Type 1 DiabetesPhase 3ASPIRENCT01497938

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

A Phase 3 study testing Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature and Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 70 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature and Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 17 sitesUnited States
Study dates: Dec 2011to Jun 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Show all 18Show fewer

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)

Who cannot join

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)

Show all 27Show fewer

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

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

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

Other trials in United States

About this study

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

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.

Conditions: Type 1 Diabetes
Being tested: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature, Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) featureDevice
Automatic suspension of insulin delivery when glucose is low.
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 PumpDevice
No Automatic suspension of insulin delivery when glucose is low.

Study groups in NCT01497938
Study group	Role	What they receive
Low Glucose Suspend feature (LGS)	Experimental	According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study Receives: Device: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature
Control Arm	Experimental	The Low Glucose Suspend feature will not be available to subjects in the control arm Receives: Device: Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Jun 2013

First posted23 Dec 2011 (estimated)
Study startDec 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01497938
Sponsor's protocol ID: CEP 237
Acronym: ASPIRE
Status last verified: Jan 2014
First submitted: 18 Dec 2011
Last updated: 17 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 26237308
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.
PubMed 25986629
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.
PubMed 23911183
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.
PubMed 23789889

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01497938
Acronym / sponsor ID: ASPIRE / CEP 237
Conditions: Type 1 Diabetes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 23 Dec 2011 (estimated)
Results: Posted 17 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Introduction:

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Low Glucose Suspend feature (LGS)	Experimental	Device: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) featureAccording to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study
Control Arm	Experimental	Device: Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 PumpThe Low Glucose Suspend feature will not be available to subjects in the control arm

Who may qualify

Ages: 16 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (18 listed)

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

Key exclusion criteria (27 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) featureAutomatic suspension of insulin delivery when glucose is low.	Device	Low Glucose Suspend feature (LGS)
Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 PumpNo Automatic suspension of insulin delivery when glucose is low.	Device	Control Arm

Primary outcome

Change in A1C From Baseline to End of Study Participation
Time frame: 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)
Time frame: 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.

Results and safety

Results posted to the registry on 17 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Glucose Suspend Feasure (LGS)	121	116
Control Arm	126	124

Primary outcome: Change in A1C From Baseline to End of Study Participation

Time frame: 5 months. Mean (Standard Deviation). Unit: Percent

Measure	Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' n = 116	Group B Without Low Glucose Suspend (LGS) Feature n = 124
Value	0.00 (0.44)	-0.04 (0.42)

Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' vs Group B Without Low Glucose Suspend (LGS) Feature: Mean Difference (Final Values): 0.05, ANCOVA

Primary outcome: 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. Mean (Standard Deviation). Unit: mg/dL x min

Measure	Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' n = 121	Group B Without Low Glucose Suspend (LGS) Feature n = 126
Value	980 (1200.1)	1568 (1994.9)

Group A With Low Glucose Suspend (LGS) Feature Turned 'ON' vs Group B Without Low Glucose Suspend (LGS) Feature: Mean Difference (Final Values): -588, p <0.025, ANCOVA

Adverse events

Time frame: Severe adverse event data and adverse event data were collected during approximately 4 months of study duration. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'	0 of 121 (0%)	39 of 121 (32.2%)	Not reported
Group B Without Low Glucose Suspend (LGS) Feature	2 of 126 (1.6%)	41 of 126 (32.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26237308Weiss 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.
Derived from this study: PubMed 25986629Weiss 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.
Derived from this study: PubMed 23911183Klonoff 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.
Derived from this study: PubMed 23789889Bergenstal 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in A1C From Baseline to End of Study Participation (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01497938, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.