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CEP249 Pediatric Accuracy Study

NCT01991470 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2018-09-27

Study results available
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Summary

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.

Conditions

  • Insulin Requiring Diabetes

Interventions

DEVICE

Enlite sensors

Subject wears enlite sensor first and followed by enlite 3 sensor.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • 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

  • 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

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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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 NCT01991470 on ClinicalTrials.gov