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/1 `3" 1180511 BTLEOSOTD

1. TEXT FIELD 2 FIG 8 US 8 206 340 B2 1 INTEGRATED GLUCOSE MONITOR AND INSULIN INJECTION PEN WITH AUTOMATIC EMERGENCY NOTIFICATION BACKGROUND OF THE INVENTION 1 Field of the Invention The present invention relates to managing diabetes symp toms and more particularly to a device and method for con trolling diabetes symptoms and monitoring a diabetes patient 2 Description of Related Art The prior art includes devices for monitoring blood glucose levels of diabetes patients and devices for administering insu lin to control blood glucose levels Known blood glucose monitors take many forms For example one type of monitor is implanted in a patient and transmits blood glucose readings to an external display more or less continuously Other devices require the patient to take periodic blood samples for analysis by the glucose monitor In the latter type of device the patient typically lances a finger and places a blood sample on a medium such as a test strip The monitor analyzes the test strip and provides a digital readout of the blood glucose level on a monitor display Depending on the patient s blood glucose level it may or may not be necessary to administer a dose of insulin Insulin delivery devices also take many forms Broadly speaking insulin delivery can be either essentially automatic by perma nently attaching the patient to an insulin pump or as needed by using an injection device such as a hy
2. 8 into the ROM in the device microprocessor 300 that will enable the programs stored therein to calculate insulin dos ages and specify treatment regimens based on the user pa tient s tested glucose level This data can be input using a portable USB drive not shown on which the necessary infor mation has been stored by the healthcare provider and which is then plugged into the USB port 22 or by sending the information to the unit over the Internet via a receiver included in the Wi Fi circuitry 304 or the cellular telephone circuitry 310 included in the unit The necessary data is loaded into the unit s ROM by the healthcare provider so that it is available when the patient uses theunit The data would typically include information such as insulin dosages and types and amounts of glucose producing substances to be consumed based on tested blood glucose levels and any other data or parameters required by the algo rithms in the ROM used by the device to determine a given insulin dosage or amount and type of glucose producing sub stance to be ingested appropriate to a patient s tested blood glucose level The exact nature of this data does not form a part of the present invention and literature such as the refer ences already discussed above illustrate the type of data that can be used in this regard The data loaded into the unit also includes at least four blood glucose levels for the particular patient user L1 Threshold level for s
3. FIG 4 shows the system components for providing the operating functions of the unit in accordance with particular embodiments of the invention The unit is under the overall control of a microprocessor 300 that incorporates a read only memory ROM storing an operating system and executable programs that use algorithms and data provided to the unit to determine insulin dosages and other parameters useful in US 8 206 340 B2 7 managing the patient s symptoms and that control the opera tion ofthe various other components of the system described just below The microprocessor 300 also includes a random access working memory RAM to enable the microprocessor to execute programs stored in the ROM A clock 302 in the housing 12 is under the control of the microprocessor 300 The clock provides time and date information to the micro processor for display on the LCD display as discussed below The microprocessor 300 can also condition the clock 302 to function as a timer for providing elapsed time data to the microprocessor for purposes also discussed below In the present embodiment the unit 10 further includes Wi Fi circuitry 304 in the housing 12 and under the control of the microprocessor 302 The Wi Fi circuitry can communi cate with remote locations via wireless connection to the Internet if the unit 10 is sufficiently close to a Wi Fi router This enables information to be sent and received by the unit wirelessly at very high speeds The
4. a housing of a size suitable for transport in a handbag or clothing pocket of the user a blood glucose monitoring system in said housing for receiving a sample of the user s blood said blood glu US 8 206 340 B2 19 cose monitoring system being operable to detect the glucose level in the blood sample an insulin administration mechanism in said housing for administering an insulin dosage to the user a microprocessor in said housing for calculating an insulin dosage appropriate to a hyperglycemic detected blood glucose level wherein said insulin administration mechanism is operable to provide a signal to said micro processor indicating that an insulin dosage has been administered a display mounted on said housing for displaying the detected blood glucose level and the calculated insulin dosage amanually operable mode switch on said housing having a first position for actuating said blood glucose monitor ing system to cause detection of the glucose level in the received blood sample and a second position for admin istering an insulin dosage a sensor for sensing when said administration mechanism is in place for administering insulin wherein setting said mode switch to the second position automatically pro vides a signal to said microprocessor to cause said insu lin administering mechanism to administer an insulin dosage when the sensor indicates that said administering mechanism is in place and a communication devic
5. 7 device as in claim 1 wherein said communication device includes a cellular telephone and the remote emer gency service provider is at least one of a public emergency service provider and an emergency service to which the user has subscribed 8 A device as in claim 7 wherein said communication device is at least one of 1 a cellular telephone separate from said housing and circuitry within said housing for establish ing a wireless connection to said cellular telephone and ii cellular telephone circuitry within said housing 9 A device as in claim 1 further comprising circuitry in said housing for detecting the location of the device wherein said communication device transmits information regarding the location to the remote emergency service provider 10 A device as in claim 9 wherein said circuitry for detect ing the location of the device comprises a GPS receiver 11 A device as in claim 1 wherein said device stores information regarding a particular user s treatment require ments and said microprocessor determines treatment regi mens specific to the particular user based on the detected blood glucose level and the stored information and displays the treatment regimens on said display 12 A device as in claim 11 wherein said treatment regi mens include ingestion ofat least one blood glucose producing substance in an amount determined by said microprocessor based on the detected blood glucose level if the d
6. 14 not shown to hold the cap 14 in place on the housing in a manner similar to that described above for the cap 32 The outside peripheral surfaces of the cap 14 and housing 12 are flush in order to maintain the unitary appearance ofthe unit 10 when the cap is in place on the housing U S Pat No 5 728 074 mentioned above describes various ways of implement ing an insulin injection mechanism Any of those mecha nisms or variations thereof can be used in the unit 10 of the present invention and those portions of U S Pat No 5 728 074 describing insulin injection mechanisms are incorpo rated by reference as if set out in full herein Many oftheother patents discussed above also describe insulin injection mechanisms and any ofthose mechanisms can be used in the unit 10 as well If the user has to gain access to the interior components of the insulin injection mechanism for any rea son such as to replace a cartridge containing plural insulin doses the cover 24 can be removed to provide such access Referring back to FIG 1A the side of the housing 12 opposite the side having the insulin injection mechanism access opening 24 and the battery compartment 26 can be considered the front of the unit It has a user interface that comprises two manual input devices 102 and 108 and an LCD display 200 The manual input device 102 is a circular touch activated device in which each of four regions separated by 90 provide an input signal when to
7. 2006 01 an insulin dosage appropriate to the detected blood glucose A61B 5 00 2006 01 level and sets the insulin injection mechanism to administer 52 U S Cl 604 66 604 131 604 151 600 347 the calculated insulin dosage A communication device auto 600 365 matically informs a remote emergency service provider such 58 Field of Classification Search 604 65 67 as 911 or an emergency service to which the user has sub 604 131 155 600 300 347 309 365 scribed if the microprocessor determines that the detected See application file for complete search history blood glucose level presents a potential danger to the user The microprocessor also calculates treatment regimens spe 56 References Cited cific to a particular user based on the detected blood glucose level and displays the treatment regimens on an LCD display U S PATENT DOCUMENTS In a particularly advantageous embodiment a GPS receiver 4 731 726 3 1988 Allen within the housing detects the location of the device and the 5 019 974 5 1991 Beckers communication device which can be a cellular telephone 5 536 249 7 1996 Castellano separate from the housing connected wirelessly to the unit via 5 593 390 1 1997 Castellano a Bluetooth connection or cellular telephone circuitry within HE E 5 the housing itself transmits information regarding the loca 5 840 020 A 11 1998 Heinonen tion to the remote emergency service 5 925 021 A 7 199
