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
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
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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 ]

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
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Time Frame Severe adverse event data and adverse event data were collected during approximately 4 months of study duration
Additional Description Adverse events during run-in (training) period are available upon request

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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.

Other Adverse Events
    Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'     Group B Without Low Glucose Suspend (LGS) Feature  
Total, other (not including serious) adverse events      
# participants affected / at risk     39/121     41/126  
Ear and labyrinth disorders      
Ear pain * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Eye disorders      
Conjunctivitis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Gastrointestinal disorders      
Toothache * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Nausea * 1    
# participants affected / at risk     2/121 (1.65%)     1/126 (0.79%)  
# events     2     1  
Food poisoning * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Vomit * 1    
# participants affected / at risk     1/121 (0.83%)     2/126 (1.59%)  
# events     1     2  
Stomach Discomfort * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
General disorders      
Injection site haemorrhage * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Dental bridge failure * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Pyrexia * 1    
# participants affected / at risk     3/121 (2.48%)     0/126 (0.00%)  
# events     3     0  
Application site bleeding * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Infections and infestations      
Acute Sinusitis * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Bacterial Infection * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Bronchitis Acute * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Cellulitis * 1    
# participants affected / at risk     1/121 (0.83%)     1/126 (0.79%)  
# events     1     1  
Ear Infection * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Gastroenteritis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Gastroenteritis Viral * 1    
# participants affected / at risk     2/121 (1.65%)     1/126 (0.79%)  
# events     2     1  
Infection * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     2  
Influenza * 1    
# participants affected / at risk     1/121 (0.83%)     2/126 (1.59%)  
# events     1     2  
Infusion Site Infection * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Kidney Infection * 1    
# participants affected / at risk     0/121 (0.00%)     2/126 (1.59%)  
# events     0     2  
Nasopharyngitis * 1    
# participants affected / at risk     3/121 (2.48%)     7/126 (5.56%)  
# events     3     7  
Otitis media * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Pharyngitis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Respiratory Tract Infection * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Sinusitis * 1    
# participants affected / at risk     2/121 (1.65%)     2/126 (1.59%)  
# events     2     2  
Tonsillitis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Tooth Abscess * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Upper Respiratory Track Infection * 1    
# participants affected / at risk     3/121 (2.48%)     5/126 (3.97%)  
# events     4     5  
Urinary Tract Infection * 1    
# participants affected / at risk     1/121 (0.83%)     1/126 (0.79%)  
# events     1     1  
Vaginal Mycosis * 1    
# participants affected / at risk     2/121 (1.65%)     0/126 (0.00%)  
# events     2     0  
Gingival infection * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Injury, poisoning and procedural complications      
Contusion * 1    
# participants affected / at risk     1/121 (0.83%)     2/126 (1.59%)  
# events     1     2  
Fibula fracture * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Skin laceration * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Foot fracture * 1    
# participants affected / at risk     0/121 (0.00%)     2/126 (1.59%)  
# events     0     2  
Meniscus lesion * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Tibia fracture * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Metabolism and nutrition disorders      
Hyperglycaemia * 1    
# participants affected / at risk     4/121 (3.31%)     3/126 (2.38%)  
# events     4     3  
Hypoglycemia * 1    
# participants affected / at risk     0/121 (0.00%)     3/126 (2.38%)  
# events     0     3  
Musculoskeletal and connective tissue disorders      
Neck pain * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Chest wall pain * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Osteoarthritis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Exostosis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Nervous system disorders      
Migraine * 1    
# participants affected / at risk     2/121 (1.65%)     1/126 (0.79%)  
# events     2     1  
Respiratory, thoracic and mediastinal disorders      
Pharyngolaryngeal Pain * 1    
# participants affected / at risk     3/121 (2.48%)     1/126 (0.79%)  
# events     3     1  
Sinus congestion * 1    
# participants affected / at risk     3/121 (2.48%)     0/126 (0.00%)  
# events     4     0  
Cough * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
Nasal congestion * 1    
# participants affected / at risk     1/121 (0.83%)     2/126 (1.59%)  
# events     1     2  
Skin and subcutaneous tissue disorders      
Ecchymosis * 1    
# participants affected / at risk     1/121 (0.83%)     1/126 (0.79%)  
# events     1     2  
Nail hypertrophy * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Dermatitis contact * 1    
# participants affected / at risk     1/121 (0.83%)     1/126 (0.79%)  
# events     1     1  
Skin irritation * 1    
# participants affected / at risk     0/121 (0.00%)     2/126 (1.59%)  
# events     0     3  
Rash * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Dermatitis * 1    
# participants affected / at risk     1/121 (0.83%)     0/126 (0.00%)  
# events     1     0  
Surgical and medical procedures      
Endodontic procedure * 1    
# participants affected / at risk     0/121 (0.00%)     1/126 (0.79%)  
# events     0     1  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 15.0



  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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