Comparative Trial Between 3 Types of Insulin Infusion Protocols

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00582309
First received: December 19, 2007
Last updated: August 3, 2011
Last verified: December 2009
Results First Received: September 12, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


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


No publications provided


Responsible Party: Gary Iwamoto, MD, 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: August 3, 2011
Health Authority: United States: Institutional Review Board