1 What is continuous glucose monitoring (CGM)?

CGM refers to the monitoring technology that can indirectly reflect the blood glucose level by monitoring the glucose concentration in the subcutaneous interstitial fluid with a glucose sensor. Being capable of providing continuous, comprehensive, and reliable all-day blood glucose information, it can identify hypoglycemia and hyperglycemia that cannot be easily identified by traditional “point-like” fingertip blood glucose monitoring, thus facilitating people to better grasp the law of blood glucose fluctuation.

2 Why choose CGM system?

Traditional blood glucose monitoring methods mainly include “blood glucose self-monitoring (fingertip blood glucose monitoring)” and “glycosylated hemoglobin (HbA1c) detection”, both of which are subjected to certain limitations in blood glucose management. For example, fingertip blood glucose monitoring can only provide the blood glucose value at a single time point, which is just like a blind man touching an elephant and cannot truly reflect the overall profile of blood glucose changes. However, the level of HbA1c cannot reflect the blood glucose fluctuation during the day but only the mean blood glucose level in the past 2 to 3 months. In this case, it cannot provide a basis for the immediate adjustment of the blood glucose control protocol.

Classification		Advantage	Disadvantage
Traditional Blood Glucose Monitoring	HbA1c	Able to effectively reflect blood glucose control in DM patients in the past 2 to 3 months	Unable to evaluate hypoglycemia and the degree of blood glucose fluctuation Unable to distinguish FBG and preprandial/postprandial blood glucose	Difficult to identify postprandial hyperglycemia, nocturnal hypoglycemia, and asymptomatic hypoglycemia due to certain limitations Difficult to realize individualized blood glucose management due to poor patient compliance
	Fingertip Blood Glucose	Low cost Easy to operate Used in clinical practice for years	Unable to show blood glucose fluctuation Unable to provide continuous all-day blood glucose
CGM		Simple without repeated blood sampling Able to timely identify hyperglycemia, hypoglycemia and blood glucose fluctuation based on TIR, AGP, MBG, post-intervention blood glucose change, daytime blood glucose fluctuation, and estimated HbA1c	N/A

By comparison, the Continuous Glucose Monitoring System (CGMS) can provide more comprehensive and convenient blood glucose monitoring services. It can form a continuous blood glucose curve by summarizing the continuously monitored blood glucose data, so as to reflect the fluctuation trend of the user’s blood glucose more comprehensively, thus timely identifying hyperglycemia and hypoglycemia that cannot be easily identified by traditional monitoring methods. In addition, it can also provide vigorous data support for optimizing the blood glucose control protocol, which is of great significance for guiding the treatment of DM.

SIBIONICS CGM System, independently developed and produced by Shenzhen SiBionics Co., Ltd. (hereinafter referred to as SiBionics), is the first “14-day, calibration-free, and real-time” glucose monitoring system in China. In 2021, it was approved for marketing by the National Medical Products Administration (NMPA).

3 Product Characteristics of SIBIONICS CGM System

(1) Free from fingertip blood and calibration

It is free from a finger prick and calibration in the whole process, which can avoid pain and improve the monitoring compliance of users, thus facilitating them to feel more comfortable in blood glucose control.

After you wear it for one hour, your blood glucose data will be automatically uploaded to the mobile APP. Without a manual scan to obtain such data, it is indeed worry-free and labor-saving.

(2) High measurement accuracy

The mean absolute relative difference (MARD) of SIBIONICS CGM System is 8.83%, and the proportion of Zone A + Zone B in the Clarke error grid is 99.22%. Therefore, high measurement accuracy can be guaranteed to bring more reassurance to users in blood glucose control.

The results of the clinical trial titled Safety and Effectiveness of SIBIONICS CGM System and conducted by Shandong Provincial Hospital, Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and Shenzhen University General Hospital show that the four main evaluation indicators of SIBIONICS CGM System are superior to the standard of NMPA and it can meet the demand for clinical application by virtue of high numerical and clinical accuracy.

(3) 14-day durable use

With the sensor having a service life of as long as 14 days, SIBIONICS CGM System can continuously monitor blood glucose 24 hours a day, so that users can clearly know about their blood glucose and feel more reassured in blood glucose control.

(4) Reminder of abnormalities in hyperglycemia and hypoglycemia

When the blood glucose exceeds the preset hyperglycemia and hypoglycemia values, SIBIONICS CGM System will automatically send a reminder message to reduce your worries and bring you more reassurance in blood glucose control.

(5) An IP level of IPX8, without any impact on personal daily life

The considerate waterproof design allows users to bathe without any pressure every day. With the IP level of IPX8, SIBIONICS CGM System can withstand immersion into 1-meter-deep water for as long as 1 hour, without any impact on personal daily life.

(6) Light, compact, and skin-friendly

With the microelectrode of the flexible sensor implanted subcutaneously in a minimally invasive manner, SIBIONICS CGM System is almost painless to implant and wear, which is more convenient to operate. Being made of medical-grade low-sensitivity materials, the sensor is light and compact with a thickness of only 5.3 mm, which has good concealment.

(7) Data sharing and remote monitoring

Blood glucose data can be shared with others. If the wearer is an elderly person or an individual with poor self-management ability, the blood glucose data can be shared with his/her relatives and friends so that the latter can take timely intervening measures for hyperglycemia/hypoglycemia where necessary or jointly supervise the former to develop a good living habit, thus making blood glucose control safer.

(8) High performance-price ratio and lower cost

With an affordable daily mean monitoring cost, SIBIONICS CGM System can bring great health benefits relative to the possible harm induced by hypoglycemia and ketoacidosis.

(9) Individualized blood glucose monitoring report

After a user wears it for 14 days, SIBIONICS CGM System will issue a blood glucose monitoring report to comprehensively evaluate his/her blood glucose and provide an individualized auxiliary blood glucose control protocol covering diet and exercise.

4 Installation Tutorial of SIBIONICS CGM System

5 Application Site of SIBIONICS CGM System

As shown in the figure below, it is recommended that a user should wear the product on the back of his/her left or right upper arm.

SIBIONICS, Protect your blood glucose health scientifically!

Reference:

[1] Chinese Journal of Diabetes Mellitus, November 2017, VoL 9, No.11

[2] http://en.sisensing.com/

[3] www.sibionicslife.com

[4]www.sibionicscgm.com

Media Contact
Company Name: Sibionics Technology
Contact Person: Yanmian Huang
Email: Send Email
City: Shenzhen
State: Guangdong
Country: China
Website: http://en.sisensing.com/