FAQ

FreeStyle Libre allows for a painless way to check glucose by scanning the FreeStyle Libre sensor with a compatible smartphone.

1) Haak, Thomas., et al. Flash glucose-sensing technology as a replacement for blood glucose monitoring for the management of insulin-treated type 2 diabetes: a multicenter, open-label randomized controlled trial. Diabetes Therapy 8.1 (2017): 55-73

2) The FreeStyle LibreLink app and the FreeStyle Libre reader have similar but not identical features. Finger pricks are required if readings do not match symptoms or expectations. The FreeStyle Libre sensor communicates with the FreeStyle Libre reader that started it or the FreeStyle LibreLink app that started it. A sensor started by the FreeStyle Libre reader will also communicate with the FreeStyle LibreLink app. The FreeStyle LibreLinkapp is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app.Use of FreeStyle LibreLink requires registration with LibreView.

The portion of the Sensor that gets inserted under the skin is less than 0.4 millimeter wide (1mm is about the thickness of a few strands of human hair) and it’s inserted only about 5mm 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

The FreeStyle Libre system has two main parts: a compatible smartphone or reader and a disposable Sensor, which is worn on the back of the upper arm. The user wirelessly scans the Sensor with the compatible smartphone or reader to get glucose readings.  The Sensor pack is used with the Sensor applicator to prepare the Sensor for use. The Sensor is applied to the back of the upper arm with the aid of the Sensor applicator.  The small, disposable, 14-day Sensor is worn on the back of the upper arm and continuously measures glucose.*

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

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: 

1) Bolinder J,et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes a multicentre, non-masked, randomized controlled trial. The Lancet 2016.

2) 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 randomized controlled trial. Diabetes Ther. 2016.

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, in fact, are likely to be different.

AGP is a visual snapshot of a patient’s typical day using dense glucose data revealing hypoglycaemic and hyperglycaemic 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 hypoglycaemia, hyperglycaemia 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 hypoglycaemia. 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 shows 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.

In clinical studies of the FreeStyle Libre System, an evaluation tool used was a Consensus Error Grid (CEG), a scatter chart divided into 5 performance zones. For the FreeStyle Libre system, 99.9%1 of the readings fell within the two desirable zones of the grid (Zones A and B). Results in Zones A and B have no effect on the clinical action (clinical accuracy) or the action would have little effect on the clinical outcome.

Research has shown that 14 days of glucose data is sufficient to produce daily glucose patterns with certainty approaching 90%.1,2

The FreeStyle Libre system is designed to replace routine blood glucose testing in the self-management of diabetes.1,2 The FreeStyle Libre system provides accurate results that you can rely on when you are making day-to-day therapy decisions (based on your health care provider’s recommendations).

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

Flash Glucose Monitoring is designed as an affordable and easy way to generate the dense glucose data needed for an insightful glycaemic 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 fingerstick calibration, no routine fingersticks* and that automatically measures, captures and stores 90 days of glucose data†.

*A fingerstick 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.

†Based on the Sensor being replaced once every 14 days and scanned at least once every 8 hours.

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.

The FreeStyle Libre system is clinically proven to be accurate, stable and consistent over 14 days with no fingerstick calibrations.  The FreeStyle Libre system has a 9.2 %1 MARD with 99.9%2 of readings in Zones A and B of the Consensus Error Grid.

1)FreeStyle Libre Performance Data Sheet

2) Data on file, Abbott Diabetes Care, Inc

The FreeStyle Libre Sensor is approved for use on the back of the upper arm for children older than 4 years and adults.

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.

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.  1 Bolinder, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The Lancet, published online 12 Sep 16.  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.

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

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.

Abbott Diabetes Care 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.

List of compounds tested and the level at which no interference seen*

*The maximum circulating/therapeutic concentration for ISF is not known. Data on file. Abbott Diabetes Care Inc.

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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.

You can scan your FreeStyle Libre sensor with the FreeStyle LibreLink app available on compatible smartphones (Apple and Android). Alternatively you can scan your FreeStyle Libre sensor using a FreeStyle Libre Reader.

The FreeStyle Libre system is clinically proven to be accurate, stable and consistent for up to 14 days without the need for fingerstick calibration. 

• The FreeStyle Libre Sensor is factory calibrated and manufactured with minimal Sensor-to-Sensor variation eliminating the need for fingerstick calibration. 
• To achieve stable performance, the FreeStyle Libre Sensor uses Wired Enzyme technology that :
  • Is not dependent on oxygen to produce glucose readings and
  • Allows the Sensor to operate at a very low electrical potential of 40mV vs a silver/silver chloride reference electrode.

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

There are no interfering substances.

The FreeStyle Libre Flash Glucose Monitoring System is designed to replace routine blood glucose monitoring*. The system represents one of the products in a new category of flash glucose monitoring, which is a type of continuous glucose monitoring system.  It is different from traditional continuous glucose monitoring systems which typically have alarms. This system may provide a good alternative for patients that are bothered by alarms or suffer from ‘alarm fatigue’ but still want real time glucose information. 

*A fingerstick 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.

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 into the Sensor.

At certain times, interstitial glucose levels, as measured by the Sensor and reported as current, may not accurately reflect blood glucose levels. A fingerstick 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.

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.

HCPs can make more informed treatment decisions because they get a complete glycaemic picture from the FreeStyle Libre system reader reports and the associated software reporting system.  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.

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 1.1mmol/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

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.

The FreeStyle Libre system does not contain any latex.

There are no limitations as to when to apply the Sensor.

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

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

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 it to air dry.

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

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).

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 health care professional before continuing to use the FreeStyle Libre system.

No, the FreeStyle Libre system does not automatically calculate insulin dosages.  However, you can log your insulin doses, along with other notes in the reader with your glucose readings.

The FreeStyle Libre system and the FreeStyle Libre Pro system are separate devices and are not compatible with each other.  The FreeStyle Libre system is a flash glucose monitoring system consisting of a handheld reader and a Sensor worn on the back of the upper arm designed to liberate patients from the hassles of glucose monitoring and provide HCPs with deeper insights to make more informed treatment decisions.  The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional flash glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The FreeStyle Libre Pro system is intended for use by health care professionals.

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.

Yes. The Sensor can be worn while bathing, showering, swimming or exercise. 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.

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.

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.

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.

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.

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

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

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.

If for any reason the Sensor does not work, an error message will appear on the reader prompting users to replace the Sensor.  Users should not ignore symptoms that may be due to low or high blood glucose. If users have symptoms that do not match the FreeStyle Libre system reading or if users suspect that their reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter. If users are experiencing symptoms that are not consistent with glucose readings, users should consult their healthcare professional.

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 FreeStyle LibreLink app or reader will identify that it is a new Sensor and ask users if they want to start it.  If a sensor falls off or stops working before the end of the 14 days, please contact the Abbott Diabetes Customer Support.

Please refer to Sensor packaging for the expiry date. If you have multiple Sensors, you should use the shortest date first.

To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.  The FreeStyle Libre sensor should be applied to the back of the upper arm.  No other site is indicated for application.

No, the user can get an updated glucose reading every minute when they scan the reader over the Sensor.

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 14 days, the user removes the Sensor by peeling off the adhesive pad. 

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.

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.

The flexible Sensor is introduced by a u-shaped sharp that is equivalent in diameter to a 23-gauge (0.64 mm) needle.

We have not conducted studies with FreeStyle Libre in tanning beds. Please consider that the sensor temperature operating is 10 °C to 45 °C. Additionally, excess sweating may loosen the adhesive.

Users can scan as often as they want, but the reading will never change more frequently than every 60 seconds.

The Sensor has limited storage capacity to keep the Sensor profile small. In the interest of preserving 8 hours for a typical overnight period, 15 minutes was chosen for the interval.

The FreeStyle Libre system has specific regulatory requirements that often vary by country.  Thus, FreeStyle Libre readers and Sensors purchased in one market may not be compatible with FreeStyle Libre readers and Sensors purchased in other markets. If you are traveling, it is advisable to ensure that you take enough Sensors with you to last the duration of your trip.

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 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.

The user is provided with one last opportunity to scan the Sensor after the 14 days have ended.  The reader will acquire any data still remaining on the Sensor that was obtained prior to the end of 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 14 days after being started. Time to Sensor end is shown on the Home and Results screens.  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. The Sensor should be replaced with a new Sensor.

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.

The FreeStyle Libre reader and the FreeStyle Libre Sensor can be exposed to common electrostatic (ESD) and electromagnetic interference (EMI), including airport metal detectors. You can keep your FreeStyle Libre Sensor on while going through these.  However, the FreeStyle Libre reader and the FreeStyle Libre Sensor should not be exposed to some airport full-body scanners (i.e. x-ray and millimeter radio-wave). To avoid removing your FreeStyle Libre Sensor, you should request another type of screening to be performed by the Security Officer.  If in doubt about the type of security scan you are passing through, notify the Security Officer prior to proceeding through the airport security checkpoint.

The Sensor pack and Sensor applicator need to match because the Sensor is factory calibrated.  Information about the calibration of the sensing element (also known as the Sensor tip) is programmed in the Sensor at the factory and these two components must be used together.

