Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature (ASPIRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01497938
First received: December 18, 2011
Last updated: January 31, 2014
Last verified: January 2014
Results First Received: October 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Device: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature
Device: Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump

  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
Low Glucose Suspend Feasure (LGS)

According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study

Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low.

Control Arm

The Low Glucose Suspend feature will not be available to subjects in the control arm

Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low.


Participant Flow:   Overall Study
    Low Glucose Suspend Feasure (LGS)     Control Arm  
STARTED     121     126  
COMPLETED     116     124  
NOT COMPLETED     5     2  
Adverse Event                 0                 1  
Physician Decision                 0                 1  
Withdrawal by Subject                 4                 0  
Device Violation                 1                 0  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in A1C From Baseline to End of Study Participation   [ Time Frame: 5 months ]

2.  Primary:   The Event Area Under the Curve (AUC) Was Used to Demonstrate the Reduction of Nocturnal Hypoglycemia With the Low Glucose Suspend (LGS) Feature (LGS ON)   [ Time Frame: 5 months ]


  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