Patent Application
20100198196
Diabetic patients typically administer insulin to sustain their physiological conditions. Typically, these patients administer doses of either fast acting or slow acting insulin using needle type syringes, for example, prior to meals, and/or at a suitable time during the course of each day contemporaneously with the blood glucose level testing using fingerstick blood glucose testing, for example. If insulin is not suitably administered, the diabetic patients risk serious if not fatal damage to the body.
Continued development and improvement in the external infusion pump therapy in recent years have drawn much appeal to the diabetic patients for, among others, improved management of diabetes by better regulating and controlling the intake of insulin. Typically, the patient inserts a cannula which is connected to as infusion tubing attached to an external pump, and insulin is administered based on a preprogrammed basal profiles. Moreover, the external infusion devices presently available include computational capability to determined suitable bolus doses such as carbohydrate bolus and correction bolus, for example, to be administered in conjunction with the infusion device executing the patient's basal profile.
Commercially available infusion devices such as insulin pumps are programmable and include sophisticated functionalities to enhance therapy management. Consistent with the sophistication of these devices, it is often cumbersome and trying to program these complex devices to the desired delivery, notification, modification and/or other adjustments or settings to be suitable for each user's physiology or therapy. Often, the infusion devices are miniaturized to provide each of portability and comfort in extended wear or use. However, with miniaturization necessarily follows compact or miniaturized user interface including, for example, small display screens, compact buttons or input mechanisms and the like.
Initial programming of such compact devices, for example, may be challenging and include a steep learning curve, often times dissuading the user from the use of the devices themselves, or modifying the existing programming in the infusion device.
Embodiments of the subject disclosure include methods device for programming a therapy delivery device such as a medication infusion device including, for example insulin pump. More particularly, embodiments of the present disclosure include generating and customizing empirical rules for deriving initial delivery settings, automating the application of these rules for patient use, detecting a connection to a therapy delivery device, identifying the connected delivery device, receiving data download request from the delivery device, retrieving updated data associated with the connected delivery device, allowing user to review and confirm the changes, and automatically transmitting the retrieved updated data to the delivery device.
Also provided are systems, computer program products, and kits.
Within the scope of the present disclosure, there are provided method and system for programming a therapy delivery device such as an infusion device via a remote terminal automatically, or semi-automatically, where the therapy profile or prescription is entered via the remote terminal such as a computer terminal and thereafter transferred to the therapy delivery device upon establishing communication link between the device and the remote terminal. In aspects of the present disclosure, the user or the healthcare provider may, enter the appropriate therapy profile in the remote terminal via its user interface, and upon establishing a communication link with the therapy delivery device, the therapy profile is uploaded into the therapy delivery device automatically or upon acknowledgement or confirmation by the user, to program the therapy delivery device and thereafter for execution of the therapy profile.
In one embodiment, using the remote terminal, the physician or the user or patient of the therapy delivery device may program one or more suitable basal delivery profiles, alarm or alert notification parameters, and other appropriate therapy or device related parameters, and when a communication link is established between the device and the remote terminal, the programmed basal delivery profiles, alarm or alert notification parameters and/or other appropriate therapy or delivery device related parameters are transferred to the device for execution and/or storage.
In one aspect, there is provided an automated approach to process existing empirical rules or relationships used by the healthcare provides to determine the initial insulin delivery settings.
In one embodiment, the empirical rules or relationships may be integrated into the delivery device configuration program, minimizing potential error in the translation of the settings, parameters, and/or configurations.
Accordingly, in one embodiment, healthcare providers may be provided with an automated tool to extract the relevant information from the patient or the user and to program the appropriate parameters to the delivery device.
In one embodiment, the empirical rules may be generalized and customized for different healthcare providers, (each may use different rules depending on how conservative they are at the initial setup, and the patient type and levels of control). They can apply their own set of rules to their patients. In one aspect, having an automated tool that removes the paper transcription and translation process may reduce errors and improve workflow.
Before the present disclosure is described in additional detail, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present disclosure, the preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the context clearly dictates otherwise.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.
As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present disclosure.
The figures shown herein are not necessarily drawn to scale, with some components and features being exaggerated for clarity.
In one aspect, the therapy delivery device 110 may include one or more user interface components such as a display, input buttons, speakers for providing audible or audio output, and the like. In one aspect, the therapy delivery device is ambulatory and configured to be carried around by the user. In still a further aspect, the therapy delivery device 110 may include a communication component which allows the device 110 to connect to or communicate with one or more of the controller unit 120 and the data processing terminal 130. The communication link between the therapy delivery device 110 and the one or more of the controller unit 120 and the data processing terminal 130 may include RF communication, Infrared communication, 801.x1 based communication protocol, cellular network based communication protocol and the like. In accordance with aspects of the present disclosure, the communication between the various components of the overall system 100 shown in
In one aspect, the therapy delivery device 110 may be configured to deliver medication such as insulin using an infusion set connectable to the housing of the device and in fluid communication with one or more reservoirs housed within the device 110, where the infusion set includes a cannula for medication delivery to the user or patient. In a further aspect, the therapy delivery device 110 is microprocessor driven and controlled by one or more microprocessor units to execute functions related to the medication delivery, operational condition monitoring of the therapy delivery device, and the like.
Referring back to
Optionally, the controller unit 120 may include a strip port for receiving an in vitro blood glucose test strip for determining a blood glucose measurement. Additionally, the controller unit 120 may include the functionalities of an analyte monitoring device which may be configured to be in communication with an analyte sensor for monitoring an analyte level of a user. Further detailed descriptions of embodiments of the continuous analyte monitoring system, embodiments of its various components are provided in U.S. Pat. No. 6,175,752 issued Jan. 16, 2001 entitled “Analyte Monitoring Device and Methods of Use”, and in application Ser. No. 10/745,878 filed Dec. 26, 2003 entitled “Continuous Glucose Monitoring System and Methods of Use”, each assigned to the Assignee of the present application, disclosure of each of which are incorporated by reference for all purposes.
Referring back to
In this manner, in accordance with aspects of the present disclosure, programming or modification of parameters and/or operational conditions for the therapy delivery device 110 may be directly input to the data processing terminal 130 which may include a more user friendly user interface (for example, a larger display, full size keyboard or other input device, as well as software programming which allows for the entry of the appropriate operational parameters or functions associated with the delivery device 120 such as a software configured to be responsive to the user input values or parameters for the operation of the delivery device 110.
Referring back to
For example, in one aspect, the user or the physician may have established or stored in the data processing terminal 130 suitable modification to the therapy profile, one or more new therapy profiles, modified physiological and/or device related notification parameters such as alarms, and/or alerts, prior to the connection with the therapy delivery device, which may then be transferred to the delivery device for storage and/or execution (250).
In the manner described, in accordance with embodiments of the present disclosure, therapy delivery device 110 (
In another aspect, this communication may be bi-directional where the stored data transfer may be implemented in both directions either simultaneously or sequentially, and further, where each device (therapy device and the remote terminal) includes programming to resolve any data, information or parameter conflicts detected. In this manner, once the communication link between the delivery device and the remote terminal is established, each device or one or more devices within the overall system 100 (
Referring back to
In the manner described, in accordance with aspects of the present disclosure, programming of the therapy delivery device 110 (
In addition to the user inputted information, as shown in
In another aspect, each of these steps and the order of the steps may be modified by the physician based on their preferences. For example, the empirical number to generate the carbohydrate to insulin ratio and insulin correction factor may be adjusted based on the level of control of the patient, the knowledge of the patient, and how conservative the physician likes to be getting a new user on the pump.
Also, the physician may add a whole new step to query a particular relevant health state of the patient which may be associated with a more aggressive or more conservative approach to the initial insulin delivery setting. Some relevant parameters or queries may include frequency of hypoglycemic or hyperglycemic events, frequency of exercise and its intensity, and the like. Once configured, the series of steps can be used to improve the workflow of setting up initial settings for additional patients.
Also shown in these Figures are graphical illustrations associated with the programming tool, where the dosage information may by visually presented and using the user interface, such as a computer mouse, the dosing parameters may be modified, for example, by selecting and moving the cursor relative to the graphical display shown in for example,
Indeed, as shown in
In this manner, in accordance with one aspect of the present disclosure, there is provided formulating one or more known or customized empirical rules to determine the relevant patient information for deriving at initial delivery device operational settings, applying the known or customized empirical rules, automatically transferring the initial delivery device configuration settings to a delivery device, where the automatically transferring may include detecting a connection to a therapy delivery device, identifying the connected delivery device, receiving or initiating data download request from the delivery device, retrieving updated data associated with the connected delivery device, reviewing and confirming the changes, and automatically transmitting the retrieved updated data to the delivery device.
One aspect may include formulating one or more of generating new queries, modifying the order of query presentation, or utilizing one or more new empirical values to determine one or more of an insulin sensitivity or a carbohydrate to insulin ratio.
Identifying the connected delivery device may include comparing an identification information received from the delivery device to a prestored information associated with the delivery device.
The retrieved updated data may include programming data for the therapy delivery device.
The programming for the therapy delivery device may include fluid dispensing protocol.
The fluid dispensing protocol may include one or more of a basal delivery profile, or a bolus delivery profile.
The retrieved updated data may include one or more operational parameters associated with the operation of the delivery device.
One aspect may include synchronizing the data from the delivery device with stored data.
Another aspect may include reconciling the data from the delivery device with stored data.
In another embodiment, a method may comprise, establishing communication with a remote terminal, transferring stored data to the remote terminal, acknowledging request to transmit delivery operation information, receiving device operation information, visualizing changes in the device operation information for comparison and confirmation, and executing one or more functions associated with the received device operation information.
One aspect may include automatically implementing the device operation information after disconnecting with the remote terminal or the pump.
Another aspect may include displaying the current parameter residing on the delivery device and the new parameter to be sent to the device and executed on the delivery device.
In another embodiment, an apparatus may comprise, a data communication interface, one or more processors operatively coupled to the data communication interface, and a memory for storing instructions which, when executed by the one or more processors, causes the one or more processors to detect a connection to a therapy delivery device, identify the connected delivery device, receiving data download request from the delivery device, to retrieve updated data associated with the connected delivery device, and automatically transmit the retrieved updated data to the delivery device.
The memory for storing instructions which, when executed by the one or more processors, may cause the one or more processors to compare an identification information received from the delivery device to a prestored information associated with the delivery device.
The retrieved updated data may include programming data for the therapy delivery device.
The memory for storing instructions which, when executed by the one or more processors, may cause the one or more processors to program for the therapy delivery device including fluid dispensing protocol.
The fluid dispensing protocol may include one or more of a basal delivery profile, or a bolus delivery profile.
The retrieved updated data may include one or more operational parameters associated with the operation of the delivery device.
The memory for storing instructions which, when executed by the one or more processors, may cause the one or more processors reconciling the data from the delivery device with stored data.
In another embodiment of the disclosure, one or more storage devices having processor readable code embodied thereon, said processor readable code for programming one or more processors to estimate an analyte level may comprise, detecting a connection to a therapy delivery device, identifying the connected delivery device, receiving data download request from the delivery device, retrieving updated data associated with the connected delivery device, and automatically transmitting the retrieved updated data to the delivery device.
The various processes described above including the processes performed by the delivery device 110, the controller unit 120, and the data processing terminal 130 (
Various other modifications and alterations in the structure and method of operation of this disclosure will be apparent to those skilled in the art without departing from the scope and spirit of the embodiments of the present disclosure. Although the present disclosure has been described in connection with particular embodiments, it should be understood that the present disclosure as claimed should not be unduly limited to such particular embodiments. It is intended that the following claims define the scope of the present disclosure and that structures and methods within the scope of these claims and their equivalents be covered thereby.
