Model based variable risk false glucose threshold alarm prevention mechanism
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Publication Number
US-12727833-B2
Publication Date
2026-09-08
Expiration Date
Abstract
Methods of determining when to activate an analyte, e.g. glucose, related alarm, such as a hypoglycemia alarm, of a continuous analyte monitor is provided. Also provided are systems, devices and kits.
Core Innovation
The invention relates to monitoring a glucose concentration of a user using a glucose sensor that is transcutaneously positioned in contact with bodily fluid. The system receives first measurement data from the glucose sensor and determines a value of the glucose concentration based on the first measurement data. The method further determines a best-estimate of the glucose concentration based on the first measurement data, providing a modeled representation of the user’s glucose concentration from sensor information and related inputs.
Additional glucose measurement data is gathered from the glucose sensor over time to form a set of measurement data. The method determines convergence between the set of measurement data gathered over time and the best-estimate. When the convergence is detected, at least one condition for activating an alarm is modified based on the convergence between the best-estimate and the set of measurement data, such that alarm activation is linked to agreement between model output and sensor measurements.
In described implementations, the best-estimate is computed using model-based processing such as a Kalman filter and state observers, including uncertainty and a range of values represented by upper and lower bounds. The alarm activation logic is described as using convergence-based delay timers and threshold adjustments for hypoglycemia and hyperglycemia alarm handling, and incorporating confirmatory alarm de-assertion logic based on finger stick confirmation to address sensor dropout artifacts such as CGM signal dropouts.
Claims Coverage
The document provides two independent claims covering, respectively, a method and a glucose monitoring system. Across the independent claims, the shared core inventive concept is modifying alarm-activation conditions based on determining convergence between a best-estimate glucose concentration and a time-accumulated set of glucose sensor measurement data; the independent method claim further includes determining the best-estimate and convergence, while the independent system claim includes on-body electronics and a wireless display that perform these functions.
Transcutaneous glucose sensor measurements and best-estimate determination
Receiving, from a glucose sensor, first measurement data related to the glucose concentration of the user, wherein at least a portion of the glucose sensor is transcutaneously positioned in contact with a bodily fluid of the user; determining a value of the glucose concentration of the user based on the first measurement data received from the glucose sensor; and determining a best-estimate of the glucose concentration of the user based on the first measurement data received from the glucose sensor.
Convergence between sensor measurement set and best-estimate for alarm conditioning
Gathering additional glucose measurement data from the glucose sensor, resulting in a set of measurement data being obtained from the glucose sensor over time, the set of measurement data including the first measurement data; determining that there is a convergence between the set of measurement data, which is gathered over time, and the best-estimate; and modifying at least one condition for activating an alarm based on the convergence between the best-estimate and the set of measurement data.
System architecture with on-body electronics and wireless display processing
A glucose sensor configured to be transcutaneously positioned in contact with a bodily fluid of a user to monitor a glucose concentration; on-body electronics electrically and communicatively coupled with the glucose sensor; and a display device comprising one or more processors and a memory communicatively coupled with the one or more processors and in wireless communication with the on-body electronics, wherein the memory comprises instructions which, when executed by the one or more processors, cause the display device to receive, from the on-body electronics, first measurement data related to the glucose concentration of the user; determine a value of the glucose concentration; determine a best-estimate of the glucose concentration based on the first measurement data received from the glucose sensor; gather additional glucose measurement data over time to form a set of measurement data including the first measurement data; modify at least one condition for activating an alarm when the set of measurement data converges with the best-estimate; and activate the alarm based on determining that the at least one condition is satisfied.
The claims cover both a method and a system in which transcutaneous glucose sensor measurements are used to determine a best-estimate glucose concentration, collect additional measurement data over time, determine convergence between the measurement-data set and the best-estimate, and modify alarm-activation conditions accordingly; in the system claim, these functions are executed by a wireless display device that receives data from on-body electronics coupled to the glucose sensor.
Stated Advantages
Reduces false alarms by modifying alarm-activation conditions based on convergence between the best-estimate and sensor measurements.
Documented Applications
Glucose monitoring with hypoglycemia and hyperglycemia alarm handling that accounts for sensor signal artifacts such as CGM dropout.
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