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Navigator 1.5 Accuracy Study

2014-08-27 03:15:36 | BioPortfolio

Summary

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Diabetes Mellitus

Intervention

FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5

Location

Diablo Clinical Research
Walnut Creek
California
United States
94598

Status

Completed

Source

Abbott Diabetes Care

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:36-0400

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PubMed Articles [20039 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Self evaluation of whole blood glucose levels outside the clinical laboratory. A digital or battery-operated reflectance meter may be used. It has wide application in controlling unstable insulin-dependent diabetes.

A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.

The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.

A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.

A pathological state in which BLOOD GLUCOSE level is less than approximately 140 mg/100 ml of PLASMA at fasting, and above approximately 200 mg/100 ml plasma at 30-, 60-, or 90-minute during a GLUCOSE TOLERANCE TEST. This condition is seen frequently in DIABETES MELLITUS, but also occurs with other diseases and MALNUTRITION.

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