N/A
Completed N=102
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Source: ClinicalTrials.gov NCT04378114 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose — -0.46; 0.86; -4.78; -4.45 mg/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bias (mg/dL) Between the Guardian™ Sensor (3) Values and Yellow Springs Instrument™ (YSI™) Plasma Glucose |
-0.46; 0.86; -4.78; -4.45; 14.83; 19.57 | — |
| SECONDARY Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose |
8.45; 8.38; 5.99; 6.56; 16.65; 18.02 | — |
| SECONDARY Percentage of Guardian™ Sensor (3) Values That Were Within 20% of YSI™ Plasma Glucose Values |
93.27; 94.44; 99.03; 96.40; 68.90; 67.82 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04378114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.