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

Clalit Health Services

Status: Enrolling

Conditions: Diabetes Mellitus; Non-critically Ill Patients

Treatments: Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03510078

0695-17-RMC

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Intensive glycemic control

Experimental group

Description:

With a target of blood glucose range of 130 mg/dL or less

Treatment:

Drug: Insulin

Conventional glycemic control

Experimental group

Description:

With a target of blood glucose range of 130-180 mg/dL

Treatment:

Drug: Insulin