FreeStyle Navigator Continuous Glucose Monitoring System with TRUstart algorithm, a 1-hour warm-up time.

Background: The first-generation FreeStyle Navigator® Continuous Glucose Monitoring System (FreeStyle Navigator CGM) requires a 10 h warm-up period to avoid inaccurate glucose readings caused by sensor insertion trauma and wound-healing processes. The performance of a second-generation FreeStyle Navigator CGM that begins reporting glucose 1 h after sensor insertion is described.

Methods: Second-generation FreeStyle Navigator CGM performance was evaluated in an in-clinic study using the YSI Model 2300 STATPlus Glucose Analyzer as reference with 47 subjects with type 1 diabetes.

Continuous glucose monitoring in subcutaneous tissue using factory-calibrated sensors: a pilot study.

Background: Commercial continuous subcutaneous glucose monitors require in vivo calibration using capillary blood glucose tests. Feasibility of factory calibration, i.e.

Comparison of the clinical information provided by the FreeStyle Navigator continuous interstitial glucose monitor versus traditional blood glucose readings.

Background: The purpose of the analysis was to compare the clinical utility of data from traditional self-monitoring of blood glucose (SMBG) to that of continuous glucose monitoring (CGM).

Methods: A clinical study of the clinical accuracy of the FreeStyle Navigator CGM System (Abbott Diabetes Care, Alameda, CA), which includes SMBG capabilities, was conducted by comparison to the YSI blood glucose analyzer (YSI Inc., Yellow Springs, OH) using 58 subjects with type 1 diabetes.

Alarm characterization for a continuous glucose monitor that replaces traditional blood glucose monitoring.

Background: Continuous glucose monitoring (CGM) devices available in the United States are approved for use as adjuncts to self-monitoring of blood glucose (SMBG); all CGM alarms require SMBG confirmation before treatment. In this report, an analysis method is proposed to determine the CGM threshold alarm accuracy required to eliminate SMBG confirmation.

Method: The proposed method builds on the Clinical and Laboratory Standards Institute (CLSI) guideline for evaluating CGM threshold alarms using data from an in-clinic study of subjects with type 1 diabetes.

Alarm characterization for continuous glucose monitors used as adjuncts to self-monitoring of blood glucose.

Background: Continuous glucose monitoring (CGM) devices available in the United States are approved for use as adjuncts to self-monitoring of blood glucose (SMBG). Alarm evaluation in the Clinical and Laboratory Standards Institute (CLSI) guideline for CGM does not specifically address devices that employ both CGM and SMBG. In this report, an alarm evaluation method is proposed for these devices.

The chemistry of commercial continuous glucose monitors.

The analytical methodologies of the continuous glucose monitors (CGMs) commercialized to date are described. The devices include two noninvasive products: the GlucoWatch (Cygnus, Redwood City, CA) G2 Biographer uses iontophoresis to obtain a sample and electrochemistry for glucose detection, and PENDRA (Pendragon Medical Ltd., Zurich, Switzerland) utilizes impedance spectroscopy.

Detection of hypoglycemia with continuous interstitial and traditional blood glucose monitoring using the FreeStyle Navigator Continuous Glucose Monitoring System.

Background: The objective of the analysis was to compare detection of hypoglycemic episodes (glucose <70 mg/dL lasting >15 min) with the FreeStyle Navigator Continuous Glucose Monitoring System (FSN-CGM) (Abbott Diabetes Care, Alameda, CA) alarms to detection with traditional finger stick testing at an average frequency of eight tests per day.

Methods: The performance of FSN-CGM alarms was evaluated in a clinic setting using 58 subjects with type 1 diabetes mellitus (T1DM) monitoring interstitial glucose concentration over a 5-day period compared to reference YSI measurements (instrument manufactured by YSI, Yellow Springs, OH) at 15-min intervals. Finger stick glucose testing was evaluated in the home environment with 91 subjects with TIDM monitoring with the blood glucose meter integrated into the FreeStyle Navigator (FSN-BG) over a 20-day period.

Accuracy of the 5-day FreeStyle Navigator Continuous Glucose Monitoring System: comparison with frequent laboratory reference measurements.

Objective: The purpose of this study was to compare the accuracy of measurements of glucose in interstitial fluid made with the FreeStyle Navigator Continuous Glucose Monitoring System with Yellow Springs Instrument laboratory reference measurements of venous blood glucose.

Research Design And Methods: Fifty-eight subjects with type 1 diabetes, aged 18-64 years, were enrolled in a multicenter, prospective, single-arm study. Each subject wore two sensors simultaneously, which were calibrated with capillary fingerstick measurements at 10, 12, 24, and 72 h after insertion.