Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU

This study has been completed.
Sponsor:
Collaborators:
Sanofi
Grady Memorial Hospital, Atlanta
Piedmont Hospital, Atlanta
University of Tennessee
Information provided by (Responsible Party):
Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier:
NCT00394524
First received: October 31, 2006
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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
Diabetes or With New Hyperglycemia
Device: Glucommander
Drug: Standard insulin infusion drip
Drug: Glulisine drip using columnar algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Trial Between a Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Mean Glucose [ Time Frame: daily mean blood glucose during the insulin infusion ] [ Designated as safety issue: No ]
    glucose in mg/dl assessed with inpatient calibrated glucometers


Secondary Outcome Measures:
  • Differences Between Treatment Groups in Hypoglycemia [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • Length of Intensive Care Unit (ICU) Stay [ Time Frame: mean number of days in the ICU during the hospital stay ] [ Designated as safety issue: No ]
    average number of days in the intensive care unit

  • Mean Hospital Length of Stay in Days [ Time Frame: during the entire hospitalization ] [ Designated as safety issue: No ]
    mean number of days in the hospital


Enrollment: 157
Study Start Date: June 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Glucommander computer assisted insulin infusion
Device: Glucommander
Computer-guided IV insulin infusion (Glucommander)
Device: Glucommander
Glucommander computer assisted program to run glulisine insulin drip
Other Name: Apidra
Active Comparator: 2
Glulisine insulin infusion
Drug: Standard insulin infusion drip
Insulin infusion with glulisine per columnar algorithm
Other Name: Apidra
Drug: Glulisine drip using columnar algorithm
Apidra insulin per insulin infusion algorithm
Other Name: Apidra

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females between the ages of 18 and 70 years admitted to a medical ICU
  2. 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).

    • Blood glucose greater than 120 mg/dl on ≥ 2 occasions for known, treated diabetics or greater than 140 mg/dl on ≥ 2 occasions for those with new hyperglycemia.
  3. Subjects must have an admission blood glucose < 400 mg/dL, without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 milliequivalents/L or positive serum or urinary ketones).

Exclusion Criteria:

  1. Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state [38].
  2. Patients with known HIV, severely impaired renal function (serum creatinine ≥3.0 mg/dl).
  3. Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  4. Female subjects who are pregnant or breast feeding at time of enrollment into the study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00394524

Locations
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Piedmont Hopsital
Atlanta, Georgia, United States, 30309
United States, Tennessee
University of Tennessee Health Science Center, Memphis
Memphis, Tennessee, United States, 38103
United States, Washington
University of Washington, Seattle
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Emory University
Sanofi
Grady Memorial Hospital, Atlanta
Piedmont Hospital, Atlanta
University of Tennessee
Investigators
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
  More Information

Publications:
Responsible Party: Guillermo Umpierrez, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00394524     History of Changes
Other Study ID Numbers: IRB00021877, IRB 830-2005
Study First Received: October 31, 2006
Results First Received: December 8, 2008
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
ICU
hyperglycemia
glucommander

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014