Degludec Insulin Use in Critically Ill Patients

NCT ID: NCT06056167

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2024-05-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Degludec

Group Type: EXPERIMENTAL

Degludec insulin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Zainab Alduhailib

Consultant Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Faisal Specialist Hospital & Research Centre

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

KingFaisal

Identifier Type: -

Identifier Source: org_study_id