Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
NCT04378114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2023-09-08
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.
Conditions
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
Interventions
- DEVICE
-
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used.
- DEVICE
-
Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.
Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used.
- DRUG
-
Acetominophen
One time administration of acetaminophen.
Sponsors & Collaborators
-
Medtronic Diabetes
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-18
- Primary Completion
- 2020-07-17
- Completion
- 2020-07-17
- FDA Device
- Yes
Countries
- United States
Study Locations
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