Glycemic ControlNCT06810596
Comparing Efficacy Between Two Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU
A study testing Insulin infusion protocol in people with Glycemic Control and Critical Care, run by Suez Canal University at 1 site in Egypt.
Trial summary
The goal of clinical trial is to improve the adequacy of blood sugar control in diabetic critically ill adult patients who admitted to the intensive care unit(ICU) in Suez Canal University (SCU) hospitals by comparing glycemic control efficacy between the NHS in the UK and suggested SCU Protocols of Intravenous… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glycemic Control, Critical Care, Diabetes Mellitus
- What is being tested?
- Insulin infusion protocol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who admitted to the hospital with a potentially life-threatening condition (Critically ill patients) with HbA1C >6.0.
Who cannot join
- DKA patients.
- Pregnant or breast-feeding patients.
- Hyperosmolar Non-Ketotic Coma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Suez Canal University Hospitals
Ismailia, 41522
Aiman Al-Touny, MD, +201008185785, aimantouny@med.suez.edu.eg
Mohamed Abdel Gaffar, MD, +201003179831, mohamed_abdelghafa@med.suez.edu.eg
About this study
Official title: Comparing Glycemic Control Efficacy Between The National Health System and Suez Canal University Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU
The goal of clinical trial is to improve the adequacy of blood sugar control in diabetic critically ill adult patients who admitted to the intensive care unit(ICU) in Suez Canal University (SCU) hospitals by comparing glycemic control efficacy between the NHS in the UK and suggested SCU Protocols of Intravenous Insulin Infusion.
The main questions it aims to answer are:
Read more
Is SCU protocol of Intravenous Insulin Infusion more effective than NHS protocol in achieving blood glucose control targets in critically ill adult patients?
Researchers will compare glycemic control efficacy between the NHS in UK and suggested SCU Protocols of Intravenous Insulin Infusion for critically ill Adults in ICU to determine the best protocol in achieving good blood glucose control in diabetic critically ill adult patients in SCU Hospitals.
Read the detailed description
Patients will be randomized into 2 equal groups; Group 1 (SCU group) will follow the SCU protocol of Intravenous Insulin Infusion in diabetic critically ill patients Group 2 (NHS group) will follow the NHS protocol of Intravenous Insulin Infusion in critically ill diabetic patients in UK.
Randomization will be done using a web randomizer and the randomization sequence will be concealed in numbered opaque envelopes that will be opened after patient enrollment to define his or her group assignment.
In both groups, control of blood glucose will be achieved with the use of an intravenous infusion of regular insulin in saline. Insulin will be administered, reduced, or discontinued according to the protocol in the different groups.
Two nurses must check and prepare the variable rate intravenous insulin infusion (VRIII) and every time the rate of infusion is changed. Insulin must be drawn up using an insulin syringe to draw up 50 units of prescribed Human Act rapid insulin and add to 49.5 ml of 0.9% sodium chloride in a 50 ml syringe. Mix thoroughly; this will provide a concentration of 1 unit / 1 ml.
VRIII will be stopped when RBS <80mg/dl and repeat the measure of RBS after one hour.
Laboratory investigations of routine blood tests will be requested on admission and at least once daily and in case of abnormal potassium level will be measured every 6 hours.
Regarding Serum K:
If K is 3.5-5.5 mmol/l- This is the target: total K+ given should be 1.5 mmol/kg/day If K is >5.5 mmol/l - no K is to be added to the infusion fluid this day. If K is <3.5mmol/l - K+ given should be 2.0 mmol/kg/day. K+ replacement will be initiated if there are ECG changes of hypokalemia. If K is <2.5mmol/l - bolus K+ replacement 1 mEq/kg will be infused over 3 hours and serum K+ level rechecked 2 hours after the end of infusion. If recheck serum K+ level < 2.5mmol/l bolus K+ replacement will be infused again over 3 hours. If recheck serum K+ level >3mmol/l K+ maintenance will be infused 2.0 mmol/kg/day.
Data collection :
At baseline, demographic and clinical characteristics, including the Acute Physiology and Chronic Health Evaluation II (APACHE II) score and the diagnostic criteria for severe sepsis will be collected.
Medical history :
- Medical chronic disorders and the used treatment for them, such as hypertension, diabetes, liver or renal diseases .
- Any known allergies to the drugs to be used . laboratory investigations:
- Daily Routine Blood test (CBC, ABG, Electrolytes). b) Prothrombin time (PT), partial tissue thromboplastin time (PTT) and International randomized ratio (INR), Liver function tests and Kidney function tests every 3 days.
- HBA1c on admission.
Follow up:
- Nutrition: NPO, Enteral or parental.
- Mechanical Ventilation days.
- Complications: DKA, Hyperglycemia or Hypoglycemia.
- ICU Discharge Date.
- Hospital Discharge Date.
- Outcome: Discharge or Death.
- Conditions
- Glycemic Control, Critical Care, Diabetes Mellitus
- Being tested
- Insulin infusion protocol
- Keywords
- Glycemic Control, Insulin Infusion Protocol, Critically ill
- Medical subject headings
- Diabetes Mellitus, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin infusion protocolProcedure or surgery
comparing the efficacy of 2 different protocols for glycemic control in diabetic critically ill patients.
| Study group | Role | What they receive |
|---|---|---|
| Suez Canal University variable rate Protocol | Active comparator | Variable rate intravenous insulin infusion will be administrated according to random blood glucose and adjusted body weight (ABW).
ABW = IBW + 0.33x (actual body weight - IBW)
If the RBS level is 80 - 200 mg/dl, the Insulin infusion rate = RBS/ 100, and for insulin-sensitive patients = RBS/150 If the RBS level is 201 - 250 mg/dl, the Insulin infusion rate = RBS/ 80, and for insulin-sensitive patients = RBS/80 If the RBS level is 251 - 300 mg/dl, the Insulin infusion rate = RBS/ 60, and for insulin-sensitive patients = RBS/60 If the RBS level > 300 mg/dl, the Insulin infusion rate = 0.1 ml /kg/h adjusted body weight (Max: 10 unit/h) Receives: Procedure: Insulin infusion protocol |
| NHS group | Active comparator | If the RBS level is 72- 144 mg/dl, the Insulin infusion rate = 1 ml/hr, for insulin-sensitive patients 0.5 ml/hr, and for Insulin resistance patients = 2 ml/hr If the RBS level is 145- 216mg/dl, the Insulin infusion rate = 2 ml/hr, for insulin-sensitive patients 1 ml/hr, and for Insulin resistance patients = 4 ml/hr If the RBS level is 217- 288 mg/dl, the Insulin infusion rate = 4 ml/hr, for insulin-sensitive patients 2 ml/hr, and for Insulin resistance patients = 6 ml/hr If the RBS level is 289- 360 mg/dl, the Insulin infusion rate = 5 ml/hr, for insulin-sensitive patients 3 ml/hr, and for Insulin resistance patients = 7 ml/hr If the RBS level is 361- 432 mg/dl, the Insulin infusion rate = 6 ml/hr, for insulin-sensitive patients 4 ml/hr, and for Insulin resistance patients = 8 ml/hr If the RBS level is >433 mg/dl, the Insulin infusion rate = 8 ml/hr, for insulin-sensitive patients 6 ml/hr, and for Insulin resistance patients = 10 ml/hr Receives: Procedure: Insulin infusion protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time needed to achieve the target blood glucose (80-180)
Assess the time needed to achieve the target blood glucose (80-180) in both protocols of intravenous insulin infusion in management of hyperglycemia in diabetic critically ill patients.
Measured: up to 28 days
Secondary outcomes (5)
Assess the effect of different factors in the management of hyperglycemia in critical ill patients.
Assess the effect of different factors in the management of hyperglycemia in critical ill patients (age, gender comorbidities, etc.)
Measured: up to 28 days
Assess the incidence of hypoglycemia among the patients of both groups.
Assess the incidence of hypoglycemia among the patients of both groups.
Measured: up to 28 days
Compare Ventilator Free Days between two groups.
Compare Ventilator Free Days between two groups
Measured: up to 28 days
Compare the ICU stay and hospital stay between the two groups.
Compare the ICU stay and hospital stay between the two groups.
Measured: up to 28 days
Compare ICU and 30 days Mortality rates between the two groups.
Compare ICU and 30 days Mortality rates between the two groups.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start15 Dec 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
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 Suez Canal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiman Al-Touny, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810596
- Sponsor's protocol ID
- 4960#
- Status last verified
- Nov 2024
- First submitted
- 24 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Glycemic Control Efficacy Between The National Health System and Suez Canal University Protocols of Intravenous Insulin Infusion for Diabetic Adults in ICU
- ClinicalTrials.gov ID
- NCT06810596
- Acronym / sponsor ID
- 4960#
- Conditions
- Glycemic Control, Critical Care, Diabetes Mellitus
- Keywords
- Glycemic Control, Insulin Infusion Protocol, Critically ill
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 5 Feb 2025 (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 goal of clinical trial is to improve the adequacy of blood sugar control in diabetic critically ill adult patients who admitted to the intensive care unit(ICU) in Suez Canal University (SCU) hospitals by comparing glycemic control efficacy between the NHS in the UK and suggested SCU Protocols of Intravenous Insulin Infusion.
The main questions it aims to answer are:
Is SCU protocol of Intravenous Insulin Infusion more effective than NHS protocol in achieving blood glucose control targets in critically ill adult patients?
Researchers will compare glycemic control efficacy between the NHS in UK and suggested SCU Protocols of Intravenous Insulin Infusion for critically ill Adults in ICU to determine the best protocol in achieving good blood glucose control in diabetic critically ill adult patients in SCU Hospitals.
Detailed description
Patients will be randomized into 2 equal groups; Group 1 (SCU group) will follow the SCU protocol of Intravenous Insulin Infusion in diabetic critically ill patients Group 2 (NHS group) will follow the NHS protocol of Intravenous Insulin Infusion in critically ill diabetic patients in UK.
Randomization will be done using a web randomizer and the randomization sequence will be concealed in numbered opaque envelopes that will be opened after patient enrollment to define his or her group assignment.
In both groups, control of blood glucose will be achieved with the use of an intravenous infusion of regular insulin in saline. Insulin will be administered, reduced, or discontinued according to the protocol in the different groups.
Two nurses must check and prepare the variable rate intravenous insulin infusion (VRIII) and every time the rate of infusion is changed. Insulin must be drawn up using an insulin syringe to draw up 50 units of prescribed Human Act rapid insulin and add to 49.5 ml of 0.9% sodium chloride in a 50 ml syringe. Mix thoroughly; this will provide a concentration of 1 unit / 1 ml.
VRIII will be stopped when RBS <80mg/dl and repeat the measure of RBS after one hour.
Laboratory investigations of routine blood tests will be requested on admission and at least once daily and in case of abnormal potassium level will be measured every 6 hours.
Regarding Serum K:
If K is 3.5-5.5 mmol/l- This is the target: total K+ given should be 1.5 mmol/kg/day If K is >5.5 mmol/l - no K is to be added to the infusion fluid this day. If K is <3.5mmol/l - K+ given should be 2.0 mmol/kg/day. K+ replacement will be initiated if there are ECG changes of hypokalemia. If K is <2.5mmol/l - bolus K+ replacement 1 mEq/kg will be infused over 3 hours and serum K+ level rechecked 2 hours after the end of infusion. If recheck serum K+ level < 2.5mmol/l bolus K+ replacement will be infused again over 3 hours. If recheck serum K+ level >3mmol/l K+ maintenance will be infused 2.0 mmol/kg/day.
Data collection :
At baseline, demographic and clinical characteristics, including the Acute Physiology and Chronic Health Evaluation II (APACHE II) score and the diagnostic criteria for severe sepsis will be collected.
Medical history :
- Medical chronic disorders and the used treatment for them, such as hypertension, diabetes, liver or renal diseases .
