Development and validation of a clinical score for identifying patients with high risk of latent autoimmune adult diabetes (LADA): The LADA primary care-protocol study

Abstract

Background Latent autoimmune diabetes in adults (LADA) is a type of diabetes mellitus showing overlapping characteristics between type 1 Diabetes Mellitus and type 2 Diabetes Mellitus (T2DM), and autoimmunity against insulin-producing pancreatic cells. For its diagnosis, at least one type of anti-pancreatic islet antibody (GADAb is the most common) is required. Many authors recommend performing this measure in all newly diagnosed patients with DM, but it is not possible in Primary Health Care (PHC) due to its high cost. Currently, a relevant proportion of patients diagnosed as T2DM could be LADA. Confusing LADA with T2DM has clinical and safety implications, given its different therapeutic approach. The main objective of the study is to develop and validate a clinical score for identifying adult patients with DM at high risk of LADA in PHC. Methods This is an observational, descriptive, cross-sectional study carried out in Primary Care Health Centers with a centralized laboratory. All people over 30 years of age diagnosed with diabetes within a minimum of 6 months and a maximum of 4 years before the start of the study will be recruited. Individuals will be recruited by consecutive sampling. The study variables will be obtained through clinical interviews, physical examinations, and electronic medical records. The following variables will be recorded: those related to Diabetes Mellitus, sociodemographic, anthropometric, lifestyle habits, laboratory parameters, presence of comorbidities, additional treatments, personal or family autoimmune disorders, self-perceived health status, Fourlanos criteria, and LADA diagnosis (as main variable) according to current criteria. Discussion The study will provide an effective method for identifying patients at increased risk of LADA and, therefore, candidates for antibody testing. However, a slight participation bias is to be expected. Differences between participants and non-participants will be studied to quantify this potential bias.

Association of latent autoimmune diabetes of adults with type 3 polyglandular autoimmune syndrome—a diagnostic challenge

“…LADA individuals lack a family history of diabetes but often have a familial background of autoimmune diseases such as autoimmune thyroiditis, Graves' disease (GD), Biemer's anaemia, leukoderma, coeliac sprue, primary adrenal insufficiency, and others. [1][2][3][4][5] According to a polycentric study carried out in Europe, Asia, and North America, roughly 4% to 14% of patients with type 2 diabetes who also tested positive for T1DM-related autoantibodies were later diagnosed with LADA. 6 Tuomi et al first described latent autoimmune diabetes of adulthood in 1993.…”

“…LADA can be challenging to diagnose and may lead to difficulties in controlling blood glucose levels. [2][3][4] It was initially discovered in 1983 and Tuomi et al termed it LADA in 1993. Tuomi et al described this category of patients as likely to have expression patterns consistent with T2DM and immunological characteristics consistent with T1DM.…”