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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00302874
First received: March 14, 2006
Last updated: March 23, 2007
Last verified: October 2002
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00302874     History of Changes
Other Study ID Numbers: gil362-HMO-CTIL
Study First Received: March 14, 2006
Last Updated: March 23, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014