The US Food and Drug Administration (FDA) has approved the first mobile medical application "Dexcom Share Direct Secondary Displays" (hereinafter referred to as "DSDSD") for use with the Dynamic Blood Glucose Monitoring System (CGM). DSDSD developed by the California Medical Dekang glucose monitoring equipment manufacturers (DexCom), its Dexcom G4 PLATINUM continuous glucose monitoring system supporting the use of remote real-time monitoring of blood glucose levels in diabetic patients, in a more flexible way to share data. Dexcom G4 PLATINUM is a CGM device with an LED display that can be used to present blood glucose levels and activities in a tabular format. The device consists of three parts, one is a sensor under the skin, a transmitter, and a display with a USB port. The Dexcom G4 works with insulin syringes and insulin pumps to help adjust the dose for better results. The Dexcom G4 updates data every 5 minutes so patients can keep abreast of blood sugar levels. The DSDSD uses two app programs to instantly take readings from the Dexcom G4 PLATINUM. One App is installed on the patient's mobile device and the other is installed on the remote sharer's mobile device, and the patient can specify the sharer. The application receives real-time blood glucose readings from the Dexcom G4 PLATINUM and stores them in the cloud storage for the sharer to download and display. Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostic and Radiation Health, said: "For this innovative technology, the diabetes-related group has been waiting for a long time, especially for health care professionals who want to remotely monitor the blood sugar levels of children with diabetes. Today, the approval of this app will pave the way for similar technologies to be listed and used in the United States." Because these apps are low to moderate risk, the FDA classifies them as Class II products, exempting pre-market applications. This means that similar products in the future will not require FDA pre-market approval prior to listing. Of course, you still need to register with the FDA. The FDA also stated that approval of these applications does not mean they can replace real-time blood glucose monitors or standard home blood glucose monitoring devices. In addition, these applications cannot be used to determine the dose of a diabetic patient. There are approximately 370 million people with diabetes worldwide, and approximately 25.8 million in the United States, more than 90% of whom are type 2 diabetes. At present, diabetes is still unable to cure.
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