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

October 15, 2009 updated by: Charles University, Czech Republic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 128 00
        • General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective cardiac surgery

Exclusion Criteria:

  • insulin allergy
  • mental incapacity
  • language barrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
first 24 hours after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
first 24 hours after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Martin Haluzik, Prof, D.Sc., 3rd Department of Medicine, General University Hospital, Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

October 16, 2009

Last Update Submitted That Met QC Criteria

October 15, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGM-eMPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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