The ELSA Study (CPMS 52726, IRAS 309252)

UPDATED - 07/06/2024

Type 1 diabetes (T1D) is an autoimmune condition, and one of the most common, chronic conditions of childhood. Three stages of T1D are recognised, with stage 1 and 2 T1D characterised by autoimmunity (presence of two or more diabetes antibodies) where individuals are pre-symptomatic. Stage 3 T1D is the classical symptomatic presentation, when insulin commencement is necessary. Almost all children with two or more T1D antibodies, will develop T1D in their lifetime. Earlier detection of T1D will identify individuals who can be offered novel therapies for T1D prevention and allow insulin treatment to be started sooner, reducing the risk of long-term complications and avoid T1D being diagnosed as an emergency.

We propose to explore the feasibility and acceptability of a system for identifying children in the general population at risk of type 1 diabetes (T1D).We aim to recruit 20,000 children aged 3-13 years, over a 3 year study period, and will compare the feasibility of different community recruitment strategies including online and social media, general practices, childhood immunisation programmes, and schools.

We will undertake fingerstick antibody testing of 20,000 children. Those at risk will be further risk stratified with oral glucose challenge testing. All children testing positive for diabetes antibodies will be invited to an education session with their family, to be informed about the signs and symptoms of T1D, monitoring programmes available for long-term follow-up, and trials their child may be eligible for to delay the onset of T1D.

Mixed-methods qualitative work including distress questionnaires and interviews with parents of children testing positive or negative for antibodies will be performed to assess acceptability. 

An important consideration for screening relates to cost-effectiveness.

Costs for the study advertising, recruitment, study procedures, staff time, and screening programme interventions will be calculated to evaluate the health economics of the ELSA study screening programme.

Inclusion Criteria:

The eligibility criteria is very inclusive and only requires that the participant and/or parent is willing to take part in a diabetes screening programme. A parent/guardian can enrol more than one child in the

ELSA 2 study provided the children are aged 3-13 years. Children with or without a family history of T1D can participate as can children who were previously found to be autoantibody positive.

Inclusion criteria for the screening programme :

1. Children aged 3-13 years inclusive

2. Children of parents/guardians who consent to participation

Inclusion criteria for qualitative interviews:

1. For the qualitative work, we will include children and parents/guardians of children who participated in the ELSA 2 study. The qualitative work is an optional part of the ELSA study. 

2. We will also invite individuals who expressed interest in the ELSA 2 study and were eligible, but who decided not to take part in the

screening programme

3.“Stakeholders who were involved in the delivery of the ELSA study, including recruitment, consenting, and sampling children enrolled in ELSA, will also be invited to take part in a qualitative interview to obtain feedback on the screening process. This will be a purposive sample.

Exclusion criteria for screening programme:

1. Children with a previous diagnosis of T1D.

2. Children of parents/guardians who are unable/unwilling to consent to participation

Exclusion criteria for qualitative interviews:

1. Parents/children/stakeholders who have not agreed to take part in the interview study.

Parents who are not eligible for the ELSA study will be invited to complete the ELSA study expression of interest form. Consent to contact will be confirmed and preferred contact methods will be collected, for example, email or post and/or phone to join a mailing list tohear about related studies. These details will be stored securely on REDcap for the duration of the study. This is important for families who do not live in the West Midlands region, so that we can inform the family if and when recruitment extends nationally, and if they become eligible to take part.

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

Jodie Button – jodie.button@nihr.ac.uk

James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

These resources have been developed based on the criteria provided by the relevant study team and whilst every effort has been made to make them universally implementable they rely on read codes and the data stored in the individual practice's clinical system. These resources are intended to assist with identification but should be used in conjunction with clinical oversight and a clear understanding of the study parameters.

While we endeavour to keep the information, tools and resources provided up to date and correct, we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the tools provided for any purpose. Any reliance you place on such information is therefore strictly at your own risk.

In no event will we be liable for any loss or damage including without limitation, indirect or consequential loss or damage, or any loss or damage whatsoever arising from loss of data or profits arising out of, or in connection with, the use of the tools provided.