NCT03510078

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Non-critically Ill Patients

Interventions

Type	Name	Description
DRUG	Insulin	Insulin for glycemic control according to the allocation

Timeline

• Start date: 2018-04-17
• Primary completion: 2025-05-01
• Completion: 2026-10-01
• First posted: 2018-04-27
• Last updated: 2024-04-11

Locations

2 sites across 1 country: Israel