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A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

NCT01464346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-05-30

Study results available
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Summary

The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.

Conditions

Interventions

DEVICE

Enlite Sensor

This is the Enlite sensor (all subjects)

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Scott Lee, MD · Medtronic Diabetes

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-03-31
Completion
2012-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01464346 on ClinicalTrials.gov