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The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.
Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system. |
|
| 2 | Active Comparator | intensive insulin therapy guided by an algorithm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time glucose monitoring system (Guardian, Medtronic) | Device | Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period | 72h |
| Measure | Description | Time Frame |
|---|---|---|
| Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias | 72h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Holzinger, MD | Medical University of Vienna, Department of Medicine III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| intensive insulin therapy | Drug | intensive insulin therapy according to an algorithm |
|
|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |