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CompletedNCT06178874Updated Aug 5, 2024

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

An interventional study of Insulin Glargine and Insulin Degludec in Glycemic Control, Insulin and Critical Illness, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-05.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Glycemic Control
  • Insulin
  • Critical Illness
03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's enrollment of 90 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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 · Drug: Insulin regular

  • 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 Degludec · Drug: Insulin regular

  • 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

Interventions

  • DrugInsulin Glargine

    hyperglycemic control

  • DrugInsulin Degludec

    hyperglycemic control

  • DrugInsulin regular

    hyperglycemic control

06

What researchers measure

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.

    Time frame: 10 days of ICU stay

Secondary outcomes

  1. length of ICU stay

    the effect of using long acting insulin on the length of icu stay.

    Time frame: from admission till discharge from ICU through a period of 2 weeks

07

Study locations

1 site
  • Ain shams university
    Cairo, 12245, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06178874
Lead sponsor
Ain Shams University
Responsible party
Adham Haggag (Associate proffesor, Ain Shams University) — Principal investigator
First posted
Dec 21, 2023
Start date
Dec 1, 2023
Primary completion
May 25, 2024
Completion
Jun 1, 2024
Last update
Aug 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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