Abbott’s FreeStyle Libre – Transforming Glucose Monitoring Through Utter Simplicity, Fingersticks Aside!
In October, Abbott launched its highly awaited FreeStyle Libre Flash Glucose Monitoring system in Europe. This article discusses our experience wearing and using the device, its accuracy compared to the Dexcom G4 Platinum CGM, how European readers can get it, when we might see it in the US, and how it’s different from CGM.
FreeStyle Libre includes a very tiny glucose sensor (0.2 inches in length, about the thickness of a hair) worn under the skin and connected to a water resistant, plastic on-body patch the size of a one-dollar coin. To use FreeStyle Libre, users take a touchscreen reader device, hold it near (within 1.5 inches) the sensor patch, and wait for it to beep. While the upper arm seems like a very noticeable and perhaps annoying location, the sensor patch is so small and light that we forgot we were wearing it. Unlike traditional CGM, FreeStyle Libre does not continuously send real-time glucose data to the reader; rather, the sensor patch must be “scanned” with the reader to obtain the real-time glucose value, trend arrow, and trend graph. Abbott did an outstanding job of designing the scanning process to take less than three seconds.
There is a certain fun quality, cool factor, and psychological pleasure to scanning the sensor patch. Overall, FreeStyle Libre’s accuracy was downright impressive and seemed reliable enough for dosing insulin. The sensor technology in FreeStyle Libre is based off the highly accurate FreeStyle Navigator CGM, which originally launched in the US in 2008 and was discontinued in 2011.
On-device reports provide outstanding overview of recent glucose history and problem areas. The FreeStyle Libre reader takes Abbott’s FreeStyle Insulinx meter and adds a sharp color screen. The highlight of the reader is unquestionably the history menu, which includes a slew of excellent reports to understand glucose trends and problem areas. Average Glucose (displayed by time of day) – A great way to see if one six-hour chunk of the day is particularly problematic.
Daily graphs – An awesome way to scroll day-by-day and see the 24-hour trend graph obtained on that day. In presentations leading up to the launch, Abbott also promoted the Mac- and PC-compatible software that comes with FreeStyle Libre. FreeStyle Libre is available at online web-shops in seven European countries: UK, France, Germany, Italy, the Netherlands, Spain, and Sweden. Abbott is currently conducting an accuracy study of FreeStyle Libre in the US – more information is here. FreeStyle Libre incorporates elements of continuous glucose monitoring, such as a sensor placed under the skin, glucose values taken every minute, trend arrows, and downloadable data. FreeStyle Libre does not have alarms or alerts, since the glucose sensor data is not sent continuously to the reader device. FreeStyle Libre is “factory calibrated,” meaning users don’t have to enter any blood glucose meter values into the system. FreeStyle Libre is approved for dosing insulin except in three cases: when hypoglycemic, when glucose is changing rapidly, or when symptoms don’t match the system’s readings.
At just €59.90 (~$77 US) for the touchscreen reader and each 14-day sensor, FreeStyle Libre has a much lower cost relative to current CGM. Our mission is to help individuals better understand their diabetes and to make our readers happier & healthier. Our mission is to help individuals better understand their diabetes and to make our readers happier and healthier. The University of Georgia Veterinary Teaching Hospital now has iPro continuous glucose monitoring devices available for cats and dogs with diabetes mellitus. The iPro continuous glucose monitoring device features a small disposable sensor, about the size of a paper clip.
Three to five days after the sensor and recorder are put in place, they are removed and mailed to the veterinary teaching hospital.
With the devices, animals do not need to have blood drawn every two hours, and owners can keep their pets at home.
The biggest benefit is the information collected is more accurate with the monitor than with a standard blood test drawn every two hours. Murphy Hansen, a silky terrier who was diagnosed with diabetes five years ago, was outfitted with one of the devices to provide information about his blood glucose levels since he gets insulin shots three times a day. Pet owners are still responsible for keeping a log of food intake, insulin shots and exercise during the time the pet has the iPro.


Animal owners interested in learning more about continuous glucose monitoring should contact the teaching hospital through a referral from their family veterinarian. If you are logging in for the first time after June 29, 2015, you will need to create a new account. In order to make this long standing vision a reality one of the key components is a high quality continuous glucose monitor, providing high accuracy, long term operation and low calibration frequency. GluSense approach is significantly different from currently available CGM products – we develop a miniature implantable sensor that will be injected under the skin and will transmit accurate glucose measurements to an external wearable unit over a full year. The unique product is intended as a replacement for blood glucose meters, while giving patients many of the benefits of continuous glucose monitoring (CGM), including real-time glucose values, trend information and comprehensive reports.
In short, it is transformative compared to the limited information provided by traditional blood glucose meters, all in a package anyone can pick up and learn to use. The sensor remains inserted for 14 days and does not require fingerstick calibrations (it’s “factory calibrated”).
The insertion process took us less than 15 seconds, could be done with one hand, and passed the no-instruction-manual test with flying colors – (i) press sensor onto applicator; and (ii) press applicator onto upper arm. Once the 60-minute countdown ends, the system gives real-time glucose values and trend information.
The sensor patch stores up to eight hours of glucose data at a time (values are taken every minute).
Hitting the single button on the touchscreen reader immediately turns it on and brings up the “Scan Sensor” menu.
Each scan is accompanied by an encouraging “ding” sound, followed by seeing the data on the reader.
To test real-world accuracy, Adam wore the FreeStyle Libre at the same time as a Dexcom G4 Platinum sensor (calibrated twice per day).
The reader is small, light, and easy to navigate with a touchscreen, icon-based interface (check glucose, history, and settings). The software seeks to simplify glucose data analysis, both through a traffic light system (to identify problem areas) and a single one-page report called the Ambulatory Glucose Profile. The touchscreen reader (one time cost) and each 14-day sensor cost €59.90 (~$77 US) – significantly cheaper than paying cash for traditional CGM although definitely more expensive than several strips a day (what is covered for many type 2 patients). Rather, a scan of the sensor patch using the reader obtains the glucose data and trend information. After the sensor is started and worn for one hour, it can show glucose data points and trends. Dexcom and Medtronic CGM both require a prescription and have a longer on-boarding process (training, insurance verification, phone calls, etc.). The devices, commonly used for human patients with diabetes, are used to gather data on the patient’s response to insulin. The sensor is discarded, and the recorder is plugged into a computer where the data is downloaded and analyzed.
When blood is drawn repeatedly in a veterinary hospital setting, dogs and cats can get agitated, which can artificially increase glucose levels. With your help, we will provide a friendly, safe, easy to use place on the Web for everyone in the area to share not only opinions but also information of community interest. We give FreeStyle Libre an emphatic thumbs up and would recommend it to nearly anyone with diabetes, especially those on insulin who test their blood glucose frequently and want more actionable information than fingersticks alone can provide. After putting it on the upper arm and waiting one hour, it immediately begins reading glucose and trend information. The reader device displays reports on its screen that can be downloaded to Mac and PC-compatible software. Pain wise, Kelly found the upper arm insertion completely painless, and she tends to be very pain sensitive. Kelly’s sensor stayed on for all 14 days, and once the sensor session ended, it required a bit of force to remove. Adam averaged 11 scans per day during his wear and captured nearly 100% of the glucose data. It feels almost like magic to be cheating the hassle of traditional blood glucose meters, especially because there is no limit or cost associated with additional scans. He compared the real-time information generated by both devices to 46 blood glucose meter values taken over two weeks.
However, the fact that FreeStyle Libre maintains the accuracy of the Navigator  - but without fingersticks – represents a major accomplishment. It has a micro-USB port for recharging (we only needed two charges over two weeks of wear, though this depends on usage), and it can be downloaded to Mac or PC software.


The goal is to equip healthcare providers and patients with simple tools to better tailor and individualize their therapy. Abbott would then need to secure FDA approval of FreeStyle Libre, which would likely take at least 12 months.
Conversely, Medtronic and Dexcom CGMs require startup calibration, as well as daily calibrations to maintain the sensor’s accuracy.
By contrast, Medtronic and Dexcom users are currently supposed to confirm every CGM value with a fingerstick before dosing insulin.
Most US patients have reimbursement for CGM, so they pay less than that price; however, most European patients don’t have reimbursement for CGM, making FreeStyle Libre’s affordable price that much more notable. Once the sensor is in place, a small recorder about the size of a quarter is plugged into the other end of the sensor to collect data.
UGA veterinarians evaluate insulin levels and recommend changes, if necessary, in medication levels.
UGA faculty will analyze the resulting data and then can work with the referring veterinarian to manage diabetes treatment. One key point of difference from CGM is that FreeStyle Libre does not have high or low alarms, meaning it is not as ideal for those with lots of hypoglycemia or hypoglycemia unawareness.
FreeStyle Libre is approved for dosing insulin except in three cases when a fingerstick is recommended: when hypoglycemic, when glucose is changing rapidly, or when symptoms don’t match the system’s readings.
The system is currently available in Europe (pricing information below) for people with both type 1 and type 2 diabetes. Adam experienced a bit of pain, as the spot he chose did not have very much subcutaneous fat.
Adam’s sensor fell off on day 13, and he tends to be very active; by contrast, his Dexcom sensor only lasted until day 11, and that required additional taping.
Like viewing data on a CGM receiver, there is no limit to the number of scans that can be taken. The scanning process works through many layers of clothing, allowing for excellent discretion and flexibility. And importantly, FreeStyle Libre displays the number and trend arrow in black, no matter how high or low it is – it’s a very non-judgmental product, which takes some of the stress away from obtaining such detailed glucose data.
On average, FreeStyle Libre was only 12% different from the meter value, very similar to 13% for the Dexcom G4 Platinum (note: Adam was not using Dexcom’s new 505 software, released in November, which does improve the G4’s accuracy). Lag time between the meter value and the sensor value was similar with FreeStyle Libre and the Dexcom G4 Platinum – about five to ten minutes at most. The reader also includes a built-in FreeStyle blood glucose meter for the few cases where Abbott recommends a confirmatory fingerstick (hypoglycemia, fast rates of change, when symptoms don’t match the reader).
Payment for the system is out-of-pocket right now, though Abbott is currently enrolling participants for two clinical trials that should help support reimbursement throughout Europe. This makes CGM a more attractive choice for those with lots of hypoglycemia and hypoglycemia unawareness.
To ensure the device stays in place and the pet does not bother it, a snug garment is put on the animal. Abbott does plan to bring it to the US, though we estimate it won’t come stateside until at least mid-2016. However, for both Adam and Kelly, insertion was much easier, more intuitive, and less painful than inserting the Dexcom G4 Platinum and Medtronic Enlite sensors. From the home screen, you can also add tags to each scan, such as carbs, insulin, exercise, and customizable options.
Hypoglycemia is appropriately shown on the trend graph in bright red, however, to call attention to it.
In addition, both devices had a similar number of sensor values that were more than 20% off from the meter value (seven with FreeStyle Libre vs. However, those who are bothered by lots of alarms might prefer the design of FreeStyle Libre. The FreeStyle Libre sensor is very tiny – only 0.2 inches – making it over three times shorter (roughly) than the Dexcom and Medtronic devices. If so, you need a friend with a credit card based in one of the countries that it’s available, plus their ability to access the Freestyle Libre website in that country – plus, the ability to pay for this fascinating technology.



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Comments

  1. 31.03.2015 at 14:31:51


    When a patient is diagnosed with diabetes - whether low blood sugar - sort.

    Author: APT
  2. 31.03.2015 at 19:39:33


    Another symptom that occurs glucose level of 20 mg/dL mK, Burke J, Gustafson AB, et al.

    Author: 232