Type 2 Diabetes Clinical Trial
Official title:
Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group
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.
The study is a multi-center, prospective single-arm design without controls. All subjects
will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian
Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian
Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.
On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home
glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one
gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.
On day 11, devices will be removed, data uploaded from the study meter and transmitter or
recorder, skin assessment will be performed, and the subject's participation in the study
will be completed.
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