Frequently Asked Questions

What is Flash Glucose Monitoring?

Flash Glucose Monitoring is designed as an affordable and easy way to generate the dense glucose data needed for an insightful glycemic picture. What makes flash glucose monitoring unique is the quick scan of the reader over the Sensor to collect glucose data. Another key feature of the flash glucose monitoring system is the small and fully disposable Sensor that lasts up to 14 days, requires no finger prick calibration, no routine finger pricks* and that automatically measures, captures and stores 90 days of glucose data.

*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 hypoglycemia or impending hypoglycemia is reported by the system or when symptoms do not match the system readings.
Based on the Sensor being replaced once every 14 days and scanned at least once every 8 hours.

How does the FreeStyle Libre system work?

To obtain a glucose reading, the user simply scans the reader over the Sensor. This easy 1-sec painless scan gives the user more information than BGM without the need for finger pricks.* The FreeStyle Libre system also offers a software called LibreView to generate concise reports that provide a clear analysis of the user’s glucose data.

*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 hypoglycemia or impending hypoglycemia is reported by the system or when symptoms do not match the system readings.

How is FreeStyle Libre flash glucose monitoring different than blood glucose monitoring and continuous glucose monitoring?

Traditional blood glucose monitoring provides users with glucose readings that represent distinct points in time. Users do not get comprehensive information regarding how their glucose levels have been changing, nor do they get information about where their glucose levels are going. Without such information, it can be easy to miss significant glucose fluctuations - the ups and downs.

Continuous glucose monitoring gives a more complete picture of glucose fluctuations by providing glucose values dependent on the system from every minute to every 5 minutes. Understanding how their glucose levels have been changing makes it possible for users and their healthcare team to take appropriate actions and make therapy adjustments.

The FreeStyle Libre system is a new and user-friendly way to discreetly obtain glucose readings. The FreeStyle Libre system offers benefits of both CGM and BGM – on one hand it provides a complete picture of glucose variations while on the other, it allows users to get their current glucose readings in a flash by just scanning the reader over the Sensor.

What benefit will FreeStyle Libre Flash Glucose Monitoring provide to patients?

One of the primary reasons patients do not check their blood glucose as often as they should is the pain and inconvenience associated with current blood glucose monitoring systems.1 Blood glucose monitoring is indiscreet and involves many hassles and inconveniences including finger pricks. Flash Glucose Monitoring is designed to provide a solution to easily, quickly and discreetly capture complete glucose information with a simple scan.

1Hortensius, Johanna., et al. Perspectives of patients with type 1 or insulin-treated type 2 diabetes on self-monitoring of blood glucose: a qualitative study. BMC Public Health 12.1 (2012):167.

For which diabetes patients can FreeStyle Libre Flash Glucose Monitoring 
 be used?

Flash Glucose Monitoring is designed as a useful tool for all people with diabetes, especially for those who are using insulin. It is designed as an alternative to blood glucose monitoring*.

*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 hypoglycemia or impending hypoglycemia is reported by the system or when symptoms do not match the system readings.

What benefit will Flash Glucose Monitoring provide to HCPs?

For HCPs, Flash Glucose Monitoring is designed to be an easy way to provide patients' complete glycemic picture for more informed treatment decisions while supporting a dialogue between the HCP and their patient.

Why does the system require a one-hour warm up period?

Abbott’s Diabetes Care Division is committed to making its products safe for the user. Soon after the insertion of a Sensor, there are physiological processes that happen as the Sensor and the body equilibrates. These processes are part of the body's natural response to the Sensor insertion. The equilibration process can vary from one person to another and may not always happen in the same manner for any one person. Therefore, we have decided to let the system equilibrate for 1 hour to ensure that the system is providing accurate glucose readings.

Can I start a 2nd Sensor when I have less than 24 hours left on my old Sensor?

No, the FreeStyle Libre Reader can only be connected to a single Sensor. At the completion of the Sensor-wear, a new Sensor can then be started.

Can the FreeStyle Libre system be prescribed for children?

Yes. The indication for children (age 4 – 17) is limited to those who are supervised by a caregiver at least 18 years old who is responsible for supervising, managing, and assisting the child in using the FreeStyle Libre system and interpreting its readings.

Is the FreeStyle Libre system used by adults the same for children?

Yes, the same system is used for both children and adults.

Where should the FreeStyle Libre Sensor be applied to a child or young person?

The FreeStyle Libre Sensor is approved for use on the back of the upper arm.

Can the FreeStyle Libre system be prescribed for pregnant women with diabetes?

Please refer to the Indications for Use in the FreeStyle Libre system User’s Manual to determine if the system is indicated for pregnant women with diabetes in your country.

Can the FreeStyle Libre system be used by dialysis patients?

The FreeStyle Libre system has not been evaluated for use by persons on dialysis.

What substances could interfere with the results generated by the FreeStyle Libre system?

Ascorbic acid and salicylic acid may interfere with the Sensor glucose readings. Taking ascorbic acid while wearing the Sensor may falsely raise the Sensor glucose readings. Taking salicylic acid may slightly lower the Sensor glucose readings. The level of inaccuracy depends on the amount of the interfering substance active in the body.

Does acetaminophen alter the glucose readings of the FreeStyle Libre System?

The FreeStyle Libre system has no contraindications or warnings for acetaminophen use.

In vitro study was conducted to examine the effect of acetaminophen (Tylenol), on FreeStyle Libre Sensor glucose readings. However, the effect of this substance in vivo has not been studied and may differ.

The finding is as follow: Acetaminophen was tested at a concentration of 20 mg/dL (or 1.1 mmol/L) in glucose- containing solution (10 times the maximum of the therapeutic range for acetaminophen) and demonstrated minimal impact on reported Sensor glucose values.*

*Acetaminophen Interference on ISF Based Glucose Monitoring Systems Alva, S., Chen, T., Naegeli, A. poster presented at DTT 2017.

Do users have to remove the Sensor during MRI/CT scan?

If the user has a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X- ray, MRI (Magnetic Resonance Imaging), or CT (Computed Tomography) scan, they need to remove the Sensor they are wearing and apply a new Sensor after the appointment. The effect of these types of procedures on the performance of the system has not been evaluated.

I have a Pacemaker. Will the FreeStyle Libre system interfere with my pacemaker?

Performance of the FreeStyle Libre system when used with other implanted medical devices, such as pacemakers, has not been evaluated, therefore a person wearing a pacemaker should not use the FreeStyle Libre system.

Do users need a separate blood glucose meter when using FreeStyle Libre system?

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

How can the FreeStyle Libre system be used to make informed diabetes management decisions?

HCPs can make more informed treatment decisions because they get a complete glycemic picture from the FreeStyle Libre system reader reports and LibreView.

Users can better understand the impact of their actions like food, exercise, and insulin on their glucose levels. They can also make day-to-day therapy decisions (based on HCP recommendations) using the FreeStyle Libre system.

Can the doctor access my glucose results or reports remotely e.g. over the internet or cloud?

For markets with LibreView

Yes, you may upload data into LibreView and allow your healthcare professional to access the reports.

Has the FreeStyle Libre system been tested in (a) water and (b) sea water?

a. The FreeStyle Libre system was tested to IP27 standards and can be used while swimming, up to 1 meter for up to 30 minutes.

b. The FreeStyle Libre system has not been tested in seawater. There is no reason to expect performance in seawater would be different from fresh water as the salinity would not affect the ability of water to get in to the Sensor.

Are there any clinical studies that support the use of the FreeStyle Libre system?

The FreeStyle Libre system has been studied in two landmark randomized controlled trials (RCTs) which demonstrated improvements in diabetes outcomes for both Type 1 and Type 2 patients with diabetes, those are: Bolinder J, et al. Novel glucose-sensing technology and hypoglycemia in type 1 diabetes a multicentre, non- masked, randomized controlled trial. The Lancet 2016.

Haak T, Hanaire H, Aijan R et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicentre, open-label randomised controlled trial. Diabetes Ther. 2016.

Does the FreeStyle Libre system connect with an insulin pump?

The FreeStyle Libre system does not currently communicate with an insulin pump. However, as with any new technology, Abbott is researching a wide variety of potential applications.

Will the FreeStyle Libre system be compatible with smartphones?

For markets without FreeStyle LibreLink, LibreView

Not at this time. However, as with any new technology, including mobile applications, Abbott is researching a wide variety of potential applications.

