Systems and methods for optimizing insulin dosage

• US 9,918,635 B2
• Filed: 06/18/2010
• Issued: 03/20/2018
• Est. Priority Date: 12/23/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Bousamra, Steven, Weinert, Stefan, Rasch-Menges, Juergen, Walling, P. Douglas, Price, John F., Eikmeier, Heino, Kraeling, Birgit, Werner, Karl, Porsch, Ulrich
• Primary Examiner(s): Agahi, Puya
• Application Number:
  US12/818,310
• Publication Number:
  US 20110015511A1
• Time in Patent Office: 2,832 Days
• Field of Search: 600309, 600316, 600345-347, 600365, 600300, 600301, 434 4, 434 14, 436 68, 422 50, 422420-429, 20440301-40315, 702 23, 604 64- 66
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/05 Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves impedance plethysmography A61B5/0295; measuring movement of the entire body or parts thereof A61B5/11; detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof A61B5/24
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: C12Q 1/006 for glucose
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• 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 40/63 for local operation
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

Embodiments of a testing method suitable for diabetic persons to optimize their administered insulin dosage comprise collecting one or more sampling sets of biomarker data, wherein each sampling set comprises a sufficient plurality of non-adverse sampling instances and wherein each sampling instance comprises an acceptable biomarker reading at a single point in time recorded upon compliance with adherence criteria, determining a biomarker sampling parameter from each sampling set, comparing the biomarker sampling parameter to a target biomarker range, calculating an insulin adjustment parameter associated with the biomarker sampling parameter if the biomarker sampling parameter falls outside the target biomarker range, adjusting the insulin dosage by the insulin adjustment parameter if the biomarker sampling parameter falls outside the target biomarker range and if the insulin dosage does not exceed maximum dosage, and exiting the testing method if the adjusted insulin dosage is optimized. The insulin dosage is optimized when one or more biomarker sampling parameters fall within a target biomarker range.

Claims

1. A testing method suitable for a diabetic person to optimize an administered insulin dosage comprising:

providing a structured collection procedure from a server of a health care provider to a collection device configured to guide the diabetic person through the structured collection procedure and optimize the administered insulin dosage, wherein the collection device comprises a meter configured to measure one or more selected biomarkers, a processor disposed inside the meter and coupled to a memory, wherein the memory stores the structured collection procedure provided from the server, and software having instructions that when executed by the processor causes the processor to instruct the diabetic person to collect one or more sampling sets of biomarker data in accordance with the structured collection procedure, wherein the server is a central repository for a plurality of the structured collection procedures;

executing the software on the collection device and according to instructions and timing provided by the structured collection procedure;

collecting one or more sampling sets of biomarker data, wherein each of the one or more sampling sets comprises a plurality of sampling instances recorded over a collection period and each sampling instance of the plurality of sampling instances comprises an acceptable biomarker reading recorded upon compliance with one or more acceptance criterion that is applied to the one or more sampling sets of biomarker data, wherein the one or more acceptance criterion comprises one or more considerations selected from the group consisting of;

a patient diet, fasting or eating regimen;

a patient exercise regimen;

a patient lifestyle;

a patient sleep regimen;

insulin dosage amounts; and

timing of biomarker reading collection;

wherein after each collection of the one or more sampling sets of biomarker data, said processor performs the processes of;

determining a biomarker sampling parameter from the one or more sampling sets of biomarker data whereby only these biomarker data are considered which are in compliance with the one or more acceptance criterion;

comparing the biomarker sampling parameter to a target biomarker range;

calculating an insulin adjustment parameter associated with the biomarker sampling parameter in response to the biomarker sampling parameter falling outside the target biomarker range;

adjusting an insulin dosage by an amount of the insulin adjustment parameter in response to the biomarker sampling parameter falling outside the target biomarker range and in response to the insulin dosage not exceeding maximum dosage;

exiting the testing method in response to the adjusted insulin dosage being optimized as an optimized insulin dosage such that the optimized insulin dosage is administered as the administered insulin dosage, otherwise repeating with a next sampling set of the one or more sampling sets of biomarker data, the optimized insulin dosage being achieved when the one or more biomarker sampling parameters fall within the target biomarker range; and

wherein the one or more acceptance criterion comprises an adherence criteria, and in response to the diabetic person failing to meet the adherence criteria, the processor tags the failing as an adherence event and informs the diabetic person via a display, then continues the testing method, wherein in response to a determination that a number of the adherence events in a sample period are obtained or a total number of the adherence events are reached in the testing method, the testing method is terminated;

categorizing, via the processor, the adherence events into tiers of either a lower weighted adherence event in response to a determination that the adherence event will not cause an error in at least one acceptable biomarker reading, or a higher weighted adherence event in response to a determination that the adherence event will cause the error in the at least one acceptable biomarker reading, wherein the lower weighted adherence event is an event that is not weighted as heavily as the higher weighted adherence event that affects the one or more sampling sets of biomarker data;

maintaining, by the health care provider, an electronic medical record for the diabetic person on the server; and

generating a hardcopy report of results of the collection procedure for the diabetic person via a computer of the health care provider.

2. The testing method of claim 1 wherein the insulin dosage is optimized when at least two consecutive biomarker sampling parameters fall within the target biomarker range.

3. The testing method of claim 1 further comprising conducting a new testing method after achieving the optimized insulin dosage.

4. The testing method of claim 1 wherein the collection period for the one or more sampling sets of biomarker data is defined as multiple sampling instances within a day, multiple sampling instances within a week, multiple sampling instances within consecutive weeks, or multiple sampling instances on consecutive days within a week.

5. The testing method of claim 1 wherein each sampling instance of the plurality of sampling instances comprises the acceptable biomarker reading and other contextual data associated with the acceptable biomarker reading, wherein the contextual data is selected from the group consisting of a time of collection, a date of collection, a time when the last meal was consumed, and combinations thereof.

6. The testing method of claim 1 further comprising collecting one or more additional sampling sets of biomarker data when the biomarker sampling parameter falls outside of the target biomarker range.

7. The testing method of claim 1 further comprising informing the health care provider of any biomarker readings indicative of an adverse event.

8. The testing method of claim 7 further comprising reducing the administered insulin dosage for any biomarker readings indicative of an adverse event.

9. The testing method of claim 7 wherein the adverse event is a hypoglycemic event.

10. The testing method of claim 1 wherein a biomarker reading below a lower threshold is indicative of an adverse event.

11. The testing method of claim 1 further comprising contacting the health care provider for any biomarker readings indicative of an adverse event.

12. The testing method of claim 1 wherein the administered insulin dosage is decreased for any biomarker readings indicative of an adverse event.

13. The testing method of claim 1 further comprising meeting entry criteria required for beginning to collect the one or more sampling sets of biomarker data.

14. The testing method of claim 1 wherein the one or more acceptance criterion requires that a prescribed dosage be administered throughout the collection period.

15. The testing method of claim 1 wherein the one or more acceptance criterion requires a fasting period before collection of the one or more sampling sets of biomarker data.

16. The testing method of claim 13 wherein the entry criteria requires that the diabetic person be afflicted with type 2 diabetes.

17. The testing method of claim 13 wherein the entry criteria requires that the diabetic person be limited to oral diabetes medication prior to conducting the testing method.

18. The testing method of claim 1 wherein the maximum insulin dosage is set by the health care provider.

19. The testing method of claim 1 wherein the biomarker sampling parameter is determined by averaging sampling instances, summing the sampling instances, performing a graphical analysis on the sampling instances, performing a mathematical algorithm on the sampling set, or combinations thereof.

20. The testing method of claim 1 wherein the biomarker sampling parameter is determined by averaging sampling instances.

21. The testing method of claim 1 wherein the calculating of the insulin adjustment parameter comprises locating the insulin adjustment parameter associated with the biomarker parameter in an insulin adjustment parameter lookup table, utilizing an algorithm, and combinations thereof.

22. The testing method of claim 1 wherein the acceptable biomarker reading includes information concerning a biomarker type selected from glucose, triglycerides, low density lipids, and high density lipids.

23. The testing method of claim 1 wherein the acceptable biomarker reading is a blood glucose reading.

24. The testing method of claim 1 wherein the admistered insulin dosage is a basal insulin dosage.

25. The testing method of claim 1 further comprising exiting the testing method for the occurrence of a violation event.

26. A testing method suitable for a diabetic person to optimize an administered insulin dosage comprising:

providing a structured collection procedure from a server of a health care provider to a collection device configured to guide the diabetic person through the structured collection procedure and optimize the administered insulin dosage, wherein the collection device comprises a meter configured to measure one or more selected biomarkers, a processor disposed inside the meter and coupled to a memory, wherein the memory stores the structured collection procedure provided from the server, and software having instructions that when executed by the processor causes the processor to instruct the diabetic person to collect one or more sampling sets of biomarker data in accordance with the structured collection procedure, wherein the server is a central repository for a plurality of the structured collection procedures;

collecting one or more sampling sets of biomarker data by the collection device, wherein each of the one or more sampling sets comprises a plurality of sampling instances recorded over a collection period and each sampling instance of the plurality of sampling instances comprises an acceptable biomarker reading recorded upon compliance with one or more acceptance criterion that is applied to the one or more sampling sets of biomarker data, wherein the one or more acceptance criterion require collection of the acceptable biomarker reading by the diabetic patient at a time required by the collection device and wherein the one or more acceptance criterion comprises one or more considerations selected from the group consisting of;

a patient diet, fasting or eating regimen;

a patient exercise regimen;

a patient lifestyle;

a patient sleep regimen;

insulin dosage amounts; and

timing of biomarker reading collection;

wherein after each collection of the one or more sampling sets of biomarker data, said processor performs the processes of;

determining a biomarker sampling parameter from the one or more sampling sets of biomarker data whereby only these biomarker data are considered which are in compliance with the one or more acceptance criterion;

comparing the biomarker sampling parameter to a target biomarker range;

calculating an insulin adjustment parameter associated with the biomarker sampling parameter in response to the biomarker sampling parameter falling outside the target biomarker range;

adjusting an insulin dosage by an amount of the insulin adjustment parameter in response to the biomarker sampling parameter falling outside the target biomarker range and in response to the insulin dosage not exceeding maximum dosage;

exiting the testing method in response to the adjusted insulin dosage being optimized as an optimized insulin dosage such that the optimized insulin dosage is administered as the administered insulin dosage, otherwise repeating with a next sampling set of the one or more sampling sets of biomarker data, the optimized insulin dosage being achieved when the one or more biomarker sampling parameters fall within the target biomarker range; and

wherein the one or more acceptance criterion comprises an adherence criteria, and in response to the diabetic person failing to meet the adherence criteria, the processor tags the failing as an adherence event and informs the diabetic person via a display, then continues the testing method, wherein in response to a determination that a number of the adherence events in a sample period are obtained or a total number of the adherence events are reached in the testing method, the testing method is terminated; and

categorizing, via the processor, the adherence events into tiers of either a lower weighted adherence event in response to a determination that an event will not cause an error in at least one acceptable biomarker reading, or a higher weighted adherence event in response to a determination that the event will cause the error in the at least one acceptable biomarker reading, wherein the lower weighted adherence event is an event that is not weighted as heavily as the higher weighted adherence event that affects the one or more sampling sets of biomarker data; and

maintaining, by the health care provider, an electronic medical record for the diabetic person on the server and;

generating a hardcopy report of results of the collection procedure for the diabetic person via a computer of the health care provider.

27. The testing method of claim 26 wherein the administered insulin dosage is optimized when at least two consecutive biomarker sampling parameters fall within the target biomarker range.

28. The testing method of claim 26 further comprising conducting a new testing method after achieving the optimized insulin dosage.

29. The testing method of claim 26 wherein each sampling instance of the plurality of sampling instances comprises the acceptable biomarker reading and other contextual data associated with the acceptable biomarker reading, wherein the contextual data is selected from the group consisting of a time of collection, a date of collection, a time when the last meal was consumed, and combinations thereof.

30. The testing method of claim 26 further comprising collecting one or more additional sampling sets of biomarker data when the biomarker sampling parameter falls outside of the target biomarker range.

31. The testing method of claim 26 further comprising meeting entry criteria required for beginning to collect the one or more sampling sets of biomarker data.

32. The testing method of claim 26 further comprising exiting the testing method for the occurrence of a violation event.