United Kingdom User Evaluation, MiniMed Paradigm® X54 System (X54User)

This study has been completed.
Sponsor:
Information provided by:
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01267175
First received: December 23, 2010
Last updated: February 16, 2011
Last verified: February 2011
Results First Received: January 21, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Diabetes Mellitus, Type 1
Intervention: Device: X54 insulin pump with low suspend feature

  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
X54 Pump All subjects transferred from current pump to X54

Participant Flow:   Overall Study
    X54 Pump  
STARTED     31  
COMPLETED     29  
NOT COMPLETED     2  
Withdrawal by Subject                 1  
Lost to Follow-up                 1  



  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.
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Reporting Groups
  Description
X54 Pump All subjects transferred from current pump to X54

Baseline Measures
    X54 Pump  
Number of Participants  
[units: participants]
  31  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     31  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.9  ± 10.64  
Gender  
[units: participants]
 
Female     21  
Male     10  
Region of Enrollment  
[units: participants]
 
United Kingdom     31  



  Outcome Measures
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1.  Primary:   Usability of the X54 Insulin Pump Meets Expectations   [ Time Frame: 5 weeks ]

2.  Secondary:   Usability of the Training Material Meets Expectations   [ Time Frame: 5 weeks ]


  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 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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Harold Torunsky
Organization: Medtronic Diabetes
phone: (818) 576 5445
e-mail: harold.torunsky@medtronic.com


No publications provided by Medtronic Diabetes

Publications automatically indexed to this study:

Responsible Party: Scott Lee, MD, Medtronic
ClinicalTrials.gov Identifier: NCT01267175     History of Changes
Other Study ID Numbers: ETP08-2625
Study First Received: December 23, 2010
Results First Received: January 21, 2011
Last Updated: February 16, 2011
Health Authority: United Kingdom: Research Ethics Committee