Flash Glucose Monitoring System
VIEW ANSWERS TO COMMONLY ASKED QUESTIONS ABOUT FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM
FreeStyle Libre allows for a painless1 way to check glucose by scanning the FreeStyle Libre sensor with a compatible smartphone2
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 radomised 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.
1) Rebrin 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.
2) Data on File, Abbott Diabetes Care Inc, Clinical Report: Evaluation of the Accuracy of the Abbott Sensor-Based Interstitial Glucose Monitoring System 2014.
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.
1) Hirsch 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.
2) Kohnert K. Vogt L. Salzsieder E. Advances in understanding glucose variability and the role of continuous glucose monitoring. Eur Endocrinol. 2010: 6:53-56.
3) Bergenstal 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.
4) Data on file. Abbott Laboratories Limited.
Research has shown that 14 days of glucose data is sufficient to produce daily glucose patterns with certainty approaching 90%.1,2
1) Bailey Timothy., et al. The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System. Diabetes Technology &Therapeutics.2015;17(11):787-794
2) Hoss, Udo.,Budiman, Erwin.Factory-Calibrated Continuous Glucose Sensors: The Science Behind theTechnology. Diabetes Technology & Therapeutics 19.S2 (2017): S-44
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).
1) Bolinder J, Antuna R, Geelhoed-Duijvestijn P, et al. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial [published online ahead of print November 5, 2016]. Lancet. 2016;388(10057):2254-2263. doi:10.1016/S0140-6736(16)31535-5.
2) Haak T, Hanaire H, Ajjan R, 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 [published online ahead of print December 20, 2016]. Diabetes Ther. 2017;8(1):55-73. doi:10.1007/s13300-016-0223-6.
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.
Your dietitian can help you determine a diet plan that can help you safely and effectively manage your weight.
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.
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.
Yes, the same system is used for both children from the age of 4 years and adults.