Patent Publication Number: US-2009221890-A1

Title: Diabetes Management System

Description:
RELATED APPLICATIONS 
     The present application relates to design application number ______, to Daniel Saffer et al., filed Feb. 28, 2008, entitled “Remote Control Device for a Diabetes Management System”, which also relates to design application number ______, to Daniel Saffer et al., also filed Feb. 28, 2008, entitled “Soft Shell for a Diabetes Management System”, the disclosures of which are hereby incorporated by reference in their entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to the field of medical devices, and in particular, to a diabetes management system that includes a pump, a glucose system, and a remote device for communicating with the pump and glucose monitor. 
     BACKGROUND OF THE INVENTION 
     Patients with diabetes, otherwise known as diabetics, have a chronic disease that is characterized by a disordered metabolism resulting in high blood sugar. There are two types of diabetes. Type 1 diabetes involves a permanent loss or destruction of the beta cells of the pancreas which produces insulin. This often results in low levels or the complete absence of naturally produced insulin in the body. Type 2 diabetes involves a combination of an unusual resistance to naturally produced insulin and a relative insulin deficiency. As a result of both types of diabetes, a patient&#39;s blood sugar must be specially regulated. In the case of Type 2 diabetes, blood sugar regulation can sometimes be accomplished through a carefully maintained diet and exercise regime. In the case of Type 1 diabetes, blood sugar regulation almost always requires insulin supplementation. 
     Supplementation of insulin traditionally comes in two forms, basal injections and bolus injections. Basal injections are low level insulin injections meant to cover the patient&#39;s general insulin deficiency at low insulin need times such as between meals and at night, although even during higher insulin need times the basal injections may be administered. Bolus injections are higher level insulin injections usually administered before a meal or to correct an unusually high blood glucose level. 
     Both Type 1 and Type 2 diabetics who require insulin supplementation have a cycle that they repeat several times a day: checking their blood sugar level (otherwise known as blood glucose level), interpreting the results of that test, and then acting to adjust their blood sugar if necessary. A patient&#39;s blood glucose level is often checked using a finger prick mechanism, capturing the blood on a testing strip or feeding a certain amount of blood into a glucose level reader. After checking blood glucose levels, diabetics need to interpret the results of their blood glucose test. Traditionally, the blood glucose level reading is simply a raw number. Normally, blood glucose levels are between 70 to 150 mg/dL. If the patient&#39;s blood glucose level falls outside of this range, the patient will need to adjust it using an insulin injection. Generally, insulin dosages are calculated based on a formula that is unique to each patient, and then adjustments are made based on several other changing factors. These factors include taking into account what and how much food the patient had or will be having shortly, if the patient has just completed or plans to complete a specified amount of physical activity, and whether the patient has switched or plans to switch into a different mode of operation such as switching from awake mode to sleep mode. Once all of these factors have taken into account and an insulin dosage has been calculated, then the insulin is injected. Insulin is injected either with a syringe or a pump. This cycle must be done as often as necessary and is complex, time consuming, uncomfortable, and sometimes even embarrassing. 
     In order to perform these steps there are currently products on the market that help Diabetics take blood glucose readings, interpret results, and adjust blood glucose levels. However, the current products require diabetics carry-around with them and manage a tremendous amount of equipment. Diabetics often have to carry a glucose meter, a lancet for taking blood samples, and testing strips, an insulin syringe, one or more vials of insulin or an insulin pump. Taking a blood glucose reading manually requires a finger prick blood sample, catching the blood sample on a testing strip, and feeding the testing strip into the blood glucose meter. This is painful, potentially embarrassing, prone to error, and cannot be done while the patient is involved in other activities such as exercise or sleeping. Additionally, the equipment is often aesthetically unpleasing and “medical looking”; there are too many parts to easily manage; equipment is unsightly when seen poking out from under the patient&#39;s clothing; the equipment is bulky to carry in a shirt or pants pocket; the equipment is typically not waterproof; the long cannula stretching from the pump to the injection site can be uncomfortable and irritating for patient and can get caught on other objects; and the equipment comes in a limited choice of colors. Furthermore, current products are not context aware and they do not record and learn from the testing and dosing operations performed by the patient. Currently, there are no integrated products that help a patient easily test, interpret, and dose discretely. 
     Diabetes can be a very fatiguing disease to live with. Diabetes is a disease that must be constantly managed. Diabetes forces people to be more regimented in their lifestyles, eating patterns, and awareness of time. Furthermore, diabetes is typically managed alone, often without much community support. Remaining motivated to provide proper self care, especially over decades of living with the disease, is a significant challenge. Despite these serious problems, current products on the market assist very little in helping diabetics comfortably live with and manage their disease, set goals, or keep motivated. 
     Therefore, it would be highly desirable to provide a system and method for addressing the above mentioned problems associated with wearing and using diabetic devices, checking blood glucose, interpreting test results, adjusting blood glucose, and remaining motivated to deal with the disease. Specifically, it would be desirable to provide an integrated system that has fewer and smaller components; is easier to wear; can make better use of data; keeps patients in control; is easy to learn and teach; involves less interpretation by the patient (e.g., fewer numbers); and gives the patient a platform to view and share data, view long term trends, interact with a health care professional, and provide other methods for remaining motivated. 
     SUMMARY 
     In some embodiments, a patient wears a glucose monitor and a pump system covered by a soft, flesh colored, rubber-like shell which is comfortable and unobtrusive. A patient also carries a small, touch-screen, remote device that communicates wirelessly with the glucose monitor and the pump system. The remote device has a form factor that can be worn or carried in various ways such as on a keychain, necklace, or armband. 
     In some embodiments, a method for managing diabetes proceeds as follows. A glucose monitoring system attached to a patient measures a patient&#39;s blood glucose level. The glucose monitoring system wirelessly transmits the patient&#39;s blood glucose level to a remote device. The remote device wirelessly receives the blood glucose level of the patient. Then, in some embodiments, the wireless device compares the blood glucose level to a previous blood glucose level and displays the blood glucose level trending data on its display screen. 
     The trending data can be displayed in the form of a trending arrow, a trending graph, a change in an ambient display, or any combination of the aforementioned options. The ambient display is customizable. The patient can choose ambient display themes such as weather, digital pet, lava lamp, or patterned colors. If a change in ambient display is used to display trending information, the display image is a positive display when the trending is in a normal blood glucose level range, and is a negative image when the trending is outside of, or nearly outside of the normal range. For example, if the ambient display is weather themed, a darker sky is displayed when trending outside of the normal range and a lighter sky is displayed when trending in the normal range. If the ambient display is digital pet themed, an unhappy digital pet is displayed when trending outside of the normal range and a happy digital pet is displayed when trending in the normal range. If the ambient display is a lava lamp theme or a colored background theme, a warm color is displayed when trending outside of the normal range and a cool color is displayed when trending in the normal range. 
     In some embodiments, the remote device also displays the latest blood glucose level along with the trending data. In other embodiments, the remote device displays the latest blood glucose level alone. In some embodiments, the remote device also compares the measured blood glucose level to a pre-determined dosage cycle trigger level. In some embodiments, the pre-determine dosage cycle trigger level is selected from the group consisting of: a blood glucose level, a time of day, a period of time since a previous insulin dosage, and an alert message. In some embodiments, the remote device determines whether to initiate a suggested dosage cycle based on the result of its comparison to the predetermined dosage cycle trigger level. In other embodiments, the patient separately initiates a dosage cycle. If the suggested dosage cycle is initiated, then the remote device determines a suggested insulin dosage based on the blood glucose level and a patient profile, which includes historical blood glucose levels, stored on the remote device. In some embodiments, the suggested insulin dosage suggesting is at least partially based on a patient specified mode such as a sleep mode, a rest mode, an exercise mode, a work mode, a school mode, an eating mode, and a default mode. In some embodiments, the patient then accepts, rejects, or modifies the suggested insulin dosage. In some embodiments, the patient can modify the suggested insulin dosage by inputting units of carbohydrates he anticipates eating in the near future. 
     The remote device then calculates an insulin dosage to be administered. In some embodiments, the insulin dosage to be administered is the same as the suggested insulin dosage; in other embodiments, they are different. In most embodiments, the patient then verifies the insulin dosage to be administered. In some basal dosages, a low level insulin drip can be automatically administered without patient verification. The remote device wirelessly transmits the dosage to be administered to a pump system attached to a patient. The pump wirelessly receives the insulin dosage to be administered and then administers the corresponding amount of insulin to the patient. 
     In some embodiments, the blood glucose monitoring system, the pump system, and the remote device are distinct from one another. In other embodiments, the blood glucose monitoring system and the pump system can be covered under one soft shell cover. In this embodiment the pump system and blood glucose system is called a single pump-monitor system regardless of whether or not they are embodied in a single housing. 
     In some embodiments, if a blood glucose level reaches below a predetermined blood glucose alert level an alert is triggered. The alert can be visual, haptic, audio, or a combination of more than one of these types. In some embodiments, similar alerts will be activated if a technical problem occurs. For example, if the insulin level in the reservoir is low, there is a malfunction in the blood glucose monitoring system, there is a malfunction in the pump system, the pump is disconnected from a cannula, a cannula is disconnected from a needle, the remote device is out of range with the blood glucose monitoring system, or the remote device is out of range with the pump system an alert will also be activated. 
     In some embodiments, the remote device sends, either wirelessly or by means of a USB port, a patient profile to an external computing device for tracking long term trends, tracking trends in various modes, or assisting patients in goal setting. 
     In some embodiments, the remote device has a touch sensitive display screen, a wireless transmitter for wirelessly transmitting an insulin dosage to be administered to a patient, a wireless receiver for wirelessly receiving a blood glucose level of a patient, a processor, a power source, and a memory comprising: an operating system, a patient profile, and a dosage calculator for calculating the insulin dosage to be administered. In some embodiments, the memory further comprises a machine learning algorithm, a patient predictive model, and a monitoring algorithm. 
     In some embodiments, the remote device has a USB port. In some embodiments, the remote device also has an attachment means. In embodiments with an attachment means, the remote device can be attached to a necklace, arm band, keychain, or other object. In some embodiments, the remote device&#39;s display screen rotates depending on the orientation of the remote device. In some embodiments, the remote device has a hand-held form factor. In some embodiments, the remote device is no larger than 1 in by 3 inches by ½ an inch. 
     In some embodiments, the pump system has a pump for injecting a patient with insulin, an insulin reservoir fluidly connected to said pump for providing said pump with insulin, a cannula fluidly connected to said pump, a needle fluidly connected to said cannula, and a wireless receiver for receiving an insulin dosage to be administered to a patient from said remote device. 
     In some embodiments, the glucose monitoring system has a glucose sensor for sensing a blood glucose level of a patient and a wireless transmitter for transmitting said blood glucose level of a patient to said remote device. 
     In some embodiments, the pump system and said glucose monitoring system are covered by a soft flesh-colored shell attached to the patient for smooth and comfortable wear. In some embodiments, the shell is substantially waterproof. In some embodiments, the pump system, glucose monitoring system, and remote device are also substantially waterproof. 
     In some embodiments, the wireless transmitter and the wireless receiver of the remote device, the wireless receiver of the pump system, and the wireless transmitter of the glucose monitoring system communicate by a wireless means such as infrared technology, WiFi, cellular telephone technology, radio frequency technology, or Bluetooth technology. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       For a better understanding of the nature and embodiments of the invention, reference should be made to the Description of Embodiments below, in conjunction with the following drawings in which like reference numerals refer to corresponding parts throughout the figures. 
         FIG. 1  is a schematic diagram of a diabetes management system according to some embodiments. 
         FIG. 2  shows different perspective views of the remote device of  FIG. 1 . 
         FIG. 3  is a block diagram of the internal elements of the remote device of  FIGS. 1 and 2 . 
         FIG. 4  is a schematic diagram of a combined pump system and glucose monitor system of  FIG. 1  including a soft shell mounted on a patient, according to some embodiments. 
         FIGS. 5A-5C  show the remote device of  FIGS. 1-3  attached to a keychain, an armband, and a necklace, according to some embodiments. 
         FIGS. 6A-6D  show several themes a patient can choose for the ambient display of the remote device of  FIGS. 1-3 , according to some embodiments. 
         FIG. 7  is a flow chart illustrating a method for operating a glucose monitoring system of  FIG. 1 , according to some embodiments. 
         FIG. 8  shows screen shots of the remote device of  FIGS. 1-3  showing a method for operating the remote device, according to some embodiments. 
         FIG. 9  shows screen shots of the remote device of  FIGS. 1-3  showing various alerts, according to some embodiments. 
         FIG. 10  shows screen-shots of the remote device of  FIGS. 1-3  showing a method for initiating dosing, according to some embodiments. 
         FIGS. 11A-11C  are schematic diagrams of the soft shell of  FIG. 4 , according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     In some embodiments, a diabetes management system is provided that includes a unit containing both an insulin pump system and a glucose monitor system covered by a soft shell. Systems can be incorporated in a single housing or separate shells. The pump and glucose monitor systems are monitored and/or controlled by a remote device. 
       FIG. 1  is an illustration of a diabetes management system  100 . The diabetes management system includes three interrelated devices, i.e., a glucose monitoring system  102 , a remote device  104 , and a pump system  106 . The glucose monitoring system  102  periodically or continuously takes readings of the patient&#39;s blood glucose level. The glucose monitoring system  102  transmits the readings to the remote device  104 . The remote device  104  receives blood glucose level readings from the glucose monitoring system  102  and stores these readings. The remote device  104  also calculates insulin dosage to be administered, either automatically or with, patient input, and transmits the insulin dosage to be administered to the pump system  106 . The pump system  106  receives the insulin dosage to be administered and injects the appropriate amount of insulin into the patient. In some embodiments, the glucose monitoring system  102  and the pump system  104  can be located in the same device. In some embodiments, the communications between the pump system  106 , remote device  104 , and glucose monitoring system  102  occur over a wireless link. For example, infrared, Bluetooth, WiFi, radio frequency, or cellular telephone networks can be use to transmit information between the remote device  104  and the glucose monitoring system  102  and the pump system  106 . In other embodiments, the information can be communicated via wires, cables, or other physical means. In some embodiments, all of the elements of the glucose monitoring system  102  are substantially waterproof. 
       FIG. 2  shows the remote device  104  of  FIG. 1 . In the embodiment shown in  FIG. 2 , the remote device  104  wirelessly communicates with the pump system  106  and the glucose monitoring system  102 . In some embodiments, the remote device has a small form factor such that it can fit easily into a patient&#39;s hand. In some embodiments, it can be at most 1 inch by 3 inches by ½ an inch. This form factor has tremendous advantages in that it is small, unobtrusive, mobile, and easy to attach to a keychain or other item already carried by the patient. However other embodiments can be larger. 
