Clinical trial NCT03510078: Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
Official title: Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Non-critically Ill Patients
Keywords: Diabetes Mellitus
hyperglycemic control
hospitalization
internal medicine
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 at any stage of hospitalization.
* 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.

Primary outcomes:
measure: Composite outcome of: 1. mortality in 30 days
timeFrame: 30 days
measure: Severe hypoglycemia
timeFrame: 30 days
measure: Severe infections
timeFrame: 30 days
measure: Cerebro-Vascular accidents
timeFrame: 30 days
measure: Cardiac ischemic events
timeFrame: 30 days
Secondary outcomes:
measure: Each component of the primary outcomes
timeFrame: 30 days
measure: Repeat hospitalizations within 90 days
timeFrame: 90 days
measure: Severe infections within 90 days
timeFrame: 90 days
measure: Length of hospitalization
timeFrame: 90 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References: