Integrated delivery device for continuous glucose sensor

Patent metadata

Field	Value
Publication number	US-9050413-B2
Application number	US-201213460365-A
Country	US
Kind code	B2
Filing date	Apr 30, 2012
Priority date	Feb 26, 2004
Publication date	Jun 9, 2015
Grant date	Jun 9, 2015

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.

First claim

What is claimed is:

1. An integrated diabetes management system for selectively switching between fully-automated and semi-automated modes, the system comprising:
a glucose sensor, wherein the glucose sensor is configured to substantially continuously measure glucose concentration in a host for a period exceeding one hour, and is configured to output a data stream, including one or more sensor data points; and
a processor module operably connected to the glucose sensor, wherein the processor module that receives the data stream calculates a therapy comprising instructions for administration of a medicament and sends the instructions to a medicament delivery device, wherein the processor module operates the integrated system in a fully-automated mode unless a semi-automated mode is triggered, wherein the fully automated mode does not require user interaction to send instructions to the medicament delivery device, wherein the semi-automated mode requires user interaction before sending instructions to the medicament delivery device, and wherein the semi-automated mode is automatically triggered responsive the processor module detecting a clinical risk.

2. The integrated system of claim 1 , wherein the clinical risk is an identified danger or potential risk to the health of the host based on a measured or estimated glucose concentration value of the host.

3. The integrated system of claim 1 , wherein the clinical risk is an identified danger or potential risk to the health of the host based on a measured or estimated rate of change of the glucose concentration of the host.

4. The integrated system of claim 1 , wherein the clinical risk is an identified danger or potential risk to the health of the host based on an estimated or measured acceleration of the glucose concentration of the host.

5. The integrated system of claim 1 , wherein the clinical risk is determined based on clinical acceptability evaluation of a discrepancy between a glucose concentration measured by a single point glucose monitor and the one or more sensor data points of the continuous glucose sensor that could cause a risk to the patient if incorrect therapy is administered.

6. A method for selectively switching between semi-automated and fully-automated modes of an integrated diabetes management system, the method comprising:
generating a data stream from a substantially continuous glucose sensor, the data stream, including one or more sensor data points;
receiving the data stream, by a processor module;
calculating a therapy, by the processor module, wherein the therapy comprises instructions for administration of a medicament;
detecting a clinical risk;
switching the integrated system from a fully-automated mode to a semi-automated mode responsive to the clinical risk detection; and
sending the instructions for administration of a medicament to a medicament delivery device, wherein the fully automated mode does not require user interaction to send the instructions to the medicament delivery device, and wherein the semi-automated mode requires user interaction before sending the instructions to the medicament delivery device.

7. The method of claim 6 , wherein the clinical risk is an identified danger or potential risk to the health of the host based on a measured or estimated glucose concentration value of the host.

8. The method of claim 6 , wherein the clinical risk is an identified danger or potential risk to the health of the host based on a measured or estimated rate of change of glucose concentration of the host.

9. The method of claim 6 , wherein the clinical risk is an identified danger or potential risk to the health of the host based on an estimated or measured acceleration of the glucose concentration of the host.

10. The method of claim 6 , wherein the clinical risk is determined based on clinical acceptability evaluation of a discrepancy between a glucose concentration measured by a single point glucose monitor and the one or more sensor data points of the continuous glucose sensor that could cause a risk to the patient if incorrect therapy is administered.

11. An integrated diabetes management system comprising a computer readable medium stored in memory that causes a processor to receive a data stream from a substantially continuous glucose sensor, the data stream, including one or more sensor data points, to calculate a therapy comprising instructions for administration of a medicament, and to automatically send the instructions to a medicament delivery device in a fully-automated mode unless a semi-automated mode is triggered, wherein the fully automated mode does not require user interaction to send instructions to the medicament delivery device, wherein the semi-automated mode requires user interaction before sending instructions to the medicament delivery device, and wherein the semi-automated mode is triggered responsive to detection of a clinical risk.

Assignees

• Brauker James H
• Tapsak Mark A
• Saint Sean T
• Kamath Apurv Ullas
• Neale Paul V
• Simpson Peter C
• Mensinger Michael Robert
• Markovic Dubravka
• Dexcom Inc

Inventors

• Brauker James H
• Tapsak Mark A
• Saint Sean T
• Kamath Apurv Ullas
• Neale Paul V
• Simpson Peter C
• Mensinger Michael Robert
• Markovic Dubravka

Classifications

• G06F19/3406

  Physics · mapped topic

• A61B2560/0443

  Modular apparatus · CPC title

• A61B5/14532

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/0002

  Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07) · CPC title

• A61B5/4839

  combined with drug delivery · CPC title