FDA approves first continuous blood glucose monitoring system that can replace fingertip acupuncture
Release date: 2016-12-23 On December 20th, the FDA approved the G5 mobile blood glucose monitoring system produced by Dexcom to expand the use of diabetes in patients over the age of 2, instead of the traditional fingertip test blood glucose to determine the use of insulin. This is the first time the FDA has approved the monitoring of blood glucose through the Continuous Blood Glucose Monitoring (CGM) system without the use of traditional finger prick test blood glucose. Previously, Dexcom's system was only approved for use as a supplement to conventional test methods or as an auxiliary instrument. Dr. Alberto Gutierrez, Director of the Office of In Vitro Diagnostic and Radiation Health at the FDA's Equipment and Radiation Health Center, said: The FDA has been doing its utmost to study the safety and accuracy of new medical devices for routine disease management use, although Dexcom The G5 mobile blood glucose monitoring system still requires at least two calibrations per day (at least every 12 hours) through the traditional fingertip acupuncture test, but it does give the diabetic patients more comfort during the treatment process. The way to help patients truly do continuous blood glucose monitoring behavior, thus helping doctors and patients to achieve better treatment decisions. The G5 mobile blood glucose monitoring system monitors blood glucose through a small sensor embedded under the skin. The real-time monitoring result is uploaded to the dedicated receiving device or the mobile phone or tablet APP compatible with the application every 5 minutes by wireless transmission. When the level is above or below the set blood glucose threshold, an alert is issued. The system monitors blood glucose levels in subcutaneous tissue fluids, but still requires at least two needle acupuncture test corrections per day. Compared to other mobile blood glucose testing systems, the FDA considers the system to be accurate and no additional is required. The blood glucose test determines the blood glucose level again to determine the next treatment decision. The FDA evaluated the G5 mobile blood glucose monitoring system through two clinical trial data. The trial included 130 children over 2 years of age and adults with diabetes. The study included a 7-day G5 mobile blood glucose monitoring system with traditional blood glucose. Control experiments with the tester and laboratory method tests did not show serious adverse reactions throughout the study. 1) In some cases, the blood glucose information provided by the device is not accurate; 2) Due to hardware reasons or incorrect settings, the instrument has an early warning of excessive or too low blood sugar; 3) Inaccurate measurement results due to skin inflammation or redness caused by monitoring patches; 4) After using this system, the blood sugar level of patients taking acetaminophen may be misreported (higher). The mobile blood glucose monitoring system is manufactured by Dexcom Corporation (Decan Medical) in San Diego, California. Source: Medical Valley
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The FDA also cautioned that the use of the G5 mobile blood glucose monitoring system may present the following risks (including but not limited to):