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
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

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
Low Glucose Suspend Feature (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.

Total Total of all reporting groups

Baseline Measures
    Low Glucose Suspend Feature (LGS)     Control Arm     Total  
Number of Participants  
[units: participants]
  121     126     247  
Age  
[units: participants]
     
<=18 years     4     5     9  
Between 18 and 65 years     110     114     224  
>=65 years     7     7     14  
Age  
[units: years]
Mean ± Standard Deviation
  41.6  ± 12.83     44.8  ± 13.82     43.3  ± 13.41  
Gender  
[units: participants]
     
Female     75     76     151  
Male     46     50     96  
Region of Enrollment  
[units: participants]
     
United States     121     126     247  



  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
  Hide 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.


  More Information
  Hide More Information

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.


Results Point of Contact:  
Name/Title: Thomas Troub
Organization: Medtronic
phone: (818) 576-3142
e-mail: thomas.troub@medtronic.com


No publications provided by Medtronic Diabetes

Publications automatically indexed to this study:

Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01497938     History of Changes
Other Study ID Numbers: CEP 237
Study First Received: December 18, 2011
Results First Received: October 24, 2013
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration