The USA food and drug administration in Washington has approved the country's first "integrated dynamic blood glucose monitoring system" to monitor the blood sugar of diabetics over the age of 2 and can be used in conjunction with devices such as insulin automatic syringes.
The dynamic blood glucose monitor, called the "Decon G6", is slightly larger than a dime and sits on the skin of the abdomen, allowing diabetics to measure blood sugar levels without needling their fingertips. The monitor can be replaced every 10 days. The device sends data to mobile medical software every five minutes, and alerts when blood sugar is too high or too low.
The instrument can also be used with other diabetes management equipment such as insulin automatic syringe, insulin pump and rapid blood glucose meter. If used with an automatic insulin syringe, elevated blood sugar will trigger insulin release.
"It can work with a variety of compatible devices to give patients the flexibility to create personalized diabetes management tools," the FDA said.
As it can be used seamlessly with other devices, the FDA classifies the decoction G6 as "level 2" (special control category) in medical equipment, which facilitates the development of the subsequent integrated dynamic blood glucose monitor.
The FDA evaluated two clinical studies in which 324 children and adults with diabetes who were 2 years of age or older had no significant adverse effects during the 10-day monitoring period.
As the device is at risk of error, the FDA will set special control standards to ensure its accuracy and reliability.
Contact Person: Mr. Hyman Chow