Study to Compare Efficacy of the MiniMed Paradigm REAL-Time System Vs. MDI in Subjects Naive to Insulin Pump Therapy (STAR3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT00417989
First received: January 2, 2007
Last updated: December 6, 2011
Last verified: December 2011
Results First Received: December 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Intervention: Device: MiniMed Paradigm REAL-Time 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
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
722 Sensor Augmented Pump 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
Multiple Daily Injection (MDI) MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year

Participant Flow:   Overall Study
    722 Sensor Augmented Pump     Multiple Daily Injection (MDI)  
STARTED     244 [1]   241  
COMPLETED     224     219  
NOT COMPLETED     20     22  
Withdrawal by Subject                 13                 13  
Lost to Follow-up                 1                 6  
Protocol Violation                 1                 0  
Death                 0                 1  
Physician Decision                 5                 2  
[1] Intent to Treat include safety population & subjects with baseline & 1 post baseline A1C measurement



  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
722 Sensor Augmented Pump 722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
Multiple Daily Injection (MDI) MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
Total Total of all reporting groups

Baseline Measures
    722 Sensor Augmented Pump     Multiple Daily Injection (MDI)     Total  
Number of Participants  
[units: participants]
  244     241     485  
Age  
[units: years]
Mean ± Standard Deviation
  32.2  ± 17.47     31.50  ± 16.50     31.90  ± 16.98  
Age, Customized  
[units: participants]
     
<=18 years     77     72     149  
Between 19 and 70 years     167     169     336  
Gender  
[units: participants]
     
Female     104     107     211  
Male     140     134     274  
Region of Enrollment  
[units: participants]
     
United States     216     211     427  
Canada     28     30     58  



  Outcome Measures
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1.  Primary:   Change in A1c From Baseline to 52 Weeks   [ Time Frame: Baseline and 52 weeks ]

2.  Secondary:   Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;   [ Time Frame: Baseline and 52 weeks ]

3.  Secondary:   Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52   [ Time Frame: Baseline and 52 weeks ]

4.  Secondary:   Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;   [ Time Frame: Baseline and 52 weeks ]

5.  Secondary:   Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52   [ Time Frame: Baseline and 52 weeks ]

6.  Secondary:   Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score   [ Time Frame: Baseline and 52 weeks ]

7.  Secondary:   Quality of Life - Short Form-36 (SF-36v2™), General Health   [ Time Frame: Baseline and 52 Weeks ]

8.  Secondary:   Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy   [ Time Frame: Baseline and 52 Weeks ]

9.  Secondary:   Health Economic Outcomes (MRU)   [ Time Frame: Baseline and 52 weeks ]
Results not yet posted.   Anticipated Posting Date:   07/2011   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Scott Lee, M.D.
Organization: Medtronic
phone: 8185764204
e-mail: scott.w.lee@medtronic.com


No publications provided by Medtronic Diabetes

Publications automatically indexed to this study:

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT00417989     History of Changes
Other Study ID Numbers: CEP179/Z25
Study First Received: January 2, 2007
Results First Received: December 24, 2010
Last Updated: December 6, 2011
Health Authority: United States: Food and Drug Administration