HK1219035B - Medical device and external device coordination systems and methods - Google Patents

Description

Medical device and external device coordination system and method

Technical Field

The present disclosure relates to handheld medical devices, and more particularly to data distribution and revocation systems and methods for coordinating operation of external devices with handheld blood glucose (bG) measurement devices.

Background

People with diabetes have difficulty regulating blood glucose levels in their bodies. As a result, many of these people carry special electronic meters, known as blood glucose meters, which allow them to periodically measure their glucose levels and take appropriate action, such as administering insulin. These persons may also carry with them a portable communication device such as a mobile phone, personal digital assistant, tablet or similar device. People often rely on their portable communication devices as the primary means for planning, scheduling, and communicating with others. As a result, most portable communication devices are equipped with sophisticated software that provides a user-friendly means for viewing and inputting data.

The user interface of a handheld diabetes management device that includes a blood glucose meter may be limited to limiting complications associated with operating the diabetes management device. There is a need to enable a user to simply configure various parameters of a diabetes management device, simply register the diabetes management device, and/or allow the user to more easily understand the analysis of data obtained via the diabetes management device.

The background description provided herein is for the purpose of generally presenting the context of the disclosure. Work of the presently named inventors, to the extent it is described in this background section, as well as aspects of the description that may not otherwise qualify as prior art at the time of filing, are neither expressly nor impliedly admitted as prior art against the present disclosure.

Disclosure of Invention

In a first feature, an automated method for enrolling a medical device via an application residing on a mobile computing device is described. The method comprises the following steps: confirming, by the mobile computing device, a wireless communication link between the medical device and the mobile computing device hosting the application; requesting, by the mobile computing device, identification data of the medical device via the wireless communication link; and receiving, by the mobile computing device, identification data of the medical device via the wireless communication link, the identification data of the medical device being received in response to the request for the identification data. The method further comprises the following steps: presenting, by the mobile computing device, an option to register the medical device on a display of the mobile computing device; receiving, by the mobile computing device, a positive indication to register the medical device; and requesting, by the mobile computing device, input of patient identifiable data for a user of the medical device, the request for input being performed in response to receiving a positive indication of registration. The method further comprises the following steps: receiving, by the mobile computing device, patient identifiable data for a user of the medical device in response to the request for input; associating, by the mobile computing device, patient identifiable data of the user with identification data of the medical device to form registration data of the medical device; and registering, by the mobile computing device, the medical device with a manufacturer of the medical device using the registration data.

In a second feature, a coordination method for setting up a medical device using an application residing on a mobile computing device is described. The method comprises the following steps: establishing, by a mobile computing device, a wireless communication link between a medical device and the mobile computing device hosting an application; requesting, by the mobile computing device, identification data of the medical device via the wireless communication link; receiving, by the mobile computing device, identification data of the medical device via the wireless communication link, the identification data of the medical device being received in response to the request for the identification data; and presenting, by the mobile computing device, on a display of the mobile computing device, a first option to synchronize a first date and time tracked by the medical device with a second date and time tracked by the mobile computing device. The method further comprises the following steps: receiving, by a mobile computing device, a first indication to synchronize a first date and time with a second date and time; transmitting, by the mobile computing device, the second date and time tracked by the mobile computing device to the medical device via the wireless communication link, the sending being performed in response to the first indication to synchronize the first date and time with the second date and time; presenting, by the mobile computing device, a second option on a display of the mobile computing device to configure the medical device to automatically wirelessly transmit medical data; receiving, by the mobile computing device, a second indication to configure the medical device to automatically wirelessly transmit medical data; and transmitting, by the mobile computing device, a request to the medical device to configure the medical device to automatically wirelessly transmit medical data, the transmitting being performed in response to receiving the second indication. The method further comprises the following steps: presenting, by the mobile computing device, a third option on the display to register the medical device with the manufacturer of the medical device; receiving, by the mobile computing device, a third indication to register the medical device; requesting, by the mobile computing device, input of patient identifiable data for a user of the medical device, the request for input being performed in response to receiving the third indication; receiving, by the mobile computing device, patient identifiable data for a user of the medical device in response to the request for input; associating, by the mobile computing device, patient identifiable data of the user with identification data of the medical device to form registration data of the medical device; and registering, by the mobile computing device, the medical device with a manufacturer of the medical device using the registration data.

In a third feature, a mobile computing device executing an application for coordinating operation of the mobile computing device with a handheld diabetes management device is described. The mobile computing device includes: a touch screen display; a processor; and a memory. The memory includes instructions that, when executed, cause the mobile computing device to: establishing a wireless communication link between the handheld diabetes management device and the mobile computing device; receiving identification data of the handheld diabetes management device via the wireless communication link; requesting identification data of the handheld diabetes management device via the wireless communication link; present, on the touch screen display, a first option to synchronize a first date and time tracked by the handheld diabetes management device with a second date and time tracked by the mobile computing device; and transmitting the second date and time to the handheld diabetes management device via the wireless communication link in response to the first indication to synchronize the first date and time with the second date and time. The instructions when executed further cause the mobile computing device to: presenting, on the touch screen display, a second indication to configure the handheld diabetes management device to automatically wirelessly transmit medical data; transmitting a request to configure the handheld diabetes management device to automatically wirelessly transmit the medical data to the handheld diabetes management device in response to a second indication to configure the handheld diabetes management device to automatically wirelessly transmit the medical data; presenting a third option on the touch screen display to register the handheld diabetes management device with a manufacturer of the handheld diabetes management device; presenting, on the touch screen display, a request for entry of patient identifiable data for a user of the handheld diabetes management device in response to a third indication to register the handheld diabetes management device; and transmitting the identification data and the patient identifiable data to the registration server.

In the following, further embodiments are disclosed which can be combined with the methods and devices described herein.

The identification data of the medical device may include at least a model identifier of the medical device and a serial number of the model identifier. Presenting the option to register the medical device may include presenting the option to register the medical device on a touch screen display of the mobile computing device. The method may also include presenting, by the mobile computing device, a second option on the display to configure the medical device to automatically transmit the medical data to the mobile computing device in response to a measurement of the medical data by the medical device. The medical data may include measured blood glucose (bG). The method may also include presenting, by the mobile computing device, at least a portion of the keyboard on the display, the presenting of the at least a portion of the keyboard being performed in response to receiving a positive indication of registration. The method may also include presenting, by the mobile computing device, on the display, a second option to update the first date and time tracked by the medical device to a second date and time tracked by the mobile computing device. The method may also include transmitting, using the mobile computing device, the second date and time and a request to update the first date and time to the second date and time to the medical device, the transmitting being performed in response to receiving a positive indication to update the first date and time. The method may also include transmitting, using the mobile computing device, the enrollment data to a remote data server. The method may also include transmitting the enrollment data to a remote data server using the mobile computing device via the internet.

The method may further include receiving, by the mobile computing device from the medical device, an indication that the medical device set the first date and time to the second date and time; and presenting, by the mobile computing device, a confirmation of the synchronization of the first date and time with the second date and time on the display. The method may also include wirelessly receiving, by the mobile computing device, medical data wirelessly transmitted by the medical device. The patient identifiable data may include at least a name of the user and contact information for the user.

Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the disclosure.

Drawings

The present disclosure will become more fully understood from the detailed description and the accompanying drawings, wherein:

FIG. 1 illustrates a patient and a health care professional along with various devices that may be used to assist the patient in monitoring and controlling health;

FIG. 2 shows a patient with a Continuous Glucose Monitor (CGM), an ambulatory, permanent insulin infusion pump, an ambulatory, non-permanent insulin infusion pump, and a blood glucose (bG) management device;

FIG. 3 illustrates a diabetes care system that may be used in a system for managing diabetes;

FIG. 4 is a high-level diagram of an example implementation of a diabetes management apparatus;

FIG. 5 includes a functional block diagram of an example implementation of the diabetes management apparatus 402;

FIG. 6A is a high-level illustration of an example implementation of a mobile device;

FIG. 6B is a functional block diagram of an example communication system including the mobile device of FIG. 6A and the diabetes management device of FIGS. 4-5;

FIG. 7 is a sequence diagram illustrating example communications that may occur between a mobile device and a diabetes management device to coordinate the operation of a diabetes management application executed by the mobile device with the operation of the diabetes management device; and

fig. 8A and 8B include a flow diagram depicting an example method that may be performed by a mobile device.

Referring now to fig. 1, a diabetic patient 100 and a healthcare professional 102 are shown in a clinical setting. The diabetic patient 100 may be diagnosed with metabolic syndrome, pre-diabetes, type 1 diabetes, type 2 diabetes, gestational diabetes, etc. Health care providers of diabetes are diverse and include nurses, nurse practitioners, physicians, endocrinologists, and the like, and are collectively referred to as health care professionals.

During a healthcare consultation, the patient 100 typically shares a variety of data with the healthcare professional 102, including blood glucose (bG) measurements, continuous glucose monitoring data, the amount and type of insulin administered, the amount of food and beverages consumed, exercise schedules, health status, and other lifestyle information. Additional data for patient 100, such as a measurement of HbA1C, cholesterol level, plasma glucose, triglycerides, blood pressure, and weight, are available to health care professional 102. The data can be recorded manually or electronically on a handheld diabetes management device 104 (e.g., a handheld bG monitor device), diabetes analysis software executing on a Personal Computer (PC) 106, and/or a web-based diabetes analysis site. The healthcare professional 102 can analyze the patient data manually or electronically using analytical diabetes analysis software and/or a web-based diabetes analysis site. After analyzing the data and reviewing how effective the previously prescribed therapy is and how well the patient 100 follows the previously prescribed therapy, the health care professional 102 can decide whether to modify the prescribed therapy for the patient 100.

Referring now to fig. 2, the patient 100 may use a Continuous Glucose Monitor (CGM) 200, an ambulatory, permanent insulin infusion pump 204 or an ambulatory, non-permanent insulin infusion pump 202 (collectively, insulin pump 204) and the diabetes management device 104. The CGM 200 may use a subcutaneous sensor to sense and monitor the amount of glucose (e.g., glucose concentration) of the patient 100. The CGM 200 communicates the glucose measurement to the diabetes management device 104.

The diabetes management device 104 performs various tasks including measuring and recording bG measurements, determining the amount of insulin administered to the patient 100 via the insulin pump 204, receiving user input via a user interface, archiving data, performing structured bG tests, and the like. The diabetes management device 104 can transmit instructions to the insulin pump 204, and the insulin pump 204 selectively dispenses insulin to the patient 100. Insulin may be delivered in the form of meal bolus doses, correction bolus doses, basal doses, and the like.

Referring now to FIG. 3, a diabetes management system 300 is shown that may be used by the patient 100 and/or the healthcare professional 102. The system 300 may include one or more of the following: a diabetes management device 104, a CGM 200, an insulin pump 204, a mobile device 302, diabetes management software executing on a computer 106, and one or more other healthcare devices 304.

The diabetes management device 104 can be configured as a system "hub" and communicate with one or more of the other devices of the system 300. The insulin pump 204, the mobile device 302, or other suitable device may alternatively function as a system hub. Communication between the various devices in system 300 may be performed using a wireless interface (e.g., bluetooth) and/or a wired interface (e.g., USB). The communication protocols used by these devices may include protocols compliant with the IEEE 11073 standard as extended using the guidelines provided by the health and wellness alliance (Continua health) design guidelines. In addition, Health care recording systems such as Microsoft Health Vallt and Google Health ™ systems can be used by the patient 100 and the Health care professional 102 to exchange information.

Referring now to FIG. 4, a high-level diagram of an example embodiment of a (handheld) diabetes management device 402 is presented. The diabetes management device 402 includes, among other things, a housing 404, a display 408, a bG test strip port 420, and a bG test strip roller (not shown). The bG test strip roll can house a plurality of bG test strips, such as the bG test strip 416. The diabetes management device 402 also includes user interface switches/buttons, such as an up button 424, a down button 428, a back button 432, and an enter button 436. The user interface switches/buttons may also include other buttons or switches, such as an on/off switch and/or one or more other switches/buttons or other types of control devices that the patient may use to control the functions/operations of the diabetes management device 104.

The bG test strip 416 may be inserted into the bG test strip port 420 by a user. The bG test chip 416 is shown as having been inserted into the bG test chip port 420 in the example of FIG. 4 and not having been inserted into the bG test chip port 420 in the example of FIG. 5. In various implementations, the display 408 of the diabetes management device 402 may be a non-touch screen display. Various information may be selectively displayed on the display 408. For example, when a bG measurement is taken in response to insertion of a bG test strip, the bG measurement can be displayed on the display 408.

The above description is a broad description of the diabetes management device 402. Indeed, the diabetes management device 402 may include additional controls, input ports, output ports, etc., as may be desired to further enhance its utility or its use with other components and devices (e.g., computers, infusion pumps, cell phones, etc.). The description of the diabetes management device 402 should not be construed as limiting with respect to the structure of the diabetes management device 402 or with respect to the features and capabilities of the diabetes management device 402.

Referring now to FIG. 5, a functional block diagram of an example implementation of the diabetes management apparatus 402 is presented. The diabetes management device 402 can include a processor module (e.g., a microprocessor-based subsystem) 504 that can receive information from the bG management engine 508. The bG management engine 508 can be disposed adjacent to the bG test slice port 420.

The bG measurement engine 508 reads (measures) the bG levels of the bG test slices 416 inserted into the bG test slice port 420. The processor module 504 can power up other components of the diabetes management device 402, such as the display 408 and/or one or more other components, in response to the action of an insert or on/off button or switch of a bG test strip into the bG test strip port 420.

The bG measurement engine 508 generates bG sample data 516 based on its readings for the bG test slice 416. The bG sample data 516 includes, among other things, data indicative of the bG level of the bodily fluid sample on the bG test strip 416. The processor module 504 can also receive bG sample data from other sources, such as via the CGM 200 and/or another suitable source. The processor module 504 may receive user input via one or more user input/output (I/O) devices 514, such as buttons 424-436.

The bG measurement engine 508 may also generate bG sample data 516 to indicate the date and time when the bG test slice 416 was read. In other words, the bG measurement engine 508 can include a timestamp with the bG sample data 516. In various implementations, the processor module 504 can selectively time stamp the bG sample data 516 and can time stamp the user input data and other data (as it is received). The clock 518 may provide a date and time. Setting the date and time of the clock 518 is discussed further below, and the clock 518 may thereafter track the current date and time.

The bG measurement engine 508 can also stamp the bG sample data 516 with a sample identifier selected in a predetermined sequence. Based on the sample identifiers of the sample data received from the diabetes management device 402 and the predetermined sequence, the external device may determine whether it receives all of the sample data stored by the diabetes management device 402. If less than all of the sample data has been received from the diabetes management device 402, the external device may identify which sample data it has not received and obtain (e.g., only) that sample data from the diabetes management device 402. An example of such a system and method can be found in commonly assigned U.S. patent application No. 13/195,884 filed on 8/2/2011, which is incorporated herein in its entirety.

The diabetes management device 104 includes a data register 532. For example only, the data store 532 may include memory and/or one or more other suitable tangible computer-readable media. Various data, such as device data 540, may be stored in the data temporary storage 532. The device data 540 may include, for example, product type data, product version data, region data, software certificates, unique device identifiers, device/user certificates, and other suitable device-specific data. The product type data may include, for example, diabetes management devices, insulin pumps, CGM, etc. The product version data may indicate, for example, a version (or generation), a model name/number, etc. of the diabetes management device 402. The software certificate may include, for example, a version or identifier of the software executed by the diabetes management device 402. The unique device identifier may include data unique to the diabetes management device 402, such as a serial number and/or another suitable unique identifier.

bG sample data 544 and other types of data can also be stored in the data scratchpad 532. The bG sample data 544 may include bG sample data generated by the bG measurement engine 508, such as the bG sample data 516. The bG sample data 544 can also include other types of data related to bG samples.

One or more I/O interfaces, such as I/O interface 524, facilitate communication between the user I/O device 514 and the processor module 504. The I/O interface(s) may also facilitate communication between the processor module 504 and one or more communication modules, such as communication module 548. The communication module 548 may include a wireless transceiver and communicate (transmit and receive) wirelessly via one or more antennas.

Fig. 6A is a high-level illustration of an example embodiment of a mobile device 604. FIG. 6B is a functional block diagram of a communication system including the mobile device 604 and the diabetes management device 402. Referring now to fig. 6A and 6B, the mobile device 604 may be any type of mobile/portable computing device, such as a mobile phone (as shown), a tablet computer, a laptop computer, a portable media player, and so forth.

The mobile device 604 includes a display 608. The display 608 may be a touch display as shown and will be referred to as a touch display. Touch display 608 may include any touch sensitive display device, such as a capacitive sensing display. The mobile device 604 may additionally or alternatively include a physical character layout, such as a QWERTY based keyboard (not shown) in part.

Touch display 608 may display information to user 612 and receive input from user 612. For example only, a physical character layout may be displayed as a "soft keyboard" on a portion of the touch display 608 as desired, and the user 612 may input information to the mobile device 604 via the touch display 608 using one or more fingers. User 612 may additionally or alternatively input information to mobile device 604 via touch display 608 using a stylus, mouse, trackball, or the like. User 612 may additionally or alternatively interface with mobile device 604 via one or more user input devices, such as user input device 616.

Mobile device 604 may include or be connected to one or more audio output devices (not shown), such as one or more speakers. Mobile device 604 may include one or more audio input devices (also not shown), such as one or more microphones. Mobile device 604 may audibly communicate the information to user 612 via the audio output device(s). For example, the mobile device 604 may audibly communicate the level of the bG measurement, a prompt, etc. to the user 612. The mobile device 604 may receive input from the user 612 via the audio input device(s).

The mobile device 604 may also include a user interface module 620, a processor module 624, and a communication module 628. It should be appreciated that the mobile device 604 may include additional computing components, such as a data store and a power source, and that the functions of the user interface module 620 and the communication module 628 may be performed in whole or in part by the processor module 624. Thus, the terms user interface module 620, processor module 624, and communication module 628 as used herein may include one or more processors that execute instructions to perform the described functions.

The user interface module 620 may control communication with the user 612 via the touch display 608. User interface module 620 may provide user 612 with a variety of different display configurations via touch display 608. For example, the user interface module 620 may selectively provide the user 612 with a partial or full standard QWERTY keyboard via the touch display 608. Different portions or functions of a standard QWERTY keyboard may also be selectively displayed via the touch display 608.

The processor module 624 controls most of the operation of the mobile device 604 and may communicate with the user interface module 620 and the communication module 628. For example, processor module 624 may perform tasks such as, but not limited to, loading/controlling an operating system of mobile device 604, loading/executing programs and functions, loading/configuring communication parameters of communication module 628, and controlling data storage/retrieval operations. Although processor module 624 is shown, processor module 624 may include multiple individual processors operating in a parallel or distributed configuration, which may be utilized instead of a single processor. Accordingly, the term processor as used herein may refer to one or more processors that operate to perform the described functions.

The communication module 628 controls communication between the mobile device 604 and other devices and systems. The communication module 628 may be configured to communicate using both wired communication protocols (e.g., universal serial bus) and wireless communication protocols (e.g., i.e.e.e.802. XX, cellular, etc.). The communication module 628 communicates wirelessly via one or more antennas. The communication module 628 may, for example, communicate with a computing network 632, such as the internet (hereinafter "network 632"), a mobile telephone (cellular) network 636, a satellite network 640, and/or other types of communication devices or systems.

The communication module 628 may also communicate wirelessly with the diabetes management device 402. The communication module 628 and the diabetes management device 402 may communicate wirelessly using any wireless communication protocol, such as bluetooth, bluetooth low energy, Radio Frequency (RF), Near Field Communication (NFC), and the like.

The mobile device 604 may execute the diabetes management application in response to a user input to the mobile device 604. The diabetes management application is embodied as code residing in a computer readable medium for execution by one or more processors of the mobile device 604. The diabetes management application is designed for use by a diabetes management device, such as the diabetes management device 402. By way of the diabetes management application, the user 612 may synchronize the date and time of the diabetes management device 402 with the date and time of the mobile device 604, enable automatic synchronization of the date and time of the diabetes management device 402 with the date and time of the mobile device 604, enable automatic transfer of bG sample data stored by the diabetes management device 402 to the mobile device 604, register the diabetes management device 402, review and analyze the received bG sample data, and obtain other relevant information regarding diabetes management.

FIG. 7 is a sequence diagram illustrating communications that may occur between the mobile device 604 and the diabetes management device 402 to coordinate the operation of the diabetes management application with the operation of the diabetes management device 402. Fig. 8A and 8B include a flow diagram depicting an example method that may be performed by the mobile device 604 when executing a diabetes management application. The sequence diagram of fig. 7 will be explained in conjunction with fig. 8A and 8B.

Referring now to fig. 8A and 8B, control may begin, for example, when the diabetes management device 402 is powered on and the mobile device 604 is executing a diabetes management application. The processor module 504 can power up the diabetes management device 402, such as when a user actuates an on/off button/switch of the diabetes management device 402 or when a bG slice is inserted into the bG test slice port 420.

At 704, the mobile device 604 may establish a wireless data connection (or link) with the diabetes management device 402. The mobile device 604 may determine at 708 using the diabetes management application whether this is a first example of use of the diabetes management device 402. If 708 is true, control continues with 712. If 708 is false, the configuration of the diabetes management device 402 may end.

The mobile device 604 wirelessly transmits a request for device data to the diabetes management device 402 at 712. The device data of the diabetes management device 402 can include, for example, data indicating the model of the diabetes management device 402, the serial number of the diabetes management device 402, and other suitable data indicating characteristics of the diabetes management device 402.

At 716, the mobile device 604 may determine whether device data has been received from the diabetes management device 402. If 716 is true, control continues with 720. If 716 is false, control may stay at 716. If the device data is not received within a predetermined period of time after the request for device data is transmitted, the mobile device 604 may retransmit the request for device data, time out, or take one or more other appropriate actions.

At 720, the mobile device 604 displays its current date and time on the touch display 608 along with a question to the user 612 directed to whether to update the date and time tracked by the clock 518 to the date and time tracked by the mobile device 604. The user 612 may select to update the date and time tracked by the clock 518 or to decline to update the date and time tracked by the clock 518 by touching a predetermined area on the display 608 or providing other suitable user input.

The diabetes management device 402 can also display a question on the display 408 of the diabetes management device 402 whether to update the date and time tracked by the clock 518 to the date and time tracked by the mobile device 604. The user 612 may select to update the date and time tracked by the clock 518 or decline to update the date and time tracked by the clock 518 via the diabetes management device 402. If the user 614 enters his or her selection via the diabetes management device 402, the diabetes management device 402 wirelessly transmits an indicator of the selection to the mobile device 604.

At 724, the mobile device 604 determines whether the user 612 has entered his or her selection as to whether to update the clock 518 of the diabetes management device 402. If not, control may return to 720 to continue displaying the problem. If the user does not enter his or her selection within a predetermined period of time, mobile device 604 may time out and end or take one or more other appropriate actions. If the user 612 has instructed to update the clock 518 of the diabetes management device 402 to the date and time tracked by the mobile device 604, then control continues with 728. If the user 612 has declined to update the clock 518 of the diabetes management device 402 to the date and time tracked by the mobile device 604, control may transfer to 740 (discussed further below) or the configuration of the diabetes management device 402 may end.

At 728, the mobile device 604 wirelessly transmits a request to update the date and time tracked by the clock 518 and data indicative of the date and time tracked by the mobile device 604 to the diabetes management device 402. The diabetes management device 402 updates the current date and time tracked by the clock 518 to the date and time tracked by the mobile device 604 in response to receiving the request and the data indicative of the date and time tracked by the mobile device 604. The clock 518 thereafter continues to update the current date and time as time elapses. In an implementation, the update may be performed once or each time the diabetes management device 402 and the mobile device 604 establish a data connection in response to the user 612 indicating to update the clock 518 of the diabetes management device 402 with a date and time tracked by the mobile device 604.

At 732, the mobile device 604 determines whether a confirmation regarding the update of the date and time of the diabetes management device 402 has been received from the diabetes management device 402. If 732 is false, control may stay at 732. If an acknowledgement is not received within a predetermined period of time, the mobile device 604 may time out and end or take one or more other appropriate actions. If 732 is true, the mobile device 604 may display an indication that the date and time of the diabetes management device 402 has been successfully updated on the touch display 608 at 736, and control may continue with 740.

The mobile device 604 displays a question on the touch display 608 at 740 that is being directed to whether to configure the diabetes management device 402 to automatically wirelessly transmit bG sample data to the mobile device 604 whenever a bG measurement is obtained. The user 612 may select whether to configure the diabetes management device 402 to automatically wirelessly transmit (push) bG sample data to the mobile device 604 via a predetermined area on the touch display 608 or providing other suitable user input.

The diabetes management device 402 may also display questions to the user 612 on the display 408. The user 612 may select whether to configure the diabetes management device 402 to automatically wirelessly transmit bG sample data to the mobile device 604 via the diabetes management device 402. If the user 614 inputs his or her selection via the diabetes management device 402, the diabetes management device 402 wirelessly transmits an indicator of the selection to the mobile device 604.

At 744, the mobile device 604 determines whether the user 612 has entered his or her selection as to whether to configure the diabetes management device 402 to automatically wirelessly transmit bG sample data to the mobile device 604. If not, control may return to 740 to keep the question displayed. If user 612 does not enter his or her selection within a predetermined period of time, mobile device 604 may time out and end or take one or more other appropriate actions. If the user 612 has declined to configure the diabetes management device 402 to automatically wirelessly transmit bG sample data to the mobile device 604, control may transfer to 760 (FIG. 8B, discussed further below) or the configuration of the diabetes management device 402 may end. If the user 612 has instructed to configure the diabetes management device 402 to automatically wirelessly transmit bG sample data to the mobile device 604, control continues with 748.

The mobile device 604 wirelessly transmits a request to the diabetes management device 402 at 748 that will configure the diabetes management device 402 to automatically transmit the bG sample data to the mobile device 604. The diabetes management device 402 can alter the predetermined memory location, for example, in response to the request. Based on the request, when the bG management is later obtained, the diabetes management device 402 will automatically attempt to wirelessly transmit bG sample data indicative of the bG management to the mobile device 604.

At 752, the mobile device 604 determines whether a confirmation of an automatically transmitted update of the bG sample data features of the diabetes management device 402 has been received from the diabetes management device 402. If 752 is false, control may stay at 752. If an acknowledgement has not been received within a predetermined period of time, the mobile device 604 may time out and end or take one or more other appropriate actions. If 752 is true, the mobile device 604 may display an indication on the touch display 608 at 756 that the diabetes management device 402 has successfully configured to automatically transfer bG sample data to the mobile device 604, and control may continue at 760.

At 760 (FIG. 8B), the mobile device 604 displays a question on the touch display 608 that is directed to whether to register the diabetes management device 402 with the manufacturer of the diabetes management device 402. The user 612 may select whether to register the diabetes management device 402 via touching a predetermined area on the display 608 or providing other suitable user input.

The diabetes management device 402 may also display a question to the user 612 (whether to register the diabetes management device 402 with the manufacturer) on the display 408 of the diabetes management device 402. The user 612 may select whether to register the diabetes management device 402 via the diabetes management device 402. If the user 612 inputs his or her selection via the diabetes management device 402, the diabetes management device 402 wirelessly transmits an indicator of the selection to the mobile device 604.

At 764, the mobile device 604 determines whether the user 612 has entered his or her selection as to whether to register the diabetes management device 402 with the manufacturer. If not, control may return to 760 to keep the question displayed. If user 612 does not enter his or her selection within a predetermined period of time, mobile device 604 may time out and end or take one or more other appropriate actions. If the user 612 has declined to register the diabetes management device 402, the configuration of the diabetes management device 402 may end. If the user 612 has instructed to register the diabetes management device 402 with the manufacturer, then control continues with 768.

The mobile device 604 displays 768 a check-in User Interface (UI) on the touch screen display 608. The registration UI may include a number of fields in which the user 612 may enter patient identifiable data for the user 612, such as first name, last name, middle initial or first name, date of birth, street address, city, state, zip code, contact phone number, and/or other patient identifiable data for the user 612. The mobile device 604 receives 722 patient identifiable data entered by the user 612. The mobile phone 604 may also optionally display a physical character layout on the touch display 608 to facilitate registration of patient identifiable data.

At 780, the mobile device 604 generates registration data based on the device data of the diabetes management device 402 and the patient identifiable data of the user 612. For example, the mobile device 604 associates device data with patient identifiable data. The mobile device 604 transmits 784 the registration data (including device data and patient identifiable data) to the manufacturer's registration server 800 via the internet. Control may then end.

Due to the limited UI and display of the diabetes management device 402, the ability to enter patient identifiable data using the mobile device 604 may ease the entry of patient identifiable data relative to using the diabetes management device 402. Registration of the diabetes management device 402 may thus be made relatively easy using the mobile device 604. Even if the patient identifiable data is successfully entered into the diabetes management device 402, the diabetes management device 402 may still be unable to register the diabetes management device 402 with the manufacturer due to the inability of the diabetes management device 402 to communicate with the registration server 800.

Once the diabetes management device 402 has been registered with the manufacturer, the manufacturer may contact the user 612, the diabetes management device 402 may be updated, etc., as required by one or more regulatory agencies, such as the U.S. Food and Drug Administration (FDA). For example, the device data transmitted during enrollment may be used to identify the version of code executed by the diabetes management device 402. If the updated version of the code is released, user 612 may be contacted. The user 612 may update the code executed by the diabetes management device 402, such as by downloading new code via the mobile device 604 and transferring the new code from the mobile device 604 to the diabetes management device 402. An example of such a system and method can be found in commonly assigned U.S. patent application No. 13/195,893, filed on 8/2/2011, which is incorporated herein in its entirety.

Moreover, the ability to correctly update the date and time of the diabetes management device 402 and configure the diabetes management device 402 to automatically transmit bG sample data may be relatively easy using the mobile device 604. Due to the greater processing power of the mobile device 604, the more extended UI of the mobile device 604, and the increased connectivity of the mobile device 604, bG sample data received by the mobile device 604 from the diabetes management device 402 may also be more fully analyzed by the user 612 via the mobile device 604.

The above provides an easy way to set the operation of the diabetes management device 402 using a diabetes management application executing on the mobile device 604, accurately set the date and time of the diabetes management device 402, and register the diabetes management device 402 with the manufacturer. Once the setup is complete, the bG measurements taken by the diabetes management device 402 can be automatically transmitted to the mobile device 604. However, the diabetes management device 402 may still perform bG measurements during setup if a bG test strip is inserted into the bG test strip port 420. With the mobile device 604, the user 612 can more fully analyze their bG data and use the bG data to make decisions regarding the management of diabetes.

Further, once the diabetes management device 402 is registered, consumable products may be sent to the user 612 as needed. For example, the manufacturer may selectively send or distribute the replacement battery of the diabetes management device 402 to the user 612 at the address provided by the user. Additionally or alternatively, the manufacturer can selectively send or have dispensed additional bG test strips to the user 612 for use by the diabetes management device 402.

In a first feature, an automated method for enrolling a medical device via an application residing on a mobile computing device is described. The method comprises the following steps: confirming, by the mobile computing device, a wireless communication link between the medical device and the mobile computing device hosting the application; requesting, by the mobile computing device, identification data of the medical device via the wireless communication link; and receiving, by the mobile computing device, identification data of the medical device via the wireless communication link, the identification data of the medical device being received in response to the request for the identification data. The method further comprises the following steps: presenting, by the mobile computing device, an option to register the medical device on a display of the mobile computing device; receiving, by the mobile computing device, a positive indication to register the medical device; and requesting, by the mobile computing device, input of patient identifiable data for a user of the medical device, the request for input being performed in response to receiving a positive indication of registration. The method further comprises the following steps: receiving, by the mobile computing device, patient identifiable data for a user of the medical device in response to the request for input; associating, by the mobile computing device, patient identifiable data of the user with identification data of the medical device to form registration data of the medical device; and registering, by the mobile computing device, the medical device with a manufacturer of the medical device using the registration data.

In still further features, the identification data of the medical device includes at least a model identifier of the medical device and a serial number of the model identifier.

In still further features, presenting the option to register the medical device comprises presenting the option to register the medical device on a touch screen display of the mobile computing device.

In still further features, the method further comprises presenting, by the mobile computing device, a second option on the display to configure the medical device to automatically transmit the medical data to the mobile computing device in response to a measurement of the medical data by the medical device.

In further features, the medical data includes measured blood glucose (bG).

In still further features, the method further comprises presenting, by the mobile computing device, at least a portion of the keyboard on the display, the presenting of the at least a portion of the keyboard being performed in response to receiving a positive indication of the registration.

In still further features, the method further comprises presenting, by the mobile computing device, on the display, a second option to update the first date and time tracked by the medical device to a second date and time tracked by the mobile computing device.

In still further features, the method further comprises transmitting, using the mobile computing device, the second date and time and a request to update the first date and time to the second date and time to the medical device, the transmitting being performed in response to receiving a positive indication to update the first date and time.

In still further features, the method further comprises transmitting, using the mobile computing device, the enrollment data to a remote data server.

In still further features, the method further comprises transmitting the enrollment data to a remote data server using the mobile computing device via the internet.

In a second feature, a coordination method for setting up a medical device using an application residing on a mobile computing device is described. The method comprises the following steps: establishing, by a mobile computing device, a wireless communication link between a medical device and the mobile computing device hosting an application; requesting, by the mobile computing device, identification data of the medical device via the wireless communication link; receiving, by the mobile computing device, identification data of the medical device via the wireless communication link, the identification data of the medical device being received in response to the request for the identification data; and presenting, by the mobile computing device, on a display of the mobile computing device, a first option to synchronize a first date and time tracked by the medical device with a second date and time tracked by the mobile computing device. The method further comprises the following steps: receiving, by a mobile computing device, a first indication to synchronize a first date and time with a second date and time; transmitting, by the mobile computing device, the second date and time tracked by the mobile computing device to the medical device via the wireless communication link, the sending being performed in response to the first indication to synchronize the first date and time with the second date and time; presenting, by the mobile computing device, a second option on a display of the mobile computing device to configure the medical device to automatically wirelessly transmit medical data; receiving, by the mobile computing device, a second indication to configure the medical device to automatically wirelessly transmit medical data; and transmitting, by the mobile computing device, a request to the medical device to configure the medical device to automatically wirelessly transmit medical data, the transmitting being performed in response to receiving the second indication. The method further comprises the following steps: presenting, by the mobile computing device, a third option on the display to register the medical device with the manufacturer of the medical device; receiving, by the mobile computing device, a third indication to register the medical device; requesting, by the mobile computing device, input of patient identifiable data for a user of the medical device, the request for input being performed in response to receiving the third indication; receiving, by the mobile computing device, patient identifiable data for a user of the medical device in response to the request for input; associating, by the mobile computing device, patient identifiable data of the user with identification data of the medical device to form registration data of the medical device; and registering, by the mobile computing device, the medical device with a manufacturer of the medical device using the registration data.

In still further features, the method further comprises transmitting, using the mobile computing device, the enrollment data to a remote data server.

In still further features, the identification data of the medical device includes at least a model identifier of the medical device and a serial number of the model identifier.

In still further features, presenting the third option to register the medical device includes presenting an option to register the medical device on a touch screen display of the mobile computing device.

In further features, the medical data includes measured blood glucose (bG).

In still further features, the method further comprises presenting, by the mobile computing device, at least a portion of the keyboard on the display, the presenting of the at least a portion of the keyboard being performed in response to receiving the third indication.

In still further features, the method further comprises receiving, by the mobile computing device from the medical device, an indication that the medical device set the first date and time to the second date and time, and presenting, by the mobile computing device on the display, a confirmation of synchronization of the first date and time with the second date and time.

In still further features, the method further comprises wirelessly receiving, by the mobile computing device, the medical data wirelessly transmitted by the medical device.

In still further features, the patient identifiable data includes at least a name of the user and contact information of the user.

In a third feature, a mobile computing device executing an application for coordinating operation of the mobile computing device with a handheld diabetes management device is described. The mobile computing device includes: a touch screen display; a processor; and a memory. The memory includes instructions that, when executed, cause the mobile computing device to: establishing a wireless communication link between the handheld diabetes management device and the mobile computing device; receiving identification data of the handheld diabetes management device via the wireless communication link; requesting identification data of the handheld diabetes management device via the wireless communication link; present, on the touch screen display, a first option to synchronize a first date and time tracked by the handheld diabetes management device with a second date and time tracked by the mobile computing device; and transmitting the second date and time to the handheld diabetes management device via the wireless communication link in response to the first indication to synchronize the first date and time with the second date and time. The instructions when executed further cause the mobile computing device to: presenting, on the touch screen display, a second option to configure the handheld diabetes management device to automatically wirelessly transmit medical data; transmitting a request to configure the handheld diabetes management device to automatically wirelessly transmit the medical data to the handheld diabetes management device in response to a second indication to configure the handheld diabetes management device to automatically wirelessly transmit the medical data; presenting a third option on the touch screen display to register the handheld diabetes management device with a manufacturer of the handheld diabetes management device; presenting, on the touch screen display, a request for entry of patient identifiable data for a user of the handheld diabetes management device in response to a third indication to register the handheld diabetes management device; and transmitting the identification data and the patient identifiable data to the registration server.

The foregoing description is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. The broad teachings of the disclosure can be implemented in a variety of forms. Therefore, while this disclosure includes particular examples, the true scope of the disclosure should not be so limited since other modifications will become apparent upon a study of the drawings, the specification, and the following claims. As used herein, at least one of the phrases A, B and C should be construed to mean logic (a or B or C) that uses a non-exclusive logical or. It should be understood that one or more steps within a method may be performed in a different order (or simultaneously) without altering the principles of the present disclosure.

In this application (including the definitions below), the term module may be replaced with the term circuit. The term module may refer to or include the following or a portion of the following: an Application Specific Integrated Circuit (ASIC); digital, analog, or hybrid analog/digital discrete circuits; digital, analog, or hybrid analog/digital integrated circuits; a combinational logic circuit; a Field Programmable Gate Array (FPGA); a processor (shared, dedicated, or group) that executes code; a memory (shared, dedicated, or group) that stores code executed by the processor; other suitable hardware components that provide the desired functionality; or a combination of some or all of the above, for example in a system on a chip.

The term code, as used above, may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, and/or objects. The term shared processor includes a single processor that executes some or all code from multiple modules. The term group processor includes processors that execute some or all code from one or more modules in combination with additional processors. The term shared memory includes a single memory that stores some or all code from multiple modules. The term group memory includes memory combined with additional memory to store some or all code from one or more modules. The term memory may be a subset of the term computer readable medium. The term computer-readable medium does not include transitory electrical and electromagnetic signals propagating through a medium, and thus may be considered tangible and non-transitory. Non-limiting examples of the non-transitory tangible computer readable medium include nonvolatile memory, volatile memory, magnetic storage, and optical storage.

The apparatus and methods described in this application may be implemented in part or in whole by one or more computer programs executed by one or more processors. The computer program includes processor-executable instructions stored on at least one non-transitory tangible computer-readable medium. The computer program may also include and/or rely on stored data.

Claims (20)

1. An automated method for enrolling medical devices via applications residing on a mobile computing device, comprising:

-confirming, by the mobile computing device, a wireless communication link between the medical device and the mobile computing device hosting the application;

-requesting, by the mobile computing device, identification data of the medical device via a wireless communication link;

-receiving, by the mobile computing device, identification data of the medical device via the wireless communication link, the identification data of the medical device being received in response to a request for the identification data;

-presenting, by the mobile computing device, an option to register the medical device on a display of the mobile computing device;

-receiving, by the mobile computing device, a positive indication to register the medical device;

-requesting, by the mobile computing device, input of patient identifiable data for a user of the medical device, the request for input being performed in response to receiving the positive indication of registration;

-receiving, by the mobile computing device, patient identifiable data for the user of the medical device in response to the request for input;

-associating, by the mobile computing device, the patient identifiable data of the user with the identification data of the medical device to form registration data of the medical device; and

-registering, by the mobile computing device, the medical device with a manufacturer of the medical device using the registration data.

2. The method of claim 1, wherein the identification data of the medical device includes at least a model identifier of the medical device and a serial number of the model identifier.

3. The method of claim 1 or 2, wherein presenting the option to register the medical device comprises presenting the option to register the medical device on a touch screen display of the mobile computing device.

4. The method of claim 1 or 2, further comprising presenting, by a mobile computing device, on the display, a second option to configure the medical device to automatically transmit medical data to the mobile computing device in response to a measurement of the medical data by the medical device.

5. The method of claim 4, wherein the medical data comprises measured blood glucose.

6. The method of claim 1 or 2, further comprising presenting, by the mobile computing device, at least a partial keyboard on the display, the presenting of the at least partial keyboard being performed in response to receiving the positive indication of registration.

7. The method of claim 1 or 2, further comprising presenting, by the mobile computing device, on the display, a second option to update a first date and time tracked by the medical device to a second date and time tracked by the mobile computing device.

8. The method of claim 7, further comprising transmitting, using the mobile computing device, the second date and time and a request to update the first date and time to the second date and time to the medical device, the transmitting performed in response to receiving a positive indication to update the first date and time.

9. The method of claim 1 or 2, further comprising transmitting, using the mobile computing device, the enrollment data to a remote data server.

10. The method of claim 9, further comprising transmitting the enrollment data to the remote data server using the mobile computing device via the internet.

11. A coordinated method of setting up a medical device using an application residing on a mobile computing device, comprising:

-establishing, by the mobile computing device, a wireless communication link between the medical device and the mobile computing device hosting the application;

-requesting, by the mobile computing device, identification data of the medical device via the wireless communication link;

-receiving, by the mobile computing device, identification data of the medical device via the wireless communication link, the identification data of the medical device being received in response to a request for the identification data;

-presenting, by the mobile computing device, on a display of the mobile computing device, a first option to synchronize a first date and time tracked by the medical device with a second date and time tracked by the mobile computing device;

-receiving, by the mobile computing device, a first indication to synchronize the first date and time with the second date and time;

-transmitting, by the mobile computing device, the second date and time tracked by the mobile computing device to the medical device via the wireless communication link, the transmitting being performed in response to the first indication synchronizing the first date and time with the second date and time;

-presenting, by the mobile computing device, a second option on the display of the mobile computing device to configure the medical device to automatically wirelessly transmit medical data;

-receiving, by the mobile computing device, a second indication to configure the medical device to automatically wirelessly transmit medical data;

-transmitting, by the mobile computing device, a request to the medical device to configure the medical device to automatically wirelessly transmit medical data, the transmitting being performed in response to receiving the second indication;

-presenting, by the mobile computing device, a third option on the display to register the medical device with the manufacturer of the medical device;

-receiving, by the mobile computing device, a third indication to register the medical device;

-requesting, by the mobile computing device, input of patient identifiable data for a user of the medical device, the request for input being performed in response to receiving the third indication;

-receiving, by the mobile computing device, the patient identifiable data for the user of the medical device in response to the request for input;

-associating, by the mobile computing device, the patient identifiable data of the user with the identification data of the medical device to form registration data of the medical device; and

-registering, by the mobile computing device, the medical device with the manufacturer of the medical device using the registration data.

12. The method of claim 11, further comprising transmitting, using the mobile computing device, the enrollment data to a remote data server.

13. The method of claim 11 or 12, wherein the identification data of the medical device includes at least a model identifier of the medical device and a serial number of the model identifier.

14. The method of claim 11 or 12, wherein presenting the third option to register the medical device comprises presenting an option to register the medical device on a touch screen display of the mobile computing device.

15. The method of claim 11 or 12, wherein the medical data comprises measured blood glucose.

16. The method of claim 11 or 12, further comprising presenting, by the mobile computing device, at least a partial keyboard on the display, the presenting of the at least partial keyboard being performed in response to receiving the third indication.

17. The method of claim 11 or 12, further comprising:

receiving, by the mobile computing device from the medical device, an indication that the medical device set the first date and time to the second date and time; and

presenting, by the mobile computing device, a confirmation of synchronization of the first date and time and the second date and time on the display.

18. The method of claim 11 or 12, further comprising wirelessly receiving, by the mobile computing device, the medical data wirelessly transmitted by the medical device.

19. The method of claim 11 or 12, wherein the patient identifiable data includes at least a name of the user and contact information of the user.

20. A mobile computing device executing an application for coordinating operation of the mobile computing device with a handheld diabetes management device, the mobile computing device comprising:

-a touch screen display;

-a processor; and

-a memory comprising instructions that, when executed, cause the mobile computing device to:

-establishing a wireless communication link between the handheld diabetes management device and the mobile computing device;

-request identification data of the handheld diabetes management device via the wireless communication link;

-receive identification data of the handheld diabetes management device via the wireless communication link;

-present a first option on the touch screen display to synchronize a first date and time tracked by the handheld diabetes management device with a second date and time tracked by the mobile computing device;

-transmit the second date and time to the handheld diabetes management device via the wireless communication link in response to a first indication to synchronize the first date and time with the second date and time;

-presenting a second option on the touch screen display to configure the handheld diabetes management device to automatically wirelessly transmit medical data;

-transmit a request to the handheld diabetes management device to configure the handheld diabetes management device to automatically wirelessly transmit medical data in response to a second indication to configure the handheld diabetes management device to automatically wirelessly transmit medical data;

-presenting a third option on the touch screen display to register the handheld diabetes management device with the manufacturer of the handheld diabetes management device;

-in response to registering the third indication of the handheld diabetes management device, presenting on the touch screen display a request for entry of patient identifiable data for a user of the handheld diabetes management device; and

-transmitting the identification data and the patient identifiable data to a registration server.