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

NCT ID: NCT00996099

Last Updated: 2009-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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Conditions

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Hyperglycemia Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM-eMPC

Group Type ACTIVE_COMPARATOR

Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment

Intervention Type DEVICE

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

Control

Group Type OTHER

Intensive insulin therapy using standard protocol

Intervention Type OTHER

Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* elective cardiac surgery

Exclusion Criteria

* insulin allergy
* mental incapacity
* language barrier
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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3rd Department of Medicine, Charles University, Prague

Principal Investigators

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Martin Haluzik, Prof, D.Sc.

Role: PRINCIPAL_INVESTIGATOR

3rd Department of Medicine, General University Hospital, Prague

Locations

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General University Hospital

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CGM-eMPC

Identifier Type: -

Identifier Source: org_study_id

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