Degludec Insulin Use in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol)

Conditions
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Diabetes Mellitus, Critical Illness, Hyperglycemia

Intervention / Treatment
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* Drug: Degludec insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years and above Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours Medical or surgical ICU patients Exclusion Criteria: Patients who were already started on insulin infusion based on physician discretion. Postoperative patients with expected ICU stay less than 48 hours Diabetic ketoacidosis or hyperosmolar hyperglycemic state. Patients with Do-Not-Attempt-Resuscitation (DNAR) status or imminent plan to palliation due to terminal disease. Refusal of the treating physician to enroll the patient into the study. Patients with diabetes mellitus Type 1. Patients who already eating prior to study enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degludec<br> | Drug: Degludec insulin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |