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(12) Patent Application Publication (10) Pub. No.: US 2005/0027181 A1 Goode, JR US 20050027181A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2005/0027181 A1 Goode, JR. et al. (43) Pub. Date: Feb. 3, 2005 (54) SYSTEM AND METHODS FOR PROCESSING (52) U.S. Cl. ........................... 600/365; 128/920; 600/309 ANALYTE SENSOR DATA (76) Inventors: Paul V. Goode JR., Murrieta, CA (US); (57) ABSTRACT James H. Brauker, San Diego, CA (US); Apurv U. Kamath, San Diego, Systems and methods for processing Sensor analyte data, CA (US) including initiating calibration, updating calibration, evalu Correspondence Address: ating clinical acceptability of reference and Sensor analyte KNOBBE MARTENS OLSON & BEAR LLP data, and evaluating the quality of Sensor calibration. During 2040 MAIN STREET initial calibration, the analyte Sensor data is evaluated over FOURTEENTH FLOOR a period of time to determine stability of the sensor. The Sensor may be calibrated using a calibration Set of one or IRVINE, CA 92614 (US) more matched Sensor and reference analyte data pairs. The (21) Appl. No.: 10/633,404 calibration may be updated after evaluating the calibration set for best calibration based on inclusion criteria with newly (22) Filed: Aug. 1, 2003 received reference analyte data. Fail-safe mechanisms are provided based on clinical acceptability of reference and Publication Classification analyte data and quality of Sensor calibration. Algorithms provide for optimized prospective and retrospective analysis (51) Int. Cl. .................................................... A61B 5/00 of estimated blood analyte data from an analyte Sensor. 10 19 - 23 32(s 17 16 14 12 Patent Application Publication Feb. 3, 2005 Sheet 1 of 13 US 2005/0027181 A1 FIG. 1 Patent Application Publication Feb. 3, 2005 Sheet 2 of 13 US 2005/0027181 A1 20 22 POTENTIOSTAT 21 AVD CONVERTER 24 EEPROM 25 BATTERY RF TRANSCEIVER 26 CRYSTAL 28 CRYSTAL FIG. 2 Patent Application Publication Feb. 3, 2005 Sheet 3 of 13 US 2005/0027181 A1 8000 7500 P s 7000 al SENSOR i DATA 6500 (counts) 6000 s i SN; : i.r i 5500 2300 2400 2500 2600 TIME (minutes) FIG. 3 Patent Application Publication Feb. 3, 2005 Sheet 4 of 13 US 2005/0027181 A1 11:05AM 12:05 PM 282 F.G. 4B Patent Application Publication Feb. 3, 2005 Sheet 5 of 13 US 2005/0027181 A1 40 F.G. 4D Patent Application Publication Feb. 3, 2005 Sheet 6 of 13 US 2005/0027181 A1 50 53 CRYSTAL 51 52 54 RF TRANSCEIVER SRAM MICROPROCESSOR 55 58 56 59 CRYSTAL COMPORT USER INTERFACE (REFERENCE ANALYTE KEYBOARD MONITOR) 57 SPEAKER WIBRATOR BACKLIGHT CD BUTTONS FIG. 5 Patent Application Publication Feb. 3, 2005 Sheet 7 of 13 US 2005/0027181 A1 INITIAL CALIBRATION 61 RECEIVE SENSOR DATA FROM CONTINUOUSANALYTE SENSOR 62 RECEIVE REFERENCE DATA FROM REFERENCE ANALYTE SOURCE 63 MATCH TIME CORRESPONDING SENSOR DATA AND REFERENCE DATA TO PROVIDE MATCHED DATA PARS FORMA CALIBRATION SET FROM MATCHED PAIR(S) EVALUATE STABILITY OF CONTINUOUSANALYTE SENSOR OVER A PERIOD OF TIME 66 YES 67 CALCULATE CONVERSION FUNCTION USING CALIBRATION SET CONVERT SENSOR DATA USNG CONVERSION FUNCTION FIG. 6 PROVIDE OUTPUT TO USER Patent Application Publication Feb. 3, 2005 Sheet 8 of 13 US 2005/0027181 A1 RAW SENSOR DATA (counts) REFERENCE ANALYTE VALUE (mg/dL) FG. 7 Patent Application Publication Feb. 3, 2005 Sheet 9 of 13 US 2005/0027181 A1 EVALUATE CLINICAL ACCEPTABILITY OF REFERENCE AND SENSOR DATA RECEIVE REFERENCE DATA FROM REFERENCE ANALYTE SOURCE EVALUATE CLNICAL ACCEPTABILITY OF REFERENCE DATA TO SUBSTANTIALLY TIME CORRESPONDING SENSOR DATA CLINICALLY ACCEPTABLET) OPTIONALLY RE-CALCULATE NO CONVERSION FUNCTION USING NEW REFERENCE DATA (FIG. 10) CONTINUOUSLY CONVERT SENSOR DATA USING CONVERSION FUNCTION CONTROL USER INTERFACE BASED ON CLNICAL ACCEPTABILITY FIG. 8 Patent Application Publication Feb. 3, 2005 Sheet 11 of 13 US 2005/0027181 A1 VALUATE CALIBRATION SET FOR BEST CALIBRATION BASED ON INCLUSION CRITERA RECEIVE NEW REFERENCE DATA FROM REFERENCE ANALYTE SOURCE MATCH TIME CORRESPONDING SENSOR DATA TO UPDATED REFERENCE DATA TO PROVIDE NEWMATCHED DATA PAR EVALUATE CALIBRATION SET WITH NO NEWMATCHED DATA PAR BASED ON INCLUSION CRITERA UPDATE CALIBRATION SET2 YES UPDATE CONVERSION FUNCTION USING NEW CALIBRATION SET BASED ON RESULTS OF EVALUATION CONVERT SENSOR DATAUSING UPDATED CONVERSION FUNCTION FIG. 10 Patent Application Publication Feb. 3, 2005 Sheet 12 of 13 US 2005/0027181 A1 EVALUATE OUALITY OF CALIBRATION SET DATA ASSOCATION 111 RECEIVE SENSOR DATA FROM CONTINUOUS GLUCOSE SENSOR 112 RECEIVE REFERENCE DATA FROM REFERENCE GLUCOSE SOURCE 113 MATCH TIME CORRESPONDING SENSOR DATA AND REFERENCE DATA TO PROVIDE MATCHED DATA PAIRS 114 FORM CALIBRATION SET USING MATCHED DATA PAIR(S) 115 CALCULATE CONVERSION FUNCTION USING CALIBRATION SET 116 CONVERT SENSOR DATA USING CONVERSION FUNCTION 117 EVALUATE THE OUALITY OF CALIBRATION SET DATA ASSOCATION 118 CONTROL USER INTERFACE BASED ON OUALITY OF DATA ASSOCATION FIG. 11 Patent Application Publication Feb. 3, 2005 Sheet 13 of 13 US 2005/0027181 A1 2500 2000 SENSOR DATA 1500 (Counts) 1OOO O 500 O O 50 1OO 150 200 250 300 350 REFERENCE DATA (mg/dL) FIG. 12A 2500 2000 1500 SENSOR DATA (Counts) 1000 O 50 100 150 200 250 300 350 REFERENCE DATA (mg/dL) FIG. 12B US 2005/0027181 A1 Feb. 3, 2005 SYSTEMAND METHODS FOR PROCESSING 0007. In a first embodiment a method is provided for ANALYTE SENSOR DATA initializing a Substantially continuous analyte Sensor, the method including: receiving a data Stream from an analyte FIELD OF THE INVENTION Sensor, including one or more Sensor data points, receiving reference data from a reference analyte monitor, including 0001. The present invention relates generally to systems two or more reference data points, providing at least two and methods for analyte Sensor data processing. Particularly, matched data pairs by matching reference analyte data to the present invention relates to retrospectively and/or pro Substantially time corresponding Sensor data; forming a Spectively initiating a calibration, converting Sensor data, calibration Set including the at least two matching data pairs, updating the calibration, evaluating received reference and and determining a Stability of the continuous analyte Sensor. Sensor data, and evaluating the calibration for the analyte SCSO. 0008. In an aspect of the first embodiment, the step of determining the Stability of the Substantially continuous BACKGROUND OF THE INVENTION analyte Sensor includes waiting a predetermined time period between about one minute and about Six weeks. 0002 Diabetes mellitus is a disorder in which the pan creas cannot create Sufficient insulin (Type I or insulin 0009. In an aspect of the first embodiment, the step of dependent) and/or in which insulin is not effective (Type 2 determining the Stability of the Substantially continuous or non-insulin dependent). In the diabetic State, the victim analyte Sensor includes evaluating at least two matched data Suffers from high blood Sugar, which may cause an array of pairs. physiological derangements (e.g., kidney failure, skin ulcers, or bleeding into the vitreous of the eye) associated 0010. In an aspect of the first embodiment, the step of with the deterioration of Small blood vessels. A hypoglyce determining the Stability of the Substantially continuous mic reaction (low blood Sugar) may be induced by an analyte Sensor includes evaluating one of pH, oxygen, inadvertent overdose of insulin, or after a normal dose of hypochlorite, interfering Species, correlation of matched insulin or glucose-lowering agent accompanied by extraor pairs, R-value, baseline drift, baseline offset, and amplitude. dinary exercise or insufficient food intake. 0011. In an aspect of the first embodiment, the method 0.003 Conventionally, a diabetic person carries a self further includes providing one of an audible, Visual, or monitoring blood glucose (SMBG) monitor, which typically tactile output to a user based on the Stability of the Sensor. comprises uncomfortable finger pricking methods. Due to 0012. In an aspect of the first embodiment, the step of the lack of comfort and convenience, a diabetic will nor providing output based on the Stability of the Sensor includes mally only measure his or her glucose level two to four times indicating at least one of a numeric estimated analyte value, per day. Unfortunately, these time intervals are So far spread a directional trend of analyte concentration, and a graphical apart that the diabetic will likely find out too late, Sometimes representation of an estimated analyte value. incurring dangerous Side effects, of a hyper- or hypo glycemic condition. In fact, it is not only unlikely that a 0013 In an aspect of the first embodiment, the step of diabetic will take a timely SMBG value, but the diabetic will receiving Sensor data includes receiving Sensor data from a not know if their blood glucose value is going up (higher) or Substantially continuous glucose Sensor. down (lower) based on conventional methods, inhibiting their ability to make educated insulin therapy decisions. 0014. In an aspect of the first embodiment, the step of receiving Sensor data includes receiving Sensor data from an SUMMARY OF THE INVENTION implantable glucose Sensor. 0004 Systems and methods are needed that accurately 0015. In an aspect of the first embodiment, the step of provide estimated glucose measurements to a diabetic receiving Sensor data includes receiving Sensor data from patient continuously and/or in real time So that they may Subcutaneously implantable glucose Sensor. proactively care for their condition to safely avoid hyper 0016. In an aspect of the first embodiment, the step of and hypo-glycemic conditions. Real time and retrospective receiving reference data includes receiving reference data estimated glucose measurements require reliable data pro from a Self-monitoring blood glucose test. cessing in order to provide accurate and useful output to a patient and/or doctor. 0017. In an aspect of the first embodiment, the step of 0005 Similarly, systems and methods are needed that receiving reference data includes downloading reference accurately provide Substantially continuous estimated ana data via a cabled connection.
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