Clinical trial NCT00394524: Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Official title: Trial Between a Computer-Guided Intravenous Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes or With New Hyperglycemia
Keywords: ICU
hyperglycemia
glucommander
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Sanofi
name: Grady Health System
name: Piedmont Healthcare
name: University of Tennessee
First posted: 2006-11-01
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a multicenter, prospective, open-label randomized study to compare the safety and efficacy of continuous insulin infusion (CII) via a computer-guided(Glucommander) and a standard paper form protocol among the patients hospitalized in a medical intensive care unit (ICU).

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Detailed description: 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. The study hypothesizes 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. The study also aims 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 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.

Primary outcomes:
measure: Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion
timeFrame: First 10 days of ICU stay
Secondary outcomes:
measure: Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm
timeFrame: First 10 days of ICU stay
measure: Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group
timeFrame: During ICU hospitalization, up to 30 days
measure: Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion
timeFrame: During the complete length of hospitalization, up to 60 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hopsital
state: Georgia
city: Memphis
country: United States
facility: University of Tennessee Health Science Center, Memphis
state: Tennessee
city: Seattle
country: United States
facility: University of Washington, Seattle
state: Washington
Study officials:
affiliation: Emory University SOM/Grady Health System
name: Guillermo E Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Hospital
name: Bruce Bode, MD
role: STUDY_DIRECTOR
affiliation: University of Tennessee Health Science Center, Memphis
name: Abbas E Kitabchi, PhD,MD
role: STUDY_DIRECTOR
affiliation: University of Washington
name: Irl B Hirsch, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1002/jhm.816.