Diabetes MellitusNCT06056167
Degludec Insulin Use in Critically Ill Patients
A study testing Degludec insulin in people with Diabetes Mellitus and Critical Illness, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
Trial summary
Background: Dysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Critical Illness, Hyperglycemia
- What is being tested?
- Degludec insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 17 May 2023to 30 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and above
- Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours
- Medical or surgical ICU patients
Who cannot join
- Patients who were already started on insulin infusion based on physician discretion.
- Postoperative patients with expected ICU stay less than 48 hours
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- Patients with Do-Not-Attempt-Resuscitation (DNAR) status or imminent plan to palliation due to terminal disease.
- Refusal of the treating physician to enroll the patient into the study.
- Patients with diabetes mellitus Type 1.
- Patients who already eating prior to study enrollment
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Centre
Riyadh
About this study
Official title: The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol)
Background:
Dysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes.
Read more
The American association of diabetes recommends initiation of insulin infusion for critically ill patients aiming to target glucose levels 140-180 mg/dl. However, several limitations prevent the use of insulin infusion in critically ill such as the requirements of frequent blood glucose measurement and nursing staff workload, which in turn led to the use of the subcutaneous rapid acting and basal insulin during critical illness. The evidence on the use of subcutaneous insulin therapy compared to insulin infusion is mainly derived from observational studies that showed conflicting results.
Multiple RCTs demonstrated the comparable efficacy of degludec versus glargine in blood glycemic control and better safety profile in terms of nocturnal hypoglycemia and severe hypoglycemia in the outpatient/inpatient diabetic population. Studies addressing the role, safety, and efficacy of degludec in critically ill patients are lacking.
Study aim:
To assess the effectiveness of using insulin degludec as basal insulin in conjunction with subcutaneous regular insulin sliding scale (ISS) in the glycemic control in critically ill patients.
- Conditions
- Diabetes Mellitus, Critical Illness, Hyperglycemia
- Being tested
- Degludec insulin
- Medical subject headings
- Diabetes Mellitus, Critical Illness, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Degludec insulinDrug
Enrolled patients will be initiated on regular insulin sliding scale (ISS) every 6 hours, administrated subcutaneously at 0600, 1200, 1800 and 2400 in patients who are nil per os and on intravenous fluid or parenteral nutrition or continuous tube feeding, according to King Faisal Specialist Hospital \& Research Center (KFSH\&RC) protocol.
Patients with two capillary point of care glucose levels of > 10 mmol/L (180 mg/dl) will be initiated on insulin degludec at dose of 0.2 units/ kg.
Dose adjustments will be carried out on daily basis based on blood glucose levels following a written protocol.
| Study group | Role | What they receive |
|---|---|---|
| Degludec | Experimental | Not described Receives: Drug: Degludec insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
Measured: until stopping the intervention and up to 28 days
Secondary outcomes (9)
The average or mean blood glucose in the whole cohort
Measured: until stopping the intervention and up to 28 days
The proportions of patients achieving the target glycemic control
Measured: until stopping the intervention and up to 28 days
The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
Measured: until stopping the intervention and up to 28 days
The rate of developing hypoglycemia during therapy
Measured: until stopping the intervention and up to 28 days
Glucose variability during therapy
Measured: until stopping the intervention and up to 28 days
To determine the covariates associated with failure to achieve target glycemic control
To assess the factors that are associated with failure to achieve the target glycemic control (using regression analysis).
Measured: During therapy and up to 28 days
To determine the covariates associated with the development of hypoglycemia
To assess the factors that are associated with the development of hypoglycemia (using regression analysis).
Measured: During therapy and up to 28 days
The rate of 28-day Mortality
Death rate at day 28
Measured: Censored at day 28
Intensive care unit (ICU) length of stay
Measured: Censored at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start17 May 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Alduhailib, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056167
- Sponsor's protocol ID
- KingFaisal
- Status last verified
- Jun 2024
- First submitted
- 13 Sep 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Degludec Insulin Use for Glycemic Control in Critically Ill Patients: A Prospective Interventional Study (Protocol)
- ClinicalTrials.gov ID
- NCT06056167
- Acronym / sponsor ID
- KingFaisal
- Conditions
- Diabetes Mellitus, Critical Illness, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 28 Sep 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.
