NCT01991470

CEP249 Pediatric Accuracy Study

A Performance Evaluation of the Enlite™ and Enlite 3 Glucose Sensor to Support Use in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, single arm, multi-center, in-clinic study.. There will be two consecutive phases of the study: A total of up to 260 subjects (2-18 years old) will be enrolled at up to 15 investigational centers Subjects will come for clinic visit for YSI reference glucose testing and for Enlite Sensor™ and Enlite 3 Sensor™ testing. SMBG (Self-Monitoring of Blood Glucose) reference measurement is for subjects 2-6 years of age and cannot tolerate YSI. Study has a run-in period and a study period with a total of 10 visits

Conditions

• Insulin Requiring Diabetes

Interventions

Type	Name	Description
DEVICE	Enlite sensors	Subject wears enlite sensor first and followed by enlite 3 sensor.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2013-11-25
• Last updated: 2018-09-27
• Results posted: 2018-09-27

Locations

11 sites across 1 country: United States