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OpenTrials
Completed

NCT Number: NCT01076218

Navigator 1.5 Accuracy Study

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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Key information

Conditions

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

Diablo Clinical Research, Walnut Creek, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

Device

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

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

In Clinic Evaluation of the FreeStyle Navigator® Continuous Glucose Monitoring System Version 1.5

Acronym: FSNQS

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Feb 26, 2010
Registry last updated
Jun 17, 2024

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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