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

Completed

• Conditions: Hyperglycemia

• Registration Number: NCT01763567
• Lead Sponsor: Medtronic Diabetes

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

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-09
• Results First Submitted: 2014-10-14
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Results First Posted: 2015-05-07
• Last Update Posted: 2015-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Subject is at least 18 years old

2. Subject is admitted to the ICU

3. Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl

4. Subject has a treatment regimen that includes an intended continuous intravenous insulin for at least 24 hours

   a. Including patients with no previous diagnosis of Diabetes Mellitus

5. Subject has anticipated life expectancy greater than 96 hours

6. Subject has recent platelet count greater than 30,000 per micro-liter

Exclusion Criteria

1. Subject currently has a suspected or diagnosed medical condition that, in the opinion of the Investigator, warrants exclusion from the study or prevents the subject from completing the study
2. Subject is currently participating in another investigational drug or device study
3. Subject is pregnant, as determined by hospital admission
4. Subject is receiving treatment that includes Hydroxyurea.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Performance: Accuracy of HGMS	up to 72 hours	Mean Absolute Relative Difference (MARD), calculated as the absolute difference of \[(sensor glucose values - iSTAT glucose values) / iSTAT glucose values\].; The portable i-STAT handheld makes patient-side testing easy: * Requires no special sample preparation or user calibration; maintenance is minimal; * Weighs 18 ounces, making it portable; * Patient-side testing is as easy as entering the operator and patient information into the handheld, inserting one of the several filled test cartridges, and then viewing test results: * The system prompts users step by step through the testing process; * Operator and patient information can be entered via barcode scanner; * Operator lockout prevents unauthorized users from performing or viewing test results; * Test results are uploaded automatically when the i-STAT handheld is placed in a downloader

Trial Locations

Locations (1)

St Luke's Hospital Mid America Heart Institute; 🇺🇸 Kansas City, Missouri, United States