Trial Between a Computer-Guided Insulin Infusion Protocol Versus a Standard Insulin Infusion Algorithm in Medical ICU
Condition: Diabetes or With New Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

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).

      .
    

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.
    

Intervention name(s): Glucommander; Standard insulin infusion algorithm
Intervention type(s): Device; Other
Intervention description(s): Glucommander is a Computer-guided Intravenous (IV) insulin infusion protocol used for glycemic control in inpatients. This algorithm directs the administration of IV insulin in response to Blood Glucose (BG) measurement at the patient's bedside. In this study, the Glucommander program was loaded into a PalmOne (Zire 31, Tungsten E2 by Palm Inc.) handheld personal digital assistant (PDA) device. During the infusion, the nurse entered BG levels into the system and the computer recommended the insulin infusion rate and a variable time to check the next glucose testing. An alarm prompted the scheduled glucose check. The insulin infusion followed the formula: Insulin/Hour = Multiplier × (BG- 60).; Standard insulin infusion Algorithm is a standard paper form insulin infusion algorithm. The algorithm is divided into four columns based on empirically determined insulin sensitivity. The first column was for the most insulin-sensitive patients, and the fourth column was for the most insulin resistant patients. The majority of patients are started in the algorithm 1 column. Insulin resistant patients, such as those receiving glucocorticoids or receiving >80 units of insulin per day as outpatients, started in the algorithm 2 column. The insulin infusion rate was determined by the patient's BG level and was measured hourly until the patient was stable and within the target range. If BG targets were not achieved and the BG had not decreased by at least 60 mg/dL in the preceding hour, the patient was moved to the next column.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICU; hyperglycemia; glucommander