Trial Outcomes & Findings for Calibration Study of a Blood Alcohol Level Smart Watch (NCT NCT03574181)

NCT ID: NCT03574181

Last Updated: 2021-02-18

Results Overview

Wristwatch sensor BAL is continuously measured for entirety of 6-hour alcohol self administration trial. BAL from breathalyzer (BrAC) is measured at 15-minute intervals throughout 6-hour alcohol self administration trial. The correlation between wristwatch transdermal BAL (TAC) and breathalyzer BAL (BrAC) for all subjects will be calculated.

• Recruitment status: TERMINATED
• Target enrollment: 9 participants
• Primary outcome timeframe: 6 hours during alcohol self administration trial
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Transdermal Alcohol Sensor Single-arm study. All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of five hours following consumption of alcohol.
Overall Study STARTED	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Calibration Study of a Blood Alcohol Level Smart Watch

Baseline characteristics by cohort

Measure	Transdermal Alcohol Sensor n=9 Participants All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of five hours following consumption of alcohol.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours during alcohol self administration trial

Population: 6 of 9 participants were included in data analyses. Three participants were excluded from analyses due to inability to obtain TAC data from wristwatches during alcohol self administration trials.

Wristwatch sensor BAL is continuously measured for entirety of 6-hour alcohol self administration trial. BAL from breathalyzer (BrAC) is measured at 15-minute intervals throughout 6-hour alcohol self administration trial. The correlation between wristwatch transdermal BAL (TAC) and breathalyzer BAL (BrAC) for all subjects will be calculated.

Outcome measures

Measure	Transdermal Alcohol Sensor n=6 Participants Single-arm study. All eligible subjects consume two mixed drinks calibrated to raise their blood alcohol level to 0.05 g/dL over 60 minutes. Subjects are fitted with a transdermal alcohol sensor on each wrist. Breathalyzer measurements are taken every 15 minutes for a period of three hours following consumption of alcohol.
Correlation Between Breathalyzer and Wristwatch Sensor BAL Measurements	0.3183 coefficient of determination (R^2)

Adverse Events

Transdermal Alcohol Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eric Devine

Boston Medial Center

Phone: 617-638-7888

Email: eric.devine@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place