Integrated delivery device for continuous glucose sensor
First Claim
1. An integrated system for monitoring and treating diabetes, the system comprising:
- a glucose sensor, wherein the glucose sensor measures glucose in a host for a period exceeding one hour, and outputs a data stream, including one or more sensor data points generated at predetermined intervals;
a receiver operably connected to the glucose sensor, wherein the receiver is configured to receive the data stream; and
a continuous medicament delivery device, wherein the delivery device is operably connected to the receiver, wherein at least one of the receiver or the medicament delivery device comprises programming that, when executed by a processor, automatically detects impending clinical risk based on the one or more sensor data points, wherein the continuous medicament delivery device is switched from a medicament delivery mode to a fail-safe mode responsive to the detection of impending clinical risk, and wherein the at least one of the receiver or the medicament delivery device further comprises programming that, when executed by a processor, requires the at least one of the receiver or the medicament delivery device to be at least one of validated or confirmed by a user interaction in response to a prompt on a user interface of at least one of the receiver or the medicament delivery device for delivery of a determined medicament therapy recommendation in the fail-safe mode.
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Accused Products
Abstract
Systems and methods for integrating a continuous glucose sensor, including a receiver, a medicament delivery device, and optionally a single point glucose monitor are provided. Manual integrations provide for a physical association between the devices wherein a user (for example, patient or doctor) manually selects the amount, type, and/or time of delivery. Semi-automated integration of the devices includes integrations wherein an operable connection between the integrated components aids the user (for example, patient or doctor) in selecting, inputting, calculating, or validating the amount, type, or time of medicament delivery of glucose values, for example, by transmitting data to another component and thereby reducing the amount of user input required. Automated integration between the devices includes integrations wherein an operable connection between the integrated components provides for full control of the system without required user interaction.
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Citations
45 Claims
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1. An integrated system for monitoring and treating diabetes, the system comprising:
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a glucose sensor, wherein the glucose sensor measures glucose in a host for a period exceeding one hour, and outputs a data stream, including one or more sensor data points generated at predetermined intervals; a receiver operably connected to the glucose sensor, wherein the receiver is configured to receive the data stream; and a continuous medicament delivery device, wherein the delivery device is operably connected to the receiver, wherein at least one of the receiver or the medicament delivery device comprises programming that, when executed by a processor, automatically detects impending clinical risk based on the one or more sensor data points, wherein the continuous medicament delivery device is switched from a medicament delivery mode to a fail-safe mode responsive to the detection of impending clinical risk, and wherein the at least one of the receiver or the medicament delivery device further comprises programming that, when executed by a processor, requires the at least one of the receiver or the medicament delivery device to be at least one of validated or confirmed by a user interaction in response to a prompt on a user interface of at least one of the receiver or the medicament delivery device for delivery of a determined medicament therapy recommendation in the fail-safe mode. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. An integrated system for monitoring and treating diabetes, the system comprising:
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a glucose sensor, wherein the glucose sensor measures glucose in a host for a period exceeding one hour, and outputs a data stream, including one or more sensor data points generated at predetermined intervals; a receiver operably connected to the glucose sensor, wherein the receiver is configured to receive the data stream; and a continuous medicament delivery device, wherein the delivery device is operably connected to the receiver, wherein at least one of the receiver or the medicament delivery device comprises programming that, when executed by a processor, automatically detects impending clinical risk, and programming that, when executed by a processor, operates the integrated system in a first mode unless a second mode is triggered, wherein the programming that, when executed by a processor, operates the integrated system does not require user interaction for administration of medicament using the medicament device while in the first mode, wherein the programming that, when executed by a processor, operates the integrated system requires user interaction for administration of medicament using the medicament device while in the second mode, wherein the second mode is triggered responsive to the detection of the impending clinical risk, and wherein the at least one of the receiver or the medicament delivery device further comprises programming that, when executed by a processor, requires the at least one of the receiver or the medicament delivery device to be at least one of validated or confirmed by a user interaction in response to a prompt on a user interface of at least one of the receiver or the medicament delivery device for administration of the medicament in the second mode. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35)
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36. An integrated system for monitoring and treating diabetes, the system comprising:
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a glucose sensor, wherein the glucose sensor substantially continuously measures glucose in a host for a period exceeding one hour, and outputs a data stream, including one or more sensor data points; a receiver operably connected to the glucose sensor, wherein the receiver is configured to receive the data stream; and a medicament delivery device, wherein the delivery device is operably connected to the receiver, wherein at least one of the receiver or the medicament delivery device automatically detect impending clinical risk and calculates a therapy recommendation responsive to the impending clinical risk, wherein the at least one of the receiver or the medicament delivery device further require the at least one of the receiver or the medicament delivery device to be at least one of validated or confirmed by a user interaction in response to a prompt on a user interface of at least one of the receiver or the medicament delivery device for administration of the therapy recommendation, wherein the integrated system operates in a fully-automated mode unless a semi-automated mode is triggered, wherein the semi-automated mode is triggered responsive to the detection of the impending clinical risk, wherein the medicament device comprises bolus medicament delivery, wherein, while in the fully-automated mode, the programming that, when executed by a processor, operates the integrated system does not require user interaction to administer medicament using the continuous medicament delivery and does not require user interaction to administer a bolus administration of medicament, and wherein, while in the semi-automated mode, the programming that, when executed by a processor, operates the integrated system does not require user interaction to administer medicament using the continuous medicament delivery and requires user interaction to administer medicament a bolus administration of medicament. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45)
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Specification