Description:
Fast-Track and Direct to Phase II proposals will be accepted.
Number of anticipated awards: 1-3
Budget (total costs, per award): Phase I: up to $500,000 for up to 9 months; Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Background
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks a wearable or otherwise discreet device capable of measuring, recording and storing blood alcohol levels in real time. Alcohol biosensors that are unnoticeable by the user and provide continuous alcohol use monitoring will advance the mission of NIAAA in the arenas of research, treatment, rehabilitation, and recovery.
For example, research that seeks to understand the progression of medical conditions exacerbated by alcohol to discover treatments depends on the ability to accurately measure and record alcohol consumption continuously over time. Alcohol biosensors will simplify the process of determining close to real time alcohol consumption for both the scientists and the participants by providing an objective, biomedical measure of alcohol consumption; allowing participants to avoid the inconvenience and discomfort of having blood drawn at regular intervals. Likewise, during treatment of individuals with alcohol use disorder (AUD), and especially in clinical trials designed to identify the most effective treatments for AUD, it is essential to know accurately the extent of alcohol consumption of trial participants to determine the effectiveness of the intervention being studied. The current method of determining alcohol consumption (Time-Line Followback (TLFB)) is cumbersome, time-consuming, relies on retrospective recall and can be highly variable from one interviewer to another. Alcohol biosensors in contact with the human body will decrease the assessment variability experienced with the TLFB and increase the rigor and reproducibility of measuring alcohol consumption in clinical trials. Current technological developments in electronics, miniaturization, wireless technology, and biophysical techniques of alcohol detection in humans increase the likelihood of successful development of a useful alcohol biosensor in the short term.
Objectives
NIAAA seeks the design and production of a discreet device to measure, record, and store blood alcohol levels in real time (or close to real-time). The device should be inconspicuous, low profile, and appealing to the wearer. The design can take the form of jewelry, clothing, or any other format located in contact with the human body. The detection of alcohol should be passive, close to real time, and accurate.
Alcohol biosensors that detect consumed alcohol in sweat or sweat vapor have been used in criminal justice settings for a decade or more. More recently, advances in more discreet wearable alcohol sensing devices has been made; however, these still depend on detection of alcohol in the sweat, rather than in blood. It is important to note that there is a forty-minute to two-hour lag in detection of alcohol in sweat relative to actual blood alcohol levels. Under certain circumstances, this can have significant consequences. For this reason, this solicitation seeks the development of techniques that are not sweat-based. Only advances in alcohol detection that depart from measuring alcohol in sweat or sweat vapor will be responsive to this solicitation. Offerors are encouraged to pursue any technology - including but not limited to- biophysical, optical, wave, or other novel approaches that passively quantify blood alcohol in human subjects... NIAAA recognizes that there are other technologies that also offer promise; so innovative, original approaches to alcohol quantification as well as the adaptation and miniaturization of existing technologies are welcome.
The device should be able to quantitate blood alcohol level, interpret, and store the data or transmit it to a smartphone or other device by wireless transmission. The device should have the ability to verify standardization at regular intervals and to
indicate loss of functionality. The power source should be dependable and rechargeable. Data storage and transmission must be completely secure for the protection of the privacy of the individual. A form of subject identification would be an added benefit. If the device is removable by the user, the ability to record the exact time the device is removed is preferred. Ideally, the device will be stable, with expectation of long-term function. The design should be acceptable to the wearer from comfort, privacy, financial, and convenience standpoints.
It is envisioned that subject alcohol monitoring will serve useful purposes in research, clinical, and treatment settings, may play a role in public safety, and will be of interest in the consumer market to individuals interested in tracking personal health parameters. Designs may emphasize any of these potential market subsets or may seek to be broadly marketable.
While achievable lower limits of detection remain to be demonstrated, devices capable of detecting 0.02% BAC would be of value to NIAAA.
To apply for this topic, offerors should:
Include a description of the technology by which the device will quantitate blood alcohol level. Provide preliminary data or cite literature to support the rationale for the underlying approach. If modifying an existing technology to wearable scale, describe the potential for success of the miniaturization process. Explanations of data handling should discuss how the device will collect, interpret, store and protect the data or transmit it to a smartphone or other device by wireless transmission and address data security measures. The approach should address the ability to verify standardization at regular intervals and to alert a loss of functionality. The power source, charging duration, and battery life (if applicable) should be addressed.
Since alcohol biosensors may be of great benefit to treatment professionals, clinicians, researchers, and individuals, designs may emphasize any of these potential market subsets or may seek to be broadly marketable. Proposals should identify the intended target audience(s) and provide the rationale for their design decisions regarding both technology and form factor.
This SBIR will not support:
Development or improvement of biosensors that detect alcohol exuded through the skin in sweat or vapor.
Phase I activities and expected deliverables
• Demonstration of the ability of the technology to detect alcohol.
• Demonstration that the detection signal is proportional to amount or concentration of alcohol.
• Demonstration of the specificity of alcohol detection in blood or a solution approximating the physiological mixture.
• Demonstration of the limit of detection (sensitivity).
While not required, if validation of new or existing technology in human subjects is proposed in the Phase II portion, evidence of the availability of existing clinical infrastructure and knowledge and familiarity with NIH and FDA regulations on human protections must be provided before progression to the Phase II.
As the development of a wearable alcohol biosensor is a priority for NIAAA ((https://www.niaaa.nih.gov/sites/default/files/StrategicPlan_NIAAA_optimized_2017-2020.pdf) and NIH (https://www.nih.gov/sites/default/files/about-nih/strategic-plan-fy2016-2020-508.pdf), NIAAA envisions that the Phase I milestones will be quickly met, leading to rapid advancement to the Phase II period.
Phase II activities and expected deliverables
• Incorporation the alcohol sensor into a discreet device in a form factor in contact with the human body.
• Refinements of functionality, accuracy, security, and integration of data collection, data transmission and data storage.
• Further refinement of accuracy of quantitation of blood alcohol concentration. Development of an algorithm that accurately converts the detection signal to blood alcohol concentration.
• Demonstration that the detection of alcohol is passive, not requiring action on the part of the wearer.
• Demonstration of frequency of measurement.
• Demonstration that the device shows the time of detection and that the BAC value corresponds to the time of measurement.
• Summary of human testing completed.
• Plans for process of manufacture.
• Evidence of a functional, marketable, alcohol biosensor is the specific deliverable of the Phase II portion of the contract.
