Committed to exploring the application of the most cutting-edge medical methods, professional and dedicated,
solving people's blood glucose control problems.
SIBIONICS started research and development work. It was the rapid development stage for the extensive application of CGM products in Europe and the United States, and SiAmbulatory wanted to create China's own CGM brand.
SIBIONICS independently completed the core technology breakthrough of CGM second generation sensor, and broke foreign technology monopoly.
SIBIONICS completed prospective, multi-center clinical trials. The accuracy core indicator MARD value was 8.83%, leading in the world
SIBIONICS entered the National Innovative Medical Device Special Approval Channel (No. 13, 2020)
SIBIONICS was approved by National Medical Products Administration for marketing, providing high-quality blood glucose management services to hundreds of millions of diabetics and more extensive population.
Electron mediator function to substitute in vivo oxygen
SiAmbulatory researchers have found that fluctuations of in vivo oxygen levels may cause various unstable factors in the continuous monitoring of blood glucose in interstitial fluid, and affect the accuracy of monitoring. Can we develop a material to substitute oxygen (electron mediator function)?In the cycle of test - observation - retest, by means of inch-by-inch test, SIBIONICS researchers have synthesized electron mediators in hundreds of different chemical structures for thousands of electrochemical tests. Combined with tens of thousands of groups of test data, the electron mediator with low operating voltage and high sensitivity is finally screened and applied to SIBIONICS CGM product. It can get rid of the dependence on the oxygen level in interstitial fluid, and realize accurate measurement of blood glucose in various scenes under any state of body movement.
Since SIBIONICS CGM is inseparable from users for up to 14 days, how to ensure waterproofness during the wearing period is an important technical problem.The sealing structure design and sealing process parameters of the product have an important impact on its waterproofness. The researchers use fluorescence imaging technology to continuously analyze every bubble in the dispensing seal, constantly improve the micron-level structure design, and optimize the millisecond-level lighting time. Through process innovation and upgrading, the researchers finally realize the seamless fine nesting design for internal sealing structure, which enables the waterproofness of SIBIONICS CGM to meet the needs of users in various environments during the wearing period.
Create a new dynamic structure
In the early stage of structure development, the researchers found that the subtle differences between product structure and production process directly determined the "success rate of wearing" and "pain degree" of the product. What kind of product can safely and effectively work under the skin for a long time without causing any pain to users?In response, the researchers turned to a new field and studied on the principle of human pain and the impact of pressure on the skin. They found that the skin pain mainly came from the tear and tension of sensor needle in contact with skin, so scientific skin touch has become the focus of pain relief. The hardware team started implant testing and constantly updated and iterated. After a long period of "mouse test", it finally improved the success rate of wearing the product significantly with the micron-level high-end production process and the patented "dual automatic" product structure, and reduced the pain to several tenths of the mainstream products in the market, realizing painless and feelingless implantation and reducing the mass production cost.