Source: http://www.google.com/patents/US20070208244?dq=6,240,376
Timestamp: 2015-11-30 19:38:05
Document Index: 35503945

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60']

Patent US20070208244 - Transcutaneous analyte sensor - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host....http://www.google.com/patents/US20070208244?utm_source=gb-gplus-sharePatent US20070208244 - Transcutaneous analyte sensorAdvanced Patent SearchPublication numberUS20070208244 A1Publication typeApplicationApplication numberUS 11/734,178Publication dateSep 6, 2007Filing dateApr 11, 2007Priority dateAug 1, 2003Also published asUS8160669, US8788007, US20120172691Publication number11734178, 734178, US 2007/0208244 A1, US 2007/208244 A1, US 20070208244 A1, US 20070208244A1, US 2007208244 A1, US 2007208244A1, US-A1-20070208244, US-A1-2007208244, US2007/0208244A1, US2007/208244A1, US20070208244 A1, US20070208244A1, US2007208244 A1, US2007208244A1InventorsJames Brauker, Apurv Kamath, Paul Goode, Mark BristerOriginal AssigneeBrauker James H, Kamath Apurv U, Paul Goode, Mark BristerExport CitationBiBTeX, EndNote, RefManReferenced by (249), Classifications (21), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetTranscutaneous analyte sensor
US 20070208244 A1Abstract
The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. Images(65) Claims(36)
1. A system for monitoring a glucose concentration in a host, the system comprising: a continuous glucose sensor configured to produce a signal indicative of a glucose concentration in a host; and a receiver operably connected to the sensor, wherein the receiver comprises a single point glucose measuring device, wherein the single point glucose measuring device is built into the receiver, and wherein the single point glucose measuring device is configured to receive a biological sample from the host and to measure a concentration of glucose in the biological sample, wherein the measured glucose concentration in the biological sample comprises reference data, and wherein the receiver further comprises programming configured to calibrate or confirm the signal based at least in part on the reference data. 2. The system of claim 1, wherein the receiver comprises programming configured to calibrate and confirm the signal based at least in part on the reference data. 3. The system of claim 1, wherein the receiver comprises programming configured to calibrate the signal only when a rate of change of the signal is less than a predetermined threshold. 4. The system of claim 3, wherein the signal is a calibrated signal and wherein the predetermined threshold is 2 mg/dL/min. 5. The system of claim 1, wherein the receiver comprises programming configured to evaluate an accuracy of the reference data as compared to time-corresponding signal data. 6. The system of claim 1, wherein the receiver comprises programming configured to prompt the host to provide a biological sample to the single point glucose measuring device. 7. The system of claim 6, wherein the programming configured to prompt the host is based at least in part on events. 8. The system of claim 6, wherein the programming configured to prompt the host is based at least in part on timing. 9. The system of claim 6, wherein the receiver comprises programming configured to calibrate the signal, and wherein the programming is configured to prompt the host based at least in part a value of the calibrated signal or at least in part rate of change of the calibrated signal. 10. The system of claim 1, wherein the programming configured to calibrate or confirm is configured to calibrate the signal, wherein the receiver further comprises a user interface, and wherein the receiver comprises programming configured to display at least one of the calibrated signal and the reference data on the user interface. 11. The system of claim 10, wherein the receiver comprises programming configured to display the calibrated signal and the reference data on the user interface. 12. The system of claim 1, wherein the receiver comprises an alarm, wherein the receiver comprises programming configured to estimate glucose data for a future time, and wherein the receiver comprises programming further configured to trigger the alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. 13. The system of claim 1, wherein the receiver comprises a user interface, and wherein the programming configured to calibrate or confirm is configured to calibrate the signal, to display a graphical representation of the calibrated signal on the user interface, and to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. 14. A device comprising a computer readable memory, the computer readable memory comprising code for processing data from a continuous glucose measuring device and a single point glucose measuring device, wherein the code comprises: instructions configured to process a signal received from a continuous glucose measuring device; instructions configured to measure a concentration of glucose in a biological sample received from a host, the measured glucose concentration in the sample comprising reference data; and instructions configured to calibrate or confirm the signal based at least in part on the reference data. 15. The device of claim 14, wherein the instructions configured to calibrate or confirm the glucose data are configured to calibrate and confirm the signal based at least in part on the reference data. 16. The device of claim 14, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal only when a rate of change of the signal is less than a predetermined threshold. 17. The device of claim 16, wherein the signal is a calibrated signal and wherein the predetermined threshold is 2 mg/dL/min. 18. The device of claim 14, further comprising instructions configured to evaluate an accuracy of the reference data as compared to time-corresponding signal data. 19. The device of claim 14, further comprising instructions configured to prompt the host to provide a biological sample to the single point glucose measuring device. 20. The device of claim 19, wherein the instructions configured to prompt the host are based at least in part on events. 21. The device of claim 19, wherein the instructions configured to prompt the host are based at least in part on timing. 22. The device of claim 19, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal, and wherein the instructions configured to prompt the host are based at least in part on a value of the calibrated signal or at least in part on a rate of change of the calibrated signal. 23. The device of claim 14, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal, and wherein the device further comprises instructions configured to display at least one of the calibrated signal and the reference data on a user interface. 24. The device of claim 23, wherein the instructions configured to display at least one of the calibrated signal and the reference data on the user interface are configured to display the calibrated signal and the reference data on the user interface. 25. The device of claim 14, further comprising instructions configured to estimate glucose data for a future time and instructions configured to trigger an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. 26. The device of claim 14, wherein the instructions configured to calibrate or confirm are configured to calibrate the signal, wherein the device further comprises instructions configured to display a graphical representation of the calibrated signal on a user interface and instructions configured to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. 27. A method for monitoring glucose concentration in a host, the method comprising: generating a signal from a continuous glucose measuring device indicative of a glucose concentration in a host; receiving the signal from the continuous glucose measuring device in a receiver; measuring a concentration of glucose in a biological sample in a single point glucose measuring device built into the receiver, the measured glucose concentration in the biological sample comprising reference data; and calibrating or confirming the signal based at least in part on the reference data. 28. The method of claim 27, wherein the step of calibrating or confirming the signal comprises calibrating and confirming the signal based at least in part on the reference data. 29. The method of claim 27, wherein the step of calibrating the signal is allowed only when a rate of change of the signal is less than a predetermined threshold. 30. The method of claim 29, wherein the step of calibrating or confirming the signal comprises calibrating the signal and wherein the predetermined threshold is 2 mg/dL/min. 31. The method of claim 27, further comprising evaluating an accuracy of the reference data as compared to time-corresponding signal data. 32. The method of claim 27, further comprising prompting the host through a user interface to provide a biological sample to the single point glucose measuring device. 33. The method of claim 27, wherein the step of calibrating or confirming the signal comprises calibrating the signal, and wherein the method further comprises displaying at least one of the calibrated signal and the reference data on a user interface. 34. The method of claim 33, wherein the step of displaying at least one of the calibrated signal and the reference data on a user interface comprises displaying the calibrated signal and the reference data on the user interface. 35. The method of claim 27, further comprising estimating glucose data for a future time and triggering an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. 36. The method of claim 27, wherein the step of calibrating or confirming the signal comprises calibrating the signal, and wherein the method further comprises displaying a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on a user interface.
RELATED APPLICATIONS [0001] This application is a continuation-in-part of U.S. application Ser. No. 11/334,876 filed Jan. 18, 2006. U.S. application Ser. No. 11/334,876 is a continuation-in-part of U.S. application Ser. No. 10/633,367 filed Aug. 1, 2003. U.S. application Ser. No. 11/334,876 is a continuation-in-part of U.S. application Ser. No. 11/007,920 filed Dec. 8, 2004, which claims priority under 35 U.S.C. � 119(e) to U.S. Provisional Application No. 60/528,382 filed Dec. 9, 2003, U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004. U.S. application Ser. No. 11/334,876 is a continuation-in-part of U.S. application Ser. No. 10/991,966 filed Nov. 17, 2004, which claims priority under 35 U.S.C. � 119(e) to U.S. Provisional Application No. 60/523,840 filed Nov. 19, 2003, U.S. Provisional Application No. 60/587,787 filed Jul. 13, 2004, and U.S. Provisional Application No. 60/614,683 filed Sep. 30, 2004. U.S. application Ser. No. 11/334,876 is a continuation-in-part of U.S. application Ser. No. 11/077,715 filed Mar. 10, 2005, which claims priority under 35 U.S.C. � 119(e) to the U.S. Provisional No. 60/587,787 filed on Jul. 13, 2004, U.S. Provisional Application No. 60/587,800 filed Jul. 13, 2004, U.S. Provisional No. 60/614,683 filed Sep. 30, 2004, and U.S. Provisional Application No. 60/614,764 filed Sep. 30, 2004. Each of the above-referenced applications is hereby incorporated by reference herein in its entirety, and each of the above-referenced applications is hereby made a part of this specification.
FIELD OF THE INVENTION [0002] The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous measurement of glucose in a host. BACKGROUND OF THE INVENTION [0003] Diabetes mellitus is a disorder in which the pancreas cannot create sufficient insulin (Type I or insulin dependent) and/or in which insulin is not effective (Type 2 or non-insulin dependent). In the diabetic state, the victim suffers from high blood sugar, which can cause an array of physiological derangements associated with the deterioration of small blood vessels, for example, kidney failure, skin ulcers, or bleeding into the vitreous of the eye. A hypoglycemic reaction (low blood sugar) can be induced by an inadvertent overdose of insulin, or after a normal dose of insulin or glucose-lowering agent accompanied by extraordinary exercise or insufficient food intake. [0004] Conventionally, a person with diabetes carries a self-monitoring blood glucose (SMBG) monitor, which typically requires uncomfortable finger pricking methods. Due to the lack of comfort and convenience, a person with diabetes normally only measures his or her glucose levels two to four times per day. Unfortunately, such time intervals are so far spread apart that the person with diabetes likely finds out too late of a hyperglycemic or hypoglycemic condition, sometimes incurring dangerous side effects. It is not only unlikely that a person with diabetes will take a timely SMBG value, it is also likely that he or she will not know if his or her blood glucose value is going up (higher) or down (lower) based on conventional method. This inhibits the ability to make educated insulin therapy decisions. SUMMARY OF THE INVENTION [0005] In a first aspect, a system for monitoring a glucose concentration in a host is provided, the system comprising a continuous glucose sensor configured to produce a signal indicative of a glucose concentration in a host; and a receiver operably connected to the sensor, wherein the receiver comprises a user interface, and wherein the receiver further comprises programming configured to calibrate the signal, to display a graphical representation of the calibrated signal on the user interface, and to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. [0006] In an embodiment of the first aspect, the receiver comprises programming configured to display the direction and the rate of change of the calibrated signal by a rotation of the directional arrow with a resolution of from about 1 degree to about 45 degrees. [0007] In an embodiment of the first aspect, the directional arrow is indicative of a direction and a rate of change over a predetermined time period. [0008] In an embodiment of the first aspect, predetermined time period is at least about 15 minutes. [0009] In an embodiment of the first aspect, the receiver comprises programming configured to display at least one of a boundary representative of an upper glucose threshold and a boundary representative of a lower glucose threshold on the user interface. [0010] In an embodiment of the first aspect, the receiver comprises programming configured to permit a user to set the upper glucose threshold and the lower glucose threshold. [0011] In an embodiment of the first aspect, the system further comprises an alarm configured to provide at least one of a visual signal, an audible signal, and a tactile signal when the calibrated signal is below the lower glucose threshold. [0012] In an embodiment of the first aspect, the system further comprises an alarm configured to provide at least one of a visual signal, an audible signal, and a tactile signal when the calibrated signal is above the upper glucose threshold. [0013] In an embodiment of the first aspect, the receiver comprises programming configured to estimate glucose data for a future time. [0014] In an embodiment of the first aspect, the system further comprises an alarm configured to provide at least one of a visual signal, an audible signal, and a tactile signal when the estimated glucose data for the future time is above a predetermined threshold. [0015] In an embodiment of the first aspect, the system further comprises an alarm configured to provide at least one of a visual signal, an audible signal, and a tactile signal when the estimated glucose data for the future time is below a predetermined threshold. [0016] In an embodiment of the first aspect, the receiver further comprises a single point glucose measuring device, wherein the single point glucose measuring device is built into the receiver, and wherein the single-point glucose measuring device is configured to receive a biological sample from the host and to measure a concentration of glucose in the biological sample, wherein the measured glucose concentration in the biological sample is reference data. [0017] In an embodiment of the first aspect, the programming configured to calibrate the signal is configured to calibrate the signal at least in part based on the reference data. [0018] In an embodiment of the first aspect, the receiver comprises programming configured to confirm at least one of the signal and the calibrated signal at least in part based on the reference data. [0019] In a second aspect, a device is provided comprising a computer readable memory, the computer readable memory comprising code for processing a signal from a continuous glucose measuring device, wherein the code comprises instructions configured to process a signal received from the continuous glucose measuring device; instructions configured to calibrate the signal; instructions configured to calculate a rate of change of the calibrated signal; and instructions configured to display a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on a user interface. [0020] In an embodiment of the second aspect, the device further comprises instructions configured to display at least one of a boundary representative of an upper glucose threshold and a boundary representative of a lower glucose threshold on the user interface. [0021] In an embodiment of the second aspect, the device further comprises instructions configured allow at least one of the upper glucose threshold and the lower glucose threshold to be modified by a user. [0022] In an embodiment of the second aspect, the device further comprises instructions configured to provide an alarm comprising at least one of a visual signal, an audible signal, and a tactile signal when the calibrated signal is below the lower glucose threshold. [0023] In an embodiment of the second aspect, the device further comprises instructions configured to provide an alarm comprising at least one of a visual signal, an audible signal, and a tactile signal when the calibrated signal is above the upper glucose threshold. [0024] In an embodiment of the second aspect, the device further comprises instructions configured to estimate glucose data for a future time. [0025] In an embodiment of the second aspect, the device further comprises instructions configured to provide an alarm comprising at least one of a visual signal, an audible signal, and a tactile signal when the estimated glucose data for the future time is above a predetermined threshold. [0026] In an embodiment of the second aspect, the device further comprises instructions configured to provide an alarm comprising at least one of a visual signal, an audible signal, and a tactile signal when the estimated glucose data for the future time is below a predetermined threshold. [0027] In a third aspect, a method is provided for displaying data from a continuous glucose measuring device, the method comprising generating a signal from a continuous glucose measuring device indicative of a glucose concentration in a host; calibrating the signal; and displaying, substantially in real-time, a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal. [0028] In an embodiment of the third aspect, the method further comprises alarming the host when the calibrated signal is below a predetermined threshold, wherein the alarm comprises at least one of a visual signal, an audible signal, and a tactile signal. [0029] In an embodiment of the third aspect, the method further comprises alarming the host when the calibrated signal is above a predetermined threshold, wherein the alarm comprises at least one of a visual signal, an audible signal, and a tactile signal. [0030] In an embodiment of the third aspect, the method further comprises estimating glucose data for a future time. [0031] In an embodiment of the third aspect, the method further comprises alarming the host when the estimated glucose data for the future time is above a predetermined threshold, wherein the alarm comprises at least one of a visual signal, an audible signal, and a tactile signal. [0032] In an embodiment of the third aspect, the method further comprises alarming the host when the estimated glucose data for the future time is below a predetermined threshold, wherein the alarm comprises at least one of a visual signal, an audible signal, and a tactile signal. [0033] In a fourth aspect, a system is provided for monitoring glucose concentration in a host, the system comprising a continuous glucose sensor configured to produce a signal indicative of a glucose concentration in a host; and a receiver comprising an alarm, wherein the receiver is operably connected to the sensor, wherein the receiver further comprises programming configured to estimate glucose data for a future time, and wherein the receiver comprises programming further configured to trigger the alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. [0034] In an embodiment of the fourth aspect, the alarm is at least one of a visual alarm, an audible alarm, and a tactile alarm. [0035] In an embodiment of the fourth aspect, the predetermined threshold is user configurable. [0036] In an embodiment of the fourth aspect, the future time is at least about 5 minutes in the future. [0037] In an embodiment of the fourth aspect, the future time is at least about 10 minutes in the future. [0038] In an embodiment of the fourth aspect, the future time is at least about 15 minutes in the future. [0039] In an embodiment of the fourth aspect, the future time is at least about 20 minutes in the future. [0040] In an embodiment of the fourth aspect, the receiver comprises programming further configured to calibrate the signal using a conversion function, and wherein the programming configured to estimate glucose data for a future time is configured use the conversion function to extrapolate glucose data for the future time. [0041] In an embodiment of the fourth aspect, the conversion function is calculated from a linear regression. [0042] In an embodiment of the fourth aspect, the conversion function is calculated from a non-linear regression. [0043] In an embodiment of the fourth aspect, the conversion function is calculated from reference data obtained from a single point glucose measuring device. [0044] In an embodiment of the fourth aspect, the single point glucose measuring device is built into the receiver. [0045] In an embodiment of the fourth aspect, the receiver comprises programming configured to filter the signal, and wherein the estimated glucose data is calculated from the filtered signal. [0046] In an embodiment of the fourth aspect, the receiver comprises programming configured to apply at least one boundary to the estimated glucose data for the future time. [0047] In an embodiment of the fourth aspect, the boundary is a physiological boundary. [0048] In an embodiment of the fourth aspect, the receiver further comprises a user interface, wherein the receiver comprises programming further configured to calibrate the signal, and wherein the receiver comprises programming configured to display