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

NCT00394524 | Completed Results DMC FDA Device

• 2 other identifiers: IRB00021877IRB 830-2005
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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). .

Conditions

Diabetes or With New Hyperglycemia

Keywords

ICU; hyperglycemia; glucommander

Outcome Measures

Primary Outcomes (1)

• Mean Blood Glucose (BG) in mg/dl Among Glucommander Group Compared to Standard Insulin Infusion

  Daily mean blood glucose concentrations during insulin infusion with the Glucommander and a standard paper form insulin infusion algorithm are measured every day up until 10 days and a mean values of these levels are calculated. The Mean blood glucose concentrations are measured once the target blood glucose levels are achieved after admission

  First 10 days of ICU stay

Secondary Outcomes (3)

• Number of Patients With Severe Hypoglycemia Episodes Among the Glucommander Group Compared to Standard Algorithm

  First 10 days of ICU stay

• Mean Length of Intensive Care Unit (ICU) in Days Stay Among Glucommander Group Compared to Standard Insulin Infusion Group

  During ICU hospitalization, up to 30 days

• Mean Hospital Length of Stay in Days Among the Glucommander Group Compared to Standard Insulin Infusion

  During the complete length of hospitalization, up to 60 days

Study Arms (2)

Computer assisted IV insulin infusion

EXPERIMENTAL

Subjects in this group will receive continuous intravenous (IV) Insulin Infusion using glucommander computer guided system. All patients in the study will receive Glulisine(Apidra R ) a rapid acting insulin approved by Food and Drug Administration (FDA)

Device: Glucommander

Standard insulin infusion algorithm

ACTIVE COMPARATOR

Subjects in this group will receive Insulin using Standard insulin infusion algorithm. All patients in the study will receive Glulisine(Apidra R ) a rapid acting insulin approved by Food and Drug Administration (FDA)

Other: Standard insulin infusion algorithm

Interventions

Glucommander DEVICE

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).

Computer assisted IV insulin infusion

Standard insulin infusion algorithm OTHER

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.

Standard insulin infusion algorithm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects with acute hyperglycemic crises such as diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state \[38\].
• Patients with known HIV, severely impaired renal function (serum creatinine ≥3.0 mg/dl).
• Patients with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
• Female subjects who are pregnant or breast feeding at time of enrollment into the study.

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator
• Grady Health System: collaborator
• Piedmont Healthcare: collaborator
• University of Tennessee: collaborator

Study Sites (4)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Piedmont Hopsital

Atlanta, Georgia, 30309, United States

Location

University of Tennessee Health Science Center, Memphis

Memphis, Tennessee, 38103, United States

Location

University of Washington, Seattle

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 20945468 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

Study was conducted in the medical ICU and excluded postsurgical patients and subjects expected to undergo a major surgical procedure, patients with severe renal insufficiency and with a history of hyperglycemic crises.

Results Point of Contact

• Title: Guillermo Umpierrez, MD
• Organization: Emory University

geumpie@emory.edu

404-778-1665

Study Officials

• Guillermo E Umpierrez, MD

  Emory University SOM/Grady Health System

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: June 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 30, 2018
• Results First Posted: September 30, 2013

Record last verified: 2018-10

Locations

US (4)