SYSTEM FOR DEVELOPING PATIENT SPECIFIC THERAPIES BASED ON DYNAMIC MODELING OF PATIENT PHYSIOLOGY AND METHOD THEREOF

• US 20090006061A1
• Filed: 05/12/2008
• Published: 01/01/2009
• Est. Priority Date: 06/27/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Weinert, Stefan, Galley, Paul, Chittajallu, Siva, Thukral, Ajay
• Granted Patent: US 8,818,782 B2
• Time in Patent Office: Days
• US Class Current: 703/11
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• 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 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A system for developing patient-specific therapies based on dynamic modeling of patient-specific physiology and method thereof are disclosed. The system includes software modules configured to provide access via a computer to one or more data collection protocols defining at least a type of patient-specific data to be collected and a manner in which the patient-specific data is to be collected, and to information from which one or more patient-specific models, configured to simulate one or more aspects of the patient'"'"'s physiology, is developed. Another software module of the system is configured to provide access via the computer to one or more software tools that apply patient-specific data, collected according to the one or more data collection protocols, to the one or more patient specific models to determine therefrom one or more patient-specific therapies.

Claims

1. A computerized system used by a user(s) to developing patient specific therapies for chronic disease management of a patient(s), the system comprising:

a data collection module which enables the system to collect patient specific data according to a data collection protocol and performs integrity and quality checks on the patient specific data;

a user interface which enables the user to select a patient model from a plurality of patient models provided by the system;

a module validation module which enables the system to validate the selected patient model;

an analyses module which enables the system to apply the patient specific data to the selected patient model to extract useful patient specific physiological information, and to use the extracted patient specific physiological information to develop one or more patient specific therapies for treating the chronic disease of the patient;

a result validation and presentation module which enables the system to validate the one or more patient specific therapies and to present validated ones of the one or more patient specific therapies on the user interface for approval.

2. The computerized system according to claim 1 wherein the data collection protocol dictates specific data to be collected, manner to be collected, and compliancy procedure.

3. The computerized system according to claim 1 wherein for the integrity and quality checks the data collection module enables the system to check for inconsistencies between collected patient specific data and the data collection protocol and time stamps, to determine whether collection performed over a required time period, and to determine for the collected patient data whether data values are in predefined ranges and provide a predetermined number of samples within a certain time window.

4. The computerized system according to claim 1 wherein the system provides the plurality of patient models from at least one of a client computer, a computer server, a portable memory device, computer storage, and a computer readable medium.

5. The computerized system according to claim 1 wherein the plurality of patient models each mathematically represents at least one aspect of human physiology, and provides mapping to different physiological states, conditions or parameters.

6. The computerized system according to claim 1 wherein the module validation module enables the system to perform on the selected patient model at least one of a Bayesian analysis, a cost function analysis, parameter estimation, statistical analysis, numeric analysis, range analysis, gain values analysis, test scenarios analysis, simulations, and modeling.

7. The computerized system according to claim 1 wherein the model validation module enables the system to determine model parameters which are then used to validate the selected patient model.

8. The computerized system according to claim 1 wherein the analyses module provides analysis tools which enables the system to perform at least one of simulations, statistical analysis, sensitivity analysis, visualizations, information extraction, optimizations, and to provide recommendations which include at least one of type, amount, and timing for dosing, exercise, and meals.

9. The computerized system according to claim 1 further comprising a rule/guideline sets module which governs the system in collection of the patient specific data according to the data collection protocol.

10. The computerized system according to claim 1 wherein the result validation and presentation module provides simulation tools which enable the system to test the one or more patient specific therapies for at least one of robustness, stability, sensitivity to parameter variation, and effectiveness, and to generate confidence intervals.

11. The computerized system according to claim 1 wherein the system is a client/server system.

12. A computerized system for developing patient-specific therapies based on dynamic modeling of patient-specific physiology, the system comprising a computer configured to provide access to a number of software modules stored in at least one database or other memory unit, the number of software modules including:

a first software module configured to provide access via the computer to one or more data collection protocols defining at least a type of patient-specific data to be collected and a manner in which the patient-specific data is to be collected,

a second software module configured to provide access via the computer to information which develop one or more patient-specific models configured to simulate one or more aspects of physiology of the patient,

a third software module configured to provide access via the computer to one or more software tools that apply patient-specific data, collected according to the one or more data collection protocols, to the one or more developed patient specific models to determine therefrom one or more patient-specific therapies, and

a fourth software module configured to provide access via the computer to one or more software validation tools that validate the patient-specific therapies and to present the one or more patient-specific therapies on the computer.

13. A computer implemented method of developing patient specific therapies for chronic disease management of a patient(s) on a computerized system, the method comprising:

providing a data collection module which enables the system to collect patient specific data according to a data collection protocol and performs integrity and quality checks on the patient specific data;

providing a user interface which enables the user to select a patient model from a plurality of patient models provided by the system;

providing a module validation module which enables the system to validate the selected patient model;

providing an analyses module which enables the system to apply the patient specific data to the selected patient model to extract useful patient specific physiological information, and to use the extracted patient specific physiological information to develop one or more patient specific therapies for treating the chronic disease of the patient;

providing a result validation and presentation module which enables the system to validate the one or more patient specific therapies and to present validated ones of the one or more patient specific therapies on the user interface for approval.

14. The computer implemented method according to claim 13 further comprises using the data collection protocol to dictate specific data to be collected, manner to be collected, and a compliancy procedure.

15. The computer implemented method according to claim 13 further comprises using the system to check for inconsistencies between collected patient specific data and the data collection protocol and time stamps, to determine whether collection performed over a required time period, and to determine for the collected patient data whether data values are in predefined ranges and provide a predetermined number of samples.

16. The computer implemented method according to claim 13 further comprises using the system to provide the plurality of patient models from at least one of a computer server, a portable memory device, computer storage, and a computer readable medium.

17. The computer implemented method according to claim 13 further comprises using the system to modify the selected patient model and add a new patient model which mathematically represent at least one aspect of human physiology, and which provides mapping to different physiological states, conditions or parameters.

18. The computer implemented method according to claim 13 further comprises using the system to perform on the selected patient model at least one of a Bayesian analysis, a cost function analysis, parameter estimation, statistical analysis, numeric analysis, range analysis, gain values analysis, test scenarios analysis, simulations, and modeling.

19. The computer implemented method according to claim 13 further comprises using the system to determine model parameters which are then used to validate the selected patient model.

20. The computer implemented method according to claim 13 further comprises using the system to perform at least one of simulations, statistical analysis, sensitivity analysis, visualizations, information extraction, optimizations, and to provide recommendations which include at least one of type, amount, and timing for dosing, exercise, and meals.

21. The computer implemented method according to claim 13 further comprising using a rule/guideline sets module which governs the system in collection of the patient specific data according to the data collection protocol.

22. The computer implemented method according to claim 13 further comprises using system to test the one or more patient specific therapies for at least one of robustness, stability, sensitivity to parameter variation, and effectiveness, and to generate confidence intervals.

23. The computer implemented method according to claim 13 further comprises providing the system as a client/server system.

24. A computer implemented method for developing patient-specific therapies based on dynamic modeling of patient-specific physiology on a computer, comprising:

configuring the computer to provide access to a number of software modules stored in at least one database or other memory unit;

configuring a first one of the software modules to provide access via the computer to one or more data collection protocols defining at least a type of patient-specific data to be collected and a manner in which the patient-specific data is to be collected,

configuring a second one of the software modules to provide access via the computer to information which develop one or more patient-specific models configured to simulate one or more aspects of physiology of the patient,

configuring a third one of the software modules to provide access via the computer to one or more software tools that apply patient-specific data, collected according to the one or more data collection protocols, to the one or more developed patient specific models to determine therefrom one or more patient-specific therapies, and

configuring a fourth one of the software modules to provide access via the computer to one or more software validation tools that validate the patient-specific therapies and present the one or more patient-specific therapies on the computer.