Can the FreeStyle Libre system be used on animals?

The FreeStyle Libre system has not been evaluated for use with animals hence it is not indicated for use.

System Components

What components are included in the FreeStyle Libre system?

The FreeStyle Libre system has two main parts: a handheld reader and a disposable Sensor, which is worn on the back of the upper arm. The user wirelessly scans the Sensor with the reader to get glucose readings.

  • The small, disposable Sensor is worn on the back of the upper arm and continuously measures glucose for up to 14 days
  • The compact, handheld reader displays a current glucose reading, 8-hour history, an arrow showing the direction in which the users glucose is heading and stores up to 90 days of glucose data.* The user can also view reports on the reader as well as enter notes.

*Based on the Sensor being replaced once every 14 days and scanned once every 8 hours.

What kind of cleaning or disinfection procedure is required to use the 
 FreeStyle Libre system?

The Sensor is intended for single-use and does not require cleaning and disinfection. You may clean the reader using a cloth dampened with a mixture of 1 part household bleach to 9 parts water. Gently wipe the exterior of the reader and allow to air dry.

Does the FreeStyle Libre system contain latex?

The FreeStyle Libre system does not contain any latex (other questions about adhesive, Sensor content should be directed to Scientific Affairs).

I’m traveling – can I get a Sensor from a different country? Will it work 
 with my reader?

The FreeStyle Libre reader/sensor is only compatible with the FreeStyle Libre sensor / reader purchased through Abbott official stores / authorized stores or dealers in the Philippines. If you are travelling, it is advisable to ensure that you take enough Sensors with you to last the duration of your trip.

Accuracy

How accurate is the FreeStyle Libre system?

The FreeStyle Libre system has been clinically proven to be accurate, stable, and consistent over 14 days. It does not require finger prick calibration and may be used in place of routine finger prick glucose testing.1*

1Bailey, et al. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technology & Therapeutics, Volume 17, Number 11, 2015.

*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 hypoglycemia or impending hypoglycemia is reported by the system or when symptoms do not match the system readings.

What substances could interfere with the results generated by the FreeStyle Libre system?

  • Use of products containing ascorbic acid and salicylic acid on the Sensor location may interfere with the Sensor glucose readings.
  • Taking ascorbic acid while wearing the Sensor may falsely raise the Sensor glucose readings.
  • Taking salicylic acid may slightly lower the Sensor glucose readings.
  • In either case, the level of inaccuracy depends on the amount of the interfering substance active in the body.

Is the accuracy of the Sensor consistent over the 14-day wear period?

Yes, the accuracy of the Sensor remains consistent for up to 14 days. The FreeStyle Libre system is clinically proven to be highly accurate, stable, and consistent over 14 days with no finger prick calibrations

Calibration

How is the FreeStyle Libre system calibrated?

The FreeStyle Libre system is a factory-calibrated Sensor that has been proven to safely and successfully replace routine self-monitoring of blood glucose (SMBG) and deliver important clinical benefits.1,2 Specific details about our calibration process are proprietary.

1Bolinder, et al. Novel glucose-sensing technology and hypoglycemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The Lancet, published online 12 Sep16.

2Haak T, Hanaire H, Aijan R et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicentre, open-label randomised controlled trial. [published online ahead of print December 20, 2016]. Diabetes Ther. 2017;8(1):55-73. doi:10.1007/ s13300-016-0223-6.

Why doesn’t the FreeStyle Libre system need calibrating?

Unlike other sensor-based glucose monitoring systems that are currently available, the FreeStyle Libre Sensor is factory calibrated and requires no finger prick calibrations during the 14-day wear period. FreeStyle Libre system is a factory calibrated Sensor that has been proven to safely and successfully replace SMBG and deliver important clinical benefit. Specific details about our calibration process are proprietary.

Does the Sensor need to be calibrated?

No finger prick calibration is required. Unlike other sensor-based glucose monitoring systems that are currently available, the FreeStyle Libre Sensor is factory calibrated. Once activated, the Sensor starts recording glucose readings automatically after the 1-hour warm-up period.

Interstitial Fluid vs Blood Glucose

Is interstitial fluid (ISF) a reasonable alternative for blood? What about the lag?

ISF is a reasonable alternative for blood. Glucose can be measured in the ISF–the fluid around the body’s cells where glucose freely diffuses from capillaries to the interstitial space.1 The physiological delay in ISF glucose with respect to changes in blood glucose is about 5-10 minutes2 which is unlikely to impact routine day-to-day treatment decisions. The average lag time of the FreeStyle Libre system is approximately 5 minutes.3

1Rebrin K, Steil GM. Can interstitial glucose assessment replace blood glucose measurements? Diabetes Technol Ther. 2000;2(3):461-472.

2Rebrin 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.

3Data on File, Abbott Diabetes Care Inc, Clinical Report: Evaluation of the Accuracy of the Abbott Sensor-Based Interstitial Glucose Monitoring System 2014.

What are the differences between interstitial fluid (ISF) and blood glucose (BG) readings?

Glucose levels can be measured from the bloodstream, or from the interstitial fluid (ISF), which surrounds the body’s cells. There is a 5- to 10-minute delay in ISF glucose response to changes in blood glucose,1 which is unlikely to impact routine day-to-day treatment decisions. The average lag time of the FreeStyle Libre system is approximately 5 minutes.2

ISF glucose and BG measurements taken simultaneously won’t always match, and are likely to be different.

1Rebrin 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.

2Data on File, Abbott Diabetes Care Inc, Clinical Report: Evaluation of the Accuracy of the Abbott Sensor-Based Interstitial Glucose Monitoring System 2014.

Software and Reports

What types of reports are available on the reader, if any?

A variety of reports are included on the reader:

  • Average Glucose is information about the average of your Sensor glucose readings. The overall average for the time is displayed above the graph. The average is also shown for four different 6-hour periods of the day. Readings above or below your Target Glucose Range are orange, while readings in range are blue. This information can be viewed for the last 7, 14, 30 or 90 days.
  • Daily Patterns is a graph showing the pattern and variability of your Sensor glucose over a typical day. The thick black line shows the median (midpoint) of your glucose readings. The gray shading represents a range (10-90 percentiles) of your Sensor readings. Note: Daily Patterns needs at least 5 days of glucose data before displaying results. This information can be viewed for the last 7, 14, 30 or 90 days.
  • Time In Target is a graph showing the percentage of time the users Sensor glucose readings were above, below or within their Target Glucose Range. This information can be viewed for the last 7, 14, 30 or 90 days.
  • Low Glucose Events is information the number of low glucose events measured by your Sensor. A low glucose event is recorded when the users Sensor glucose reading is lower than 70 mg/dL (3.9 mmol/L) for longer than 15 minutes. The total number of events is displayed above the graph. The bar graph displays the low glucose events in four different 6-hour periods of the day. This information can be viewed for the last 7, 14, 30 or 90 days.
  • Daily Graph is a graph of your Sensor glucose readings by day. The graph shows users Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered. These reports are all constructed from historical glucose data – no real-time scan results or strip readings.
  • Log Book shows entries for each time users scanned their Sensor or performed a blood glucose or ketone test. Users can touch the entry to review the detailed information, including any Notes entered. Users can add or edit (change) Notes for the most recent Logbook entry, provided their glucose reading was within the last 15 minutes and they have not used software to create reports.
  • Sensor Usage information shows how often users scan their Sensor. The reader reports an average of how many times users scanned their Sensor each day and the percentage of possible Sensor data the reader recorded from their scans over a time period (7,14, 30, 90 days).

 

Is the FreeStyle Libre software required for me to use the FreeStyle Libre system?

No, the FreeStyle Libre software is not required to use your FreeStyle Libre system, but it can help you more easily spot trends and patterns in your data.

What type of reporting software is compatible with the FreeStyle Libre system?

The FreeStyle Libre system is compatible with FreeStyle Libre software and, in some markets, the LibreView data management application. Product availability may vary by market.

How much does the FreeStyle Libre software cost?

The software is free of charge and does not expire so you can use it for as long as you like.

What are the system requirements for the software?

System requirements for the FreeStyle Libre software include a computer running one of the following operating systems

  • Microsoft Windows 7 (32/64)
  • Microsoft Windows 8 (32/64)
  • Microsoft Windows 10 (32/64)
  • macOS High Sierra

At minimum, a computer with a USB 2.0 compatible hub with a dual-core 1.6GHz processor and 2 GB RAM is required.

What type of reports does the software generate?

  • Snapshot - Summary of the glucose, Sensor usage, carbohydrate, and insulin data within the selected timeframe and estimated A1c.
  • Glucose Pattern Insights - Shows glucose over the “typical” day based on all days within the selected timeframe. It includes an assessment of Glucose Control Measures and the Ambulatory Glucose Profile.
  • Daily Patterns - Shows glucose, carbohydrate and insulin data over the “typical” day based on all days within the selected timeframe. It includes the Ambulatory Glucose Profile (AGP).
  • Mealtime Patterns - The Mealtime Patterns report shows glucose, carbohydrate and insulin data for “typical” meals based on all food notes within the selected timeframe.
  • Monthly Summary - The Monthly Summary report shows glucose and Sensor usage data in a calendar format for each month within the selected timeframe.
  • Weekly Summary - The Weekly Summary report shows daily glucose, carbohydrate, insulin, and other data in a weekly format for each week within the selected timeframe.
  • Daily Log - The Daily Log report shows the detailed glucose, carbohydrate, insulin, and other data for each day within the selected timeframe. This report is the only one that includes strip test results.
  • Reader Details - The Reader Details report shows the current settings on the Reader and any changes to the settings over the last 30 days.

Note: Consult the software “User’s Manual” or your healthcare professional if you are having difficulty understanding or using the reports.

What is eA1c?

eA1c is an estimated value for A1c based on the average Sensor glucose over the timeframe selected. eA1c is calculated using a formula from the published reference below.1 eA1c is not meant to replace or predict the A1c tested in a laboratory. Instead, you can use this value to monitor changes to eA1c over time. With the FreeStyle Libre system, a minimum of 5 days of data is required to product an eA1c.

1Nathan DM, Kuenen J, Borg R, et al. Translating the A1C assay into estimated average glucose values. Diabetes Care. 2008;31:1473-1478.

What is Ambulatory Glucose Profile?

The Ambulatory Glucose Profile (AGP) graph, found on several reports, provides a visual reference for changing glucose levels over time. Sensor glucose data of 5 days or more are combined and plotted into a single 24-hr chart. By plotting data this way, you can see patterns of variability that may be common to a specific time of day.

Why is the Ambulatory Glucose Profile (AGP) an important tool when assessing glucose?

AGP is a visual snapshot of a patient’s typical day using dense glucose data revealing hypoglycemic and hyperglycemic trends behind A1c results to facilitate better patient therapy and interaction.

  • Glucose variability in addition to A1c result may be a more reliable indicator of glycemic control than A1c alone.1
  • AGP goes beyond A1c by revealing hypoglycemia, hyperglycemia and glucose variability.
  • The most important identified aspect of AGP is that it reveals glucose variability, post-prandial glucose excursions and hypoglycemic trends.2
  • High glucose variability can lead to increased risk for hypoglycemia. This is because efforts to control the highs can result in dangerous lows at the other side of the range.3,4
  • AGP reveals glucose variability by 2 measures. The distance between the 10th and 90th percentile curves show how widely glucose readings have varied at that time of the day. A median curve that rises and falls shows glucose instability across the day.

1Hirsch I and Brownlee M. Should minimal blood glucose variability become the gold standard of glycemic control? Journal of Diabetes and its Complications, 2005:19:178-181.

2Kohnert K. Vogt L. Salzsieder E. Advances in understanding glucose variability and the role of continuous glucose monitoring. Eur Endocrinol. 2010: 6:53-56.

3Bergenstal RM, Ahmann AJ, Bailey T, et al. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the ambulatory glucose profile (AGP). Diabetes Technol & Ther. 2013;15(3):198-211.

4Data on file. Abbott Laboratories Limited.

Am I able to share my data from the FreeStyle Libre system with my Healthcare Professional?

You are encouraged to always share your data with your healthcare professional so that they can better work with you to manage your daily routine. The FreeStyle Libre software is free to download and use by you and your health care professional.

How many Notes can I add or create?

There are 5 standard notes and 6 custom notes that you can create for a total of 11 notes.

How many Reminders can I add or create?

You can create up to 12 reminders.

What do I need to do to access LibreView?

LibreView lets you create clear, easy-to-understand glucose reports, and allows you to share them with your healthcare professional. LibreView is free and only takes a few minutes to sign up and get started.

To use LibreView, you will need to connect the glucose device to any Windows PC or Mac computer with an Internet connection. Log in with your credentials and then follow the on-screen instructions to upload data.

Your glucose data is stored securely in LibreView, through which you can also share it with your healthcare professional.

How is the Sensor applied to the body?

The Sensor is applied to the back of the upper arm with a simple, disposable device called an applicator. When the Sensor is applied, a small (5mm) filament is inserted just under the skin, and held in place with a small adhesive pad. Most patients don't feel pain when applying the FreeStyle Libre Sensor.

Data on file. In a study conducted by Abbott Diabetes Care, 93.4% of patients surveyed (n=30) did not feel discomfort under the skin while wearing the Sensor.

How big is the Sensor?

The Sensor is 5mm in height and 35 mm in diameter.

When applying the Sensor to my arm, do I need to stretch or pinch the skin?

No. Apply Sensors only on the back of your upper arm. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). Choose a site that is at least 2.5 cm (1 inch) away from an insulin injection site. To prevent discomfort or skin irritation, you should select a different site other than the one most recently used. For more information, please refer to the FreeStyle Libre user’s manual.

What if I have a hairy arm and have trouble applying the Sensor?

The site selected on the back of the upper arm should be clean-shaven.

Can the Sensor be applied to tattooed skin?

Yes, there is no interaction expected between tattoo ink and the Sensor. It is advised to avoid areas with scars, moles, stretch marks or lumps when applying the FreeStyle Libre Sensor.

Can the Sensor be used at altitudes > 10,000 feet (3,048 meters)?

Sensor performance has been tested to 10,000 feet (3,048 meters) only and is not indicated for use in altitudes > 10,000 feet (3,048 meters). It is not indicated for use above 10,000 feet (3,048 meters).

What happens if the FreeStyle Libre Sensor is worn beyond 14 days?

The Sensor automatically stops collecting glucose data and should be removed 14 days after being started.

Will the user feel the Sensor while wearing it?

The portion of the Sensor that gets inserted under the skin is less than 0.4 millimeter wide (1 mm is about the thickness of a few strands of human hair) and it’s inserted only about 5 mm under the skin, so most people will not feel the Sensor while it is being worn.

Data on file. In a study conducted by Abbott Diabetes Care, 93.4 % of patients surveyed (n=30) did not feel discomfort under the skin while wearing the Sensor.

Should the Sensor be removed if there is bleeding?

If there is bleeding that does not stop, remove the Sensor, and apply a new one at a different site.

Is it necessary to apply a Sensor in a different location if I feel discomfort or in case of a mis-application?

To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.

What are the potential skin reactions with the FreeStyle Libre system?

Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under your Sensor, remove the Sensor and stop using the FreeStyle Libre system. Contact your healthcare professional before continuing to use the FreeStyle Libre system.

What do I do if there is bruising around my sensor?

Applying the sensor may cause bruising or bleeding. If there is bleeding that does not stop, remove the Sensor, and apply a new one at a different site.

Can users bathe, shower, swim or exercise while wearing a Sensor?

Yes. The Sensor can be worn while bathing, showering, swimming or exercising. The Sensor should not be taken below 1 meter of water (3 feet), and should not be submerged in water for more than 30 minutes. The adhesive is designed to keep the Sensor securely and comfortably in place for up to 14 days.

Is there any problem with the Sensor if you sweat a lot?

Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. If your Sensor comes loose, you may get no readings or unreliable readings, which may not match how you feel. If this should happen apply and start a new Sensor.

Can an over-bandage be used with the Sensor?

Medical grade adhesive bandage or tape can be used. When using an over-bandage, it must be applied at the time of Sensor application. The opening/hole in the center of the Sensor must not be covered. Additional bandages/tape can be applied but do not remove bandages/tape once applied until Sensor is ready for removal.

How long can the Sensor be worn?

The disposable Sensor is designed to adhere to the back of the upper arm and provide accurate glucose readings for up to 14 days. After the 14 days, the user removes the Sensor by peeling off the adhesive pad.

