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

Cardiac Surgery Clinical Trial

Official title:

Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996099
• Other study ID #: CGM-eMPC
• Status: Completed
• Phase: N/A
• First received: October 15, 2009
• Last updated: October 15, 2009
• Start date: September 2008

Study information

• Verified date: October 2009
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective cardiac surgery

Exclusion Criteria:

• insulin allergy

• mental incapacity

• language barrier

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Hyperglycemia

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	General University Hospital	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)		first 24 hours after cardiac surgery	Yes
Secondary	Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range		first 24 hours after cardiac surgery	No