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

NCT03510078 | Completed

• 1 other identifier: 0695-17-RMC
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 5

Brief 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

Keywords

Diabetes Mellitus; hyperglycemic control; hospitalization; internal medicine

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Each component of the primary outcomes

  30 days

• Repeat hospitalizations within 90 days

  90 days

• Severe infections within 90 days

  90 days

• Length of hospitalization

  90 days

Study Arms (2)

Intensive glycemic control

EXPERIMENTAL

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

Drug: Insulin

Conventional glycemic control

EXPERIMENTAL

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

Drug: Insulin

Interventions

Insulin DRUG

Insulin for glycemic control according to the allocation

Conventional glycemic control; Intensive glycemic control

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diabetic ketoacidosis or hyperosmolar non-ketotic state.
• 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.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (5)

Rabin Medical Center

Petah Tikva, Israel, Israel

Location

Soroka University Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Shamir Medical Center

Ẕerifin, Israel

Location

Unit of Geriatric Medicine University of Modena and Reggio Emilia, University Hospital of Baggiovara

Modena, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Internal Medicine Doctor, Principal Investigator

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: April 27, 2018
• Study Start: April 17, 2018
• Primary Completion: July 1, 2025
• Study Completion: December 10, 2025
• Last Updated: April 30, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4); IT (1)