I-Corps: A wearable device for continuous, real-time, and multiplexed monitoring of biomarkers present in interstitial fluid

这个i-Corps项目的更广泛的影响/商业潜力是开发一种无痛的皮下实验室可穿戴技术，用于连续和实时监测多种重要的生物标志物，如酒精、葡萄糖、乳酸、酮体、睾酮、皮质醇、胰岛素等。拟议的皮下实验室设备可能会促进公共健康，以治疗和预防酒精滥用，在不断增长的糖尿病患者群体中更有效地管理糖尿病，并在医院或家庭环境中及时诊断、治疗和恢复感染性疾病，如败血症。此外，该设备可用于性能、健康和健身使用案例，这可能有助于教育个人了解自己的生理和新陈代谢，以及个性化营养。该i-Corps项目基于可穿戴传感器的开发，用于持续监测模型分析物，即酒精、葡萄糖和乳酸。这项拟议的技术基于四分之一大小的电化学传感器，该传感器使用微针阵列，并与佩戴者的智能手机进行无线通信。几乎看不见的微米级微针阵列使人们能够以无痛和无不适的方式连续接触皮肤下分子信息丰富的生物流体。连续监测的初步结果对所有研究的生物标志物都是有希望的，传感器的数据与金标准指标获得的数据完全相关。通过与整个i-Corps项目中的潜在最终用户、决策者和有影响力的人进行访谈，产品和市场验证活动将带来更大的确定性，并在产品开发过程中将重点放在作为潜在市场细分市场迫切需要的生物标志物的选择上。此外，该奖项的目标是满足最终用户的真实需求，并开发具有有形商业价值和对社会产生更广泛影响的产品。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this I-Corps project is the development of a pain-free, lab-under-the-skin wearable technology for continuous, and real-time monitoring of multiple biomarkers of significance such as alcohol, glucose, lactate, ketone bodies, testosterone, cortisol, insulin, and more. The proposed lab-under-the-skin device may potentially promote public health for the treatment and prevention of alcohol misuse, more effective management of diabetes in the ever-growing population of people affected with diabetes, and timely diagnosis, treatment, and recovery of infectious diseases such as sepsis in hospitals or at-home settings. In addition, the device may be adopted for performance, health, and fitness use cases, which may aid in educating individuals in understanding their own physiology and metabolism, and personalized nutrition.This I-Corps project is based on the development of a wearable sensor for continuous monitoring of model analytes namely alcohol, glucose, and lactate. The proposed technology is based on a quarter-sized electrochemical sensor that uses a microneedle array with wireless communication to the wearer’s smartphone. The barely visible micron-scale array of microneedles enables continuous access to the molecular information-rich biofluid beneath the skin in a pain- and discomfort-free manner. The preliminary results of continuous monitoring were promising for all investigated biomarkers, with the sensors’ data being in perfect correlation with those obtained from gold-standard metrics. Product and market validation activities by the interviews with potential end-users, decision-makers, and influencers throughout this I-Corps project will bring increased certainty and focus during the product development efforts on the choice of biomarkers that are immediate needs of the prospect market segments. In addition, the goal is to address the true need of the end-user, and to develop what has tangible commercial value and a broader impact on society.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.