WO2007051139A2

WO2007051139A2 - Diabetes management systems and methods

Info

Publication number: WO2007051139A2
Application number: PCT/US2006/060260
Authority: WO
Inventors: Luis Malave; John Garibotto; Jefferey Smith; Robert Campbell
Original assignee: Insulet Corporation
Priority date: 2005-10-27
Filing date: 2006-10-26
Publication date: 2007-05-03
Also published as: WO2007051139A3

Abstract

The present invention is directed to diabetes management systems comprising a substantially continuous glucose sensor, an insulin delivery device and a remote controller. The present invention is also directed to methods for managing diabetes with a diabetes management system.

Description

DIABETES MANAGEMENT SYSTEMS AND METHODS

RELATED APPLICATIONS

[001 ] This application is related to the following applications, each of which is herein incorporated by reference: U.S. Pat. App. Ser. Nos. 10/820195, 10/195745, 10/835727, 10/836525, 10/836720.

FIELD OF THE INVENTION

[002] This invention relates to medical devices / systems and, more particularly, to medical devices / system having a drug delivery portion, a physiological condition sensor portion and a remote control portion wherein one or more of said systems communicate with one another wirelessly.

BACKGROUND

[003] A wide variety of ambulatory infusion devices / pumps have been developed to deliver liquid medicaments to patients for the treatment of various diseases. Depending upon the disease and the corresponding medication it may be useful to obtain feedback from the patient during the course treatment and use such feedback to modify the treatment regimen. [004] In the treatment of diabetes with continuous subcutaneous insulin infusion ("CSII") it is known to sample the patient's glucose levels to determine whether the patient requires more or less insulin to be delivered. A variety of glucose measurement methods are known and/or are being developed, including a variety of blood glucose test strips and strip readers and, more recently, implanted continuous glucose sensors, subcutaneous interstitial fluid glucose sensors, non-invasive sensors and others. [005] Many insulin delivery systems and glucose measurement systems are not well integrated with one another. Some steps have been taken to integrate glucose test strips and strip readers with insulin delivery systems. One example of an integrated insulin delivery system and strip/strip reader system is described in U.S. Pat. App. No. 10/827582. Some systems that integrate insulin delivery systems with continuous or discrete, high frequency glucose sensing have also been proposed. However, such proposed systems suffer from various disadvantages. For example, some such systems require additional system components to coordinate the glucose data and the insulin delivery. In addition, some systems require that the patient be electronically tethered to a device that is dedicated to receiving and storing the continuous or discrete high frequency glucose data. In such systems, the user must stay in close proximity to a such a sensor data receiver. If the user is away out of range of the receiver for even a relatively short period, such as about 1 5 minutes, sensor data will be lost and the effectiveness of the system may be compromised.

SUMMARY OF THE INVENTION

[006] The present invention is directed to diabetes management systems comprising a substantially continuous glucose sensor, an insulin delivery device and a remote controller. The present invention is also directed to methods for managing diabetes with a diabetes management system. The details of one or more implementations are set forth in the accompanying drawings and the description below. Other features and advantages will become apparent from the description, the drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[007] FIG. 1 is a diagrammatic view of a diabetes management system in accordance with the present invention;

[008] FIG 2 is a diagrammatic view of an integrated delivery device and sensor assembly in accordance with a preferred embodiment of the present invention; and

[009] FIG 3 is a diagrammatic view of a diabetes management system in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] Referring to FIG. 1 , there is shown a diabetes management system

500 in accordance with the present invention. The basic components of the system 500 include an insulin delivery device 2000, a glucose sensor assembly 3000 and a remote controller 1000.

[001 1 ] The system 500 preferably comprises a delivery device 2000. The delivery device 2000 comprises a delivery device controller 2002 coupled to: a delivery device communication circuit 2001 , a delivery device memory

3005, and a dispensing mechanism 2003. The delivery device controller may also be coupled to a delivery device output mechanism 2006. The delivery device may also comprise a transcutaneous access tool 2004. [0012] The delivery device controller 2002 may be a microprocessor adapted to cause the dispensing mechanism 2003 to dispense insulin in accordance with dispensing instructions stored in the delivery device memory 2005. Preferably, the delivery device 2000 receives the dispensing instructions from the remote controller 1000 through an RF signal received by the delivery device communication circuit 2001 and stores the dispensing instructions in the delivery device memory 2005. Preferably, the delivery device memory 2005 is sufficient to store the delivery device operating system as well as at least 72 hours of basal rate dispensing instructions. Preferably, the delivery device memory 2005 is at least about 8 kilobytes. In an alternative embodiment of the present invention, the delivery device memory 2005 is sufficient to store sensor data received from the sensor assembly 3000 in addition to the operating system and 72 hours of basal rate instruction data. As discussed in more detail below, in such an embodiment, the delivery device controller 2002 may be programmed to compress and/or discard sensor data when the available delivery device memory 2005 is full. The delivery device controller 2002 may also comprise a plurality of controllers.

[0013] The delivery device communication circuit 2001 preferably comprises an RF transceiver capable of receiving RF signals from the remote controller 1000. The delivery device communication circuit 2001 is preferably capable of sending and receiving RF signals from the remote controller 1000 and the sensor assembly 3000. Preferably, the delivery device communication circuit 2001 is capable of sending and receiving RF signals from the remote controller 1000 and the sensor assembly 3000 over a distance of about 1 to 6 feet.

[0014] The dispensing mechanism 2003 may be any mechanism for dispensing insulin from a reservoir to a patient at a variable rate in accordance with programmed dispensing instructions. Many suitable dispensing mechanisms 2003 are known to those skilled in the art, including programmable syringe pumps with drives capable of advancing a plunger in a syringe reservoir at a variable rate (see, for example, U.S. Pat. App. Ser. Nos. 10/261003, 10/907286, and 10/907287), programmable valve regulated pumps using one or more controllable valves to regulate the insulin delivery rate (see, for example, U.S. Patent Nos. 10/683659), and programmable peristaltic pumps. The dispensing mechanism may include a fluid path connecting a reservoir to an exit port of the insulin delivery device. The exit port may be adapted to be connected to a transcutaneous access tool 2004 or, preferably may include an integrated transcutaneous access tool (See, for example, U.S. patent No. 10/907286, and 10/907287). [001 5] The insulin delivery device 2000 also preferably includes a delivery device output mechanism 2006 for alerting the user of one or more conditions concerning the delivery device or the user's glucose level. The delivery device output mechanism 2006 may be one or more devices capable of generating an audible, visible or tactile signal discernible by the user. Preferably, the delivery device output mechanism 2006 comprises at least an audible piezo alarm. Alternatively, the delivery device output mechanism 2006 may comprise a mechanism for vibrating the delivery device 2000 and/or a visible warning light or a digital display. Preferably, the delivery device controller 2002 is adapted to control the delivery device output mechanism 2006 to provide different signals corresponding to different delivery device conditions and or user glucose level conditions. Preferably, the delivery device comprises no user input components. [0016] The system 500 also preferably comprises a glucose sensor assembly 3000. The sensor assembly 3000 comprises a sensor assembly controller 3002, coupled to a sensor assembly communication circuit 3001 , a sensor assembly memory 3005, and a glucose sensor 3003. The sensor assembly controller 3002 may also be coupled to a sensor assembly output mechanism 3006.

[001 7] The glucose sensor 3003 may be any glucose sensor adapted to continuously generate a signal representative of a user's glucose level. Alternatively, the sensor 3003 may be adapted to generate a discrete signal representative of a user's glucose level, provided that repeated discrete signals may be generated by the sensor 3003 repeatedly and without user intervention each time a signal is generated. Preferably, the sensor 3003 generates a signal representative of the user's glucose level continuously or substantially continuously, where "substantially continuously" means at a frequency at which the gaps between readings are not clinically significant. Preferably, the sensor 3003 is a glucose sensor implanted in a user's blood vessel or other tissue, a subcutaneous glucose sensor, or a non-invasive sensor. Many such sensors that may be employed on a continuous or substantially continuous basis are known or are in development [001 8] The sensor assembly controller 3002 is coupled to the sensor 3003 and is programmed to obtain a signal from the sensor on a continuous or substantially continuous basis. In one embodiment of the present invention, the sensor assembly controller 3002 is programmed to store the sensor values in the sensor assembly memory 3005 until the sensor assembly controller 3002 receives a transmit data command via the sensor assembly communication circuit 3001 . The sensor assembly controller 3002 may be programmed to transmit the sensor data to one or both of the remote controller 1000 or the delivery device 2000 in response to a transmit data command. The sensor assembly controller 3002 may also be programmed to automatically send (i.e., without having received a transmit data command) an alarm signal to the delivery device 2000 in the event that the sensor 3003 detects a glucose level above or below a specified threshold or, in the event that the sensor assembly controller 3002 determines that a series of glucose sensor signals matches a predetermined pattern. Preferably the alarm signal contains information identifying the nature of the recognized glucose level condition, such as, high, low, trending high or trending low. In an alternative embodiment, the sensor assembly controller 3002 may be programmed to automatically send sensor data to the delivery device 2000 on a continuous or periodic basis rather than (or in addition to) in response to a transmit data command.

[0019] The sensor assembly memory 3005 is coupled to the sensor assembly controller and is used for storing programming instructions of the sensor assembly controller, communication data and/or sensor data. The size of the sensor assembly memory 3005 depends upon whether, and for how long, sensor data will be retained in the sensor assembly 3000. In an embodiment where sensor data is retained in the sensor until a transmit data command is received, the sensor assembly memory is preferably sufficient to retain 24 hours worth of substantially continuous sensor data. Alternatively, the sensor assembly memory is sufficient to retain only a clinically significant amount of substantially continuous sensor data. A "clinically significant" amount of sensor data is an amount of sensor data useful for generating a suggested correction bolus. In such an embodiment, the sensor assembly memory 2005 would be sufficient to retain only about 6 hour of sensor data at a frequency of about once per minute. Preferably the sensor assembly memory is about 2 to about 32 kilobytes. [0020] The sensor assembly communication circuit 3001 preferably comprises an RF transceiver capable of receiving RF signals from the remote controller 1000 and/or the delivery device 2000. Preferably, the sensor assembly communication circuit 3001 is capable of sending and receiving RF signals from the remote controller 1000 and/or the delivery device 2000 over a distance of at least about 1 to 4 feet.

[0021 ] The sensor assembly controller 3002 may also be coupled to a sensor assembly output mechanism 3006 for alerting the user of one or more conditions concerning the user's glucose level. The sensor assembly output mechanism 3006 may be one or more devices capable of generating an audible, visible or tactile signal discernible by the user. Preferably, the sensor assembly output mechanism 3006 comprises at least an audible piezo alarm. Alternatively, the sensor assembly output mechanism 3006 may comprise a mechanism for vibrating the sensor assembly 3000 and/or a visible warning light. Preferably, the sensor assembly controller 3002 is adapted to control the sensor assembly output mechanism to provide different signals corresponding to different user glucose level conditions. [0022] In an alternative embodiment of the present invention, the sensor assembly is incorporated into the delivery device (FIG. 2). In such an embodiment, one or more of the sensor assembly controller, sensor assembly memory, the sensor assembly user output, the sensor assembly user input may be the same as the corresponding delivery device components to avoid unnecessary duplication. An exemplary delivery device with integrated sensor assembly is also shown in U.S. Patent App. No. 10/ 195745.

[0023] The system 500 also preferably comprises a remote controller 1000. The remote controller 1000 comprises a remote controller controller 1002 coupled to a remote controller communication circuit 1001 , a remote controller user input 1007, a remote controller user output 1006, and a remote controller memory 1005.

[0024] The remote controller user input mechanism 1007 may be any user input mechanism enabling a user to input delivery instructions to be transmitted to the delivery device 2000, transmit data commands, or other information, to be sent to the sensor assembly 3000 and or the delivery device 2000, as well as any other information or instructions the user might input into the system 500. Preferably, the remote controller user input mechanism 1007 is one or both of a plurality of buttons (keyboard) and a touch screen. The remote controller user input mechanism 1007 may also comprise a microphone and voice recognition software. The remote controller user output mechanism 1006 may be any mechanism sufficient to communicate the information the user needs to operate the system 500 and interpret the sensor data from the sensor assembly via one or more of visible, audible or tactile signals. Preferably, the remote controller user output mechanism 1006 is a combination of a visible display screen of the type typically found in small portable personal computing devices and a device capable of generating a variety of different audible signals, such as a piezo alarm.

[0025] The remote controller communication circuit 1001 preferably comprises an RF transceiver capable of sending and receiving RF signals to/from the delivery device 2000 and/or the sensor assembly 3000. Preferably, the remote controller communication circuit 1001 is capable of sending and receiving RF signals from the delivery device 2000 and/or the sensor assembly 3000 over a distance of at least about 1 to 4 feet. [0026] The embodiment of the system 500 described above is intended for the treatment of diabetes. However, the system 500 may also be adapted for the treatment of diseases other than diabetes where it is useful to deliver a medication on a continuous or substantially continuous basis and where it is also useful to monitor a physiological condition of the patient on a continuous or substantially continuous basis and where the user might adjust the delivery of the medication based on the monitored physiological condition. In such cases, the sensor may be adapted to sense the corresponding physiological condition, the delivery device may be adapted to deliver the appropriate corresponding medication, and the remote controller may be adapted to present the user with information and command options appropriate to treating the corresponding disease. [0027] The present invention is also directed to methods for treating diabetes with a system comprising a delivery device, sensor assembly and remote controller.

[0028] In one method for treating diabetes in accordance with the present invention, the user is supplied with a diabetes management system comprising a sensor assembly a delivery device and a remote controller. The sensor assembly senses the user's glucose level substantially continuously and stores the results in the sensor assembly memory. When the user desires to know his glucose level, the user queries the system with the remote controller. The query causes the remote controller to send a sensor data transmit command to the sensor assembly. The sensor assembly responds by transmitting the stored sensor data to the remote controller. The remote controller preferably outputs the sensor data to the user. [0029] In another method for treating diabetes in accordance with the present invention, the user is supplied with a diabetes management system comprising a sensor assembly a delivery device and a remote controller. The sensor assembly senses the user's glucose level substantially continuously and stores the results in the sensor assembly memory. When the user desires to know his glucose level, the user queries the system with the remote controller. The query causes the remote controller to send a sensor data transmit command to the sensor assembly. The sensor assembly responds by transmitting the stored sensor data to the delivery device. The delivery device then transmits the sensor data to the remote controller. The remote controller preferably outputs the sensor data to the user. [0030] In another method for treating diabetes in accordance with the present invention, the user is supplied with a diabetes management system comprising a sensor assembly a delivery device and a remote controller. The sensor assembly senses the user's glucose level substantially continuously and stores the results in the sensor assembly memory. When the user desires to know his glucose level, the user queries the system with the remote controller. The query causes the remote controller to send a sensor data transmit command to the delivery device. The delivery device responds by transmitting a transmit data command to the sensor assembly. The sensor assembly responds by transmitting the stored sensor data to the delivery device. The delivery device then transmits the sensor data to the remote controller. The remote controller preferably outputs the sensor data to the user.

[0031 ] In connection with any of the foregoing methods, the transmit data command may alternatively be triggered any time the user activates the remote controller regardless of whether the user intends to review the sensor data or calculate a bolus (or basal adjustment) using the sensor data. [0032] In connection with any of the foregoing methods, once the sensor data is received in the remote controller, the remote controller preferably, outputs the sensor data to the user in the form of a graph of the user's glucose level over time. The remote controller may also use the sensor data (current and/or historical) in conjunction with a bolus estimation algorithm to generate a suggested bolus dose for the user to correct for any actual or projected deviation from the user's target glucose level or range. Alternatively, the remote controller may use the sensor data in conjunction with some other algorithm to generate a suggested change to one or more of the user's pre-programmed basal rates.

[0033] In another method for treating diabetes in accordance with the present invention, the user is supplied with a diabetes management system comprising a sensor assembly a delivery device and a remote controller. The sensor assembly senses the user's glucose level substantially continuously. The sensor assembly substantially continuously compares the sensor data to one or more predetermined alert conditions. The predetermined alert condition may be any condition or pattern that the user and/or the user's health care provide determines requires the user's attention. Typical alert conditions would include glucose level above a specified threshold, glucose level below a specified threshold, glucose level trending high or low at a predetermined rate, et al. If the sensor assembly detects a glucose level or a pattern that satisfies a predetermined alert condition, the sensor assembly notifies the user of the alert condition with the sensor assembly user output. Alternatively, if the sensor assembly detects a glucose level or a pattern that satisfies the alert condition, the sensor assembly transmits an alert signal to the delivery device. Upon receipt of the alert signal, the delivery device alerts the user of the existence the alert condition with the delivery device user output. Preferably, the sensor assembly and/or the delivery device provides different alert signals for different conditions so that the user knows the general nature of the alert without further interaction with the system. Preferably, if and when the user activates the remote controller, the sensor assembly and/or the delivery device transmits the alert signal to the remote controller.

[0034] In conjunction with any of the foregoing methods, the sensor assembly and/or delivery device preferably retains the sensor data in the sensor assembly and/or delivery device memory until receiving a transmit sensor data command. As a result, the sensor data may exceed the storage capacity of the sensor assembly or delivery device memory prior to receiving a transmit data command from the remote controller. In one embodiment of the present invention, when the sensor assembly or delivery device memory has reached its capacity, new data replaces the oldest data in a simple first in first out manner. In an alternative embodiment, sensor assembly or delivery device memory is made available by thinning the retained sensor data starting with the oldest sensor data so that a portion of the oldest sensor data is retained, but at a reduced frequency. Thus, the newest retained sensor data is denser than the oldest retained sensor data. Preferably, at least the most recent 6 hours of substantially continuous sensor data is always retained in the sensor assembly or delivery device memory until a transmit data command is received. [0035] A number of implementations of the present invention have been described. Nevertheless, it will be understood that various modifications may be made. Accordingly, other implementations are within the scope of the following claims.

Claims

What is claimed is:

1. A diabetes management system comprising: an insulin delivery device including: means for sending and receiving RF signals; means for dispensing insulin in accordance with dispensing instructions received from a remote controller; a glucose sensor assembly including: means for generating sensor data corresponding to the user's glucose level; means for storing the sensor data; means for receiving a sensor data download request; means for transmitting the sensor data from the data storage means in the sensor to data storage means in another device in response to a sensor data download request; a remote controller comprising: means for receiving input from the user; means for delivering output to the user; means for sending dispensing instructions to the delivery device by RF signals; means for sending sensor data download requests to the sensor assembly by

RF signals; means for receiving sensor data from the sensor assembly by RF signals; means for storing the sensor data.

2. The system of claim 1 , wherein the sensor assembly comprises means for sending an alarm signal to the delivery device in response to the sensor assembly sensing a predetermined glucose condition in the user; and the delivery device comprises means for receiving an alarm signal from the sensor assembly and means for generating an alarm signal that may be discerned by the user.

3. The system of claim 2, wherein the user discernable delivery device alarm signal is at least one of an audible, visual or tactile signal.

4. The system of claim 3, wherein the sensor assembly comprises means for generating a second alarm signal to the delivery device in response to the sensor assembly sensing a second predetermined glucose condition in the user.

5. The system of claim 4, wherein the delivery device comprises means for generating a first alarm signal in response to the first sensor assembly alarm signal and a second alarm signal in response to the second sensor assembly alarm signal.

6. The system of claim 1 , wherein there is no means for user input on the delivery device.

7. The system of claim 1 , wherein the sensor assembly senses the user's glucose substantially continuously and the sensor assembly memory is sufficient to store at least 1 2 hours of substantially continuous sensor data.

8. The system of claim 1 , wherein the means for sending sensor data download requests to the sensor assembly is activated by user input on the remote controller.

9. The system of claim A, wherein the sensor assembly comprises software for predicting whether the user's glucose level will exceed or fall below a threshold level in the future.

10. The system of claim 9, wherein the sensor assembly comprises means for sending an alarm signal to the delivery device in response to the predicting means predicting that the user's glucose level will exceed or fall below a threshold level in the future; and the delivery device comprises means for receiving an alarm signal from the sensor assembly and means for generating an alarm signal that may be discerned by the user.

1 1. The system of claim 9, wherein the sensor assembly comprises means for sending an alarm signal to the remote controller in response to the predicting means predicting that the user's glucose level will exceed or fall below a threshold level in the future; and the remote controller comprises means for receiving an alarm signal from the sensor assembly and means for generating an alarm signal that may be discerned by the user.

1 2. The system of claim 1 1 , wherein the alarm signal from the sensor assembly includes information concerning the reason for the alarm and wherein the output means of the remote controller has means to output the information to the user.

1 3. The system of claim 1 , wherein the delivery device and the sensor assembly are integrated into the same housing.

14. An insulin management system comprising: a glucose sensor assembly including: means for generating sensor data corresponding to the user's glucose level; means for transmitting the sensor data to data storage means in another device; an insulin delivery device including: means for sending and receiving RF signals; means for dispensing insulin in accordance with dispensing instructions received from a remote controller; means for storing the sensor data; a remote controller comprising: means for receiving input from the user; means for delivering output to the user, means for sending dispensing instructions to the delivery device; means for sending sensor data download requests to the delivery device; means for receiving sensor data from the delivery device; means for storing the sensor data.

1 5. The system of claim 14, wherein the sensor further comprises means for storing the sensor data and means for receiving a sensor data download request.

16. The system of claim 14, wherein the delivery device comprises means generating an alarm signal that may be discerned by the user in response to receiving glucose sensor data reflecting a predetermined glucose condition in the user.

1 7. The system of claim 16, wherein the delivery device alarm signal is at least one of an audible, visual or tactile signal.

1 8. The system of claim 17, wherein the delivery device comprises means for generating a second alarm signal that may be discerned by the user in response to receiving glucose sensor data reflecting a second predetermined glucose condition in the user.

19. The system of claim 14, wherein there is no means for user input on the delivery device.

20. The system of claim 14, wherein the sensor assembly senses the user's glucose substantially continuously and the delivery device data storage means is sufficient to store at least 1 2 hours of substantially continuous glucose sensor data.

21. The system of claim B, wherein the sensor assembly transmits sensor data to the delivery device automatically.

22. The system of claim 21 , wherein the delivery device transmits the sensor data to the remote controller automatically.

23. The system of claim 21 , wherein the delivery device comprises means for receiving a sensor data download request and for transmitting the sensor data to the remote controller in response to the sensor data download request.

24. The system of claim 23, wherein the means for sending sensor data download requests to the pump is activated by user input on the remote controller.

25. The system of claim 14, wherein the delivery device comprises software means for predicting whether the user's glucose level will exceed or fall below a threshold level in the future based on the received sensor data.

26. The system of claim 25, wherein the delivery device comprises means for generating an alarm signal that may be discerned by the user in response to the software means predicting that the user's glucose level will exceed or fall below a threshold level in the future based on the received sensor data.

27. The system of claim 14, wherein the delivery device and the sensor assembly are integrated into the same housing.

28. A method for treating diabetes comprising the steps of: providing a user with a diabetes management system comprising a sensor assembly a delivery device and an remote controller; generating sensor data by sensing the user's glucose level substantially continuously; storing the sensor data in the sensor assembly memory; causing the sensor assembly to transmit the sensor data in response to a transmit command received by the sensor assembly.

29. The method of claim 28, wherein the remote controller generates a transmit data command in response to a glucose level query from the user.

30. The method of claim 28, wherein the remote controller generates a transmit data command any time the user activates the remote controller.

31. The method of claim 29, wherein the remote controller transmits the transmit data command to the sensor assembly.

32. The method of claim 29, wherein the remote controller transmits the transmit data command to the delivery device and the delivery device transmits the transmit data command to the sensor assembly.

33. The method of claim 31 , wherein the sensor assembly transmits the sensor data to the remote controller.

34. The method of claim 31 , wherein the sensor assembly transmits the sensor data to the delivery device and the delivery device transmits the sensor data to the remote controller.

35. The method of claim 32, wherein the sensor assembly transmits the sensor data to the delivery device and the delivery device transmits the sensor data to the remote controller.

36. The method of claim 28, further comprising the steps of: comparing the sensor data to at least one predetermined condition; and generating an alert signal discernable by the user if the sensor data satisfies the alert condition.

37. The method of claim 36, wherein the step of comparing comprises comparing the sensor data to a plurality of predetermined condition and the step of generating an alert signal comprises the generating a predetermined alert signal that corresponds to the predetermined condition.

38. The method of claim 36, wherein the condition comprises at least one of a glucose level above a specified threshold, a glucose level below a specified threshold, a change in glucose level greater than a specified level.

39. The method of claim 37, wherein the condition comprises at least one of a glucose level above a specified threshold, a glucose level below a specified threshold, a change in glucose level greater than a specified level.

40. The method of any of claims 36, 37, 38 or 39, wherein the sensor assembly comprises sensor assembly output means to generate the user discernable alert signal.

41. The method of any of claims 36, 37, 38 or 39, wherein the delivery device comprises delivery device output means to generate the alert signal, the sensor assembly transmits an alert command to the delivery device and the delivery device generates the user discernable alert signal using the delivery device output means.

42. The method of claim 28, further comprising the step of outputting at least a portion of the sensor data to the user on the remote controller.

43. The method of claim 42, wherein the remote controller outputs at least a portion of the sensor data to the user in the form of a graph of sensed glucose levels over time.

44. The method of claim 28, further comprising the step of using at least a portion of the sensor data to recommend to the user a change in insulin delivery.

45. The method of claim 44, wherein the recommendation is in the form of a suggested bolus dose of insulin.

46. The method of claim 44, wherein the recommendation is in the form of an adjustment to the user's basal rate of insulin delivery.

47. The method of claim 28, further comprising the step of thinning the oldest sensor data stored in the sensor assembly memory when the used sensor assembly memory reaches a predetermined threshold, wherein the step of thinning comprises replacing part, but not all, of the oldest sensor data with the newest sensor data such that the newest retained sensor data is of higher density than the older sensor data.

48. The method of claim 47, wherein at least newest 1 2 hours of sensor data is substantially continuous.

49. A method for treating diabetes comprising the steps of: providing a user with a diabetes management system comprising a sensor assembly a delivery device and an remote controller; generating sensor data by sensing the user's glucose level substantially continuously; automatically transmitting the sensor data from the sensor assembly to the delivery device; and causing the delivery device to transmit the sensor data to the remote controller in response to a transmit command.

50. The method of claim 49, wherein the remote controller generates a transmit data command in response to a glucose level query from the user.

51. The method of claim 49, wherein the remote controller generates a transmit data command any time the user activates the remote controller.

52. The method of claim 50, wherein the remote controller transmits the transmit data command to the remote controller.

53. The method of claim 49, further comprising the steps of: comparing the sensor data to at least one predetermined condition; and generating an alert signal discernable by the user if the sensor data satisfies the alert condition.

54. The method of claim 53, wherein the step of comparing comprises comparing the sensor data to a plurality of predetermined condition and the step of generating an alert signal comprises the generating a predetermined alert signal that corresponds to the predetermined condition.

55. The method of claim 53, wherein the condition comprises at least one of a glucose level above a specified threshold, a glucose level below a specified threshold, a change in glucose level greater than a specified level.

56. The method of claim 54, wherein the condition comprises at least one of a glucose level above a specified threshold, a glucose level below a specified threshold, a change in glucose level greater than a specified level.

57. The method of any of claims 53, 54, 55 or 56, wherein the sensor assembly comprises sensor assembly output means to generate the user discernable alert signal.

58. The method of any of claims 53, 54, 55 or 56, wherein the delivery device comprises delivery device output means to generate the alert signal, the sensor assembly transmits an alert command to the delivery device and the delivery device generates the user discernable alert signal using the delivery device output means.

59. The method of claim 49, further comprising the step of outputting at least a portion of the sensor data to the user on the remote controller.

60. The method of claim 59, wherein the remote controller outputs at least a portion of the sensor data to the user in the form of a graph of sensed glucose levels over time.

61 . The method of claim 49, further comprising the step of using at least a portion of the sensor data to recommend to the user a change in insulin delivery.

62. The method of claim 61 , wherein the recommendation is in the form of a suggested bolus dose of insulin.

63. The method of claim 61 , wherein the recommendation is in the form of an adjustment to the user's basal rate of insulin delivery.

64. The method of claim 49, further comprising the step of thinning the oldest sensor data stored in the sensor assembly memory when the used sensor assembly memory reaches a predetermined threshold, wherein the step of thinning comprises replacing part, but not all, of the oldest sensor data with the newest sensor data such that the newest retained sensor data is of higher density than the older sensor data.

65. The method of claim 64, wherein at least newest 1 2 hours of sensor data is substantially continuous.

66. A method for treating diabetes comprising the steps of: providing a user with a diabetes management system comprising a sensor assembly a delivery device and an remote controller; generating sensor data by sensing the user's glucose level substantially continuously; comparing the sensor data to at least one predetermined condition; and generating an alert signal discernable by the user if the sensor data satisfies the alert condition.

67. The method of claim 66, wherein the step of comparing comprises comparing the sensor data to a plurality of predetermined conditions and the step of generating an alert signal comprises the generating a predetermined alert signal that corresponds to the predetermined condition.

68. The method of claim 66, wherein the condition comprises at least one of a glucose level above a specified threshold, a glucose level below a specified threshold, a change in glucose level greater than a specified level.

69. The method of claim 67, wherein the condition comprises at least one of a glucose level above a specified threshold, a glucose level below a specified threshold, a change in glucose level greater than a specified level.

70. The method of any of claims 66, 67, 68 or 69, wherein the sensor assembly comprises sensor assembly output means to generate the user discernable alert signal.

71. The method of any of claims 66, 67, 68 or 69, wherein the delivery device comprises delivery device output means to generate the alert signal, the sensor assembly transmits an alert command to the delivery device and the delivery device generates the user discernable alert signal using the delivery device output means.