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.

Abstract: 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.

Abstract: Embodiments of methods of assessing a diabetes treatment protocol comprise determining a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol by utilizing the processor, determining a patient proficiency level corresponding to a skill set of the patient in conducting the diabetes treatment protocol by utilizing the processor, comparing the protocol complexity level to the patient proficiency level via the processor, and providing an output based on the comparison.

Abstract: A system is provided for collecting patient information for diabetes management. The system may comprise a patient interface device, a patient notification device, an input device for entering patient information, and an information collecting unit. The information collecting unit may include a processor electrically coupled to a memory having stored therein at least one algorithm executable by the processor to activate the patient notification device followed by presenting instructions to the patient via the patient interface device to collect specified information from the patient via the input device.

Abstract: A method and system for calculating daily weighted averages of glucose measurements (or derived quantities) with time-based weights are disclosed. The present invention computes an average daily glucose value using the time based weights based on only consecutive glucose measurements in the plurality of glucose measurements with acceptable time intervals that do not exceed a predefined maximum time interval. The invention further relates to a computer program for implementing the method for calculating daily weighted averages of spot monitoring glucose measurements (or derived quantities) with the time-based weights.

Abstract: 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.

Abstract: A collection device with a selective display of test results and method thereof are disclosed. A structured collection procedure defining data collection times and the associated context of the collection also defines what information regarding the results of the collection may be viewable by a user performing the structured collection procedure on the device. In this manner, the patient can be monitored according to the structured collection procedure while preventing the patient from modifying his or her behavior based on collection results.

Abstract: Methods and systems are disclosed for estimating a glucose level of a person having diabetes comprises. One method may comprise: receiving into a computing device a plurality of measured glucose results from a glucose sensor coupled to the person; using the computing device to analyze the plurality of measured glucose results with a probability analysis tool configured to determine a probability of glucose sensor accuracy based on the plurality of measured glucose results; and using the computing device to estimate a glucose level of the person with a recursive filter configured to estimate the glucose level based on the plurality of measured glucose results weighted with the probability of glucose sensor accuracy.

Abstract: A blood glucose and lifestyle tracking apparatus is disclosed. The blood glucose and lifestyle tracking apparatus provides a method for recording both blood glucose values for fasting, postprandial, and preprandial time periods and lifestyle factors.

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.

Abstract: Embodiments of methods of querying a diabetic patient regarding compliance with adherence criteria comprises instructing the diabetic patient to collect at least one sample in a sampling set of biomarker data, wherein each sampling set comprises a sufficient plurality of samples recorded over a collection period, comparing the collected samples to an acceptable range, wherein the acceptable range encompasses biomarker values that would be expected upon compliance with the adherence criteria, and informing the diabetic patient if at least one sample is an unacceptable value which falls outside of the acceptable range, and performing at least one additional task after detecting the unacceptable value.

Abstract: A diagnosis, therapy and prognosis system (DTPS) and method thereof to help either the healthcare provider or the patient in diagnosing, treating and interpreting data are disclosed. The apparatus provides data collection based on protocols, and mechanism for testing data integrity and accuracy. The data is then driven through an analysis engine to characterize in a quantitative sense the metabolic state of the patient's body. The characterization is then used in diagnosing the patient, determining therapy, evaluating algorithm strategies and offering prognosis of potential use case scenarios.

Abstract: 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.

Abstract: A device and method are disclosed for supporting a patient with a disease, comprising a display facility, a user interface, a processor, and a user interface, and with an application module comprising program instructions, which are configured, on executing by the processor to bring about the following: providing medical protocols for diagnostic and/or therapeutic purposes, collecting time information concerning a future event which is a trigger for at least one medical protocol, selecting one of the medical protocols which indicates a group of cohesive protocol events which are spaced apart chronologically over a protocol period in accordance with a protocol regime, monitoring a chronological interval between a current date and the future event, and issuing a user start notice concerning the beginning of the medical protocol at a time which from a chronological point of view lies at least by the protocol period before the future event.

Abstract: Methods and systems for authorizing access to a medical device are disclosed. The methods and systems use authorization certificates to allow and prevent access to one or more operations of the medical device. The methods and systems also allow the tracking of changes made to the medical device by an authorized user.

Abstract: A blood glucose and lifestyle tracking apparatus is disclosed. The blood glucose and lifestyle tracking apparatus provides a method for recording both blood glucose values for fasting, postprandial, and preprandial time periods and lifestyle factors.

Abstract: Embodiments of methods of querying a diabetic patient regarding compliance with adherence criteria comprises instructing the diabetic patient to collect at least one sample in a sampling set of biomarker data, wherein each sampling set comprises a sufficient plurality of samples recorded over a collection period, comparing the collected samples to an acceptable range, wherein the acceptable range encompasses biomarker values that would be expected upon compliance with the adherence criteria, and informing the diabetic patient if at least one sample is an unacceptable value which falls outside of the acceptable range, and performing at least one additional task after detecting the unacceptable value.

Abstract: A method and system for calculating daily weighted averages of glucose measurements (or derived quantities) with time-based weights are disclosed. The present invention computes an average daily glucose value using the time based weights based on only consecutive glucose measurements in the plurality of glucose measurements with acceptable time intervals that do not exceed a predefined maximum time interval. The invention further relates to a computer program for implementing the method for calculating daily weighted averages of spot monitoring glucose measurements (or derived quantities) with the time-based weights.

Abstract: Embodiments of methods of assessing a diabetes treatment protocol comprise determining a protocol complexity level corresponding to a degree of difficulty of completing the diabetes treatment protocol by utilizing the processor, determining a patient proficiency level corresponding to a skill set of the patient in conducting the diabetes treatment protocol by utilizing the processor, comparing the protocol complexity level to the patient proficiency level via the processor, and providing an output based on the comparison.

Abstract: 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.