Back to resultsEfficiency of Continuous Glucose Monitoring in Critically Ill Patients
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Real-time glucose monitoring system (Guardian, Medtronic)
intensive insulin therapy
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring
Eligibility 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
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
intensive insulin therapy guided by an algorithm
Outcomes
Primary Outcome Measures
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
Secondary Outcome Measures
Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias
Full Information
NCT ID
NCT00494078
First Posted
June 27, 2007
Last Updated
November 29, 2010
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00494078
Brief Title
Efficiency of Continuous Glucose Monitoring in Critically Ill Patients
Official Title
Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
Arm Title
2
Arm Type
Active Comparator
Arm Description
intensive insulin therapy guided by an algorithm
Intervention Type
Device
Intervention Name(s)
Real-time glucose monitoring system (Guardian, Medtronic)
Other Intervention Name(s)
Guardian (Medtronic), Novorapid (NovoNordisk)
Intervention Description
Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.
Intervention Type
Drug
Intervention Name(s)
intensive insulin therapy
Other Intervention Name(s)
Novorapid (NovoNordisk)
Intervention Description
intensive insulin therapy according to an algorithm
Primary Outcome Measure Information:
Title
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
Time Frame
72h
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Holzinger, MD
Organizational Affiliation
Medical University of Vienna, Department of Medicine III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Efficiency of Continuous Glucose Monitoring in Critically Ill Patients
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