Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients

This study has been completed.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00996099
First received: October 15, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 15, 2009
October 15, 2009
September 2008
August 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperglycemia
  • Cardiac Surgery
  • Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
    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
  • Other: Intensive insulin therapy using standard protocol
    Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.
  • Active Comparator: CGM-eMPC
    Intervention: Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment
  • Control
    Intervention: Other: Intensive insulin therapy using standard protocol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

  • insulin allergy
  • mental incapacity
  • language barrier
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00996099
CGM-eMPC
No
prof. M. Haluzik, MD, D.Sc., 3rd Department of Medicine, Charles University, Prague
Charles University, Czech Republic
Not Provided
Principal Investigator: Martin Haluzik, Prof, D.Sc. 3rd Department of Medicine, General University Hospital, Prague
Charles University, Czech Republic
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP