FDA approves first continuous glucose monitoring system that does not require fingerstick test
WASHINGTON, D.C. — The U.S. Food and Drug Administration approved its first continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation via a traditional fingerstick test. The FDA announced it expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.
“The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions. This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”
The G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device running a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds. The system measures glucose in fluid under the skin and must be calibrated at least two times per day using blood obtained from fingerstick tests. However, additional daily fingerstick blood tests are generally no longer necessary because unlike other continuous glucose monitoring systems, results from this device can now be used directly by patients to make diabetes treatment decisions without confirmation from a traditional fingerstick test, stated the FDA.
Filed under: General Problems
Kandiapple, it is Reli On . Fred Meyers/Kroger have one also but we haven’t tried it. If you forget the name just talk to the pharmacist. That’s what we did. Good luck!
Wal Mart carries a tester that I good and cheap and the strips are only $10. Was cheaper for us to buy the new tester than the strips for the one he had. Checked accuracy against the more expensive one and it was fine
Can you say what device it is? I’ve become really hypoglycemic and like mary said, the supplies are out of budget range!
Being the eternal pessimist I see some potential problems but the basic idea sounds good.
With my recent pancreas issuue,,we had to buy a glucose monitore,,,the monitore itself wasn’t that bad,,25 bucks,,,but those stinken ,”strips” were 50 bucks!!!!plus there is just something wrong when i have to stick myself,,,,it doesn’t feel nature to hurt yourself,,i kinda got nauseated the 1st time i had to stick myself,,like this goes against nature to willfully hurt yourself and visual see ur selve hurting yourself,,,it sound weird,,but it true,,jmo,,Soo if there will be something cheaper and NOT have to stick yourself,,,,im all for it,,,mary
This interesting info,,,mary