The US Food and Drug Administration approved the first “integrated dynamic blood glucose monitoring system” in China on the 27th to monitor blood glucose levels in diabetic patients over 2 years of age, and it can be used with insulin auto-injectors. And other equipment used together.
This monitor called the “Dkang G6″ is a blood glucose monitor that is slightly larger than a dime and placed on the skin of the abdomen so that diabetics can measure blood glucose without needling a fingertip. The monitor can be used every 10 hours. Change once a day. The instrument transmits the data to the mobile phone’s medical software every 5 minutes, and alerts when the blood glucose is too high or too low.
The instrument can also be used with other insulin management devices such as insulin autoinjectors, insulin pumps, and fast glucose meters. If used in conjunction with an insulin auto-injector, insulin release is triggered when blood glucose rises.
The relevant person in charge of the US Drug Administration said: “It can work with different compatible devices to allow patients to flexibly create personalized diabetes management tools.”
Thanks to its seamless integration with other equipment, the US Pharmacopoeia has classified the Dekang G6 as a “secondary” (special regulatory category) in medical devices, providing convenience for the development of an integrated integrated continuous blood glucose monitor.
The US Pharmacopoeia evaluated two clinical studies. The sample included 324 children over the age of 2 and adults with diabetes. No serious adverse reactions were found during the 10-day monitoring period.