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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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International Navigator Hypoglycaemia Study

The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitori...

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FreeStyle Libre Flash Glucose Monitoring System Accuracy Study

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PubMed Articles [19840 Associated PubMed Articles listed on BioPortfolio]

Optimising use of rate-of-change trend arrows for insulin dosing decisions using the FreeStyle Libre flash glucose monitoring system.

Continuous glucose monitoring and flash glucose monitoring systems are increasingly used by people with diabetes on multiple daily injections of insulin and continuous subcutaneous insulin infusion. A...

Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes.

The FreeStyle® Libre Flash Glucose Monitoring System (FGM, Abbott) measures glucose concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aged > 4 years...

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Currently, two systems for continuous tissue glucose monitoring (CGM) (Dexcom G5 [DG5] and FreeStyle Libre [FL]) are intended to replace blood glucose monitoring (BGM) and, according to manufacturer l...

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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.

Continuous measurement of the movement and forces of blood in the CARDIOVASCULAR SYSTEM.

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.

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