Would the Sensor’s life be the same if the time on the reader is changed? 
 For example, if someone is travelling and needs to go forward in time for 6 hours, would the sensor end 14 days minus 6 hours?

No, the wear time of the FreeStyle Libre Sensor is not impacted by the clock setting on the FreeStyle Libre reader. The timer used for wear duration in the FreeStyle Libre Sensor is independent of clock time on the FreeStyle Libre reader.

How do you remove the Sensor?

Pull up the edge of the adhesive that keeps your Sensor attached to your skin. Slowly peel away from your skin in one motion. Note: Any remaining adhesive residue on the skin can be removed with warm soapy water, baby oil, or isopropyl alcohol.

What if the user needs to remove the Sensor before 14 days (or if it falls off)?

A Sensor that has been removed or that has fallen off cannot be reused. Users should replace the Sensor and start a new Sensor. The reader will identify that it is a new Sensor and ask users if they want to start it.

What happens to the Sensor after the 14-day wear period?

After 14 days of wear, the reader notifies the user that the Sensor has ended. The Sensor automatically stops collecting glucose data and should be removed. The reader displays the number of days before the sensor ends. Three days before the Sensor ends, it tells users with the first scan of each day. In the final 8 hours, it tells users with each scan that the Sensor should be replaced with a new Sensor.

Can users get a glucose reading through their clothing?

Yes, users can get glucose readings even through clothing by scanning the reader over the Sensor. The reader can capture data from the Sensor when it is within 1 cm to 4 cm of the Sensor.

How many glucose readings can be taken while the Sensor is being worn?

Users can take as many glucose readings as they want while the Sensor is being worn. In order to get a 24 hour glycemic picture users need to scan at least once every 8 hours. The value is updated every minute.

How frequently does the Sensor capture and store glucose readings?

The FreeStyle Libre Sensor automatically reports the glucose concentration in the interstitial fluid every minute. It also automatically records the glucose concentration every 15 minutes, storing that data in a rolling 8-hour log. When the Sensor is scanned by the reader, the Sensor automatically transmits data to the reader via radio frequency identification (RFID) communication, conforming to the ISO 15693 RFID standard.

When I scan my Sensor, the FreeStyle Libre reader says “Sensor Ended” but I have not worn my Sensor for 14 days yet?

If for any reason the Sensor stops working, please call Customer Service.

What happens to the Sensor if it is worn outside of the recommended temperature range?

If the Sensor stops working due to extreme temperature, the user will get an error message indicating ‘Glucose Reading unavailable’. The FreeStyle Libre operating temperature range is 10°C to 45°C.

Can the FreeStyle Libre system be used during a flight?

If restricted by flight regulations, we recommend that readers be powered off during a flight and not used for scanning a Sensor. Aviation regulations dictate that a flight crew may decide that they do not want any electronic devices powered on during a flight regardless of device. In general, the FreeStyle Libre system is not restricted by flight regulations and can be used since it meets the RTCA guidance of use of medical devices on planes.

The strip port on the reader can be used to take blood glucose or ketone readings during flight. Turning on the reader with the Home Button will activate the radio. Users must turn on the reader by inserting a test strip to avoid activating the radio.

What is the FreeStyle Libre Sensor shelf life?

Please refer to Sensor packaging for the expiry date. If customer has multiple Sensors, they should use the shortest date first. Check with your demand planner to confirm shelf life for your country.

Does the expiration date indicate the last day the user can apply the Sensor or the last day it can be used?

The expiration date indicates the last day you can use the Sensor. Do not use the FreeStyle Libre Sensor past the expiration date. If your Sensor expires during the 14-day wear, start a new Sensor before the Sensor expires.

During what situations/scenarios would one get "Check Sensor" messages?

The Check Sensor message occurs when the user tries to check glucose and the Sensor does not seem to be “active”. This usually means that the Sensor has come loose or has not been applied properly. If it appears to be applied properly, the user should try starting it again. This message will not appear once a glucose result appears.

How frequently does the reader need to be recharged?

There is a battery icon on the reader which will indicate battery life. With normal use, the reader can be used for approximately 7 days before it needs to be recharged. A Low Battery warning will appear on the reader when it needs to be recharged. A Low Battery message accompanies a result when users have enough charge remaining for about one day of use. Users can scan their Sensor when the battery is low and when charging the reader.

