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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03510078
• Other study ID #: 0695-17-RMC
• Status: Recruiting
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Rabin Medical Center
• Contact: Alon Grossman, Prof
• Phone: +972-504065545
• Email: along[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Non-critically Ill Patients

Intervention

Drug:
• Insulin
Insulin for glycemic control according to the allocation

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcome of: 1. mortality in 30 days		30 days
Primary	Severe hypoglycemia		30 days
Primary	Severe infections	Severe infections will be defined as a hospitalization as a result of sepsis, pneumonia or soft tissue infection or other infection requiring intravenous antibiotic therapy that occurred during hospitalization.	30 days
Primary	Cerebro-Vascular accidents		30 days
Primary	Cardiac ischemic events		30 days
Secondary	Each component of the primary outcomes		30 days
Secondary	Repeat hospitalizations within 90 days	Repeated hospitalizations will be defined as the number of repeated hospitalizations in 90 days.	90 days
Secondary	Severe infections within 90 days	Severe infections will be defined as a hospitalization as a result of sepsis, pneumonia or soft tissue infection or other infection requiring intravenous antibiotic therapy that occurred during hospitalization.	90 days
Secondary	Length of hospitalization	Will be measured as the number of days from the admission to the discharge from hospital.	90 days