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Completed

NCT Number: NCT01763567

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

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.

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Key information

Conditions

Hyperglycemia Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St Luke's Hospital Mid America Heart Institute

Kansas City, Missouri, 64111, United States

About this study

Assess safety and device performance of the Medtronic HGMS in the critically-ill setting and analyze the following:

  • Device Performance:
  • Functionality of HGMS
  • Alerts/Alarms Specificity and Sensitivity
  • System Workflow
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject is at least 18 years old
  • Subject is admitted to the ICU
  • Subject has a treatment regimen that includes a glucose target range of ≥140 mg/dl
  • 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

  • Subject has anticipated life expectancy greater than 96 hours
  • Subject has recent platelet count greater than 30,000 per micro-liter

Exclusion criteria

  • 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
  • Subject is currently participating in another investigational drug or device study
  • Subject is pregnant, as determined by hospital admission
  • Subject is receiving treatment that includes Hydroxyurea.

Treatment and study plan

Primary outcomes

  1. Device Performance: Accuracy of HGMS

    Time frame: 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

Other outcomes

  1. Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected

    Time frame: up to 72 hours

    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.

  2. Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected

    Time frame: 72 hours

    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.

  3. Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert

    Time frame: Up to 72 hours

    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.

  4. Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert

    Time frame: Up to 72 hours

    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.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study 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

Acronym: MAHI

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 9, 2013
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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