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NCT01497938 · ClinicalTrials.gov registry record · Phase 3
Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature
A Phase 3 study, sponsored by Medtronic MiniMed.
- Completed
- Registry status
- Phase 3
- Development phase
- 247
- Enrollment target
NCT01497938: Completed Phase 3 study, sponsored by Medtronic MiniMed.
NCT01497938 is a Phase 3 study that has completed, run by Medtronic MiniMed. The registered enrollment target is 247 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497938, a Phase 3 study, has completed, sponsored by Medtronic MiniMed.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 247 participants
- Enrollment target
Study 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.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 247 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01497938
The ClinicalTrials.gov registry entry for NCT01497938 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic MiniMed, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature is the first listed.
NCT01497938 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01497938 about?
NCT01497938 is a clinical study titled "Outpatient Study to Evaluate Safety and Effectiveness of the Low Glucose Suspend Feature". 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 diabete...
What is the current status of trial NCT01497938?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 247 participants. The study started on 2011-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01497938?
The interventions under investigation include: Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature (DEVICE), Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump (DEVICE).
Who is sponsoring clinical trial NCT01497938?
This trial is sponsored by Medtronic MiniMed, which has 29 total clinical trials registered on ClinicalTrials.gov.
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