NCT01763567

Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)

A Multi-Phased, Multi-Center Study to Evaluate Safety and Device Performance of the Medtronic Hospital Glucose Management System (HGMS) in Critically Ill Adult Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 19 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety and device performance of the Medtronic Hospital Glucose Management System (HGMS) for up to 72-hours.

Detailed description

Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following: 1. Device Performance: * Functionality of HGMS * Alerts/Alarms Specificity and Sensitivity * System Workflow 2. Safety: * Descriptive statistics will be used to characterize safety events * Moderate and severe anticipated device and procedure related adverse events * All serious adverse events and unanticipated adverse device effects related events

Conditions

• Hyperglycemia

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2013-01-09
• Last updated: 2015-05-07
• Results posted: 2015-05-07

Locations

1 site across 1 country: United States