Introduction: 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: 1. 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. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
247
Automatic suspension of insulin delivery when glucose is low.
No Automatic suspension of insulin delivery when glucose is low.
Arkansas Diabetes Clinic and Research Center
Little Rock, Arkansas, United States
AMCR Institute, Inc
Escondido, California, United States
Frank Diabetes Research Institute/ Mills-Peninsula Health Center
San Mateo, California, United States
University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Physicians Research Associates
Lawrenceville, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Rocky Mountains Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
Iowa Diabetes and Endocrinology Research Center
Des Moines, Iowa, United States
...and 7 more locations
Change in A1C From Baseline to End of Study Participation
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
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)
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
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