     The remote device  104  embodies a display screen  202 . In some embodiments, the display screen  202  is touch sensitive, i.e. it includes a tactile input  214  to allow the patient to interact with the device by tapping, scrolling, or sliding his finger on the display screen  202 . For example, in the embodiment shown in  FIG. 2 , dynamic or soft buttons  204  appear on the display screen  202  allowing the patient to “change SETTINGS,” “dose by CARBS,” and “dose by UNITS.” In some embodiments, there is a headphone jack such that the patient can be alerted to warnings while sleeping without waking a partner. Furthermore, a patient can listen to calming or motivational music while dosing on performing other activities. In some embodiments, there are also permanent or hard buttons on the remote device  104 . For example, there can be a permanent on/off button or switch, a re-start or re-boot button, a return to default settings recessed button, or any other button that might be useful to a patient without needing to interact with the tactile input  214  on the display screen  202 . In some embodiments, the screen has a lock option, such that when the patient is not actively interacting with the remote device  104 , the patient will not inadvertently change a setting by accidentally touching the display screen  202 . The tactile input  214  can be unlocked by either a physical unlock button located on the remote device  104 , or it can be unlocked by a particular stroke on the display screen  202  such as a finger slide, a tapping pattern, or a swirl motion. The unlocking method can be determined by the user and stored in the patient&#39;s preferences  322  ( FIG. 3 ) on the remote device  104 . 
     In some embodiments, the remote device  104  contains a port  206 , such as a USB port, for communicating with an external computing device, such as a desktop computer. The information contained in the remote device&#39;s  104  memory can be uploaded via the port  206 . Data, additional programs, features, and firmware, can be downloaded from the external computing device to the remote device  104  via the port  206 . In other embodiments, the information can be communicated wirelessly and not via the port  206 . In some embodiments, the port  104  is covered by a protective cap  208  that can be removed from covering the port  206 . In other embodiments, the cap  208  is attached to the remote device  104  via a cord, swivel device, or any suitable means to keep the cap from becoming permanently separated from the port  206 , while still allowing the port to plug into an external computing device. In some embodiments, the cap  208  can contain a loop  212  such that a necklace, cord, keychain or other mechanism can be strung through the loop  212  as shown in  FIGS. 5A-5C . 
     Downloading the information from the remote device  104  to an external computing device, allows the patient to visualize long term trends such as month long glucose level trends or the patient&#39;s reactions to various levels of insulin doses during various modes of operation. Larger and more complex graphs and trend tracking may be available on the external computing device. The patient can compare his results with other patient&#39;s results on a virtual community of patients using the diabetic monitoring system, share best practice tips, share diabetic recipes, challenge other patient&#39;s to specific goals, etc. The patient can also send his information to a health care professional and get individualized advice without a need to visit a doctor&#39;s office or clinic. Interaction with a larger community may also help a patient remain motivated, get advice, feel supported by others in a similar situation, and set goals. Even when not communicating with a virtual community or viewing long term trends on an external computing device, the patient may find it easier to remain motivated, and set short and long term goals using the diabetic management system because of its ease of use and ability to unobtrusively integrate with the patient&#39;s lifestyle. 
       FIG. 3A  is a block diagram of the internal elements of the remote device of  FIGS. 1 and 2 . The remote device  104  includes: the port  206 , a processor  304 , a clock  306 , a power source  308 , an optional speaker system  310 , an optional vibration mechanism  312 , an optional tilt-sensor  314 , a wireless transceiver  316 , a memory  318 , display screen  202 , and a tactile input mechanism  214 , all coupled to one another via at least one bus  302 . The central processing unit, or processor  304 , interacts with the aforementioned components via the bus  302 . The clock  306  displays the time on the display screen  202 , and is required by the processor  304 . In some embodiments, the clock  306  can form a part of the processor  304 . The remote device is powered by a power source  308 , such as a battery. If a rechargeable battery is used, it can be re-charged though the port  206 . 
     In some embodiments, the remote device  104  contains a speaker system  310  so that audio alerts or messages can be communicated the patient. Audio alerts can be any number of tones, rings, or tunes which are customizable by the patient. The volume of the audio alert can be variable. Furthermore, additional audio alerts can be added to the memory  318  of the remote device  104 . In some embodiments songs can be downloaded such that the patient can play relaxing music while administering insulin or motivating music while working out. In some embodiments, the remote device  104  contains a vibration mechanism  312  such that it can communicate haptic alerts to the patient. The haptic alerts can be of various types and intensities of vibration, can be patient customizable and/or additional haptic alerts can be downloaded into the remote device  104 . 
     In some embodiments, the remote device  104  contains a tilt-sensor  314  or other mechanism for determining the orientation of the remote device  104 . The display screen  202  may re-orient its display to match the orientation of the remote device  104 . In some embodiments, the remote device  104  can also contain a digital camera, media player, etc. 
     The remote device  104  contains a wireless transceiver  316 . This wireless transceiver  316  automatically communicates with the transceiver  414  of the pump system  106  and/or the wireless transceiver  418  ( FIG. 4 ) of the glucose monitor system  102 . In some embodiments, the pump system  106  may contain only a receiver for receiving instructions from the remote device  104 . Likewise, in some embodiments, the glucose monitor system  102  may contain only a transmitter for sending information to the remote device  104 . As such, if a communication is not successfully transmitted or received, the remote device  104  will be alerted. If no transmission is possible, there is likely a malfunction; the remote is out of range with the combined pump monitor  400 ; or another error has occurred. The remote device  104  will activate an alert by a combination of one or more of visual, haptic, or audio alerts to notify the patient of the condition. The remote device is also capable of receiving a manual input of a blood glucose level reading. This option is useful if a manual glucose reading is taken to double check the glucose monitor system&#39;s readings. Manual input is also useful for calibration of the diabetes management system  100 . 
     The memory  318  contains a number of elements. In some embodiments, the memory  318  contains one or more of the following: an operating system  319  that stores instructions for communicating, processing data, accessing data, storing data, searching data, etc.; a machine learning algorithm  320 ; communication procedures  321 ; preferences  322 ; a dosage calculator  323 ; modes  324 ; a patient predictive model  325 ; a monitoring algorithm  326 ; ambient displays  600 ; and a patient profile  328 . The communication procedures  321  facilitate communication with the glucose monitor system  102  and the pump system  106 . The dosage calculator  323  calculates patient inputted carbohydrates and produces suggested insulin dosages. 
     The memory  318  also contains a patient profile  328  shown in  FIG. 3B . The patient profile  328  contains all of the raw data collected on a patient. The patient profile  328  stores historical information received from the glucose monitor system  102 . The patient profile  328  may contain the time, date, and mode of operation each time a blood glucose level is received from the blood glucose monitoring system  102 . Furthermore, the patient profile  328  contains the time, date, and mode of operation every time an insulin dosage is transmitted to the pump system  106 . The patient profile  328  contains data for both monitoring algorithm  326  initiated and patient initiated doses for both basal and bolus insulin doses. Furthermore, in some embodiments, for each event, the time since the previous dose, the previous carbohydrate consumption guess, the amount of the previous dose, and any warnings or alerts that were given are also recorded and stored in the patent profile  328 . 
     The information stored in the patient profile  328  is used to create a patient specific predictive model  325 . The machine learning algorithm  320  builds the predictive model  325 . The patient predictive model  325  is generated from the historical data stored in the patient profile  328  to model how a patient reacts to a certain dosage, at a certain time, and mode. For example, it may fit a curve to the raw data, or it may use any other suitable statistical or neural technique to generate the patient predictive model  325 . 
     The monitoring algorithm  326  receives blood glucose readings and checks these readings against pre-determined dosage cycle trigger levels for the current mode  324  stored in the memory  318 . The monitoring algorithm  326  initiates a dosing cycle if a predetermined dosage cycle trigger level is reached. In some embodiments, the monitoring algorithm  326  is triggered by a low blood glucose level. In other embodiments, the monitoring algorithm  326  is triggered by a particular time of day. For example, in some embodiments, the monitoring algorithm  326  will initiate a dosing cycle at noon because the patient usually eats at that time. 
     Once the dosing cycle is initiated, the dosage calculator  323  uses the patient predictive model  325  to generate a suggested insulin dosage. The dosage calculator  323  accomplishes this by using the patient predictive model  325  to determine the typical dosage that has been administered in the past for a blood glucose level at a given time and mode. 
     The memory  318  may contain preferences  322  such as the patient&#39;s preferred audio alerts, visual alerts, haptic alerts, ambient displays, the text font and size, basal dosage, glucose monitoring schedule, and any number of other elements that the patient has optionally selected and stored. Many of these preferences can be linked to particular modes  324 . Modes  324  are the pre-set options regarding glucose monitoring, glucose displaying, insulin dosing, alerts levels, the alert type, alert volume or intensity, ambient displays, and other options that are pre-set for a standard repeatable situation. Setting-up modes  324  saves the patient time customizing particular preferences. A patient can utilize as many or as few modes  324  as desired. Some modes  324  are pre-set but customizable, such as sleep mode, exercise mode, school mode, work mode, neutral mode, default mode, emergency mode, etc. The patent can also create new modes  324 . The modes can be pre-set for a 24 hour period, a weekly period, a monthly period, or a combination thereof. For example, a patient may wish to pre-assign a particular mode during the times the patient is normally sleeping, eating, and involved in work or school activities. Alternatively, a patient may wish to program a slightly different mode pattern on the weekends when he stays up later and goes to a weekly exercise class. Ambient displays  600  are also stored in the memory  318 . Some examples of ambient displays  600  are a color pattern, a digital pet, weather, and a lava lamp as discussed in relation to  FIGS. 6A-D . 
     The remote device  104  may also contain additional software programs. For example, it may contain a calendar, an address book, or the option to send and receive information such as e-mail wirelessly for sending immediate readings to a health care professional, for requesting advice, or for setting up future appointments. The remote may also contain a picture folder for customizable ambient displays  326 , a calculator for manual insulin dosage calculation, or any other useful program to assist the patient in operating the diabetes management system  100 . In some embodiments, the memory  318  may also contain a telephone means, which utilizes the speaker system  310  and tactile input  214  to call for help. In some embodiments, in the case of an emergency, such as the patient passing out, the telephone will automatically connect to a cellular telephone network and transmit an emergency message to a trusted friend, relative, or health care professional. 
     In some embodiments, the remote device  104  can act as not only a communication device with the glucose monitor system  102  and the pump system  106 , but also as a complete personal digital assistant for a patient&#39;s daily life. This reduces the number of items that a patient needs to carry on a daily basis. Alternatively, in some embodiments, the functions of a remote device  104  may be transferred to an alternative handheld device such as a cellular telephone or personal digital assistant. In these embodiments, the alternative handheld device may perform the functions of the remote device  104  described above. The screen, speaker, clock, vibration mechanism, and memory of the alternative handheld device may be utilized. The pump system  106  and the glucose monitoring system  102  wirelessly communicate with the alternative device by infrared, Bluetooth, WiFi, or cellular telephone networks. 
       FIG. 4  shows an embodiment wherein a soft shell  1100 , shown in dashed lines in this figure, covers a pump system  106  and glucose monitor system  102  on a patient&#39;s body. When the pump system  106 , and glucose monitor system  102  are both positioned under the same shell  1100 , the elements under the shell  1100  are called a combined pump-monitor  400 , even when the pump system  106  and the glucose monitor system  102  are not physically combined within a single housing. In some embodiments, the combined pump-monitor  400  will include a glucose monitor system  102  physically embodied within the pump system  106 . In these embodiments, the needle  410  for the pump system  106  also contains a glucose sensor  416 , such that only one needle is inserted into the patient. 
     In some embodiments, the glucose monitor system  102  is positioned a certain distance away from the pump system  106  to facilitate obtaining a more accurate blood glucose level reading. Therefore, in some embodiments, the glucose monitor system  102  is positioned on another part of the patient&#39;s body, and not under the same shell  1100  as the pump system  106 . In those embodiments, the glucose monitor system  102  can be positioned under a separate soft shell  1100  or may not be covered by a shell at all. 
     The glucose monitor system  102  includes a glucose sensor  416 , a needle  420  and a transmitter or transceiver  418 , as shown in  FIG. 4 . During a typical glucose monitoring operation the glucose sensor  416  measures the patient&#39;s blood glucose level using a small portion of blood obtained by the needle  420 . The transmitter or  418  wirelessly transmits the blood glucose level to the remote device  104  ( FIG. 1 ). The glucose monitoring system  102  can be worn continuously over a period of time without having to be repositioned. In some embodiments, that period of time is one day, one week, one month, or even longer. 
     The pump system  106  includes a pump  404 , an insulin reservoir  406 , one or more cannula  408 , one or more needles  410 , and a transmitter or transceiver  414 . Unlike current products, in some embodiments, the reservoir  406  is soft such that it appears less bulky under the shell  1100 . In other embodiments, the reservoir  406  is hard, but due to its snug fit inside the shell  1100 , the reservoir  406  appears soft. In some embodiments, the reservoir  406  is refilled by injection through the shell  1100 . In some embodiments, the pump  404  and/or insulin reservoir  406  can be permanently or semi-permanently embedded in the shell  1100 . In some embodiments, the pump  404  can easily slide off of the cannula  408 . The pump system  106  can be worn continuously for a period of time without having to be repositioned. In some embodiments, that period of time can be one day, one week, one month, or even longer. 
     During a typical dosing operation, the pump&#39;s transceiver  414  receives an actual dosage transmission from the remote device  104  ( FIG. 1 ). The transceiver  414  communicates the appropriate dosage to the pump  404 . The pump  404  then transfers the appropriate amount of insulin from the insulin reservoir  406 , through the cannula  408 , and into the needle  410  such that the appropriate amount of insulin is administered to the patient. In some embodiments, after the dosage has been administered to the patient, the transceiver  414  transmits the amount of insulin that was delivered back to the wireless device  104 . In some embodiments, if the insulin reservoir  406  is out of insulin, if the needle  410  has disengaged from the patient, if the cannula  408  has detached from the needle  410  or the pump  404 , or if any other malfunction occurs that could affect the insulin dosage to the patient, the transceiver  414  will communicate an appropriate warning or alert to the remote device  104 . 
     The shell  1100  allows the pump system&#39;s transceiver  414  and the glucose monitor system&#39;s  102  transceiver  418  to wirelessly communicate with the remote controller  104  ( FIG. 1 ). As such, during normal operation the patient does need to manually interact with either the glucose monitor system  102  or the pump system  106 . This makes glucose monitoring and insulin dosing easy for a patient to check and administer discretely from almost anywhere. 
       FIGS. 5A-5C  show the remote device  104  attached to a keychain  502 , an armband  504 , and a necklace  506  respectively. In other embodiments, the remote device  104  is attached to a shoe lace, a cord or ribbon on a coat, a backpack, purse or any other means to keep the remote device  104  near a patient. The remote device  104  can also be carried loose in a pocket, purse, or by other means. The small form factor and durability of the remote device  104  allows it to be easily carried with the patient. It can attach to anything small enough to fit through the loop  212  on the cap  208 , as for example, the keychain  504  and the necklace  506  fit through the loop  212  in  FIGS. 5A and 5C  respectively. In some embodiments, the loop  212  is disposed on the body of the remote device  104 , rather than on the cap  208 . 
     The keychain  502  of  FIG. 5A  can be made of any suitable material for sliding through the loop  212 . For example, it can be made of metal, plastic, fabric, or any similar material. The keychain  502  can be of any shape and is not required to be round. The keychain  502  embodiment allows the remote device  104  to be attached to other items, and may not necessarily also hold keys. For example, a carabineer might be used to attach the remote device  104  to a patient&#39;s belt or clothing. 
     The armband  504  of  FIG. 5B  can be made of any suitable material such as fabric, plastic, elasticized material, or metal. In  FIG. 5B , the armband  504  is attached to the back of the remote device  104 . In some embodiments, this attachment is accomplished by Velcro, snaps, loops, or any similar attachment means for securing the remote device  104  to the body of the armband  504 . In other embodiments, the remote device  104  can slip into a pocket in the armband  504 . The armband  504  need not only be attached to a patient&#39;s arm, but can also be worn on the wrist, around the ankle, upper arm, or around other part of the patient&#39;s body. Furthermore, the armband  504  can be used to attach the remote device to another object such as a backpack strap, purse strap, can be used as a coffee mug sleeve, or any suitable item which the armband  504  can wrap around. In some embodiments, the armband  504  contains a means for attaching and detaching from itself such that it can wrap around the patient&#39;s arm or another object. For example, it can have snaps, Velcro, or a buckle attachment means. 
     The necklace  506  of  FIG. 5C  can be made of any suitable material such as a plastic cord, a metal chain, a ribbon, or fabric cord. The necklace  506  can be worn around the patient&#39;s neck, worn around the patient&#39;s waist, wound around the patient&#39;s wrist, tied in a patient&#39;s hair, or worn in any other suitable method. The necklace  506  can also be tied or draped over another object such as tied onto a handlebar of a bicycle, backpack, baby stroller, or any suitable object. The necklace  506  cord can be attached through the remote device&#39;s loop  212 , or can be attached to the remote device  104  by another means. For example, it can attach at the back of the remote device, such that the device hangs in a landscape orientation when worn around the neck of a patient. In some embodiments, it slides into a pocket in a thick necklace  506  cord. 
     These attachment means are provided as examples only. Any other attachment devices that provided a mechanism for a patient to carry the remote device can also be used. For example, in other embodiments, the functionality of the remote device may be embodied inside a watch, such that the patient may wear it on his wrist, and the ambient display is a watch face when not actively communicating diabetes related information to the patient. 
       FIGS. 6A-6D  show various sample ambient display background image themes. The sample themes include an abstract design themed ambient display  602  in  FIG. 6A , a digital pet themed ambient display  604  in  FIG. 6B , a weather themed ambient display  606  in  FIG. 6C , and a lava lamp themed ambient display  608  in  FIG. 6D . In other embodiments, themes include an aquarium theme, flower theme, beach theme, a nature theme, and a solid color or pattern. A person skilled in the art would recognize than many other themes are also possible. Furthermore, a patient can download other ambient display  600  themes not-pre-loaded onto the remote device  104 . A patient can also customize the ambient display with a personal photograph or other background. 
     As shown in  FIGS. 6B and 6C , in some embodiments the ambient displays changes to subtly show a patient blood glucose level trending information. For example, when a patient&#39;s blood glucose level is trending downward; the ambient display  600  changes its image to subtly alert the patient that negative trending of blood glucose levels is occurring. For example, in some embodiments, the digital pet looks happy  604  when the blood glucose levels are in the normal range. The digital pet looks sad  605  and shows an empty food dish if the blood glucose levels are outside of the normal range. Another example, show in  FIG. 6C , is for a weather themed ambient display  606 . Normal blood glucose levels are shown by a sunny sky  606 , and abnormal blood glucose levels can be shown as a cloudy sky  607 . In some embodiments, color changes are used to indicate changes in blood glucose levels. For example, warm colors like yellows and reds are used to indicate abnormal blood glucose levels, and cool colors like blues and purples are used to indicate normal blood glucose levels in the abstract design theme  602  of  FIG. 6A  and the lava lamp theme  608  of  FIG. 6D . This method for alerting a patient to negative or positive trending is especially useful for patients, such as children, who cannot read. In some embodiments, the change in ambient display can be set to show a negative trending situation, even if the blood glucose range is still normal, thus the ambient display gives a patient advanced warning of a potential need to adjust his blood glucose level before adjustment is immediately necessary. 
     In some embodiments, the orientation of the ambient display is landscape view as is shown in  FIGS. 6A-6C . In some embodiments, the ambient display is portrait view, as is shown for the lava lamp themed ambient display  608  in  FIG. 6D . In some embodiments, the background image can orient itself in either landscape or portrait depending on the orientation of the remote device  104  at the time of viewing. 
     In some embodiments, the ambient display includes icons conveying general information along with a background image. For example,  FIG. 6A  shows the time  610 , blood glucose level  612 , blood glucose trending information  614 , battery life  616 , visual indication of approximate amount of insulin left in the insulin reservoir  618 , and the numerical amount of insulin left in the insulin reservoir  620 . This additional information provides the patient with a variety of information at a glance. The patient can customize the ambient display to show as many or as few of these icons as the patient prefers. The patient can also customize the size of these icons. For example, if the patient finds it hard to read the print size of the amount of insulin left in the insulin reservoir  620 , he or she can choose to customize the print size to be larger. Other icons can also be displayed in the ambient display. For example, the patient may wish to display an icon every time an automatic basal insulin injection has occurred. A patient may also wish to display a timer showing how long it has been since the last bolus or basal injection has occurred. 
       FIG. 7  schematically illustrates a typical monitoring and dosing cycle. The monitoring cycle proceeds as follows. The glucose monitoring system  102  measures a blood glucose level at  724 . This may be because of an instruction to measure received from the patient at  722 . Alternatively, measuring the blood glucose level at  724  may be performed periodically and automatically. Blood glucose level measurements can be taken every minute, every five minutes, every ten minutes, once an hour, several times a day, once a day, or the like. The glucose monitoring system  102  then wirelessly transmits the blood glucose level to the remote device  104  at  726 . The blood glucose level can be transmitted continuously or periodically. For example, blood glucose level transmissions can occur every minute, every five minutes, every ten minutes, once an hour, several times a day, once a day or the like. 
     The remote device  104  receives a reading of the current glucose level from a glucose monitoring system  102  at  700 . The remote device  104  stores at  702  this glucose level in its memory  318  ( FIG. 3A ), along with the date, time, and mode settings at the time of the glucose reading as a part of a continuously updated patient profile  328  ( FIG. 3B ). The remote device generates at  703  on updated patient predictive model  325  ( FIG. 3A ) based on the newly stored information and the information in the patient profile  328 . Then the updated patient predictive model  325  is stored at  704 . 
     In some embodiments, at any time after receiving the blood glucose level at  700 , the remote device  104  displays the current blood glucose level reading on a display screen at  701 , either as an individual glucose level or an average glucose level over a period of time. An average glucose level display protects against statistical variations resulting from an individual glucose level measurement malfunction. The blood glucose level can be displayed continuously or periodically. For example, the blood glucose level can be displayed every minute, every five minutes, every ten minutes, once an hour, several times a day, once a day, or the like. The patient can specify how often the readings are taken and also how often the readings are displayed. In some embodiments, trending information of the current glucose measurement as compared to the previously displayed glucose measurement is displayed in the form of a graph, arrow, or change in ambient display  600 . In some embodiments, the trending information can be displayed only as a change in ambient display  600  ( FIG. 6 ). In other embodiments, the trending information can be displayed simultaneously with the glucose reading or average glucose reading. 
     The dosage cycles described below normally apply to bolus dosages, although they can apply to basal dosages as well. A basal dosage is an insulin dosage lower than a bolus dosage. A bolus dosage is usually used to cover high insulin needs such as during mealtimes. A basal dosage is often set up to automatically deliver insulin between meals or at times of rest. It is not necessary that both a bolus and a basal dosage be given to a particular patient. For example, one patient may only require basal level doses while another patient may need only bolus doses. However, some patients require both basal and bolus doses. 
     In some embodiments, patient input at  707  begins a dosage cycle at  706 . In other embodiments, the monitoring algorithm  326  ( FIG. 3A ) at  705  initiates a dosing cycle at  706  based on a trigger. Periodically, the patient profile  328  is read by the monitoring algorithm  326 . For example, the patient profile  328  can be read every minute, every five minutes, every ten minutes, once an hour, several times a day, once a day, or the like. The monitoring algorithm  326  monitors the patient&#39;s blood glucose level, time, and other changing situation to see if they fall below or above a dosage cycle trigger level. In some embodiments, if a patient&#39;s blood glucose reading falls below a low blood glucose trigger level, then the monitoring algorithm  326  initiates a dosing cycle at  706 . In some embodiments, the monitoring algorithm  326  initiates a dosage cycle at  706  based on another trigger such as by a particular time of day; time since previous insulin dosage; an alert message; or the like. Setting the dosage cycle trigger level assists the patient in goal setting. For example, if the patient wishes to more closely control his or her blood glucose level, he could set a trigger to always begin dosing cycle if I reach 120 mg/dL. 
     In the embodiment where the decision to begin a dosage cycle at  706  is initiated by the monitoring algorithm  326 , the remote device  104  then calculates, at  708 , a suggested insulin dosage. The suggested insulin dosage is calculated at  708  based on the received blood glucose level  700  and the patient predictive model  325  ( FIG. 3A ), stored at  704 , using the dosage calculator  323  ( FIG. 3A ). The remote device  104  then displays the suggested insulin dosage at  709 . In some embodiments, input is received from the patient to accept, reject, or modify the suggested insulin dosage at  711 . If the patient chooses to modify the dosage, the patient can modify it by either inputting units of insulin or inputting units of projected carbohydrates that the patient plans to eat. The remote device  104  then uses the dosage calculator  323  to calculate at  701  the insulin dosage to be administered at  710 . The remote device  104  then displays an insulin dosage to be administered at  712 . 
     In some embodiments, the calculation of the insulin dosage to be administered at  710  is determined by the patient input approving or modifying the suggested insulin dosage at  711 . In other embodiments, if no patient input  711  is received after a pre-determined amount of time has passed the remote device  104  determines that the insulin dosage to be administered  710  is calculated as the suggested insulin dosage  708 . In yet other embodiments, the patient can select the mode  324  ( FIG. 3A ) such that the insulin dosage to be administered  710  is always the suggested insulin dosage at  710  such that the step of displaying the suggested insulin dosage at  709  is skipped. In this embodiment, only the insulin dosage is displayed  712 . 
     In the embodiment where the decision to begin a dosage cycle at  706  is initiated by the patient at  707 , the following steps vary depending on the original patient input at  707 . In some embodiments, the patient initiates the dosage cycle at  706  by simply entering instructions to begin a suggested insulin dosage calculation at  707 . In this embodiment, the steps are the same as described above for the dosage cycle initiated by the monitoring algorithm  326 . 
     In some embodiments, the patient enters the approximate amount of carbohydrates that the patient plans to eat at  707 . The remote device  104  calculates the suggested insulin dosage, at  708 , using the dosage calculator  323  ( FIG. 3A ) and taking into account not only the patient inputted carbohydrate amount but also the received blood glucose level  700  and the patient predictive model  325  ( FIG. 3A ), stored at  704 . The suggested insulin dosage is displayed at  709 . The patient then accepts, rejects or modifies the suggested dosage at  711 . The dosage calculator  323  then determines the insulin dosage, to be administered at  710 , and displays it at  712 . 
     In other embodiments, the patient enters the amount of insulin units the patient would like to receive at  707 . In this case no suggested dosage need be calculated at  708  or displayed at  709 . In some embodiments, the remote device  104  proceeds immediately to the step of displaying the insulin dosage to be administered at  712 . In other embodiments, the remote device calculates at  710  the insulin dosage to be administered based on the received blood glucose level  700  and the patient predictive model  325  ( FIG. 3A ), stored at  704 . The calculated value, determined at  710 , and the original patient inputted value, received at  707 , are compared at  728 . The comparison value is checked against a warning trigger level at  729 . If a warning trigger level is not reached, i.e. if the calculated value for the insulin dosage to be administered  710  falls within a preset range of values close to what the patient inputted at  707 , then the amount that the patient initially entered is displayed at  712 . However, if the warning trigger level is reached, i.e. if the value calculated at  710  differs substantially from the value inputted by the patient at  707 , then a patient specific warning  906  ( FIG. 9 ) informing the patient that the amount of insulin that the patient entered is potentially incorrect is displayed at  730 . This double check mechanism helps protect a patient from accidental insulin overdosing. In some embodiments, a similar patient specific warning  906  appears if the approximate amount of carbohydrates is substantially different from the patient&#39;s normal intake of carbohydrates. In some embodiments, the patient specific warning  906  trigger levels are pre-set by a medical professional. In other embodiments, the patient can set the trigger levels for when these patient specific warnings  906  are displayed. 
     No matter how dosage cycle is initialed, for the safety of the patient, prior to transmitting the actual insulin dosage for a bolus level injection, the patient confirms that the dosage should be administered at  713 . This is a safety feature to protect the patient from a potentially lethal overdose of insulin. However, certain low level basal injections can be set to administer by drip. In some embodiments, basal injections by drip do not require patient input at  713  before transmission. This can be especially helpful if the patient is sleeping or otherwise engaged and does not wish to be bothered for low level basal injections. Finally, the actual dosage is wirelessly transmitted, at  714 , to the pump. 
     The pump system  106  ( FIG. 1 ) receives, at  716 , from the remote device  104  the insulin dosage to be administered. The pump system  106  then injects the appropriate amount of insulin into the patient at  718 . In some embodiments, the pump system  106  then transmits at  720  injection information back to the remote device  104 . For example, if the injection is successful, the pump system  106  transmits a success message, or if an injection malfunction occurred, an alert is transmitted  720 . 
       FIG. 8  shows various interface screens that may appear while a patient is using the remote device  104 . Following unlocking, the landing screen  1002  appears. The patient can tap on the graph  1004  to proceed to the glucose overview screen  802 . At the glucose overview screen  802 , the patient can view and change the time period  804  of the graph  1004 . In some embodiments, the time period of the graph  1004  is changed using the plus key  806  and the minus key  808 . The upper and lower limit guide lines  1006  are modified by similar means. Other information regarding the graph may also be displayed. For example, in the embodiment shown in  FIG. 8 , the blood glucose range  810  and the blood glucose average  812  are displayed. Similar information as specified by the patient such as the percentage of time that the patient remained within the specified upper and lower guide lines  1006  can also be shown. 
     If the patient chooses the “change SETTINGS”  1008  soft button  204  ( FIG. 2 ) in the landing screen  1002 , the patient will be taken to the menu screen  814 . In the menu screen  814 , several options are available to the patient such as the soft buttons  204  for “Change STYLE”  816 , “Change MODE”  818 , and “Change PROFILE”  820 . If the patient chooses the “Change STYLE” button  816  the patient is taken to a Style screen, not shown, where in some embodiments, the patient can change the ambient display, change the font, color, or size of the display text, change the shape of the options buttons, or any similar settings which relate to the visual style of the display screens. The patient can adjust these levels by various tactile input  214  methods such as tapping, scrolling, or sliding their finger up and down on the touch sensitive display screen  202 . 
     If the patient chooses the “change MODE” button  818 , the patient is taken to the Mode screen  822  where, in some embodiments, the patient can chose modes  324  ( FIG. 3 ) of operation by taping on the mode menu options  324 . Different modes  324  can be stored, such as sleep, exercise and normal. Once the proper mode  324  is selected, the patient will choose the “USE” button  826  to start using this mode  324 . For example, the patient may change to the sleep mode  324  right before bed. 
     The patient can also edit the modes by selecting the “EDIT” button  828 . In some embodiments, the patient can pre-set a variety of options for each mode  324 , such as the dosage for a basal injection, how often the basal injection should be administered, and how often to check the patient&#39;s blood glucose level. In some embodiments, the patient can pre-set a schedule for daily mode  324  changes. For example, the patient can set a 24 hour period of time with a sleep mode  324  from 11 PM to 6 AM, an eating mode  324  from 6 AM to 7 AM, a work mode  324  from 7 AM until NOON, a eating mode  324  from NOON to 1 PM, work mode  324  from 1 PM to 6 PM, an exercise mode  324  from 6 PM to 7 PM, eating mode  324  from 7 PM to 8 PM, and a leisure mode  324  from 8 PM to 11 PM. In this embodiment, the patient will not need to manually change modes  324  before eating, going to work, bed, etc. 
       FIG. 9  shows two examples of visual alerts  900  that can appear in special circumstances. In some embodiments, the visual alerts  900  are also be accompanied by audio and/or haptic alerts. In other embodiments, an audio and/or a haptic alert is used without a visual alert  900 . The visual alerts  900  background colors can be red or another eye catching color. 
     Some alerts warn of a device malfunction or technical problems  902 . These can relate to any technical problem occurring with the diabetes management system  100  ( FIG. 1 ). One example, shown in  FIG. 9 , is a pump disconnection warning  904 . Other technical problems  902  including, a low insulin level in the insulin reservoir  306 , a malfunction of the glucose monitor, a malfunction of the pump  304 , a low battery, a needle that has detached from the patient, or any similar physical malfunction will also trigger a malfunction warning  902 . Another example of a malfunction  902  that causes an alert occurs when the remote device  104  is moved out of range with the pump system  106 , the monitor system  102 , or the combined pump monitor  400  ( FIG. 4 ), because although all of the physical elements are functioning properly individually, they cannot properly perform their functions unless they are able to communicate with one another. 
     Another type of visual alert is a patient specific warning  906 . For example, the alert shown in  FIG. 9  conveys information regarding a high glucose reading  908 . Other patient specific warnings  906  include a low glucose reading alert, a potential overdose of insulin, an unusual trending cycle as compared to the patient profile, a warning that the amount of insulin or the number of carbohydrates that the patient entered is potentially incorrect, and any other similar patient specific issues that demand a patient&#39;s attention. For example, if a patient attempts to dose himself with a large bolus insulin dosage shortly after administering a previous large bolus insulin dosage, a high insulin dosage alert appears warning the patient that the current insulin in his body could reach too high of a level if the new bolus were administered. 
     The patient can choose to perform a function to correct the problem. For example in  FIG. 9 , the patient can choose the “INSULIN” button  910  to begin a dosage cycle  705  ( FIG. 7 ). Alternatively, the patient can choose the “DISMISS” button  912  to dismiss the warning screen. In some embodiments, after dismissal, the patient specific warning  906  will permanently disappear, while in other embodiments, the warning  906  may temporarily disappear, and will reappear if the problem persists. In other embodiments, the warning will re-appear if the next blood glucose reading is a pre-determined amount lower than the previous blood glucose level. In still other embodiments, choosing the “DISMISS” button  912  will display a screen where the patient can choose whether to permanently dismiss or temporarily postpone the warning. Similar options are also available for all technical problem alerts  902 . 
     In some embodiments, patient warnings  906  are customized to the patient. For example, the patient can set the high glucose alert to only appear if two or three glucose readings in a row appear outside of a pre-determined range used for patient warnings  406 . In other embodiments, the patient customizes the pre-determined range. In yet other embodiments, the warnings become patient specific by means of the machine learning algorithm  320  ( FIG. 3 ). In some embodiments, a warning appears if a certain small problem that was previously a precursor to a larger problem recurs. For example, if a patient&#39;s blood sugar trends up quickly at around noon, it may indicate that the patient forgot to inject himself with a bolus dosage prior to lunch, as happened on a previous day at around the same time. Thus, even though the blood glucose level has not yet exceeded the pre-determined range, a warning can appear that alerts a patient to a potential need to perform a bolus injection. 
       FIG. 10  shows various interface screens that may appear as a patient interacts with the remote device  104  ( FIG. 1 ) to calculate an insulin dosage. Once a patient unlocks the ambient display  600  ( FIG. 6 ) the landing screen  1002  will appear. In some embodiments, unlocking will occur through pressing a button or flipping a switch located on the body of the remote device  104  separate from the display screen  202  ( FIG. 2 ). In other embodiments, unlocking will be accomplished through tapping, sliding, swirling or another operation performed on the touch screen itself. In some embodiments, the patient can customize the unlocking stroke. 
     In the landing screen  1002 , the patient will get more information about his or her blood glucose levels over a period of time in the format of a graph  1004 . In some embodiments, this graph  1004  is customized to be a part of the ambient display  600 . The period of time that the graph covers can be altered by the patient, such as the last hour, the last day, or the last week. In some embodiments, the graph also shows guide lines  1006 . The guide lines  1006  mark the range of blood glucose levels that the patient wishes to stay between. In some embodiments, the high blood glucose level and the low blood glucose level values are displayed. In other embodiments, as is shown in  FIG. 10 , the guide lines  1006  are pictorially represented by white lines without values. In some embodiments, a line showing when an insulin dosage should be administered is also be depicted in the graph  1004 . 
     Soft buttons  204  ( FIG. 2 ) display various dosing options in the landing screen  1002 . In some embodiments, the soft button  204  information is stored under a patient&#39;s preferences  322  ( FIG. 3 ). The patient can choose the “change SETTINGS” options button  1008  to change the settings of his remote device  104  as described in  FIG. 8 . The patient can choose to initiate an insulin injection by choosing the soft button  204  “dose by CARBS”  1010  or the soft button  204  “dose by UNITS”  1012 . 
     If a patient chooses to “dose by CARBS”  1010 , the carbohydrate adjustment screen  1013  appears. In some embodiments, the remote device  104  makes a guess as to how many carbohydrates the patient is likely to eat and displays a suggested carbohydrates amount  1014 . This suggested carbohydrate amount  1014  is based on information stored in a patient&#39;s profile  328  ( FIG. 3 ). In some embodiments, the patient&#39;s profile  328  stores how many carbohydrates a patient guessed he would be eating at all previous meals, the times of those meals, the mode of operation, and the insulin dosage administered. The learning algorithm  320  ( FIG. 3 ) uses the information in the patient profile  328  to determine a suggested carbohydrate amount  1014 . The patient can then adjust the number of carbohydrates he or she is planning to eat using the up arrow  1016  or the down arrow  1018 . In some embodiments, when the patient is finished, the insulin dosage screen  1022  appears automatically. In other embodiments, the patient verifies that he or she is done making a carbohydrate guess by pressing the “NEXT” key  1020 . 
     The insulin dosage screen  1022  appears after the patient has finished with the carbohydrate adjustment screen  1013 . However, the insulin dosage screen  1022  will appear immediately if the patient chooses the “dose by UNITS”  1012  soft button  204  in the landing screen  1002 . At the insulin dosage screen  1022 , an intelligent guess as to how much insulin is needed is displayed as a suggested insulin dosage  1024 . In some embodiments, the amount of insulin left in the patient&#39;s body  1026  will also be displayed. In some embodiments, the total amount of insulin that will be in the patient&#39;s body after the injection  1028  is also displayed. This additional information may help the patient better understand his or her insulin needs. The patient chooses the up arrow  1016  or the down arrow  1018  to modify the bolus dosage. In some embodiments, when the patient is finished, the dosing verification screen  1030  appears automatically. In other embodiments, the patient chooses to proceed to the dosing verification screen by pressing the “NEXT” key  1020 . 
     The dosing verification screen  1030  displays the amount of insulin to be administered  1032 . The patient is then asked to verify that the insulin should be injected now by selecting the “YES” button  1034 , or that the insulin should not be injected by selecting the “NO” button  1036 . After the patient chooses the “YES” button  1034 , the active dosing screen appears  1038  indicating that dosing is currently occurring. The remote controller  104  ( FIG. 1 ) sends the dosage amount to the pump system  106  ( FIG. 1 ), where the correct amount of insulin is then administered to the patient. While the insulin is being injected the patient can monitor the injection progress by observing the progress bar  1040  in the active dosing screen. In some embodiments, after a successful insulin injection has occurred, a success screen appears. In other embodiments, the remote controller  104  immediately returns to the ambient display screen  600 . 
     In some modes  324  ( FIG. 3 ), only a subset of the above described screens appear. For example, the patient can set both the basal and bolus injections to be automatically calculated by the remote device  104  ( FIG. 1 ). In these embodiments, the patient is required to only verify the automatically calculated dosage at the dosing verification screen  1030  prior to active dosing. In still other embodiments, the basal injections can be administered by drip such that no interface screens appear. This might be useful during sleep mode, exercise mode, or a school mode for young children. 
     In should also be apparent to one skilled in the art, that the above described functions could be accomplished by any similar means. The screens to do not need to look precisely like the ones shown in  FIG. 10 . For example, in some embodiments, different information can appear on the landing screen  1002 . Furthermore, some screens can be combined while the same or similar functions are performed. 
       FIG. 11A-C  shows an embodiment of a soft shell  100  made of rubber or a rubber-like material.  FIG. 11A  shows the shell attached to a patient&#39;s body.  FIGS. 11B and 11C  show two possible shapes of the internal cavity  1101  within the shell  1100 . The shell  100  can be attached directly to a patient&#39;s body in any appropriate place such that the shell firmly attaches to the patient&#39;s skin. For example, it can be attached to the patient&#39;s stomach, back, side, hip, thigh, etc. The shell  1100  blends in with the patient&#39;s body by having a softness, color, and texture similar to the patient&#39;s skin. For example, it may be similar to “cutlets”, or breast inserts, that women sometimes wear with strapless dresses. The shell  1100  is configured to smoothly cover the one or more of the following: a glucose monitor system  102 , an insulin pump  404 , an insulin reservoir  406 , a cannula  408 , a needle  410 , or any other related items shown in  FIG. 4 . The smoothness of the shell  1100  reduces the likelihood that one or more of these elements will be caught on the patient&#39;s clothing or on other external items. Also, the shell allows the patient&#39;s clothing to smoothly slide over these elements. As such, these items will not appear bulky or protrude from the patient&#39;s clothing, and an external observer may be un-aware that the patient is wearing diabetics related equipment because of the seamless way the shell  1100  blends in with the contours of the patient&#39;s body. 
     In some embodiments, the shell  1100  is attached to the patient by glue around the perimeter of the shell  1100 . Alternatively, it can attach through suction or any other suitable attachment means. In some embodiments, the shell  1100  includes a built in insulin reservoir in the internal cavity  1101 . In some embodiments, the internal cavity is large enough to cover all of the glucose monitoring system  100  ( FIG. 1 ) items under the shell  1100 . In other embodiments, the internal cavity  1101  is configured with individual pockets to fit separately and snugly around the insulin reservoir, the pump, the glucose monitor, or any other bulky piece of the glucose monitoring system  100 . 
     In some embodiments, the shell  1100  is customizable to match the patient&#39;s skin tone. In other embodiments, the shell  1100  is clear, brightly colored, patterned, or made to mimic a skin embellishment such as a tattoo, jewel, or cartoon character. In yet other embodiments, the shell  1100  is customizable such that a patient can change its color by swapping out a faceplate or layer. In some embodiments, the shell  1100  is re-usable, while in other embodiments, the shell  1100  is designed for a one time use. 
     In some embodiments, the shell  1100  is waterproof, and can be worn during swimming or showering. It can be worn for numerous days in a row, and may only need to be removed for maintenance such as to re-fill the insulin reservoir. In some embodiments, the shell  1100  is configured such that the insulin reservoir is refilled by an injection through the shell  1100 . In this embodiment, the shell  1100  does not need to be removed for insulin reservoir refilling. A patient can wear the shell  1100  during all normal daily activities such as to work, to school, while exercising, and while sleeping. 
     The term “patient” has been used throughout this description. However, one skilled in the art would realize that at many times a person other than the patient could be performing the interactions with the remote device. For example, a physician or pharmacist may set the original profile of a patient before the patient uses the device. Also, if the patient was unconscious, another user can interact with the remote device to dose insulin. Alternatively, a patient may be too young or otherwise incapable of understanding how to dose themselves and a parent or guardian may be the one interacting with the remote controller instead. 
     The foregoing descriptions of specific embodiments of the present invention are presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. Furthermore, the order of steps in the described methods is not necessarily intended to occur in the sequence laid out. In addition, use of singular terms also includes their plural. It is intended that the scope of the invention be defined by the following claims and their equivalents.