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Pilot Study of the Navigator Continuous Glucose Monitor

NCT00166673 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-05

No results posted yet for this study

Summary

This study is being done to find out how accurate the Navigator continuous glucose monitor is in children. It is also being done to see if use of the Navigator can improve blood sugar control and help prevent low blood sugar events. This study has three basic parts: Use of the Navigator at home for one week without being able to see the blood sugar readings; a Baseline visit or a 24-hour admission to a research unit of the hospital to find out how well the Navigator measures the blood sugar; and then 3 months use of the Navigator at home as an aid to diabetes care.

Conditions

  • Diabetes Mellitus, Insulin-Dependent

Interventions

DEVICE

FreeStyle Navigator Continuous Glucose Monitoring System

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • William V Tamborlane, M.D. · Yale University

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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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 NCT00166673 on ClinicalTrials.gov