Diabetes Mellitus, Non-critically Ill Patients
Conditions
Keywords
Diabetes Mellitus, hyperglycemic control, hospitalization, internal medicine
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.
Interventions
DRUGInsulin
Insulin for glycemic control according to the allocation
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of: 1. mortality in 30 days | 30 days | — |
| Severe hypoglycemia | 30 days | — |
| Severe infections | 30 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. |
| Cerebro-Vascular accidents | 30 days | — |
| Cardiac ischemic events | 30 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Each component of the primary outcomes | 30 days | — |
| Repeat hospitalizations within 90 days | 90 days | Repeated hospitalizations will be defined as the number of repeated hospitalizations in 90 days. |
| Severe infections within 90 days | 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. |
| Length of hospitalization | 90 days | Will be measured as the number of days from the admission to the discharge from hospital. |
Countries
Israel, Italy
Outcome results
None listed