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

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia

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 Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St Luke's Hospital Mid America Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit (ICU) and on intravenous (IV) insulin therapy for the treatment of transient or diabetes-related hyperglycemia

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Principal Investigator: Mikhail Kosiborod, M.D, St Luke's Hospital - Mid America Heart Institute

Publications and helpful links

General Publications

• Kosiborod M, Gottlieb RK, Sekella JA, Peterman D, Grodzinsky A, Kennedy P, Borkon MA. Performance of the Medtronic Sentrino continuous glucose management (CGM) system in the cardiac intensive care unit. BMJ Open Diabetes Res Care. 2014 Jul 21;2(1):e000037. doi: 10.1136/bmjdrc-2014-000037. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: January 4, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes; Intensive Care Unit; Hospital; Continuous Glucose Monitor; Medtronic
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: CEP244