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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Non-critically Ill Patients

Intervention / Treatment
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* Drug: Insulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, hyperglycemic control, hospitalization, internal medicine