Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults

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.

Inclusion criteria

• Individual is 18 - 80 years of age at time of enrollment.
• 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.
• Subject has adequate venous access as assessed by investigator or appropriate staff.

Exclusion criteria

• Subject has history of allergy to acetaminophen or has been told by a health care provider they may not ingest acetaminophen
• 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.
• Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection).
• 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.)
• Subject is female of child-bearing potential and has a pregnancy screening test that is positive.
• 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.
• Subject is female and plans to become pregnant during the course of the study.
• Subject is breast feeding.
• Subject has a chronic heavy alcohol use as determined by investigator.
• Subject has a history of a seizure disorder.
• Subject has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
• Subject has a history of adrenal insufficiency.
• Subject is a member of the research staff involved with the study.