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

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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Conditions

• Diabetes or With New Hyperglycemia

Interventions

DEVICE

Glucommander

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).

OTHER

Standard insulin infusion algorithm

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.

Sponsors & Collaborators

• Sanofi

  collaborator INDUSTRY

• Grady Health System

  collaborator OTHER

• Piedmont Healthcare

  collaborator OTHER

• University of Tennessee

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Guillermo E Umpierrez, MD · Emory University SOM/Grady Health System

• Bruce Bode, MD · Piedmont Hospital

• Abbas E Kitabchi, PhD,MD · University of Tennessee Health Science Center, Memphis

• Irl B Hirsch, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2008-09-30

Completion

2008-09-30

FDA Device

Yes

Countries

• United States

Study Locations