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ObservationalSuspendedISRCTN97974414

ELSA: EarLy Surveillance for Autoimmune diabetes (UK)

What this study tests

A UK general-population screening study for early type 1 diabetes. The current ELSA program covers ages 2–17 but its official website says screening is paused. Earlier results in children aged 3–13 are interim evidence, not completion of the expanded program.

Editorial review: .

Most recent recorded citation date: 2026-03-02. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
The current program covers UK children and young people aged 2–17 without known T1D, regardless of family history. Screening is currently paused; the official site offers updates on reopening. The original published study enrolled ages 3–13. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
The official study website says screening is paused. The ISRCTN record, last updated 12 August 2025, lists a target of 50,000, final enrollment 30 August 2029 and completion 31 August 2029; these are plans, not results. A 2024 case series reported 14 children diagnosed with stage 3 T1D during or after screening: two had DKA before antibody confirmation, while all eight who completed screening before diagnosis avoided DKA. This small descriptive series has no randomized control group. The January 2026 university announcement reports interim screening counts and more than 37,000 families signed up as of November 2025, not 37,000 completed screens. The associated Lancet letter has a March 2026 correction; the full corrected results were not accessible in this review, so its screening-yield numbers remain unverified here.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: United Kingdom. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

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

The full picture

Purpose and current access

ELSA studies whether general-population childhood screening for type 1 diabetes is feasible and acceptable in the UK. The official program currently describes ages 2–17 but says screening is paused. Its website is the source for reopening updates; the older registry’s recruitment dates are not an invitation to enroll.12

The original protocol covered children aged 3–13 without known T1D. It used finger-prick dried blood spots collected at home or in clinical and community settings to test islet autoantibodies. Positive results triggered a confirmatory venous test; multiple antibodies led to metabolic staging with an oral glucose tolerance test and education. Screening detects risk or disease; it is not itself a treatment.4

Design and recruitment counts

The original feasibility protocol planned 20,000 children. The ISRCTN record, last updated 12 August 2025, increased the target to 50,000, with final enrollment planned for 30 August 2029 and completion on 31 August. These targets are distinct from the number actually screened.24

The university’s January 2026 announcement says more than 37,000 families had signed up by November 2025. That is not a count of completed blood screens. It describes ELSA 2 expanding the age range to 2–17 and continuing through autumn 2029.7

Results and verification limits

The original 2024 case series described 14 children with stage 3 T1D identified during or after participation. Two had DKA before their antibody status was confirmed. All eight who completed the screening process before diagnosis avoided DKA. This is a small descriptive series, not a randomized estimate of screening’s effect on DKA.3

A January 2026 Lancet Diabetes & Endocrinology research letter reported interim screening findings and received a correction in March 2026. The full corrected article and correction text were not accessible for this review. We therefore do not present the university press release’s detailed antibody counts as independently verified results.56

Sources

  1. [1]
    The ELSA Study: current screening pause and age range · Open-source community — Official program site checked 16 September 2026; screening paused; current age range 2–17.

    The ELSA Study. Official website: current age range and screening pause.

  2. [2]
    ELSA screening study ISRCTN97974414 · Trial registry

    ISRCTN97974414. Registry record, last updated 12 August 2025.

  3. [3]
    Presentation and characteristics of children with screen-detected type 1 diabetes: learnings from the ELSA general population pediatric screening study · Peer-reviewed study

    Quinn LM, et al. Presentation and characteristics of children with screen-detected type 1 diabetes. BMJ Open Diabetes Research & Care (2024);12:e004480.

  4. [4]
    Protocol for the ELSA feasibility and acceptability study · Peer-reviewed study

    Quinn LM, et al. Protocol for the ELSA feasibility and acceptability study. Diabetic Medicine (2024); full text PMC12006551.

  5. [5]
    Feasibility of general population screening for type 1 diabetes in the UK: the ELSA study · Peer-reviewed study · 2026-01-20 — Correction published online 2 March 2026. Full corrected screening-yield results were not accessible in this review.

    Quinn LM, et al. Feasibility of general population screening for type 1 diabetes in the UK: the ELSA study. Lancet Diabetes & Endocrinology (2026);14:197–199.

  6. [6]
    Correction to Lancet Diabetes Endocrinol 2026; 14: 197–99 · Peer-reviewed study · 2026-03-02

    Correction to Lancet Diabetes Endocrinol 2026;14:197–99. Online 2 March 2026.

  7. [7]
    Childhood type 1 diabetes screening is effective and could prevent thousands of emergency diagnoses · Science journalism · 2026-01-20

    University of Birmingham. Childhood type 1 diabetes screening is effective and could prevent thousands of emergency diagnoses, 20 January 2026.