (UK)

A UK general-population study testing whether it is feasible and acceptable to screen children aged 3-13 for the early immune "fingerprints" of type 1 diabetes using a finger-prick dried-blood-spot test. It is still recruiting. ISRCTN now lists a 50,000-child target and completion in 2029; an interim analysis of 17,283 screened children is not the full result.

Primary endpoints

  • Feasibility of general-population screening: comparing recruitment routes (home, community/school, general practice, hospital) and uptake by demographics (age, sex, ethnicity, deprivation, family history) and proportion of usable dried-blood-spot samples
  • Acceptability to families and professionals, assessed through qualitative interviews and validated anxiety/depression questionnaires before and after results/education
  • Clinical yield: UK autoantibody seroprevalence and the number of children identified at stage 1-3 type 1 diabetes

Results so far

Still recruiting. ISRCTN97974414 last edited 12 August 2025: target n=50,000 (was 20,000); date of final enrolment 30 August 2029; completion 31 August 2029. That expansion is not a result. An interim analysis announced January 2026 covered 17,283 children aged 3–13: 160 (about 0.9%) had two or more islet autoantibodies, 75 had a single autoantibody, and 7 already had undiagnosed type 1 diabetes. Among the small number reaching stage 3 through the programme, only about 1 in 7 presented in DKA — and those mildly. A University of Birmingham 20 January 2026 news piece quotes more than 37,000 children screened over three years; that is accrual, not a second efficacy table. ELSA 2 is extending screening to ages 2–17 through autumn 2029.

The full picture

What ELSA is testing, and why it matters

Type 1 diabetes doesn't appear overnight. Years before any symptoms, the immune system starts attacking the insulin-making cells, and that attack leaves detectable "fingerprints" in the blood called islet autoantibodies.1 A child with two or more of these autoantibodies is almost certain to develop insulin-dependent type 1 diabetes eventually.1 The problem: today most children are only diagnosed once they are already seriously ill - in the UK, more than a quarter are first diagnosed in diabetic ketoacidosis (DKA), a dangerous emergency.2

ELSA (EarLy Surveillance for Autoimmune diabetes) asks a practical public-health question: can we screen ordinary UK children - not just those with a diabetic relative - to catch this early, and will families accept it?3

Who it's for, and how it works

ELSA is open to any child aged 3-13 living in England, Scotland, Wales or Northern Ireland who isn't already known to have type 1 diabetes; no family history is needed.3 A parent consents online and the child gives a small finger-prick dried blood spot - done at home, at school or community clinics, or in hospital - which is tested for islet autoantibodies.3 Children who test positive for two or more autoantibodies are invited for a confirmatory blood test and an oral glucose tolerance test to "stage" how far the condition has progressed, followed by an education session for the family.3

Design

This is an observational feasibility-and-acceptability study, not a drug trial - there is no randomisation and no treatment.3 The original protocol was powered to screen 20,000 children to find roughly 60 with early-stage (stage 1-3) type 1 diabetes, based on the ~0.3% rate seen in Germany's Fr1da programme.3 The live ISRCTN record (last edited 12 August 2025) now lists a 50,000-child target, final enrolment 30 August 2029, and completion 31 August 2029 — so the original 20,000 figure is the protocol sample-size calculation, not the current registry target.4 Recruitment opened in November 2022 and the study is led from the University of Birmingham, co-funded by Diabetes UK and Breakthrough T1D.35

Key results so far

The January 2026 analysis is an interim snapshot, not completion. Of 17,283 children aged 3–13 screened at the time of that analysis, 160 had two or more autoantibodies (early-stage type 1 diabetes), 75 had a single autoantibody (raised risk), and 7 were found to already have undiagnosed type 1 diabetes.2 The same University of Birmingham news piece quotes more than 37,000 children screened over three years; that is later accrual, not a second results table, and it is still short of the live 50,000 target.24 Critically, among children who reached clinical diabetes through the programme, very few arrived in DKA, and those who did had only mild cases - a striking contrast to standard diagnosis.6 The researchers concluded that general-population screening in the UK is both feasible and acceptable to families.2

What it means / what's next

ELSA provides the evidence base for a possible national childhood screening programme, which could spare thousands of children an emergency diagnosis and give families time to prepare - and to access prevention treatments such as teplizumab, which can delay type 1 diabetes.12 A larger follow-on, ELSA 2, is extending screening to children aged 2–17 through autumn 2029.2 The original ISRCTN record remains recruiting; passing the old 20,000 protocol target is not a posted efficacy result.

References

  1. Quinn LM, Dias RP, Greenfield SM, et al. Protocol for a feasibility and acceptability study for UK general population paediatric type 1 diabetes screening - the EarLy Surveillance for Autoimmune diabetes (ELSA) study. Diabetic Medicine (2024). According to PubMed (PMID 39623620). https://doi.org/10.1111/dme.15490 ↩ ↩2 ↩3

  2. University of Birmingham. Childhood type 1 diabetes screening is effective and could prevent thousands of emergency diagnoses. University of Birmingham News (20 January 2026). https://www.birmingham.ac.uk/news/2026/childhood-type-1-diabetes-screening-is-effective-and-could-prevent-thousands-of-emergency-diagnoses ↩ ↩2 ↩3 ↩4 ↩5 ↩6

  3. Quinn LM, et al. Protocol for the ELSA study (Methods: study population, dried-blood-spot screening, OGTT staging, sample size, recruitment routes). Diabetic Medicine (2024). Full text via PubMed Central PMC12006551. https://pmc.ncbi.nlm.nih.gov/articles/PMC12006551/ ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7

  4. ISRCTN. ISRCTN97974414: ELSA — Screening for type 1 diabetes in children (last edited 12 August 2025: recruiting; target n=50,000; final enrolment 30 August 2029; completion 31 August 2029). https://www.isrctn.com/ISRCTN97974414 ↩ ↩2

  5. Diabetes UK. Open for recruitment: UK-first ELSA study to screen 20,000 children for type 1 diabetes. Diabetes UK News (2024). https://www.diabetes.org.uk/about-us/news-and-views/elsa-trial-screen-children-type-1-diabetes ↩

  6. Quinn LM, Dias RP, Bidder C, et al. Presentation and characteristics of children with screen-detected type 1 diabetes: learnings from the ELSA general population pediatric screening study. BMJ Open Diabetes Research & Care (2024). PMC11429353. https://doi.org/10.1136/bmjdrc-2024-004480 ↩