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A Performance Evaluation of the Enlite® 3 Sensor to Support a Full 168 Hours (7 Days) of Use
The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.
This study is a multi-center, randomized, in-clinic trial that aims to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes for at least one year. Subjects are randomized into either Group A or Group B. The groups assigned will determine when the subject will be participating in the in-clinic YSI frequent sample testing (FST). For example on Day 1: Group A begins FST 30 minutes after Enlite 3 Sensor Insertion. Group B begins FST 14 hours after Enlite 3 Sensor Insertion.
Age
14 - 75 years
Sex
ALL
Healthy Volunteers
No
AMCR Institute
Escondido, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Barbara Davis Center
Aurora, Colorado, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Start Date
September 1, 2014
Primary Completion Date
August 1, 2015
Completion Date
August 1, 2015
Last Updated
November 2, 2016
118
ACTUAL participants
Enlite 3
DEVICE
Guardian Mobile App
DEVICE
640G Insulin Pump
DEVICE
Lead Sponsor
Medtronic Diabetes
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587