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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Rambam Medical Center
RECRUITING
Haifa
Rabin Medical Center
RECRUITING
Petah Tikva
Contact Information
Primary
Alon Grossman, Prof
along@clalit.org.il
+972-504065545
Backup
Irit Ayalon Dangur, Dr
iritayalon1234@gmail.com
+972-525940042
Time Frame
Start Date: 2018-04-17
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 600
Treatments
Experimental: Intensive glycemic control
With a target of blood glucose range of 130 mg/dL or less
Experimental: Conventional glycemic control
With a target of blood glucose range of 130-180 mg/dL
Related Therapeutic Areas
Sponsors
Leads: Rabin Medical Center

This content was sourced from clinicaltrials.gov