Systems and methods for replacing signal artifacts in a glucose sensor data stream
DC CAFCFirst Claim
1. A glucose sensor system that detects a signal artifact that can result in an erroneous glucose concentration measurement, the system comprising:
- an electrochemical glucose sensor comprising a plurality of electrodes and an enzyme-containing membrane, wherein the electrochemical sensor is configured to be in contact with a biological fluid;
sensor electronics comprising a processor for executing a computer program code stored in a memory to cause the sensor electronics to;
apply a voltage across the electrodes of the electrochemical glucose sensor,measure a signal response of the electrochemical glucose sensor responsive to the applied voltage,determine a level of severity of the signal artifact based at least in part on the measured signal response, anddynamically select an algorithm or apply a signal estimation algorithm factor based on the level of severity evaluated to generate;
(i) a first glucose value for display based on the measured signal response from the electrochemical glucose sensor when the signal artifact is evaluated having a first level of severity, and(ii) a second glucose value, different from the first glucose value, for display based on the measured signal response from the electrochemical glucose sensor when the signal artifact is evaluated having a second level of severity different from the first level of severity, wherein the second level of severity is greater than the first level of severity, wherein the second glucose value is generated by applying an infinite impulse response filter, wherein the second glucose value is based at least in part on both the measured signal response and historical data; and
a user interface configured to;
display;
(i) the first glucose value when the signal artifact is detected having the first level of severity,(ii) the second, different glucose value when the signal artifact is detected having the second level of severity, and(iii) no glucose value when the signal artifact is detected having a third level of severity, wherein the third level of severity is greater than the second level of severity.
4 Assignments
Litigations
2 Petitions
Accused Products
Abstract
Systems and methods for minimizing or eliminating transient non-glucose related signal noise due to non-glucose rate limiting phenomenon such as ischemia, pH changes, temperatures changes, and the like. The system monitors a data stream from a glucose sensor and detects signal artifacts that have higher amplitude than electronic or diffusion-related system noise. The system replaces some or the entire data stream continually or intermittently including signal estimation methods that particularly address transient signal artifacts. The system is also capable of detecting the severity of the signal artifacts and selectively applying one or more signal estimation algorithm factors responsive to the severity of the signal artifacts, which includes selectively applying distinct sets of parameters to a signal estimation algorithm or selectively applying distinct signal estimation algorithms.
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Citations
69 Claims
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1. A glucose sensor system that detects a signal artifact that can result in an erroneous glucose concentration measurement, the system comprising:
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an electrochemical glucose sensor comprising a plurality of electrodes and an enzyme-containing membrane, wherein the electrochemical sensor is configured to be in contact with a biological fluid; sensor electronics comprising a processor for executing a computer program code stored in a memory to cause the sensor electronics to; apply a voltage across the electrodes of the electrochemical glucose sensor, measure a signal response of the electrochemical glucose sensor responsive to the applied voltage, determine a level of severity of the signal artifact based at least in part on the measured signal response, and dynamically select an algorithm or apply a signal estimation algorithm factor based on the level of severity evaluated to generate; (i) a first glucose value for display based on the measured signal response from the electrochemical glucose sensor when the signal artifact is evaluated having a first level of severity, and (ii) a second glucose value, different from the first glucose value, for display based on the measured signal response from the electrochemical glucose sensor when the signal artifact is evaluated having a second level of severity different from the first level of severity, wherein the second level of severity is greater than the first level of severity, wherein the second glucose value is generated by applying an infinite impulse response filter, wherein the second glucose value is based at least in part on both the measured signal response and historical data; and a user interface configured to; display; (i) the first glucose value when the signal artifact is detected having the first level of severity, (ii) the second, different glucose value when the signal artifact is detected having the second level of severity, and (iii) no glucose value when the signal artifact is detected having a third level of severity, wherein the third level of severity is greater than the second level of severity. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film, wherein the first electrode comprises an electrode surface; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with at least one condition selected from the group consisting of an ischemia, a pH, a temperature associated with the electrochemical glucose sensor, a biochemical species, an available electrode surface area, a local environment associated with the electrode surface of the first electrode, a diffusion transport of glucose or a measured species, and a pressure or a stress associated with the electrochemical glucose sensor, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (15, 16, 17, 18, 19)
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20. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with an available electrode surface area, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (21, 22, 23, 24, 25)
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26. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is caused by a temperature associated with the electrochemical glucose sensor, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (27, 28, 29, 30, 31)
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32. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film, wherein the first electrode comprises an electrode surface; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a local environment associated with the electrode surface of the first electrode, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (33, 34, 35, 36, 37)
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38. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a diffusion transport of glucose or a measured species, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (39, 40, 41, 42, 43)
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44. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a pressure or a stress associated with the electrochemical glucose sensor, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (45, 46, 47, 48, 49)
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50. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a biochemical species, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (51, 52, 53, 54, 55)
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56. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a biological fluid to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with an oxygen deficit, determine a value associated with a severity of the erroneous signal, and discard a glucose measurement when the value associated with the severity of the erroneous signal is outside of a predetermined threshold value. - View Dependent Claims (57, 58, 59, 60, 61)
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62. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film, wherein the first electrode comprises an electrode surface; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with at least one condition selected from the group consisting of an ischemia, a pH, a temperature associated with the electrochemical glucose sensor, a biochemical species, an available electrode surface area, a local environment associated with the electrode surface of the first electrode, a diffusion transport of glucose or a measured species, and a pressure or a stress associated with the electrochemical glucose sensor, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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63. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with an available electrode surface area, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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64. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a temperature associated with the electrochemical glucose sensor, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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65. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film, wherein the first electrode comprises an electrode surface; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a local environment associated with the electrode surface of the first electrode, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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66. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a diffusion transport of glucose or a measured species, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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67. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a pressure or a stress associated with the electrochemical glucose sensor, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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68. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with a biochemical species, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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69. A glucose sensor system, the system comprising:
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an electrochemical glucose sensor configured to be in contact with a blood sample to obtain a glucose measurement, wherein the electrochemical glucose sensor comprises a first electrode, a second electrode, and an enzyme-containing film; and sensor electronics comprising a processor for executing computer program code stored in a memory to cause the processor to; apply a voltage to the electrochemical glucose sensor, wherein applying the voltage comprises at least one process selected from the group consisting of switching, cycling, and pulsing a voltage applied to the electrochemical glucose sensor; measure a signal response of the electrochemical glucose sensor responsive to the applying, detect an erroneous signal based at least in part on the signal response of the electrochemical glucose sensor to the applying, wherein the erroneous signal is associated with an oxygen deficit, determine a value associated with a severity of the erroneous signal, generate a glucose value for display when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, and discard a glucose measurement when the value associated with the severity of the erroneous signal does not satisfy the predetermined threshold value; and a user interface configured to display the generated glucose value when the value associated with the severity of the erroneous signal satisfies a predetermined threshold value, wherein the user interface allows a user to toggle between a first screen, a second screen, and a third screen, wherein the first screen presents the generated glucose value in a glucose measurement trend graph extending over a first time period, wherein the second screen presents the generated glucose value in a glucose measurement trend graph extending over a second time period that is different in length from the first time period, wherein the third screen presents the generated glucose value as a numerical value, and wherein the user interface is configured to generate an alert responsive to detection of a hypoglycemic condition or a hypoglycemic condition based on the generated glucose value.
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Specification