Patent Publication Number: US-7901383-B2

Title: Systems and methods for administering a medical regimen

Description:
REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 11/554,138 filed Oct. 30, 2006, now U.S. Pat. No. 7,534,230, which is a continuation of International Application No. PCT/US2005/014041 filed Apr. 25, 2005 (which was published in English), which claims the benefit of U.S. Patent Application Ser. No. 60/566,976 filed Apr. 30, 2004, which is hereby incorporated by reference in its entirety. 
    
    
     BACKGROUND 
     There are known various devices which measure, record and receive input data relating to a bodily characteristic or administration of treatment. These devices can store the data for review on a display of the device, or for subsequent transfer to a computer or other device which facilitates the review and analysis of the uploaded data. 
     For persons with medical conditions requiring a measurement device and an administration device, each device can be employed independently of one another to maintain the recorded data separately in each device. Inconvenience is created by having to review and transfer the recorded data from each device, and comparison and analysis of the separate data can be unreliable if, for example, the data is not synchronized with regard to time, date or source. Still other systems do not allow for or adequately facilitate employment of separate measurement and administration devices independently of one another for the recordation and/or viewing of data. Thus, the user must employ the measurement and administration devices within the system to view the stored data for each device. Furthermore, systems employing multiple devices may not readily conceal that the devices are for medical treatment purposes, which can create embarrassment and inconvenience for the user. 
     Accordingly, there remains a need for additional systems and methods for measurement and treatment of bodily conditions which address these deficiencies, among others. 
     SUMMARY 
     According to one aspect, a diagnostic and medication delivery system includes a medication delivery pen including a controller; a monitor for monitoring a characteristic of a bodily fluid, the monitor including a controller; and a case including a compartment for removably storing each of the medication delivery pen and the monitor, the case including a communications link for establishing communication between the controller of the pen and the controller of the monitor. 
     In one embodiment, communication between the pen and monitor is disabled when one of the pen and monitor is removed from the compartment. In a further embodiment, the compartment is internal of the case. 
     According to another aspect, a diagnostic and medication delivery system includes a medication delivery pen including a controller; a monitor for monitoring a characteristic of a bodily fluid, the monitor including a controller; and a case including a compartment for removably storing the medication delivery pen and for removably storing the monitor within the case, the case including a communications link in the compartment configured to electrically connect the controller of the pen and the controller of the monitor when the pen and the monitor are positioned in the compartment. 
     In one embodiment, the pen includes at least one communications port and the monitor includes at least one communications port. Communication between the pen and monitor is established when the communications port of the pen is positioned in contact with the first electrical contact and at least one communications port of the monitor is positioned in contact with the second electrical contact. 
     According to another aspect, a kit is provided with a medication delivery pen including a controller; a monitor for monitoring a characteristic of a bodily fluid, the monitor including a controller; and a case including a compartment for removably storing the medication delivery pen and removably storing the monitor with the controllers in electrical communication with one another. 
     In one embodiment, the pen includes at least one communications port and the monitor includes at least one communications port. The case includes a data connection assembly including a first contact and a second contact. Electrical communication is established between the pen and the monitor with at least one communications port of the pen positioned in the compartment in contact with the first contact and at least one communications port of the monitor positioned in the compartment in contact with the second contact. 
     According to a further aspect, a device for storing a medication delivery pen and a monitor includes a case including a compartment, the compartment including a first portion for receiving the medication delivery pen and a second portion for receiving the monitor, the first and second portions including a data communications link extending therebetween for establishing communication between the pen and the monitor when the pen is placed in the first portion and the monitor is placed in the second portion. 
     These and other aspects will be further discussed below with reference to the illustrated embodiments. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG. 1  is a schematic of a diagnostic and medication delivery system according to one aspect of the invention. 
         FIG. 2  is a perspective view of one embodiment of a case comprising a portion of the system of  FIG. 1  in a closed configuration. 
         FIG. 3  is an end view of the case in  FIG. 2  in an open configuration. 
         FIG. 4  is an exploded perspective view of one embodiment of the system of  FIG. 1 . 
         FIG. 5  is a perspective view of an upper portion of the case of  FIG. 2 . 
         FIG. 6  is a perspective view of a lower portion of the case of  FIG. 2 . 
         FIG. 7  is a flowchart of a routine programmable with the system of  FIG. 1 . 
         FIG. 8  is a flowchart of another embodiment of the routine of  FIG. 7 . 
         FIG. 9  is a flowchart of another embodiment of the routine of  FIG. 7 . 
     
    
    
     DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS 
     For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is hereby intended, such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated herein being contemplated as would normally occur to one skilled in the art to which the invention relates. 
     According to one embodiment there is provided a system for delivery of diabetes treatment, such as insulin. The system includes a diabetes blood glucose monitor and medication delivery pen for insulin delivery in a convenient integrated system facilitating the management and treatment of diabetes. The pen and monitor each include a controller operable to record data relating to specific events associated therewith. For example, the pen controller can be programmed to measure and record data relating to one or more injection events. Such data may include the time, date and quantity of insulin injected by the pen. The monitor controller can be programmed to measure and record measurement event data. Measurement event data may include the time, date, blood characteristic, caloric intake and activity associated with one or more measurements. When employed in the system in a cooperative mode of operation, clock data associated with an injection event of the pen is synchronized with the clock of the controller of the monitor to reliably correlate the injection event data with the measurement event data. 
     The controller of the pen can be programmed to operate in a second stand-alone mode in which the clock data relating to an injection event is provided by the pen controller independently of the clock of the monitor. In the stand-alone mode the user can employ the pen independently and outside the system to obtain clock data for each injection. In the stand-alone mode the injection event data is not downloadable to the monitor since the clock data relating to the stored injection events has not been synchronized with the clock of the monitor. 
     A case is provided to conveniently and discretely store the pen and monitor for transport by the user. In one form, the case includes an exterior look of a case that is commonly carried on the person, such as a pen and pencil case, a make-up case, or an eyeglass case, for example. The case can be securely closed to conceal the pen and monitor in a compartment of the case, and can be readily opened to access the pen and monitor. The compartment is configured to securely retain the pen and monitor in respective receptacles within the compartment. The receptacles are coupled to one another with a communications link that establishes communication between the pen and monitor when the pen and monitor are placed in their respective portions of the compartment. When one of the pen and monitor are removed from the case, the communications link is interrupted. 
     The pen and/or monitor are removed from the case by the user in order to, for example, make an injection or measure a blood characteristic. The pen and monitor measure, receive and store data associated with the particular function for which it was employed. When the pen and monitor are each positioned in the case, a communication link is established between the pen and monitor. The injection event data is uploaded from the controller of the pen to the controller of the monitor. The controller of the monitor can function as a central controller. The centrally stored data on the monitor controller relating to the injection and measurement events can be maintained for review on a display of the monitor. The centrally stored data can also be uploaded from the monitor to a computer for display and analysis with appropriate software. Still further the multiple injection event data can be stored and viewed on the pen both before and after transfer to the monitor. 
     In  FIG. 1  there is shown a schematic block diagram of a diagnostic and medication delivery system  20 . System  20  includes a case  22  including a compartment  23  for removably storing a pen  100  and a monitor  200  therein in communication with one another. Pen  100  includes a controller  101  with memory  106  and a microprocessor  102 . A communications port  104  is coupled to controller  101 . Microprocessor  102  is programmable to process data input therein relating to an injection event and record the data in memory  106 . Monitor  200  includes a controller  201  with a memory  206  and a microprocessor  202 . A communications port  204  is coupled to controller  201 . Microprocessor  202  is programmable to process data input therein relating to a measurement event and record the data in memory  206 . Microprocessor  202  is further programmable to process injection event data received from memory  106  of pen  100  and record the injection event data in memory  206 . 
     Controllers  101 ,  201  may each be comprised of one or more components configured as a single unit or of multi-component form. Controllers  101 ,  201  may each be programmable, a state logic machine or other type of dedicated hardware, or a hybrid combination of programmable and dedicated hardware. One or more components of controllers  101 ,  201  may be of the electronic variety defining digital circuitry, analog circuitry, or both. As an addition or alternative to electronic circuitry, controllers  101 ,  201  may include one or more mechanical or optical control elements. 
     In one embodiment including electronic circuitry, controllers  101 ,  201  each include the microprocessors  102 ,  202  operatively coupled to one or more solid-state memory devices defining, at least in part, memory  106 ,  206 , respectively. For this embodiment, memory  106 ,  206  each contains programming to be executed by the respective microprocessors  102 , 202  and is arranged for reading and writing of data in accordance with one or more routines executed by microprocessors  102 ,  202 . 
     Memory  106 ,  206  each may include one or more types of solid-state electronic memory and additionally or alternatively may include the magnetic or optical variety. For example, memory  106 ,  206  each may include solid-state electronic Random Access Memory (RAM), Sequentially Accessible Memory (SAM) (such as the First-In, First-Out (FIFO) variety or the Last-In First-Out (LIFO) variety), Programmable Read Only Memory (PROM), Electrically Programmable Read Only Memory (EPROM), or Electrically Erasable Programmable Read Only Memory (EEPROM); or a combination of any of these types. Also, memory  106 ,  206  each may be volatile, nonvolatile or a hybrid combination of volatile and nonvolatile varieties. 
     Besides memory  106 ,  206 , controllers  101 ,  201  may also each include any control clocks, interfaces, input devices, display device, signal conditioners, filters, limiters, Analog-to-Digital (A/D) converters, Digital-to-Analog (D/A) converters, communication ports, or other types of operators as would occur to those skilled in the art to implement the present invention. 
     Case  22  includes a data connection assembly  150  for connection with communication ports  104 ,  204  to establish communication between controllers  101 ,  201 . In one embodiment, communications between pen  100  and monitor  200  can be established when both are positioned in compartment  23  with the respective communication ports  104 ,  204  in contact with data connection assembly  150 . Data stored in memory  106  of pen  100  can be automatically transferred to controller  201  of monitor  200  when communication is established and upon satisfaction of certain validation conditions, which will be discussed further below. The pen memory data can be processed by processor  202  and stored in memory  206  of monitor  200 . 
     Data from memory  206  of monitor  200 , including data transferred from memory  106  of pen  100 , can be uploaded to a computer or other device with a processor or microprocessor via communication link  208  for viewing and/or analysis. Alternatively or additionally, case  22  can include a communication link  25  coupled to communication port  204  of monitor  200  for transfer of data stored in memory  206  of monitor  200  to a third device. It is further contemplated that communication link  25  can be coupled to communication port  104  to transfer data from memory  106  of pen  100  to a third device. 
     In  FIGS. 2-4  there is shown one embodiment of diagnostic and medication delivery system  20  including case  22  with internal compartment  23 . Case  22  includes a top member  24  hingedly coupled along one side thereof with an adjacent side of a bottom member  26 . When case  22  is opened, as shown in  FIG. 3 , top member  24  can be pivoted 180 degrees about hinge mechanism  28  to provide access to pen  100  and monitor  200  positioned within compartment  23 . When the case is closed, as shown in  FIG. 2 , the compartment and its contents are enclosed by top and bottom members  24 ,  26  to conceal the contents of case  22  and to protect the contents of case  22  from jarring, dropping or other physical abuse. Other embodiments contemplate that top member  24  and bottom member  26  can be configured to form any angle or position relative to one another, including disassembly, so long as the contents in compartment  23  are accessible. 
     Pen  100  and monitor  200  are removably stored in compartment  23  of case  22  between top member  24  and bottom member  26 . It is contemplated that bottom member  26  includes a pair of compartment portions for securely retaining pen  100  and monitor  200  therein. Pen  100  is an insulin delivery pen with controller  101  operable to process and record data associated with one or more injection events. One example of an insulin delivery pen is described in PCT Publication No. WO 02/092153. 
     As shown in  FIG. 4 , pen  100  provides an overall appearance of an ink pen. Pen  100  includes a housing  110  and a cap assembly  112 . A drive mechanism (not shown) is housed within housing  110  along with controller  101 . An input and display system  116  is provided along housing  110  to provide push buttons, switches and displays for the user to input and view information to and from controller  101  and to turn pen  100  on or off. A dosing knob  114  is provided at one end of pen  100  adjacent housing  110  to provide a means to manually input dosing instructions to controller  101 . An injection mechanism including a needle and cartridge (not shown) is operably coupled with the drive mechanism and positioned in cap assembly  112 . 
     Monitor  200  is a blood glucose monitor with controller  201  operable to process and record data associated with a blood glucose measurement event. Monitor  200  includes a body portion  210  and a lancer  212 . Lancer  212  can be storable within a receptacle of body portion  210 , or integrated within body portion  210 . It is further contemplated that monitor  200  can be provided without a lancer device. Body portion  210  houses controller  201  and includes a test strip interface  214 . A test strip with a blood sample can be positioned in interface  214  and analyzed by monitor  200 . The results can be displayed on display  216  and stored in memory  206 . Input device  218  allows the user to enter or review data stored in memory  206  and turn monitor  200  on or off. A hinge  220  is provided to open and close a compartment in monitor  200  for internal storage of test strips or other items. 
     Case  22  further includes a data connection assembly  150  positioned therein for establishing a communications link between pen  100  and monitor  200  for transfer of data therebetween. Data connection assembly  150  includes a first contact  152 , a second contact  154  and an electrical connector  156  therebetween. First contact  152  and second contact  154  are each in exposed in compartment  23  of case  22 . When pen  100  is positioned in its proper location and orientation in the compartment, an electrical connection is made between a series of conductive pads on the pen exterior serving as communications port  104  of pen  100  and resilient brush-like elements of first contact  152 . Similarly, when monitor  200  is positioned in its proper location and orientation in the compartment, an electrical connection is made between a series of conductive pads on the pen exterior serving as communications port  204  of monitor  200  and resilient brush-like elements of second contact  154 . Electrical connector  156  transmits signals between controllers  101 ,  201  when the electrical connections with contacts  152 ,  154  are made. Data connection assembly  150  can be a hard-wired connection as shown, or can be a wireless interface, such as radio frequency link, an infrared link, or a Bluetooth link, for example. 
     Compartment  23  of case  22  can further be adapted to store and securely retain ancillary devices useful with pen  100  and/or monitor  200 . For example, a pen needle  40  and a lancet  42  can be stored in case  22 . Case  22  can further provide for the storage of other items in compartment  23 , such as test strips, instructions, and lancer devices, for example. 
     Referring to  FIGS. 4-6  further details with regard to case  22  will be discussed. Top member  24  and bottom member  26  can each be provided as an integral or one piece member, as shown in  FIG. 4  with respect to top member  24 . Alternatively, top member  24  and bottom member  26  can each be provided in one or more components, such as shown with respect to bottom member  26  in  FIG. 4 . 
     Top member  24  includes a body  30  having lip  55  extending therearound. As shown in  FIG. 5 , body  30  defines an upper compartment portion  56  orientable toward bottom member  26 . In the illustrated embodiment, a latching mechanism  59  projects from lip  55  toward bottom member  26 . Top member  24  is pivotally coupled to bottom member  26  opposite latching mechanism  59  along a hinge mechanism represented at  28 . Hinge mechanism  28  can be provided in any suitable form for pivotally coupling top and bottom members  24 ,  26  to one another. One example includes one or more integral or living hinges between top and bottom members  24 ,  26 . Another example includes alignable cylinder members extending from top and bottom members  24 ,  26  which receive and are rotatable about a rod extending through and interconnecting the cylinders. In yet another example, top and bottom members are not pivotally coupled to one another, but are slidable, movable, or otherwise displaceable from one another to access the compartment. 
     Latching mechanism  59  can be provided in any suitable form or device for releasably retaining top and bottom members  24 ,  26  in a closed position. Although one latching mechanism  59  is shown, multiple latching mechanisms  59  could be provided along one or more sides of top and bottom members  24 ,  26 . In still another embodiment, no latching mechanisms are provided, and top and bottom members are biased to a closed position with a spring mechanism, magnetic mechanism, interfitting components that snap fit or releasably engage one another, or other suitable closing arrangement. 
     Top member  24  includes opposite longitudinal sidewalls  54  and a pair of opposite lateral sidewalls  58  extending between longitudinal sidewalls  54 . Sidewalls  54 ,  58  extend about an upper compartment portion  56  and recessed wall  57 . Wall  57  is recessed sufficiently to accommodate the portions of pen  100  and monitor  200  projecting upwardly from the compartment portions of bottom member  26  when case  22  is closed. A pen needle cradle  62  is formed along recessed wall  57  and is configured to hold pen needle  40  by frictional engagement, with the walls of the cradle extending about pen needle  40 . 
     In the illustrated embodiment, bottom member  26  includes a lower or outer skin  34  positionable about a lower liner  36  that forms a lower portion of compartment  23  such that the compartment  23  is defined between the internal liner  36  and the top member  24 . Lower or internal skin  34  can be comprised of a material that provides a rigid protective barrier to protect the contents placed in compartment  23 . Materials contemplated include aluminum, stainless steel, plastic material, and other suitable materials and combinations of materials. It is further contemplated that top member  24  can be provided with a rigid outer protective barrier that is comprised of the same or differing material as the compartment portion  56 . 
     Various means for securing liner  36  to its skin  34  are contemplated. For example, lower liner  36  can be provided with recesses  74  that align with protrusions  66  extending from lower skin  34  for a snap fit between lower skin  34  and lower liner  36 . Other means for securing liner  36  to the skin  34  are also contemplated, including fasteners, adhesives, and fusion of the internal liner to the respective outer skin, for example. 
     Lower liner  36  includes opposite first and second longitudinal sidewalls  76 , and a pair of opposite lateral sidewalls  78  extending between longitudinal sidewalls  76 . Sidewalls  76 ,  78  extend about a lower compartment portion which includes a first compartment portion  80  and a second compartment portion  82 . First compartment portion  80  is sized to accommodate pen  100  therein. Second compartment portion  82  is sized to accommodate monitor  200  therein. First and second compartment portions  80 ,  82  are shown in  FIG. 6  with contours that correspond to the outer shape of the pen or monitor to be positioned therein. This prevents lateral movement or twisting of the pen and monitor in their respective compartment portions, and can also provide frictional engagement with lower liner  36  to assist in retaining pen  100  and monitor  200  in the respective compartment portions  80 ,  82 . In other embodiments, first and second compartment portions  80 ,  82  can also be provided with contours that do not correspond to the outer shape of the pen and monitor to be positioned therein. A lancet cradle  84  is provided in a recess at one end of and adjacent to second compartment portion  82  to receive lancet  42  therein in frictional engagement with the wall portions of the cradle extending thereabout. 
     First compartment portion  80  includes a first data port opening  81  formed therethrough, and second compartment portion  82  includes a second data port opening  83  formed therethrough. First contact  152  of data connection assembly  150  is positioned in first data port opening  81  so that communications port  104  of pen  100  can be positioned thereon in electrical communication therewith. Similarly, second contact  154  of data connection assembly  150  is positioned in second data port opening  83  so that communications port  204  of monitor  200  can be positioned thereon in electrical communication therewith. Electrical connector  156  extends between contacts  152 ,  154  positioned in data port openings  81 ,  83 , and is located or housed between lower liner  36  and bottom skin  34  when assembled. 
     Lower liner  36  further includes clip receptacle  85  for receiving clip member  160  ( FIG. 4 ) therein. Clip member  160  includes a bottom portion  162  and a pair of opposite resilient arms  164 ,  166  extending from and movable relative to bottom portion  162 . Clip member  160  is positioned in clip receptacle  85  with arms  164 ,  166  extending upwardly therefrom to receive pen  100  therebetween. For example, arms  164 ,  166  can be received in a recess between knob  114  and housing  110 . Arms  164 ,  166  move away from one another about an integral hinge at the connection of arms  164 ,  166  to bottom member  162  as pen  100  passes therebetween. Arms  164 ,  166  return toward their pre-pen insertion orientation when pen  100  is seated in first compartment portion  80  to grip pen  100  therebetween. A spring member  168  can be embedded in or positioned in a channel (not shown) formed in clip member  160  to maintain the gripping force of arms  164 ,  166  even after repeated insertion and removal of pen  100  from clip member  160 . 
     Lower liner  36  further includes a pair of gripping members  86 ,  87  positioned on opposite sides of second compartment portion  82 . Gripping members  86 ,  87  are movable about an integral hinge formed with lower liner  36 . As monitor  200  is positioned in second compartment portion  82 , gripping members  86 ,  87  move away from one another to accommodate insertion of monitor  200  therebetween. When monitor  200  is finally positioned in second compartment portion  82 , gripping members  86 ,  87  return toward their pre-monitor insertion configuration and grip monitor  200  in second compartment portion  82 . 
     Gripping members  86 ,  87  and clip member  160  securely retain monitor  200  and pen  100  in their respective compartment portions  82 ,  80 . Such securement maintains the communication ports of the pen and monitor remain in electrical communication with the respective electrical contacts of data communication assembly  150 , facilitating an uninterrupted data transfer from pen  100  to monitor  200  when each are positioned in case  22 . 
     Lower liner  36  further includes slots  88 ,  89  to receive ejection levers  170 ,  175 , ( FIG. 4 ) respectively. Ejection lever  170  includes a handle member  171  and lower connection members  172 ,  173  extending transversely to handle member  171 . Connection members  172 ,  173  are rotatably secured in openings (not shown) in the walls of lower liner  36  adjacent first compartment portion  80  and are movably received in slot  88 . An ejection member  174  is positioned below pen  100  and, when unactuated, is recessed in slot  88  so that pen  100  can be fully seated in first compartment portion  80 . When handle member  171  is manually raised, ejection member  174  is also raised from slot  88  and into contact with pen  100  to lift pen  100  out of first compartment portion  80  and out of engagement with clip member  160 . 
     Similarly, ejection lever  175  includes a handle member  176  and lower connection members  177 ,  178  extending transversely to handle member  176 . Connection members  177 ,  178  are rotatably secured in openings (not shown) in the walls of lower liner  36  adjacent second compartment portion  82  and are movably received in slot  89 . An ejection member  179  is positioned below monitor  200  and, when unactuated, recessed in slot  89  so that monitor  200  can be fully seated in second compartment portion  82 . When handle member  176  is manually raised, ejection member  179  is also raised from slot  89  and into contact with monitor  200  to lift it out of second compartment portion  82  and between gripping members  86 ,  87 . 
     A datum spring  180  ( FIG. 4 ) can engage pen  100  when pen  100  is positioned in first compartment portion  80  to maintain communications port  104  in contact with first contact  152  of data connection assembly  150 . Datum spring  180  includes an L-shaped body with a lower portion  182  mountable to the underside of lower liner  36 , and an upper portion  184  extending through an opening  79  ( FIG. 6 ) in lower liner  36 . Opening  79  is in communication with first compartment portion  80  adjacent an end of pen  100 . With pen  100  in first compartment portion  80 , upper portion  184  of datum spring  180  pushes against the end of pen  100  to maintain an axial location of pen  100  in compartment portion  80 . Datum spring  180  can also bias pen  100  downwardly into first compartment portion  80 . Other embodiments contemplate that datum spring  180  is not provided, and pen  100  is maintained in the desired axial position in first compartment portion  80  with any one or combination of clip member  160  and the tolerances between pen  100  and the walls of lower liner  36  about first compartment portion  80 . 
     It is contemplated that the material at least along the compartment portions housing the various devices includes sufficient rigidity to maintain structural integrity, and also sufficient elasticity and resiliency to accommodate the snap fit or frictional fit of the various devices therein without damaging the compartment portions or the outer surfaces of the devices. Suitable materials include plastics and polymers, for example. 
     In use, monitor  200  is removed from case  22  and employed to measure a blood characteristic. Other measurement event data associated with a measured blood characteristic can also be entered into controller  201  for storage in memory  206 , such as whether the measurement event was associated with a meal, rest, or exercise. Pen  100  is removed from case  22  and employed by the user to make an insulin injection. With the pen powered on, the user can review injection event data stored in memory  106 , dial the pen for injection of a dose, or prime the pen to prepare for an injection. Each prime event can be tagged by the user and stored in the memory  106  of pen  100 . Other data associated with the injection event can be input and labeled in memory  106 , such as whether the injection event was associated with a meal, rest, or exercise. 
     To display data stored in pen  100 , it is contemplated that pen  100  includes a digital display coupled with controller  101  to display information, such as the date, time, dose reading, prime tags, battery life indicator, error information and indicators, and other information and indicators. It is further contemplated that pen  100  includes one or more data entry devices, such as push buttons, knobs, keypad or the like to facilitate user-initiated commands to controller  101 . To display data stored in monitor  200 , it is contemplated that monitor  200  includes a digital display coupled with controller  201  to display information, such as the date, time, blood glucose level, activity indicators, battery life indicator, error information and indicators, the data transferred from pen  100 , and other information and indicators. It is further contemplated that monitor  200  includes one or more data entry devices, such as push buttons, knobs, keypad or the like to facilitate user entry of commands to controller  201 . 
     The injection event data stored in memory  106  of pen  100  can be transferred to controller  201  of monitor  200  via data connection assembly  150  when pen  100  and monitor  200  are positioned in case  22  in their respective portions  80 ,  82  of compartment  23 . In order to initiate and complete data transfer, the communication port  104  of pen  100  is placed in electrical engagement with first contact  152  of data connection assembly  150 , and communication port  204  of monitor  200  is placed in electrical engagement with second contact  154  of data connection assembly  150 . 
     Referring to  FIG. 7 , a communications protocol for pen  100  and monitor  200  includes a routine  300  programmable in controller  101  of pen  100  and controller  201  of monitor  200  is shown. After completing one or more injection events with pen  100 , pen  100  can be repositioned in case  22  and docked with data connection assembly  150 , as indicated in stage  302 . With pen  100  and monitor  200  docked in case  22 , a communications protocol between pen  100  and monitor  200  is automatically initiated when pen  100  is operating in its cooperative mode. The communications protocol includes a validation test at stage  304 . The validation test, as discussed further below, can include checking for connection between the pen and the monitor, and checking clock settings. The validation test can also include identifying and checking a serial number associated with pen  100 . After validation of pen  100  and monitor  200 , the data relating to the injection events, including prime events, stored in memory  106  of pen  100  are transferred via data connection assembly  150  to monitor  200  at stage  306 . Transferred data can be marked to ensure that it is not re-transferred when pen  100  is removed from case  22  and re-docked therewith. When the data transfer is complete, the pen clock is synchronized with the monitor clock at stage  307 . After synchronization, the pen and monitor each return to a standby or sleep mode at stage  308 . 
     The injection event data transferred to and stored in memory  206  of monitor  200  can be accessed and reviewed on a display of monitor  200  along with the measurement date stored in memory  206  of monitor  200 . It is further contemplated that the data stored in memory  206  of monitor  200  can be uploaded to a computer or a third device for reporting, analysis and/or processing purposes. Transferred injection event data can further be retained in memory  106  of pen  100  for subsequent viewing with pen  100  until overwritten by subsequent injection event data. 
     Further details with respect to the validation of pen  100  in routine  300  are provided in  FIG. 8 . Pen  100  is docked with case  22  at stage  302  with a serial low to high transition interrupt of controller  101  enabled after the last dose. At stage  310 , if pen  100  is in a sleep mode when positioned in case  22 , a signal is transmitted upon connection of communication port  104  of pen  100  with contact  152  of data connection assembly  150  to wake controller  101  of pen  100 . At stage  312 , pen  100  sends a pulse to monitor  200  through data connection assembly  150  to identify that pen  100  is docked in case  22  and connected with monitor  200 . At stage  314  it is determined whether pen  100  is connected with monitor  200 . If monitor  200  returns a signal to pen  100  through data connection assembly  150  to set the serial input to low, then the connection has been established and routine  300  continues at stage  324 . 
     If at stage  314  it is determined that the serial input of pen  100  stays high, communication has not established between pen  100  and monitor  200  due to, for example, the lack of connection of one or both of pen and monitor with data connection assembly  150 . The connection identification can be re-tried for a set number of retry attempts, such as three attempts. If a connection is not identified, an error indicator to the user is provided at stage  318 . The error indicator can be any one or combination of an audible indication, a display message, or a lighted indicator on either or both of pen  100  and monitor  200 . Once an error indication is made, the serial low to high transition interrupt of pen  100  is disabled at stage  320 . If it is determined at stage  322  that the pen is not disabled due to, for example, communication between the pen and monitor being established by the user in view of the error indication at stage  318 , then routine  304  returns to stage  312 . If the pen  100  is disabled at stage  322 , pen  100  returns to a standby or sleep mode at end stage  308 . 
     If at stage  314  it is determined that the serial transition interrupt of pen  100  is set to low by monitor  200 , then routine  300  continues at stage  324  to determine whether the monitor clock is set. At stage  324 , monitor  200  determines whether a previous communication has been received from pen  100  that indicates the clock of pen  100  is synchronized with the clock of monitor  200 . If so, routine  300  continues at stage  332 . If there has not been any previous communication from pen  100  received by monitor  200 , then monitor  200  checks to see if the clock of monitor  200  is set. If the monitor clock is set, then routine  300  continues at stage  332 . If the monitor clock has not been set, then routine  300  continues at stage  326  where the clock of the monitor is initially set to correspond to the clock of pen  100 . If it is determined at stage  328  that no errors in setting the monitor clock with the pen clock have occurred, then routine  300  continues at stage  332 . If there is an error in setting the monitor clock with the pen clock, then after a set number of retry attempts routine  300  continues at stage  318  to provide an error indicator and continue as discussed above. Accordingly, the monitor clock can either be pre-set prior to use in system  200 , or, if the pen clock has been set and the monitor clock is not set, then routine  300  initially sets the monitor clock to correspond to the pen clock. 
     At stage  332 , pen  100  sends its serial number to monitor  200 . If the serial number is recognized as valid at stage  334 , then routine  300  continues at stage  306 . If the serial number is not valid, and after a set number of retry attempts the serial number error persists, routine  300  continues at stage  318  to provide a serial number error indication. Recognition of a valid serial number of pen  100  ensures that pen  100  is properly programmed for communication with monitor  200 . In addition, serial number identification can be used to stack and identify data from multiple pens  100  for storage in memory  206  of monitor  200 . 
     After recognition of a valid serial number, untransferred injection event data stored in memory  106  of pen  100  can be transferred to monitor  200  at stage  306 . It is contemplated that memory  106  of pen  100  can include data corresponding to multiple injection events, and that data associated with each event is transferred to monitor  200 . When the injection event data is successfully transferred at stage  338 , routine  300  ends at stage  308 . If there is an error in transferring injection event data after a set number of retry attempts, then routine  300  continues at stage  318  to provide an error indicator and continues from stage  318  as discussed above. 
     Referring to  FIG. 9 , there is shown additional details of data transfer stage  306  of routine  300 . After validation of the pen at stage  304 , pen  100  determines whether any untransferred dose or injection event data remain in memory  106  at stage  342 . If untransferred injection event data is stored in pen  100  at stage  342 , then routine  300  continues at stage  344  where the injection event data is transmitted to monitor  200 . If the injection event data is not successfully transferred at stage  346  after set number of retries, then routine  300  continues to stage  318  to provide an error indicator and continues from stage  318  as discussed above. 
     If the injection event data is successfully transferred at stage  346 , then routine  300  continues at stage  350  where the dose is marked as transferred. This allows dose or injection event data to remain stored in pen  100  for subsequent viewing with pen  100 . However, the marked injection event data will be recognized as transferred data, preventing a subsequent transfer of the marked injection event data and expediting execution of routine  300 . After marking the transferred injection event data, routine  300  returns to stage  342 , where it is determined whether any untransferred injection event data is stored in memory  106  of pen  100 . If so, then the next injection event data is transferred at stage  344 , marked at stage  350 , and routine  300  continues as discussed above. If not, then routine  300  continues from stage  342  to stage  352  to synchronize the pen clock with the monitor clock. 
     If all injection event data has been transferred, or if there were no untransferred injection event data, routine  300  synchronizes the clock of pen  100  with the clock of monitor  200  at stage  352 . Pen  100  transmits a signal to monitor  200  indicating the pen  100  is ready to receive clock data from monitor  200 . Monitor  200  sends the clock data to pen  100 , which is checked at stage  354 . If the transfer is successful and the clock data is synchronized, then at stage  358  pen  100  signals to monitor  200  that the synchronization is complete, and pen  100  and monitor  200  return to a standby or sleep mode at stage  308 . If the clock synchronization has not been successfully completed after a set number of retries, then routine  300  provides an error indicator at stage  318  and continues as discussed above. 
     It is contemplated that when pen  100  is operating in its cooperative mode that the validation, data transfer (if necessary) and clock synchronization are completed each time pen  100  is placed in case  22  with monitor  200 . After transfer of unmarked injection event data to monitor  200 , the clock of pen  100  is synchronized with the clock of monitor  200  to ensure a reliable and accurate comparison of data recorded with each device. Synchronization can include setting the time and date of the clock of pen  100  to correspond to the time and date of the clock of monitor  200 . Synchronization of the clocks ensures that an accurate comparison of injection and prime event data can be made with the measurement event data stored in monitor  100 . It is contemplated that once the clock in pen  100  is synchronized with the clock of monitor  200 , the clock in pen  100  cannot be adjusted or changed by the user. This will ensure the recorded data of pen  100  and monitor  200  can be accurately and reliably compared and analyzed. 
     The injection event data remains stored in memory  106  of pen  100  even after transfer until over-written with a new injection event data. In one embodiment, pen  100  is capable of storing data for multiple injection events, including prime events. All, some or none of the injection event data stored in pen  100  may be marked as being transferred to monitor  200 . Transferred and untransferred injection event data can be viewed with pen  100  in reverse chronological order, starting with the most recent injection event, and scrolled through by the user with an input device of pen  100 . 
     Pen  100  and monitor  200  are each also operable in a stand-alone mode in which the clock of pen  100  is operable independently of monitor  200 , and in which injection event data is not transferred from pen  100  when positioned in case  22  in communication with monitor  200 . In one embodiment, pen  100  is operable in its stand-alone mode after a period of time elapses in which pen  100  is not positioned in communication with monitor  200 . After the period of time elapses, the clock of pen  100  can be set independently by the user. This provides the user the flexibility to employ pen  100  and monitor  200  as stand-alone devices. In one embodiment, the pen converts to stand-alone mode automatically after a period of 14 days elapses without communication between pen  100  and monitor  200 . It is contemplated that a warning indicator can be provided to provide an indication to the user prior to the pen converting to stand-alone mode. It is further contemplated that data stored in pen  100  while pen  100  is operating in the stand-alone mode can be flagged or marked so it is not downloaded to monitor  200 . 
     While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the invention are desired to be protected.