FreeStyle Libre System Overview

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You can use the built-in meter to check your blood ketone levels using  FreeStyle Optium b-ketone test strips. You should perform a blood ketone test on your fingertip only. Be sure to read the test strip instructions for use prior to using the built-in meter.

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No. For convenience, there is a built-in FreeStyle Optium blood glucose and ketone meter within the reader that can be used for blood glucose and ketone readings.

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The FreeStyle Libre flash glucose monitoring system is the first product in the flash glucose monitoring category and is designed to liberate people with diabetes from many of the hassles of glucose monitoring, such as routine finger pricking.

The FreeStyle Libre system contains two components:

FreeStyle Libre sensor: A small, disposable 14-day sensor that is worn on the back of the upper arm and automatically measures glucose levels and stores them for a period of 8 hours. Every time the user scans the reader over the sensor, the glucose data from sensor is transferred to the reader in 1 second.

FreeStyle Libre reader: A compact, handheld reader that displays glucose readings and stores up to 90 days of glucose data. When the reader is scanned over the sensor, it shows a current glucose reading, last 8-hours of data as well as a trend arrow (indicating if glucose is going up, down or staying steady). To obtain a glucose reading, simply perform a quick, 1-second scan of the reader over the sensor. This easy scan gives you more information than blood glucose monitoring without the need for routine finger pricks1.

 

1 A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycaemia or impending hypoglycaemia is reported by the system or when symptoms do not match the system readings.

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'Flash' reflects the fact that users can obtain glucose readings quickly by just scanning the reader over the sensor. Flash glucose monitoring also provides a flash of insight to people with diabetes and their healthcare professionals.

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To obtain a glucose reading, simply perform a quick 1-second scan of the reader over the sensor.

This easy scan gives you more information than a blood glucose test without the need for routine finger pricks1. The FreeStyle Libre system also offers software to generate concise reports that provide a clear analysis of your glucose data.

 

1 A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycaemia or impending hypoglycaemia is reported by the system or when symptoms do not match the system readings.

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No, the FreeStyle Libre sensor is calibrated during the manufacturing process so you don't have to. The sensor is activated by scanning and then, after a 1 hour warm up period, it starts to record glucose readings automatically.

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The FreeStyle Libre system is clinically proven to be accurate, stable and consistent over 14 days compared to blood glucose testing without the need for finger prick calibration

  • In a clinical study, the FreeStyle Libre system achieved 11.4% Mean Absolute Relative Difference (MARD) compared to blood glucose testing2
  • 99.7% of glucose results fall within Zone A and Zone B of the Consensus Error Gridwhen compared against blood glucose testing2
    • The measurement errors associated with these zones have no effect on clinical action and little or no effect on clinical outcomes3

 

Bailey, T, et al. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System.  Diabetes Technology and Therapeutics v17 n11 July 2015 (10.1089/dia.2014.0378)

Parkes J, Slatin S, Pardo S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-1148.

 

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Interstitial fluid-based glucose readings are a reliable indicator of blood glucose levels4

  • The physiological lag in ISF glucose, with respect to changes in blood glucose, is about 5-10 minutes4
  • The average lag time of the FreeStyle Libre system is approximately 5 minutes, which is unlikely to impact routine day-to-day treatment decisions3, 4

 

Parkes J, Slatin S, Pardo S, et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000;23(8):1143-1148.

4 Rebrin K, Sheppard NF Jr, Steil GM. Use of subcutaneous interstitial fluid glucose to estimate blood glucose: revisiting delay and sensor offset. J Diabetes Sci Technol. 2010;4(5):1087-1098.

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Traditional blood glucose monitoring provides users with glucose readings that represent distinct points in time. Users do not get information regarding how their glucose levels have been changing, nor do they get information about where their glucose levels are heading. Without such information, it can be easy to miss significant glucose fluctuations - the ups and downs. The FreeStyle Libre system is a new way to obtain glucose readings. It allows the user to get their current glucose reading by just scanning the reader over the sensor, and also provides a complete picture of glucose variations.

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The FreeStyle Libre Flash Glucose Monitoring System is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus. The indication for children (age 4 - 17) is limited to those who are supervised by a caregiver who is at least 18 years of age.

The caregiver is responsible for managing or assisting the child to manage the FreeStyle Libre Flash Glucose Monitoring System and also for interpreting or assisting the child to interpret FreeStyle Libre readings.

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Both the reader and the sensor should be stored between 4°C and 25°C.

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Flash glucose monitoring is a new, user-friendly way to discreetly obtain glucose readings. A flash glucose monitoring system provides a complete picture showing the current glucose reading plus you can see how glucose levels are changing in a flash by just scanning the reader over the sensor.

What makes flash glucose monitoring system unique is that a quick scan of the reader over the sensor provides a complete picture of your glucose including the current glucose reading, 8 hour history and trend arrow showing if your glucose level is going up, down or staying steady.

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