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

Not Applicable

Completed

• Conditions: Hyperglycemia; Cardiac Surgery
• Interventions: Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment; Other: Intensive insulin therapy using standard protocol

• Registration Number: NCT00996099
• Lead Sponsor: Charles University, Czech Republic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Last Update Submitted: 2009-10-15
• Study First Posted: 2009-10-16
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• elective cardiac surgery

Exclusion Criteria

• insulin allergy
• mental incapacity
• language barrier

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM-eMPC	Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment	-
Control	Intensive insulin therapy using standard protocol	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

General University Hospital; 🇨🇿 Prague, Czech Republic