Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
Primary Purpose
Diabetes Mellitus, Non-critically Ill Patients
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, hyperglycemic control, hospitalization, internal medicine
Eligibility Criteria
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.
Sites / Locations
- Rambam Medical CenterRecruiting
- Rabin Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intensive glycemic control
Conventional glycemic control
Arm Description
With a target of blood glucose range of 130 mg/dL or less
With a target of blood glucose range of 130-180 mg/dL
Outcomes
Primary Outcome Measures
Composite outcome of: 1. mortality in 30 days
Severe hypoglycemia
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.
Cerebro-Vascular accidents
Cardiac ischemic events
Secondary Outcome Measures
Each component of the primary outcomes
Repeat hospitalizations within 90 days
Repeated hospitalizations will be defined as the number of repeated hospitalizations in 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.
Length of hospitalization
Will be measured as the number of days from the admission to the discharge from hospital.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03510078
Brief Title
Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
Official Title
Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Non-critically Ill Patients
Keywords
Diabetes Mellitus, hyperglycemic control, hospitalization, internal medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive glycemic control
Arm Type
Experimental
Arm Description
With a target of blood glucose range of 130 mg/dL or less
Arm Title
Conventional glycemic control
Arm Type
Experimental
Arm Description
With a target of blood glucose range of 130-180 mg/dL
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin for glycemic control according to the allocation
Primary Outcome Measure Information:
Title
Composite outcome of: 1. mortality in 30 days
Time Frame
30 days
Title
Severe hypoglycemia
Time Frame
30 days
Title
Severe infections
Description
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.
Time Frame
30 days
Title
Cerebro-Vascular accidents
Time Frame
30 days
Title
Cardiac ischemic events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Each component of the primary outcomes
Time Frame
30 days
Title
Repeat hospitalizations within 90 days
Description
Repeated hospitalizations will be defined as the number of repeated hospitalizations in 90 days.
Time Frame
90 days
Title
Severe infections within 90 days
Description
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.
Time Frame
90 days
Title
Length of hospitalization
Description
Will be measured as the number of days from the admission to the discharge from hospital.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alon Grossman, Prof
Phone
+972-504065545
Email
along@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Irit Ayalon Dangur, Dr
Phone
+972-525940042
Email
iritayalon1234@gmail.com
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mogher Khamaisi, Prof
Email
Khamaisi@gmail.com
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alon Grossman, Prof
Phone
+972504065545
Email
along@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Irit Ayalon Dangur, Dr
Phone
+972525940042
Email
iritayalon1234@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Intensive Versus Conventional Hyperglycemic Control in Hospitalized Non-critically Ill Patients
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