Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

To evaluate the clinical accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System with respect to a reference standard.

Completed

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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

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
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
Skin abnormalities at the insertion sites that would confound the assessment of the effect of the device on the skin
Seizure disorder
Myocardial ischemia
History of stroke
Severe hypoglycemia unawareness
Other concomitant medical conditions that in the opinion of the investigator, would affect the evaluation of device performance and/or safety

Treatment and study plan

FreeStyle Navigator Continuous Glucose Monitoring System

Device

Subjects wore 2 Navigator sensors for approximately 122 hours. Subjects and clinical staff were masked to continuous glucose data. During the time the subjects wore the continuous sensor, they were instructed to continue with their current diabetes management plan. Subjects stayed at the clinic for approximately 50 hours during the study period. While in the clinic, venous blood samples were collected every 15 minutes to determine whole blood reference glucose concentrations using the Yellow Springs Instrument. Subjects were also asked to obtain up to 50 FreeStyle finger blood glucose measurements using the system in the Navigator receiver for comparative analysis and system calibration. This was not a treatment study.

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

Protocol #TS05-066 Clinical Evaluation of the Accuracy of the FreeStyle Navigator Continuous Glucose Monitoring System

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Jun 15, 2009
Registry last updated: Jun 15, 2009

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.

Published trials that share one or more normalized conditions with this study.

Completed