NCT06056167

Degludec Insulin Use in Critically Ill Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus
• Critical Illness
• Hyperglycemia

Interventions

Type	Name	Description
DRUG	Degludec insulin	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.

Timeline

• Start date: 2023-05-17
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2023-09-28
• Last updated: 2024-06-13

Locations

1 site across 1 country: Saudi Arabia