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

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378114 on ClinicalTrials.gov