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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Non-critically Ill Patients
• Intervention / Treatment: Drug: Insulin

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alon Grossman, Prof; Phone Number: +972-504065545; Email: along@clalit.org.il
• Study Contact Backup: Name: Irit Ayalon Dangur, Dr; Phone Number: +972-525940042; Email: iritayalon1234@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Rambam Medical Center
    • Contact: Mogher Khamaisi, Prof; Email: Khamaisi@gmail.com
  • Petah Tikva, Israel
    • Recruiting
    • Rabin Medical Center
    • Contact: Alon Grossman, Prof; Phone Number: +972504065545; Email: along@clalit.org.il
    • Contact: Irit Ayalon Dangur, Dr; Phone Number: +972525940042; Email: iritayalon1234@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive glycemic control; With a target of blood glucose range of 130 mg/dL or less	Drug: Insulin; Insulin for glycemic control according to the allocation
Experimental: Conventional glycemic control; With a target of blood glucose range of 130-180 mg/dL	Drug: Insulin; Insulin for glycemic control according to the allocation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of: 1. mortality in 30 days		30 days
Severe hypoglycemia		30 days
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
Cerebro-Vascular accidents		30 days
Cardiac ischemic events		30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Each component of the primary outcomes		30 days
Repeat hospitalizations within 90 days	Repeated hospitalizations will be defined as the number of repeated hospitalizations in 90 days.	90 days
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
Length of hospitalization	Will be measured as the number of days from the admission to the discharge from hospital.	90 days

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2018
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; hospitalization; internal medicine; hyperglycemic control
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 0695-17-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No