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

Measure Type Primary
Measure Title Change in A1C From Baseline to End of Study Participation
Measure Description The first study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is safe and is not associated with glycemic deterioration, as measured by change in A1C from baseline to end of study participation.
Time Frame 5 months  
Safety Issue Yes  

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
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' No text entered.
Group B Without Low Glucose Suspend (LGS) Feature No text entered.

Measured Values
    Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'     Group B Without Low Glucose Suspend (LGS) Feature  
Number of Participants Analyzed  
[units: participants]
  116     124  
Change in A1C From Baseline to End of Study Participation  
[units: Percent]
Mean ± Standard Deviation
  0.00  ± 0.44     -0.04  ± 0.42  


Statistical Analysis 1 for Change in A1C From Baseline to End of Study Participation
Groups [1] All groups
Non-Inferiority/Equivalence Test [2] Yes
Method [3] ANCOVA
Mean Difference (Final Values) [4] 0.05
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  pre-specified non-inferiority margin of 0.4% was used for sample size calculation. sample size is based on two-sample t test with one-sided type 1 error of 2.5%. Assuming a same mean of change in A1C for the treatment arm and control arm and a common standard deviation of 1% for both treatment groups, it showed that a total of 200 subjects will provide over 80% power to detect the non-inferiority with a margin of 0.4%
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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 ]

Measure Type Primary
Measure Title 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)
Measure Description An event is identified as: LGS feature in the correct setting; CGM values <= 65 mg/dL continuously with starting time between 10pm - 8am; No evidence of patient intervention during the first 20 minutes when CGM value was <= 65 mg/dL; The rate of change before reaching sensor glucose value of <= 65 mg/dL was <= 5 mg/dl/minutes; If the time between two successive events was less than 30 minutes, they will be combined as one event; An evaluable event is defined as any event with CGM value <= 65 mg/dL of greater than 20 minutes and the LGS feature is on the correct setting; Event AUC analysis was performed based on logarithm of AUC data.
Time Frame 5 months  
Safety Issue Yes  

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
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' No text entered.
Group B Without Low Glucose Suspend (LGS) Feature No text entered.

Measured Values
    Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'     Group B Without Low Glucose Suspend (LGS) Feature  
Number of Participants Analyzed  
[units: participants]
  121     126  
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)  
[units: mg/dL x min]
Mean ± Standard Deviation
  980  ± 1200.1     1568  ± 1994.9  


Statistical Analysis 1 for 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)
Groups [1] All groups
Method [2] ANCOVA
P Value [3] <0.025
Mean Difference (Final Values) [4] -588
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.




  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