a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. [0049] In a fifth aspect, a device is provided comprising a computer readable memory, the computer readable memory comprising code for processing data from a continuous glucose measuring device, wherein the code comprises instructions configured to process a signal received from a continuous glucose measuring device; instructions configured to estimate glucose data for a future time; and instructions configured to trigger an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. [0050] In an embodiment of the fifth aspect, the device further comprises instructions configured to allow a user to modify the predetermined threshold. [0051] In an embodiment of the fifth aspect, the future time is at least about 5 minutes in the future. [0052] In an embodiment of the fifth aspect, the future time is at least about 15 minutes in the future. [0053] In an embodiment of the fifth aspect, the device further comprises instructions configured to calibrate the signal using a conversion function, and wherein the instructions configured to estimate glucose data for a future time are configured use the conversion function to extrapolate glucose data for the future time. [0054] In an embodiment of the fifth aspect, the conversion function is calculated from a linear regression. [0055] In an embodiment of the fifth aspect, the conversion function is calculated from a non-linear regression. [0056] In an embodiment of the fifth aspect, the conversion function is calculated from reference data obtained from a single point glucose measuring device. [0057] In an embodiment of the fifth aspect, the single point glucose measuring device is integral with the device. [0058] In an embodiment of the fifth aspect, the device further comprises instructions configured to filter the signal, and wherein the instructions configured to estimate glucose data estimate glucose data from the filtered signal. [0059] In an embodiment of the fifth aspect, the device further comprises instructions configured to apply at least one boundary to the estimated glucose data for the future time. [0060] In an embodiment of the fifth aspect, the boundary is a physiological boundary. [0061] In an embodiment of the fifth aspect, the device further comprises instructions configured to calibrate the signal and instructions configured to display a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on a user interface. [0062] In a sixth aspect, a method is provided for monitoring a glucose concentration in a host, the method comprising generating a signal from a continuous glucose measuring device indicative of a glucose concentration in a host; processing the signal to estimate glucose data for a future time; and alarming the host when the estimated glucose data for the future time is above or below at least one predetermined threshold. [0063] In an embodiment of the sixth aspect, the step of alarming comprises providing at least one of a visual signal, an audible signal, and a tactile signal. [0064] In an embodiment of the sixth aspect, the method further comprises calibrating the signal using a conversion function, wherein the step of processing the signal to estimate glucose data for a future time is configured use the conversion function to extrapolate glucose data for the future time. [0065] In an embodiment of the sixth aspect, the method further comprises a step of filtering the signal, wherein the step of processing the signal to estimate glucose data estimates the glucose data from the filtered signal. [0066] In an embodiment of the sixth aspect, the method further comprises applying a boundary to the estimated glucose data for the future time. [0067] In an embodiment of the sixth aspect, the method further comprises calibrating the signal and displaying a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. [0068] In a seventh aspect, a system is provided for monitoring a glucose concentration in a host, the system comprising a continuous glucose sensor configured to produce a signal indicative of a glucose concentration in a host; and a receiver operably connected to the sensor, wherein the receiver comprises a single point glucose measuring device, wherein the single point glucose measuring device is built into the receiver, and wherein the single point glucose measuring device is configured to receive a biological sample from the host and to measure a concentration of glucose in the biological sample, wherein the measured glucose concentration in the biological sample comprises reference data, and wherein the receiver further comprises programming configured to calibrate or confirm the signal based at least in part on the reference data. [0069] In an embodiment of the seventh aspect, the receiver comprises programming configured to calibrate and confirm the signal based at least in part on the reference data. [0070] In an embodiment of the seventh aspect, the receiver comprises programming configured to calibrate the signal only when a rate of change of the signal is less than a predetermined threshold. [0071] In an embodiment of the seventh aspect, the signal is a calibrated signal and wherein the predetermined threshold is 2 mg/dL/min. [0072] In an embodiment of the seventh aspect, the receiver comprises programming configured to evaluate an accuracy of the reference data as compared to time-corresponding signal data. [0073] In an embodiment of the seventh aspect, the receiver comprises programming configured to prompt the host to provide a biological sample to the single point glucose measuring device. [0074] In an embodiment of the seventh aspect, the programming configured to prompt the host is based at least in part on events. [0075] In an embodiment of the seventh aspect, the programming configured to prompt the host is based at least in part on timing. [0076] In an embodiment of the seventh aspect, the receiver comprises programming configured to calibrate the signal, and wherein the programming is configured to prompt the host based at least in part a value of the calibrated signal or at least in part rate of change of the calibrated signal. [0077] In an embodiment of the seventh aspect, the programming configured to calibrate or confirm is configured to calibrate the signal, wherein the receiver further comprises a user interface, and wherein the receiver comprises programming configured to display at least one of the calibrated signal and the reference data on the user interface. [0078] In an embodiment of the seventh aspect, the receiver comprises programming configured to display the calibrated signal and the reference data on the user interface. [0079] In an