Continuous Alcohol Monitoring for Pancreatitis (CAMP)

Application of a Wearable Alcohol Sensor for Prevention of Pancreatitis

The purpose the research is to demonstrate the feasibility of using a transdermal alcohol sensing device (BACtrack Skyn), and to correlate biological and self-reported alcohol measures with the transdermal alcohol measures in patients with a history of pancreatitis. The results from this study will inform tailored, self-directed interventions for reducing alcohol consumption in persons with pancreatitis.

Study Overview

• Status: Unknown
• Conditions: Alcohol Drinking; Pancreatitis
• Intervention / Treatment: Other: Wearable alcohol sensor

Detailed Description

Alcohol is the leading cause of recurrent acute and chronic pancreatitis, which greatly elevates the risk of pancreatic cancer. Reducing alcohol intake in patients with a history of alcoholic pancreatitis prevents progression of pancreatitis. Provider-based education on alcohol reduction has not translated to sustainable behaviors change, and more effective and scalable interventions are needed. Wearable alcohol sensors can empower patient-directed behavior change through real-time feedback on alcohol levels in the blood. BACtrack Skyn, the winner of NIAAA's Wearable Alcohol Biosensor Challenge, is a validated transdermal alcohol sensor that estimates blood alcohol concentration. In this pilot study, the investigators aim to (a) determine the feasibility and acceptability of using BACtrack Skyn to monitor changes in blood alcohol concentration among patients at risk for pancreatitis, (b) assess correlations between alcohol levels measured with BACtrack Skyn, breathalyzer, patient-reported alcohol consumption, and urine alcohol metabolite levels, (c) explore whether the use of a wearable alcohol sensor results in a decrease in alcohol consumption over a two-week period. Sixteen participants with known history of alcoholic pancreatitis will be assigned to wearing BACtrack Skyn for 2 weeks with the goal of not exceeding a blood alcohol concentration of 0.08%. Patient-reported drinking history, urine will be collected to correlate reported drinking levels and alcohol metabolic levels with the blood alcohol concentration readings in BACtrack Skyn. Findings from this study will be used as preliminary data to support and optimize subsequent grant applications and inform larger, randomized trials. The proposed study aligns closely with the mission of Cedars-Sinai and contributes to the growing body of research focusing on novel technologies for cancer prevention and control, as well as translational studies on alcoholic gastrointestinal diseases.

• Study Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients will have acute or chronic pancreatitis without calcification and have alcohol consumption score of ≥ 3 as measured using the validated TWEAK scale.

Description

Inclusion Criteria:

• Aged 18-75 years at the time of eligibility assessment
• History of at least one AP per Revised Atlanta Classification (20) within past 3 years from screening, which requires two of the following evidence of pancreatitis:
• Abdominal pain consistent with AP (acute onset of a persistent, severe, epigastric pain often radiating to the back)
• Serum lipase activity (or amylase activity) at least three times greater than the upper limit of normal
• Characteristic findings of AP on contrast-enhanced computed tomography (CECT), magnetic resonance imaging (MRI) or transabdominal ultrasonography
• Access to a mobile or portable device that has the capability to sync to the BACtrack sensor and internet connection for syncing purposes.

Exclusion Criteria:

• Pancreatitis presumed to be related to: gallstones, medication, trauma, autoimmune pancreatitis, post-ERCP pancreatitis, pancreatic ductal adenocarcinoma, suspected cystic neoplasm, neuroendocrine tumors, and other uncommon tumors.
• Episode of acute pancreatitis requiring hospitalization in the past 4 weeks.
• Current medical or psychiatric illnesses that in the investigator's opinion would compromise their ability to tolerate study procedures.
• Currently incarcerated.
• Known pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Continuous alcohol monitoring; Wearable BACtrack Skyn device	Other: Wearable alcohol sensor; BACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of enrolled patients who wore the BACTrack sensor for at least 7 days within the 14-day period	Feasibility based on proportion of patients who wore the BACTrack sensor for at least 50% of study duration	up to 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the BACtrack Skyn using the System Usability Scale (SUS)	SUS is a 10 item questionnaire, with 5 Likert-type response options (range 1(strongly disagree) to 5 (strongly agree)). Sensors will be deemed acceptable if ≥75% of the study population report an acceptability score of 68 or greater	14 days
Blood alcohol concentration (BACtrack breathalyzer)	Daily levels of estimated BAC using breathalyzer (continuous)	up to 14 days
Patient-reported alcohol consumption	Number of alcoholic beverages each day	up to 14 days
Urine alcohol consumption	Urine alcohol metabolite (ethyl glucuronide [EtG]) levels (continuous)	14 days
Patient-reported pain	Daily visual analog scale (range 0(low)-10 (high))	up to 14 days

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (ACTUAL): April 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 28, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Remote monitoring; Pancreatitis; Wearable technology; Continuous alcohol monitoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Drinking Behavior; Pancreatic Diseases; Alcohol Drinking; Pancreatitis
• Other Study ID Numbers: STUDY00000526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No