INTEGRATED DELIVERY DEVICE FOR CONTINUOUS GLUCOSE SENSOR

• US 20120191063A1
• Filed: 03/30/2012
• Published: 07/26/2012
• 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 8,721,585 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 system for monitoring and treating diabetes, the system comprising:

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 a processor module 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 processor module is configured to calculate the at least one parameter using a glucose concentration measured by the single point glucose monitor as an input value.

2. The integrated system of claim 1, wherein glucose sensor comprises an enzyme membrane system for electrochemical detection of glucose and the single point glucose monitor comprises an enzyme membrane system for electrochemical detection of glucose.

3. The integrated system of claim 1, wherein the single point glucose monitor is detachably connectable to the receiver.

4. The integrated system of claim 1, wherein the single point glucose monitor is operably connectable to the receiver by a wired connection.

5. The integrated system of claim 1, wherein the single point glucose monitor is operably connectable to the receiver by a wireless connection.

6. The integrated system of claim 1, wherein the processor module is further configured to identify a danger or potential risk to the health of a host, and wherein the parameter of a medicament is calculated responsive to the identification of a danger or potential risk to the health of the host.

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

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

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

10. The integrated system of claim 1, wherein the at least one parameter is calculated responsive to a mealtime event, an exercise event or a sleep event associated with the host.

11. The integrated system of claim 1, wherein the processor module is further configured to identify a dosing pattern of the host using a pattern recognition algorithm, wherein the at least one parameter is calculated responsive to the identified dosing pattern.

12. The integrated system of claim 1, wherein the at least one parameter is calculated responsive to identifying a clinically risky discrepancy, the clinical risky discrepancy identified by evaluating a discrepancy between the glucose concentration measured by the single point monitor and a glucose concentration measured by the continuous glucose sensor.

13. The integrated system of claim 1, wherein the integrated system is configured to operate in a plurality of modes, the plurality of modes comprising:

a fully-automated mode that does not require user interaction to administer medicament using the medicament delivery device;

a semi-automated mode that requires user interaction to administer medicament using the medicament delivery device; and

wherein the processor module is configured to operate the integrated system in the fully-automated mode unless the semi-automated mode is triggered, wherein the semi-automated mode is automatically triggered responsive to the integrated system determining that a predetermined condition is met.

14. The integrated system of claim 13, wherein the processor module is configured to prompt the user for the biological sample while in the semi-automated mode.

15. The integrated system of claim 13, wherein the predetermined condition is based on an evaluation of a clinical risk.

16. The integrated system of claim 13, wherein the predetermined condition is based on an evaluation of information manually inputted by a user into the receiver.

17. The integrated system of claim 13, wherein the predetermined condition is based on an evaluation of input associated with at least one of time of day, meals, sleep, calories, exercise or sickness.

18. The integrated system of claim 13, wherein the predetermined condition is adaptive over time.

19. The integrated system of claim 13, wherein the processor module is configured to learn a behavior pattern of the host, wherein the predetermined condition is based on the learned behavior pattern.

20. A method for monitoring and treating diabetes, the system comprising:

receiving sensor data from a continuous glucose sensor the sensor data comprising one or more sensor data points; and

calculating, using a processor module, at least one parameter of a medicament to deliver via a 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 at least one parameter is calculated using a glucose concentration measured by a single point glucose monitor as an input value.