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.

• 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.

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.

• 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.

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:

• 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).

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.