embodiment of the seventh aspect, the receiver comprises an alarm, wherein the receiver comprises programming configured to estimate glucose data for a future time, and wherein the receiver comprises programming further configured to trigger the alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. [0080] In an embodiment of the seventh aspect, the receiver comprises a user interface, and wherein the programming configured to calibrate or confirm is configured to calibrate the signal, to display a graphical representation of the calibrated signal on the user interface, and to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. [0081] In an eighth aspect, a device is provided comprising a computer readable memory, the computer readable memory comprising code for processing data from a continuous glucose measuring device and a single point glucose measuring device, wherein the code comprises instructions configured to process a signal received from a continuous glucose measuring device; instructions configured to measure a concentration of glucose in a biological sample received from a host, the measured glucose concentration in the sample comprising reference data; and instructions configured to calibrate or confirm the signal based at least in part on the reference data. [0082] In an embodiment of the eighth aspect, the instructions configured to calibrate or confirm the glucose data are configured to calibrate and confirm the signal based at least in part on the reference data. [0083] In an embodiment of the eighth aspect, the instructions configured to calibrate or confirm are configured to calibrate the signal only when a rate of change of the signal is less than a predetermined threshold. [0084] In an embodiment of the eighth aspect, the signal is a calibrated signal and wherein the predetermined threshold is 2 mg/dL/min. [0085] In an embodiment of the eighth aspect, the device further comprises instructions configured to evaluate an accuracy of the reference data as compared to time-corresponding signal data. [0086] In an embodiment of the eighth aspect, the device further comprises instructions configured to prompt the host to provide a biological sample to the single point glucose measuring device. [0087] In an embodiment of the eighth aspect, the instructions configured to prompt the host are based at least in part on events. [0088] In an embodiment of the eighth aspect, the instructions configured to prompt the host are based at least in part on timing. [0089] In an embodiment of the eighth aspect, the instructions configured to calibrate or confirm are configured to calibrate the signal, and wherein the instructions configured to prompt the host are based at least in part on a value of the calibrated signal or at least in part on a rate of change of the calibrated signal. [0090] In an embodiment of the eighth aspect, the instructions configured to calibrate or confirm are configured to calibrate the signal, and wherein the device further comprises instructions configured to display at least one of the calibrated signal and the reference data on a user interface. [0091] In an embodiment of the eighth aspect, the instructions configured to display at least one of the calibrated signal and the reference data on the user interface are configured to display the calibrated signal and the reference data on the user interface. [0092] In an embodiment of the eighth aspect, the device further comprises instructions configured to estimate glucose data for a future time and instructions configured to trigger an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. [0093] In an embodiment of the eighth aspect, the instructions configured to calibrate or confirm are configured to calibrate the signal, wherein the device further comprises instructions configured to display a graphical representation of the calibrated signal on a user interface and instructions configured to display a directional arrow indicative of a direction and a rate of change of the calibrated signal on the user interface. [0094] In a ninth aspect, a method for monitoring glucose concentration in a host is provided, the method comprising generating a signal from a continuous glucose measuring device indicative of a glucose concentration in a host; receiving the signal from the continuous glucose measuring device in a receiver; measuring a concentration of glucose in a biological sample in a single point glucose measuring device built into the receiver, the measured glucose concentration in the biological sample comprising reference data; and calibrating or confirming the signal based at least in part on the reference data. [0095] In an embodiment of the ninth aspect, the step of calibrating or confirming the signal comprises calibrating and confirming the signal based at least in part on the reference data. [0096] In an embodiment of the ninth aspect, the step of calibrating the signal is allowed only when a rate of change of the signal is less than a predetermined threshold. [0097] In an embodiment of the ninth aspect, the step of calibrating or confirming the signal comprises calibrating the signal and wherein the predetermined threshold is 2 mg/dL/min. [0098] In an embodiment of the ninth aspect, the method further comprises evaluating an accuracy of the reference data as compared to time-corresponding signal data. [0099] In an embodiment of the ninth aspect, the method further comprises prompting the host through a user interface to provide a biological sample to the single point glucose measuring device. [0100] In an embodiment of the ninth aspect, the step of calibrating or confirming the signal comprises calibrating the signal, and wherein the method further comprises displaying at least one of the calibrated signal and the reference data on a user interface. [0101] In an embodiment of the ninth aspect, the step of displaying at least one of the calibrated signal and the reference data on a user interface comprises displaying the calibrated signal and the reference data on the user interface. [0102] In an embodiment of the ninth aspect, the method further comprises estimating glucose data for a future time and triggering an alarm when the estimated glucose data for the future time is above or below at least one predetermined threshold. [0103] In an embodiment of the ninth aspect, the step of calibrating or confirming the signal comprises calibrating the signal, and wherein the method further comprises displaying a graphical representation of the calibrated signal and a directional arrow indicative of a direction and a rate of change of the calibrated signal on a user interface.