The FreeStyle Libre reader and the FreeStyle Libre Sensor can be exposed to common electrostatic (ESD) and electromagnetic interference (EMI), including airport metal detectors. Your FreeStyle Libre reader and Sensor can safely go through these when packed in luggage/carry-on or in the security tray. However, the FreeStyle Libre reader and the FreeStyle Libre Sensor should not be exposed to some airport scanners (i.e. x-ray and millimeter radio-wave). If in doubt about the type of security scan your FreeStyle reader and Sensor are passing through, notify the Security Officer prior to proceeding through the airport security checkpoint and request another type of screening to be performed by the Security Officer.

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.

The languages on the reader are country-specific and therefore vary from country to country.

The reader can be used while charging via an electrical outlet, but cannot be used while charging via 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.

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

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.

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

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. 

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 scan 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.

No, the reader does not automatically adjust for daylight savings.

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

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.

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.

If the time on the reader is changed by more than one hour, the scan results screen will not show data in the graph that was collected by the Sensor prior to the time change.  A clock icon will show on the display indicating this.  (The data is still logged by the reader and is used in calculations.) On the Daily Graph on the reader, moving forward in time will result in a gap in the graph; moving back in time will result in some data being suppressed.  In both cases, a clock icon will be shown indicating the time change.

The reader identifies what data is new with each scan and does not double-count any data.

The 8-hour graph will disappear, and a clock sign will appear indicating the time change.

If a user adds a food note or rapid acting insulin dose note, it will appear on the Sensor Glucose Results and Daily Results screens in the form of icons.

Sounds can be turned on/off in the Settings menu on the Reader. To get to the Settings menu, touch the Settings symbol on the Home Screen.

Confirmation Sound – The Confirmation tone is used upon the display of routine information and messaging such as the display of glucose results. This type of signal can follow a user engaged function of the system to provide confirmatory feedback to the user (e.g. successful scan of the Sensor.) 

Notification Sound – The Notification tone accompanies situations such as high or low glucose. The Notification signal is used at times where getting the user‘s attention is important to the resolution of system issues or patient health conditions. 

Reminder Sound – This tone is broadcast upon the display of a user defined reminder or during system conditions that do not necessarily require an immediate response from the user. 

Repeated Reminder – This signal is broadcast when a reminder is received or shows up on home button press. It vibrates for 30 seconds.

Confirmation Vibration Signal – The Confirmation vibration signal is a vibration alert that is used upon the display of routine information and messaging such as the display of glucose results. This type of signal can follow a user engaged function of the system to provide confirmatory feedback to the user (i.e. successful scan of the Sensor.) 

Notification Vibration Signal – The Notification vibration signal is a vibration alert that accompanies situations such as high or low glucose. The Notification signal is used at times where getting the user‘s attention is important to the resolution of system issues or patient health conditions. 

Reminder Vibration Signal – The Reminder vibration signal is a vibration alert that is broadcast upon the display of a user defined reminder or during system conditions that do not necessarily require an immediate response from the user. 

Repeated Reminder Vibration Signal – This is a vibration alert that is broadcast when a reminder is received or shows up on home button press. It plays for 30 seconds.

If HI appears on the reader when users scan over the Sensor it means the reading is higher than 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.

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.

If LO appears on the reader when users scan the reader over the Sensor it means the reading is lower than 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.

The FreeStyle Libre flash glucose monitoring system is not a blood glucose meter but a Sensor-based monitoring system to measure glucose levels in interstitial fluid. There is no current ISO standard for measuring glucose in interstitial fluid. The on-board blood glucose meter in the FreeStyle Libre reader does meet the ISO 15197 (2013) standard.

The user cannot add notes when doing a blood ketone test or control solution test.

The FreeStyle Libre flash glucose monitoring system is indicated for self-management of diabetes. This system is not for use in diagnosis of and screening for diabetes mellitus, but should be used for monitoring diabetes.

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

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

The FreeStyle Libre system is only approved for use on the back of the upper arm as this was used to collect data in our pivotal clinical studies.

Several studies have been conducted to support the accuracy of the FreeStyle Libre system:  The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System1 study (2015) evaluated the performance and usability of the FreeStyle Libre flash glucose monitoring system by comparing interstitial glucose results against fingerstick glucose results.  Both the IMPACT2 and the REPLACE3 studies showed that the FreeStyle Libre system could safely and successfully replace routine self-monitoring of blood glucose (SMBG) and deliver important clinical benefits.  Both the IMPACT2 and the REPLACE3 studies showed that the FreeStyle Libre system could safely and successfully replace routine self-monitoring of blood glucose (SMBG) and deliver important clinical benefits.  The REPLACE study produced results that were published online in Diabetes Ther in 2016.  2Bolinder, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomized controlled trial. The Lancet, published online, 12 Sept 16.  3Haak 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 randomized controlled trial. [published online ahead of print December 20, 2016]. Diabetes Ther. 2017;8(1):55-73. doi:10.1007/s13300-016-0223-6.

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.

For specific information about interactions between illness and your glucose levels, please contact your health care professional.

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 fingerstick calibrations.