An Epidermal Microfluidic Screening Panel for Diabetes Mellitus Related Disorders

糖尿病（DM）是一种常见的、多方面的病症，影响全世界大量的个体。2型DM（T2 D）占患者人群的估计90%，与最重要的长期DM相关疾病（包括慢性肾脏疾病（CKD）、心血管疾病和神经病）和急性疾病（如酮症酸中毒）的严重不良健康结局相关。缺乏针对DM相关合并症（尤其是CKD和酮症酸中毒）发作的简易诊断工具，使干预和治疗受到限制。尽管已经提出了多种生物分子和生物物理标志物用于DKD、酮症酸中毒和神经病，但目前还没有标准化的方法或仪器。迫切需要改进的测量方法，其将像目前监测葡萄糖一样容易地在家庭环境中评估糖尿病相关病理。 在这里，拟议的工作将开发一种新型的可穿戴系统，该系统集成了对外分泌汗液和生物物理活动传感的生化标志物的分析，以建立DM相关的筛选面板。汗液含有大量与健康状况相关的生物标志物，包括电解质、代谢物、有机化合物、炎症/应激生物标志物、蛋白质和激素。出汗率和组成的方面已经用于评估囊性纤维化、药物使用、身体疲劳、认知状态、抑郁和高血压等病症。这一完全集成的系统代表了改善DM相关并发症和疾病进展的临床评估的重要一步。该平台将容纳多用途柔性电子设备和底层微流体通道网络以及用于非侵入性收集和分析关键汗液生物标志物的生化分析。微流体部分是单次使用的基底，其将具有与用于实时分析的所识别的生物分析物相对应的板载比色和电化学测定。监测的关键生物物理和生化参数对应于DKD、酮症酸中毒或神经病的疾病状态的有希望的指标。

Diabetes Mellitus (DM) is a common, multifaceted condition affecting a vast number of individuals worldwide. Type-2 DM (T2D) comprises an estimated 90% of the patient population and is associated with substantial adverse health outcomes with the most important long-term DM-related disorders comprising chronic kidney disease (CKD), cardiovascular disease, and neuropathy and acute conditions such as ketoacidosis. The lack of facile diagnostic tools for the onset of DM-related comorbidities, particularly CKD and ketoacidosis, imposes intervention and treatment limitations. Although multiple biomolecular and biophysical markers have been proposed for DKD, ketoacidosis, and neuropathy, no standardized method or instrumentation currently exists. There is a critical need for improved measurement methods that will evaluate diabetes associated pathology in the home setting as easily as glucose is presently monitored. Here, the proposed work will develop a novel wearable system that integrates analysis of biochemical markers from eccrine sweat and biophysical activity sensing to establish a DM-relevant screening panel. Sweat contains a wealth of biomarkers relevant to health status, including electrolytes, metabolites, organic compounds, inflammatory/stress biomarkers, proteins and hormones. Aspects of sweat rate and composition have been used in assessing cystic fibrosis, drug use, physical fatigue, cognitive state, depression, and hypertension, among other conditions. This fully-integrated system represents a significant step towards improving the clinical assessment of the onset of DM-relevant complications and disease progression. The platform will house multi-use flexible electronics and a network of underlying microfluidic channels and biochemical assays for non-invasive collection and analysis of key sweat biomarkers. The microfluidics portion is a single use substrate that will have onboard colorimetric and electrochemical assays corresponding to identified bioanalytes for real-time analysis. The key biophysical and biochemical parameters monitored correspond to promising indicators of disease states for DKD, ketoacidosis, or neuropathy.