Calculating a medicament dose

• US 10,506,972 B2
• Filed: 10/19/2018
• Issued: 12/17/2019
• Est. Priority Date: 03/18/2011
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Schabbach, Michael, Heisiep, Jorg, Muller-Pathle, Stephan, MacArthur, Ross
• Primary Examiner(s): Downey, John R
• Application Number:
  US16/165,726
• Publication Number:
  US 20190053755A1
• Time in Patent Office: 424 Days
• Field of Search: 600300, 600301
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/222 combined with detection or measurement of physiological parameters, e.g. heart rate
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A device for determining and displaying a dose of a medicament to be administered to a user based, at least in part, on a measure of physical activity of the user described herein includes a determining unit configured determine a measure of physical activity of the user using information provided by one or more sensors. The device also includes a computer readable memory storing a set of predefined templates comprising predefined actions, rules, and parameters defining at least an initial medicament dose value, the measure of physical activity of the user, a time elapsed between an instance of physical activity and a current time, and a target blood glucose value, wherein the determining unit is further configured to determine the medicament dose based, at least in part, on the measure of physical activity of the user, by execution of one or more templates from the set of predefined templates.

Claims

1. A device for determining and displaying a dose of a medicament for treatment of a user with basal insulin or analogues thereof, or glargine insulin or analogues thereof to achieve glycemic control and to be administered to the user based, at least in part, on a measure of physical activity of the user, the device comprising:

a determining unit configured to determine a measure of physical activity of the user using information provided by one or more sensors;

a computer readable memory storing a set of predefined templates comprising predefined actions, rules, and parameters defining at least an initial medicament dose value, the measure of physical activity of the user, a time elapsed between an instance of physical activity and a current time, and a target blood glucose value, wherein the determining unit is further configured to determine the dose of the medicament based, at least in part, on the measure of physical activity of the user, by execution of one or more templates from the set of predefined templates, at least one of the predefined templates, upon execution, being configured to afford a higher weight to an instance of physical activity having a higher level of intensity such that the higher level of intensity results in a disproportionately greater increase in the weight afforded to the medicament dose than a respective recorded value of the determined level of intensity;

a display unit configured to indicate the determined dose of the medicament to the user; and

a dose setting unit configured to receive the determined dose of the medicament from the determining unit and set the determined dose in a dose delivering unit, wherein the dose delivering unit is configured to deliver the determined dose to treat the user.

2. A device as claimed in claim 1, wherein the device further comprises a blood glucose measurement unit configured to measure a glucose level of a sample of blood from the user.

3. A device as claimed in claim 1, wherein the set of predefined templates further comprises a parameter defining a dose increase step.

4. A device as claimed in claim 1, wherein the set of predefined templates further comprises a parameter defining a time interval for increasing the dose.

5. A device as claimed in claim 1, wherein the set of predefined templates further comprises a parameter defining a low blood glucose threshold value.

6. A device as claimed in claim 1, wherein the set of predefined templates further comprises a parameter defining a low blood glucose medicament dose decrease step.

7. A device as claimed in claim 1, wherein the set of predefined templates further comprises a hypoglycemic blood glucose threshold value.

8. A device as claimed in claim 1, wherein the set of predefined templates further comprises a hypoglycemic blood glucose medicament dose decrease step.

9. A device as claimed in claim 1, wherein the one or more sensors include a pedometer and the measure of physical activity is based on a number of steps taken by the user within a predetermined period.

10. A device as claimed in claim 9, wherein the pedometer is integrated with the device.

11. A device as claimed in claim 1, wherein the one or more sensors include an accelerometer integrated with the device.

12. A device as claimed in claim 1, wherein the device further comprises a communications receiver configured to receive information from one or more external sensors.

13. A device as claimed in claim 12, wherein the device is configured to verify that information received using the communications receiver relates to a user registered with the device and to disregard information other than the verified information when calculating the medicament dose.

14. A device as claimed in claim 12, wherein the device is configured to receive information relating to heart rate and/or blood pressure of the user and the determining unit is configured to determine the measure of physical activity based on the heart rate and/or blood pressure information.

15. A device as claimed in claim 12, wherein the device is configured to receive information relating to work done by the user or power exerted by the user from an external ergometer and the determining unit is configured to determine the measure of physical activity by processing the work done or power information.

16. A device as claimed in claim 1, wherein the set of predefined templates further comprise a list of rules.

17. A device as claimed in claim 1, wherein the device further comprises a user input unit configured to receive input from a user;

and

wherein execution of the one or more predefined templates is based on the user input, or a determination of which of the plurality of predefined templates to execute is based, at least in part, on the user input, or parameters of the one or more templates are personalized based on the user input.

18. A device as claimed in claim 1, wherein the determining unit is further configured to afford a higher weight to an instance of physical activity occurring more recently with respect to the current time.

21. A device as claimed in claim 1, wherein at least one of the predefined templates, upon execution, is configured to disregard instances of physical activity occurring at a time before a previous delivery of a dose of the medicament.

22. A device as claimed in claim 1, wherein the determined dose is for treatment of the specific user based on the physical activity of the user during the predetermined time with the determined dose of at least one of basal insulin, glargine insulin or analogues to achieve glycemic control.

19. A method of operating a device for determining and displaying a dose of a medicament for treatment of a user with basal insulin or analogues thereof, or glargine insulin or analogues thereof to achieve glycemic control based, at least in part, on a measure of physical activity of the user, the method comprising:

determining, by a determining unit of the device, a measure of physical activity of a user using information provided by one or more sensors;

executing, using one or more processors of the device, one or more predefined templates from a set of predefined templates stored in a computer readable memory to determine a dose of the medicament based, at least in part, on the measure of physical activity of the user, the set of predefined templates comprising parameters defining at least an initial medicament dose value, the measure of physical activity of the user, a time elapsed between an instance of physical activity and a current time, and a target blood glucose value, at least one of the predefined templates, upon execution, being configured to afford a higher weight to an instance of physical activity having a higher level of intensity such that the higher level of intensity results in a disproportionately greater increase in the weight afforded to the medicament dose than a respective recorded value of the determined level of intensity;

indicating, by a display unit, the determined dose of the medicament to the user;

setting, by a dose setting unit configured to receive the determined dose of the medicament from the determining unit, the determined dose in a dose delivering unit; and

delivering, by the dose delivering unit, the determined dose to treat the user.

20. A method as claimed in claim 19, wherein the method further comprises selecting the one or more templates to be executed from the set of predefined templates.