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OpenTrials
Completed

NCT Number: NCT03510078

Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients

Hyperglycemia is a common condition among hospitalized patients. The occurrence of severe hyperglycemia is associated with increased morbidity and mortality in several populations. Several trials assessed the benefits of aggressive versus conventional glucose control. These studies evaluated different patient populations, glucose targets and treatment protocols and as a result reported conflicting results. To date there are no clear guidelines regarding to the preferred glucose target range in hospitalized non-critically ill patients. The common practice is to maintain glucose level lower than 180 mg/dl however there are no evidence based regarding to the outcomes of hospitalized patients treated with intensive compared to conventional glycemic control. This prospective randomized controlled study will compare intensive vs. standard glycemic control in hospitalized non-critically ill patients.

Within 24 hours of hospitalization in the internal medical or geriatric departments, patients who are expected to require hospitalization for at least three consecutive days will be randomly assigned into one of the two study groups - intensive with a target blood glucose range of 130 mg per deciliter or less, or conventional glucose control, with a target of 130-180 mg per deciliter. The investigators defined the primary end point as a composite outcome of mortality in 30 days, severe hypoglycemia, severe infections within 30 days, CVA and cardiac ischemic events within 30 days.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center, Petah Tikva, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age older than 18 years old.
  • History of type 2 diabetes mellitus for at least three months or a blood glucose level of 200 mg per deciliter or higher in two different consecutive measurements.
  • A minimum of three days of hospitalization.

Exclusion criteria

  • Diabetic ketoacidosis or hyperosmolar non-ketotic state.
  • Patients expected to require intensive care unit admission or immediate surgical intervention.
  • History of current drug or alcohol abuse.
  • History of current mental illness.
  • Child-bearing potential or a positive urine pregnancy test.

Treatment and study plan

Insulin

Drug

Insulin for glycemic control according to the allocation

Primary outcomes

  1. Composite outcome of: 1. mortality in 30 days

    Time frame: 30 days

  2. Severe hypoglycemia

    Time frame: 30 days

  3. Severe infections

    Time frame: 30 days

    Severe infections will be defined as a hospitalization as a result of sepsis, pneumonia or soft tissue infection or other infection requiring intravenous antibiotic therapy that occurred during hospitalization.

  4. Cerebro-Vascular accidents

    Time frame: 30 days

  5. Cardiac ischemic events

    Time frame: 30 days

Secondary outcomes

  1. Each component of the primary outcomes

    Time frame: 30 days

  2. Repeat hospitalizations within 90 days

    Time frame: 90 days

    Repeated hospitalizations will be defined as the number of repeated hospitalizations in 90 days.

  3. Severe infections within 90 days

    Time frame: 90 days

    Severe infections will be defined as a hospitalization as a result of sepsis, pneumonia or soft tissue infection or other infection requiring intravenous antibiotic therapy that occurred during hospitalization.

  4. Length of hospitalization

    Time frame: 90 days

    Will be measured as the number of days from the admission to the discharge from hospital.

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Apr 27, 2018
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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