Roche Diabetes Care, Inc.

Roche Diagnostics Operations, Inc.

Boehringer Mannheim Gmbh

Roche Diagnostics Gmbh

F. Hoffmann-La Roche Ag

John F Price

Paul J Galley

Richard W Wilson

Ulrich Porsch

Alan Greenburg

Robin S Wagner

Marshall M Parker

Raymond Strickland

Stefan Weinert

Steven Bousamra

Juergen Rasch-Menges

Heino Eikmeier

Karl Werner

Daniel P Birtwhistle

P Douglas Walling

Birgit Kraeling

Lisa McCool

Blaine Edward Ramey

Mark Nierzwick

Thomas D Gurley

Stefan Lindegger

James R Long

Reto Sigrist

Nicole Bernini

Kent M Kost

Thomas J Lindsay

Alan M Greenburg

According to some embodiments of the present disclosure, a device and method for determining an allowable amount of blood glucose (bG) of a patient is disclosed. The method further includes receiving a current bG measurement, determining a target bG value, and determining a correction delta bG value based on one or more advice history records. The method includes determining a correction meal rise value and determining a maximum allowed bG value based on the target bG value, the correction delta bG value, and the correction meal rise value. The method includes setting the allowable amount of bG value equal to the maximum allowed bG value when the current bG measurement is greater than the target bG value and determining the allowable amount of bG value using the target bG value and the correction delta bG value when the current bG measurement is less than the target bG value.

Handheld diabetes management device with bolus calculator

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

A device and method for delivering insulin to a patient is disclosed. The method includes receiving an amount of insulin to deliver to a patient and beginning delivery of the insulin to the patient. The method further includes monitoring the delivery of the insulin to determine whether the insulin pump is able to deliver the entire amount of insulin and maintaining a timer until the insulin pump recommences the delivery of the insulin. The method includes comparing an amount of time indicated by the timer to a threshold. The method further includes generating a first insulin delivery record indicating that a first amount of insulin was delivered when the amount of time indicated by the timer is less than the threshold and a second insulin record indicating that a second amount of insulin was delivered when the amount of time indicated by the timer is greater than the threshold.

Insulin pump and methods for operating the insulin pump

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.

According to some aspects of the present disclosure a method for presenting a GUI for modifying medical data on a handheld medical device is disclosed. The method includes determining a correction bolus amount and a meal bolus amount for the patient. The method also includes presenting the GUI on a display of the medical device and presenting the correction bolus amount, the meal bolus amount and a total bolus amount in the GUI. The method also includes presenting a correction bolus amount modification field and a meal bolus amount field in the GUI. The correction bolus amount modification field and the meal bolus amount modification field allow the patient to provide input to modify the correction bolus amount and meal bolus amount, respectively. The method further includes receiving the input and generating an advice history record based on the input.

Graphical user interface for a handheld diabetes management device with bolus calculator

A computer-implemented diabetes management system is provided that supports enhanced security between a diabetes care manager in data communication with a medical device. The diabetes care manager includes: a first application that operates to request access to a first security role supported by the medical device, where the first security role is associated with a first set of commands for accessing data on the medical device that are defined as a private extension of the communication protocol; and a second application that operates to request access to a second security role supported by the medical device, where the second security role is associated with a second set of commands for accessing data on the medical device that are defined as a private extension of the communication protocol. The second set of commands has one or more commands that are mutually exclusive from the first set of commands.

Coexistence of multiple radios in a medical device

A method of improving updatability of entry, adherence, and exit criteria stored in memory of a handheld diabetes management device, the method includes: providing the handheld diabetes management device with a blood glucose (bG) measurement engine that measures a bG level in a sample of blood of a user and that generates sample data indicative of the bG level; providing the handheld diabetes management device with the memory and a touchscreen display; providing the handheld diabetes management device with a processor module that is in communication with the bG measurement engine, the touchscreen display, and the memory; storing firmware that is executable by the processor module for performing operations to carry out a structured bG test in a non-modifiable portion of the memory; and storing the entry, adherence, and exit criteria in a modifiable portion of the memory.

Updatability of structured blood glucose tests performed on handheld diabetes management devices

A method for conducting a Testing In Pairs (TIPs) blood glucose (bG) test using a handheld diabetes management device carried by a user. A processing subsystem of the device implements a software module for managing the TIPs test. The software module generates a plurality of predetermined acceptance time windows corresponding to different user defined events. The processing subsystem can identify specific ones of a plurality of bG test values read by the device that are obtained during the predetermined bG acceptance time windows, and which are identified as being related pairs of accepted bG test values that correspond to specific ones of the user defined events. The related pairs of accepted bG test values can then be stored in a database.

