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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
Results First Received: December 8, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes or With New Hyperglycemia
Interventions: Device: Glucommander
Drug: Standard insulin infusion drip
Drug: Glulisine drip using columnar algorithm

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
4 hospital centers between October 2006 and July 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Some patients were consented for the trial, however withdrew prior to initiation of active arm.

Reporting Groups
  Description
Glucommander continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm
Standard Insulin Infusion standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm

Participant Flow:   Overall Study
    Glucommander   Standard Insulin Infusion
STARTED   79   78 
COMPLETED   68   68 
NOT COMPLETED   11   10 
Withdrawal by Subject                11                10 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Glucommander insulin infusion per Glucommander
Standard Insulin Infusion standard insulin infusion with columnar algorithm
Total Total of all reporting groups

Baseline Measures
   Glucommander   Standard Insulin Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   78   157 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   62   52   114 
>=65 years   17   26   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.4  (11)   58  (14)   57.7  (12.3) 
Gender 
[Units: Participants]
     
Female   46   42   88 
Male   33   36   69 
Region of Enrollment 
[Units: Participants]
     
United States   79   78   157 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Glucose   [ Time Frame: daily mean blood glucose during the insulin infusion ]

2.  Secondary:   Length of Intensive Care Unit (ICU) Stay   [ Time Frame: mean number of days in the ICU during the hospital stay ]

3.  Secondary:   Mean Hospital Length of Stay in Days   [ Time Frame: during the entire hospitalization ]

4.  Secondary:   Differences Between Treatment Groups in Hypoglycemia   [ Time Frame: daily ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Guillermo Umpierrez, MD
Organization: Emory University
phone: 404-778-1665
e-mail: geumpie@emory.edu


Publications of Results:

Responsible Party: Guillermo Umpierrez, Emory University
ClinicalTrials.gov Identifier: NCT00394524     History of Changes
Other Study ID Numbers: IRB00021877
IRB 830-2005
Study First Received: October 31, 2006
Results First Received: December 8, 2008
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board