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An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance

NCT00865345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2012-11-06

Study results available
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Summary

The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy when used for six days. This study will also test sensor safety and accuracy when inserted in an alternate body location (buttock area in addition to abdomen area). The study hypothesis is that the sensor performance will not greatly diminish when used for six days, or in an alternate insertion area.

Conditions

Interventions

DEVICE

MMT-7003 subcutaneous glucose sensor

All subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy.

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • John Mastrototaro, PHD · Medtronic Diabetes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-01-31
Completion
2010-01-31

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 NCT00865345 on ClinicalTrials.gov