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

NCT01497938 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2014-03-17

Study results available
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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.

Conditions

Interventions

DEVICE

Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature

Automatic suspension of insulin delivery when glucose is low.

DEVICE

Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump

No Automatic suspension of insulin delivery when glucose is low.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01497938 on ClinicalTrials.gov