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ADCMDP180051

– Date of Preparation March 2018

FreeStyle, Libre and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions

The FreeStyle Libre flash glucose monitoring 
system is indicated for measuring interstitial fluid 
glucose levels in people (age 4 and older) with 
diabetes mellitus, including pregnant women.  

The indication for children (age 4 - 12) 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.

The FreeStyle Libre Flash Glucose Monitoring System 
Indication of Use 

Summary of Contents for FreeStyle Libre

Page 1: ...The FreeStyle Libre Flash Glucose Monitoring System NEW STARTER CLINIC LONDON...

Page 2: ...e age 4 and older with diabetes mellitus including pregnant women The indication for children age 4 12 is limited to those who are supervised by a caregiver who is at least 18 years of age The caregiv...

Page 3: ...e levels interstitial glucose levels as measured by the sensor and reported as current may not accurately reflect blood glucose levels When glucose levels are falling rapidly glucose readings from the...

Page 4: ...caemia is reported by the System or when symptoms do not match the System readings For a complete glycaemic picture scan sensor every 8 hours Flash glucose monitoring is an easy way to generate the de...

Page 5: ...The FreeStyle Libre sensor has a thin sterile filament that is inserted approximately 5 mm under skin to continuously measure glucose in the body using interstitial fluid ISF How does the sensor stor...

Page 6: ...ries to the interstitial space 1 The FreeStyle Libre sensor contains glucose sensitive reagents that measure glucose in the ISF continuously Glucose diffusion between capillary and ISF is shown to hav...

Page 7: ...CMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions The FreeStyle Libre Flash Glucose Monitoring Syste...

Page 8: ...ious jurisdictions The FreeStyle Libre Flash Glucose Monitoring System A new category and experience in glucose monitoring The FreeStyle Libre reader The FreeStyle Libre sensor The LibreView software...

Page 9: ...ious jurisdictions Sensor pack Sensor Sensor applicator 1 sensor pack used with the sensor applicator and contains the sensor 1 sensor applicator applies the sensor to the back of the upper arm Alcoho...

Page 10: ...scan patients can see their glucose variations including night time lows In a study conducted by Abbott Diabetes Care 95 7 of patients surveyed n 30 agreed that the FreeStyle Libre system would reduc...

Page 11: ...hold with a colour touchscreen 1 USB cable can connect to a computer to generate reports and used to charge the reader 1 power adapter use with the USB cable to charge the battery for 3 hours the batt...

Page 12: ...ry An optional message with information about critical glucose levels A symbol indicating that food or rapid acting insulin notes have been added in the last 8 hours Glucose Trend Arrow Direction and...

Page 13: ...Every 15 minutes 8 hour glucose history is updated Patients can check their glucose as often as they want The sensor continuously measures glucose every minute It stores this glucose data every 15 min...

Page 14: ...following the 1 second scan of the reader over the sensor 1 Current glucose reading Based on the most recently updated glucose value 1 minute 2 8 hour history The graph is made up of 15 minute readin...

Page 15: ...owly the patient s glucose is changing With this information patients can better understand their glucose levels Glucose is going up quickly more than 0 1 mmol L per minute Glucose Reading Screen Gluc...

Page 16: ...ADCMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Setting Up the FreeStyle Libre Reader...

Page 17: ...s Care Inc in various jurisdictions How to Set Up the Reader After the reader is charged the first step is to set up date and time 2 Use up down arrows to set the current date touch next to continue 1...

Page 18: ...t d 4 Next use the up down arrows to set the glucose target range Touch next to continue Patients should work with their Healthcare Professional to determine their target glucose range 5 There are 2 s...

Page 19: ...ADCMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Applying The FreeStyle Libre Sensor...

Page 20: ...g the lid off completely 1 1 CAUTION Do NOT use if the sensor pack or the sensor applicator seem to be damaged or already opened Do NOT use if past expiration date Avoid areas with scars moles stretch...

Page 21: ...he cap from the sensor applicator and set the cap aside 5 Line up the dark mark on the sensor applicator with the dark mark on the sensor pack On a hard surface press firmly down on the sensor applica...

Page 22: ...erent site Make sure the sensor is secure after application 7 Place the sensor applicator over the prepared site and push down firmly to apply the sensor to the back of the upper arm A thin flexible s...

Page 23: ...ks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Home Screen Before Sensor Activation After reader set up the home screen lets you start a new sensor After sensor activation the...

Page 24: ...the sounds are enabled or a vibration will confirm that sensor has been activated Once patients activate a sensor withareader it can only be used with that reader 1 Press the Home Button to turn on t...

Page 25: ...owly 1 Press the Home Button to turn on the reader A screen showing Check Glucose will appear Bring the reader close within 4 cm to sensor to scan it 2 Initial scan will display current glucose level...

Page 26: ...nsor is going to end in less than 3 days a message appears on the reader after the scan before presenting a reading Sensor ending soon A message is always displayed showing the amount of time remainin...

Page 27: ...Patients will see this screen on their reader notifying them that it is time to replace their sensor The sensor automatically stops working after 14 days and must be replaced If a sensor is removed b...

Page 28: ...Sensor The sensor is easy to remove Patients simply pull up the edge of the adhesive and slowly peel away from the skin in one motion 1 After patients remove their sensor they should apply and start...

Page 29: ...ld follow the instructions on how to apply and activate a new sensor The reader can only read one sensor at a time and the sensor will only give glucose readings to the reader that started it If a sen...

Page 30: ...8 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Puck sensor Sharps bin Applicator with cap on Biohazard bag Sensor pack General waste How...

Page 31: ...Diabetes Care Inc in various jurisdictions Abbott Customer Careline Telephone 0800 170 1177 Mon Fri 8 00am 8 00pm Email adchelpuk abbott com Maximum of 3 replacement FreeStyle Libre sensors can be is...

Page 32: ...ADCMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions The FreeStyle Libre Reader Reports...

Page 33: ...st Commonly Seen Screens Patients will see the following screen when they turn on the reader using power button After each scan patients will see a screen like the example shown below Patients can ret...

Page 34: ...Glucose Reading Screen patients can easily record their activities if they choose to By touching the pencil symbol patients can easily record food insulin exercise and or medication Food and rapid ac...

Page 35: ...rapid acting insulin and food can be quickly added using the up and down arrows These will appear on the 8 hour history graph and other reports For example after food is logged the appears on the grap...

Page 36: ...c in various jurisdictions There are 7 reports on the reader Logbook Time in Target Low Glucose Events Daily Graph Average Glucose Sensor Usage Daily Patterns They are accessed via the Review History...

Page 37: ...shows that a note was added The Logbook will record other entries such as high or low messages time and date changes Logbook entries can be edited within 15 minutes after checking glucose results The...

Page 38: ...e Shows percentage of time above below or within the target glucose range listed at the bottom of the report This reader report can show the last 7 14 30 and 90 days Time in Target More information on...

Page 39: ...vents at 4 different times of the day Low Glucose Events are recorded when glucose readings are lower than 3 9 mmol for longer than 15 minutes This reader report can show the last 7 14 30 and 90 days...

Page 40: ...ADCMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Understanding Ambulatory Glucose Profile AGP...

Page 41: ...brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions The AGP graph is shown as a clear group of lines which can help you see How AGP Can Help Make Glucose Information Cleare...

Page 42: ...DP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions Digital Health Solutions For The FreeStyle Libre Sys...

Page 43: ...or the latest versions of Google Chrome and Mozilla Firefox running on a 550MHz Pentium III 512MB DRAM 2G Hard Drive USB 2 0 LCD Screen with resolution of 1024x768 2 LibreView including the LibreLink...

Page 44: ...app requires registration with LibreView a service provided by Abbott and NewYu Inc Data charges may apply when downloading the FreeStyle LibreLink app 2 The FreeStyle LibreLink app is compatible with...

Page 45: ...ADCMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions LibreView For The FreeStyle Libre System...

Page 46: ...toring and collaboration with your care team Key benefits 1 FreeStyle LibreLink app requires registration with LibreView a service provided by Abbott and NewYu Inc Data charges may apply when download...

Page 47: ...a with your healthcare professional online Your healthcare professional will send you an email link or give you a practice ID code If given a practice code simply go to your account settings click on...

Page 48: ...80051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions FreeStyle LibreLink LibreLinkUp for the FreeStyle Libre...

Page 49: ...ice provided by Abbott and NewYu Inc Data charges may apply when downloading the FreeStyle LibreLink app 2 The FreeStyle LibreLink app is compatible with NFC enabled phones running Android OS 5 0 or h...

Page 50: ...s of glucose history on your phone Explore graphs that reveal trends and patterns that enable patients and HCPs to make more informed treatment decisions 1 Use of the FreeStyle LibreLink app requires...

Page 51: ...treatment decisions How to use the FreeStyle LibreLink app and the FreeStyle Libre reader with the same sensor NOTE When both the reader and a phone are used to scan the same sensor the data captured...

Page 52: ...ve notifications when glucose readings are too high or too low Stay connected to help manage diabetes together LibreLinkUp Simulated date for illustrative purposes only not real patient or data The Fr...

Page 53: ...ADCMDP180051 Date of Preparation March 2018 FreeStyle Libre and related brand marks are trademarks of Abbott Diabetes Care Inc in various jurisdictions The FreeStyle Libre System Education...

Page 54: ...scan at a time The FreeStyle Libre Academy is a unique resource committed to supporting you to get the most from the FreeStyle Libre system A range of bite size modules that will introduce you to the...

Page 55: ...dictions Visit www FreeStyleLibreAcademy co uk Create a FreeStyle Progress account to access the FreeStyle Libre Academy Each module will guide you through the features of the FreeStyle Libre system E...

Page 56: ...ing diabetes management How the FreeStyle Libre system works Everything you need to know about the FreeStyle Libre system Trend arrows Discover what the trend arrows really mean and how they can help...

Page 57: ...nges using your data Practical solutions to make positive changes to your diabetes day Using your smart phone Find out how your smart phone can make managing your diabetes even easier Using LibreView...

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