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Adult Accuracy Study of the Enlite 3 Glucose Sensor

NCT02246582 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2016-11-02

Study results available
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Summary

The purpose of this study is to demonstrate the performance of the Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen and used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years with type 1 or type 2 diabetes.

Conditions

Interventions

DEVICE

Enlite 3

Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen \& arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.

DEVICE

Guardian Mobile App

DEVICE

640G Insulin Pump

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Ronald Brazg, M.D · Rainier Clinical Research Center

  • Mark Christiansen, M.D · Diablo Clinical Research

  • Timothy Bailey, M.D · AMCR Institute

  • Satish Garg, M.D · Barbara Davis Center

  • Robert Slover, M.D · Barbara Davis Center

  • Bruce Bode, M.D · Atlanta Diabetes Associates

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02246582 on ClinicalTrials.gov