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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01763567
First received: December 21, 2012
Last updated: May 5, 2015
Last verified: May 2015
  Purpose

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.


Condition
Hyperglycemia

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Device Performance: Accuracy of HGMS [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Functionality of HGMS: Alerts and Alarms - % of Hypo Events Correctly Detected [ Time Frame: up to 72 hours ] [ Designated as safety issue: No ]
    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.

  • Functionality of HGMS: Alerts and Alarms - % of Hyper Events Correctly Detected [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.

  • Functionality of HGMS: Alerts and Alarms - % of Hypo False Alert [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
    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.

  • Functionality of HGMS: Alerts and Alarms - % of Hyper False Alert [ Time Frame: Up to 72 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763567

Locations
United States, Missouri
St Luke's Hospital Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Medtronic Diabetes
Investigators
Principal Investigator: Mikhail Kosiborod, M.D St Luke's Hospital Mid America Heart Institute
  More Information

No publications provided

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01763567     History of Changes
Other Study ID Numbers: CEP244
Study First Received: December 21, 2012
Results First Received: October 14, 2014
Last Updated: May 5, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Diabetes:
Medtronic
Diabetes
Hospital
Continuous Glucose Monitor
Intensive Care Unit

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 28, 2015