# US 10,368,745 B2 · Systems and methods for optimizing insulin dosage > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,368,745 B2 - Document ID: US10368745B2 - Status: Granted - Kind: B2 - Application number: 15/887,239 - Filed: 2018-02-02 - Published: 2018-06-21 - Granted: 2019-08-06 - Earliest claimed: 2008-12-23 - Assignees: Roche Diabetes Care, Inc. - Applicants: Roche Diabetes Care, Inc. - Inventors: Steven Bousamra; Stefan Weinert; Juergen Rasch-Menges; P. Douglas Walling; John F. Price; Heino Eikmeier; Birgit Kraeling; Karl Werner; Ulrich Porsch - Web page: https://patentgrep.com/patent/US10368745B2 ## CPC - A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - G16H 10/20: for electronic clinical trials or questionnaires - G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis - G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients - G16H 20/17: delivered via infusion or injection - G16H 40/63: for local operation - G16H 40/67: for remote operation - G16H 80/00: ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring - A61B 5/05: Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves (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) - 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}) - A61M 2230/201: Glucose concentration - C12Q 1/006: {for glucose} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## Abstract Embodiments of a testing method for diabetics to optimize their administered insulin dosage comprise collecting sampling sets of biomarker data, each sampling set comprising a sufficient plurality of non-adverse sampling instances and each sampling instance comprising 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 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 biomarker sampling parameters fall within the target biomarker range. ## Claims ### Claim 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 based on at least one of a schedule-based action or a patient-based action and that is applied to the one or more sampling sets of biomarker data; wherein after each collection of the one or more sampling sets of biomarker data, said processor performs the processes of: calculating a biomarker sampling parameter from the one or more sampling sets of biomarker data and as a function of only these biomarker data that 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; and 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) The testing method of claim 1 further comprising conducting a new testing method after achieving the optimized insulin dosage. ### Claim 4 (depends on 1) 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. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) 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. ### Claim 7 (depends on 1) The testing method of claim 1 further comprising informing the health care provider of any biomarker readings indicative of an adverse event that is a hypoglycemic event. ### Claim 8 (depends on 1) The testing method of claim 1 wherein a biomarker reading below a lower threshold is indicative of an adverse event. ### Claim 9 (depends on 1) The testing method of claim 1 further comprising contacting the health care provider for any biomarker readings indicative of an adverse event. ### Claim 10 (depends on 1) The testing method of claim 1 wherein the administered insulin dosage is decreased for any biomarker readings indicative of an adverse event. ### Claim 11 (depends on 1) The testing method of claim 1 wherein the one or more acceptance criterion requires at least one of that a prescribed dosage be administered throughout the collection period and that a fasting period before collection of the one or more sampling sets of biomarker data. ### Claim 12 (depends on 1) 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. ### Claim 13 (depends on 12) The testing method of claim 12 wherein the entry criteria requires at least one of that the diabetic person be afflicted with type 2 diabetes and that the diabetic person be limited to oral diabetes medication prior to conducting the testing method. ### Claim 14 (depends on 1) The testing method of claim 1 wherein the maximum insulin dosage is set by the health care provider. ### Claim 15 (depends on 1) The testing method of claim 1 wherein the biomarker sampling parameter is determined by at least one of averaging sampling instances, summing the sampling instances, performing a graphical analysis on the sampling instances, and performing a mathematical algorithm on the sampling set. ### Claim 16 (depends on 1) 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. ### Claim 17 (depends on 1) The testing method of claim 1 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. ### Claim 18 (depends on 1) The testing method of claim 1 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. ### Claim 19 (depends on 18) The testing method of claim 18 wherein said processor performs the processes of 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. ### Claim 20 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 based on at least one of a schedule-based action or a patient-based action and 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; wherein after each collection of the one or more sampling sets of biomarker data, said processor performs the processes of: calculating a biomarker sampling parameter from the one or more sampling sets of biomarker data and as a function of only these biomarker data that 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; and 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.