Discreet Wearable device for Continuous Real-time Monitoring of Alcohol - Project Summary / Abstract Alcohol Use Disorder (AUD) affects ~29 million Americans each year, drives >140,000 deaths, and costs the U.S. nearly $300 billion annually. Current monitoring methods—self-reports, breathalyzers, and transdermal devices—are episodic, delayed, or inaccurate. ActioX addresses this critical gap with the Continuous Alcohol Monitor (CAM), a minimally invasive, factory-calibrated microneedle patch that continuously samples interstitial fluid and delivers real-time, blood-correlated alcohol readouts with sub-minute response and no user calibration. In Phase I/II, ActioX validated CAM in >70 participants across >300 drinking episodes, yielding >10,000 data points. Results demonstrated strong venous/breath correlation, <5% drift over 3 days, rapid response (<1 min rise), and high user acceptability. The device’s penny-sized form factor, <$7 projected cost, and $19.95/7-day price point position it as scalable and broadly accessible. This Phase IIB will finalize design lock, implement ISO 13485/21 CFR 820-compliant manufacturing at ≥10,000 units/day, and conduct FDA-aligned studies: (i) bench/biocompatibility/electrical/cybersecurity validation, (ii) an in-clinic alcohol dosing study (N=36) with venous/breath references, and (iii) a 7-day real-world observational study (N=50). Year 3 will include a pivotal, multi-site OTC clinical performance trial (~200 subjects) supported by a 1,000-unit validation lot. By enabling continuous, discreet, and affordable monitoring, CAM can transform clinical trials, recovery programs, forensic compliance, and consumer wellness. It directly advances NIAAA’s mission to reduce alcohol-related morbidity and mortality while opening a new era of data-driven AUD therapeutics, public health, and consumer safety
