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Sponsors and Collaborators: |
Emory University Sanofi-Aventis Grady Memorial Hospital, Atlanta Piedmont Hospital, Atlanta University of Tennessee University of Washington |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00394524 |
High blood sugars increase the risk of complications and death in diabetic patients admitted to the hospital. Recent studies hve shown that strict blood sugar control with intravenous (IV) insulin lowers the risk of such complications and death in the ICU. Several insulin infusion protocols have been reported in the literature, but it is not known which is the best. These protocols use tables and formulas that may be confusing and difficult to follow. To facilitate patient care, insulin protocols could be placed on a computer and used at the patient's bedside to direct the nursing staff administering the IV insulin. The Glucommander is one of such computer-derived insulin infusion protocol which has been used successfully in patients with diabetes since 1984. We hypothesize that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol will facilitate smoother glycemic control with a lower rate of low blood sugars than treatment following a standard insulin infusion algorithm in the medical intensive care unit. We will aim to determine differences in glycemic control between treatment with a computer-guided intravenous infusion protocol (Glucommander) and a standard insulin infusion algorithm in critically ill patients in the ICU.
Condition | Intervention |
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Diabetes or With New Hyperglycemia |
Device: Computer-guided IV insulin infusion (Glucommander) Drug: IV insulin glulisine |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparative Trial Between a Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU |
Estimated Enrollment: | 180 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Research Summary:
Increasing evidence from observational studies in hospitalized patients with and without diabetes indicates that hyperglycemia is a predictor of poor outcome. Blood glucose control with intensive insulin therapy in patients with acute critical illness reduces the risk of multiorgan failure and systemic infection, and decreases short- and long-term mortality.
The use of intravenous insulin infusion is the preferred route of insulin administration for the management of diabetic subjects with diabetic ketoacidosis and nonketotic hyperosmolar state, intraoperative and postoperative care, the postoperative period following heart surgery and organ transplantation, acute myocardial infarction, stroke, and critical care illness. Some of these settings may be characterized by, or associated with, severe or rapidly changing insulin requirements, generalized patient edema, impaired perfusion of subcutaneous sites, requirement for pressor support, and/or use of total parenteral nutrition. In these settings, the intravenous route for insulin administration has been considered superior than the subcutaneous injection of split-mixed regimen of intermediate and regular insulin with respect to rapidity of effect in controlling hyperglycemia, overall ability to achieve glycemic control, and most importantly, preventing hypoglycemic episodes. Recently, several insulin infusion protocols have been reported in the literature; these algorithms and formulas, however, may be confusing and difficult to follow and may increase the risk of dosing errors. To facilitate patients care, insulin algorithms could be placed on a computer and used at the patient bedside to direct the nursing staff administering the intravenous insulin. The Glucommander is one of such computer-derived insulin infusion protocol which has been used successfully in over 5,802 patients with diabetes between 1984 and 1998. We hypothesize that management of inpatient hyperglycemia with a computer-guided intravenous infusion protocol will facilitate smoother glycemic control with a lower rate of hypoglycemic events than treatment following a standard insulin infusion algorithm in critically ill patients in medical the ICU. We will aim to determine differences in glycemic control between treatment with a computer-guided intravenous infusion protocol (Glucommander) and a standard insulin infusion algorithm in critically ill patients in the ICU.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A known history of diabetes mellitus or with new hyperglycemia untreated or treated by diet, insulin therapy or with any combination of antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
Exclusion Criteria:
Contact: Guillermo E Umpierrez, MD | 4047781665 | geumpie@emory.edu |
Contact: Dawn D Smiley, MD | 4047781664 | dsmiley@emory.edu |
United States, Georgia | |
Grady Memorial Hospital | Recruiting |
Atlanta, Georgia, United States, 30303 | |
Principal Investigator: Guillermo E Umpierrez, MD | |
Sub-Investigator: Dawn D Smiley, MD | |
Piedmont Hopsital | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Sub-Investigator: Bruce ` Bode, MD | |
United States, Tennessee | |
University of Tennessee Health Science Center, Memphis | Not yet recruiting |
Memphis, Tennessee, United States, 38103 | |
Sub-Investigator: Abbas Kitabchi, PhD,MD | |
United States, Washington | |
University of Washington, Seattle | Not yet recruiting |
Seattle, Washington, United States, 98195 | |
Sub-Investigator: Irl B Hirsch, MD |
Principal Investigator: | Guillermo E Umpierrez, MD | Emory University SOM/Grady Health System |
Study Director: | Bruce Bode, MD | Piedmont Hospital |
Study Director: | Abbas E Kitabchi, PhD,MD | University of Tennessee Health Science Center, Memphis |
Study Director: | Irl B Hirsch, MD | University of Washington |
Responsible Party: | Emory University School of Medicine ( Guillermo Umpierrez, MD ) |
Study ID Numbers: | 830-2005, IRB 830-2005 |
Study First Received: | October 31, 2006 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00394524 History of Changes |
Health Authority: | United States: Institutional Review Board |
ICU hyperglycemia glucommander |
Hypoglycemic Agents Insulin glulisine Metabolic Diseases Hyperglycemia |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Insulin glulisine Metabolic Diseases Hyperglycemia |
Physiological Effects of Drugs Glucose Metabolism Disorders Pharmacologic Actions Insulin |