General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit: a proof-of-concept study (the T1Early study)

Objective: Type 1 diabetes (T1D) screening programmes testing islet autoantibodies (IAbs) in childhood can reduce life-threatening diabetic ketoacidosis. General population screening is required to detect the majority of children with T1D, since in >85% there is no family history. Age 3–5 years has been proposed as an optimal age for a single screen approach. Design: Capillary samples were collected from children attending their preschool vaccination and analysed for IAbs to insulin, glutamic acid decarboxylase, islet antigen-2 and zinc transporter 8 using radiobinding/luciferase immunoprecipitation system assays. Acceptability was assessed using semistructured interviews and open-ended postcard questionnaires with parents. Setting: Two primary care practices in Oxfordshire, UK. Main outcome measures: The ability to collect capillary blood to test IAbs in children at the routine preschool vaccination (3.5–4 years). Results: Of 134 parents invited, 66 (49%) were recruited (median age 3.5 years (IQR 3.4–3.6), 26 (39.4%) male); 63 provided a sample (97% successfully), and one participant was identified with a single positive IAb. Parents (n=15 interviews, n=29 postcards) were uniformly positive about screening aligned to vaccination and stated they would have been less likely to take part had screening been a separate visit. Themes identified included preparedness for T1D and the long-term benefit outweighing short-term upset. The perceived volume of the capillary sample was a potential concern and needs optimising. Conclusions: Capillary IAb testing is a possible method to screen children for T1D. Aligning collection to the preschool vaccination visit can be convenient for families without the need for an additional visit

General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit:a proof-of-concept study (the T1Early study)

Objective: Type 1 diabetes (T1D) screening programmes testing islet autoantibodies (IAbs) in childhood can reduce life-threatening diabetic ketoacidosis. General population screening is required to detect the majority of children with T1D, since in >85% there is no family history. Age 3–5 years has been proposed as an optimal age for a single screen approach. Design: Capillary samples were collected from children attending their preschool vaccination and analysed for IAbs to insulin, glutamic acid decarboxylase, islet antigen-2 and zinc transporter 8 using radiobinding/luciferase immunoprecipitation system assays. Acceptability was assessed using semistructured interviews and open-ended postcard questionnaires with parents. Setting: Two primary care practices in Oxfordshire, UK. Main outcome measures: The ability to collect capillary blood to test IAbs in children at the routine preschool vaccination (3.5–4 years). Results: Of 134 parents invited, 66 (49%) were recruited (median age 3.5 years (IQR 3.4–3.6), 26 (39.4%) male); 63 provided a sample (97% successfully), and one participant was identified with a single positive IAb. Parents (n=15 interviews, n=29 postcards) were uniformly positive about screening aligned to vaccination and stated they would have been less likely to take part had screening been a separate visit. Themes identified included preparedness for T1D and the long-term benefit outweighing short-term upset. The perceived volume of the capillary sample was a potential concern and needs optimising. Conclusions: Capillary IAb testing is a possible method to screen children for T1D. Aligning collection to the preschool vaccination visit can be convenient for families without the need for an additional visit

General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit:a proof-of-concept study (the T1Early study)

Objective: Type 1 diabetes (T1D) screening programmes testing islet autoantibodies (IAbs) in childhood can reduce life-threatening diabetic ketoacidosis. General population screening is required to detect the majority of children with T1D, since in >85% there is no family history. Age 3–5 years has been proposed as an optimal age for a single screen approach. Design: Capillary samples were collected from children attending their preschool vaccination and analysed for IAbs to insulin, glutamic acid decarboxylase, islet antigen-2 and zinc transporter 8 using radiobinding/luciferase immunoprecipitation system assays. Acceptability was assessed using semistructured interviews and open-ended postcard questionnaires with parents. Setting: Two primary care practices in Oxfordshire, UK. Main outcome measures: The ability to collect capillary blood to test IAbs in children at the routine preschool vaccination (3.5–4 years). Results: Of 134 parents invited, 66 (49%) were recruited (median age 3.5 years (IQR 3.4–3.6), 26 (39.4%) male); 63 provided a sample (97% successfully), and one participant was identified with a single positive IAb. Parents (n=15 interviews, n=29 postcards) were uniformly positive about screening aligned to vaccination and stated they would have been less likely to take part had screening been a separate visit. Themes identified included preparedness for T1D and the long-term benefit outweighing short-term upset. The perceived volume of the capillary sample was a potential concern and needs optimising. Conclusions: Capillary IAb testing is a possible method to screen children for T1D. Aligning collection to the preschool vaccination visit can be convenient for families without the need for an additional visit

General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit: a proof-of-concept study (the T1Early study)

Objective: Type 1 diabetes (T1D) screening programmes testing islet autoantibodies (IAbs) in childhood can reduce life-threatening diabetic ketoacidosis. General population screening is required to detect the majority of children with T1D, since in >85% there is no family history. Age 3–5 years has been proposed as an optimal age for a single screen approach. Design: Capillary samples were collected from children attending their preschool vaccination and analysed for IAbs to insulin, glutamic acid decarboxylase, islet antigen-2 and zinc transporter 8 using radiobinding/luciferase immunoprecipitation system assays. Acceptability was assessed using semistructured interviews and open-ended postcard questionnaires with parents. Setting: Two primary care practices in Oxfordshire, UK. Main outcome measures: The ability to collect capillary blood to test IAbs in children at the routine preschool vaccination (3.5–4 years). Results: Of 134 parents invited, 66 (49%) were recruited (median age 3.5 years (IQR 3.4–3.6), 26 (39.4%) male); 63 provided a sample (97% successfully), and one participant was identified with a single positive IAb. Parents (n=15 interviews, n=29 postcards) were uniformly positive about screening aligned to vaccination and stated they would have been less likely to take part had screening been a separate visit. Themes identified included preparedness for T1D and the long-term benefit outweighing short-term upset. The perceived volume of the capillary sample was a potential concern and needs optimising. Conclusions: Capillary IAb testing is a possible method to screen children for T1D. Aligning collection to the preschool vaccination visit can be convenient for families without the need for an additional visit

EarLy Surveillance for Autoimmune diabetes - protocol for a qualitative study of general population and stakeholder perspectives on screening for type 1 diabetes in the UK [ELSA 1]

Objective Type 1 diabetes (T1D) is the most common form of diabetes in children, accounting for 96% of all diabetes, with 29,000 children affected in the UK. Studies have recently identified immunotherapies that safely delay the development of T1D for at least three years, and further therapies are in development. General population screening programmes in other countries can now accurately identify children with presymptomatic T1D who can be entered into prevention studies. The UK does not have such a system in place. We aim to explore whether parents and children in the UK would want to be part of such a programme of testing for T1D in the general population, how they would want to be informed and participate in such a programme, and how any barriers to recruitment and participation can be addressed. Additionally, the views of stakeholders who would be involved in the testing programme will be collected and analysed. Research Design and Methods We will interview parents/guardians and children aged 3-13 years about their views on screening for T1D. We will recruit purposefully to ensure representation across ethnicities and socioeconomic groups. Interviews will be transcribed, analysed, and used to inform iterative co-design work with additional families to address any issues raised. Similar qualitative work will be undertaken with professional stakeholders who would be involved in implementing any future screening programme. Where possible, all aspects of this study will be performed remotely by phone or online to minimise infection risk. Conclusions This qualitative study will provide the first insights into acceptability of testing and monitoring for T1D in the general population, from the perspective of families and stakeholders in the UK. Co-design work will help establish the barriers and identify strategies to mitigate and overcome these issues, as an important step towards consideration of national testing for T1D