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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00996099
Enrollment
24
Registered
2009-10-16
Start date
2008-09-30
Completion date
Unknown
Last updated
2009-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Hyperglycemia

Keywords

continuous glucose monitoring, intensive insulin therapy, critically ill, cardiac surgery, hyperglycemia of critically ill

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.

Interventions

DEVICEContinuous 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

OTHERIntensive 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.

Sponsors

Charles University, Czech Republic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* elective cardiac surgery

Exclusion criteria

* insulin allergy * mental incapacity * language barrier

Design outcomes

Primary

MeasureTime 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)first 24 hours after cardiac surgery

Secondary

MeasureTime frame
Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target rangefirst 24 hours after cardiac surgery

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026