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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM-eMPC | Active Comparator |
| |
| Control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment | 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 |
| Measure | Description | 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) | first 24 hours after cardiac surgery |
| Measure | Description | 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 | first 24 hours after cardiac surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Haluzik, Prof, D.Sc. | 3rd Department of Medicine, General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital | Prague | 128 00 | Czechia |
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|
| Intensive insulin therapy using standard protocol | Other | Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague. |
|
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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