Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature
ASPIRE
ASPIRE (Automation to Simulate Pancreatic Insulin Response): Pivotal In Home Study to Determine Safety and Efficacy of the LGS Feature in Sensor-augmented Pumps
1 other identifier
interventional
247
1 country
17
Brief Summary
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2011
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 18, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
March 17, 2014
CompletedMarch 17, 2014
January 1, 2014
1.5 years
December 18, 2011
October 24, 2013
January 31, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
5 months
Study Arms (2)
Low Glucose Suspend feature (LGS)
EXPERIMENTALAccording to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Control Arm
EXPERIMENTALThe Low Glucose Suspend feature will not be available to subjects in the control arm
Interventions
Automatic suspension of insulin delivery when glucose is low.
No Automatic suspension of insulin delivery when glucose is low.
Eligibility Criteria
You may qualify if:
- Subjects who are 16-21 years are determined by the investigator to have the appropriate, requisite support (family, caregiver or social network) to successfully participate in this study
- Subjects who are determined by the investigator to be psychologically sound in order to successfully participate in this study.
- Subject was \< 40 years at disease onset
- Subject has been diagnosed with type 1 diabetes ≥ 2 years
- Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
- Subject is willing to perform required sensor calibrations
- Subject is willing to wear the system continuously throughout the study
- Subject is willing to keep a log to record at minimum:
- Sick days
- Days with exercise and days with symptoms of low glucose
- Subject has an A1C value 5.8% to 10.0% (as processed by Central Lab) at time of screening visit
- Subject must be on pump therapy use for \>6 months prior to Screening
- Subject has been followed by a well trained diabetes health care provider(s) for 6 months prior to screening
- Subject is willing to upload data weekly from the study pump, must have Internet access and a computer system that meets the requirements for uploading the study pump
- If subject has celiac disease, it has been adequately treated as determined by the investigator
- +3 more criteria
You may not qualify if:
- Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
- Medical assistance (i.e. Paramedics, Emergency room or Hospitalization)
- Coma
- Seizures
- Subject is unable to tolerate tape adhesive in the area of sensor placement
- Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study
- Subject has had any of the following new diagnoses within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
- Subject is being treated for hyperthyroidism at time of screening
- Subject has an abnormality (out of upper reference range, as processed by Central Lab) in creatinine at time of screening visit
- Subject has an abnormality (out of reference range, as processed by Central Lab) in thyroid-stimulating hormone (TSH) at time of screening visit
- Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
- Subject has been hospitalized or has visited the emergency room in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
- Subject is currently abusing illicit drugs
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Arkansas Diabetes Clinic and Research Center
Little Rock, Arkansas, 72205, United States
AMCR Institute, Inc
Escondido, California, 92026, United States
Frank Diabetes Research Institute/ Mills-Peninsula Health Center
San Mateo, California, 94401, United States
University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30309, United States
Physicians Research Associates
Lawrenceville, Georgia, 30046, United States
Endocrine Research Solutions
Roswell, Georgia, 30046, United States
Rocky Mountains Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Iowa Diabetes and Endocrinology Research Center
Des Moines, Iowa, 50314, United States
International Diabetes Center
Minneapolis, Minnesota, 55416, United States
Naomie Barrie Diabetes Center
New York, New York, 10032, United States
Joslin Diabetes Center
Syracuse, New York, 13210, United States
Ohio University College of Osteopathic Medicine
Athens, Ohio, 45701, United States
Texas Diabetes
Austin, Texas, 78731, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
University of Wisconsin - Madison
Madison, Wisconsin, 53717, United States
Related Publications (4)
Weiss R, Garg SK, Bode BW, Bailey TS, Ahmann AJ, Schultz KA, Welsh JB, Shin JJ. Hypoglycemia Reduction and Changes in Hemoglobin A1c in the ASPIRE In-Home Study. Diabetes Technol Ther. 2015 Aug;17(8):542-7. doi: 10.1089/dia.2014.0306. Epub 2015 Jun 2.
PMID: 26237308DERIVEDWeiss R, Garg SK, Bergenstal RM, Klonoff DC, Bode BW, Bailey TS, Thrasher J, Schwartz F, Welsh JB, Kaufman FR; ASPIRE In-Home Study Group. Predictors of Hypoglycemia in the ASPIRE In-Home Study and Effects of Automatic Suspension of Insulin Delivery. J Diabetes Sci Technol. 2015 May 18;9(5):1016-20. doi: 10.1177/1932296815586014.
PMID: 25986629DERIVEDKlonoff DC, Bergenstal RM, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann A, Welsh JB, Lee SW. ASPIRE In-Home: rationale, design, and methods of a study to evaluate the safety and efficacy of automatic insulin suspension for nocturnal hypoglycemia. J Diabetes Sci Technol. 2013 Jul 1;7(4):1005-10. doi: 10.1177/193229681300700424.
PMID: 23911183DERIVEDBergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann AJ, Welsh JB, Lee SW, Kaufman FR; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369(3):224-32. doi: 10.1056/NEJMoa1303576. Epub 2013 Jun 22.
PMID: 23789889DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Troub
- Organization
- Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2011
First Posted
December 23, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
March 17, 2014
Results First Posted
March 17, 2014
Record last verified: 2014-01