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

Hyperglycemia Clinical Trial

— MAHI  

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 Details — Status: Completed

Administrative data

• NCT number: NCT01763567
• Other study ID #: CEP244
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: May 5, 2015
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: May 2015
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperglycemia

Locations

Country	Name	City	State
United States	St Luke's Hospital Mid America Heart Institute	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected	The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes below 70 mg/dL setting levels. The % of hypo events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.	up to 72 hours	No
Other	Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected	The device alarmed within 30 minutes before or after the reference blood glucose value (i-STAT) goes above 250 mg/dL setting levels. The % of hyper events correctly detected was calculated as: total number of correct events divided by total number of events from all 19 participants.	72 hours	No
Other	Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert	Definition of % of hypo false alert: within 30 minutes before or after the sensor alarmed at 70 mg/dL, there is no reference blood glucose value (i-STAT) that goes below 70 mg/dL. The % of hypo false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hypo False Alert and % Hypo Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.	Up to 72 hours	No
Other	Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert	Definition of % of Hyper False Alert: within 30 minutes before or after the sensor alarmed at 250 mg/dL, there is no reference blood glucose value (i-STAT) that goes above 250mg/dL . The % of hyper false alert was calculated as: total number of false events divided by total number of events from all 19 participants. NOTE: % of Hyper False Alert and % Hyper Event Correctly Detected do not necessarily add up to 100% because the denomintors are not the same.	Up to 72 hours	No
Primary	Device Performance: Accuracy of HGMS	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	up to 72 hours	No