Internal Medicine Specialist, Member of the MADIABETES Research Group, Principal Investigator, Los Alpes Health Center, Madrid, Spain.
Member of the MADIABETES Research Group, Monóvar Health Center, Madrid, Spain.
PLoS One. 2023 Feb 9;18(2):e0281657. doi: 10.1371/journal.pone.0281657. eCollection 2023.
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.
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.
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.
成人隐匿性自身免疫性糖尿病（LADA）是一种具有 1 型糖尿病和 2 型糖尿病（T2DM）以及胰岛细胞自身免疫特征的糖尿病。其诊断需要至少一种胰岛自身抗体（最常见的是 GADA）。许多作者建议在所有新诊断的糖尿病患者中进行此项检测，但在基层医疗保健（PHC）中由于其费用较高而无法实现。目前，相当一部分诊断为 T2DM 的患者可能是 LADA。由于其治疗方法不同，将 LADA 与 T2DM 混淆会产生临床和安全影响。本研究的主要目的是开发和验证一种临床评分，以识别 PHC 中患有糖尿病的成年人中患有 LADA 的高风险患者。
这是一项在基层医疗保健中心进行的观察性、描述性、横断面研究，实验室为中心化。所有年龄在 30 岁以上、在研究开始前至少 6 个月且最长 4 年内被诊断患有糖尿病的患者将被招募。将通过连续抽样招募患者。研究变量将通过临床访谈、体格检查和电子病历获得。将记录以下变量：与糖尿病相关的变量、社会人口统计学、人体测量学、生活方式习惯、实验室参数、合并症的存在、其他治疗、个人或家族自身免疫性疾病、自我感知的健康状况、Fourlanos 标准以及根据当前标准的 LADA 诊断（作为主要变量）。
该研究将提供一种有效的方法来识别患有 LADA 风险增加的患者，因此也是抗体检测的候选者。但是，预计会存在轻微的参与偏倚。将研究参与者和非参与者之间的差异，以量化这种潜在的偏倚。
