Medical system and method for providing information for glycemic control

• US 10,478,100 B2
• Filed: 02/03/2010
• Issued: 11/19/2019
• Est. Priority Date: 02/04/2009
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Tubb, Andrew
• Primary Examiner(s): Morgan, Robert W
• Assistant Examiner(s): Coleman, Charles P
• Application Number:
  US13/146,968
• Publication Number:
  US 20120109687A1
• Time in Patent Office: 3,576 Days
• Field of Search: 705 2, 705 3, 705 20
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A medical device and a method for configuring a process for determining a dose of insulin to be administered for glycemic control is provided, wherein the dose is stepwise adapted, comprising defining different dose adjustment profiles for stepwise adapting the dose, wherein each of the different dose adjustment profiles is based at least on a specific initial dose value, a specific time interval for increasing the dose, a specific dose increase step and a specific low blood glucose threshold value, storing the different dose adjustment profiles, selecting one of the stored different dose adjustment profiles based on specific requirements for stepwise adapting the dose, and personalizing the selected dose adjustment profile by defining at least a specific target blood glucose value for a specific user.

Claims

1. A method for controlling a medical device to administer a dose of insulin for glycemic control, wherein the dose is stepwise adapted, the method comprising the steps of:

a computer system defining different stepwise adapting dose adjustment profiles for stepwise adapting the dose, wherein each of the different stepwise adapting dose adjustment profiles is based at least on a specific initial dose value, a specific pre-defined time interval for increasing the dose, a specific dose increase step for increasing the dose after the pre-defined time interval and a specific low blood glucose threshold value, wherein the different stepwise adapting dose adjustment profiles are provided for different insulin types and different diabetes types;

the computer system storing the different stepwise adapting dose adjustment profiles;

the computer system selecting one of the stored different stepwise adapting dose adjustment profiles based on specific requirements for stepwise adapting the dose, wherein the specific requirements for stepwise adapting the dose are defined by a diabetes type and an age of a diabetes patient;

the computer system personalizing the selected stepwise adapting dose adjustment profile by defining at least a specific target blood glucose value for a specific user;

the computer system transmitting the personalized stepwise adapting dose adjustment profile to the medical device;

the medical device receiving the personalized stepwise adapting dose adjustment profile and being updated with the received personalized stepwise adapting dose adjustment profile;

the updated medical device determining the dose according to the received personalized stepwise adapting dose adjustment profile; and

the updated medical device administering the determined dose to the specific user.

2. The method according to claim 1, wherein the specific requirements are further defined by a categorization of a diabetes patient.

3. The method according to claim 1, wherein the personalizing step comprises identifying the user of the selected stepwise adapting dose adjustment profile.

4. The method according to claim 1, wherein the different stepwise adapting dose adjustment profiles are defined by selecting the specific initial dose value from a predefined set of initial dose values, the specific time interval for increasing the dose from the predefined set of time intervals, the specific dose increase step from a predefined set of dose increase steps and the specific low blood glucose threshold value from a predefined set of low blood glucose threshold values.

5. The method according to claim 4, further comprising the step of defining plausibility rules which define predetermined combinations for selectable initial dose values, low blood glucose threshold values, time intervals and dose increase steps.

6. The method according to claim 1, further comprising the step of protecting the defined different stepwise adapting dose adjustment profiles from unauthorized changes.

7. The method according to claim 6, wherein the protecting step comprises:

receiving security data;

validating the received security data;

providing validation data corresponding to the validation of the received security data; and

controlling the defining step based on the validation data.

8. The method according to claim 1, wherein the different stepwise adapting dose adjustment profiles are defined on a data processing unit and the defined different stepwise adapting dose adjustment profiles are transmitted to the medical device for determining a dose of insulin to be administered for glycemic control.

20. The method of claim 1, wherein the medical device comprises one of an insulin pen, an insulin pump, or an inhale device.

9. A system for controlling a medical device to administer a dose of insulin for glycemic control, wherein the dose is stepwise adapted, the system comprising:

a data processing unit including one or more processors to define different stepwise adapting dose adjustment profiles for stepwise adapting the dose, wherein each of the different stepwise adapting dose adjustment profiles is based at least on a specific initial dose value, a specific pre-defined time interval for increasing the dose, a specific dose increase step for increasing the dose after the pre-defined time interval and a specific low blood glucose threshold value, wherein the different stepwise adapting dose adjustment profiles are provided for different insulin types and different diabetes types;

a storage unit to store the different stepwise adapting dose adjustment profiles;

a selection unit to select one of the stored different stepwise adapting dose adjustment profiles based on specific requirements for stepwise adapting the dose, wherein the specific requirements for stepwise adapting the dose are defined by a diabetes type and an age of a diabetes patient;

a personalization unit to personalize the selected stepwise adapting dose adjustment profile by defining at least a specific target blood glucose value for a specific user;

a transmitting unit to transmit the personalized profile to the medical device that receives and is updated with the transmitted personalized stepwise adapting dose adjustment profile;

an adapting unit of the medical device to stepwise determine the dose according to the transmitted personalized stepwise adapting dose adjustment profile; and

a dose delivering unit of the medical device, wherein the dose delivering unit is configured to administer the determined dose to the specific user.

10. The system according to claim 9, wherein the specific requirements are further defined by a categorization of a diabetes patient.

11. The system according to claim 9, wherein the personalization unit is configured to identify the user of the selected stepwise adapting dose adjustment profile.

12. The system according to claim 9, wherein the data processing unit is configured to provide a predefined set of initial dose values, a predefined set of target blood glucose values, a predefined set of low blood glucose threshold values, the predefined set of time intervals and a predefined set of dose increases and to select the specific initial dose value from the predefined set of initial dose values, the specific target blood glucose value from the predefined set of target blood glucose values, the specific low blood glucose threshold value from the predefined set of low blood glucose threshold values, the specific time interval for increasing the dose from the predefined set of time intervals and the specific dose increase step from the predefined set of dose increase steps.

13. The system according to claim 12, wherein the data processing unit is further configured to define plausibility rules which define predetermined combinations for selectable initial dose values, target blood glucose values, low blood glucose threshold values, time intervals and dose increases.

14. The system according to claim 9, wherein the computer system further comprises a protection unit to protect the defined different stepwise adapting dose adjustment profiles from unauthorized changes.

15. The system according to claim 14, wherein the protection unit comprises:

a receiving unit to receive security data;

a validating unit to validate the received security data and to provide validation data corresponding to the validation of the received security data; and

a safety unit to control the data processing unit based on the validation data.

16. The system according to claim 9, wherein the data processing unit comprises the transmitting unit to transmit the defined different dose adjustment profiles to the medical device for determining a dose of insulin, and wherein the medical device for determining the dose of insulin comprises a receiving unit to receive the defined different dose adjustment profiles, the storage unit, the selection unit and the adapting unit.

17. A non-transitory computer readable medium having instructions stored thereon that, in response to execution by one or more processors of a computer system, cause the one or more processors to perform operations, the instructions comprising:

instructions for defining different stepwise adapting dose adjustment profiles for stepwise adapting a dose, wherein each of the different stepwise adapting dose adjustment profiles is based at least on a specific initial dose value, a specific pre-defined time interval for increasing the dose, a specific dose increase step for increasing the dose after the pre-defined time interval and a specific low blood glucose threshold value;

instructions for storing the different stepwise adapting dose adjustment profiles;

instructions for selecting one of the stored different stepwise adapting dose adjustment profiles based on specific requirements for stepwise adapting the dose, wherein the specific requirements for stepwise adapting the dose are defined by a diabetes type and an age of a diabetes patient;

instructions for personalizing the selected stepwise adapting dose adjustment profile by defining at least a specific target blood glucose value for a specific user; and

instructions for transmitting the personalized profile from the computer system to a medical device that receives and is updated with the received personalized stepwise adapting dose adjustment profile, the updated medical device being configured to determine the dose according to the personalized stepwise adapting dose adjustment profile,

wherein the medical device is configured to administer the determined dose.

18. A method for controlling a medical device to administer a dose of insulin for glycemic control, wherein the dose is stepwise adapted, the method comprising the steps of:

a computer system defining different stepwise adapting dose adjustment profiles for stepwise adapting the dose, wherein each of the different stepwise adapting dose adjustment profiles is based at least on a specific initial dose value, a specific pre-defined time interval for increasing the dose, a specific dose increase step for increasing the dose after the pre-defined time interval and a specific low blood glucose threshold value, wherein the different stepwise adapting dose adjustment profiles are provided for different insulin types and different diabetes types;

the computer system storing the different stepwise adapting dose adjustment profiles;

the computer system selecting one of the stored different stepwise adapting dose adjustment profiles based on specific requirements for stepwise adapting the dose, wherein the specific requirements for stepwise adapting the dose are defined by a diabetes type and an age of a diabetes patient;

the computer system personalizing the selected stepwise adapting dose adjustment profile by defining at least a specific target blood glucose value for a specific user;

the computer system determining the dose according to the personalized stepwise adapting dose adjustment profile;

the computer system transmitting the determined dose to the medical device that receives and is updated with the determined dose; and

the medical device administering the determined dose to the specific user.

19. A method for controlling a medical device to administer a dose of insulin for glycemic control, wherein the dose is stepwise adapted, the method comprising the steps of:

a computer system defining different stepwise adapting dose adjustment profiles for stepwise adapting the dose, wherein each of the different stepwise adapting dose adjustment profiles is based at least on a specific initial dose value, a specific pre-defined time interval for increasing the dose, a specific dose increase step for increasing the dose after the pre-defined time interval and a specific low blood glucose threshold value, wherein the different stepwise adapting dose adjustment profiles are provided for different insulin types and different diabetes types;

the computer system storing the different stepwise adapting dose adjustment profiles;

the computer system selecting one of the stored different stepwise adapting dose adjustment profiles based on specific requirements for stepwise adapting the dose, wherein the specific requirements for stepwise adapting the dose are defined by a diabetes type and an age of a diabetes patient;

the computer system personalizing the selected stepwise adapting dose adjustment profile by defining at least a specific target blood glucose value for a specific user;

the computer system determining the dose according to the personalized stepwise adapting dose adjustment profile;

the computer system transmitting the determined dose to the medical device that receives and is updated with the determined dose;

the medical device proposing the determined dose to be administered to the specific user, wherein the medical device is configured to receive an input from the specific user indicating whether the proposed dose should be maintained or changed to a different value;

the medical device receiving an input from the specific user indicating that the proposed dose should be maintained; and

the medical device administering the proposed dose to the specific user.