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Comparative Trial Between 3 Types of Insulin Infusion Protocols

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Gary Iwamoto, University of New Mexico
ClinicalTrials.gov Identifier:
NCT00582309
First received: December 19, 2007
Last updated: May 26, 2015
Last verified: May 2015
Results First Received: September 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hyperglycemia
Interventions: Procedure: Glucommander-Guided Intravenous Insulin Infusion
Procedure: Standard Intravenous Insulin Infusion
Procedure: Simple Calculated Intravenous Insulin Infusion

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Glucommander-Guided Intravenous Insulin Infusion Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
Standard Intravenous Insulin Infusion Algorithm Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
Simple Calculated Intravenous Insulin Infusion Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose

Participant Flow:   Overall Study
    Glucommander-Guided Intravenous Insulin Infusion   Standard Intravenous Insulin Infusion Algorithm   Simple Calculated Intravenous Insulin Infusion
STARTED   56   49   46 
COMPLETED   56   49   44 [1] 
NOT COMPLETED   0   0   2 
Protocol Violation                0                0                2 
[1] 2 did not have enough data collected to be used



  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-Guided Intravenous Insulin Infusion Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
Standard Intravenous Insulin Infusion Algorithm Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
Simple Calculated Intravenous Insulin Infusion Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
Total Total of all reporting groups

Baseline Measures
   Glucommander-Guided Intravenous Insulin Infusion   Standard Intravenous Insulin Infusion Algorithm   Simple Calculated Intravenous Insulin Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   49   46   151 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   35   33   27   95 
>=65 years   21   16   19   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (10.6)   60.6  (12.3)   61.4  (13.6)   61.2  (11.3) 
Gender 
[Units: Participants]
       
Female   24   25   23   72 
Male   32   24   23   79 
Region of Enrollment 
[Units: Participants]
       
United States   56   49   46   151 


  Outcome Measures

1.  Primary:   Differences in Glycemic Control as Measured by Time Reach Glycemic Control for Each Treatment Group.   [ Time Frame: 24 hours ]


  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
Limitations of trial. Variable length of stay the first 48 hours was analyzed as the sample size decreased after that.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Gary Iwamoto
Organization: UNM
phone: 505-272-4751
e-mail: giwamoto@salud.unm.edu



Responsible Party: Gary Iwamoto, University of New Mexico
ClinicalTrials.gov Identifier: NCT00582309     History of Changes
Other Study ID Numbers: HRRC 06-288
Study First Received: December 19, 2007
Results First Received: September 12, 2009
Last Updated: May 26, 2015