The FreeStyle Libre flash glucose monitoring system is the first product in the flash glucose monitoring category and is designed to liberate patients from the hassles of glucose monitoring and provide HCPs with deeper insights to make more informed treatment decisions.
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 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 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.
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 hypoglycaemia or impending hypoglycaemia is reported by the system or when symptoms do not match the system readings.
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.
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.
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 hypoglycaemia or impending hypoglycaemia is reported by the system or when symptoms do not match the system readings.
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 their patient.
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.
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.
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.
Yes, the same system is used for both children and adults.
The FreeStyle Libre Sensor is approved for use on the back of the upper arm.
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.
The FreeStyle Libre system has not been evaluated for use by persons on dialysis.
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.
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.
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.
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.
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.
HCPs can make more informed treatment decisions because they get a complete glycaemic 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.
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.
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 hypoglycaemia 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 radomised controlled trial. Diabetes Ther. 2016.
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.
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.
The FreeStyle Libre system has not been evaluated for use with animals hence it is not indicated for use.
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.
*Based on the Sensor being replaced once every 14 days and scanned once every 8 hours.
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.
The FreeStyle Libre system does not contain any latex (other questions about adhesive, Sensor content should be directed to Scientific Affairs).
The FreeStyle Libre reader/sensor is only compatible with the FreeStyle Libre sensor / reader purchased through Abbott official stores / authorized stores or dealers in Malaysia. If you are travelling, it is advisable to ensure that you take enough Sensors with you to last the duration of your trip. For further information, please contact Abbott Customer Service at 1800 88 2328.
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 hypoglycaemia or impending hypoglycaemia is reported by the system or when symptoms do not match the system readings.
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
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.
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.
A variety of reports are included on the reader:
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.
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.
There are 5 standard notes and 6 custom notes that you can create for a total of 11 notes.
You can create up to 12 reminders.
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 Sensor is 5mm in height and 35 mm in diameter.
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.
The site selected on the back of the upper arm should be clean-shaven.
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.
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).
There are a number of steps and recommendations that can help with sensor adhesion. You can learn more by viewing our Adhesion Guide
The Sensor automatically stops collecting glucose data and should be removed 14 days after being started.
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.
If there is bleeding that does not stop, remove the Sensor, and apply a new one at a different site.
To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.
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.
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.
Yes. The Sensor can be worn while bathing, showering, swimming or exercising. The Sensor should not be taken below 1 metre 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.
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.
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.
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.
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.
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.
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.
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.
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.
Users can take as many glucose readings as they want while the Sensor is being worn. In order to get a 24 hour glycaemic picture users need to scan at least once every 8 hours. The value is updated every minute.
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.
If for any reason the Sensor stops working, please call Customer Service.
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.
Please refer to Sensor packaging for the expiry date. If customer has multiple Sensors, they should use the shortest date first.
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 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.
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 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.
The reader needs to be recharged if it runs out of power. The stored glucose readings on the reader are not lost.
The reader should fully charge in approximately 3 hours if the battery is completely discharged.
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.
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 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.
Users can only add/edit notes associated with the last scan or last blood glucose strip test within 15 minutes.
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 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 direction in which glucose is heading
Glucose is rising quickly (more than 2 mg/dL (0.1 mmol/L) per minute)
Glucose is rising (between 1 and 2 mg/dL (0.06 and 0.1 mmol/L) per minute)
Glucose is changing slowly (less than 1 mg/dL (0.06 mmol/L) per minute)
Glucose is falling (between 1 and 2 mg/dL (0.06 and 0.1 mmol/L) per minute)
Glucose is falling quickly (more than 2 mg/dL (0.1 mmol/L) per minute)Note: The Glucose Trend Arrow may not always appear with your reading.
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.
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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