Can the reader be used while charging?

The reader can be used while charging via an electrical outlet but cannot be used while charging via a computer. The ability to perform a blood glucose test via a test strip is disabled when the FreeStyle Libre reader is connected via the USB cable and adapter.

What happens if the reader runs out of power? Do you lose glucose readings if the reader runs out of power?

The reader needs to be recharged if it runs out of power. The stored glucose readings on the reader are not lost.

How long does it take to completely charge the reader?

The reader should fully charge in approximately 3 hours if the battery is completely discharged.

Does the reader automatically turn off?

For most screens, the reader dims after 45 seconds and turns off after 60 seconds. When doing a finger prick test, removing the test strip will turn off the display.

Can the reader communicate with more than one Sensor at any given time?

No, if the Sensor is already activated by another reader use of that Sensor is not allowed. The reader can only communicate with one Sensor at a time. “Sensor already in use” will be displayed.

What will happen if users do not scan the reader over the Sensor in an 
 8-hour period?

Users will start losing the oldest glucose readings if the reader is not scanned at least once during an 8-hour period. For example, users scan the reader over the Sensor at 13:00 and scans again at 22:00 then users will lose glucose data from 13:00-14:00. The reader will indicate this missing data on reports. There will be a gap on the Daily Trace that impacts the statistics on Sensor usage however it will not be indicated in other reports.

Can users Add/Edit notes to any scan within 15 minutes or just last scan only?

Users can only add/edit notes associated with the last scan or last blood glucose strip test within 15 minutes.

What does LO mean when it appears after users scan the reader over the Sensor?

If LO appears on the reader when users scan the reader over the Sensor, it means the reading is lower than 40 mg/dL (2.2 mmol/L). Users can touch the message button for more information. Users should check their blood glucose on their fingertip with a test strip. If users get a second LO they should contact their healthcare professional immediately.

What does HI mean when it appears after scanning the reader over the Sensor?

If HI appears on the reader when users scan over the Sensor it means the reading is higher than 500 mg/dL (27.8 mmol/L). Users can touch the message button for more information. Users should check their blood glucose on their fingertip with a test strip. If users get a second HI they should contact their healthcare professional immediately.

What is a Trend Arrow? How does it work? What does it tell users?

The FreeStyle Libre system offers a Trend Arrow with each glucose reading which tells users which way and how quickly glucose levels are changing. So, at any given time, users not only know what their glucose level is currently, but also which way it is heading. Depending on the direction of the trend arrow, users can find out if their glucose levels are changing gradually, moderately, or rapidly, facilitating decision-making.

What does HI mean when it appears after scanning the reader over the Sensor?

If HI appears on the reader when users scan over the Sensor it means the reading is higher than 500 mg/dL (27.8 mmol/L). Users can touch the message button for more information. Users should check their blood glucose on their fingertip with a test strip. If users get a second HI they should contact their healthcare professional immediately.

Glucose trend arrow

The direction in which glucose is heading

Arrow pointing upGlucose is rising quickly (more than 2 mg/dL (0.1 mmol/L) per minute)
Arrow pointing slightly upGlucose is rising (between 1 and 2 mg/dL (0.06 and 0.1 mmol/L) per minute)
Arrow pointing to the rightGlucose is changing slowly (less than 1 mg/dL (0.06 mmol/L) per minute)
Arrow pointing slightly downGlucose is falling (between 1 and 2 mg/dL (0.06 and 0.1 mmol/L) per minute)
Arrow pointing downGlucose is falling quickly (more than 2 mg/dL (0.1 mmol/L) per minute)

Does the FreeStyle Libre system have alarms?

The FreeStyle Libre system notifies you of a low/high event only when you scan your Sensor with your reader. It does not have automatic alarms/alerts.

What is the usable life of the FreeStyle Libre Reader?

The typical use of the FreeStyle Libre Reader is 3 years.

Abbreviation: A1c: glycated haemoglobin.

References: 1. American Diabetes Association. Standards of Medical Care in Diabetes—2022. Diabetes Care. 2022;45(Suppl 1). 2. Gibb FW, et al. Br J Diabetes. 2020;20(1):32-40. 3. Fokkert M, et al. BMJ Open Diab Res Care. 2019;7(1):e000809.

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