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Updated: Jun 6, 2025
A High-Throughput Multiplexed Screening for Type 1 Diabetes, Celiac Diseases, and COVID-19
Published on: July 5, 2022
Protocol for a feasibility and acceptability study for UK general population paediatric type 1 diabetes screening-the
Lauren M Quinn1, Renuka P Dias2,3, Sheila M Greenfield2
1Institute of Immunology and Immunotherapy, College of Medicine and Health, University of Birmingham, Birmingham, UK.
Insights
The EarLy Surveillance for Autoimmune (ELSA) study assessed the feasibility of screening 20,000 UK children for type 1 diabetes. Findings will inform a potential national screening program for early detection and intervention.
Area of Science:
- Pediatric Endocrinology
- Autoimmune Disease Screening
- Public Health
Background:
- Type 1 diabetes (T1D) diagnosis in children often occurs during emergencies.
- Early detection of T1D enables timely insulin initiation and family preparation.
- Current UK screening for T1D in the general paediatric population is limited.
Purpose of the Study:
- To evaluate the feasibility and acceptability of a UK-wide general population screening program for T1D in children.
- To identify optimal recruitment strategies for paediatric T1D screening.
- To assess parental and stakeholder experiences with the screening process.
Main Methods:
- Screening 20,000 children aged 3-13 years for islet autoantibodies using dried blood spots.
- Offering metabolic staging (oral glucose challenge testing) for children with two or more autoantibodies.
- Conducting qualitative interviews with parents and stakeholders to assess acceptability and implementation barriers.
Main Results:
- The study is powered to detect approximately 0.3% of children with stage 1-3 T1D.
- Feasibility will be assessed by comparing recruitment rates across different demographic factors and modalities.
- Acceptability will be determined through parental and stakeholder feedback on the screening experience.
Conclusions:
- The EarLy Surveillance for Autoimmune (ELSA) study provides crucial data on the feasibility and acceptability of paediatric T1D screening.
- Results will inform the development of a national screening program, facilitating earlier diagnosis and intervention.
- Successful implementation could lead to improved health outcomes for children with T1D and opportunities for future prevention trials.
Aim:
The EarLy Surveillance for Autoimmune (ELSA) study aims to explore the feasibility and acceptability of UK paediatric general population screening for type 1 diabetes.
Methods:
We aim to screen 20,000 children aged 3-13 years for islet-specific autoantibodies through dried blood spot sample collection at home, hospital or community settings. Children with two or more autoantibodies are offered metabolic staging via oral glucose challenge testing. Feasibility assessments will compare recruitment modalities and uptake according to demographic factors (age, gender, ethnicity, level of deprivation and family history of diabetes) to determine optimal approaches for general population screening. The study is powered to identify 60 children (0.3%) with type 1 diabetes (stage 1-3). Parents are invited to qualitative interviews following ELSA completion (child screened negative or positive, single autoantibody or multiple, stage 1-3) to share their screening experience, strengths of the programme and any areas for improvement (acceptability assessments). Parents who decline screening or withdraw from participation are invited to interview to explore any concerns. Finally, we will interview professional stakeholders delivering the ELSA study to explore barriers and facilitators to implementation.
Conclusion:
Early detection of type 1 diabetes allows insulin treatment to be started sooner, avoids diagnosis as an emergency, gives families time to prepare and the opportunity to benefit from future prevention trials and treatments. ELSA will provide essential feasibility and acceptability assessments for UK general population screening to inform a future national screening programme for paediatric type 1 diabetes.
