Clinical trial NCT06056167: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Critical Illness
Hyperglycemia
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
timeFrame: until stopping the intervention and up to 28 days
Secondary outcomes:
measure: The average or mean blood glucose in the whole cohort
timeFrame: until stopping the intervention and up to 28 days
measure: The proportions of patients achieving the target glycemic control
timeFrame: until stopping the intervention and up to 28 days
measure: The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
timeFrame: until stopping the intervention and up to 28 days
measure: The rate of developing hypoglycemia during therapy
timeFrame: until stopping the intervention and up to 28 days
measure: Glucose variability during therapy
timeFrame: until stopping the intervention and up to 28 days
measure: To determine the covariates associated with failure to achieve target glycemic control
timeFrame: During therapy and up to 28 days
measure: To determine the covariates associated with the development of hypoglycemia
timeFrame: During therapy and up to 28 days
measure: The rate of 28-day Mortality
timeFrame: Censored at day 28
measure: Intensive care unit (ICU) length of stay
timeFrame: Censored at day 28
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
Study officials:
References: