Screening
Decades of research and monitoring of individuals with islet autoantibody positivity have led to the paradigm shift recognising that type 1 diabetes is a continuum of stages, from genetic risk through to autoimmunity and then metabolic disease.[62] This evolving understanding raises the possibility of early intervention in individuals at high risk, which could facilitate earlier diagnosis and help to prevent complications such as diabetic ketoacidosis (DKA). In the UK, autoantibody testing is not yet part of routine clinical practice for screening individuals at risk of developing type 1 diabetes. However, several UK research studies (e.g., ELSA, T1DRA) are actively investigating the feasibility and effectiveness of such screening, with the aim of determining the practicality of implementing autoantibody screening in the general population.[130][131] Screening programmes are also available in other parts of the world, including the US, Australia, and parts of Europe, through enrolment in research studies.[6] Such programmes include identifying individuals who may be eligible for disease-modifying therapies, providing early access to diabetes education and support services, and potentially mitigating the severity of the disease at the time of diagnosis, with evidence showing that such monitoring in research studies can significantly reduce the incidence of DKA at diagnosis (although the impact of monitoring in general clinical practice on DKA rates is not known).[62]
The American Diabetes Association (ADA) has produced a staging system for type 1 diabetes based on clinical features, glycaemic levels, and the presence of islet cell autoantibodies and autoantibodies to insulin, glutamic acid decarboxylase (GAD), islet antigen 2 (IA-2), or zinc transporter 8 (ZnT8):[6]
Stage 1: is the presence of autoimmunity in the absence of dysglycaemia (presymptomatic)
Stage 2: is autoimmunity and dysglycaemia in the prediabetic range (presymptomatic)
Stage 3: is clinical type 1 diabetes with autoimmunity and overt hyperglycaemia (symptomatic)
Together, the ADA and European Association for the Study of Diabetes have published guidelines recommending periodic medical monitoring, including regular assessment of glucose levels and regular education about symptoms of diabetes and DKA, for people who test positive for islet autoantibodies.[62] ADA guidelines recommend that when multiple autoantibodies are identified, referral to a specialised centre for further evaluation and/or consideration of a clinical trial or approved therapy to potentially delay development of clinical diabetes should be considered.[6]
Teplizumab is a CD3-directed monoclonal antibody that has been approved in the US by the US Food and Drug Administration (FDA) and is recommended by the ADA to delay the onset of stage 3 type 1 diabetes in people aged ≥8 years with stage 2 type 1 diabetes.[6] It is not yet approved in the UK or Europe.
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