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

October 31, 2006
November 12, 2013
June 2006
September 2008   (final data collection date for primary outcome measure)
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
  • The primary outcome of the study is to determine
  • differences in glycemic control as measured by mean daily blood
  • glucose concentration between treatment groups.
Complete list of historical versions of study NCT00394524 on ClinicalTrials.gov Archive Site
  • 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
  • Secondary outcomes include differences between treatment groups
  • in any of the following measures: number of hypoglycemic events
  • (blood glucose < 60 mg/dl), length of ICU stay and length of hospital stay,
  • and number of hyperglycemic episodes (blood glucose > 200 mg/dl).
Not Provided
Not Provided
 
Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Comparative Trial Between a Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes or With New Hyperglycemia
  • Device: Glucommander
    Computer-guided IV insulin infusion (Glucommander)
  • Drug: Standard insulin infusion drip
    Insulin infusion with glulisine per columnar algorithm
    Other Name: Apidra
  • Device: Glucommander
    Glucommander computer assisted program to run glulisine insulin drip
    Other Name: Apidra
  • Drug: Glulisine drip using columnar algorithm
    Apidra insulin per insulin infusion algorithm
    Other Name: Apidra
  • Experimental: 1
    Glucommander computer assisted insulin infusion
    Interventions:
    • Device: Glucommander
    • Device: Glucommander
  • Active Comparator: 2
    Glulisine insulin infusion
    Interventions:
    • Drug: Standard insulin infusion drip
    • Drug: Glulisine drip using columnar algorithm
Newton CA, Smiley D, Bode BW, Kitabchi AE, Davidson PC, Jacobs S, Steed RD, Stentz F, Peng L, Mulligan P, Freire AX, Temponi A, Umpierrez GE. A comparison study of continuous insulin infusion protocols in the medical intensive care unit: computer-guided vs. standard column-based algorithms. J Hosp Med. 2010 Oct;5(8):432-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00394524
IRB00021877, IRB 830-2005
Yes
Guillermo Umpierrez, Emory University
Emory University
  • Sanofi
  • Grady Memorial Hospital, Atlanta
  • Piedmont Hospital, Atlanta
  • University of Tennessee
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
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP