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

Charles University, Czech Republic24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hyperglycemia Cardiac Surgery

Interventions

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

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

Intensive insulin therapy using standard protocolOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * elective cardiac surgery Exclusion Criteria: * insulin allergy * mental incapacity * language barrier

Locations (1)

General University Hospital

Prague, Czechia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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