ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00494078
Recruitment Status : Completed
First Posted : June 29, 2007
Last Update Posted : November 30, 2010
Sponsor:
Information provided by:
Medical University of Vienna

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Illness Device: Real-time glucose monitoring system (Guardian, Medtronic) Drug: intensive insulin therapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
Study Start Date : June 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


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 Name: Novorapid (NovoNordisk)




Primary Outcome Measures :
  1. Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period [ Time Frame: 72h ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00494078


Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ulrike Holzinger, MD Medical University of Vienna, Department of Medicine III

Responsible Party: Ulrike Holzinger MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00494078     History of Changes
Other Study ID Numbers: 488/2005
First Posted: June 29, 2007    Key Record Dates
Last Update Posted: November 30, 2010
Last Verified: January 2009

Keywords provided by Medical University of Vienna:
critical illness
hyperglycemia
intensive insulin therapy
glucose monitoring

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs