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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arkansas Diabetes Clinic and Research Center
  • AMCR Institute, Inc
  • Frank Diabetes Research Institute/ Mills-Peninsula Health Center
  • University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes
  • Metabolic Research Institute
  • Atlanta Diabetes Associates
  • Physicians Research Associates
  • Endocrine Research Solutions
  • Rocky Mountains Diabetes and Osteoporosis Center
  • Iowa Diabetes and Endocrinology Research Center
  • International Diabetes Center
  • Naomie Barrie Diabetes Center
  • Joslin Diabetes Center
  • Ohio University College of Osteopathic Medicine
  • Texas Diabetes
  • Rainier Clinical Research Center
  • University of Wisconsin - Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low Glucose Suspend feature (LGS)

Control Arm

Arm Description

According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study

The Low Glucose Suspend feature will not be available to subjects in the control arm

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2011
Last Updated
January 31, 2014
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT01497938
Brief Title
Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature
Acronym
ASPIRE
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Glucose Suspend feature (LGS)
Arm Type
Experimental
Arm Description
According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
The Low Glucose Suspend feature will not be available to subjects in the control arm
Intervention Type
Device
Intervention Name(s)
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature
Intervention Description
Automatic suspension of insulin delivery when glucose is low.
Intervention Type
Device
Intervention Name(s)
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
Intervention Description
No Automatic suspension of insulin delivery when glucose is low.
Primary Outcome Measure Information:
Title
Change in A1C From Baseline to End of Study Participation
Description
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
Title
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)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arkansas Diabetes Clinic and Research Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
AMCR Institute, Inc
City
Escondido
State/Province
California
ZIP/Postal Code
92026
Country
United States
Facility Name
Frank Diabetes Research Institute/ Mills-Peninsula Health Center
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Metabolic Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Physicians Research Associates
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Endocrine Research Solutions
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Rocky Mountains Diabetes and Osteoporosis Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
International Diabetes Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Naomie Barrie Diabetes Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Joslin Diabetes Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Ohio University College of Osteopathic Medicine
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Texas Diabetes
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Rainier Clinical Research Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
University of Wisconsin - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26237308
Citation
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.
Results Reference
derived
PubMed Identifier
25986629
Citation
Weiss 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.
Results Reference
derived
PubMed Identifier
23911183
Citation
Klonoff 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.
Results Reference
derived
PubMed Identifier
23789889
Citation
Bergenstal 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.
Results Reference
derived

Learn more about this trial

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

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