Trials / Completed
CompletedNCT04378114
Impact of Acetaminophen on Performance of Guardian™ Sensor (3) in Adults
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 104 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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., C algorithm and Zeus algorithm) in subjects age 18 - 80 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-05-18
- Primary completion
- 2020-07-17
- Completion
- 2020-07-17
- First posted
- 2020-05-07
- Last updated
- 2023-09-08
- Results posted
- 2023-09-08
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04378114. Inclusion in this directory is not an endorsement.