Handheld diabetes management device having testing in pairs blood glucose test

A computer-implemented diabetes management system is provided for configuring a structured collection procedure implemented on a collection device having a meter that measures the concentration of glucose in blood. The system includes: a collection application that executes a structured collection procedure for obtaining measurement data from the meter and provides access to the measurement data via a communication protocol defined in accordance with IEEE standard 11073-20601; a configuration application that accesses and manipulates the parameters of the structured collection procedure using a set of action commands, where the set of action commands are defined in compliance with the communication protocol; and a collection interface that receives an action command from the configuration application, executes the received action command and issues a response command in response thereto, where the response command is defined in compliance with the communication protocol.

Communication protocol that supports structured collection procedures used in diabetes care

Systems and methods for disease management

A method for monitoring blood glucose (bG) levels of a diabetic user. The method may be implemented on a non-transitory computer readable medium adapted to run on a processing subsystem, the processing subsystem forming a portion of a handheld diabetes management device for monitoring the bG levels of a diabetic user and determining a correction bolus to be provided to the user. The method may comprise using a memory to store information in a plurality of different time blocks. The information may include a plurality of differing user defined health events that each include a predetermined associated percentage value set by the user by which a correction bolus calculation will be modified to account for one of an increase or a decrease in insulin associated with each one of the defined health events. The processing subsystem may be used to communicate with the memory and to obtain the information and to calculate therefrom the correction bolus.

A device, method, and graphical user interface for displaying diabetes related information sets aligned by the occurrence of a particular event are disclosed. After receiving a request for an event-aligned display of diabetes related information based on an event, a search for a plurality of tagged occurrences of the event and retrieval of an information set for each of the plurality of tagged occurrences is provided. Each information set may include diabetes related information chronologically related to the tagged occurrence. The retrieved information sets is displayed on a display, wherein the retrieved information sets are shown on the display aligned by their tagged occurrences such that all diabetes related information is positioned relative the event based on its chronological relationship with the event.

Device, method, and graphical user interface for searching, filtering and displaying event-aligned information sets related to diabetes

A method is disclosed for managing a three day profile blood glucose (bG) measurements that are provided by a user using a handheld diabetes management device. The method may involve configuring a database carried by the device to store a plurality of bG test values input by a user for each day of a three day test period. The bG test values are required to be provided by the user in accordance with a predetermined plurality of differing acceptance time windows during each day of the three day test period. If two or more windows are open concurrently when a given bG test value is obtained, the system allows the user to select the appropriate time window that the given bG test value should be associated with. A processing subsystem of the device determines if at least a predetermined minimum plurality of the stored bG test values has been provided by the user during the predetermined plurality of differing acceptance time windows for each day of the three day test period and, if so, the processing subsystem accepts the bG test values provided by the user when compiling results for a three day bG profile.

Handheld diabetes management device for obtaining three day blood glucose profile

A method and apparatus for measuring the concentration of an analyte present in a biological fluid is disclosed. The method includes the steps of applying NIR radiation to calibration samples to produce calibration data, analyzing the calibration data to identify and remove outliers, constructing a calibration model, collecting and analyzing unknown samples to identify and remove outliers, and predicting analyte concentration of non-outliers from the calibration model. Analysis of the calibration data includes data pretreatment, data decomposition to remove redundant data, and identification and removal of outliers using generalized distances. The calibration model may utilize principal component regression, partial least squares, multiple linear regression, or artificial neural networks, and reduction using principal component analysis or partial least squares scores. Unknown sample data is analyzed using data pretreatment followed by projection into the calibration model space, and identification and removal of outliers, with prediction of analyte concentration using the calibration model. The apparatus includes a pump which circulates a sample through tubing to fill a flowcell. Light from a NIR source is synchronized with a detector, facilitating light and dark measurements, and passes through a monochrometer and the flowcell and strikes the detector, whereby radiation transmitted through the sample is measured. Measurement data is stored in a general purpose programmable computer also controlling the pump, the detector, synchronization, and the monochrometer. The computer includes a general purpose microprocessor configured with computer program code employing the steps of the method.

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McCordsville, IN, United States of America

John F Price