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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Insulin; Glycemic Control
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Insulin regular; Drug: Insulin Degludec

Detailed Description

A standard monitor will be attached to the patients including 5 leads ECG, pulse oximeter, NIBP and IV line will be secured. The hemodynamic parameters will be recorded every 15 minutes.

The random blood sugar in the patients in group S will be managed using regular insulin based on a sliding scale as in Table 1 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.

The random blood sugar in the patients in group L will be managed using regular insulin based on a sliding scale as in table 1 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.

The random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale THE total dose of insulin will be monitored, episodes of hypoglycaemia ' decrease of blood sugar less than 60gm/dl, the length of the hospital stay, the serum potassium level , the incidence of infection as evidenced by increase WBC or clinical evidence of infection, incidence of diabetic ketoacidosis and the incidence of acute kidney risk as evidenced by decrease of urine output < 0.5 ml/kg/hr for more than 6 hr and/or increase of the serum creatinine 1.5-2 times the baseline of Acute kidney injuries as evidenced by decrease of urine output < 0.5 ml/kg/hr for more than 12 hr and/or increase of the serum creatinine 2-3 times the baseline.

The CBC, Kidney function test, liver enzymes, serum creatinine, s.Na+, s.K+ , s.albumin, RBS will be collected on admission and every three days if there is no indication for close monitoring. Glycated haemoglobin will be collected once.

The blood sugar will be checked hourly using finger prick test and the glucose variabilities will be monitored.

Action for Hypoglycaemia: [18]

Mild (Adults who are conscious, orientated and able to swallow):

Check ABCDE, stop IV insulin Give 15-20g of quick acting carbohydrate, such as 5-7 sugar canned tablets or 150-200ml pure fruit juice. Test blood glucose level after 10-15 minutes and if still less than 70 mg/dl repeat treatment as above up to 3 times. If still hypoglycaemic, IV dextrose will be given

Moderate (Person conscious and able to swallow, but confused, disorientated or aggressive):

Check ABCDE, stop IV insulin. If capable and cooperative, treat as for mild hypoglycaemia. If not capable and cooperative but can swallow give 2 tubes of 40% glucose gel (squeezed into mouth between teeth and gums). Test blood glucose level after 10-15 minutes and if still less than 70mg/dl repeat as above up to 3 times. If still hypoglycaemic, consider IV dextrose or IM glucagon as per "severe" pathway Severe (Person unconscious/fitting or very aggressive or nil by mouth (NBM)) Check ABCDE, stop IV insulin. Give 100ml 20% dextrose or 200ml 10% dextrose over 15 minutes. Recheck glucose after 10 minutes and if still less than 70mg/dl, repeat treatment as above.

For all degrees of hypoglycaemia:

• once glucose > 70 mg/dl, and the patient is able to swallow, 20 gm of long-acting carbohydrates (two biscuits, slice of bread, 200-300ml milk) will be given, and if the patient is not able to swallow or NBM, 10% glucose infusion at 100ml/hr will be given until no longer NBM.
• once glucose > 70 mg/dl, intravenous regular insulin will be resumed at a rate 0.5U/hour for all groups and for group L and S, there will be reduction 20-30% in the next subcutaneous long-acting insulin.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group S; 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; hyperglycemic control; Drug: Insulin regular; hyperglycemic control
Active Comparator: Group L; 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 regular; hyperglycemic control; Drug: Insulin Degludec; hyperglycemic control
Active Comparator: Group R; The random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale	Drug: Insulin regular; hyperglycemic control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of ICU stay	the effect of using long acting insulin on the length of icu stay.	from admission till discharge from ICU through a period of 2 weeks

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 18, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 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; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: FMASU R322/2023

Drug and device information, study documents

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