Continuous glucose monitoring (CGM) has been linked to better blood sugar control. Now, the FDA has approved a new device—the Abbott FreeStyle Libre Flash Glucose Monitoring System—that may give anyone who hates finger sticks a reason to celebrate. (Does anyone like finger pricks?).
The new device is expected to be on the market, by prescription only, by late 2017 or early 2018, says Chris Thomas, a spokesperson for the company. He declined to give exact pricing information but says insurance reimbursement is likely.1,2
Pricing will likely to be similar to costs in Europe, where the device is already in use. In the UK,3 for instance, the price for a starter pack, with the reader and two 14 days of sensors, has been the equivalent of about $200.
The new device will reduce hassle and discomfort while providing a more comprehensive view of blood glucose status, Thomas says. "With traditional blood glucose monitoring, some people with diabetes may have to finger stick up to 12 times a day, to test their glucose levels, which only provides readings that represent distinct points in time," he says.
"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," he says.
The FDA OK'd it for adults 18 years and over. Unlike the professional version or the UK version which is a 14-day wear, it can be worn up to 10 days. There is a 12-hour startup required. It is meant for use by anyone who uses insulin, whether you get it by injections or a pump.
Abbott's new glucose monitoring device has a small sensor wire about the size of two stacked-together quarters. This is applied to the upper arm and the wire goes below the skin’s surface, where it constantly measures and monitors sugar (glucose) levels in the fluid under the skin.
To get real-time glucose readings, a small, hand-held reader is simply waved over the sensor. The readout provides the user with highs, lows, and stable trends, along with 8 hours of blood glucose history.
According to the company (and offices who are already using the professional version, which uses the same reader), the reader can get numbers even through clothing. That discretion, Thomas says, is much appreciated. Discretion is impossible, he points out, with traditional finger sticks.
While the device eliminates the need for ''routine'' finger sticks, there are some instances where the user still needs to do them:
Among other issues, the FDA says, skin irritation around the device is one of them. The device also can't provide real-time alerts or alarms without the user initiating them. For that reason, you won't know about low blood sugar levels, when you are sleeping.1,2
Overall, says Thomas of Abbott, research has found that users of the device who have type 1 diabetes spent 38% less time in hypoglycemia and those with type 2 spent 50% less time in hypoglycemia.
Another plus, blood glucose readings are not impacted by the use of acetaminophen in the way the CGM devices currently on the market are affected.
Numerous studies have found a benefit to the continuous monitoring of blood sugar levels to keep them at a steadily normal level.
What do doctors think of the new device?
"This would be a good option for any patient that needs intensive glucose monitoring, especially those with type 1 diabetes, labile blood sugars (also known as brittle diabetes, a form of type 1) and especially those with frequent hypoglycemia or hypoglycemia unawareness," says Scott Isaacs, MD, FACP, FACE, an Atlanta endocrinologist and member of the Endocrine Web editorial board.
Amy Hess-Fischl, MS, RD, LDN, BC-ADM, CDE agrees adding, “Libre may be a viable option for people with diabetes who are not willing to test their blood glucose levels at all and will never wear a DexCom or Medtronic. Hess-Fischl is also a member of the OnTrack Diabetes editorial board and sees people with diabetes in her office on a daily basis. Hess-Fischl frequently assists with the monitoring of blood glucose levels. “I see this as a compromise to get data—even without alerts, alarms and finger pricks. This device could improve the overall control and quality of life for these patients as well as go a long way toward keeping them safe.”
One disadvantage, says Dr. Isaacs, is that the system is a stand alone. "So the patient will still need to act on the blood glucose readings they receive from the CGM," he says. Other systems integrate the pump and the CGM, such as the Medtronics 670 pump and the Enlite CGM, he explains.
While this device represents an advance, it may not be the answer for everyone. Talking with your diabetes care team about your specific needs is always wise.
One thing is for sure, Dr. Isaacs says, "I anticipate more advances to all CGM sensors in the future." Like smartphones, the devices will continue to improve, with more and better features and advancements.
Dr. Isaacs reports serving as a consultant for Novo Nordisk and on the speakers' bureau for Novo Nordisk, Takeda Pharmaceutical Company, Orexigen Therapeutics, Inc.