INTEGRATED DELIVERY DEVICE FOR CONTINUOUS GLUCOSE SENSOR

• US 20120215201A1
• Filed: 04/30/2012
• Published: 08/23/2012
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Tapsak, Mark A., Saint, Sean T., Kamath, Apurv U., Neale, Paul V., Simpson, Peter C., Mensinger, Michael Robert, Markovic, Dubravka
• Granted Patent: US 8,920,401 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 15/0001 Details of inhalators; Constructional features thereof
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/31525 Dosing burettes, pipettes B01L3/02
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

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.

Claims

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 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 is configured to receive the data stream, to calculate a therapy comprising instructions for administration of a medicament, and to send the instructions to a medicament delivery device, wherein the processor module is configured to operate 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 in the semi-automated mode, the processor module is configured to prompt the user for input before sending instructions to the medicament delivery device, and wherein the semi-automated mode is automatically triggered responsive to a predetermined condition.

2. The integrated system of claim 1, wherein the processor module is configured to prompt the user for user input by prompting for a biological sample to obtain a single point glucose value responsive to the semi-automated mode being triggered.

4. The integrated system of claim 1, wherein the processor module determines a trend of the glucose values based on the data stream and determines whether a possibility to reverse the trend within a predetermined time period exists, wherein the predetermined condition is the possibility to reverse the trend within the predetermined time period.

5. The integrated system of claim 1, wherein the processor module is configured to analyze the glucose sensor data stream, and wherein a determination of whether the predetermined condition met is based on the results of the analysis.

6. The integrated system of claim 1, wherein the processor module is configured for accuracy checking, and wherein a determination of whether the predetermined condition is met is based on the results of the accuracy checking.

7. The integrated system of claim 1, wherein the processor module is configured to detect signal artifacts, and wherein a determination of whether the predetermined condition is met is based on the results of the signal artifact detection.

8. 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;

switching the integrated system from a fully-automated mode to a semi-automated mode responsive to a predetermined condition being met; 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 comprises prompting the user for input before sending the instructions to the medicament delivery device.

3. The integrated system of claim 10, wherein the processor module is configured to validate the therapy based on the single point glucose value.

9. The method of claim 8, wherein the prompting the user for input comprises prompting the user for a biological sample to obtain a single point glucose value responsive to the semi-automated mode being triggered.

10. The method of claim 9, further comprising validating the therapy based on the single point glucose value.

11. The integrated system of claim 8, further comprising determining a trend of the glucose values based on the data stream and determining whether a possibility to reverse the trend within a predetermined time period exists, wherein the predetermined condition is the possibility to reverse the trend within the predetermined time period.

12. The method of claim 8, further comprising analyzing the glucose sensor data stream, wherein the predetermined condition is evaluated against the results of the analysis.

13. The method of claim 8, further comprising performing accuracy checking, wherein the predetermined condition is evaluated against the results the accuracy checking.

14. The method of claim 8, wherein the processor module is configured to detect signal artifacts, and wherein the predetermined condition is evaluated against the results the signal artifact detection.

15. An integrated diabetes management system comprising a computer readable medium stored in memory that is configured to cause 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 in the semi-automated mode, a user is prompted for input before sending instructions to the medicament delivery device, and wherein the semi-automated mode is triggered responsive to a predetermined condition.