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In-Hospital Hyperglycemia: Effects of Treatment on Glycemic Control and Clinical Outcome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302874
First Posted: March 15, 2006
Last Update Posted: July 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose

To improve glycemic control of inpatients admitted to the internal medicine wards, the researchers generated a protocol based on intensive insulin treatment for use in all inpatients with hyperglycemia.

The researchers hypothesize that intensive insulin treatment will improve the glycemic control and the outcome of hospitalized patients.

Study Information:

  • All patients with a history of diabetes admitted to the internal medicine ward were enrolled in the study.
  • At baseline, demographic and clinical information were obtained, including information necessary to determine the severity of the illness. Venous capillary blood glucose levels were checked 4 times a day by glucometer.
  • During the pre-intervention period, patients were treated according to the common practice in the hospital without any intervention. The study team collected the baseline data on the glycemic control and treatment of patients admitted with hyperglycemia.
  • During the intervention period, the study team visited the ward daily and guided the medical staff as to the use of the treatment protocol.
  • During the post-intervention period, the study team collected the data without active intervention in the implementation of the protocol.
  • Data was collected on the mode of treatment and glycemic control of all hyperglycemic patients throughout the study. The incidence of hypoglycemia, complications (myocardial infarction, stroke, infections), mortality, transfer to intensive care unit (ICU), length of hospitalization, and disposition at discharge were noted.

Condition Intervention
Diabetes Hyperglycemia Behavioral: Implementation of a protocol for treatment of hyperglycemia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: In-Hospital Hyperglycemia: Effects of Treatment on Glycemic Control and Clinical Outcome

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Mean blood glucose during hospitalization

Secondary Outcome Measures:
  • Hypoglycemic events
  • Length of in-hospital stay
  • Infections
  • Complications (myocardial infarction, stroke)
  • Disposition at discharge (home, nursing home)

Estimated Enrollment: 400
Study Start Date: February 2003
Estimated Study Completion Date: October 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to the internal medicine ward with hyperglycemia

Exclusion Criteria:

  • Patients admitted due to hypoglycemia, hyperosmolar state, and ketoacidosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302874


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Gil Leibowitz, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00302874     History of Changes
Other Study ID Numbers: gil362-HMO-CTIL
First Submitted: March 14, 2006
First Posted: March 15, 2006
Last Update Posted: July 25, 2007
Last Verified: October 2002

Keywords provided by Hadassah Medical Organization:
diabetes
hyperglycemia
hospital
medicine ward

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases