Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature (ASPIRE)
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|ClinicalTrials.gov Identifier: NCT01497938|
Recruitment Status : Completed
First Posted : December 23, 2011
Results First Posted : March 17, 2014
Last Update Posted : March 17, 2014
The purpose of the pivotal In Home study is to collect clinical data on the safety and efficacy of the Paradigm LGS System in the actual use environment and by the intended use population. ASPIRE is a multi-center, in home, randomized parallel adaptive study design with type 1 diabetes. The study will compare A1C and CGM based nocturnal hypoglycemic events in a treatment arm to a control arm. Arms are defined as:
- Treatment Arm (LGS ON) using Paradigm® VEO™ Pump
- Control Arm (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
The study's objectives are two-fold:
- 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.
- The second study objective is to demonstrate that home use of Low Glucose Suspend (LGS) is associated with reduction in nocturnal hypoglycemia when patients fail to respond.
Primary Safety Endpoint:
The change in A1C from randomization to the end of the treatment period will be used to demonstrate that the automatic insulin delivery suspension (LGS ON) does not result in an unacceptable worsening of glycemic control.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature Device: Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||247 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||ASPIRE (Automation to Simulate Pancreatic Insulin Response): Pivotal In Home Study to Determine Safety and Efficacy of the LGS Feature in Sensor-augmented Pumps|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Experimental: Low Glucose Suspend feature (LGS)
According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Device: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature
Automatic suspension of insulin delivery when glucose is low.
Experimental: Control Arm
The Low Glucose Suspend feature will not be available to subjects in the control arm
Device: Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
No Automatic suspension of insulin delivery when glucose is low.
- Change in A1C From Baseline to End of Study Participation [ Time Frame: 5 months ]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.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497938