A SYSTEM FOR ASSISTING IN ADMINISTRATION OF A DRUG

Abstract

A system and kit for assisting a subject in administering an injectable drug by use of an injection device having communication means to communicate data at least about sizes of doses expelled and a timestamp for when each dose was expelled. The system comprises a communication unit (210) adapted to communicate with the injection pen (100) to receive said dose data and comprising a display to present information and instructions to the subject. The system has a processor unit (220) comprising one or more processors and a memory storing a dose size calculation program adapted calculate a recommended dose size of drug to be injected. Responsive to a request to calculate a recommended dose size, the memory stores instructions that, when executed by the one or more processors, performs the initial step of prompting the user to perform a priming of the injection device before a calculation of a recommended dose size can be carried out.

Claims

1. A system for assisting a subject in administering an injectable drug by use of an injection device having communication structure to communicate data at least about sizes of doses expelled and a timestamp for when each dose was expelled from the device, said system comprising; a communication unit adapted to communicate with the injection device to receive said data and comprising a display to present information and instructions to the subject, a processor unit comprising one or more processors and a memory storing a dose size calculation program adapted calculate a recommended dose size of drug to be injected, said memory further storing instructions that, when executed by the one or more processors, performs the method step of, responsive to a request to calculate a recommended dose size to be injected; a) prompting the subject, via said display, to perform the step of priming said injection device by setting and expelling a predefined prime dose size in order to allow execution of said program to calculate a recommended dose size.

2. A system according to claim 1, wherein the memory further stores instructions that, when executed by the one or more processors, performs the method steps of, subsequent to the step of prompting the subject to prime the device, b) obtaining a first set of dose data from the device containing said data about at least sizes of the doses expelled and a timestamp for when each expelled dose was expelled, c) processing said first set of dose data to identify said prime dose in the data set, and d) filtering out the prime dose data from the first set of dose data to provide a second set of dose data.

3. A system according to claim 2, wherein the memory further stores instructions that, when executed by the one or more processors, performs the method steps of, subsequent to the step of filtering out the prime dose data, e) calculating by said program, based upon said second set of dose data, a recommended dose size to be injected, and f) presenting said recommended dose size to the subject via said display.

4. A system according to claim 2, wherein the step c) of identifying the prime dose comprises selecting as the prime dose the latest registered expelled dose size out of the number of expelled dose sizes in the first set of dose data.

5. A system according to claim 2, wherein the first set of dose data further includes drug type data, said memory storing instructions that, when executed by the one or more processors, further performs the method steps of, prior to the step of calculating a recommended dose; i. processing said first set of dose data to identify the type of drug in the primed device, ii. comparing the type of drug in the primed device with the type of drug for which a recommended dose is requested, and only if the two types of drug are identified as identical, then iii. executing said program to calculate a recommended dose size.

6. A system according to claim 1, wherein the drug is insulin, insulin containing drug, a GLP-1 containing drug or growth hormone.

7. A system according to claim 1, wherein the communication unit is a smartphone, tablet or computer.

8. A system according to claim 7, wherein the one or more processors and memory is provided on said smartphone, tablet or computer.

9. A system according to claim 1, wherein the one or more processors and a memory are provided on a cloud-based server remote from the communication unit.

10. A system according to claim 1, wherein the communication unit is adapted to receive, from a glucose measuring device measuring the subject's glucose level, glucose data about historic glucose levels and timestamps for when each glucose level was measured, and wherein said calculation of a recommended dose size to be injected further is based upon said glucose data.

11. A kit for assisting a subject in administering a drug and comprising; an injection device for injecting doses of drug into the body of the subject, said device comprising; a drug reservoir, an outlet for the drug, a dose setting mechanism, a dose expelling mechanism to expel set doses of drug through the outlet, a dose sensing unit for sensing the size of doses being set and/or expelled, and communication structure to communicate dose data from the device about at least sizes of the expelled doses and timestamps for each expelled dose from the device, and a system according to claim 1.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0053] FIG. 1 illustrates a diagram of an exemplary embodiment of the system according to the invention,

[0054] FIG. 2 shows a flow diagram of an exemplary method of requesting, calculating and registering a dose size of insulin using the system and kit according to the invention, and

[0055] FIG. 3 shows examples of screen layouts of a user interface of the system according to the invention.

DETAILED DESCRIPTION

[0056] In the following detailed description, more specific details are set forth in order to provide a more thorough understanding of the present disclosure. However, it will be apparent to one of ordinary skill in the art that the present disclosure may be practiced without these specific details.

[0057] In FIG. 1 an example of an injection device in the form of a pen 100 used for taking discrete doses of drug is shown. Any injection pen (durable or disposable) able to register/log and communicate data from the pen is applicable to the invention described herein.

[0058] More specifically, the pen 100 comprises a main part having a proximal body or drive assembly portion with a housing 110 in which a drug expelling mechanism is arranged or integrated to expel set doses of drug through an outlet, and a distal drug reservoir holder portion 120 holding a drug-filled transparent drug reservoir in the form of a cartridge 130 having a displaceable piston (not shown) and distal needle-penetrable septum 140. The cartridge holder has openings 150 allowing a portion of the cartridge to be inspected. The cartridge may for example contain a insulin, GLP-1 or growth hormone formulation. A proximal-most rotatable dose ring member 160 serves as dose setting mechanism to manually set a desired dose of drug shown in display window 170 and which can then be expelled when a release button 180 is actuated. The pen further comprises a dose sensing unit (not shown) for sensing and registering the size of doses being expelled, and communication means to communicate dose data from the pen, in this example via Bluetooth.

