The FDA has approved the FreeStyle Libre Flash Glucose Monitoring System, which eliminates the need for routine finger sticks to check blood glucose levels.1
"Studies have shown that a majority of people test less than three times per day because of the pain and hassles associated with finger sticks. Without comprehensive glucose data, significant glucose fluctuations may be missed, which can lead to major health consequences," says Chris Thomas, PhD, director of biosensor technology for Abbott Diabetes Care, which makes the device.
The company says the Abbott Freestyle Flash Glucose Monitoring System will be available by prescription in U.S. pharmacies by the end of 2017 or early 2018.
Thomas declined to provide exact pricing information but says it will be similar to the cost of the cash pay of FreeStyle Libre in Europe. In the UK, the price for that has been about $362 U.S. for 14 days of sensors, the reader, and the sensor, according to the Diabetes UK website.
The Freestyle Libre system is already in use by more than 400,000 in about 40 other countries, according to Abbott. It can be used by anyone who uses insulin, whether by injection or by a pump.
The FreeStyle Libre Flash includes a small sensor wire, about the size of two quarters stacked together, applied to the back of the upper arm and inserted below the skin's surface. This continuously measures and monitors glucose levels in the fluid under the skin. A small, hand-held reader is held over the sensor to provide real-time blood glucose readings. The reader can identify high, low or stable trends and review 8 hours of blood glucose history.
Unlike the professional version or the UK version which is a 14-day wear, this version is approved for adults 18 years and older with diabetes and after a 12-hour startup and can be worn for up to 10 days.
It can even receive reading through clothing. "It comes at a time when people [with diabetes] want discretion but can't have discretion," Thomas says. Discretion is difficult, he says, with traditional finger sticks.
While no routine finger sticks are needed with the new device, fingersticks are still needed to make treatment decisions in certain cases. These include when the symbol "Check Blood Glucose" appears when symptoms don't match the readings when you suspect readings are inaccurate, or when you have symptoms that seem to indicate high or low blood glucose.1
Thomas wrapped up studies focused on the benefits of the system. A major benefit is spending less time with hypoglycemia—38% less in those with type 1 who used the device, and 50% less in those with type 2 diabetes. "We think that translates to better health outcomes for people."
The FDA evaluated the new device by looking at a clinical study of participants 18 and older, comparing readings obtained by the FreeStyle Libre to those obtained by an established lab method for analyzing blood glucose levels.2
Among the potential risks, according to the FDA, are inaccurate information from the device and mild skin irritation around the device. The FreeStyle Libre also does not provide real-time alerts or alarms without the user initiating that action. So it cannot alert wearers to low blood sugar levels, for instance, when they are asleep.2
The market for continuous glucose monitoring is hot. Among the other CGM devices are Dexcom's G5, which provides real-time readings every five minutes. It still requires fingersticks for calibration. Medtronics also has a CGM sensor but it too needs to be calibrated with fingersticks three or four times a day.
Developers of the newest Dexcom device, the G6, expected to launch in late 2018, hope it, too will not need fingerstick calibration.
The new Libre device is an advance to the current CGM devices ''because it does not require fingerstick glucose calibrations," says Scott Isaacs, MD, FACP, FACE, an Atlanta endocrinologist and Endocrine Web editorial board member. He also reviewed the new information.
"The claim is that this new system does not require calibration because it is calibrated in the factory," Dr. Isaacs tells Endocrine Web. Because patients dislike fingersticks, ''this definitely represents an advance in glucose monitoring. It reduces the hassle factor and pain of doing fingerstick checks but also reduces the cost of glucose strips ($2-3 a day, or more).''
He predicts that CGM devices will only continue to improve and that other sensors, as they are improved, will also not need fingerstick calibration.
Dr. Isaacs says he feels the new Abbott device ''still may not be an advantage over the Medtronics 670." That pump is integrated with the Enlite CGM. While it does require fingerstick calibration, he says that when it is placed in auto-mode, the insulin pump's infusion rate is guided by the data from the CGM to keep the blood glucose in a very normal, narrow range.
Elena Christofides, MD, FACE, chief operating officer of Endocrinology Associates, Columbus, Ohio, and a member of the Endocrine Web editorial board predicts that the Dexcom G6 will become a leader, due to additional features of use to patients. Among those are potentially longer wear time, up to 14 days. "When the G6 comes out it is only going to cement Dexcom's role as our number one CGM," she says. She has no ties with any of the three companies making Dexcom, Medtronic or Abbott CGM devices.
Dr. Isaacs reports serving as a consultant for Novo Nordisk and on the speakers' bureau for Novo Nordisk, Takeda Pharmaceutical Company, Orexigen Therapeutics, Inc. Dr. Christofides reports grants or research support from Pfizer, GlaxoSmithKline, Janssen, Sanofi-Aventis, Novo Nordisk, Lexicon. She is a consultant for Nordisk, Eli Lilly and Chiasma and on the speakers' bureau for Pfizer; Novo Nordisk, Eli Lilly, Boehringer Ingelheim, PamLab and Shire.