BRIEF DESCRIPTION OF THE DRAWINGS [0104] FIG. 1 is a perspective view of a transcutaneous analyte sensor system, including an applicator, a mounting unit, and an electronics unit. [0105] FIG. 2 is a perspective view of a mounting unit, including the electronics unit in its functional position. [0106] FIG. 3 is an exploded perspective view of a mounting unit, showing its individual components. [0107] FIG. 4A is an exploded perspective view of a contact subassembly, showing its individual components. [0108] FIG. 4B is a perspective view of an alternative contact configuration. [0109] FIG. 4C is a perspective view of another alternative contact configuration. [0110] FIG. 5A is an expanded cutaway view of a proximal portion of a sensor. [0111] FIG. 5B is an expanded cutaway view of a distal portion of a sensor. [0112] FIG. 5C is a cross-sectional view through the sensor of FIG. 5B on line C-C, showing an exposed electroactive surface of a working electrode surrounded by a membrane system. [0113] FIG. 6 is an exploded side view of an applicator, showing the components that facilitate sensor insertion and subsequent needle retraction. [0114] FIGS. 7A to 7D are schematic side cross-sectional views that illustrate applicator components and their cooperating relationships. [0115] FIG. 8A is a perspective view of an applicator and mounting unit in one embodiment including a safety latch mechanism. [0116] FIG. 8B is a side view of an applicator matingly engaged to a mounting unit in one embodiment, prior to sensor insertion. [0117] FIG. 8C is a side view of a mounting unit and applicator depicted in the embodiment of FIG. 8B, after the plunger subassembly has been pushed, extending the needle and sensor from the mounting unit. [0118] FIG. 8D is a side view of a mounting unit and applicator depicted in the embodiment of FIG. 8B, after the guide tube subassembly has been retracted, retracting the needle back into the applicator. [0119] FIG. 8E is a perspective view of an applicator, in an alternative embodiment, matingly engaged to the mounting unit after to sensor insertion. [0120] FIG. 8F is a perspective view of the mounting unit and applicator, as depicted in the alternative embodiment of FIG. 8E, matingly engaged while the electronics unit is slidingly inserted into the mounting unit. [0121] FIG. 8G is a perspective view of the electronics unit, as depicted in the alternative embodiment of FIG. 8E, matingly engaged to the mounting unit after the applicator has been released. [0122] FIGS. 8H and 8I are comparative top views of the sensor system shown in the alternative embodiment illustrated in FIGS. 8E to 8G as compared to the embodiments illustrated in FIGS. 8B to 8D. [0123] FIGS. 9A to 9C are side views of an applicator and mounting unit, showing stages of sensor insertion. [0124] FIGS. 10A and 10B are perspective and side cross-sectional views, respectively, of a sensor system showing the mounting unit immediately following sensor insertion and release of the applicator from the mounting unit. [0125] FIGS. 11A and 11B are perspective and side cross-sectional views, respectively, of a sensor system showing the mounting unit after pivoting the contact subassembly to its functional position. [0126] FIGS. 12A to 12C are perspective and side views, respectively, of the sensor system showing the sensor, mounting unit, and electronics unit in their functional positions. [0127] FIG. 13 is an exploded perspective view of one exemplary embodiment of a continuous glucose sensor [0128] FIG. 14 is a block diagram that illustrates electronics associated with a sensor system. [0129] FIG. 15 is a perspective view of a sensor system wirelessly communicating with a receiver. [0130] FIG. 16A illustrates a first embodiment wherein the receiver shows a numeric representation of the estimated analyte value on its user interface, which is described in more detail elsewhere herein. [0131] FIG. 16B illustrates a second embodiment wherein the receiver shows an estimated glucose value and one hour of historical trend data on its user interface, which is described in more detail elsewhere herein. [0132] FIG. 16C illustrates a third embodiment wherein the receiver shows an estimated glucose value and three hours of historical trend data on its user interface, which is described in more detail elsewhere herein. [0133] FIG. 16D illustrates a fourth embodiment wherein the receiver shows an estimated glucose value and nine hours of historical trend data on its user interface, which is described in more detail elsewhere herein. [0134] FIG. 17A is a block diagram that illustrates a configuration of a medical device including a continuous analyte sensor, a receiver, and an external device. [0135] FIGS. 17B to 17D are illustrations of receiver liquid crystal displays showing embodiments of screen displays. [0136] FIG. 18A is a flow chart that illustrates the initial calibration and data output of sensor data. [0137] FIG. 18B is a perspective view of an integrated receiver housing in another embodiment, showing a single point glucose monitor including a stylus movably mounted to the integrated receiver, wherein the stylus is shown in a storage position. [0138] FIG. 18C is a perspective view of the integrated housing of FIG. 18B, showing the stylus in a testing position. [0139] FIG. 18D is a perspective view of a portion of the stylus of FIG. 18B, showing the sensing region. [0140] FIG. 18E is a perspective view of the integrated receiver housing of FIG. 18B, showing the stylus loaded with a disposable film, and in its testing position. [0141] FIG. 18F is a perspective view of a portion of the stylus of FIG. 18B, showing the sensing region with a disposable film stretched and/or disposed thereon for receiving a biological sample. [0142] FIG. 18G is a graph that illustrates one example of using prior information for slope and baseline. [0143] FIG. 19A is a flow chart that illustrates evaluation of reference and/or sensor data for statistical, clinical, and/or physiological acceptability. [0144] FIG. 19B is a graph of two data pairs on a Clarke Error Grid to illustrate the evaluation of clinical acceptability in one exemplary embodiment. [0145] FIG. 20 is a flow chart that illustrates evaluation of calibrated sensor data for aberrant values. [0146] FIG. 21 is a flow chart that illustrates self-diagnostics of sensor data. [0147] FIGS. 22A and 22B are graphical representations of glucose sensor data in a human obtained over approximately three days. [0148] FIG. 23 is a graphical representation of glucose sensor data in a human obtained over approximately seven days. [0149] FIG. 24 is a flow chart that illustrates the process of estimation of analyte values based on measured analyte values in one embodiment. [0150] FIG. 25 is a graph that illustrates the case where estimation is triggered by an event wherein a patient's blood glucose concentration passes above a predetermined threshold. [0151] FIG. 26 is a graph that illustrates a raw data stream and corresponding reference analyte values. [0152] FIG. 27 is a flow chart that illustrates the process of compensating for a time lag associated with a continuous analyte sensor to provide real-time estimated analyte data output in one embodiment. [0153] FIG. 28 is a graph that illustrates the data of FIG. 26, including reference analyte data and corresponding calibrated sensor analyte and estimated sensor analyte data, showing compensation for time lag using estimation. [0154] FIG. 29 is a flow chart that illustrates the process of matching data pairs from a continuous analyte sensor and a reference analyte sensor in one embodiment. [0155] FIG. 30 is a flow chart that illustrates the process of dynamic and intelligent estimation algorithm selection in one embodiment. [0156] FIG. 31 is a graph that illustrates one case of dynamic and intelligent estimation applied to a data stream, showing first order estimation, second order estimation, and the measured values for a time period, wherein the second order estimation shows a closer correlation to the measured data than the first order estimation. [0157] FIG. 32 is a flow chart that illustrates the process of estimating analyte values within physiological boundaries in one embodiment. [0158] FIG. 33 is a graph that illustrates one case wherein dynamic and intelligent estimation is applied to a data stream, wherein the estimation performs regression and further applies physiological constraints to the estimated analyte data. [0159] FIG. 34 is a flow chart that illustrates the process of dynamic and intelligent estimation and evaluation of analyte values in one embodiment. [0160] FIG. 35 is a graph that illustrates a case wherein the selected estimative algorithm is evaluated in one embodiment, wherein a correlation is measured to determine a deviation of the measured analyte data with the selected estimative algorithm, if any. [0161] FIG. 36 is a flow chart that illustrates the process of evaluating a variation of estimated future analyte value possibilities in one embodiment. [0162] FIG. 37 is a graph that illustrates a case wherein a variation of estimated analyte values is based on physiological parameters. [0163] FIG. 38 is a graph that illustrates a case wherein a variation of estimated analyte values is based on statistical parameters. [0164] FIG. 39 is a flow chart that illustrates the process of estimating, measuring, and comparing analyte values in one embodiment. [0165] FIG. 40 is a graph that illustrates a case wherein a comparison of estimated analyte values to time corresponding measured analyte values is used to determine correlation of estimated to measured analyte data. [0166] FIG. 41 is an illustration of the receiver in one embodiment showing an analyte trend graph, including measured analyte values, estimated analyte values, and a zone of clinical risk. [0167] FIG. 42 is an illustration of the receiver in one embodiment showing a gradient bar, including measured analyte values, estimated analyte values, and a zone of clinical risk. [0168] FIG. 43 is an illustration of the receiver in one embodiment showing an analyte trend graph, including measured analyte values and one or more clinically acceptable target analyte values. [0169] FIG. 44 is an illustration of the receiver of FIG. 43, further including estimated analyte values on the same screen. [0170] FIG. 45 is an illustration of the receiver of FIG. 44, further including a variation of estimated analyte values and therapy recommendations on the same screen to help the user obtain the displayed target analyte values. [0171] FIG. 46 is an illustration of the receiver in one embodiment, showing measured analyte values and a dynamic visual representation of a range of estimated analyte values based on a variation analysis. [0172] FIG. 47 is an illustration of the receiver in another embodiment, showing measured analyte values and a visual representation of range of estimated analyte values based on a variation analysis. [0173] FIG. 48 is an illustration of the receiver in another embodiment, showing a numerical representation of the most recent measured analyte value, a directional arrow indicating rate of change, and a secondary numerical value representing a variation of the measured analyte value. [0174] FIG. 49 depicts a conventional display of glucose data (uniform y-axis), 9-hour trend graph. [0175] FIG. 50 depicts a utility-driven display of glucose data (non-uniform y-axis), 9-hour trend graph. [0176] FIG. 51 depicts a conventional display of glucose data, 7-day glucose chart. [0177] FIG. 52 depicts a utility-driven display of glucose data, 7-day control chart, median (interquartile range) of daily glucose. [0178] FIG. 53 is an illustration of a receiver in one embodiment that interfaces with a computer. [0179] FIG. 54 is an illustration of a receiver in one embodiment that interfaces with a modem. [0180] FIG. 55 is an illustration of a receiver in one embodiment that interfaces with an insulin pen. [0181] FIG. 56 is an illustration of a receiver in one embodiment that interfaces with an insulin pump.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT [0182] The following description and examples illustrate some exemplary embodiments of the disclosed invention in detail. Those of skill in the art will recognize that there are numerous variations and modifications of this invention that are encompassed by its scope. Accordingly, the description of a certain exemplary embodiment should not be deemed to limit the scope of the present invention. [0000] Definitions [0183] In order to facilitate an understanding of the preferred embodiments, a number of terms are defined below. [0184] The term “analyte” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed. Analytes can include naturally occurring substances, artificial substances, metabolites, and/or reaction products. In some embodiments, the analyte for measurement by the sensing regions, devices, and methods is glucose. However, other analytes are contemplated as well, including but not limited to acarboxyprothrombin; acylcarnitine; adenine phosphoribosyl transferase; adenosine deaminase; albumin; alpha-fetoprotein; amino acid profiles (arginine (Krebs cycle), histidine/urocanic acid, homocysteine, phenylalanine/tyrosine, tryptophan); andrenostenedione; antipyrine; arabinitol enantiomers; arginase; benzoylecgonine (cocaine); biotimidase; biopterin; c-reactive protein; carnitine; carnosinase; CD4; ceruloplasmin; chenodeoxycholic acid; chloroquine; cholesterol; cholinesterase; conjugated 1-β hydroxy-cholic acid; cortisol; creatine kinase; creatine kinase MM isoenzyme; cyclosporin A; d-penicillamine; de-ethylchloroquine; dehydroepiandrosterone sulfate; DNA (acetylator polymorphism, alcohol dehydrogenase, alpha 1-antitrypsin, cystic fibrosis, Duchenne/Becker muscular dystrophy, glucose-6-phosphate dehydrogenase, hemoglobin A, hemoglobin S, hemoglobin C, hemoglobin D, hemoglobin E, hemoglobin F, D-Punjab, beta-thalassemia, hepatitis B virus, HCMV, HIV-1, HTLV-1, Leber hereditary optic neuropathy, MCAD, RNA, PKU, Plasmodium vivax, sexual differentiation, 21-deoxycortisol); desbutylhalofantrine; dihydropteridine reductase; diptheria/tetanus antitoxin; erythrocyte arginase; erythrocyte protoporphyrin; esterase D; fatty acids/acylglycines; free β-human chorionic gonadotropin; free erythrocyte porphyrin; free thyroxine (FT4); free tri-iodothyronine (FT3); fumarylacetoacetase; galactose/gal-1-phosphate; galactose-1-phosphate uridyltransferase; gentamicin; glucose-6-phosphate dehydrogenase; glutathione; glutathione perioxidase; glycocholic acid; glycosylated hemoglobin; halofantrine; hemoglobin variants; hexosaminidase A; human erythrocyte carbonic anhydrase I; 17-alpha-hydroxyprogesterone; hypoxanthine phosphoribosyl transferase; immunoreactive trypsin; lactate; lead; lipoproteins ((a), B/A-1, β); lysozyme; mefloquine; netilmicin; phenobarbitone; phenyloin; phytanic/pristanic acid; progesterone; prolactin; prolidase; purine nucleoside phosphorylase; quinine; reverse tri-iodothyronine (rT3); selenium; serum pancreatic lipase; sissomicin; somatomedin C; specific antibodies (adenovirus, anti-nuclear antibody, anti-zeta antibody, arbovirus, Aujeszky's disease virus, dengue virus, Dracunculus medinensis, Echinococcus granulosus, Entamoeba histolytica, enterovirus, Giardia duodenalisa, Helicobacter pylori, hepatitis B virus, herpes virus, HIV-1, IgE (atopic disease), influenza virus, Leishmania donovani, leptospira, measles/mumps/rubella, Mycobacterium leprae, Mycoplasma pneumoniae, Myoglobin, Onchocerca volvulus, parainfluenza virus, Plasmodium falciparum, poliovirus, Pseudomonas aeruginosa, respiratory syncytial virus, rickettsia (scrub typhus), Schistosoma mansoni, Toxoplasma gondii, Trepenoma pallidium, Trypanosoma cruzi/rangeli, vesicular stomatis virus, Wuchereria bancrofti, yellow fever virus); specific antigens (hepatitis B virus, HIV-1); succinylacetone; sulfadoxine; theophylline; thyrotropin (TSH); thyroxine (T4); thyroxine-binding globulin; trace elements; transferrin; UDP-galactose-4-epimerase; urea; uroporphyrinogen I synthase; vitamin A; white blood cells; and zinc protoporphyrin. Salts, sugar, protein, fat, vitamins, and hormones naturally occurring in blood or interstitial fluids can also constitute analytes in certain embodiments. The analyte can be naturally present in the biological fluid, for example, a metabolic product, a hormone, an antigen, an antibody, and the like. Alternatively, the analyte can be introduced into the body, for example, a contrast agent for imaging, a radioisotope, a chemical agent, a fluorocarbon-based synthetic blood, or a drug or pharmaceutical composition, including but not limited to insulin; ethanol; cannabis (marijuana, tetrahydrocannabinol, hashish); inhalants (nitrous oxide, amyl nitrite, butyl nitrite, chlorohydrocarbons, hydrocarbons); cocaine (crack cocaine); stimulants (amphetamines, methamphetamines, Ritalin, Cylert, Preludin, Didrex, PreState, Voranil, Sandrex, Plegine); depressants (barbituates, methaqualone, tranquilizers such as Valium, Librium, Miltown, Serax, Equanil, Tranxene); hallucinogens (phencyclidine, lysergic acid, mescaline, peyote, psilocybin); narcotics (heroin, codeine, morphine, opium, meperidine, Percocet, Percodan, Tussionex, Fentanyl, Darvon, Talwin, Lomotil); designer drugs (analogs of fentanyl, meperidine, amphetamines, methamphetamines, and phencyclidine, for example, Ecstasy); anabolic steroids; and nicotine. The metabolic products of drugs and pharmaceutical compositions are also contemplated analytes. Analytes such as neurochemicals and other chemicals generated within the body can also be analyzed, such as, for example, ascorbic acid, uric acid, dopamine, noradrenaline, 3-methoxytyramine (3MT), 3,4-dihydroxyphenylacetic acid (DOPAC), homovanillic acid (HVA), 5-hydroxytryptamine (5HT), histamine, and 5-hydroxyindoleacetic acid (FHIAA). [0185] The term “host” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to mammals, particularly humans. [0186] The term “exit-site” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the area where a medical device (for example, a sensor and/or needle) exits from the host's body. [0187] The phrase “continuous (or continual) analyte sensing” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the period in which monitoring of analyte concentration is continuously, continually, and or intermittently (regularly or irregularly) performed, for example, about every 5 to 10 minutes. [0188] The term “electrochemically reactive surface” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the surface of an electrode where an electrochemical reaction takes place. For example, a working electrode measures hydrogen peroxide produced by the enzyme-catalyzed reaction of the analyte detected, which reacts to create an electric current. Glucose analyte can be detected utilizing glucose oxidase, which produces H2O2 as a byproduct. H2O2 reacts with the surface of the working electrode, producing two protons (2H+), two electrons (2e−) and one molecule of oxygen (O2), which produces the electronic current being detected. [0189] The term “electronic connection” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to any electronic connection known to those in the art that can be utilized to interface the sensing region electrodes with the electronic circuitry of a device, such as mechanical (for example, pin and socket) or soldered electronic connections. [0190] The term “interferant” and “interferants” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to species that interfere with the measurement of an analyte of interest in a sensor to produce a signal that does not accurately represent the analyte measurement. In one example of an electrochemical sensor, interferants are compounds with oxidation potentials that overlap with the analyte to be measured. [0191] The term “sensing region” as used herein is a broad term, and is to be given its ordinary and customary meaning to a person of ordinary skill in the art (and is not to be limited to a special or customized meaning), and furthermore refers without limitation to the region of a monitoring device responsible for the detection of a particular analyte. The sensing region generally comprises a non-conductive body, a w