Roche Diagnostics Operations, Inc.

Roche Diabetes Care, Inc.

Roche Diagnostics International Ag

Disetronic Licensing Ag

Other

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Stefan Weinert

Paul J Galley

Steven Bousamra

Abhishek S Soni

Alan Greenburg

Juergen Rasch-Menges

P Douglas Walling

Ajay Thukral

Ulrich Porsch

Siva Chittajallu

Robert Hellwig

David A Hasker

Christoph Eisenhardt

Daniel ManHung Wong

David L Duke

Robert E Reinke

John F Price

Heino Eikmeier

Karl Werner

James R Long

Marco De Polo

Robin S Wagner

Morris J Young

Eric R Diebold

Nigel A Surridge

Harvey Buck

Matthias Essenpreis

Rick L Collins

Maury Zivitz

Nicole Bernini

Michael Schoemaker

Paul Douglas Walling

Kelly Heaton

Zindel Herbert Heller

Derek Brandt

Remmert Laan

Erica Diebold

Joel Jeckelmann

Birgit Kraeling

Glenn Brassington

Kym Marco

Zhengzheng Pan

Ildiko Amann-Zalan

Gunnar Meyer-Olden

David Hasker

Matthias Axel Schweitzer

James Robert Long

Dirk Voelkel

Steven A Bousamra

Alan M Greenburg

Sebastiaan LaBastide

Sebastiaan Labastide

Martin T Gerber

Siva K Chittajallu

Walling P Douglas

Paul Galley

James L Maxwell

Edna Probst

Loy Maugh Vail

A structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof are disclosed which implement a structured collection procedure based on a medical use case and/or question which provides at least one or more parameters defining entry criterion, a schedule of events, adherence criterion, and exit criterion. The entry criterion establish conditions needed to be met prior to obtaining biomarker data from the patient. Each event can include one or more of a performance time, patient guidance to perform the event, a request for information from the patient a request for patient action, and a request for collection of biomarker data from the patient. The adherence criterion can be used to assess whether an event performed is acceptable to addressing the medical use case and/or question, and the exit criterion establishes conditions needed to be met prior to exiting the collection procedure.

Structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof

Embodiments related to a self-administered, behavior modification program facilitated through a structured tailoring method and system thereof which accelerates and enhances the internalization process of the individual, and which provides help when the individual begins to fail in adhering or continuing with the behavior modification are disclosed. Program instructions that when executed by a processor causes a processor to initiate automatically a schedule of events of a structured tailoring procedure upon entry criteria being met at some unknown time, provide intervention according to the intervention preferences when the adherence criteria for one of the events has not been met, and end automatically the structured collection procedure upon exit criteria being met at some unknown time.

Structured tailoring

Embodiments related to a system and method managing the implementation, execution, data collection, data analysis and status reporting 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 cause the processor to initiate automatically a schedule of events of the structured collection procedure upon one or more entry criteria 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 criteria being met at some unknown time. Status reporting can be provided throughout the execution of the collection procedure.

Status reporting of a structured collection procedure

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.

Management method and system implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device

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.

Methods of assessing diabetes treatment protocols based on protocol complexity levels and patient proficiency levels

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.

Systems and methods for optimizing insulin dosage

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.

Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device

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.

Method and system for calculating daily weighted averages of glucose measurements (or derived quantities) with time based-weights

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.

Collection device with selective display of test results, method and computer program product thereof

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.

Methods and systems for processing glucose data measured from a person having diabetes

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Pendleton, IN, United States of America

Stefan Weinert