Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

November 29, 2010 updated by: Medical University of Vienna

Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study

The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy.
  • Age > 18 years.

Exclusion Criteria:

  • Admitted patients expected to stay <48h
  • Age ≤ 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
Device: Real-time glucose monitoring system (Guardian, Medtronic)
Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.
Other Names:
  • Guardian (Medtronic)
  • Novorapid (NovoNordisk)
Active Comparator: 2
intensive insulin therapy guided by an algorithm
Drug: intensive insulin therapy
intensive insulin therapy according to an algorithm
Other Names:
  • Novorapid (NovoNordisk)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
Time Frame: 72h
72h

Secondary Outcome Measures

Outcome Measure
Time Frame
Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias
Time Frame: 72h
72h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Ulrike Holzinger, MD, Medical University of Vienna, Department of Medicine III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

June 27, 2007

First Submitted That Met QC Criteria

June 27, 2007

First Posted (Estimate)

June 29, 2007

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 488/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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