Background:
Dysglycemia in critically ill patients is common, where 40% to 54% of patients were found to be hyperglycemic on intensive care unit admission. Several randomized controlled trials (RCT) were conducted to address the importance of glycemic control during critical illness on patient's outcomes.
The American association of diabetes recommends initiation of insulin infusion for critically ill patients aiming to target glucose levels 140-180 mg/dl. However, several limitations prevent the use of insulin infusion in critically ill such as the requirements of frequent blood glucose measurement and nursing staff workload, which in turn led to the use of the subcutaneous rapid acting and basal insulin during critical illness. The evidence on the use of subcutaneous insulin therapy compared to insulin infusion is mainly derived from observational studies that showed conflicting results.
Multiple RCTs demonstrated the comparable efficacy of degludec versus glargine in blood glycemic control and better safety profile in terms of nocturnal hypoglycemia and severe hypoglycemia in the outpatient/inpatient diabetic population. Studies addressing the role, safety, and efficacy of degludec in critically ill patients are lacking.
Study aim:
To assess the effectiveness of using insulin degludec as basal insulin in conjunction with subcutaneous regular insulin sliding scale (ISS) in the glycemic control in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Degludec | Experimental | Drug: Degludec insulin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years and above
- Newly admitted critically ill patients with diabetes and expected ICU stay ≥ 48 hours
- Medical or surgical ICU patients
Key exclusion criteria (7 listed)
- Patients who were already started on insulin infusion based on physician discretion.
- Postoperative patients with expected ICU stay less than 48 hours
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state.
- Patients with Do-Not-Attempt-Resuscitation (DNAR) status or imminent plan to palliation due to terminal disease.
- Refusal of the treating physician to enroll the patient into the study.
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 |
|---|---|---|
| Degludec insulinEnrolled patients will be initiated on regular insulin sliding scale (ISS) every 6 hours, administrated subcutaneously at 0600, 1200, 1800 and 2400 in patients who are nil per os and on intravenous fluid or parenteral nutrition or continuous tube feeding, according to King Faisal Specialist Hospital \& Research Center (KFSH\&RC) protocol. Patients with two capillary point of care glucose levels of > 10 mmol/L (180 mg/dl) will be initiated on insulin degludec at dose of 0.2 units/ kg. Dose adjustments will be carried out on daily basis based on blood glucose levels following a written protocol. | Drug | Degludec |
Primary outcome
The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
Time frame: until stopping the intervention and up to 28 days
9 secondary outcomes
The average or mean blood glucose in the whole cohort
Time frame: until stopping the intervention and up to 28 days
The proportions of patients achieving the target glycemic control
Time frame: until stopping the intervention and up to 28 days
The time-spent at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L).
Time frame: until stopping the intervention and up to 28 days
The rate of developing hypoglycemia during therapy
Time frame: until stopping the intervention and up to 28 days
Glucose variability during therapy
Time frame: until stopping the intervention and up to 28 days
To determine the covariates associated with failure to achieve target glycemic control
Time frame: During therapy and up to 28 days
To determine the covariates associated with the development of hypoglycemia
Time frame: During therapy and up to 28 days
The rate of 28-day Mortality
Time frame: Censored at day 28
Intensive care unit (ICU) length of stay
Time frame: Censored at day 28
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 13 Jun 2024.
- Individual participant dataSharing planned: Yes
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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 Degludec insulin in people with Diabetes Mellitus and Critical Illness, run by King Faisal Specialist Hospital & Research Center at 1 site in Saudi Arabia.
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 3 inclusion and 7 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 13 Jun 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 Saudi Arabia. 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?
The percentage of blood glucose readings at the target glycemic control 140- 180 mg/dL (7.8 -10 mmol/L). (time frame: until stopping the intervention and 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 13 Jun 2024.