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Study of Insulin Treatment for Blood Glucose Control in Adult Critically Ill Patients with Stress Hyperglycemia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on managing hyperglycemia (high blood sugar) in critically ill patients who are being treated in the intensive care unit (ICU). The condition being studied is known as stress hyperglycemia, which often occurs in severely ill patients even if they have not previously had diabetes. The treatment being tested involves the use of human insulin to strictly control blood sugar levels within normal fasting ranges.

The purpose of this research is to determine if keeping blood sugar levels tightly controlled within normal ranges using a specific dosing plan (called the Leuven algorithm) leads to better outcomes compared to allowing higher blood sugar levels in critically ill adult patients. During the study, patients will receive insulin through an intravenous line, with doses adjusted according to their blood sugar measurements.

The study will monitor how the treatment affects patients' recovery during their ICU stay. This includes tracking how long patients need intensive care support, checking for complications, and following their overall progress. The maximum daily dose of insulin that may be given is 1,200 international units, and patients may receive treatment for up to 12 months if needed.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial admission

    Upon admission to the intensive care unit (ICU), your blood glucose levels will be monitored.

    You will receive insulin through an intravenous line to control blood sugar levels within normal fasting ranges.

  2. Step 2

    Daily monitoring

    Your blood glucose levels will be checked regularly, particularly in the morning.

    The insulin dose will be adjusted according to a specific algorithm to maintain proper blood sugar control.

    Your vital organ functions will be continuously monitored throughout your ICU stay.

  3. Step 3

    Hospital stay monitoring

    Your overall health status will be monitored, including heart function, kidney function, and potential infections.

    Regular assessments will track your progress and any complications that may develop.

    The medical team will monitor your need for breathing support and other medical interventions.

  4. Step 4

    Follow-up period

    After 90 days, there will be an assessment of your recovery progress.

    At 2 years after joining the study, you will complete a health questionnaire about your general well-being.

    Additional health checks may continue for up to 5 years, focusing on long-term recovery and organ function.

Who can join the trial?

7 criteria

  • You must be at least 18 years old to participate in the study
  • You must be currently admitted to one of the participating intensive care units (specialized hospital departments that provide intensive monitoring and treatment for critically ill patients)
  • You may be either male or female to participate
  • You must have high blood sugar levels while being critically ill (a condition known as stress hyperglycemia)
  • You must be receiving care in the intensive care unit (ICU)
  • You must be willing to have your blood sugar levels monitored and managed according to the study protocol
  • You must not be receiving parenteral nutrition (nutrition given through a vein) during your first week in the ICU

Who cannot join the trial?

12 criteria

  • Age under 18 years or over 80 years
  • Pregnant women or nursing mothers
  • Patients with pre-existing diabetes (a condition where body cannot properly control blood sugar levels)
  • Patients receiving parenteral nutrition (nutrition delivered through veins) before ICU admission
  • Patients with known allergies to insulin or other study medications
  • Patients with severe liver disease or kidney failure requiring dialysis
  • Patients with terminal illness with life expectancy less than 7 days
  • Patients who cannot provide informed consent or have no legally authorized representative
  • Patients participating in other clinical trials
  • Patients with conditions that might interfere with blood glucose measurements
  • Patients with hypoglycemia (very low blood sugar) at admission
  • Patients with burns covering more than 20% of body surface
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Investigated drugs

  • Insulin

    This is a medication that helps control blood sugar levels in the body. In this trial, it is used to maintain tight blood glucose control within normal fasting ranges in critically ill patients in intensive care. The insulin is adjusted using a specific protocol (Leuven algorithm) to achieve target blood sugar levels.

  • Parenteral Nutrition

    This is a method of providing nutrition directly into the bloodstream through an intravenous (IV) line. In this trial, patients will not receive parenteral nutrition during their first week in intensive care, as researchers study how this approach combined with insulin therapy affects patient outcomes.

What is already known about the treatment

Insulin - A hormone medication administered through subcutaneous or intravenous injection, primarily used for controlling blood glucose levels in patients with hyperglycemia and diabetes. In critical care settings, it is particularly important for managing stress-induced hyperglycemia in severely ill patients. The medication works by facilitating glucose uptake into cells and reducing blood sugar levels by binding to insulin receptors on cell surfaces, promoting glucose transport and metabolism. This hormone belongs to the class of antidiabetic medications and plays a crucial role in intensive care protocols for maintaining optimal blood glucose levels within normal fasting ranges. Note: Since the trial data only implies the use of insulin for glucose control in critically ill patients, I've provided a description for this single medication, which is central to the study's objective.

Investigated diseases

Stress Hyperglycemia - A temporary rise in blood glucose levels that occurs during severe illness or critical medical conditions. This condition develops when the body releases stress hormones in response to severe physical stress, leading to increased glucose production by the liver and insulin resistance in tissues. Stress hyperglycemia typically appears in critically ill patients, even those without a previous history of diabetes. The condition causes elevated blood sugar levels above normal ranges, particularly during fasting periods. It is a distinct condition from regular diabetes, as it typically resolves once the underlying stress or illness improves.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510358-17-00Estimated enrolment9 230 patientsSponsorUZ Leuven

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).