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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302874
• Other study ID #: gil362-HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: March 14, 2006
• Last updated: March 23, 2007
• Start date: February 2003
• Est. completion date: October 2004

Study information

• Verified date: October 2002
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients admitted to the internal medicine ward with hyperglycemia

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

Behavioral:
• Implementation of a protocol for treatment of hyperglycemia

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood glucose during hospitalization
Secondary	Hypoglycemic events
Secondary	Length of in-hospital stay
Secondary	Infections
Secondary	Complications (myocardial infarction, stroke)
Secondary	Disposition at discharge (home, nursing home)