8. any place on the input device 102 to confirm that the unit is in position to administer the desired insulin injection Likewise once the injection is complete and the user has withdrawn the needle pressing any place on the input device signals to the unit software that an insulin injection is complete While not as independent of user input as the embodiment described above an this alternate embodiment will undoubtedly prove less expensive to manufacture and thus be more attractive economically for some users If a blood sample is taken within the allotted time the process returns to step S144 If the user s blood glucose level is within the normal range the process ends at step S146 However if the patient is still hyperglycemic after the insulin injection the process proceeds to step S148 to determine if the hyperglycemia is severe blood glucose greater than L4 If so step S150 determines that the flag status is F 1 step 5170 and places an automatic call to the subscriber service in step S178 This call will typically include information on the patient s blood glucose level and indicate that an insulin injection has been administered within the preceding 15 min utes The subscriber service will place a call to the user to confirm that he or she is not in danger Ifthe patient s blood glucose level is only mildly elevated that is greater than L3 but not greater than L4 the process proceeds to step S160 which detects that the fla
9. as possible while still managing the symptoms of his or her diabetes To do that the user must have a level of confidence that a self monitoring device can reduce the chances for negative out comes if his or her symptoms should become so severe that they present a serious or even life threatening situation By providing for automatic notification of an emergency service provider 911 and or a subscriber service as discussed herein the unit 10 gives the user patient confidence that symptoms that are so severe that he or she may not even be able to recognize their existence will automatically engender an emergency response and immediate emergency treatment or other appropriate action The other instances discussed below in which the unit 10 performs automatic emergency notifications achieve the same effect Returning to step S112 if the tested blood glucose level is higher than the level L1 the process proceeds to step S122 where the level is now compared to the predetermined mini mum level L2 for the particular patient for whom the unit has been set up A blood glucose level below L2 indicates that the patient is mildly hypoglycemic and needs to increase his or her blood glucose by ingesting a suitable blood glucose pro ducing substance To that end the microprocessor sets the LCD display 200 as indicated in display status box D106 with the LCD steadily back lit in a different color such as red to indicate a hypoglycemic condi
10. indicates that the user is hypoglyce mic and ii administration of insulin if the detected blood glucose level indicates that the user is hypergly cemic and said microprocessor causes said display to indicate 1 an amount of the at least one blood glucose producing substance to be consumed if the detected blood glucose level indicates that the user is hypoglycemic or 1 the calculated insulin dosage if the detected blood glucose level indicates that the user is hyperglycemic or 11 the different insulin dosage if the calculated insulin dosage has been changed 4 device as in claim 3 wherein receipt by said micro processor of a signal from said sensor when said switch 15 in 20 25 30 35 40 45 50 55 60 65 20 the second position changes said display to indicate a time interval after which the insulin dosage will be automatically administered 5 A device as in claim 4 wherein said insulin administra tion mechanism includes a hypodermic needle for injecting the insulin dosage and said sensor senses when said needle has penetrated the skin of the user 6 A device as in claim 2 wherein said microprocessor further includes dose lock software that causes said display to display a prompt requiring the user to confirm the desire to change the amount of insulin to be administered before per mitting said insulin administration mechanism to administer the different insulin dosage set by the user
11. that selects the highlighted choice The region at three o clock is a DATE TIME button 102e that causes the LCD display 200 to indicate the date 202 and the time of day 204 as shown in FIG 5 The LCD display also includes a battery status indicator 206 that indicates in a conventional manner the amount of battery life remaining The unit defaults to the date time display in the absence of other inputs to the device 102 The mode switch 108 has an image of a slider 108a that acts as a switch button Unit software maintains the slider image in a default position midway between the right and left ends of the image display that comprises the input device 108 A user slides the button to the right as seen in FIG 5 to activate the glucose moni toring system 16 and to the left to activate the insulin injection mechanism 50 The unit may also include a separate button not shown that locks the devices 102 and 108 so that they cannot be inadvertently actuated The use ofthe input devices and the LCD display to operate the unit is discussed in more detailas part ofthe following explanation ofhow one embodi ment ofthe unit is typically used to manage the symptoms of a diabetes patient Initialization of the Unit perform the tasks described herein the unit 10 requires initial set up by inputting data from the patient s healthcare provider In its most basic form this involves loading data un 0 35 40 45 55 65
12. 9 Castellano et al 6 192 891 2 2001 Gravel et al 15 Claims 9 Drawing Sheets MAY 3 2011 11 02 AM INJECT INSULIN TEST BLOOD US 8 206 340 B2 6 544 212 6 875 195 6 906 802 7 404 796 7 427 275 7 534 230 7 988 630 2002 0013522 2006 0173406 2008 0119705 2008 0269673 2008 0306434 2010 0010330 2010 0016700 U S PATENT DOCUMENTS B2 4 2003 Galley et al B2 4 2005 Choi B2 6 2005 Voelkel B2 7 2008 Ginsberg B2 9 2008 DeRuntz et al B2 5 2009 Follman et al B2 9 2009 Brauker et al 8 2011 Osorio etal Al 1 2002 Lavetal Al 8 2006 Hayes et al Al 5 2008 Pateletal Al 10 2008 Butoietal Al 12 2008 Dobbles et al Al 1 2010 Rankers et al Al 1 2010 Siehetal 2 604 67 600 347 eife 604 67 fs 600 365 Page2 2010 0256593 10 2010 Yodfat etal 604 504 2011 0082711 4 2011 Poezeetal es 705 3 2011 0184264 Al 7 2011 Galasso et al 600 347 2011 0282173 11 2011 Fonduca et al 600 365 600 365 2011 0320130 12 2011 Valdes etal 702 19 OTHER PUBLICATIONS Walsh J Concept 2 The Smart Insulin Pen www diabetesnet i 600 365 com diabetes technology smart pen php last visited Mar 25 No 600 365 2010 Humapen Memoir Insulin Delivery Device User Manual Eli Lilly amp Co 2006 International Search Report
13. DOSAGE not shown In order to effect any change in the dosage calculated by the unit s algorithm the user must touch or press the SELECT button 1024 to override the dose lock feature This dose lock feature helps to prevent injection of inappropriate amounts of insulin by requiring the 5 30 40 45 50 16 patient to confirm that he or she wants to override the dosage calculated by the unit The healthcare community has recently begun to focus more strongly on the potential for medical errors in many environments to have severe adverse effects on patients The unit 10 s dose lock feature provides an effective way to prevent the occurrence of serious insulin dosage errors in the environment of diabetes patients self monitoring and self treatment of their symptoms Once the dosage amount has been set either automatically by the unit s algorithm or as manually adjusted by the patient after overriding the dose lock the patient presses the SELECT button 1024 which changes the display so that the first and third numeric fields 232 and 236 are blank the second numeric field 234 displays a 5 the first text field 238 displays the message AWAITING INJECTION and the second text field 240 contains the message INSERT NEEDLE not shown in the figures The microprocessor 300 can be programmed to provide a voice message to the speaker 18 that repeats the message displayed in the second text field to provide a v
14. EL NUMERIC FIELDS 1 3 THREE DIGIT GLUCOSE LEVEL TEXT FIELD 2 GLUCOSE LEVEL LOW DISPLAY BACKLIT RED LOW GLUCOSE LEVEL DRINK 8 07 SUGARY DRINK AND EAT 3 GRAHAM CRACKERS OR INGEST 2 TUBES GLUCOSE GEL RETEST BLOOD IN 15 MIN D FIG 6A D106 U S Patent Jun 26 2012 Sheet 7 of 9 US 8 206 340 B2 5134 NO S142 S144 5146 NO END L2 NORMAL GLUCOSE LEVEL lt L3 YES 5150 CALL SUBSCRIBER 5148 SERVICE YES YES 5154 wy USER TIMER SET TIMER RESPONSE 2 TEXT FIELD 1 BLOOD GLUCOSE LEVEL NUMERIC FIELDS 1 3 THREE DIGIT GLUCOSE LEVEL ICON 222 FLASHING TEXT FIELD 2 PRESS ANY BUTTON DISPLAY FLASHES RED NO YES 5156 YES CALL 911 AND SUBSCRIBER SERVICE 160 5180 5158 FIG 6B U S Patent Jun 26 2012 SET TIMER TEXT FIELD 1 BLOOD GLUCOSE LEVEL NUMERIC FIELDS 1 3 THREE DIGIT GLUCOSE LEVEL ICON 222 ON TEXT FIELD 2 GLUCOSE LEVEL HIGH DISPLAY BACKLIT RED Sheet 8 of 9 US 8 206 340 B2 9168 CALL SUBSCRIBER SERVICE TEXT FIELD 1 BLOOD GLUCOSE LEVEL NUMERIC FIELDS 1 3 THREE DIGIT GLUCOSE LEVEL TEXT FIELD 2 RETEST BLOOD IN 15 MIN US 8 206 340 B2 Sheet 9 of 9 Jun 26 2012 U S Patent 216 214 212 21 TEXT FIELD 1 TEXT FIELD 2 FIG ce LL L gt lt MESSAGE FIELD
