Navigator 1.5 Accuracy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetes

Patients with type 1 diabetes requiring multiple daily insulin injections or using insulin pumps

FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

Intervention Type DEVICE

This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.

Interventions

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FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* History consistent with Type 1 diabetes for at least 2 years prior to enrollment;
* For at least 6 months prior to enrollment, insulin pump user or multiple daily insulin injections;
* At least 18 years of age;
* Available and capable of following the protocol instructions provided by the healthcare professional;
* Signed and dated Informed Consent form.

Exclusion Criteria

* Pregnancy;
* Type 2, gestational, or secondary diabetes;
* Known allergy to medical grade adhesives or skin disinfectant;
* Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin;
* Blood donation within 6 weeks prior to beginning study activities;
* Within past 6 months, severe hypoglycemic episode(s) resulting in hospitalization or loss of consciousness;
* Active myocardial ischemia;
* Previous history of stroke;
* Any other concomitant medical condition that in the opinion of the principal investigator would likely affect the evaluation of device performance and/or safety;
* Current participation in another clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No