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
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Change in A1C From Baseline to End of Study Participation [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 247
Study Start Date: December 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Subject is willing to take one of the following insulins and can financially afford to use either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
  • Humalog® (insulin lispro injection)
  • NovoLog® (insulin aspart)

Exclusion Criteria:

  • 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
  • Subject is currently abusing prescription drugs
  • Subject is currently abusing alcohol
  • Subject is using pramlintide (Symlin) at time of screening
  • Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
  • Subject has elective surgery planned that requires general anesthesia during the course of the study
  • Subject is a shift worker with working hours between 10pm and 8am.
  • Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
  • Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  • Subject diagnosed with current eating disorder such as anorexia or bulimia
  • Subject plans to use significant quantity of herbal preparations (use of over the counter herbal preparation for 30 consecutive days or longer period during the study) or significant quantity of vitamin supplements (four times the recommended daily allowance used for 30 consecutive days or longer period during the study) during the course of their participation in the study
  • Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  • Subject is on dialysis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497938

Locations
United States, Arkansas
Arkansas Diabetes Clinic and Research Center
Little Rock, Arkansas, United States, 72205
United States, California
AMCR Institute, Inc
Escondido, California, United States, 92026
Frank Diabetes Research Institute/ Mills-Peninsula Health Center
San Mateo, California, United States, 94401
United States, Colorado
University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Florida
Metabolic Research Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309
Physicians Research Associates
Lawrenceville, Georgia, United States, 30046
Endocrine Research Solutions
Roswell, Georgia, United States, 30046
United States, Idaho
Rocky Mountains Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Iowa
Iowa Diabetes and Endocrinology Research Center
Des Moines, Iowa, United States, 50314
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, New York
Naomie Barrie Diabetes Center
New York, New York, United States, 10032
Joslin Diabetes Center
Syracuse, New York, United States, 13210
United States, Ohio
Ohio University College of Osteopathic Medicine
Athens, Ohio, United States, 45701
United States, Texas
Texas Diabetes
Austin, Texas, United States, 78731
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98057
United States, Wisconsin
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53717
Sponsors and Collaborators
Medtronic Diabetes
  More Information

No publications provided by Medtronic Diabetes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01497938     History of Changes
Other Study ID Numbers: CEP 237
Study First Received: December 18, 2011
Results First Received: October 24, 2013
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014