Degludec Insulin Use in Critically Ill Patients

NCT06056167 | Completed DMC

• 1 other identifier: KingFaisal
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (1)

Degludec

EXPERIMENTAL

Drug: Degludec insulin

Interventions

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.

Degludec

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years and above
• Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours
• Medical or surgical ICU patients

You may not qualify if:

• 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

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Critical Illness; Hyperglycemia

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Critical Care Medicine

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 28, 2023
• Study Start: May 17, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)