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.
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.
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.
- Conditions
- Glycemic Control, Insulin, Critical Illness
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Insulin regular |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted21 Dec 2023
- Study start1 Dec 2023
- Primary completion25 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ControlStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham Haggag, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia
- ClinicalTrials.gov ID
- NCT06178874
- Acronym / sponsor ID
- FMASU R322/2023
- Conditions
- Glycemic Control, Insulin, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 25 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group S | Active comparator | Drug: Insulin Glargine, Drug: Insulin regularThe 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 |
| Group L | Active comparator | Drug: Insulin Degludec, Drug: Insulin regularThe 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 |
| Group R | Active comparator | Drug: Insulin regularThe random blood sugar in the patients in group R will be managed using regular insulin based on a sliding scale |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with Blood glucose level >250 mg/dl for more than 24 h
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Glarginehyperglycemic control | Drug | group S |
| Insulin Degludechyperglycemic control | Drug | Group L |
| Insulin regularhyperglycemic control | Drug | Group L, Group R, group S |
Primary outcome
hyperglycemic control
Time frame: 10 days of ICU stay
the insulin dose needed for achievement of the glycemic goals by insulin degludec vs insulin Glargine in critically ill patient.
1 secondary outcome
length of ICU stay
Time frame: from admission till discharge from ICU through a period of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.