The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.
The study is a multi-center, prospective, study without controls. The purpose of this study is to characterize the impact of acetaminophen ingestion on the performance of the Guardian™ Sensor (3) (i.e., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
104
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used.
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used.
AMCR Institue
Escondido, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center - Adults
Aurora, Colorado, United States
Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
Bias (mg/dL) between the Guardian™ Sensor (3) values and YSI™ plasma glucose values 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. Bias = Mean of \[Guardian™ Sensor (3) values - YSI™ plasma glucose values\].
Time frame: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
Mean absolute relative difference (MARD, %) between the Guardian™ Sensor (3) values and YSI™ plasma glucose 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. Mean Absolute Relative Difference = Mean of (\[absolute difference of Guardian™ Sensor (3) values and YSI™ plasma glucose / YSI™ plasma glucose\] \* 100%).
Time frame: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values
Percentage of Guardian™ Sensor (3) values within 20% of YSI™ plasma glucose value (±20 mg/dL \[1.1 mmol/L\] when YSI™ value less than or equal to (≤) 80 mg/dL \[4.4 mmol/L\]) during the 1 hour before through 5 hours after ingestion of acetaminophen; results are reported hourly. 20% agreement = Number of Guardian™ Sensor (3) values within 20% (±20 mg/dL) of YSI™ plasma glucose value / Total number of paired Guardian™ Sensor (3) and YSI™ plasma glucose points \* 100%.
Time frame: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
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One time administration of acetaminophen.
"Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, United States