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Medtronic MiniMed Implantable Insulin Pump

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298740
First Posted: March 3, 2006
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Medtronic
Information provided by (Responsible Party):
Johns Hopkins University
Results First Submitted: August 10, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Intervention: Device: Aventis U-400 Insulin

  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
Aventis U-400 Insulin Aventis U-400 Insulin

Participant Flow:   Overall Study
    Aventis U-400 Insulin
STARTED   12 
COMPLETED   3 
NOT COMPLETED   9 
Lack of Efficacy                6 
Withdrawal by Subject                3 



  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
Aventis U-400 Insulin Aventis U-400 Insulin

Baseline Measures
   Aventis U-400 Insulin 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  33.3% 
Male      8  66.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   12 


  Outcome Measures

1.  Primary:   Glucose Control as Assessed by Mean Glucose Levels   [ Time Frame: End of study, approximately 5 years ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Johns Hopkins ClinicalTrials.gov Program
Organization: Johns Hopkins University
phone: 410-550-6484
e-mail: registerclinicaltrials@jhmi.edu


Publications:

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00298740     History of Changes
Other Study ID Numbers: 03-05-01-08
RR00052
First Submitted: March 1, 2006
First Posted: March 3, 2006
Results First Submitted: August 10, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017