A continuous glucose monitor (CGM) device made in the United States is finally approved for use here after patients in 40 other countries already have access.
For the first time, people in the United States living with diabetes will be able to monitor blood glucose levels without routine finger sticks, after FDA approved Abbott’s Freestyle Libre Flash Glucose Monitoring System late Wednesday. The decision is considered a breakthrough by diabetes advocates who have waited for FDA to approve the device, which is on the market in more than 40 countries.
After their introduction, continuous glucose monitoring (CGM) systems required patients to conduct a blood glucose test with each insulin dose and to use blood testing to calibrate the system. But as CGM accuracy improved, patients began dosing based on this information, even though FDA had not approved the systems for this purpose. That changed earlier this year, when FDA approved the Dexcom G5 for dosing with calibration twice daily, which paved the way for Medicare reimbursement.
The Abbott device, by contrast, is factory calibrated; a sensor wire is inserted below the skin surface to constantly monitor glucose levels. Patients who use the Abbott CGM can wave a mobile reader over the device to determine if their blood glucose levels are in range, too high, or too low, and what the status has looked like for the past 8 hours.
Not only do many patients find frequent blood glucose tests painful and a hassle, but payers often limit how many test strips they will cover, putting patients in a bind if they need to do a blood test with every insulin dose or to calibrate the CGM. Thus, this gives patients another option that cuts down on blood glucose tests and can save them money.
"Today, we are celebrating a breakthrough moment for people with diabetes in the U.S.—an end to the worry and hassles associated with routine finger sticks which have been the standard of glucose testing for more than 40 years," Jared Watkin, senior vice president, Diabetes Care, Abbott, said in a statement. "At Abbott, we believe that FreeStyle Libre will transform diabetes management and we're proud to be at the forefront of innovation that empowers people to take control of their health to live their best lives."
FDA was careful to warn that people with diabetes must still test their blood sugar regularly; they simply do not need to use a blood test to calibrate the Abbott device. A press release announcing the approval states, “Risks associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions, as well as mild skin irritations around the insertion site.”
“It does not provide real-time alerts or alarms in the absence of a user-initiated action; for example, it cannot alert users to low blood glucose levels while they are asleep,” the FDA statement continued.
FDA approved the Abbott device for adults only and the sensor for 10 days; however, the sensor is approved for 14 days in Europe. The device is waterproof, and readings are not disrupted if the patient takes acetaminophen. While pricing was not disclosed, the Chicago Tribune reported it is expected to be comparable with pricing of the device in Europe, where the reader costs the equivalent of $69 and so does each sensor, although as previously mentioned, the sensors are approved to last longer in Europe.
"Diabetes management requires active participation by the patient. Regular monitoring of glucose levels is especially crucial among patients being treated with insulin," Maria Tulpan, MD, Lenox Hill Hospital, New York City, said in the announcement. "What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control."
FDA’s reluctance to approve Abbott’s Flash CGM system had long frustrated the company and diabetes advocates, including key leaders who cheered the approval Wednesday at the diaTribe Foundation’s Executive Innovation Lab in San Francisco, California. Several noted that not only was the product in use around the world, but that it is also eligible for reimbursement in countries with strict standards, including the United Kingdom and Japan.
The decision came after Abbott published 2 clinical trials involving 50,000 patients, which found that patients who used the scanner frequently had improved glycemic control and less hypoglycemia.