[0059] FIG. 1 further shows a system 200 according to the invention adapted to communicate with the injection pen 100 to receive data about sizes of doses expelled from the pen, timestamps associated with each of the expelled doses, type of drug in the pen etc. The pen 100 may further communicate information about status of the pen, such as battery status, any dysfunction in the pen, blocked outlet/needle etc.

[0060] The system 200 comprises a communication unit 210, in this example a mobile phone 213, adapted to communicate via a wireless communication unit 211 with the injection pen 100. The communication unit 210 further comprises a display unit 212 to present information and instructions to the user.

[0061] The system further comprises a processor unit 220 including one or more processors 221 and a memory 222 storing the dose calculation program adapted to calculate a recommended dose size of drug to be injected upon request from the user. The processor unit 220 further comprises an input/output module 223 for transferring data to and from the communication unit 210. The dose calculation program preferably includes dose calculation algorithm for the specific type of drug, patient and/or other parameters.

[0062] The processor unit 220 further comprises a dose history storage unit 224 for storing the historic dose data received from the injection pen 100 via the communication unit 210.

[0063] As depicted in the figure, the processor unit 220 is located on a server in the cloud, 225, remote from the communication unit 210 and communicates with the communication unit 211 via Wi-Fi. Alternatively, the communication unit 210 and processor unit 220 may be included in one single unit, such as a smartphone, tablet or computer.

[0064] Turning to FIG. 2 a flow diagram of an exemplary method of requesting, calculating and registering a dose size of insulin using the system according to the invention is shown. The flow starts by the user requests, 301, a dose calculation of a recommended dose size via a display interface on the communication unit, such as the interface on the mobile application as the shown in FIG. 3. In order to trigger a dose size calculation, the communication unit now requests, 302, via the display the user to prime the injection pen by expelling a predefined no. of units of insulin from the pen (a primed shot). The user then dials up said predefined no. of units on the pen, activates the expelling mechanism and expels the prime dose, 303.

[0065] The communication unit now obtains a first set of dose data from the pen and transfer that set of data further on to the processor unit located in the cloud. The processor unit confirm that a prime dose has been expelled and filters out the prime dose from the first set of dose data as described above and a calculation of a recommended dose can now take place, 304. A dose calculation program is executed calculating a dose based upon a second set of dose data not including the prime dose 305.

[0066] When the recommended dose size has been calculated and sent from the processor unit to the communication unit, the dose size is displayed for the patient on the display of the communication unit, 306. Next the patient will set the recommended dose size on the injection pen and inject it, 307. After the injection has taken place, the communication unit receives updated dose data from the pen, transfers the data to the of processor unit, where the updated dose data history, 308, is stored in a dose history storage unit.

[0067] In FIG. 3 are shown examples of user interfaces and associated required user steps for receiving a dose size recommendation in a system according to the invention.

[0068] The user starts opening the dose calculation application 400 on the smartphone, which can be any kind of smartphone (Android/IOS). A first screen 410 pops up where the user can hit the Start Dose Guidance button to start a dose calculation.

[0069] The next screen 420 pops up requesting the user to prepare the injection pen for a prime dose (in the figure called airshot) by dialling 2 units on the dose setting mechanism on the pen.

[0070] Now the screen 430 pops up instructing the user to activate the dose expelling mechanism on the pen by pressing the button while pointing the pen upwards and wait until 0 is shown in the unit window.

[0071] As soon as the user releases the button, a first set of dose data is sent from the pen via the mobile phone to the processor unit, in this case the mobile phone, and the 2 units prime dose will immediately be filtered out and not recorded as injected dose. The dose calculation algorithm starts calculating a dose size recommendation 440 based on the recorded second set of dose data not including the 2 units prime dose.

[0072] Finally, the screen 450 pops up displaying the calculated recommended dose size to the user, and the user injects the recommended dose (or other amount based on user's discretion). As soon as the user releases the button on the pen after having injected the dose, the dose data is sent via the mobile phone to the processor unit and the injected dose is registered in the dose data history records.

[0073] The first set of data may further include drug type information that allows the application to verify that the pen contains the correct type of drug that the user has requested a dose size recommendation for. If not, then the system will not proceed to the dose size calculation step but inform the user of the mismatch and maybe ask the user to take the pen containing the correct type of drug.

[0074] The data from the pen may further include information codes about any errors in the pen (pen is broken, injection needle/outlet blocked, low battery etc.). In the event of an error, the system will relay error message(s) to the user via the display based on error codes received from the injection pen and no dose calculation will be made.

[0075] Many modifications and variations of this invention can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. The specific embodiments described herein are offered by way of example only. The embodiments were chosen and described in order to best explain the principles of the invention and its practical applications, to thereby enable others skilled in the art to best utilize the invention and various embodiments with various modifications as are suited to the particular use contemplated. The invention is to be limited only by the terms of the appended claims, along with the full scope of equivalents to which such claims are entitled.