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EP-3694583-B1 - INTELLIGENT MEDICATION DELIVERY SYSTEMS AND METHODS FOR DOSE RECOMMENDATION AND MANAGEMENT

EP3694583B1EP 3694583 B1EP3694583 B1EP 3694583B1EP-3694583-B1

Inventors

  • SAINT, SEAN
  • PRYOR, JACK

Dates

Publication Date
20260506
Application Date
20181012

Claims (14)

  1. A system (100) for administering a medicine, comprising: an injection pen device (10) including a dose setting mechanism to set a dose of a medicine contained in a medicine cartridge that is to be dispensed by the injection pen device, a dispensing mechanism to dispense the medicine according to the set dose, and electronic circuits including a processor, a memory comprising instructions executable by the processor, and a wireless transmitter, the processor of the injection pen device configured to generate dose data associated with a dispensing event of a dose of the medicine dispensed from the injection pen device and time data associated with the dispensing event, and to wirelessly transmit the dose data; a sensor device (50) to monitor one or more health metrics of a patient user, and wherein the injection pen device includes a software application program product or the injection pen device is in wireless communication with a mobile communication device (5) that includes a data processing unit including a processor and memory to receive and process the dose data and that includes the software application program product, wherein the software application program product comprises a non-transitory computer-readable storage medium having instructions, which when executed by the processor of the data processing unit or the processor of the injection pen device, cause the mobile communication device or the injection pen device to determine a recommended dose based on health data and contextual data associated with a user of the injection pen device, the health data including one or more analyte values associated with a health condition, and the contextual data including one or more of physical activity data, location data, or nutrient data corresponding to a food, wherein the software application program product includes (i) a data aggregator (210) that obtains the health data and the contextual data, (ii) a dose calculator (220) that autonomously determines the recommended dose of the medicine, wherein dose calculator autonomously determines the recommended dose of the medicine based on the health data and contextual data without user input action of the user on the user interface, and (iii) a user interface generator (225) to produce a user interface on a display of the injection pen device or the mobile communication device that persistently displays, on the produced user interface, the recommended dose.
  2. The system of claim 1, wherein the instructions, when executed by the processor of the data processing unit or the processor of the injection pen device, cause the mobile communication device or the injection pen device to: receive the one or more analyte values associated with the health condition to which the medicine is associated; receive the health data and the contextual data associated with the user; determine a medicine metric value associated with an amount of medicine active in the body of the user; autonomously calculate the recommended dose of the medicine without input from the user based at least on the one or more analyte values, the medicine metric value, and the contextual data including the nutrient data; and continuously display, on the display of the injection pen device or the mobile computing device, the recommended dose of the medicine.
  3. The system of claim 1, wherein the user interface generator produces the user interface to display information associated with a meal that includes a preset input indicative of a particular sized meal.
  4. The system of claim 3, wherein the medicine includes insulin, and the one or more analyte values include one or more glucose values, and wherein the particular sized meal includes one or more of (i) a small meal including a first predetermined amount of carbohydrates, (ii) a medium meal including a second predetermined amount of carbohydrates, (iii) a large meal including a third predetermined amount of carbohydrates, or (iv) a snack or dessert meal including a fourth predetermined amount of carbohydrates .
  5. The system of claim 4, wherein the medicine includes insulin, and the one or more analyte values include one or more glucose values, and wherein the particular sized meal is determined by the software application based at least in part on a time of day, the location data, a recent meal eaten by the user, or historical meal information including a meal pattern.
  6. The system of claim 1, wherein the instructions, when executed by the processor of the data processing unit or the processor of the injection pen device, cause the mobile communication device or the injection pen device to: determine a subtype of the medicine to be dispensed by the injection pen device, wherein different subtypes of the medicine differ in one or both of pharmacokinetics (PK) and pharmacodynamics (PD) of the medicine, wherein the PK-PD profile of the subtype of the medicine is a calculation factor in determination of the recommended dose.
  7. The system of claim 1, wherein the recommended dose of the medicine is displayed as a next-recommended dose of the medicine including a dose amount, a type of medicine, and a time for dispensing the next-recommended dose.
  8. The system of claim 1, wherein, where the mobile communication device includes the software application program product, the instructions, when executed by the processor of the data processing unit, cause the mobile communication device to display the recommended dose of the medicine on a home screen, on an application screen, or in a form of a notification or a widget of the mobile computing device.
  9. The system of claim 1, wherein the one or more analyte values include one or more glucose values, and the medicine includes insulin, and wherein the instructions, when executed by the processor of the data processing unit or the processor of the injection pen device, cause the mobile communication device or the injection pen device to autonomously calculate the recommend dose of the insulin without input from the user by determining an insulin metric value associated with the patient user based on insulin on board (IOB) data pertaining to an estimated amount of insulin medicine active in the body of the patient user; autonomously calculating a dose of the insulin medicine based at least on the one or more glucose values and the insulin metric value; and continuously displaying, on the display, the calculated dose of the insulin medicine.
  10. The system of claim 1, wherein the one or more analyte values include one or more glucose values, and the medicine includes insulin, and wherein the recommended dose is associated with a current correction insulin dose to reach a target glucose level.
  11. The system of claim 1, wherein, where the mobile communication device includes the software application program product, the received one or more analyte values and/or the received health data and contextual data are imported from another software application operable on the mobile communication device.
  12. The system of claim 1, wherein the health data includes information pertaining to one or more of a previous dose of the medicine or a dose of another medicine taken by the user.
  13. The system of claim 1, wherein the contextual data further includes information pertaining to one or more of a measured heart rate of the user, a measured blood pressure of the user, an event attended or to be attended by the user, or a mental state of the user.
  14. The system of claim 1, wherein the mobile communication device is implemented on a smartphone, a tablet, or a wearable computing device including a smartwatch or smartglasses.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This patent document claims priorities to and benefits of U.S. Provisional Patent Application No. 62/571,538 entitled "INTELLIGENT MEDICATION DELIVERY SYSTEMS AND METHODS FOR DOSE RECOMMENDATION AND MANAGEMENT" filed on October 12, 2017. TECHNICAL FIELD This patent document relates to medicine administering and tracking systems, BACKGROUND Diabetes mellitus, also referred to as diabetes, is a metabolic disease associated with high blood sugar due to insufficient production or use of insulin by the body. Diabetes is widely-spread globally, affecting hundreds of millions of people, and is among the leading causes of death globally. Diabetes has been categorized into three categories or types: type 1, type 2, and gestational diabetes. Type 1 diabetes is associated with the body's failure to produce sufficient levels of insulin for cells to uptake glucose. Type 2 diabetes is associated with insulin resistance, in which cells fail to use insulin properly. The third type of diabetes is commonly referred to as gestational diabetes, which can occur during pregnancy when a pregnant woman develops a high blood glucose level. Gestational diabetes can develop into type 2 diabetes, but often resolves after the pregnancy. US 2016/0012205 A1 describes a medicine administering system including injection pen and companion device. US 2011/0281791 A1 describes crystalline insulin-conjugates. SUMMARY The invention is defined by the subject-matter of claim 1. Further embodiments are defined in the dependent claims. Systems, devices, and techniques are disclosed for administering and tracking medicine to patients and providing health management capabilities for patients and caregivers. In some aspects, a system for administering a medicine includes an injection pen device including a dose setting mechanism to set a dose of a medicine contained in a medicine cartridge that is to be dispensed by the injection pen device, a dispensing mechanism to dispense In particular, US 2016/0012205 A1 describes methods, systems, and devices for administering a medicament to a patient. In one aspect, a described system includes an injection pen device in wireless communication with a mobile communication device. The injection pen device includes a housing including a chamber to encase a cartridge containing medicine, a dose setting and dispensing mechanism to set the mechanism to dispense a particular dose of the medicine from the loaded cartridge, a sensor unit to detect a dispensed dose based on positions and/or movements of the dose setting and dispensing mechanism, and an electronics unit in communication with the sensor unit to process the detected dispensed dose and time data associated with a dispensing event and to wirelessly transmit the dose data to a user's device. The mobile communication device provides a software application to provide the user with health information using the processed dose data. the medicine according to the set dose, and electronic circuits including a processor, a memory comprising instructions executable by the processor, and a wireless transmitter, the processor of the injection pen device configured to generate dose data associated with a dispensing event of a dose of the medicine dispensed from the injection pen device and time data associated with the dispensing event, and to wirelessly transmit the dose data, the injection pen device in wireless communication with a mobile communication device including a data processing unit including a processor and memory to receive and process the dose data, in which the mobile communication device includes a software application program product comprising a non-transitory computer-readable storage medium having instructions, which when executed by the processor of the data processing unit, cause the mobile communication device to determine a recommended dose based on health data and contextual data associated with a user of the injection pen device, the health data including one or more analyte values associated with a health condition, and the contextual data including one or more of physical activity data, location data, or nutrient data corresponding to a food, in which the software application program product includes (i) a data aggregator that obtains the health data and the contextual data, (ii) a dose calculator that autonomously determines the recommended dose of the medicine, and (iii) a user interface generator to produce a user interface on a display of the mobile communication device that persistently displays, on the produced user interface, the recommended dose. In some aspects, a method for determining a medicine dose for administering to a patient user by an injection pen device includes receiving, by a software application operable on a mobile computing device of the patient user, one or more analyte values associated with a health condition of the patient user; receiving, by the software application, context