Roche Diagnostics Operations, Inc.

Roche Diabetes Care, Inc.

Roche Diagnostics International Ag

Boehringer Mannheim Gmbh

F. Hoffmann-la Roche Ag

James R Long

Robert E Reinke

Phillip Edgar Pash

Siva Chittajallu

Erich Imhof

Guido Konrad

Paul J Galley

Steven Bousamra

Ajay Thukral

Stefan Weinert

Jason Bush

Kristin M Westerfield

Adam R Scroggin

Leon R Organ, Iii

Hans P Jensen

Kaitlin R Stinson

Christopher R Halvorson

Morris J Young

Harvey Buck

David Bradley Markisohn

John F Price

Daniel P Birtwhistle

Robin S Wagner

Gerhard Frisch

Benhur Aysin

Ryan Scott McKinney

Troy L King

Michael L Flis

Graeme Harvey

D Bradley Markisohn

William Levy

Stefhan Weinert

Kym Marco

Roberte Reinke

Daniel Birtwhistle

Medical device data manager configuration methods and systems including a medical device, a smart mobile device including a camera, a processor, a memory communicatively coupled to the processor, and machine readable instructions stored in the memory that may cause a system to perform at least the following when executed by the processor: use the camera of the smart mobile device to capture an image of the medical device; apply an identification algorithm to the image of the medical device; identify the medical device as an identified medical device based on the image of the medical device and the identification algorithm; and automatically configure a software application tool on the smart mobile device to retrieve data associated with one or more requirements of the identified medical device.

Medical device data management configuration systems and methods of use

Configuration software implements techniques for customizing names of insulin delivery profiles with improved patient safety. The techniques include: receiving a string of characters which serve as a name for a given insulin delivery profile, where the insulin delivery profile includes at least one parameter pertaining to insulin delivery by an insulin pump and is one of a plurality of insulin delivery profiles associated with a given patient; normalizing the string of characters in accordance with a rule set; comparing the normalized string of characters with names for each of the plurality of insulin delivery profiles; and updating the name of the given insulin delivery profile in a pump configuration file residing on the configuration device when the normalized string of characters is unique in relation to the names of the plurality of insulin delivery profiles.

Customizing names of insulin delivery profiles for improved patient safety

An insulin pump is configurable by a configurator. The pump has parameter blocks, each with a respective parameter and an associated restriction setting, and the configurator has an authorization level. Configuring the pump includes receiving, by the configurator, a request to access a parameter on the pump. The method also includes identifying, by the configurator, the parameter block that includes the parameter. Moreover, the method includes retrieving, by the configurator from the pump, the parameter and the associated restriction setting, and comparing, by the configurator, the authorization level of the configurator to the restriction setting. Also, the method includes determining, by the configurator, whether the configurator is authorized to write to the parameter block based on the comparison. Additionally, the method includes writing, by the configurator, to the parameter block on the insulin pump in response to a determination that the configurator is authorized to write to the parameter block.

Method for configuring an insulin pump with configuring device

A system for configuring an insulin pump comprising: a computing device configured to receive a source device and a destination device; the source device being configured to communicate with the computing device, wherein the source device includes a source configuration file comprising a plurality of configurable source parameters; the destination device being configured to communicate with the computing device, wherein the destination device includes a destination configuration file comprising a plurality of configurable destination parameters; and the computing device being configured to determine whether a parameter mismatch occurred based on a comparison between the source configuration file and the destination configuration file; and to copies values associated with each of the plurality of source parameters to each of the plurality of destination parameters based on i) the determination of whether a parameter mismatch occurred and ii) the comparison between the source configuration file and the destination configuration file.

Pump configuration software wizard for configuring parameters of a handheld insulin pump

A computer-implemented method of operating a diabetes treatment system that includes an insulin pump and a pump controlling device is disclosed. The method includes receiving, by the device, a request for the pump to perform an operation that is dependent on a specified state of the pump. The method also includes requesting, by the device, a current state of the pump from the pump. Moreover, the method includes receiving, by the device, the current state of the pump. Also, the method includes determining, by the device, whether the current state of the pump matches to the specified state of the pump. Additionally, the method includes sending, by the device to the pump, a command to perform the operation in response to a determination that the current state of the pump matches the specified state of the pump.

Pump controller that checks operational state of insulin pump for controlling the insulin pump

A computer-implemented method is presented for synchronizing time between two handheld medical devices that interoperate with each other. The method includes: determining a first time as measured by a first clock residing in the first medical device; determining a second time as measured by a second clock residing in a second medical device; evaluating whether the first clock is synchronized with the second clock; determining whether at least one of the first clock and the second clock was set manually by a user; and setting time of the first clock in accordance with the second time when the second clock was set manually by the user.

Time synchronization improvements for interoperable medical devices

A computer-implemented system is provided for distributing product updates to medical devices. An update interface residing on a distribution platform is configured to distribute product updates and maintain a log of such distributions in an audit database. A configuration device in data communication with the update interface registers itself with the update interface and downloads product updates from the update interface, such that the registration includes providing identifying information for the configuration device and a user of the configuration device. A medical device in data communication with the configuration device registers itself with the configuration device and downloads a particular product update from the configuration device, such that the configuration device creates a record of the particular product update and communications the record of the particular product update to the update interface. In this way, product updates distributed via the configuration device are recorded and tracked for regulatory purposes.

Managing software distribution for regulatory compliance

The present teachings provide a system for modifying insulin therapy support parameters such as warning limit data and time block data on a hand-held diabetes management device. The system can include a graphical user interface module that creates a graphical user interface having a plurality of bar structures positionable on or between a first line that indicates an upper limit and a second line that illustrates a lower limit. Each of the bar structures can have a first side that indicates a start time of a time window opposite a second side that indicates an end time of the time window and a third side that indicates a lower target value for a blood glucose level opposite a fourth side that indicates an upper target value for the blood glucose level. The bar structures, the first line and the second line can be adjustable by a user input.

Time block manipulation for insulin infusion delivery

A diabetes management system is provided that supports connectivity of applications residing on a medical device. The diabetes management system includes a medical device that performs a diabetes care function in relation to a patient and a diabetes care management device in data communication with the medical device. The diabetes care management device is comprised generally of a connection management module and at least one application separate from the connection management module. The connection management module is configured to receive an associate request from the medical device and operable to establish a data connection with the medical device in accordance with IEEE standard 11073, such that the applications interacts with the connection management module to communicate via the data connection with the medical device.

Interoperability enhancement that supports connectivity of applications on a medical device

A diabetes management system having a reliable data management scheme is disclosed. The system comprises a plurality of devices, each device performing a different function relating to treatment of diabetes. Each device has a device identifier and generates data records. Each device includes a metadata generator configured to generate a metadata tag for a data record generated by the device. A metadata tag includes the device identifier of the corresponding device, a record identifier, and a source identifier indicating whether the record was originated by a human or the device. The system further includes a diabetes management device. When a device generates a new record, the metadata generator generates a new record identifier and a new metadata tag based on the new record identifier and the device identifier of the device. The first device propagates the new record and the new metadata tag to the diabetes management device.

Metadata tagging system for a diabetes management system of devices

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.

Therapy delivery system having an open architecture and a method thereof

A system for determining drug administration information may comprise an input device providing for user input of feed forward information having a first parameter component and a second parameter component, a data storage device and a processor. The data storage device may have stored therein a map correlating values of the first and second parameters to drug administration information. The processor may be responsive to user input of the feed forward information to determine corresponding drug administration information according to the map.

System and method for determining drug administration information

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.

Method and apparatus for biological fluid analyte concentration

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Fishers, IN, United States of America

James R Long