NCT01991470|CompletedResults
CEP249 Pediatric Accuracy Study
A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children
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A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children
Sponsor study identifier
interventional
186
1 country
11
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)The purpose of this study is to evaluate the Enlite Sensor™ and Enlite 3 Sensor performance in pediatric patients with insulin requiring diabetes at the beginning, middle and end of sensor wear.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 18, 2013
Actual (reported)November 25, 2013
Actual (reported)March 2015
Date type not reportedThis date has not been verified as actual or estimated.
December 2016
Actual (reported)December 2016
Actual (reported)September 27, 2018
Actual (reported)Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump
Enlite Sensor accuracy relative to the YSI (Yellow Spring Instruments) reference. Each subject wore two 530G pumps. The results for the lower serial number pump worn by each subject were arbitrarily selected and pooled across subjects for the primary dataset. MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days were pooled together for reporting purpose.
6 days
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System
Enlite 3 Sensor accuracy using Guardian Mobile System compared to YSI or SMBG (Self-Monitoring of Blood Glucose) reference values. For subjects 2-6 years of age, SMBG was used as a reference value if YSI cannot be tolerated. MARD = Mean of ((Absolute difference of reference and Sensor glucose values / reference glucose values) \* 100). Therefore, the unit of MARD is percentage (%). Note that results from multiple testing days will be pooled together for reporting purpose.
7 days
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the GST3C Transmitter
7 days
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump
6 Days
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Lower Serial Number 530G Pump, Using One Additional Calibration During FST
6 Days
Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD), With Higher Serial Number 530G Pump, Using One Additional Calibration During FST
6 Days
Enlite 3 Sensor Accuracy Mean Absolute Relative Difference (MARD), With the Guardian Mobile System, Using One Additional Calibration During FST
7 Days
Each subject will first wear enlite sensors and will come for clinic visit for YSI (Yellow Spring Instruments). Then each subject will wear enlite 3 sensors and will come for clinic visit for YSI (Yellow Spring Instruments) or SMBG (Self-Monitoring of Blood Glucose) testing. SMBG testings are for subjects 2-6 years of age and cannot tolerate YSI. In addition. In addition, subjects aged 2-6 years old will not participate in Enlite phase. They only participate in Enlite 3 phase.
Subject wears enlite sensor first and followed by enlite 3 sensor.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
AMCR Institute
Escondido, California, 92025, United States
SoCal Diabetes
Torrance, California, 90505, United States
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Barbara Davis Center
Aurora, Colorado, 80045, United States
Yale University, Yale Diabetes Research Program
New Haven, Connecticut, 06511, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
"Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Slover RH, Tryggestad JB, DiMeglio LA, Fox LA, Bode BW, Bailey TS, Brazg R, Christiansen MP, Sherr JL, Tsalikian E, Kaiserman KB, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2018 Sep;20(9):576-584. doi: 10.1089/dia.2018.0109. Epub 2018 Jul 31.
Ronald Brazg, MD
Rainier Clinical Research Center
Timothy Bailey, MD
AMCR Institute
Jeanie Tryggestad, MD
OUHSC Department of Pediatrics
Linda DiMeglio, MD
Indiana University, Riley Hospital for Children
186 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2013
First Posted
November 25, 2013
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Indiana University, Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
University of Iowa Children Hospital
Iowa City, Iowa, 52242, United States
OUHSC Department of Pediatrics
Oklahoma City, Oklahoma, 73104, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Larry Fox, MD
Nemours Children's Clinic
Jennifer Sherr, MD
Yale University, Yale Diabetes Research Program
Robert Slover, MD
Barbara Davis Center
Eva Tsalikian, MD
University of Iowa Children Hospital
Bruce Bode, MD
Atlanta Diabetes Associates
Kevin Kaiserman, MD
SoCal Diabetes
Mark Christiansen, MD
Diablo Clinical Research
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
September 27, 2018
Results First Posted
September 27, 2018
Record last verified: 2018-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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