Status:
COMPLETED
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
Lead Sponsor:
Medtronic Diabetes
Conditions:
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04378114
Start Date
May 18 2020
End Date
July 17 2020
Last Update
September 8 2023
Active Locations (6)
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1
AMCR Institue
Escondido, California, United States, 92026
2
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
3
Diablo Clinical Research
Walnut Creek, California, United States, 92025
4
Barbara Davis Center - Adults
Aurora, Colorado, United States, 80045