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

March 23, 2007 updated by: Hadassah Medical Organization

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients admitted to the internal medicine ward with hyperglycemia

Exclusion Criteria:

  • Patients admitted due to hypoglycemia, hyperosmolar state, and ketoacidosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean blood glucose during hospitalization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Gil Leibowitz, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

March 14, 2006

First Submitted That Met QC Criteria

March 14, 2006

First Posted (Estimate)

March 15, 2006

Study Record Updates

Last Update Posted (Estimate)

March 26, 2007

Last Update Submitted That Met QC Criteria

March 23, 2007

Last Verified

October 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gil362-HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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