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NCT Number: NCT01455064

Navigator II Continuous Glucose Monitor Home Use Study

This research study will test a new investigational continuous glucose monitoring system (System). The purpose of this study is to find out about the performance of the System in a home use environment over a 15 day period, in people with diabetes.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atlanta Diabetes Associates, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The subject must:

  • Have type 1 or 2 diabetes for at least 2 years prior to enrollment.
  • Require insulin therapy administered through an insulin pump or multiple daily injections (MDI) for at least 6 months prior to enrollment.
  • Be at least 18 years of age.
  • Be able to read and understand English.
  • In the investigator's opinion, be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  • Be available for all study visits.
  • Be willing to provide written signed and dated informed consent.

Exclusion criteria

The subject must not:

  • Be pregnant or likely to become pregnant during the study duration.
  • Have skin abnormalities at the insertion sites.
  • Have known allergy to medical grade adhesive or skin disinfectant.
  • Be using a continuous glucose monitor currently or within the past 6 months
  • Have a concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject.
  • Be participating in another clinical trial.

Treatment and study plan

FreeStyle Navigator II Continuous Glucose Monitoring System

Device

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

Primary outcomes

  1. Clarke Error Grid Analysis

    Time frame: 15 days sensor wear

    Percentage of CGM results in the clinically accurate Zone A and percentage of CGM results in the clinically acceptable Zones A and B of the Clarke Error Grid versus blood glucose reference.

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

FreeStyle Navigator II Continuous Glucose Monitor Home Use Evaluation (FSNv2)

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 19, 2011
Registry last updated
Jul 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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