Back to resultsContinuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
Primary Purpose
Hyperglycemia, Cardiac Surgery
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
Intensive insulin therapy using standard protocol
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring continuous glucose monitoring, intensive insulin therapy, critically ill, cardiac surgery, hyperglycemia of critically ill
Eligibility Criteria
Inclusion Criteria:
- elective cardiac surgery
Exclusion Criteria:
- insulin allergy
- mental incapacity
- language barrier
Sites / Locations
- General University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
CGM-eMPC
Control
Arm Description
Outcomes
Primary Outcome Measures
Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)
Secondary Outcome Measures
Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range
Full Information
NCT ID
NCT00996099
First Posted
October 15, 2009
Last Updated
October 15, 2009
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT00996099
Brief Title
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
Official Title
Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Cardiac Surgery
Keywords
continuous glucose monitoring, intensive insulin therapy, critically ill, cardiac surgery, hyperglycemia of critically ill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGM-eMPC
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
Intervention Description
Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery
Intervention Type
Other
Intervention Name(s)
Intensive insulin therapy using standard protocol
Intervention Description
Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.
Primary Outcome Measure Information:
Title
Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)
Time Frame
first 24 hours after cardiac surgery
Secondary Outcome Measure Information:
Title
Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range
Time Frame
first 24 hours after cardiac surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective cardiac surgery
Exclusion Criteria:
insulin allergy
mental incapacity
language barrier
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Haluzik, Prof, D.Sc.
Organizational Affiliation
3rd Department of Medicine, General University Hospital, Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
General University Hospital
City
Prague
ZIP/Postal Code
128 00
Country
Czech Republic
12. IPD Sharing Statement
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Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
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