USO10806382B2 ( 12 ) United States Patent ( 10 ) Patent No .: US 10,806,382 B2 Sloan et al . ( 45 ) Date of Patent : * Oct . 20 , 2020 ( 54 ) METHODS , DEVICES , AND SYSTEMS ( 58 ) Field of Classification Search RELATED TO ANALYTE MONITORING CPC A61B 5/14532 ; A61B 5/14546 ; A61B 5/1486 ; A61B 5/14539 ; A61B 5/0031 ( 71 ) Applicant: ABBOTT DIABETES CARE INC . , See application file for complete search history . Alameda , CA ( US ) ( 72 ) Inventors : Mark K. Sloan , Redwood City, CA ( 56 ) References Cited ( US ) ; Royce Cheng , San Francisco , CA ( US ) ; Gary A. Hayter , Oakland , CA U.S. PATENT DOCUMENTS ( US ) ; Marc B. Taub, Mountain View , 4,942,877 A * 7/1990 Sakai A61B 5/14551 CA (US ); Mani Gopal , Hillsborough , 600/323 CA ( US ) 5,262,035 A 11/1993 Gregg et al . ( Continued ) ( 73 ) Assignee : ABBOTT DIABETES CARE INC ., Alameda , CA (US ) FOREIGN PATENT DOCUMENTS ( * ) Notice : Subject to any disclaimer , the term of this WO WO 2009/146445 A1 12/2009 patent is extended or adjusted under 35 U.S.C. 154 ( b ) by 218 days . OTHER PUBLICATIONS This patent is subject to a terminal dis claimer . EP, 13859365.2 Extended Search Report, dated Jul. 5 , 2016 . ( 21 ) Appl. No .: 15 / 868,890 Primary Examiner — Eric F Winakur ( 74 ) Attorney , Agent, or Firm One LLP ( 22 ) Filed : Jan. 11 , 2018 ( 65 ) Prior Publication Data ( 57 ) ABSTRACT US 2018/0199862 A1 Jul . 19 , 2018 Generally, methods , devices , and systems related to analyte monitoring and data logging are providede.g ., as related Related U.S. Application Data to in vivo analyte monitoring devices and systems . In some ( 63 ) Continuation of application No. 14 / 092,035 , filed on aspects , methods, devices , and systems are provided that Nov. 27 , 2013 , now Pat . No. 9,872,641 . relate to enable related settings based on an expected use of an in vivo positioned sensor ; logging or otherwise recording ( Continued ) analyte levels acquired or derived - e.g ., sample analyte ( 51 ) Int. Cl . levels more frequently than they are logged or otherwise A61B 5/145 ( 2006.01 ) recorded in memory ; dynamically adjust the data logging A61B 5/00 ( 2006.01 ) frequency ; randomly determine times of acquiring or storing analyte levels from the in - vivo positioned analyte sensors ; ( Continued ) and enable recording related settings when the system is ( 52 ) U.S. CI . operable . ??? A61B 5/145 ( 2013.01 ) ; A61B 5/14532 ( 2013.01 ) ; A61B 5/7221 ( 2013.01 ) ; (Continued ) 19 Claims , 11 Drawing Sheets 1005 Receive sensor - use information for a sensor 1010 Sensor - use information for Sensor - use information for 1st type of sensor use Determine settings associated 2nd type of sensor use with the sensor - use information received 1030 1020 Configure settings of analyte Configure settings of analyte monitoring device for a 1st monitoring device for a second type of sensor use type of sensor use 1035 1025 Operate analyte monitoring Operate analyte monitoring device with settings for a 1st device with settings for a 2nd type of sensor use type of sensor use US 10,806,382 B2 Page 2 Related U.S. Application Data 6,308,089 B1 10/2001 von der Ruhr et al . 6,515,273 B2 2/2003 Al - Ali ( 60 ) Provisional application No. 61 / 731,316 , filed on Nov. 6,650,471 B2 11/2003 Doi 29 , 2012 . 6,746,582 B2 6/2004 Heller et al . 7,811,231 B2 10/2010 Jin et al . 7,894,869 B2 * 2/2011 Hoarau A61B 5/14552 ( 51 ) Int . Cl . 600/323 G16H 40/63 ( 2018.01) 2004/0078219 Al 4/2004 Kaylor et al . G16H 10/40 ( 2018.01 ) 2006/0229511 A1 10/2006 Fein et al . A61B 5/1495 ( 2006.01 ) 2008/0221930 A1 9/2008 Wekell et al . 2008/0234562 Al 9/2008 Jina ( 52 ) U.S. Ci . 2008/0255635 Al 10/2008 Bettesh et al . CPC G16H 10/40 ( 2018.01 ) ; G16H 40/63 2008/0319295 A1 12/2008 Bernstein et al . ( 2018.01 ) ; A61B 5/1495 ( 2013.01 ) ; A61B 2009/0093687 Al 4/2009 Telfort et al . 2009/0247849 Al 10/2009 McCutcheon et al . 5/14503 ( 2013.01 ) ; A61B 2560/029 ( 2013.01 ) ; 2009/0318792 Al 12/2009 Fennell et al . A61B 2562/08 ( 2013.01 ) 2010/0094111 Al 4/2010 Heller et al . 2010/0213057 Al 8/2010 Feldman et al . ( 56 ) References Cited 2010/0327057 A1 12/2010 Medina et al . 2011/0184265 A1 7/2011 Hayter U.S. PATENT DOCUMENTS 2011/0193704 A1 8/2011 Harper et al . 2011/0237960 A1 9/2011 Rantala 5,262,305 A 11/1993 Heller et al . 2011/0257495 A1 10/2011 Hoss et al. 5,264,104 A 11/1993 Gregg et al . 2011/0287528 A1 11/2011 Fern et al . 5,320,725 A 6/1994 Gregg et al . 2012/0088995 A1 4/2012 Fennell et al . 5,593,852 A 1/1997 Heller et al . 2012/0108934 A1 5/2012 Valdes et al . 5,720,293 A 2/1998 Quinn et al . 2012/0157801 Al 6/2012 Hoss et al . 5,987,343 A 11/1999 Kinast 6,175,752 B1 1/2001 Say et al . * cited by examiner U.S. Patent Oct. 20 , 2020 Sheet 1 of 11 US 10,806,382 B2 1020 1025 secondforadevicemonitoring devicewithsettingsfora2nd informationforSensoruse- 2ndtypeofsensoruse Configuresettingsofanalyte typeofsensoruse Operateanalytemonitoring sensorusetypeof 1005 1010 FIG.1 Receivesensor-useinformation forasensor Determinesettingsassociated informationwiththesensor-use received 1030 -1035 1stforadevicemonitoring devicewithsettingsfora1st informationforSensor-use sensoruse1sttypeof Configuresettingsofanalyte typeofsensoruse Operateanalytemonitoring sensorusetypeof U.S. Patent Oct. 20 , 2020 Sheet 2 of 11 US 10,806,382 B2 t t 4713 155 150 180 I 1 1 I 6TS1,+ 2TRt;+ 130 t,+5TS 125 4TS+ FIG.2 S 120 170 115 3T+t, t+TR RecordingWindow 135 R 1,219 IntervalT 140 Recording t,+TS IntervalTs 145 Sampling 160 101 Sampling 102 Recording U.S. Patent Oct. 20 9, 2020 Sheet 3 of 11 US 10,806,382 B2 205 Obtain analyte levels at sampling intervals k -210 Select sample at a recording time point -220 215 If Perform validity determination on selected valid Record selected sample within recording window sample If not valid -225 Select alternative sample within recording window 235 230 If Perform validity determination on alternative valid Record alternative sample sample If not valid 240 No Select another alternative sample ? Yes -245 Record as predetermined FIG . 3 U.S. Patent Oct. 20 9, 2020 Sheet 4 of 11 US 10,806,382 B2 -305 Obtain analyte at sampling intervals 310 Select sample at a recording time point -315 Select one or more alternative samples within the recording window -320 Generate validity metric for selected sample and one or more alternative samples within the recording window -325 Weigh validity metrics based on time deviation from the selected time - point of recording -330 Determine and record analyte level based on weighted validity metrics FIG . 4 U.S. Patent Oct. 20 9, 2020 Sheet 5 of 11 US 10,806,382 B2 -405 Receive analyte data -410 Monitor analyte data at a first frequency Adjust variable frequency based -415 on analyte data Log data at variable frequency from first frequency FIG . 5 505 Receive analyte data -510 Log analyte data at a variable frequency -515 Receive frequency - adjusting information from analyte monitoring device 520 Adjust variable frequency based on frequency - adjusting information FIG . 6 U.S. Patent Oct. 20 , 2020 Sheet 6 of 11 US 10,806,382 B2 605 Activate in - vivo positioned sensor 610 Randomly aquire analyte levels for a collection period 615 Store and send analyte levels to analyte monitoring device 620 Send analyte levels to data processing device FIG . 7 -705 Position in - vivo analyte sensor on patient -710 Activate in - vivo positioned sensor 715 Acquire randomly generated analyte levels -720 Generate plot from analyte levels -725 Review plot to provide therapeutic recommendation FIG . 8 U.S. Patent Oct. 20 , 2020 Sheet 7 of 11 US 10,806,382 B2 D 20:00 0 (dottedline)glucosereadingbasedon randomlygeneratedglucosereadings 16:00 850 deviationstandardandlinesolid)Average( 12:00 TimeofDay Displayofrandomlygeneratedglucosedatafromimplantablesensor FIG.9 8:00 805 840 1 4:00 Day1 Day2 LA ADay3 oDay4 *Day5 ?Day6 O 0:00 350 300 250 200 150 100 50 0 800 ) dL / mg ( Reading Glucose U.S. Patent Oct. 20 9, 2020 Sheet 8 of 11 US 10,806,382 B2 905 Execute communication between sensor electronics and analyte monitoring device 908 Receive the user configuration data from the analyte monitoring device 910 Calculate sampling rate with user configuration data and specification data for the sensor 915 Configure the sensor electronics to operate at the calculated sampling rate 918 Obtain measurement analyte data 920 Send analyte measurement data to analyte monitoring device FIG . 10 U.S. Patent 0ct . 20 9, 2020 Sheet 9 of 11 US 10,806,382 B2 1400 -1407 -1401 -1402 1404 -1405 DATA PRIMARY DATA PROCESSING SENSOR PROCESSING RECEIVER TERMINAL / INFUSION UNIT UNIT DEVICE 1403 SECONDARY RECEIVER UNIT - 1406 FIG . 11 U.S. Patent Oct. 20 9, 2020 Sheet 10 of 11 US 10,806,382 B2 -1501 -1505 1510 1511 -1509 SERIAL ANALOG COMMUNICATION 1512 INTERFACE SECTION 1513 -1514 -1504 LEAK -1506 DETECTION CIRCUIT RF TO / FROM PROCESSOR TRANSMITTER / PRIMARY 1502 RECEIVER RECEIVER UNIT USER INPUT 1404 -1507 1503 TEMPERATURE MEASUREMENT POWER SUPPLY SECTION 1508 CLOCK 1402 FIG . 12 U.S. Patent Oct. 20 9, 2020 Sheet 11 of 11 US 10,806,382 B2 TEST STRIP -1607 -1609 1601 INTERFACE TO / FROM SERIAL TO / FROM DATA RF COMMUNICATION DATA RECEIVER PROCESSING SECTION PROCESSING PROCESSING & STORAGE TERMINAL UNIT 1602 1402 USER SECTION 1405 INPUT OUTPUT / DISPLAY 1603 TEMPERATURE -1610 DETECTION SECTION 1604 POWER POWER CONVERSION SUPPLY CLOCK AND MONITORING -1606 1605 SECTION -1608 1404 - FIG .