2 This application for a Phase I SBIR award represents a collaboration between Clinitech, LLC and McLean 3 Hospital/Harvard Medical School to develop a wearable biosensor for detecting alcohol in the interstitial fluid of 4 humans who have consumed alcohol. Excessive use of alcohol accounts for much of the public health burden 5 related to alcohol use disorders, including fetal alcohol syndrome, fatal motor crashes, accidents and 6 homicides. On college campuses alone, alcohol use results annually in almost 2,000 deaths, 100,000 sexual 7 assaults, 600,000 injuries, and 700,000 assaults. These figures justify the need at many levels to have a 8 wearable device that can help track individual's alcohol consumption in real time. A prototype device has 9 already been developed for glucose and the current proposal is aimed at modifying the basic concept to 10 measure alcohol. All patents and licenses are in place at Clinitech and the McLean Hospital team has decades 11 of experience in administering alcohol to human volunteers and then measuring blood, breath and most 12 recently, tissue alcohol levels. Thus, the two sites are ideal to collaborate on this joint venture and are well 13 poised to initiate this project at a very rapid pace. The device, named LabPatch-alcohol, utilizes a novel 14 combination of technology that samples interstitial fluid from just underneath the skin by temporarily disrupting 15 the waterproof stratum corneum epidermal barrier, collecting interstitial fluid into a micro chamber within the 16 patch, and then applying an electrochemical reaction to measure alcohol concentration. The device is 17 unobtrusive, looks like an adhesive bandage, causes no injury to the skin and its operation cannot be 18 perceived by the person who is wearing it. The initial prototype will be wired to a computer and once the 19 detection circuitry is finalized and the calibrations with blood alcohol completed during this proposed Phase I 20 study, the next step (Phase II) would be to reduce the size of the patch even further and add the wireless 21 (Bluetooth) capability so that measures of blood alcohol levels can be sent directly to a website via a 22 smartphone application. This opens a number of major opportunities to provide real time oversight of 23 individuals' drinking patterns. The research plan will use an iterative approach by which Clinitech will develop 24 the prototypes and then McLean will test them with human subjects who have been given measured amounts 25 of alcohol to consume. Parallel samples of interstitial fluid and blood will be tested for alcohol concentration in 26 order to correlate the pharmacokinetic profile of alcohol in these two compartments. Full exchange of the data 27 will permit rapid adjustments made on the prototypes so that modified versions can be tested in a timely 28 manner. Key milestones for Phase I include: design and fabricate the initial prototype LabPatch-alcohol device, 29 perform initial calibration testing via benchtop studies, obtain IRB approval, conduct initial human testing, share 30 the data for improvements, retesting, preparation of Phase II application.
The proposed Phase I SBIR project represents a collaboration between the small business Clinitech, LLC and McLean Hospital to develop and refine a wearable unobtrusive biosensor to detect and communicate in real time alcohol in interstitial fluid and test its accuracy against blood alcohol levels in human volunteers.
