Challenges and Solutions for Monitoring Alcohol Use in Patients With Alcohol-Related Liver Disease: Pilot Study of a Wearable Alcohol Biosensor.

OBJECTIVES: Early alcohol use identification can prevent morbidity/mortality for alcohol-associated liver disease (ALD). Innovative wearable alcohol biosensors (biosensors) that identify alcohol use through perspiration are an emerging technology with potential application for patients with ALD. Our primary aim was to determine biosensor acceptability and feasibility for patients with ALD. We describe participant acceptance and challenges using biosensor technology in a pilot study of biosensors with patients with ALD. DESIGN: Participants had a recent diagnosis or hospitalization for decompensated ALD, had to be drinking within the past 3 months, and had to be followed at our center. Participants wore the biosensor daily for 3 months. Quantitative data using the Technology Acceptance Model 2 (TAM2) measure were collected at intake and study conclusion. The TAM2's 13 items cover four scales: perceived usefulness, ease of use, attitude toward technology, and intention to use on a 7-point Likert scale. Lower scores indicate higher acceptance. Participants were asked open-ended questions about issues wearing the biosensor. RESULTS: Among 27 participants, 60% were women with an average age of 45 (10) years, and 89% were White. TAM2 subscales indicated initially high acceptance (mean scores = 1.2-2.2) and remained high (mean scores = 1.3-2.3) without a statistically significant decline at study conclusion. From open-ended questions, several themes regarding problems with device wear emerged a) uncomfortable or cumbersome to wear, b) problems with biosensor appearance, and c) issues with usability. Challenges to biosensor usage included data being lost when devices were damaged and devices being lost during the study. CONCLUSIONS: Alcohol biosensors seem to be acceptable to ALD participants. However, improving the appearance, comfort, durability, and functionality of biosensor devices is critical to clinical deployment.Trial Registration:Clinicaltrials.gov identifier NCT03533660: Alcohol biosensor monitoring for alcohol liver disease.

Circulating Extracellular Vesicles Carrying Sphingolipid Cargo for the Diagnosis and Dynamic Risk Profiling of Alcoholic Hepatitis.

BACKGROUND AND AIMS: Alcoholic hepatitis (AH) is diagnosed by clinical criteria, although several objective scores facilitate risk stratification. Extracellular vesicles (EVs) have emerged as biomarkers for many diseases and are also implicated in the pathogenesis of AH. Therefore, we investigated whether plasma EV concentration and sphingolipid cargo could serve as diagnostic biomarkers for AH and inform prognosis to permit dynamic risk profiling of AH subjects. APPROACH AND RESULTS: EVs were isolated and quantified from plasma samples from healthy controls, heavy drinkers, and subjects with end-stage liver disease (ESLD) attributed to cholestatic liver diseases and nonalcoholic steatohepatitis, decompensated alcohol-associated cirrhosis (AC), and AH. Sphingolipids were quantified by tandem mass spectroscopy. The median plasma EV concentration was significantly higher in AH subjects (5.38 × 1011 /mL) compared to healthy controls (4.38 × 1010 /mL; P < 0.0001), heavy drinkers (1.28 × 1011 /mL; P < 0.0001), ESLD (5.35 × 1010 /mL; P < 0.0001), and decompensated AC (9.2 × 1010 /mL; P < 0.0001) disease controls. Among AH subjects, EV concentration correlated with Model for End-Stage Liver Disease score. When EV counts were dichotomized at the median, survival probability for AH subjects at 90 days was 63.0% in the high-EV group and 90.0% in the low-EV group (log-rank P value = 0.015). Interestingly, EV sphingolipid cargo was significantly enriched in AH when compared to healthy controls, heavy drinkers, ESLD, and decompensated AC (P = 0.0001). Multiple sphingolipids demonstrated good diagnostic and prognostic performance as biomarkers for AH. CONCLUSIONS: Circulating EV concentration and sphingolipid cargo signature can be used in the diagnosis and differentiation of AH from heavy drinkers, decompensated AC, and other etiologies of ESLD and predict 90-day survival permitting dynamic risk profiling.