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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2026-10-01

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.

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Detailed Description

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Conditions

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Diabetes Mellitus Non-critically Ill Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intensive glycemic control

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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Insulin for glycemic control according to the allocation

Conventional glycemic control

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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

Insulin for glycemic control according to the allocation

Interventions

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Insulin

Insulin for glycemic control according to the allocation

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No