Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults (NCT04378114) | Clinical Trial Compass
CompletedNot Applicable
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
United States104 participantsStarted 2020-05-18
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
âś“. Individual is 18 - 80 years of age at time of enrollment.
âś“. Subject has a clinical diagnosis of type 1 or type 2 diabetes for a minimum of 6 months duration as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis.
âś“. Subject has adequate venous access as assessed by investigator or appropriate staff.
Exclusion criteria
âś•. Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen
âś•. Subject reports history of liver cirrhosis or liver problems that a health care provider told them they should not use acetaminophen because of liver disorder.
✕. Subject will not tolerate tape adhesive in the area of Guardian™ Sensor (3) placement as assessed by a qualified individual.
âś•. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
âś•. Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. (Please note participation in an observational study is acceptable.)
âś•. Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
âś•. Subject is female of child-bearing potential and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
What they're measuring
1
Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose
Timeframe: Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported