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Fast Track CSII Using a Novel Device in Young Children With Newly Diagnosed T1DM

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00476788
First received: May 18, 2007
Last updated: December 20, 2010
Last verified: December 2010
History of Changes
Results First Received: October 12, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes Mellitus
Intervention: Device: Omnipod Insulin Management System

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Omnipod Device Patients will be placed on an Omnipod insulin pump

Participant Flow:   Overall Study
    Omnipod Device  
STARTED     14  
COMPLETED     11  
NOT COMPLETED     3  



  Baseline Characteristics
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Reporting Groups
  Description
Omnipod Device Patients will be placed on an Omnipod insulin pump

Baseline Measures
    Omnipod Device  
Number of Participants  
[units: participants]
 		  14  
Age  
[units: participants]
 		 
<=18 years     14  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  6.275  ± 2.875  
Gender  
[units: participants]
 		 
Female     7  
Male     7  
Region of Enrollment  
[units: participants]
 		 
United States     14  



  Outcome Measures
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1.  Primary:   A1c   [ Time Frame: 6.9 months (average) ]
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2.  Secondary:   Adverse Event Frequency   [ Time Frame: 6.9 months (average) ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Elaine Moreland MD
Organization: Greenville Hospital System
phone: 8644545661
e-mail: emoreland@ghs.org


No publications provided


Responsible Party: Elaine Moreland MD, UAB
ClinicalTrials.gov Identifier: NCT00476788     History of Changes
Other Study ID Numbers: X060928006
Study First Received: May 18, 2007
Results First Received: October 12, 2010
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board