Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
1 other identifier
interventional
104
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2020
CompletedResults Posted
Study results publicly available
September 8, 2023
CompletedSeptember 8, 2023
August 1, 2023
2 months
May 4, 2020
June 25, 2023
August 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 \[Guardian™ Sensor (3) values - YSI™ plasma glucose values\].
Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Secondary Outcomes (2)
Mean Absolute Relative Difference (MARD, %) Between the Guardian™ Sensor (3) Values and YSI™ Plasma Glucose
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
Frequent sample testing recordings from the 6-hour period leading to and after Acetaminophen ingestion on day 4 or day 5 reported
Study Arms (2)
Subjects with diabetes wearing Guardian™ Sensor (3). C algorithm applied retrospectively
EXPERIMENTALSubjects wear Guardian™ Sensor (3) over 7 days and undergo one frequent sample test (FST). C sensor algorithm applied retrospectively to raw sensor data.
Subjects with diabetes wearing Guardian™ Sensor (3). Zeus algorithm applied retrospectively
EXPERIMENTALSubjects wear Guardian™ Sensor (3) over 7 days and undergo one FST. Zeus sensor algorithm applied retrospectively to raw sensor data.
Interventions
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.
One time administration of acetaminophen.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
AMCR Institue
Escondido, California, 92026, United States
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Diablo Clinical Research
Walnut Creek, California, 92025, United States
Barbara Davis Center - Adults
Aurora, Colorado, 80045, United States
"Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robin Mottackel
- Organization
- Medtronic Diabetes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 7, 2020
Study Start
May 18, 2020
Primary Completion
July 17, 2020
Study Completion
July 17, 2020
Last Updated
September 8, 2023
Results First Posted
September 8, 2023
Record last verified: 2023-08