Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

NCT06178874 | Completed

• 1 other identifier: FMASU R322/2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The role of ultralong insulin in the control of the blood glucose level in diabetic patients is well known, the current study will discuss the role of ultralong insulin in controlling of hyperglycaemia in critical illness defined as failure or impending failure of an organ

Conditions

Glycemic Control; Insulin; Critical Illness

Outcome Measures

Primary Outcomes (1)

• hyperglycemic control

  the insulin dose needed for achievement of the glycemic goals by insulin degludec vs insulin Glargine in critically ill patient.

  10 days of ICU stay

Secondary Outcomes (1)

• length of ICU stay

  from admission till discharge from ICU through a period of 2 weeks

Study Arms (3)

group S

ACTIVE COMPARATOR

The random blood sugar in the patients in group S will be managed using regular insulin based on a sliding scale together with an Insulin Glargine, 0.2 units/kg , SC, initially to be titrated as per the clinical situation to be given at 9 PM

Drug: Insulin Glargine; Drug: Insulin regular

Group L

ACTIVE COMPARATOR

The random blood sugar in the patients in group L will be managed using regular insulin based on a sliding scale together with an Insulin Degludec 0.2 units/kg, SC, initially to be titrated as per the clinical situation to be given at 9 PM

Drug: Insulin Degludec; Drug: Insulin regular

Group R

ACTIVE COMPARATOR

The random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale

Drug: Insulin regular

Interventions

Insulin Glargine DRUG

hyperglycemic control

group S

Insulin Degludec DRUG

hyperglycemic control

Group L

Insulin regular DRUG

hyperglycemic control

Group L; Group R; group S

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Blood glucose level \>250 mg/dl for more than 24 h

You may not qualify if:

• Age less than 18 or greater than 60 years
• Diabetic Ketoacidosis
• Patients with recurrent episodes of hypoglycaemia-\* Stress hyperglycemia
• Patients refusing to participate in the study.
• Patients with renal insufficiency
• Patients on corticosteroids

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 12245, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance; Critical Illness

Interventions

Insulin Glargine; insulin degludec; Insulin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Proinsulin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate proffesor

Study Record Dates

• First Submitted: November 18, 2023
• First Posted: December 21, 2023
• Study Start: December 1, 2023
• Primary Completion: May 25, 2024
• Study Completion: June 1, 2024
• Last Updated: August 5, 2024

Record last verified: 2024-08

Locations

EG (1)