NCT03417466

A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.

Detailed description

This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study. Each subject will wear the following devices: • Two Enlite Sensors each connected to an iPro2 for approximately 6 days Sensor Location: • The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s. During the study, each subject will be randomized and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6). During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite Sensor.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Enlite 1 connected to iPro2 recorder	Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.

Timeline

• Start date: 2018-06-28
• Primary completion: 2018-09-20
• Completion: 2018-09-20
• First posted: 2018-01-31
• Last updated: 2019-08-20
• Results posted: 2019-08-20

Locations

3 sites across 1 country: China

Regulatory

• FDA-regulated device study