CGMs are quite expensive. It appears Abbott’s FreeStyle Libre is less expensive and quite promising. In Europe, 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. For example, Dexcom charges ~$885 for the starter kit and ~$72 per seven-day sensor.
Matt B has been testing FreeStyle Libre and according to him,
Glucose changes shown 9 minutes faster than Dexcom G4, and 6 minutes faster than the Dexcom G5.
afrezzadownunder.com/freestyle-libre/
FreeStyle Libre Pro Submitted for FDA approval, Potentially Coming to the US in 2016 8/7/15 - new now next
Twitter Summary:
@abbott submitted FreeStyle Libre Pro to @us_FDA, with high likelihood of approval in 2016. How a blinded 14-day sensor can help patients + healthcare team
What’s the latest scoop on Abbott’s FreeStyle Libre technology coming to the US?
Abbott’s quarterly update call revealed that the company has submitted the professional version of FreeStyle Libre for regulatory approval in the United States. If all goes well, the product might be approved and launched in 2016.
FreeStyle Libre Pro is a bit different from the patient version of FreeStyle Libre (available in Europe) that we tested in diaTribe in January. Libre Pro allows physicians to get continuous glucose data from patients over a two-week period. It consists of a small sensor (a bit larger than a US quarter dollar coin) worn on the arm.
After applying Libre Pro in the doctor’s office, it is worn for two weeks, and the sensor automatically records glucose values every 15 minutes. Patients then return to the doctor’s office, where the sensor is downloaded. Abbott has done a really good job of making the glucose data download easy to interpret, m
eaning healthcare providers and patients can quickly grasp what is going well and what may need improvement.
Unlike the FreeStyle Libre system currently available in Europe, the Pro version does not give patients a reader device to look at glucose values in real time. While that seems like an obvious drawback, it’s a key design choice for a few reasons:
Many patients don’t want to wear a sensor all the time; wearing this product occasionally (i.e., twice a year) could offer many of the benefits of more continuous glucose monitoring (i.e., more comprehensive glucose data to change therapy), but without having to wear a sensor all the time.
Professional glucose monitoring systems like FreeStyle Libre Pro are generally reimbursed well by insurance, including Medicare. Medicare does not currently reimburse real-time CGM.
Many patients change their behavior in response to seeing the real-time data. A blinded sensor like FreeStyle Libre Pro makes it more likely patients will stick to their normal routine – allowing providers to get a more realistic view of a patient’s day to day management.
The FDA approval process for FreeStyle Libre Pro should be easier than the real-time version, since patients can’t make insulin dosing decisions off the blinded system.
Of course, we are huge fans of arming patients with real-time knowledge about their glucose, and we’re very excited about a real-time unblinded, commercial version of FreeStyle Libre coming to the US. For now, it’s not clear when that might happen, though we assume it will come after Libre Pro launches.
The good news is that an FDA approval of FreeStyle Libre Pro might make the approval path for FreeStyle Libre easier. Our fingers are crossed! This US submission follows the Libre Pro’s launch in India earlier this year.
diatribe.org/freestyle-libre-pro-submitted-fda-approval-potentially-coming-us-2016#sthash.ToI4I4K2.dpuf
Abbott’s FreeStyle Libre – Transforming Glucose Monitoring Through Utter Simplicity, Fingersticks Aside!
1/9/15 - TEST DRIVE
diatribe.org/abbott-freestyle-libre-transforming-glucose-monitoring-through-utter-simplicity-fingersticks#sthash.thrfOWrW.dpufby Adam Brown and Kelly Close Twitter Summary:
Wearing Abbott’s #FreeStyleLibre, a 14-day sensor intended to replace glucose meters, but provide CGM-like info; now available in Europe In October, Abbott launched its highly awaited FreeStyle Libre Flash Glucose Monitoring system in Europe. 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. Though it is not yet approved in the US, we were able to test the product over the past month (the device can only be ordered online from websites in Europe). Given what we had heard from so many European bloggers,
we had high expectations going into our test, and FreeStyle Libre absolutely met them at every step – the system was easy to setup and use (a major win for healthcare providers); discreet to wear on the upper arm; accurate enough from which to dose insulin, with performance similar to Dexcom’s G4 Platinum CGM (though no fingersticks were required); and it gave an excellent picture of glucose trends through real-time and on-device 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.
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. 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.
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.
How the FreeStyle Libre Works
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. The sensor remains inserted for 14 days and does not require fingerstick calibrations (it’s “factory calibrated”). After putting it on the upper arm and waiting one hour, it immediately begins reading glucose and trend information. 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.
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. In less than a second, they can see their real-time glucose value (e.g., 102 mg/dl), a glucose trend arrow (e.g., rising), and a trend graph showing the last eight hours of data. The reader device displays reports on its screen that can be downloaded to Mac and PC-compatible software. The system is currently available in Europe (pricing information below) for people with both type 1 and type 2 diabetes. Abbott does plan to bring it to the US, though we estimate it won’t come stateside until at least mid-2016.
Cost and How to Get It in Europe
FreeStyle Libre is available at online web-shops in seven European countries: UK, France, Germany, Italy, the Netherlands, Spain, and Sweden.
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). Notably FreeStyle Libre does not require a prescription in the EU. 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. Do you want one? 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.
When is FreeStyle Libre Coming to the US?
Abbott is currently conducting an accuracy study of FreeStyle Libre in the US – more information is here. The study is expected to be completed in March. Abbott would then need to secure FDA approval of FreeStyle Libre, which would likely take at least 12 months. We imagine that at the very soonest, FreeStyle Libre could come to the US in mid-2016.
Appendix: How Is FreeStyle Libre Different From Continuous Glucose Monitoring (CGM)?
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. However, it is really a new category of glucose monitoring that is meaningfully different from CGMs offered by Medtronic and Dexcom:
FreeStyle Libre does not have alarms or alerts, since the glucose sensor data is not sent continuously to the reader device. Rather, a scan of the sensor patch using the reader obtains the glucose data and trend information. By contrast, traditional CGMs continuously send the glucose data to the receiver/pump, allowing low, high, and rate-of-change alerts. This makes CGM a more attractive choice for those with lots of hypoglycemia and hypoglycemia unawareness. However, those who are bothered by lots of alarms might prefer the design of FreeStyle Libre.
FreeStyle Libre is “factory calibrated,” meaning users don’t have to enter any blood glucose meter values into the system. After the sensor is started and worn for one hour, it can show glucose data points and trends. Conversely, Medtronic and Dexcom CGMs require startup calibration, as well as daily calibrations to maintain the sensor’s accuracy. Factory calibration represents a highly impressive R&D achievement.
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. In these cases, Abbott recommends confirming the value with a fingerstick. By contrast, Medtronic and Dexcom users are currently supposed to confirm every CGM value with a fingerstick before dosing insulin.
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. For example, Dexcom charges ~$885 for the starter kit and ~$72 per seven-day sensor. 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. Abbott is currently conducting two studies to support reimbursement.
FreeStyle Libre does not require a prescription and can be ordered online. Dexcom and Medtronic CGM both require a prescription and have a longer on-boarding process (training, insurance verification, phone calls, etc.).
