Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices (NCT04020822) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
United States19 participantsStarted 2019-07-29
Plain-language summary
The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is 18-75 years of age at time of screening
✓. A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
✓. Subject is using insulin to treat their diabetes
✓. Subject agrees to comply with the study protocol requirements
✓. Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST
Exclusion criteria
✕. Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen
✕. Subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder.
✕. Subject is unable to tolerate tape adhesive in the area of sensor placement
✕. 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 or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device
✕. Subject has a positive urine pregnancy test at time of screening
What they're measuring
1
Accuracy of Sensor Glucose Before and After Acetaminophen Administration
Timeframe: Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported
. Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study
✕. Subject is unwilling to participate in study procedures.