FDA approved the first continuous blood glucose monitoring system to replace fingertip acupuncture

On December 20, 2016, the U.S Food and Drug Administration (FDA) expanded its approval of dexcom's G5 mobile continuous blood glucose monitoring system, allowing it to replace fingertip acupuncture blood glucose test for diabetes treatment decisions in patients aged 2 and over This is the first FDA approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without the need for traditional finger acupuncture tests The system has previously been approved for supplementation, but it cannot replace the finger acupuncture test determined by diabetes treatment "FDA strives to help ensure that new technologies that reduce the burden of day-to-day disease management are safe and accurate," said Dr Alberto Gutierrez, director of the in vitro diagnostic and Radiological Health Office of the FDA's Center for equipment and radiological health "Although the system still needs to be calibrated twice a day, it can make treatment decisions without any additional finger blood glucose testing, which may allow some patients to manage their disease more comfortably and encourage them to have daily conversations with their healthcare providers about using real-time continuous blood glucose monitoring in diabetes management Because of the impairment of the body's ability to control blood glucose level, diabetic patients must regularly test and monitor blood glucose Usually, blood samples are collected from fingertips several times a day and tested with a blood glucose meter The results show whether the glucose level is too high (hyperglycemia) or too low (hypoglycemia), helping patients and their health care providers to make appropriate diabetes management decisions The G5 mobile continuous glucose monitoring system uses a small sensor line inserted under the skin to continuously measure and monitor glucose levels Real time results are sent wirelessly every five minutes to dedicated receivers and compatible mobile devices running mobile applications (for example, smartphones or tablets) An alert indicates blood sugar levels that are above or below the threshold set by the user The system measures glucose in the fluid under the skin and must be calibrated at least twice a day with blood obtained from the fingertip acupuncture test In addition, there is usually no need for additional daily blood test of fingertip acupuncture, because unlike other continuous blood glucose monitoring systems, the results of this device can now be directly used for diabetic patients to make treatment decisions without the confirmation of traditional finger acupuncture test According to the Centers for Disease Control and prevention, more than 29 million people in the United States have diabetes Diabetic patients do not produce enough insulin (type 1 diabetes) or do not use insulin properly (type 2 diabetes) Blood sugar builds up in the blood when the body doesn't have enough insulin or can't use it effectively Hyperglycemia can lead to heart disease, stroke, blindness, renal failure and amputation of feet or legs FDA evaluated data from two clinical studies from the G5 mobile continuous glucose monitoring system These studies included 130 diabetic patients aged 2 and over All studies included a seven day period in which the system readings were compared to the glucose meter values, as well as laboratory test methods for measuring glucose values No serious adverse events were reported during the study Risks associated with the use of the system include hypoglycemia or hyperglycemia, where the information provided by the device is inaccurate, or hardware or setup issues render the alarm ineffective, and skin irritation or redness around the applicator device, when used to make treatment decisions, the user must calibrate at least every 12 hours with a fingertip blood sample And taking any drug that contains paracetamol while wearing the system may erroneously increase blood sugar readings G5 mobile continuous glucose monitoring system is manufactured by dexcom company located in San Diego, California Original reading: FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions!