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)

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Diabetes Mellitus; Critical Illness
• Intervention / Treatment: Drug: Degludec insulin

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zainab Al Duhailib; Phone Number: 42817 +966112162919; Email: zalduhailib65@kfshrc.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • King Faisal Specialist Hospital & Research Centre
    • Contact: Zainab Al Duhailib, MBBS, EDIC, MSc
    • Contact: Hakeam Hakeam, BCPS, MS Pharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Degludec

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 24, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Hyperglycemia; Critical Illness; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: KingFaisal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No