Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-25 @ 7:04 PM
Study NCT ID:
NCT01763567
Status:
COMPLETED
Last Update Posted:
2015-05-07
First Post:
2012-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study to Evaluate Safety and Device Performance of the Hospital Glucose Management System (HGMS)
Sponsor:
Medtronic Diabetes
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAHI
Brief 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: