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

Hyperglycemia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01763567
Study type Observational
Source Medtronic Diabetes
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date September 2012
View Details
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