T1 Early
Research type
Research Study
Full title
Establishing the feasibility of antibody screening in primary care at the time of the pre-school vaccination, to identify children with early-onset type 1 diabetes
IRAS ID
291016
Contact name
Rachel Besser
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Research Summary:
Type 1 diabetes (T1D) is the commonest autoimmune disease of childhood, affecting 1 in 350 children. It is caused by destruction of the insulin-producing cells in the pancreas, resulting in elevated blood sugar levels. It affects every aspect of health and wellbeing, resulting in life-long insulin dependence and an increased risk of major health problems (heart disease, blindness, kidney failure) as well as premature death. It is estimated to cost the UK over £1.8bn/year.In around 25% children the diagnosis of T1D is not made until the child has become severely unwell, in “diabetic ketoacidosis (DKA)”.
An accurate test now exists that can identify children who will develop T1D at a presymptomatic stage of the disease. The test measures anti-islet cell autoantibodies, a marker of the autoimmune process, from a simple finger prick blood sample.
We aim to screen children attending their pre school vaccination, typically between age 3.5 - 4 years. At this age, the majority (70%) of children who will develop T1D in childhood will have developed Islet Abs, but only around 15% will have developed T1D.
This is a feasibility study, and will be the first to assess whether families are happy to take part, and the practicalities of collecting capillary samples for Ab testing at the time of the pre-school booster. The study will aim to recruit 60 children across two GP practices.
As T1D affects 1 in 350 children, it is unlikely that we will identify any children who will go on to develop T1D. However, if any child with one or more Abs is identified, they will be invited for a repeat fingerprick sample, and if confirmed, their parents will receive education about the signs and symptoms of T1D.
This study aims to contribute to the development of a larger grant for a diabetes antibody pre-school screening programme.
Lay summary of study results: Study Title: General population screening for type 1 diabetes using islet autoantibodies at the preschool vaccination visit: a proof-of-concept study (the T1Early study) Background Type 1 diabetes (T1D) screening programmes testing markers of early diabetes, islet autoantibodies (IAbs), in childhood can reduce a life-threatening condition called 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 has been proposed as an optimal age for screening.
Study Objectives
The T1 Early study looked at the ability to collect finger prick blood samples to test IAbs in children at the time of the routine pre-school vaccination visit, and how acceptable the process was to parents and children.
Study Management & Funding
This study was carried out by researchers at the University of Oxford and was supported by grants from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), and from an NIHR Programme Development Grant (NIHR203948).
Study Design
Finger prick blood samples were collected from children attending their pre-school vaccination and analysed for IAbs. Acceptability was assessed using semi-structured interviews and open-ended postcard questionnaires with parents.
Setting
Two primary care practices in Oxfordshire, UK.
Results
Of 134 children invited, 66 (49%) were recruited at the age of 3-5 years (and 39% were male). Of the 66 recruited,63 provided a sample that could be tested. Fifteen parents were interviewed and 29 parents returned feedback postcards). Parents were uniformly positive about screening coinciding with the vaccination visit and stated they would have been less likely to take part had screening been on a separate visit. Themes identified for taking part in screening included being prepared for a T1D diagnosis, and the long-term benefit outweighing short-term upset. The perceived volume of the finger prick sample was a potential concern.
Conclusions
Finger prick IAb testing is a possible method to screen children for T1D. Collecting blood samples from a finger prick at the time of the pre-school vaccination visit can be convenient for families and allows a universal approach without the need for an additional visit.
The routine vaccination programme is a potential opportunity to screen children for future T1D, offering improved engagement and potentially reducing the costs associated with a screening programme; all of which need exploration in a large and definitive study.
Where can I learn more about this study?
The full study results have been published, and can be accessed online: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fadc.bmj.com%252Fcontent%252F109%252F10%252F812.long%2FNBTI%2FyW24AQ%2FAQ%2F2962f6ac-ca5a-4e22-ace5-741abfe3f5b7%2F1%2Fivf6vWvhPi&data=05%7C02%7Cpreston.rec%40hra.nhs.uk%7C0ed3fc88b56f48b29fec08dce3900fa8%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638635455085028449%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=es53zfiOw715s6gh8Q4UxQsht6VHk5usp7xPKWZjfDI%3D&reserved=0REC name
North West - Preston Research Ethics Committee
REC reference
21/NW/0340
Date of REC Opinion
28 Feb 2022
REC opinion
Further Information Favourable Opinion