In the past few years, the global Continuous Glucose Monitoring (CGM) industry has developed rapidly, and the global market size has exceeded US $5 billion. However, due to the high technical barriers of CGM products, the difficult manufacturing process, the complex registration and approval process, and the large investment in market promotion and patient education, the main market share of domestic CGM products is still monopolized by Abbott and Medtronic, and the localization rate is less than 10%. In order to break the import monopoly and seize the domestic CGM market, domestic manufacturers also need to break through some problems, such as production process, product wearing experience, monitoring performance.

Despite many difficulties, in recent years, there are still many domestic start-ups that have entered the track with leading technology to achieve many innovative breakthroughs. Meanwhile, domestic old-brand BGM R&D and production enterprises have also successively entered the CGM track to transform their technology precipitation and create a multi-technology route solution. Minkang Medical Technology (Tianjin) Co., Ltd. (hereinafter referred to as "Minkang"), established in 2010, is one of them.

As an old domestic enterprise specializing in the research, development and production of blood glucose monitoring products, Minkang has established four technical systems, electrochemistry, photochemistry, colloidal gold and immunofluorescence, and has obtained more than 50 patents and software copyrights. Based on the technology accumulation of the enterprise, the cooperation with University of Science and Technology of China, and production experience of BGM , Minkang has now achieved the development and production of a full range of products covering multiple indicators such as blood glucose, blood lipids, blood ketone, uric acid, glycosylated hemoglobin, etc., and has rapidly upgraded in accordance with the development path of blood glucose detection - multiple indicators detection - intelligent detection, and has created a chronic disease management ecological closed-loop system from monitoring to data analysis, then to the implementation of the diagnosis and treatment.

Overcome the core technical barriers of carbon monoatom catalysis, improve product accuracy and reduce costs

"Although CGM is small, in order to make a breakthrough, it is necessary to overcome the four major technical barriers of sensor, transmitter, algorithm and linkage with insulin pump. As the core component of CGM, sensor is the most difficult to achieve technical breakthrough. In the three technological changes CGM has undergone, focus on how to capture the electrical signal in the process of glucose oxidation is an important topic ." said Lan Chunbo, head of Minkang Project.

Not long ago, Minkang, together with the doctoral supervisor team of the Department of Applied Chemistry of the University of Science and Technology of China, achieved the breakthrough of carbon monoatom technology, which is the core of CGM biosensor technology.

Different from traditional sensing technology, due to the homogeneity of each reaction site of carbon single atom, carbon single atom technology can make molecular recognition and interaction more accurate and specific. Therefore, through this technology, the biochemical reaction can be transformed into the recognizable physical signals, and the glucose concentration measurement can be more accurate.

It is understood that the MARD value of Minkang CGM products (MARD value is usually used as the core indicator to measure the accuracy of CGM. The lower the MARD value, the more accurate the blood sugar value. The CGM system with MARD<10% is generally considered to have good analytical performance) has been close to 7.5%.

Based on the breakthrough of carbon monoatomic technology, Minkang realized the replacement of expensive imported precious metal carbon black ink with monoatomic carbon black ink.

Monoatomic carbon black ink not only has low cost, but also can reduce the use of oxidase and dehydrogenase to a certain extent in the production process. Minkang stressed that the adjustable characteristics of monoatomic may also solve the problems of high energy consumption and high pollution in the traditional catalytic process.

Now, the company also made breakthroughs in the wearing comfort of CGM as one of the important projects of product research and development, with realizing the size of CGM products of 25x15mm, thickness of 6mm, and weight of 5.5g; insertion depth 4~6mm; finger blood is free from calibration; wearing time lasts up to 21 days.

In the future, Minkang will further expand this technology to the application fields of mobile medical sensors for chronic disease management, cardiovascular disease monitoring sensors, geriatric diseases and so on.

Join hands with the team of China University of Science and Technology to enter the artificial pancreas project and implement the service to primary medical care

The basic components of closed-loop artificial pancreas system include CGM, insulin pump and artificial algorithm. In 2021, Minkang, based on CGM products, officially launched research in the field of artificial pancreas project, realized independent research and development of CGM, insulin pump and artificial algorithm, and provided the ultimate solution for insulin application groups.

It is understood that the artificial pancreas (closed loop insulin pump) can replace the patient's manual blood glucose detection and manual insulin injection, and truly simulate the physiological secretion of human insulin. The working principle is to transfer the blood glucose value in the patient's body to the algorithm control system through the CGM product, and then process the current blood glucose level of the patient, meal situation, blood glucose levels and other information through the control algorithm, and finally transfer the calculation results to the insulin pump, adjust the insulin infusion volume and speed in real time, and form an automatic closed-loop system to maintain the blood glucose in the normal range.

Lan Chunbo told the Arterial Network that CGM is an important information source of Minkang closed-loop artificial pancreas system, which can maximize the physiological function of human pancreas, improve the TIR (time in range) index, reduce the risk of complications, and achieve the ultimate goal of diabetes management of diabetes patients to return to normal life to the greatest extent.

In fact, the research and development of closed-loop artificial pancreas system has always been one of the important development strategies of Minkang. Minkang expects to meet the needs of primary medical institutions for patients' blood glucose management model through the launch of CGM with low price, simple operation, compact and convenient, as well as the establishment of chronic disease management platform and closed-loop artificial pancreas system, and effectively solve the problems of backward information level and data gap in the field of blood glucose management of primary medical institutions. Realize the data exchange between patients' blood glucose data and large hospitals, make effective use of medical information resources, and implement products on a large scale in primary medical institutions, breaking the traditional family-centered model of blood glucose monitoring.

Anhui Progression Biotechnology Co., Ltd., invested by Minkang, has commenced construction in 2020. The project covers an area of nearly 7 hectares. It will introduce 15 automatic production lines imported from Germany, build four major technology research and development centers, and become the largest professional industrial park in China's chronic disease detection technology industry.

With the gradual completion and operation of Anhui Progression Biotechnology Co., Ltd., Minkang's capacity is expected to further increase significantly in the future, and the production cost of CGM products will also be optimized.