Continuous Glucose Monitoring System and Method

Abstract

A continuous glucose monitoring system and method has an inserter assembly for inserting a sensor through the skin and into subcutaneous tissue where an inserter housing with the sensor remains on the skin after insertion, a sensor housing cover attachable to the sensor housing after insertion where the sensor housing cover has an electronic module and a battery, and an electronic device equipped with wireless communication for communicating with the electronic module of the sensor housing cover assembly, the electronic device configured for receiving input signals from the sensor, converting the input signals to analyte date, displaying the analyte data on a user interface of the electronic device, storing the data for recall, and creating and/or sending reports of the data.

What is claimed is: 
     
         1 . A method of inserting a sensor subcutaneously, the method comprising:
 providing an inserter assembly containing a sensor and an insertion needle adapted for implanting the sensor into subcutaneous tissue wherein the inserter assembly requires a user-perpetrated initial applied force of greater than 1.5 lbs. that is followed by a decrease in applied force to an applied force of less than 1.5 lbs;   placing the inserter assembly against a patient's skin;   actuating the inserter assembly to thereby implant the sensor subcutaneously and disengaging a sensor housing containing the implanted sensor from the inserter assembly; and   removing the inserter assembly from the patient's skin.   
     
     
         2 . The method of  claim 1  wherein the providing step includes providing an inserter assembly that requires a user-perpetrated initial applied force in the range of 1.5 to 2.5 lbs. followed by a decrease in the applied force for insertion of the needle into the subcutaneous tissue wherein the applied force of the insertion needle is in the range of about 0.5 lbs to about 1.3 lbs. 
     
     
         3 . The method of  claim 1  wherein the providing step includes providing an inserter assembly that is capable of implanting the sensor subcutaneously and disengaging the post-actuation inserter assembly in a time period selected from the group consisting of less than 0.5 seconds, a range of less than 0.25 seconds to 0.8 seconds, a range of less than 0.5 seconds to 0.8 seconds, a range of 0.5 seconds to 0.8 seconds, a range of 0.25 seconds to 0.5 seconds, and 0.5 seconds. 
     
     
         4 . The method of  claim 1  wherein the actuating step implants the sensor subcutaneously and disengages the post-actuation inserter assembly in a time period selected from the group consisting of less than 0.5 seconds, a range of less than 0.25 seconds to 0.8 seconds, a range of less than 0.5 seconds to 0.8 seconds, a range of 0.5 seconds to 0.8 seconds, a range of 0.25 seconds to 0.5 seconds, and 0.5 seconds.