Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature

Phase 3

Completed

Conditions: 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

Registration Number: NCT01497938

Lead Sponsor: Medtronic Diabetes

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:

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 247

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Glucose Suspend feature (LGS)	Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature	According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Control Arm	Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump	The Low Glucose Suspend feature will not be available to subjects in the control arm

Primary Outcome Measures

Name	Time	Method
Change in A1C From Baseline to End of Study Participation	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)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (17): Arkansas Diabetes Clinic and Research Center
🇺🇸
Little Rock, Arkansas, United States
AMCR Institute, Inc
🇺🇸
Escondido, California, United States
Rainier Clinical Research Center
🇺🇸
Renton, Washington, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸
Des Moines, Iowa, United States
University of Wisconsin - Madison
🇺🇸
Madison, Wisconsin, United States
Frank Diabetes Research Institute/ Mills-Peninsula Health Center
🇺🇸
San Mateo, California, United States
Ohio University College of Osteopathic Medicine
🇺🇸
Athens, Ohio, United States
Naomie Barrie Diabetes Center
🇺🇸
New York, New York, United States
Texas Diabetes
🇺🇸
Austin, Texas, United States
Metabolic Research Institute
🇺🇸
West Palm Beach, Florida, United States
International Diabetes Center
🇺🇸
Minneapolis, Minnesota, United States
Joslin Diabetes Center
🇺🇸
Syracuse, New York, United States
Rocky Mountains Diabetes and Osteoporosis Center
🇺🇸
Idaho Falls, Idaho, United States
University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes
🇺🇸
Aurora, Colorado, United States
Physicians Research Associates
🇺🇸
Lawrenceville, Georgia, United States
Endocrine Research Solutions
🇺🇸
Roswell, Georgia, United States
Atlanta Diabetes Associates
🇺🇸
Atlanta, Georgia, United States