SYSTEMS, DEVICES AND METHODS FOR GLUCOSE SENSING AND ASSOCIATED METHODS
Embodiments of the present disclosure relate to systems, devices and methods for continuous glucose monitoring. In some embodiments, a continuous glucose monitoring (CGM) device is provided that includes a subcutaneous implantable electrochemical sensing probe (sensor). The sensor is planar and comp...
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Zusammenfassung: | Embodiments of the present disclosure relate to systems, devices and methods for continuous glucose monitoring. In some embodiments, a continuous glucose monitoring (CGM) device is provided that includes a subcutaneous implantable electrochemical sensing probe (sensor). The sensor is planar and comprises counter and working electrodes that are deposited at both sides of the sensing probe. A biocompatible layer deposited at the entire sensor circumference minimizes inflammatory reaction. A reel to reel production process provides "per sensor" layers' deposition at predefined spots on a base sheet during displacement between production stations. Production processes are conducted initially at one side of the base sheet followed by production processes on the opposite side. Sensor by sensor working electrode surface areas and layers' thickness are measured and "per sensor" data ("dry" parameters) is stored according to base sheet identifiers that could be implemented by printed or etched markings or else by other means such as RFID. In addition, batch parameters are measured on a sample basis (in vitro "wet" parameters). A factory calibration algorithm analyzes "per lot" sample of sensors' performance (in vitro "wet" parameters in glucose solutions) as well as individual sensor measurement and combines the data in a calibration algorithm to calculate individual sensor calibration parameters and data is programmed back to the individual sensor. |
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