- Any known allergies to the drugs to be used . laboratory investigations:
- Daily Routine Blood test (CBC, ABG, Electrolytes). b) Prothrombin time (PT), partial tissue thromboplastin time (PTT) and International randomized ratio (INR), Liver function tests and Kidney function tests every 3 days.
- HBA1c on admission.
Follow up:
- Nutrition: NPO, Enteral or parental.
- Mechanical Ventilation days.
- Complications: DKA, Hyperglycemia or Hypoglycemia.
- ICU Discharge Date.
- Hospital Discharge Date.
- Outcome: Discharge or Death.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suez Canal University variable rate Protocol | Active comparator | Procedure: Insulin infusion protocolVariable rate intravenous insulin infusion will be administrated according to random blood glucose and adjusted body weight (ABW). ABW = IBW + 0.33x (actual body weight - IBW) If the RBS level is 80 - 200 mg/dl, the Insulin infusion rate = RBS/ 100, and for insulin-sensitive patients = RBS/150 If the RBS level is 201 - 250 mg/dl, the Insulin infusion rate = RBS/ 80, and for insulin-sensitive patients = RBS/80 If the RBS level is 251 - 300 mg/dl, the Insulin infusion rate = RBS/ 60, and for insulin-sensitive patients = RBS/60 If the RBS level > 300 mg/dl, the Insulin infusion rate = 0.1 ml /kg/h adjusted body weight (Max: 10 unit/h) |
| NHS group | Active comparator | Procedure: Insulin infusion protocolIf the RBS level is 72- 144 mg/dl, the Insulin infusion rate = 1 ml/hr, for insulin-sensitive patients 0.5 ml/hr, and for Insulin resistance patients = 2 ml/hr If the RBS level is 145- 216mg/dl, the Insulin infusion rate = 2 ml/hr, for insulin-sensitive patients 1 ml/hr, and for Insulin resistance patients = 4 ml/hr If the RBS level is 217- 288 mg/dl, the Insulin infusion rate = 4 ml/hr, for insulin-sensitive patients 2 ml/hr, and for Insulin resistance patients = 6 ml/hr If the RBS level is 289- 360 mg/dl, the Insulin infusion rate = 5 ml/hr, for insulin-sensitive patients 3 ml/hr, and for Insulin resistance patients = 7 ml/hr If the RBS level is 361- 432 mg/dl, the Insulin infusion rate = 6 ml/hr, for insulin-sensitive patients 4 ml/hr, and for Insulin resistance patients = 8 ml/hr If the RBS level is >433 mg/dl, the Insulin infusion rate = 8 ml/hr, for insulin-sensitive patients 6 ml/hr, and for Insulin resistance patients = 10 ml/hr |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who admitted to the hospital with a potentially life-threatening condition (Critically ill patients) with HbA1C >6.0.
Key exclusion criteria (3 listed)
- DKA patients.
- Pregnant or breast-feeding patients.
- Hyperosmolar Non-Ketotic Coma.
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 infusion protocolcomparing the efficacy of 2 different protocols for glycemic control in diabetic critically ill patients. | Procedure or surgery | NHS group, Suez Canal University variable rate Protocol |
Primary outcome
Time needed to achieve the target blood glucose (80-180)
Time frame: up to 28 days
Assess the time needed to achieve the target blood glucose (80-180) in both protocols of intravenous insulin infusion in management of hyperglycemia in diabetic critically ill patients.
5 secondary outcomes
Assess the effect of different factors in the management of hyperglycemia in critical ill patients.
Time frame: up to 28 days
Assess the incidence of hypoglycemia among the patients of both groups.
Time frame: up to 28 days
Compare Ventilator Free Days between two groups.
Time frame: up to 28 days
Compare the ICU stay and hospital stay between the two groups.
Time frame: up to 28 days
Compare ICU and 30 days Mortality rates between the two groups.
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
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 infusion protocol in people with Glycemic Control and Critical Care, run by Suez Canal 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 3 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: looking for participants now, as of the sponsor's last update on 5 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aiman A. Al-Touny, MD (+201008185785, Aimantouny@med.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time needed to achieve the target blood glucose (80-180) (time frame: up to 28 days). 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 Feb 2025.