SBIR FAST-TRACK AWARD (PHASE I STUDY BASE REQUIREMENT WITH OPTION FOR PHASE II STUDY) CONTINUOUS MONITORING OF ALCOHOL USE BY WEARABLE BIOSENSORS

Alcohol use disorder (AUD) has devastating effects on human health, there is a need for new tools to better understand, diagnose, and treat AUD. Improved technology that enables to accurately measure alcohol levels in real-time would be transformative in understanding binge behavior of those who suffer from AUD and would lead to better treatment strategies. The overall goal of this program is to develop next-generation, wearable continuous alcohol monitoring (CAM) technology designed to provide reliable conveniently, quickly and cost-effectively measurements. CAM will measure, record, and store blood alcohol levels in real time. Phase I will focus on the feasibility of establishing stable, selective and highly sensitive biosensor that detect alcohol in real-time and directly from interstitial fluid, providing the most reliable alcohol monitor to date in terms of direct correlation to blood alcohol levels. Testing will be performed in buffers, solutions approximating the physiological mixture and in real human serum to demonstrate sensitivity, specificity, and long life stability to meet or exceed benchmark of 5 days. Phase II will focus on further refinement of the sensor, extend lifetime, and integrate into a wearable device, that can pair with a smartphone and demonstrate effective monitoring on human subjects over multi-day period.