15. In addition if the first blood test step S106 indicates a blood glucose level that exceeds L2 the process also proceeds to step S144 see steps S112 and S122 Step S146 can be accompanied by a message on the LCD display 200 indicating that the user s blood glucose level is normal with the background of the display lit in steady or flashing green to provide an immediately recognizable indi cation that the user s glucose level is acceptable Blood Test Results Indicate Hyperglycemia If step S144 indicates that the user s blood glucose level is above L3 the next step 5148 determines if the level is above L4 thus indicating more severe hyperglycemia If so the process proceeds to step 5150 to check the status ofthe flag Since the flag F was set 0 step S104 or step S142 the process proceeds to step 5152 At the same time the LCD display 200 displays the blood glucose level in the numeric fields 212 214 and 216 and the first text field 218 now reads BLOOD GLUCOSE LEVEL The LCD display is back lit in flashing red the star shaped alarm icon 222 begins flashing red to indicate a severe hyperglycemic condition and the second text field 220 is changed to read PRESS ANY BUT TON as seen in display status box D112 The microproces sor also sends to the speaker 18 an audible prompt such as terminate alarm condition press any button on the unit or say During the time elapsed after the timer is set in st
16. US008206340B2 a2 United States Patent 10 Patent No US 8 206 340 B2 Arefieg 45 Date of Patent Jun 26 2012 54 INTEGRATED GLUCOSE MONITOR AND Continued INSULIN INJECTION PEN WITH AUTOMATIC EMERGENCY NOTIFICATION FOREIGN PATENT DOCUMENTS EP 1102194 A2 5 2001 75 Inventor Rana J Arefieg Ridgefield CT US OTHER PUBLICATIONS 73 Assignee Thuban Inc Ridgefield CT US A New Era in Blood Glucose Monitoring Begins The Accu Chek Mobile System Trade News Vienna Austria Roche Diabetes Care Notice Subject to any disclaimer the term of this Sep 30 2009 patent is extended or adjusted under 35 Continued U S C 154 b by 0 days Primary Examiner Matthew Desanto 21 Appl Ros 90800609 74 Attorney Agent or Firm David M Quinlan P C 22 Filed Aug 18 2010 57 ABSTRACT 65 Prior Publication Data portable insulin injection pen and blood glucose monitor ing device is integrated into a single unit for testing and US 2012 0046606 A1 Feb 23 2012 treating diabetes symptoms The device has a housing of a size suitable for transport in a user s clothing pocket or hand 51 Int CI bag Within the housing is a blood glucose monitoring system A6IM 31 00 2006 01 for receiving a sample of the user s blood and detecting its A6IM 37 00 2006 01 glucose level an insulin injection mechanism for administer 61 1 00 2006 01 ing an insulin injection and a microprocessor that calculates A61B 5 05
17. and Written Opinion dated Oct 31 2011 in PCT Appln No PCT US11 01349 cited by examiner U S Patent Jun 26 2012 Sheet 1 of 9 US 8 206 340 B2 108 c CN FIG 1A 102 14 U S Patent Jun 26 2012 Sheet 2 of 9 US 8 206 340 B2 FIG 1B U S Patent Jun 26 2012 Sheet 3 of 9 US 8 206 340 B2 Sheet 4 of 9 Jun 26 2012 U S Patent li 80 90 OLE ror 3NOHd Hooma 9343938 WNHSLNI 549 801201 00 939IA3Q 140d 85 LNdNI 553906 4092 INSINVH23IN V 510 Q91 NOILOSPNI 002 vl AfldNI 4915 32019 JNOHdOUWOIIN u3AV3dS 2 1531 8l COE 0 US 8 206 340 B2 Sheet 5 of 9 Jun 26 2012 U S Patent 00018 1S31 5 193fNI WY 60 11 1100 E AYIN U S Patent Jun 26 2012 Sheet 6 of 9 US 8 206 340 B2 SWITCH 108 TO TEST BLOOD 31 5104 5106 SE F 0 S105 SET TIMER SAMPLE TAKEN TEXT FIELD 1 AWAITING BLOOD SAMPLE YES NUMERIC FIELDS 1 3 READ 0 ICON 210 FLASHING D102 5112 114 SET TIMER CALL 911 AND TEXT FIELD 1 BLOOD SUBSCRIBER GLUCOSE LEVEL SERVICE NUMERIC FIELDS 1 3 THREF DIGIT GLUCOSE LEVEL TEXT FIELD 2 PRESS ANY BUTTON DISPLAY FLASHING RED ICON 222 FLASHING 9122 YES LOW GLUCOSE LEVEL NO DRINK 4 oz SUGARY DRINK OR EAT 3 GRAHAM CRACKERS OR INGEST 1 TUBE GLUCOSE GEL RETEST BLOOD IN 15 MIN GLUCOSE LEV
18. ard units of mg dL and no indication of the units is necessary If the blood glucose level is less than L1 the LCD display is back lit in flashing red the star shaped alarm icon 222 begins flashing red to indicate a severe hypoglycemic condition and the second text field 220 is changed to read PRESS ANY BUTTON as seen in display status box D104 The microprocessor also sends to the speaker 18 an audible prompt such as terminate alarm condition press any button on the unit or say During the time elapsed after the timer is set in step S114 the microprocessor continuously checks to see if the timer has timed out This is represented by the loop including steps S116 and S118 A suitable time period is about 10 seconds and is preferably not more than one minute The purpose of this time period is to give the user an opportunity to respond in a manner that indicates that the user has not become dis oriented or even entered a diabetic coma because of the indicated severe hypoglycemia detected by the blood test If the user patient presses anyplace on the input device 102 or the microphone 22 picks up an audible signal that voice recognition software in the microprocessor recognizes as OK before this time period expires the microprocessor proceeds to the next portion of the process discussed further below However ifthe timer times out before the patient responds theunit 10 responds at step S120 with an automa
19. changes to the screen shown in display status box D116 It shows the detected blood glucose level as in display status box D114 and the second text field 234 in FIG 7 reads RETEST BLOOD IN 15 MIN Next the flag status is set to F 1 in step S170 and another time period 15 set to permit the user to complete the instructed blood test The process then proceeds to step S174 to await receipt of a blood sample within the allotted time as represented by the loop containing steps S174 and S176 If no blood test is detected within the allotted time the unit proceeds to step S168 in which the unit places an automatic call to the emer gency service provider so that it can be confirmed that the user is not in danger These steps S174 S176 and 5168 are analo gous to steps 5130 5132 and 5134 discussed above and the comments relating to that part of the process and possible alternate embodiments such as providing separate time peri ods for the waiting period and the blood testing operation apply equally here Inanalternate embodiment the user manually controls the insulin injection using the input device 102 In this embodi ment moving the mode switch 108 to the INJECT INSULIN position activates the input device 102 to permit the user to US 8 206 340 B2 17 confirm needle insertion and the completion of an injection That is instead of having a sensor that senses when the needle has penetrated the user s skin the user simply presses
20. cket of the user a blood glucose monitoring system within the housing for receiving a sample of the user s blood and detecting the glucose level thereof an insulin injection mechanism within the housing for permitting the user to self administer an insulin injection amicroprocessor within the housing for calculating an insulin dosage appropriate to the detected blood glucose level and setting the insulin injection mechanism to administer the calculated insulin dosage a display mounted on the housing for displaying the detected blood glucose level and the cal culated insulin dosage and a communication device within the housing and under the control of the microprocessor for automatically informing a remote emergency service pro vider ifthe microprocessor determines that the detected blood glucose level presents a potential danger to the user In accordance with more specific embodiments of the invention such a unit further comprises at least one manual input device operable by the user in conjunction with infor mation displayed on the display for providing a user interface for permitting the user to control predetermined operations of the unit particularly advantageous embodiment comprises a GPS receiver within the housing for detecting the location of the device wherein the communication device transmits information regarding the location to the remote emergency service US 8 206 340 B2 3 additional aspect of the invention
21. e peripheral surfaces of the cap 32 and housing 12 are flush in order to maintain the unitary appearance of the unit 10 when the cap is in place on the housing lancet 30 and test strip 33 are each typically used only once and then discarded The cap 32 can be made hollow to store sterile lancets which are accessible to a user by making an interior panel 40 in the cap removable Test strips may be stored in a cartridge in the unit and dispensed one at a time by a slider button on the side ofthe unit not shown The end ofthe unit may be made removable to enable replacement of empty test strip cartridges Those skilled in the art will recognize many ways in which the blood glucose monitoring system can be implemented while still maintaining the sleek compact appearance of the unit 10 that comprises an aspect of the invention 20 30 40 45 55 65 6 FIG 3 shows an exemplary embodiment of an insulin injection mechanism 50 The insulin injection mechanism includes a cap 14 as shown in FIGS 1A and 1B to protect the hypodermic needle 52 from damage and to prevent inadvert ent needle sticks The cap is not shown in FIG 3 As with the cap 32 the cap 14 of the insulin injection mechanism fits snugly onto the end of the housing in a manner similar to that used for the cap 32 That is the housing 12 presents an external shoulder 54 with a circumferential ridge 54a The external shoulder 54 fits into an internal shoulder on the cap
22. e in said housing and under the control ofsaid microprocessor for automatically inform ing a remote emergency service provider if said micro processor determines that the detected blood glucose level presents a potential danger to the user and if said insulin administration mechanism fails to indicate that an insulin dosage has been administered within a prede termined time interval after said microprocessor deter mines that the detected blood glucose level presents a potential danger 2 A device as in claim 1 further comprising at least one manual input device operable by the user in conjunction with information displayed on said display for providing a user interface permitting the user to set an insulin dosage that is changed from the calculated insulin dosage wherein when said mode switch is in said second position said insulin administration mechanism is operable to administer the dif ferent insulin dosage ifthe calculated insulin dosage has been changed and to administer the calculated insulin dosage if it has not been changed 3 A device as in claim 2 wherein said device stores information regarding a particular user s treatment requirements and said microprocessor deter mines treatment regimens specific to the particular user based on the detected blood glucose level and the stored information said treatment regimens include 1 ingestion of at least one blood glucose producing substance if the detected blood glucose level
23. e not strictly to scale but nevertheless will find them sufficient when taken with the detailed descriptions of pre ferred embodiments that follow to make and use the present invention DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS FIGS 1A and 1B show an integrated blood glucose moni tor and insulin pen unit 10 in accordance with one embodi ment of the invention The integrated monitor pen unit 10 has an elongated generally rectangular housing 12 most conve niently provided in a one piece molded plastic construction A cap 14 fits onto the housing 12 at one end to conceal a hypodermic needle not shown in FIG 1 that forms a part of an insulin injection mechanism described in more detail fur ther below The cap 14 is also conveniently molded from a suitable plastic material in one piece and fits snugly onto the end of the housing 12 either by friction or by a snap fit to prevent inadvertent removal of the cap and consequent expo sure of the hypodermic needle A blood glucose monitoring system 16 also includes a cap that fits snugly onto the other end of the housing 12 Further details of the blood glucose monitoring system and the insulin injection mechanism are described below in connection with FIGS 2 and 3 When the caps are in place on the housing 12 these parts together form a cylinder with a rectangular cross section that has substantially constant dimensions along its entire length and has a unitary appearance The cross s
24. e the status of the flag is checked to determine if F 1 The process also proceeds to step S160 if the user s blood glucose level is not greater than L4 as determined in step S148 In either event since F 0 Fz1 the process proceeds to step S162 where a time period is set At the same time the unit sets the LCD display 200 as shown in display status box D114 with the LCD back lit in red to indicate an abnormal condition in this case hyperglycemia with the star shaped alarm icon 222 illuminated and with the message GLUCOSE LEVEL HIGH in the second text field 220 The unit then awaits for the user to administer an insulin injection within the time period set in step S162 This is indicated by the loop including steps 164 and S166 during which the unit continuously checks to see if an insulin injection has been administered using the unit s insulin injection mechanism described above The display screen 230 in FIG 8 can be used at this point to indicate that the prescribed treatment regimen is an insulin injection not shown If the time period times out before an insulin injection is detected the unit places a call to the subscriber service in step S168 This call is similar in nature to the call placed in step S158 That is since the patient responded if severe hyperg lycemia was detected in step 148 or alternatively the patient is only mildly hyperglycemic as per step S144 the protocol of the present embodiment assumes that a
25. ecide based on personal experience that the glucose level already achieved as displayed in display status box D106 is acceptable and elect not to take a fourth blood test In that event the timer times out the unit calls the subscriber service step S134 and the patient can confirm to the caller that he or she has an acceptable glucose level and does not need assistance However if the user elects to take a fourth blood test step S136 again determines if the tested glucose level is still below L2 If so step S138 sets the flag status F 3 2 1 and when the process reaches step S140 it will detect that flag status and proceed to step S120 as discussed above In other words this particular protocol assumes that the patient requires emergency assistance since the repeated ingestion of blood glucose producing substances has not rem edied a detected hypoglycemic condition If at any time step S136 detects a blood glucose level that is not less than L2 the process proceeds to step S142 where the flag status F is set to F 0 and then proceeds to step S144 which determines if the user s blood glucose level is not above L3 thus indicating that is in the normal range between L2 and L3 If so the process terminates as indicated in step 5146 similar to step S110 If step S144 indicates that the user s blood glucose level exceeds L3 it indicates a hyperg lycemic condition possibly requiring the administration of an insulin injection
26. ection can have rounded comers which will give the unit 10 a compact appearance and facilitate handling by a user The elongated configuration of the housing enables the various mechanical and electronic components of the monitor pen unit 10 to be contained in a compact device that is easily carried in a pocket or handbag purse To that end a preferred unit will have a cross section about 1 0 x0 5 and be about 5 to 6 long Other configurations and dimensions can be used within the broadest scope of the invention For example one skilled in the art may chose to arrange the internal components of the unit discussed below in a manner that makes it preferable to use a different configuration or a different size The unit 10 further includes various components for receiving inputs from a user and communicating outputs to theuseror to other destinations as described further below A speaker 18 enables the unit to provide voice commands or prompts to the user and a microphone 20 enables the user to communicate with the unit by voice A USB port 22 enables communications between the unit and associated peripheral devices as well as permitting uploading of information to a memory in the unit and downloading information from the US 8 206 340 B2 5 memory On an adjacent side of the housing a removable cover 24 provides access to the insulin injection mechanism within the housing for purposes described below On the same side a battery compartm
27. ent with a removable cover 26 accepts batteries of a suitable rating for providing operating power to the unit The batteries can be rechargeable and recharging can be accomplished by attaching a suitable power cord to the USB port This side of the housing 12 can be considered the rear of the unit since the covers 24 and 26 are accessed relatively infrequently The covers 24 and 26 are placed on the longer side of the unit s rectangular cross sec tion to facilitate their manipulation by a user This side of the unit also includes an ON OFF switch 28 for powering the unit on and off In describing embodiments of the invention terms indicating direction or orientation such as front rear right left etc may be used to facilitate the description They do not imply that the invention is limited to a particular orientation of the pen monitor unit FIGS 2A and 2B are schematic representations of an exemplary embodiment of the blood glucose monitoring sys tem 16 FIG 2B shows a lancet 30 extending from the inside of a glucose monitoring system cap 32 that fits snugly on the end of the housing 12 as discussed above The lancet 30 is essentially a very sharp needle typically made of surgical grade stainless steel The patient pricks a finger with the lancet to draw a sufficient quantity of blood for glucose level testing FIG 2A shows the end ofthe housing 12 from which extends a glucose test strip 33 onto which the user places a b
28. ep S152 the microprocessor continuously checks to see ifthe timer has timed out This is represented by the loop including steps 5154 and 5156 A suitable time period is preferably about 10 seconds and is preferably not more than one minute The purpose of this time period is to give the user an opportunity to respond in a manner that indicates that the user has not become disoriented because of the indicated severe hyperg lycemia detected by the blood test If the user patient presses any placeon the input device 102 or the microphone 22 picks up an audible signal that voice recognition software in the microprocessor recognizes as OK before the time period expires the microprocessor proceeds to the next portion of the process which is discussed further below US 8 206 340 B2 15 However ifthe timer times out before the patient responds the unit 10 responds at step S158 with an automatic call using the unit s internal cellular telephone 310 to 911 and to the subscriber service These calls correspond to the calls described above in connection with step S120 That is the unit sends a prerecorded message to 911 and to the subscriber service that identifies the caller states that he or she is severely hyperglycemic and includes information on the unit s location provided by the GPS receiver 306 as dis cussed above Ifthe user has responded before the time period set in step 152 expires the process proceeds to step S160 wher
29. epeats the message displayed in the first text field 218 The capacity to echo a text message with a voice prompt can be an important feature because impaired vision or even blindness can be a side effect of diabetes The unit then waits at step S106 for the patient to take a blood sample and initiate a blood glucose level test To take a blood sample the patient removes the cover 32 from the blood glucose monitoring system 16 see FIG 2 retrieves a lancet 30 from inside the cap 32 affixes it to the cap and pierces a finger using the lancet 30 As described above in connection with FIG 2 the patient places a blood sample on the test strip 33 which the user has extended from a cartridge within the unit housing 12 When the blood sample reaches the glucose sensing components within the unit 10 the icon 210 stops flashing and is lit continuously while the first text field 218 contains the message TESTING GLUCOSE LEVEL not shown in FIG 6 During the time elapsed after the timer is set in step S105 the microprocessor continuously checks to see if the timer has timed out This is represented by the loop including steps S106 and S108 As before the micro processor 300 can be programmed to provide a voice message to the speaker 18 that repeats the message displayed in the first text field 218 Ifthe timer times out before the unit detects the presence of a blood sample the process terminates as shown at step S110 This causes the uni
30. etected blood glucose level indicates that the user is hypoglycemic and administration of the calculated insulin dosage determined by said microprocessor based on the detected blood glucose level if the detected blood glucose level indi cates that the user is hyperglycemic 13 A device as in claim 1 wherein said insulin adminis tration mechanism includes a hypodermic needle for inject ing the insulin dosage and said sensor senses when said needle has penetrated the skin of the user 14 A device as in claim 1 wherein said mode switch has a neutral position and said microprocessor displays a prompt on said display instructing the user to take a blood sample and detect the glucose level thereof when said mode switch is moved from its neutral position to its first position 15 A device as in claim 1 wherein receipt by said micro processor of a signal from said sensor when said switch 15 in the second position causes said display to indicate a time interval after which the insulin dosage will be automatically administered
31. evere hypoglycemia L2 Threshold level for mild hypoglycemia L3 Threshold level for mild hyperglycemia L4 Threshold level for severe hyperglycemia The description that follows of a testing treatment emer gency notification process using the unit ofthe present inven tion assumes that a treatment protocol with the necessary information appropriate to the particular patient using the unit has been stored in the unit ROM One way of uploading the necessary data to the unit uses the input device 102 and the LCD display 200 under the direction of the microprocessor 300 For example in one possible embodiment the MENU region 102a of the input device 102 would be touched when data was to be uploaded to the unit 10 The microprocessor could be programmed to prompt insertion of a USB drive into the USB port 22 if that had not already been done and then to cause the LCD to display a menu of prompts that a user can scroll through using the UP and DOWN buttons 1025 and 102c to highlight dis played prompts in order For example a menu could include anumber of options one of whichis INPUT DATA The UP and DOWN buttons would enable the user to highlight that option and activation of the SELECT button 102d would cause the data to be uploaded into the unit Any other prompt menus necessary at various times during a data upload could be displayed and chosen in the same fashion Another menu item could permit the user to choose the language in which t
32. functions so a patient with a low blood glucose level can become disoriented and confused very rapidly If the patient s blood glucose level is not corrected in time he or she can lapse into a coma and even die before being able to take necessary corrective action By the same token hyperglyce mia while less likely than hypoglycemia to present an emer gency situation can nonetheless be dangerous Accordingly devices that rely on the patient to take appropriate steps after determining his or her own blood glucose level would have greater utility if they could automatically take action to pre empt the potentially serious consequences of rapid changes in blood glucose levels SUMMARY OF THE INVENTION Itis anobject ofthe present invention to improve on known techniques involving self administration of appropriate therapy to adjust glucose levels after a patient tests his or her own blood glucose level One important aspect of the inven tion provides an automatic alert to an emergency service provider if a patient using a device for self testing his or her own blood glucose level does not respond to prompts and thus may be in need of immediate medical attention In accordance with a first aspect of the invention a portable blood glucose monitoring device and insulin injection pen integrated into a single unit for testing and treating diabetes symptoms in a user comprises a housing of a size suitable for transport in a handbag or clothing po
33. g status is F 1 step S170 In this case the unit terminates the process in step S180 One of the advantages of being able to store and guide the user through a detailed treatment protocol like that depicted in FIG 6 and described above is that it enables matching a patient s self treatment protocol to inpatient treatment proto cols For example if a detailed treatment protocol is deter mined for a particular diabetes patient in an inpatient setting this protocol can be duplicated by appropriate programming of the microprocessor of a unit according to the invention This streamlines the user s care and increases the utility ofthe unit because the user patient s outpatient treatment protocol using the unit 10 and established inpatient treatment proto col will be essentially the same This can be expected to reduce the number of times the unit performs emergency notifications and likewise reduce the number of times a user must be taken to a hospital emergency room because his or her symptoms have become too severe for self treatment Data Recording and Utilization Another aspect of the invention involves storage in the microprocessor s ROM of complete information regarding the timing and results of the blood glucose testing times and amounts of blood glucose producing substances ingested times and amounts of insulin injections calls to 911 and the subscriber service or any other aspect of the process just described For example the u
34. he unit will display messages and provide voice prompts during use of the unit for blood glucose moni toring and insulin injection For example one of the menu choices could be LANGUAGE and once that menu item is highlighted by scrolling to it using the UP or DOWN button touching the SELECT region 102d causes the LCD display to list the available languages Again the UP or DOWN button is used to scroll to and highlight the desired language choice and the SELECT region 102d is touched to select the high lighted language choice Typically the default language will be English and messages and voice prompts will be in English unless changed Using the Unit for Blood Glucose Testing and Insulin Injection US 8 206 340 B2 9 FIG 6 is a flowchart depicting the manner in which the unit 10 operates to perform a testing treatment emergency notifi cation process according to one embodiment ofthe invention It will be understood that the steps shown in the flowchart of FIG 6 are under the control of application software stored in the ROM in the microprocessor 300 and executed by the microprocessor 300 in a conventional fashion Any suitable programming language or technique can be utilized to carry out the steps depicted in FIG 6 or their equivalents and the invention is not limited to any particular software configura tion patient initiates a blood glucose test in step S102 by sliding the mode switch button image 108a to the right as
35. her possible use ofthe recorded data would be to target training and informational materials spe cific to particular aspects of the treatment and symptoms of groups of users For example a given group of users might be identified as having a certain class of symptoms about which recent research has discovered new information A healthcare provider could offer as a service the transmission of messages via cellular telephone to those users whose treatment pro files warrant The message could be in the form ofa notice for display on the LCD displays of these users units that addi tional information they could find helpful or useful or even critical can be found at a certain website Those skilled in the art will recognize that other variations on the disclosed embodiments that would fall within the scope ofthe invention are possible For example even though the input devices 102 and 106 provide a sleek streamlined appearance to the unit mechanical switches can be used to perform the same functions In another variation the testing treatment history of a user can be downloaded via a bar code displayed on the LCD display 200 rather than by using an external USB drive or an Internet connection In this varia tion the unit software can include an algorithm that converts recorded data into a bar code format that is then displayed on the LCD display Scanning the bar code transfers the infor mation to the scanning device If necessary the i
36. his is effected by the status of the flag F which was set at 2 after the second blood test Step S128 now detects that F 1 and advances the process to step S140 which detects that F3 Consequently the LCD display issues the instruction shown in display status box D110 instructing the patientto perform a third blood test and then advances to step 5130 If the third blood test indicates that the patient s glu cose level is still less than L2 step S138 sets the flag status F 3 F 2 1 and returns the process to the point where the LCD display 200 exhibits display status box D106 with the numeric fields 212 214 and 216 displaying the current glu cose level Step S124 sets the same time period again and the process proceeds to step 5128 Now F 3 that is F 1 step 5128 directs the process to step S140 which detects that F 3 This causes the unit to proceed to step S120 which is described above In other words the protocol of the present embodiment assumes that the failure of the patient s severe hypoglycemia to respond to the ingestion oflarge amounts of glucose producing substances indicates a possible emer gency condition and warrants a call to 911 Mildly hypoglycemic patient after the second blood test If the second blood test for a more mildly hypoglycemic patient still indicates a hypoglycemic condition the amount of the substances that will raise the user s blood glucose levels is increased from the amount that was ingested af
37. ime period by which the patient must provide an input to the monitoring device if the detected blood glucose level is below the first threshold or above the second threshold before automatically activating the communication device In another variation the monitoring device further comprises an insulin injection mechanism within the housing for permitting the user to self administer an insulin injection and the method further includes determining ifthe detected blood glucose level indi cates that the patient is hypoglycemic or hyperglycemic and ifthe patient is hypoglycemic instructing the patient to ingest an amount of at least one blood glucose producing substance based on the detected blood glucose level or if the patient is hyperglycemic calculating an insulin dosage appropriate to the detected blood glucose level and using the insulin injec tion mechanism to set an amount of insulin to be injected based on the detected blood glucose level BRIEF DESCRIPTION OF THE DRAWINGS The objects ofthe invention will be better understood from the detailed description of its preferred embodiments which follows below when taken in conjunction with the accompa nying drawings in which like numerals and letters refer to like features throughout The following is a brief identifica tion ofthe drawing figures used in the accompanying detailed description FIGS 1A and 1B are perspective views showing the four sides of a unitary integrated blood gl
38. includes a method of monitoring a diabetes patient including providing a portable blood glucose monitoring device comprising a housing of a size suitable for transport in a handbag or clothing pocket of the patient the housing having therein a blood glucose moni toring system for receiving a sample of the patient s blood and detecting the glucose level thereof a storage device for storing a threshold representing a blood glucose level of potential danger to the patient a GPS receiver for detecting the location of the device and a communication device for contacting a remote emergency service provider introducing to the blood glucose monitoring system a sample ofthe user s blood comparing the detected blood glucose level of the sample to the threshold blood glucose level and if the detected level is past the threshold automatically activating the communication device to transmit a message to the emer gency service provider including information on the poten tially dangerous condition ofthe user and information regard ing the location of the device In accordance with more specific method aspects of the invention the storage device stores a first threshold represent ing a blood glucose level below which the patient is severely hypoglycemic and may be disoriented or comatose and a second threshold above which the patient is severely hyper glycemic and may require immediate medical intervention and the method further includes setting a t
39. life threatening situ ation is not present Accordingly the subscriber service will typically telephone the user to determine if he or she is fully aware of the condition and has voluntarily chosen not to take action In other words this protocol judges that a call to 911 for immediate emergency assistance is not warranted Administering an Insulin Injection To activate the insulin injection mechanism 50 the patient moves the mode switch slider image 108a on the unit 10 to the left as seen in FIG 5 to the INJECT INSULIN mode of operation The microprocessor ROM contains an algorithm that uses the patient s blood glucose reading the time elapsed since the previous insulin injection and other pertinent infor mation or parameters to calculate the proper insulin dose When the results of a blood glucose test are available see above and the mode switch button 108a is in the INJECT INSULIN position the insulin dose calculated by the algo rithm is displayed not shown in the figures in the numeric fields 232 234 and 236 depicted in FIG 7 in standard dose units of 0 01 cc each The UP and DOWN buttons see FIG 5 can be used by the patient to change the amount of insulin to be injected How ever after the unit sets the dosage amount an attempt by the user to change it with the UP or DOWN button will trigger the unit s dose lock feature which causes the LCD display to display a prompt such as ARE YOU SUREYOU WANT TO CHANGE
40. lood sample by touching the lanced finger to the strip The strip then introduces the blood by capillary action into con ventional testing apparatus within the unit that determines the blood s glucose level The details of the glucose level testing do not form a part of the present invention and are well known to those skilled in the art U S Pat No 5 728 074 mentioned above describes various ways of performing such testing and obtaining a corresponding electrical signal Any of those techniques or variations thereof can be used in performing blood glucose testing with the unit 10 and those portions of U S Pat No 5 728 074 describing such testing are incorporated by reference as if set out in full herein Many of the other patents discussed above also describe ways of testing blood glucose levels and unit 10 could use any of those techniques as well Although the manner in which the patient s blood glucose level is determined is conventional the configuration of the blood glucose testing system 16 shown in FIGS 2A and 2B is particularly advantageous from the standpoint ofa user ofthe unit 10 The cap 32 has an internal shoulder 34 that fits over a corresponding external shoulder 36 on the housing 12 The internal shoulder 34 includes a circumferential groove 34a that accepts a circumferential ridge 36a on the external shoul der 36 The groove 34a and ridge 36a provide a snap fit to positively hold the cap 32 on the housing 12 The outsid
41. movable cap that conceals a hypo dermic needle for insulin injection and a lancet mechanism used by the patient to prick a finger to obtain a blood sample for analysis by a test strip on the injector housing U S Patent Pub No 2010 0010330 exemplifies the type of system that employs a blood glucose sensor implanted in the patient to provide continuous glucose level data to a bedside monitoring system that controls an insulin infusion pump The system can include software that determines if the patient s blood 20 25 30 40 45 50 55 60 65 2 glucose level is at a dangerously low level and can alert 911 or other medical emergency response provider While this fea ture enhances patient safety it has a significant drawback in that the patient is tethered to the monitoring system Many diabetics lead relatively active lives and for them being tethered to a monitoring system is obviously not accept able These patients require a treatment regimen that enables them to maintain a normal lifestyle by minimizing limitations that might otherwise be imposed by their diabetes Even though existing devices and systems permit such patients to closely monitor their own blood glucose levels and thus minimize the risk of becoming hypoglycemic or hyperglyce mic at any given time a diabetes patient still can experience either condition without much warning Hypoglycemia can be particularly dangerous because it can impair cognitive
42. nformation can be contained in multiple bar code displays which are then scanned in turn In another alternate embodiment the unit can include a removable USB storage device on which the data is recorded This will facilitate manipulation and transportation of the recorded information For example it will eliminate an inter mediate step in which the unit must be connected to a com puter through a USB port as discussed It will also enable a user to mail or otherwise transport the recorded data to a healthcare provider for those users not comfortable with transmitting data over the Internet as well as eliminating the need to visit the healthcare provider simply to have the recorded data downloaded onto a computer at the provider s location If a removable USB storage device is used the unit can be provided with multiple such devices so that the user has a supply on hand Those skilled in the art will readily recognize that only selected preferred embodiments of the invention have been depicted and described and it will be understood that various changes and modifications can be made other than those specifically mentioned above without departing from the spirit and scope of the invention which is defined solely by the claims that follow What is claimed is 1 A portable blood glucose monitoring device and insulin administering pen integrated into a single unit for testing and treating diabetes symptoms in a user the device comprising
43. nit can record the time of every glucose test and the resulting glucose level It can also record whether any alarm condition was encountered Likewise the unit can further store each calculated insulin dosage as well as the actual insulin dosage administered by the patient and time of administration The patient s healthcare provider can download this infor mation into a central computer using the USB port 22 or a Wi Fi connection and employ it for various reasons For example one important use ofthis information is to make any necessary adjustments to the patient s treatment protocol which can then be uploaded to the unit as discussed above The same information collected from numerous patients can 20 25 30 35 40 45 50 55 60 65 18 be used for public health purposes by converting it to statis tical information on diabetes treatment This data can also have significant commercial uses For example diabetes is the subject of frequent clinical trials which require judicious selection of test subjects to match the particular characteristic ofthe disease being studied ina given trial This often requires detailed knowledge of the treatment history of a potential subject as well as his or her responsive ness to any given treatment regimen The storage of all of the above information regarding a user of the unit 10 greatly facilitates screening and selection of possible subjects for such clinical trials Anot
44. nt time to take the next blood test In an alternate embodiment the unit can first set a 15 minute time period and then prompt the user to perform the next blood test by dis playing a screen similar to that shown in display status box D102 and or generating an audible signal such as a repeating beeping sound Then another time period will be set as in step S105 with atime period such as five minutes in which the user must perform the blood test In any case the microprocessor continuously checks to see if the timer has timed out as represented by the loop including steps S130 and S132 Ifthe patient fails to take another blood sample within the time allotted the unit 10 responds at step S134 with an auto matic call using the unit s internal cellular telephone 310 to the subscriber service such as the Alert One amp medical alert service discussed above The call identifies the caller states that he or she is not responding as required by his or her treatment protocol and includes a prerecorded message that includes information on the unit s location provided by the GPS receiver 306 The subscriber service will then call the user to make a judgment as to whether or not emergency service is required A call to 911 is not made at this time since it is unlikely that the user is in imminent danger of entering a diabetic coma considering the amount of blood glucose pro ducing substances that have just been ingested In another alternate embodimen
45. oice prompt to administer the injec tion If the patient has not done so already he or she removes the cap 14 to expose the hypodermic needle 52 and inserts the needle at an appropriate location to perform an intramuscular injection of insulin The insulin injection mechanism prefer ably includes a sensor that senses when the needle 52 has penetrated the patient s skin and begins a countdown in one second intervals The second numeric field 234 accordingly decrements from 5 to 0 during which time the injection mechanism administers the prescribed insulin dosage that was previously displayed The speaker 18 may accompany the visual countdown on the display with an audible count down When the count reaches 0 the second text field displays the message REMOVE NEEDLE not shown in the figures and the same message is repeated audibly by the speaker 18 When the needle is removed the injection mecha nism provides a signal to the microprocessor indicating a completed insulin injection which in turn triggers a positive response in step S164 The time period set in step S162 should be of sufficient duration to permit the user to administer an insulin injection according to this description A suitable time period will preferably be about five minutes but can be any appropriate time period between say three minutes and 10 minutes Ifthe unit detects an insulin injection before the time period expires the LCD display 200
46. podermic needle with which the patient injects an amount of insulin deter mined according to a predetermined protocol when the mea sured blood glucose level is outside an acceptable range Many devices and systems seek to automate diabetics blood glucose control protocols by computerizing conven tional devices so that insulin dosages can be automatically determined and delivered with minimum intervention by the patient The following references illustrate some typical examples of such devices and systems U S Pat No 4 731 726 U S Pat No 5 840 020 U S Pat No 7 427 275 U S Pat No 5 019 974 U S Pat No 5 925 021 U S Pat No 7 534 230 U S Pat No 5 536 249 U S Pat No 6 192 891 U S Pat No 7 591 801 USS Pat No 5 593 390 U S Pat No 6 544 212 U S Publ No U S Pat No 5 728 074 U S Pat No 6 875 195 2008 0306434 U S Pat No 5 822 715 U S Pat No 6 906 802 U S Publ No 2010 0010330 European App No 1 102 194 Devices disclosed in U S Pat No 5 728 074 embody the as needed type of insulin delivery approach Some of these disclosed devices could be particularly useful because they provide a variety of functions that a diabetic would undoubt edly find helpful in managing his or her disease For example the disclosed embodiments include devices that combine an insulin injection mechanism and a blood glucose monitor such as the pen type injector depicted in FIG 25 This device has at one end a re
47. seen in FIG 5to the TEST BLOOD mode of operation This sets a flag F to 0 in step S104 and sets a timer in step S105 to count down a sufficient time for the user to perform a blood glucose test as described below in connection with step S106 suitable time period is preferably about five minutes but can be any appropriate time period between say three min utes and 10 minutes At the same time the microprocessor 300 causes the LCD display 200 to display the screen 208 shown in FIG 7 This screen includes the battery status indicator 206 so that the user always has a visual indication of how much charge remains in the unit s batteries It further includes an icon 210 that indicates the status of the blood testing procedure three numeric fields 212 214 and 216 and two text fields 218 and 220 As seen in display status box D102 the blood test status icon 210 is flashing and the first text field 218 contains the message AWAITING BLOOD SAMPLE The numeric fields all display the numeral 0 and the second text field 220 is blank The dotted lines denoting the numeric and text fields in FIG 7 indicate the positions of the fields on the display the dotted lines are not part of the display A star shaped alarm icon 222 described in more detail below is not visible in the display indicated by the display status box D102 The microprocessor 300 can be further programmed to provide a voice message to the speaker 18 that r
48. t the microprocessor can be programmed to await the user s confirmation that the blood sugar producing substances have been ingested as instructed That is if the protocol incorporates a first 15 minute period to allow for the ingestion ofthe substances as directed by the unit the user could be required by a mes sage on the LCD display 200 and or an audible prompt to confirm that the specified substances were consumed before the second time period waiting for the next blood test 1s set If the user does not respond as directed the process would go to step 5120 This embodiment would account for a severely hypoglycemic patient who was able to respond in step S116 but nevertheless did not respond in time to the ingestion ofthe directed substances to prevent disorientation or coma If the unit receives the results of the second blood test before the timer times out the process advances to step S136 where the glucose level is again compared to L2 Ifthe patient is still hypoglycemic blood glucose level lt L2 the process first proceeds to step S138 where it increments the status of the flag by 1 so that F 2 and then returns to the point where the LCD display 200 exhibits display status box D106 with the numeric fields 212 214 and 216 now displaying the cur rent glucose level Step S124 sets the same time period a second time and the process proceeds to step 5128 Since F 2 that is Fz1 step S128 directs the process to step S140 where i
49. t is determined if F 3 It will be appreciated that ifthe first blood test taken in step 5106 resulted in a blood glucose level between L1 and L2 indicating milder hypoglycemia the process will also reach step S140 since in that event step 5128 will detect that F 0 that is F 1 Step S140 then detects Fz3 meaning that the US 8 206 340 B2 13 LCD display 200 again changes to the mode depicted in FIG 8 According to the treatment protocol represented by the present embodiment the unit s software causes the message field 236 to display the following treatment instruction as shown in display status box D110 Drink 4 oz sugary drink OR Eat 3 graham crackers OR Ingest 1 tube glucose gel In addition the second text field 234 reads RETEST BLOOD IN 15 MIN This provides sufficient time for the patient s blood glucose level to respond to the substance s ingested to raise his or her glucose levels The unit will now wait for the results of a second blood test as effected by the loop comprising steps 5130 and S132 If a blood test is not taken before the timer times out the process proceeds to step 5134 described above Severely hypoglycemic patient after the second blood test If the second blood test for a severely hypoglycemic patient still indicates a hypoglycemic condition the amount of the substances that will raise the user s blood glucose levels is reduced from the amount that was ingested after the first blood test T
50. t to go into a sleep mode to save battery life Any suitable manner of waking the device can be used For example in the sleep mode the LCD display would be off but touching either input device 5 20 25 30 35 40 45 50 55 60 65 10 102 or 108 could cause the display ofa message that touching the DATE TIME region 102e will activate the unit Blood Test Results Indicate Hypoglycemia If the microprocessor detects a blood sample before the timer times out the process proceeds to step S112 which initiates an important aspect ofthe invention As noted above the microprocessor ROM stores data relating to normal blood glucose levels particular to the patient using the unit as well as certain predetermined levels that indicate different blood glucose readings that the patient can safely tolerate In step 112 the microprocessor determines if the tested blood glu cose level is below the critical predetermined level L1 that indicates severe hypoglycemia and could result in the immi nent onset of diabetic coma in this particular patient If so another time period is set in step S114 At the same time the LCD display 200 displays the blood glucose level in the numeric fields 212 214 and 216 and the first text field 218 now reads BLOOD GLUCOSE LEVEL The display can optionally indicate the units in which the blood glucose level is displayed but in a preferred embodiment the level is expressed in the stand
51. ter the first blood test This is effected by the status of the flag F which step S138 set at 1 after the second blood test Step 5128 now detects that F 1 and the LCD display 200 displays the instruction in display status box D108 and waits for the results ofa third blood test as effected by the loop comprising steps 5130 and 5132 In other words the protocol of the present embodiment increases the amount of blood glucose produc ing substances to be ingested by the patient because of his or her failure to adequately respond to the ingestion of a smaller amount per the instruction in display status box D110 Assuming a third blood test is taken within the time allotted steps 5130 and S132 the process then determines if the user s blood glucose level is now at least L2 Ifa third blood test 15 not taken before the timer times out the process pro ceeds to step S134 described above If the third blood test indicates that the patient s glucose level is still less than L2 step S138 sets the flag status 2 1 1 The process returns to the point where the LCD display 200 exhibits display status box D106 with the numeric fields 212 214 and 216 displaying the current glu cose level 20 25 30 35 40 45 50 55 60 65 14 The patient now can ingest additional blood glucose con taining substance s and take a fourth blood test since step 5140 will detect that the flag status F 3 However the patient may d
52. ther carbohydrates or a glucose gel available for the express use of diabetic patients The amount ofthe substance will reflect that the patient s blood glucose level 15 at a dan gerously low level less than L1 see steps S112 and S126 According to one standard protocol the unit software causes the message field 236 to display treatment regimen instruc tions such as shown in display status box D108 Drink 8 oz sugary drink AND Eat 3 graham crackers OR Ingest 2 tubes glucose gel In addition the second text field 234 reads RETEST BLOOD IN 15 MIN This provides sufficient time for the patient s blood glu cose levelto respond to the ingestion ofthe prescribed substance s It will be understood by those skilled in 10 20 25 30 35 40 45 50 55 60 65 12 the art that the particular substances listed here are representative and may be other substances within the scope of the invention In addition the 15 minute waiting time is also representative and it too can be other time periods if deemed appropriate for a given patient Indeed the substances to be consumed and the waiting period between blood tests can be tailored to the individual patient user of the unit and stored in the unit ROM for display as discussed here The time period set in step S124 allows for the waiting period just discussed that is 15 minutes in the present embodiment of the invention plus an interval that will allow sufficie
53. tic call using the unit s internal cellular telephone 310 to call a public emergency service provider by dialing 911 and to call a pre subscribed emergency service such as the Alert One medi cal alert service provided by Alert One Services Inc of Williamsport Pa The unit sends a prerecorded message to 911 and to the subscriber service that identifies the caller states that he or she may be in a diabetic coma and includes information on the unit s location provided by the GPS receiver 306 The unit s ROM can include software and a database for converting the unit s global coordinates pro vided by the GPS receiver 306 into usable location informa tion such as a street address but the capability of converting the coordinates into location information can also be at the call reception location or via a handheld device such as an Apple iPhone with which the unit communicates via its Bluetooth circuitry 308 In the latter case the call to the emergency service provider can be made by the external device as well Communicating with both 911 and a private subscriber service ensures that the patient will obtain the medical attention necessary because of his or her severe hypoglycemia US 8 206 340 B2 11 The automatic notification of 911 and or an emergency subscriber service is an important aspect of the invention One of the objects of the present invention is to enable a diabetic patient to maintain a lifestyle that is as normal
54. tion with the star shaped alarm icon 222 illuminated and with the message GLU COSE LEVEL LOW in the second text field 220 At the same time the microprocessor sets another time period in step S124 fora purpose described further below As indicated in the figure the process also proceeds to step S124 after setting the flag F 1 in step 5126 when the unit detects a user response from a severely hypoglycemic patient step S116 Next the process checks the status of the flag F in step 5128 If F 1 indicating a severe hypoglycemic condition the LCD display 200 changes to the mode shown in FIG 8 to display a treatment regimen to the user This screen 230 includes a first text field 232 and a second text field 234 corresponding to the first and second text fields of screen 208 shown in FIG 7 The numeric fields of screen 208 are replaced by a message field 236 which is capable of display ing treatment instructions to the patient user As with screen 208 the dotted lines in screen 230 shown in FIG 8 denoting the text and message fields indicate the positions of the fields and are not part of the display Text field 232 now reads LOW GLUCOSE LEVEL indicating that the patient needs to ingest a carbohydrate containing substance In accordance with known treatment protocols the type of substance will generally be in the nature of a sugary drink such as a com mercially available fruit juice a solid food containing sugar and or o
55. uched by a user Touching a center region provides a SELECT command The input device 108 acts a mode switch by which the user can set a mode of operation of the device by moving an image of a slider to the right or left A more detailed description con cerning the layout and operation of the input devices is pro vided below in connection with FIG 5 These devices together with the LCD display 200 enable operation of the device as described in detail below These input devices can take alternate forms such as mechanical switches that close respective electrical circuits when pressed They can also have different configurations and be located on the unit 10 in locations other than as depicted in the accompanying draw ings In its broadest aspects the invention includes all manner of input devices capable of providing the desired control functions The LCD display 200 is capable of displaying different screens depending on the input from the manual input devices or the unit s controlling software The LCD display can be backlit with different colors for purposes described in more detail below Those skilled in the art will recognize that other types of display devices can be used within the scope of the invention more complete descrip tion of the user interface is deferred until the discussion further below of the operation of the unit 10 and its improved manner of enabling diabetes patients to more easily and safely manage their symptoms
56. ucose monitor and insu lin injection pen according to an embodiment of the present invention FIGS 2A and 2B schematically depict a lancet and blood glucose test strip that form a part of a blood glucose monitor ing system that is integrated into the blood glucose monitor and insulin pen unit shown in FIG 1 FIG 3 partially depicts in schematic fashion an insulin injection mechanism with a hypodermic needle that forms a part of the insulin pen and blood glucose monitor unit shown in FIG 1 20 25 30 35 40 45 50 55 60 65 4 FIG 4 is a simplified block diagram showing the system components for an blood glucose monitor and insulin pen unit according to one embodiment of the present invention such as that shown in FIGS 1 to 3 FIG 5 illustrates an embodiment of a user interface with an LCD display and manual input devices incorporated into the unit shown in FIG 1 FIG 6 comprising FIGS 6A 6B and 6C is a flowchart depicting the steps in a blood glucose test and insulin injec tion cycle according to an embodiment of the present inven tion FIG 7 illustrates a display mode of the LCD display shown in FIG 5 in which it can display numeric fields indicating a blood glucose level insulin dosage and other information FIG 8 illustrates a display mode of the LCD display shown in FIG 5 in which it can display messages to the user One skilled in the art will readily understand that the draw ings ar
57. unit 10 further includes a GPS Global Positioning System receiver 306 that receives signals from a GPS satellite to indicate the global longitude and latitude of the unit The unit can also include Bluetooth circuitry 308 for wireless connection to a peripheral device such as a user s cellular telephone or personal digital assistant not shown Finally the present embodiment also includes an internal cellular telephone 310 for dialing remote locations under the control of the microprocessor 300 The cellular telephone can further include so called 3G or 4G circuitry for connection to the Internet when connection to a Wi Fi router connection cannot be made The functions and purposes of these components are discussed below in connection with the operation of the unit 10 FIG 5 is a detailed view ofthe front of the unit 10 showing the layout of the manual input devices 102 and 108 and the LCD display 200 The four regions spaced at 90 around the periphery of the touch activated input device 102 provide separate input functions A MENU button 102a at a nine o clock position on the circular device 102 causes a menu of control options to be displayed on the LCD display 200 An UP button 1025 at twelve o clock and a DOWN button 102c at six o clock on the device 102 enable the user to scroll through and highlight menu choices shown on the LCD dis play Thecenter ofthe device 102 comprises a touch activated SELECT button 1024

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