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Glycemic ControlNCT06178874

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

A study testing Insulin Glargine, Insulin Degludec and Insulin regular in people with Glycemic Control and Insulin, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Glycemic Control, Insulin, Critical Illness
What is being tested?
Insulin Glargine, Insulin Degludec and Insulin regular
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Dec 2023to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain shams university

    Cairo, 12245

Other trials in Egypt

About this study

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.
Being tested
Insulin Glargine, Insulin Degludec, Insulin regular
Medical subject headings
Insulin Resistance, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin GlargineDrug

    hyperglycemic control

  • Insulin DegludecDrug

    hyperglycemic control

  • Insulin regularDrug

    hyperglycemic control

Study groups in NCT06178874
Study groupRoleWhat they receive
group SActive comparatorThe 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
Receives: Drug: Insulin Glargine; Drug: Insulin regular
Group LActive comparatorThe 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
Receives: Drug: Insulin Degludec; Drug: Insulin regular
Group RActive comparatorThe random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale
Receives: Drug: Insulin regular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. hyperglycemic control

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

    Measured: 10 days of ICU stay

Secondary outcomes (1)
  1. length of ICU stay

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2023
  2. Study start1 Dec 2023
  3. Primary completion25 May 2024
  4. Study completion1 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06178874
Sponsor's protocol ID
FMASU R322/2023
Status last verified
Aug 2024
First submitted
18 Nov 2023
Last updated
5 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Glargine, Insulin Degludec and Insulin regular in people with Glycemic Control and Insulin, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hyperglycemic control (time frame: 10 days of ICU stay). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.

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