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Background:
Dysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes.
The American association of diabetes recommends initiation of insulin infusion for critically ill patients aiming to target glucose levels 140-180 mg/dl. However, several limitations prevent the use of insulin infusion in critically ill such as the requirements of frequent blood glucose measurement and nursing staff workload, which in turn led to the use of the subcutaneous rapid acting and basal insulin during critical illness. The evidence on the use of subcutaneous insulin therapy compared to insulin infusion is mainly derived from observational studies that showed conflicting results.
Multiple RCTs demonstrated the comparable efficacy of degludec versus glargine in blood glycemic control and better safety profile in terms of nocturnal hypoglycemia and severe hypoglycemia in the outpatient/inpatient diabetic population. Studies addressing the role, safety, and efficacy of degludec in critically ill patients are lacking.
Study aim:
To assess the effectiveness of using insulin degludec as basal insulin in conjunction with subcutaneous regular insulin sliding scale (ISS) in the glycemic control in critically ill patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degludec | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degludec insulin | Drug | Enrolled patients will be initiated on regular insulin sliding scale (ISS) every 6 hours, administrated subcutaneously at 0600, 1200, 1800 and 2400 in patients who are nil per os and on intravenous fluid or parenteral nutrition or continuous tube feeding, according to King Faisal Specialist Hospital & Research Center (KFSH&RC) protocol. Patients with two capillary point of care glucose levels of > 10 mmol/L (180 mg/dl) will be initiated on insulin degludec at dose of 0.2 units/ kg. Dose adjustments will be carried out on daily basis based on blood glucose levels following a written protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L). | until stopping the intervention and up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| The average or mean blood glucose in the whole cohort | until stopping the intervention and up to 28 days | |
| The proportions of patients achieving the target glycemic control | until stopping the intervention and up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital & Research Centre | Riyadh | Saudi Arabia |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016638 | Critical Illness |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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|
| The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L). | until stopping the intervention and up to 28 days |
| The rate of developing hypoglycemia during therapy | until stopping the intervention and up to 28 days |
| Glucose variability during therapy | until stopping the intervention and up to 28 days |
| To determine the covariates associated with failure to achieve target glycemic control | To assess the factors that are associated with failure to achieve the target glycemic control (using regression analysis). | During therapy and up to 28 days |
| To determine the covariates associated with the development of hypoglycemia | To assess the factors that are associated with the development of hypoglycemia (using regression analysis). | During therapy and up to 28 days |
| The rate of 28-day Mortality | Death rate at day 28 | Censored at day 28 |
| Intensive care unit (ICU) length of stay | Censored at day 28 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |