Patent Application
20140379358
This application relates generally to the field of electronic systems and computer-implemented methods that store medical records of a user, and more specifically to systems and methods for recommending insertion sites for medical devices.
Diabetes mellitus is a chronic metabolic disorder caused by an inability of the pancreas to produce sufficient amounts of the hormone insulin, resulting in the decreased ability of the body to metabolize glucose. This failure leads to hyperglycemia, i.e. the presence of an excessive amount of glucose in the blood plasma. Persistent hyperglycemia and hypoinsulinemia have been associated with a variety of serious symptoms and life-threatening long-term complications such as dehydration, ketoacidosis, diabetic coma, cardiovascular diseases, chronic renal failure, retinal damage and nerve damages with the risk of amputation of extremities. Because restoration of endogenous insulin production is not yet possible, a permanent therapy is necessary which provides constant glycemic control in order to always maintain the level of blood glucose within normal limits. Such glycemic control is achieved by regularly supplying external insulin to the body of the patient to thereby reduce the elevated levels of blood glucose.
External biologic agents such as, for example, insulin or its analogs, can be administered as multiple daily injections of a mixture of rapid and intermediate-acting drugs via a hypodermic syringe. Improved glycemic control can be achieved by the so-called “intensive hormone” therapy which is based on multiple daily injections, including one or two injections per day of a long acting hormone for providing basal hormone and additional injections of rapidly acting hormone before each meal in an amount proportional to the size of the meal. Although traditional syringes have at least partly been replaced by insulin pens, the frequent injections are nevertheless very inconvenient for the patient, particularly those who are incapable of reliably self-administering injections. For some patients, substantial improvements in diabetes therapy have been achieved by the development of drug delivery devices, such as pumps, that relieve the patient of the need for syringes or drug pens and the need to administer multiple daily injections. Drug delivery devices can be constructed as an implantable device for subcutaneous arrangement or can be constructed as an external device with an infusion set for subcutaneous infusion to the patient via the transcutaneous insertion of a catheter, cannula or a transdermal drug transport, such as through a patch.
Blood or interstitial glucose monitoring can be used to achieve acceptable glycemic control. The determination of blood glucose concentration can be performed by means of an episodic measuring device, such as a hand-held electronic blood-glucose meter, that receives blood samples on enzyme-based test strips and calculates the blood glucose value based on an electrochemical reaction of the blood and the enzyme. An example of a handheld glucose meter/controller unit is the ONETOUCH PING™ from JOHNSON & JOHNSON®. Continuous glucose monitoring (CGM) using a sensor inserted into or implanted in the body can also be used. A combination of a CGM and a drug delivery device can be used to provide closed loop control of the insulin(s) being infused into the diabetic patients. To allow for closed-loop control of the infused insulins, proportional-integral-derivative (“PID”) controllers and model predictive controllers (MPC) have been used. The term “continuous” is convenient, but not strictly accurate. In practice, CGM sensors generally sample glucose on a regular time scale, e.g., once per five minutes. Closed-loop control updates can be performed, e.g., in the time intervals between glucose measurements.
Drug delivery devices generally provide insulin at a “basal rate,” i.e., provide a certain amount of insulin every few minutes in a pre-programmed, daily pattern. Some drug delivery devices also permit the user to specify a “temporary basal,” in which the normal daily cycle is altered for a selected length of time. Some drug delivery devices permit the user to manually request that a “bolus,” a specified amount of insulin, be delivered at a specified time. For example, before a meal, the user can request a bolus of additional insulin be delivered to process the glucose produced by digestion of the meal. Some drug delivery devices permit the specified amount to be delivered over a period of time rather than all at once; time-extended delivery is referred to as an “extended bolus.”
Insulin delivery, whether through syringe, pen, or infusion, is preferably done in specific sites on the body to provide improved absorption of insulin. Insulin is most rapidly absorbed when delivered in the abdomen, followed by the upper arm and thigh area. Drugs delivered into the hip and buttock areas are more slowly absorbed. Insulin is preferably delivered subcutaneously, and more preferably delivered into an area with fatty tissue to guard against accidental delivery of insulin into muscle or a blood vessel. As a result, there are a limited number of regions of the body to which drugs can be delivered. Furthermore, repeated delivery of insulin into the same area is likely to result in the development of fat deposits that can make the skin look lumpy, lead to scar tissue build-up and delay the absorption of insulin. This can then lead to erratic blood glucose values. Repeated insertion of CGM sensor probes into the same area can weaken the tissue in that area or cause damage over time. Therefore, it is known that it is desirable for patients to rotate insertion sites.
As used here, an “insertion site” is an area on a human body at which a medical device can be inserted into the body, e.g., for injecting or infusing insulin or other drugs, or for sensing properties of the body such as glucose level. The medical device can be inserted only for long enough to perform a specific function, e.g., inject an insulin dose, or can be left in the body, e.g., for 2-7 days. “Rotating” insertion sites refers to the process of choosing a different insertion site every nth time a medical device is to be inserted into the body, n>1. However, rotating insertion sites requires remembering which sites have been used and how recently. Remembering these data can be difficult for many patients.
In one embodiment, therefore, we have devised a decision support system for a patient. The system may include the following components:
In another embodiment, we have devised a decision support system for a patient. The system may include the following components:
In another embodiment, we have devised a method of recommending an insertion site. The method can be achieved by automatically performing the following steps using a processor:
These embodiments exemplary of the present invention provide improved management of insertion sites and rotation patterns. Various embodiments provide the patient with data regarding recently-used insertion sites so that the patient does not have to remember patterns or sites. Various embodiments assist users in tracking rotation of multiple medical devices. Various embodiments permit users to mark insertion sites that should not be used.
Accordingly, in any of the embodiments described earlier, the following features may also be utilized in various combinations with the previously disclosed embodiments. For example, the decision support system can include the processor further configured to repeatedly determine the recommendations, present the representations, receive the selections, and update the stored data; the processor configured to determine whether the selected one of the insertion sites is not recommended and, if not, to present an indication on the display; the processor configured to determine whether there is likely to be subcutaneous fat in the patient's body at each of the plurality of insertion sites using the stored medical records, so that the processor determines that each of the plurality of insertion sites is recommended only if there is likely to be subcutaneous fat at that one of the plurality of insertion sites; the processor configured to present the visual representation of one or more of the insertion sites that are different from the insertion site indicated as the one that should not be used; or the input device including a touch sensor configured or otherwise operatively arranged with respect to the display to form a touchscreen, and the processor configured to receive the selection by detecting a touch on the touchscreen at a location corresponding to the visual representation of one of the displayed insertion sites.
In various examples, the decision support system can include the processor configured to receive an indication of one of the plurality of insertion sites that is in use by the first medical device, so that the processor determines that each of the plurality of insertion sites within a selected distance of the indicated insertion site is not recommended for the second medical device; the processor configured to present the visual representation showing only ones of the plurality of insertion sites that are recommended for the selected one of the medical devices or both of the medical devices; the storage device storing data defining a medical criterion applicable to a selected one of the plurality of insertion sites and a selected one of the medical devices, and the processor configured to determine whether the stored medical records satisfy the criterion and, if not, that the selected one of the insertion sites is not recommended for the selected one of the medical devices; the processor configured to determine that each of the plurality of insertion sites is recommended for one of the medical devices only if that one of the plurality of insertion sites is not indicated in the stored data for the corresponding one of the medical devices as having been used less than a selected time ago; or the input device including a touch sensor configured with respect to the display to form a touchscreen, and the processor configured to receive the selection of one of the displayed insertion sites by detecting a touch on the touchscreen at a location corresponding to the visual representation of the one of the displayed insertion sites.
In various examples, the method can include determining whether the selected one of the insertion sites is recommended, and if not, displaying an indication; receiving a second indication of an insertion site that should not be used; automatically replacing the stored indication in the storage device with the second indication using the processor; automatically storing the second indication in the storage device so that whether each of the insertion sites is recommended is further determined using the stored second indication; the medical records including one or more items selected from the group consisting essentially of an indication of whether the patient has Type I diabetes or Type II diabetes, a height of the patient, a weight of the patient, a gender of the patient, and an age of the patient, and combinations thereof; displaying the visual representations including displaying a visual representation of whether each of the plurality of insertion sites is recommended; or displaying the visual representation including displaying the visual representation on a touchscreen in the user interface.
In the aforementioned aspects of the disclosure, the steps of extracting, defining, obtaining, dividing, displaying, deriving, determining, calculating, replacing, and/or storing (possibly in conjunction with an equation) may be performed be an electronic circuit or a processor. These steps may also be implemented as executable instructions stored on a computer readable medium; the instructions, when executed by a computer may perform the steps of any one of the aforementioned methods.
In additional aspects of the disclosure, there are computer readable media, each medium comprising executable instructions, which, when executed by a computer, perform the steps of any one of the aforementioned methods.
In additional aspects of the disclosure, there are devices, such as test meters or analyte testing devices, each device or meter comprising an electronic circuit or processor configured to perform the steps of any one of the aforementioned methods.
These and other embodiments, features and advantages will become apparent to those skilled in the art when taken with reference to the following more detailed description of various exemplary embodiments of the invention in conjunction with the accompanying drawings that are first briefly described.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain features of the invention. For the sake of clarity, like reference numerals herein represent like elements.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention or the attached claims.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values not at least ±10% of the recited value, e.g. “about 90%” may refer to the range of values from 81% to 99%. As used herein, “oscillating signal” includes voltage signal(s) or current signal(s) that, respectively, change polarity or alternate direction of current or are multi-directional. Also used herein, the phrase “electrical signal” or “signal” is intended to include direct current signal, alternating signal or any signal within the electromagnetic spectrum. The terms “processor”; “microprocessor”; or “microcontroller” are intended to have the same meaning and are intended to be used interchangeably. Throughout this disclosure, the terms “patient” and “subject” are used interchangeably. These terms can refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment. Furthermore, in this disclosure, the term “user” can refer to a patient using a glucose measuring or drug delivery device or another person (e.g., a parent or guardian, nursing staff member, home care employee, or other caretaker) using such a device. The term “healthcare provider” or “HCP” refers generally to doctors, nurses, and individuals other than the patient that provide health care services to the patient. The term “drug” may include hormones, biologically active materials, pharmaceuticals or other chemicals that cause a biological response (e.g., a glycemic response) in the body of a user or patient.
The drug delivery device 102 is configured to transmit and receive data to and from the controller 104 by, for example, a radio frequency (RF) communications link 111. In one embodiment, the drug delivery device 102 is an insulin infusion device and the controller 104 is a hand-held portable controller. In such an embodiment, data transmitted from the drug delivery device 102 to the controller 104 may include information such as, for example, insulin delivery data, blood glucose (BG) information, basal, bolus, insulin to carbohydrates ratio or insulin sensitivity factor. The controller 104 can be configured to include a closed-loop controller that has been programmed to receive continuous glucose readings from a CGM sensor 112 via a radio frequency (RF) communications link 110. The CGM sensor 112 can measure glucose levels of interstitial fluid in the body, determine corresponding blood glucose levels, and provide the BG levels to the controller 104. Data transmitted from the controller 104 to the drug delivery device 102 may include glucose test results and a food database to allow the drug delivery device 102 to calculate the amount of insulin to be delivered by the drug delivery device 102. Alternatively, the controller 104 may perform basal dosing or bolus calculation and send the results of such calculations to the drug delivery device. A glucose meter 114 (here, an episodic blood-glucose meter), alone or in conjunction with the CGM sensor 112, provides data to either or both of the controller 104 and drug delivery device 102, e.g., via a radio frequency (RF) communications link 117. The glucose meter 114 can measure a fluid sample placed on a test strip 115. The two hatched areas on the test strip 115 graphically represent two electrodes, as is discussed below with reference to
The controller 104, the drug delivery device 102, and the CGM sensor 112 can be integrated into multi-function units in any combination. For example, the controller 104 can be integrated with the drug delivery device 102 to form a combined device with a single housing. Infusion, sensing, and controlling functions can also be integrated into a monolithic artificial pancreas. In various embodiments, the controller 104 is combined with the glucose meter 114 into an integrated monolithic device having a housing 130. Such an integrated monolithic device can receive a test strip 125. In other embodiments, the controller 104 and the glucose meter 114 are two separable devices that are dockable with each other to form an integrated device. Each of the devices 102, 104, and 114 has a suitable micro-controller (not shown for brevity) programmed to carry out various functionalities. Examples of micro-controllers that can be used are discussed below with reference to a processor 386,
The drug delivery device 102 or the controller 104 can also be configured for bi-directional communication with a network 116 through, for example, a radio frequency communications link 118. One or more server(s) 126 or storage device(s) 128 can be communicatively connected to the controller 104 via the network 116. In an example, the drug delivery device 102 communicates with a personal computer (e.g., the controller 104) via BLUETOOTH™ low-energy (BLE™, also known as BLUETOOTH SMART). The controller 104 and the network 116 can be configured for bi-directional wired communication through, for example, a telephone land based communication network. The controller 104 can include a smartphone, electronic tablet, or personal computer.
The drug delivery device 102 can include any or all of: electronic signal processing components including a central processing unit and memory elements for storing control programs and operation data, a radio frequency module (not shown) for sending and receiving communication signals (e.g., messages) to and from the controller 104, a display for providing operational information to the user, a plurality of navigational buttons for the user to input information, a battery for providing power to the system, an alarm (e.g., visual, auditory or tactile) for providing feedback to the user, a vibrator for providing feedback to the user, and a drug delivery mechanism (e.g., a drug pump and drive mechanism) for forcing a insulin from a insulin reservoir (e.g., a insulin cartridge) through a side port connected via the flexible tubing 108 to an infusion set 106 and into the body of the user.
Various glucose management systems include an episodic glucose sensor (e.g., a glucose meter 114) and an infusion pump. An example of such a system is the ONETOUCH PING Glucose Management System manufactured by the Animas Corporation. The “ezBG” feature of this system computes an amount of insulin to be delivered by the infusion pump using the results of an episodic glucose measurement. Another example of a glucose management system is the ANIMAS VIBE™ insulin pump, which communicates with a DEXCOM G4™ CGM system manufactured by the DexCom Corporation. Interfaces can be provided to connect these components. Closed-loop control algorithms can be programmed in, e.g., the MATLAB™ language to regulate the rate of insulin delivery based on the glucose level of the patient, historical glucose measurement and anticipated future glucose trends, and patient specific information.
In the exemplary test strip 115, the electrode 220 is a working electrode formed by sputtering a Pd coating on a polyester base forming the planar substrate 204. A dry reagent layer is used and includes buffer, mediator, and enzyme, as described herein. The electrode 210 is a reference electrode formed by sputtering an Au coating on the polyester base forming the planar substrate 204. The electrical contact pads 201, 202 connect to the electrodes 210, 220, respectively, and permit applying or detecting electrical signals across the sample-receiving chamber 230 between the electrodes 210, 220. The sample-receiving chamber 230 can have a volume ranging from, e.g., about 0.1 microliters to about 5 microliters. Various enzymes in the sample-receiving chamber 230 can assist in transducing the analyte (e.g., glucose) in the fluid sample (e.g., blood, interstitial fluid, or control solution) into a current, potential, or other quantity that can be measured electrically. Exemplary enzymes include glucose oxidase, glucose dehydrogenase (GDH) based on a pyrroloquinoline quinone co-factor, and GDH based on a nicotinamide adenine dinucleotide co-factor.
In use, top ends of the electrodes 210, 220 are in contact with an electrolyte phase (not shown), which is a free-flowing fluid phase (e.g., a blood sample) disposed between the electrodes 210, 220. An enzyme, e.g., glucose oxidase, can cover the electrolyte phase. Depending on the state of the test strip 115, the electrode 210 can be a working electrode and the electrode 220 can be a counter electrode. In an example using glucose oxidase, a current is produced at the working electrode (and flows through the circuitry to the counter electrode). That current is representative of the concentration of glucose in the subject's body. The glucose meter 114 can measure the current through the electrodes 210, 220 to determine the glucose level of the fluid sample in the sample-receiving chamber 230. Exemplary glucose sensors and associated components are shown and described in U.S. Pat. Nos. 6,179,979, 8,163,162, and 6,444,115, which are incorporated by reference herein in their entireties.
An exemplary CGM sensor 112 utilizes amperometric electrochemical sensor technology to measure an analyte. The CGM sensor 112 includes three electrodes operably connected to the sensor electronics and covered by a sensing membrane and a biointerface membrane, which are attached by a clip.
The top ends of the electrodes are in contact with an electrolyte phase (not shown), which is a free-flowing fluid phase disposed between the sensing membrane and the electrodes. The sensing membrane may include an enzyme, e.g., analyte oxidase, which covers the electrolyte phase. The H2O2 produced from the analyte oxidase reaction further reacts at the surface of working electrode and produces two protons (2H+), two electrons (2e−), and one oxygen molecule (O2). A potentiostat is used to measure the electrochemical reaction(s) at the electrode(s) by applying a constant potential between the working and reference electrodes to produce a current value. The current that is produced at the working electrode (and flows through the circuitry to the counter electrode) is proportional to the diffusional flux of H2O2. Accordingly, a raw signal may be produced that is representative of the concentration of analyte in the user's body, and therefore may be utilized to estimate a meaningful analyte value. Details of the sensor and associated components are shown and described in U.S. Pat. No. 7,276,029, which is incorporated by reference herein. The CGM sensor 112 can measure analyte levels in, e.g., interstitial fluid.
The controller 104 can also include a peripheral system 320, a user interface 330, and a storage device 340 communicatively connected to the processor 386. The processor 386 includes one or more data processor(s) that implement processes of various embodiments described herein. A “data processor” is a device for processing data and can include a central processing unit (CPU), a desktop computer, a laptop computer, a mainframe computer, a personal digital assistant, a digital camera, a cellular phone, a smartphone, or any other device for processing data, managing data, or handling data, whether implemented with electrical, magnetic, optical, biological components, or otherwise. The phrase “communicatively connected” includes any type of connection, wired or wireless, between devices, data processors, or programs in which data can be communicated. Subsystems such as the peripheral system 320, the user interface 330, and the storage device 340 are shown separately from the processor 386 but can be stored completely or partially within the processor 386.
The storage device 340 includes or is communicatively connected with one or more tangible non-transitory computer-readable storage medium(s) configured to store information, including the information needed to execute processes according to various embodiments. The term “device” does not imply that storage device 340 include only one piece of hardware that stores data. A “tangible non-transitory computer-readable storage medium” as used herein refers to any non-transitory device or article of manufacture that participates in storing instructions which may be provided to the processor 386 for execution. Such a non-transitory medium can be non-volatile or volatile. Examples of non-volatile media include floppy disks, flexible disks, or other portable computer diskettes, hard disks, magnetic tape or other magnetic media, Compact Discs and compact-disc read-only memory (CD-ROM), DVDs, BLU-RAY disks, HD-DVD disks, other optical storage media, Flash memories, read-only memories (ROM), and erasable programmable read-only memories (EPROM or EEPROM). Examples of volatile media include dynamic memory, such as registers and random access memories (RAM).
Embodiments of the present invention can take the form of a computer program product embodied in one or more tangible non-transitory computer readable medium(s) having computer readable program code embodied thereon. Such medium(s) can be manufactured as is conventional for such articles, e.g., by pressing a CD-ROM. The program embodied in the medium(s) includes computer program instructions that can direct the processor 386 to perform a particular series of operational steps when loaded, thereby implementing functions or acts specified herein.
In an example, the storage device 340 includes a memory 341, e.g., a random-access memory, and a disk 342, e.g., a tangible computer-readable storage device such as a hard drive or a solid-state flash drive. Computer program instructions are read into the memory 341 from the disk 342, or a wireless, wired, optical fiber, or other connection. The processor 386 then executes one or more sequences of the computer program instructions loaded into the memory 341, as a result performing process steps and other processing described herein. In this way, the processor 386 carries out a computer implemented process that provides technical effects described herein. For example, blocks of the flowchart illustrations or block diagrams herein, and combinations of those, can be implemented by computer program instructions. The memory 341 can also store data used by running programs.
Program code to carry out methods described herein can execute entirely on a single processor 386 or on multiple communicatively-connected processors 386. For example, code can execute wholly or partly on a user's computer and wholly or partly on a remote computer, e.g., a server. The remote computer can be connected to the user's computer through the network 350. The user's computer or the remote computer can be non-portable computers, such as conventional desktop personal computers (PCs), or can be portable computers such as tablets, cellular telephones, smartphones, or laptops.
The peripheral system 320 can include one or more devices configured to provide digital content records or other data to the processor 386. For example, the biosensor 200 can be connected to the processor 386 via the peripheral system 320, e.g., using a BLUETOOTH SMART or other wireless link. The biosensor 200 can also be directly connected to the processor 386. The peripheral system 320 can also include digital still cameras, digital video cameras, cellular phones, or other data processors. The peripheral system 320 can also include one or more bus bridge(s), e.g., to communicatively connect devices having USB, FIREWIRE, RS-232, or other interfaces to the processor 386. The processor 386, upon receipt of data from a device in the peripheral system 320, can store that data in the storage device 340.
The processor 386 is communicatively connected to the user interface 330. The user interface 330 can include a mouse, a keyboard, another computer (connected, e.g., via a network or a null-modem cable), a microphone and speech processor or other device(s) for receiving voice commands, a camera and image processor or other device(s) for receiving visual commands, e.g., gestures, or any device or combination of devices from which data is input to the processor 386. In this regard, although the peripheral system 320 is shown separately from the user interface 330, the peripheral system 320 can be included as part of the user interface 330. In at least one embodiment, the user interface 330 can be operated by the subject 1138.
The user interface 330 also can include a display device, a touchscreen, a processor-accessible memory, or any device or combination of devices to which data is output by the processor 386. In this regard, if the user interface 330 includes a processor-accessible memory, such memory can be part of the storage device 340 even though the user interface 330 and the storage device 340 are shown separately in
In various embodiments, the processor 386 is communicatively connected to a communication interface 315 that is coupled via a network link 316 to the network 350. For example, the communication interface 315 can be a WIFI or BLUETOOTH SMART wireless transceiver and the network link 316 can be a radio-frequency (RF) communications channel. As another example, the communication interface 315 can be a network card to provide a data communication connection to a compatible local-area network (LAN), e.g., an Ethernet LAN, or wide-area network (WAN). The communication interface 315 sends and receives electrical, electromagnetic or optical signals that carry digital data streams representing various types of information across the network link 316 to the network 350. The network link 316 can be connected to the network 350 via a switch, gateway, hub, router, or other networking device.
The processor 386 can send messages and receive data, including program code, to and from the network 350 via the network link 316 and the communication interface 315. For example, requested code for an application program (e.g., a JAVA applet) can be stored on a tangible non-volatile computer-readable storage medium connected to the network 350. A network server (not shown) can retrieve the code from the medium and transmit it via the network 350 to the communication interface 315. The received code can be executed by the processor 386 as it is received, or stored in the storage device 340 for later execution.
The storage device 340 holds, e.g., in RAM or ROM, various data used by the processor 386. The storage device 340 holds data of a plurality of insertion sites, each insertion site representing an area on a human body at which a medical device can be inserted into the body, e.g., for injecting, pumping, or sensing, as described above. These data can be stored in a read-only memory. The storage device 340 also holds data indicative of the insertion sites that have been used by the patient (recently, or over a selected time horizon, as described below). These data can be stored in a nonvolatile read-write memory, e.g., a Flash memory. Examples of recommended insertion sites are described in Frid et al., “New injection recommendations for patients with diabetes,” Diabetes & Metabolism 36 (2010) S3-S18, DOI 10.1016/S1262-3636(10)70002-1 (“Frid”), incorporated herein by reference.
The data defining the plurality of insertion sites can have a desired spatial granularity. For example, Frid
The processor 386 is configured to receive via the user interface 330 medical records of the patient, e.g., via the settings dialog invoked by the soft key 414. The medical records can include any data reflective of past, present or predicted medical condition(s) of the patient such as, for example, one or more items such as an indication of whether the patient has Type I diabetes or Type II diabetes, a height of the patient, a weight of the patient, a gender of the patient, an age of the patient, or a body mass index (BMI) of the patient. Different medical records can be stored for different patients. For example, for one patient, height and weight can be stored; for another patient, BMI can be stored. An HCP can provide the medical records to the storage device 340 or can determine which medical records should be stored and used by the processor 386 in making determinations as described herein.
In various embodiments, the processor 386 is also configured to receive via the user interface an indication of an insertion site that should not be used and store the medical records and the indication in the storage device 340. This is discussed below with reference to an indication 1050,
The processor 386 is configured to, e.g., in response to a user press of the soft key 412, determine whether each of the insertion sites is recommended using (via) the stored medical records, the stored indication, the data of the plurality of insertion sites, and the data indicative of the used insertion sites. The processor 386 presents on the display 444 a visual representation of at least some of the insertion sites and whether each is recommended. In an example, the processor displays the visual representation as one or more highlights 448 on a representation 449 of a human body. The highlights 448 are shown hatched; for clarity, only one of the highlights 448 is labeled. The different hatching patterns of the highlights 448 indicate that the highlights 448 can be displayed in different colors.
The processor 386 is further configured to receive a selection of one of the displayed insertion sites via the input device, and to update the stored data in the storage device 340 indicative of the used insertion sites with the selected one of the insertion sites. The representation 449 can be mirrored or not. That is, the labeled one of the highlights 448 can correspond to the user's left leg (as if viewed in a mirror) or to the user's right leg (as if viewing another person directly).
In various embodiments, the processor 386 is further configured to repeatedly determine the recommendations, present the representations, receive the selections, and update the stored data. In this way, the processor 386 can assist the user in consistently rotating between different insertion sites.
In
In
In
The storage device 340 also holds medical records of the patient, data indicative of the insertion sites that have been used by the patient for a first medical device, and data indicative of the insertion sites that have been used by the patient for a second medical device different from the first medical device. Insertion sites can be tracked over a desired time horizon, e.g., the most recent week, month, six months, or year, or can be tracked indefinitely.
In an example, the first medical device is an insulin pump infusion set, e.g., the infusion set 106,
The processor 386 is configured to determine that each of the insertion sites is recommended for the first medical device, the second medical device, both of the medical devices, or neither of the medical devices. The processor 386 can perform this determination using the stored medical records, the stored indication, the data of the plurality of insertion sites, and the data indicative of the used insertion sites for the first and second medical devices. Examples of this determination are discussed below. The processor 386 is configured to present on the display 444 a visual representation 1049 of at least some of the insertion sites and the determined respective recommendations.
In the example shown in
The processor 386 receives via the input device a selection of one of the displayed insertion sites and a selection of one of the medical devices. In the example shown, the touch location 1010 shows that the user has touched the highlight 1041. Two graphical buttons 1001, 1002 permit the user to choose which medical device the touch location 1010 corresponds to. The graphical button 1001 represents an insulin pump and the graphical button 1002 represents a CGM sensor. In this example, the user has touched the graphical button 1001 (the pump), so the processor 386 presents the graphical button 1001 with a highlight or other indication (e.g., a radio button) that the pump has been chosen. The processor 386 is configured to update the stored data indicative of the used insertion sites for the selected one of the medical devices with the selected one of the insertion sites. In this example, the processor 386 updates the data in the storage device 340 to indicate that the insertion site corresponding to the highlight 1041 has recently been used for the first medical device.
In an example, the input device is the touch sensor 445,
In various embodiments, the processor 386 is configured to present the visual representation showing only ones of the plurality of insertion sites that are recommended for the selected one of the medical devices or both of the medical devices. In this example, when the user selects the graphical button 1001, the visual representations of insertion sites that are not recommended for the pump are hidden. Similarly, when the user selects the graphical button 1002, the visual representations of insertion sites that are not recommended for the CGM are hidden. Insertion sites that are recommended for both the pump and the CGM will be indicated by visual representations when either of the graphical buttons 1001, 1002 is selected.
The processor 386 can be configured to determine site recommendations in various ways. For example, the processor 386 can be further configured to determine that each of the plurality of insertion sites is recommended for one of the medical devices only if that one of the plurality of insertion sites is not indicated in the stored data for the corresponding one of the medical devices as having been used less than a selected time ago. This provides a basic rotation of insertion sites by not recommending a recently-used insertion site until sufficient time has passed for the subject's body to heal.
In another example, the user selects the upper-arm insertion site corresponding to the highlight 1041 for the CGM sensor. For the next week (a usage period), the highlight 1041 will indicate that insertion site is recommended for the CGM sensor. After the week has passed, as indicated in the stored data for the CGM sensor, the processor 386 will display the highlight 1041 to indicate that insertion site is not recommended for the CGM sensor. The highlight 1041 will indicate “not recommended” until three weeks have passed (a rest period). This supports an established practice or routine described in Frid of using injections spaced 1 cm apart within a particular insertion site over the course of one week (see Frid sec. 3.14). Specifically, in various embodiments the processor 386 is configured to determine that each of the plurality of insertion sites is recommended for one of the medical devices only if either that one of the plurality of insertion sites has been used within a selected usage period, as indicated in the stored data for the corresponding one of the medical devices, or that one of the plurality of insertion sites is not indicated in the stored data for the corresponding one of the medical devices as having been used during a selected rest period.
In various embodiments, the medical records stored in the storage device 340 are compared to stored criteria to determine recommended sites. For example, insulin is preferably injected into subcutaneous (SC) tissue. Frid section 3.11.2 describes that the thickness of SC tissue can vary depending on, among other things, body-mass index (BMI). The thickness of SC tissue can also vary between insertion sites on the patient's body. In various embodiments, the storage device 340 further stores data defining a medical criterion applicable to a selected one of the plurality of insertion sites and a selected one of the medical devices. The processor 386 is configured to determine whether the stored medical records satisfy the criterion and, if not, that the selected one of the insertion sites is not recommended for the selected one of the medical devices. As used herein, the term “medical records” is intended to also include any of the electronic medical records (EMR) utilized in clinics and hospitals.
For example, the selected one of the medical devices can be a syringe with an 8 mm needle. The selected one of the plurality of insertion sites can be an upper-thigh site, e.g., indicated by the highlight 1043. Frid
If the stored medical records indicate that the patient has an extremely low BMI, the processor 386 can infer that the SC thickness is 2 mm. Since 2 mm<4 mm, the criterion is not satisfied. Accordingly, in this example the processor 386 determines that this insertion site (upper thigh) is not recommended for use with the syringe. This insertion site may, however, still be recommended for a different medical device other than the syringe. Specifically, in various embodiments, the processor 386 is configured to determine whether there is likely to be subcutaneous fat in the patient's body at each of the plurality of insertion sites using the stored medical records. The processor determines that each of the plurality of insertion sites is recommended only if there is likely to be subcutaneous fat at that one of the plurality of insertion sites.
Similarly, the medical records can include data indicative of the patient's weight. Weight can indicate whether or not the subject 1138 is muscular. Since insulin injection is subcutaneous, injecting into certain insertion sites can be painful if the user is muscular. Using the weight stored in the storage device 340, the processor 386 can infer (how muscular or not the subject 1138 is. The processor 386 can then determine sites are not recommended if they are likely to be painful to users with the given weight.
In other examples, the processor 386 can determine a recommendation for each of the insertion sites based on the medical records indicating whether the subject 1138 has Type 1 or Type 2 diabetes. Preferred insertion sites for the two types can be different, so sites specifically for one type are determined not to be recommended if the medical records indicate the subject 1138 has the other type.
In another example, the processor 386 is configured to coordinate the use of the first and second (or more) medical devices. The processor 386 receives an indication of one of the plurality of insertion sites that is in use by the first medical device, e.g., the CGM sensor 112. This is represented in
In general, the processor 386 can be configured to apply various criteria to one or more of the insertion sites. Examples of such criteria discussed above include recency of use, proximity to insertion sites used for another device, and stored medical criteria. The processor 386 is configured to determine insertion site(s) (if any) that are not recommended, and to represent that determination visually to the user. Different criteria can be applied to different insertion sites. For example, stored medical records can be compared to stored criteria to determine whether certain of the insertion sites are not recommended, and recency criteria can be applied to others of the insertion sites. Multiple criteria can also be applied to the same insertion site. In various embodiments, the processor tests each insertion site against multiple stored criteria, e.g., the exemplary criteria described above. Each insertion site is recommended if and only if it satisfies each of the stored criteria.
In step 1110, medical records of a patient are received via a user interface. The user interface can include a touchscreen 144,
In step 1120, the medical records and the indication are stored in the storage device 340,
In step 1130, it is determined, e.g., by the processor 386, whether each of the insertion sites is recommended using the stored medical records, the stored indication, stored data of a plurality of insertion sites, and stored data indicative of the used insertion sites. That is, a determination of whether an insertion site is recommended or not is made for each of the insertion sites. Other insertion areas can be presented, but a determination not made for those areas. The insertion site indicated as not to be used, e.g., the insertion site corresponding to the highlight 1046, as indicated by the indication 1050, is determined to be not recommended. This advantageously permits users to, e.g., exclude from a rotation insertion sites that are particularly painful to insert into, or that are difficult for the patient or an HCP to reliably insert into. Step 1140 can be next.
In step 1140, a visual representation of the plurality of insertion sites is displayed, e.g., on the touchscreen 144 or the display 444. Examples of such representations are shown in
In various embodiments, step 1140 is followed by step 1145. In step 1145, the indication 1050 of an insertion site that should not be used is received. The indication can be received in step 1145 instead of in step 1110, or a first indication can be received in step 1110 and a second indication received in step 1145. The indication can be received (e.g., by the suitably-configured processor 386,
Multiple indications can be received and stored in step 1145. In step 1145 or step 1110, cancellations can also be received, e.g., by the suitably-configured processor 386. A cancellation, e.g., a second touch on the highlight 1046 after providing the indication 1050, removes the corresponding insertion site from the stored list of insertion sites that should not be used. The graphical buttons 1001, 1002, 1003 can be color-coded with respect to the highlights 1041, 10421043, 1044, 1045, 1046, or otherwise designed to suggest their functions to the user.
In various embodiments, step 1145 is followed by step 1130. After the indication 1050 is received, it is re-determined (e.g., by the processor 386) whether each of the insertion sites is recommended. In an example, a user indication that a certain site is not to be used for a pump may cause nearby sites to be recommended for a CGM sensor, since it can be determined that the pump will not be used at the indicated insertion site.
In step 1150, a selection of one of the insertion sites is received via the user interface, e.g., via a touch on the touchscreen 144. This is shown, e.g., by the touch indicator 610,
In step 1160, the stored data indicative of the used insertion sites are updated with the selected one of the insertion sites. This advantageously permits the processor 386 or another device carrying out steps of this method to provide suggestions for rotating insertion sites for one or more medical device(s). Decision step 1170 can be next.
In decision step 1170, it is determined whether the patient has made a request to repeat the process, e.g., by pressing the soft key 412,
In step 1155, in various embodiments, the processor 386 determines whether the selected one of the insertion sites (from step 1150) is recommended. If the selected one of the insertion sites is not recommended, an indication is displayed, e.g., on the touchscreen 144. An example is shown in
In various embodiments, a second or subsequent indication of an insertion site that should not be used can be received. This is represented by the “further indication(s)” arrow from step 1110 to itself in
In view of the foregoing, embodiments of the invention provide improved management of insertion site rotation. A technical effect of processing performed by the processor 386 is to compute insertion-site recommendations using data provided, e.g., by the user of the controller 104 and to compute graphical representations of those recommendations. Another technical effect is to communicate those recommendations or representations outside the particular computing device that performed the computations, e.g., to a human who may use the recommendations in selecting insertion sites for, e.g., insulin pumps or needles or CGM sensors. Various decision-support systems and devices described herein can be integrated with, e.g., episodic blood glucose meters or drug-delivery devices. Various methods described herein can be performed by processors in such meters or devices.
While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Separate references to “an embodiment” or “particular embodiments” or the like do not necessarily refer to the same embodiment or embodiments; however, such embodiments are not mutually exclusive, unless so indicated or as are readily apparent to one of skill in the art. The use of singular or plural in referring to “method” or “methods” and the like is not limiting. The word “or” is used in this disclosure in a non-exclusive sense, unless otherwise explicitly noted. To the extent there are variations of the invention that are within the spirit of the disclosure or are equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well.
