Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature
Public ClinicalTrials.gov record NCT01497938. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01497938
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Interventions
- Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature Device
- Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump Device
Device
Eligibility (public fields only)
- Age range
- 16 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2011
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
- Last update posted
- Mar 16, 2014
2011 – 2013
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Diabetes Clinic and Research Center | Little Rock | Arkansas | 72205 | — |
| AMCR Institute, Inc | Escondido | California | 92026 | — |
| Frank Diabetes Research Institute/ Mills-Peninsula Health Center | San Mateo | California | 94401 | — |
| University of Colorado Denver/ Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | — |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30309 | — |
| Physicians Research Associates | Lawrenceville | Georgia | 30046 | — |
| Endocrine Research Solutions | Roswell | Georgia | 30046 | — |
| Rocky Mountains Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| Iowa Diabetes and Endocrinology Research Center | Des Moines | Iowa | 50314 | — |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | — |
| Naomie Barrie Diabetes Center | New York | New York | 10032 | — |
| Joslin Diabetes Center | Syracuse | New York | 13210 | — |
| Ohio University College of Osteopathic Medicine | Athens | Ohio | 45701 | — |
| Texas Diabetes | Austin | Texas | 78731 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
| University of Wisconsin - Madison | Madison | Wisconsin | 53717 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01497938, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2014 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01497938 live on ClinicalTrials.gov.