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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
600
Insulin for glycemic control according to the allocation
Rambam Medical Center
Haifa, Israel
RECRUITINGRabin Medical Center
Petah Tikva, Israel
RECRUITINGComposite outcome of: 1. mortality in 30 days
Time frame: 30 days
Severe hypoglycemia
Time frame: 30 days
Severe infections
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.
Time frame: 30 days
Cerebro-Vascular accidents
Time frame: 30 days
Cardiac ischemic events
Time frame: 30 days
Each component of the primary outcomes
Time frame: 30 days
Repeat hospitalizations within 90 days
Repeated hospitalizations will be defined as the number of repeated hospitalizations in 90 days.
Time frame: 90 days
Severe infections within 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.
Time frame: 90 days
Length of hospitalization
Will be measured as the number of days from the admission to the discharge from hospital.
Time frame: 90 days
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