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

  • STATUS
    Recruiting
  • days left to enroll
    61
  • participants needed
    600
  • sponsor
    Rabin Medical Center
Updated on 24 January 2021
Investigator
Alon Grossman, Prof
Primary Contact
Rabin Medical Center (6.6 mi away) Contact
+1 other location
insulin
diabetes mellitus
type 2 diabetes mellitus
hyperglycemia
hypoglycemia

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.

Details
Condition Diabetes Mellitus, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Non-critically Ill Patients, Non-critically Ill Patients, diabetes mellitus (dm), Non-critically Ill Patients
Treatment insulin
Clinical Study IdentifierNCT03510078
SponsorRabin Medical Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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