search
Back to results

Degludec Insulin Use in Critically Ill Patients

Primary Purpose

Diabetes Mellitus, Critical Illness, Hyperglycemia

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Degludec insulin
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Faisal Specialist Hospital & Research CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Degludec

Arm Description

Outcomes

Primary Outcome Measures

The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).

Secondary Outcome Measures

The average or mean blood glucose in the whole cohort
The proportions of patients achieving the target glycemic control
The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
The rate of developing hypoglycemia during therapy
Glucose variability during therapy
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).
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).
The rate of 28-day Mortality
Death rate at day 28
Intensive care unit (ICU) length of stay

Full Information

First Posted
September 13, 2023
Last Updated
September 24, 2023
Sponsor
King Faisal Specialist Hospital & Research Center
search

1. Study Identification

Unique Protocol Identification Number
NCT06056167
Brief Title
Degludec Insulin Use in Critically Ill Patients
Official Title
The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Faisal Specialist Hospital & Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Critical Illness, Hyperglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
155 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Degludec
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Degludec insulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
Time Frame
until stopping the intervention and up to 28 days
Secondary Outcome Measure Information:
Title
The average or mean blood glucose in the whole cohort
Time Frame
until stopping the intervention and up to 28 days
Title
The proportions of patients achieving the target glycemic control
Time Frame
until stopping the intervention and up to 28 days
Title
The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
Time Frame
until stopping the intervention and up to 28 days
Title
The rate of developing hypoglycemia during therapy
Time Frame
until stopping the intervention and up to 28 days
Title
Glucose variability during therapy
Time Frame
until stopping the intervention and up to 28 days
Title
To determine the covariates associated with failure to achieve target glycemic control
Description
To assess the factors that are associated with failure to achieve the target glycemic control (using regression analysis).
Time Frame
During therapy and up to 28 days
Title
To determine the covariates associated with the development of hypoglycemia
Description
To assess the factors that are associated with the development of hypoglycemia (using regression analysis).
Time Frame
During therapy and up to 28 days
Title
The rate of 28-day Mortality
Description
Death rate at day 28
Time Frame
Censored at day 28
Title
Intensive care unit (ICU) length of stay
Time Frame
Censored at day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Al Duhailib
Phone
+966112162919
Ext
42817
Email
zalduhailib65@kfshrc.edu.sa
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Centre
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zainab Al Duhailib, MBBS, EDIC, MSc
First Name & Middle Initial & Last Name & Degree
Hakeam Hakeam, BCPS, MS Pharm

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Degludec Insulin Use in Critically Ill Patients

We'll reach out to this number within 24 hrs