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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: January 4, 2013
Last verified: January 2013
History of Changes
  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
Transient or Diabetes-related 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:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Safety [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    • Moderate and severe anticipated device and procedure related adverse events
    • All serious adverse events and unanticipated adverse device effects related events

  • Device Performance [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

    Functionality of HGMS

    • Accuracy
    • Alarms Specificity and Sensitivity (providing there are sufficient points)


Enrollment: 21
Study Start Date: March 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  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
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
Last Updated: January 4, 2013
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:
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013