Natural history study of type 1 diabetes risk in adults (T1DRA): protocol for screening and follow-up of UK adults
Rachel J Aitken, Ilana Kelland, Stu Toms, Clare Megson, Sarah Stollery, Ben Gillard, Zahra Hashmi, Jack Whitfield, Lilianna Bakinowska, Olivia Pearce, Vito Lampasona, Claire L Williams, Sian L Grace, Georgina L Mortimer, Anna E Long, Kathleen M GillespieIntroduction
Type 1 diabetes can be predicted through the presence of multiple circulating islet autoantibodies in the blood. However, although more than half of type 1 diabetes cases are diagnosed in adults, natural history and prediction studies to date have focused on children. This protocol describes the first type 1 diabetes natural history study in adults, both general population and relatives for screening with longitudinal monitoring.
Methods and analysis
The study launched on 14 November 2023 and the planned end date is 31 May 2027. The recruitment target is 20 000 adults. Participants are consented online and posted capillary blood kits for remote self-sampling. Serum, isolated from samples returned to the laboratory by mail, is tested for islet autoantibodies in a two-step process. Samples are initially screened for autoantibodies to truncated (t)glutamate decarboxylase 65, insulinoma-associated antigen-2 and zinc transporter 8 using a multiplex luciferase immunoprecipitation system (LIPS) screening assay. Positive samples are retested in individual LIPS assays. Autoantibodies to insulin are measured by radiobinding assay. Individuals positive for one or more islet autoantibody are recontacted and a remote confirmation sample is requested.
Once positivity is confirmed, positive participants are provided education about the symptoms of type 1 diabetes and invited to annual monitoring to allow risk of future type 1 diabetes to be accurately measured. The confirmation sample is also tested for autoantibody characteristics including affinity and positivity by a second platform to allow a tiered approach to future follow-up.
Ethics and dissemination
The study protocol was submitted to Liverpool Central Research Ethics Committee and received a favourable opinion on 26 October 2023. Results are disseminated through conference presentations, peer-reviewed journals and will be shared openly.