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 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 physically detachably connectable to the receiver, wherein at least one of the receiver and the medicament delivery device comprises programming that automatically detects impending clinical risk and calculates a therapy recommendation responsive to the impending clinical risk, and wherein the at least one of the receiver and the medicament delivery device further comprises programming that requires the at least one of the receiver and the medicament delivery device to be at least one of validated and confirmed by a user interaction in response to a prompt on the user interface.
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Reexamination
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.
1304 Citations
37 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 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 physically detachably connectable to the receiver, wherein at least one of the receiver and the medicament delivery device comprises programming that automatically detects impending clinical risk and calculates a therapy recommendation responsive to the impending clinical risk, and wherein the at least one of the receiver and the medicament delivery device further comprises programming that requires the at least one of the receiver and the medicament delivery device to be at least one of validated and confirmed by a user interaction in response to a prompt on the user interface. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13)
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11. 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; a cell transplantation device; and wherein the receiver comprises a processor, and wherein the processor comprises programming configured to determine a host'"'"'s metabolic response to cell transplantation by evaluating the sensor data points substantially corresponding to delivery or release of cells from the cell transplantation device. - View Dependent Claims (19, 20, 21)
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14. An integrated system for monitoring and treating diabetes, the system comprising:
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a continuous 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; a medicament delivery device, wherein the delivery device is at least one of physically connectable and operably connectable to the receiver; and a single point glucose monitor configured to receive a biological sample from the host and measure a concentration of glucose in the sample, wherein the single point glucose monitor is operably connectable to the receiver, and wherein the receiver comprises programming configured to calculate at least one parameter of a medicament to deliver via the medicament delivery device, wherein the parameter is selected from the group consisting of a type of medicament, an amount of medicament, a timing of delivery of medicament, and combinations thereof, wherein the programming configured to calculate comprises a glucose concentration measured by the single point glucose monitor as an input value. - View Dependent Claims (15, 22, 23, 24)
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16. 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 at least one of physically and operably connectable to the receiver, wherein the receiver comprises a processor, and wherein the processor comprises programming configured to calculate and output medicament delivery instructions, and wherein the processor further comprises programming configured to validate the medicament delivery instructions by prompting a user to provide a biological sample to a single point glucose monitor and by validating the medicament delivery instructions responsive to data obtained from the single point glucose monitor. - View Dependent Claims (25, 26, 27, 28, 29, 35, 36, 37)
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17. 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 at least one of physically and operably connectable to the receiver, wherein the receiver is configured to receive medicament delivery data responsive to medicament delivery for a first time period from the medicament delivery device, and wherein the receiver comprises a processor, and wherein the processor comprises programming configured to determine a host'"'"'s metabolic response to the medicament delivery by evaluating the sensor data points substantially corresponding to delivery and release of the medicament delivery for the first time period, wherein the processor comprises programming configured to estimate glucose values for a second time period responsive to glucose sensor data and the host'"'"'s metabolic response. - View Dependent Claims (18, 30, 31, 32, 33, 34)
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Specification