Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart

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. Identifier: NCT00206206
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : February 7, 2006
Information provided by:
Atlantic Health System

Brief Summary:

In response to the evidence supporting “tight” glucose control (70 – 110) in the critical care setting, the MMH ICU developed a protocol utilizing regular intravenous insulin. This protocol was initiated in 2002. Monitoring of the data collected revealed effective glycemic control when this protocol was used. However, limited utilization has led to overall ineffective glycemic control in this ICU. The poor utilization is largely due to a general reluctance of physicians to start their patients on an intravenous insulin infusion. As contributing to this poor compliance is the “open” nature of the ICU. The MMH ICU is an “open” ICU, meaning that many physicians across multiple subspecialties admit to this unit. Approaches to controlling hyperglycemia vary greatly, depending largely upon the treating physician. In an attempt to improve overall glycemic control in this “open” ICU, the Subcutaneaous Insulin Aspart Hyperglycemia Protocol (SIAP) was developed which incorporates a subcutaneous insulin aspart regimen that triggers the use of a regular insulin infusion protocol when the SIAP is not adequately controlling the patient’s blood glucose.

This study aims to evaluate 1) the effect the SIAP on overall glycemic control in the ICU, 2) the effectiveness that the SIAP has on controlling blood glucose as compared with past practices using regular insulin, and 3) the effect the SIAP has on patient complications and outcomes in the MMH ICU.

Condition or disease Intervention/treatment
Hyperglycemia Procedure: Hyperglycemia Protocol Procedure

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 235 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of an ICU Hyperglycemia Protocol Using Insulin Aspart.
Study Start Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia
U.S. FDA Resources

Primary Outcome Measures :
  1. 1) to evaluate the effect a subcutaneous insulin aspart hyperglycemia protocol on overall glycemic control in an ICU.
  2. 2) to evaluate the effect an insulin aspart hyperglycemia protocol has on controlling blood glucoses as compared with past practices of a regular insulin regimen.
  3. 3) to assess the effect a hyperglycemis i9nsulin aspart protocol has on patient outcomes in this ICU

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Valid physician order of the protocol. -

Exclusion Criteria: No valid phycician order for the protocol

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 identifier (NCT number): NCT00206206

United States, New Jersey
Morristown Memorial hospital
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
Principal Investigator: Rebecca Griffith Moristown Memorial Hospital Identifier: NCT00206206     History of Changes
Other Study ID Numbers: R05-04-002
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 7, 2006
Last Verified: September 2005

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs