摘要:
A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.
摘要:
Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.
摘要:
Embodiments related to a system and method managing the implementation, execution, data collection, and data analysis of a structured collection procedure running on a portable, hand-held collection device are disclosed. The collection device performing the structured collection procedure has program instructions that when executed by a processor causes the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criterions being met at some unknown time, store in memory patient data collected in accordance to the schedule of events, end automatically the structured collection procedure upon one or more exit criterions being met at some unknown time, and mark/indicate the structured collection procedure as completed if no exception occurred during performance of an event in the schedule of events.
摘要:
A system providing for user intervention in a medical control arrangement may comprise a first user intervention mechanism responsive to user selection thereof to produce a first user intervention signal, a second user intervention mechanism responsive to user selection thereof to produce a second user intervention signal, and a processor executing a drug delivery algorithm forming part of the medical control arrangement. The processor may be responsive to the first user intervention signal to include an intervention therapy value in the execution of the drug delivery algorithm, and responsive to the second user intervention signal to exclude the intervention therapy value from the execution of the drug delivery algorithm. The medical control arrangement may be a diabetes control arrangement, the drug delivery algorithm may be an insulin delivery algorithm, and the intervention therapy value may be, for example, an intervention insulin quantity or an intervention carbohydrate quantity.
摘要:
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.
摘要:
Embodiments of a testing method for optimizing a therapy to a diabetic patient comprise collecting at least one sampling set of biomarker data, computing a probability distribution function, a hazard function, a risk function, and a risk value for the sampling set of biomarker data wherein, wherein the probability distribution function is calculated to approximate the probability distribution of the biomarker data, the hazard function is a function which yields higher hazard values for biomarker readings in the sampling set indicative of higher risk of complications, the risk function is the product of the probability distribution function and the hazard function, and the risk value is calculated by the integral of the risk function, minimizing the risk value by adjusting the diabetic patient's therapy, and exiting the testing method when the risk value for at least one sampling set is minimized to an optimal risk level.
摘要:
The invention relates to a device (24) for diagnostic or therapy support of a patient (12) with a chronic disease, comprising: a display (108); a user interface (146); and a processor (102) coupled to the display (108) and the user interface (146); and program (34) instructions that when executed by the processor (102) causes the processor (102) to: prompt a plurality of medical use cases or questions related to the chronic disease for selection on the display (108), receive a selected medical use case or question via the user interface (146), select automatically a structured collection procedure (70) for the diagnostic or therapy support of the patient (12) with the chronic disease based on the selected medical use case or question from a plurality of structured collection procedures (70) stored in a memory (110), and implement the selected structured collection procedure (70), said structured collection procedure (70) having parameters (220, 222, 224, 226, 228, 230, 232, 237, 238, 240) defining a schedule of events (222), each of said events (237) comprising at least a request (240) for collection of a blood glucose value, and wherein the parameters (220, 222, 224, 226, 228, 230, 232, 237, 238, 240) of the structured collection procedure (70) further define at least one entry criterion (226) which establishes one or more conditions needed to be met in order for a processor (102) to perform the schedule of events (222).
摘要:
Method embodiments for performing a structured collection protocol by utilizing a collection device comprise collecting one or more sampling sets of biomarker data, wherein each sampling set comprises a sufficient plurality of sampling instances recorded over a collection period. The methods further include determining compliance with adherence criteria for the sampling instances, wherein noncompliance with adherence criteria is recorded as an adherence event, classifying sampling instances as primary samples or secondary samples, wherein primary samples, which do not have corresponding recorded adherence events, are sampling instances utilized in the calculations performed by the processor that yield therapy results for a diabetic person, and secondary samples are sampling instances not utilized in the calculations, unless one or more secondary samples are promoted to primary samples, and performing at least one additional task if one or more sampling instances is a primary sample with a corresponding recorded adherence event.
摘要:
The invention relates to a device (24) for diagnostic or therapy support of a patient (12) with a chronic disease, comprising: a display (108); a user interface (146); and a processor (102) coupled to the display (108) and the user interface (146); and program (34) instructions that when executed by the processor (102) causes the processor (102) to: prompt a plurality of medical use cases or questions related to the chronic disease for selection on the display (108), receive a selected medical use case or question via the user interface (146), select automatically a structured collection procedure (70) for the diagnostic or therapy support of the patient (12) with the chronic disease based on the selected medical use case or question from a plurality of structured collection procedures (70) stored in a memory (110), and implement the selected structured collection procedure (70), said structured collection procedure (70) having parameters (220, 222, 224, 226, 228, 230, 232, 237, 238, 240) defining a schedule of events (222), each of said events (237) comprising at least a request (240) for collection of a blood glucose value, and wherein the parameters (220, 222, 224, 226, 228, 230, 232, 237, 238, 240) of the structured collection procedure (70) further define at least one entry criterion (226) which establishes one or more conditions needed to be met in order for a processor (102) to perform the schedule of events (222).