INTEGRATED DELIVERY DEVICE FOR CONTINUOUS GLUCOSE SENSOR

• US 20090299276A1
• Filed: 08/06/2009
• Published: 12/03/2009
• Est. Priority Date: 02/26/2004
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Simpson, Peter C., Markovic, Dubravka, Tapsak, Mark A., Mensinger, Michael Robert, Kamath, Apurv U., Neale, Paul V., Saint, Sean T.
• Granted Patent: US 7,976,492 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• 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. A method for treating diabetes with an integrated glucose sensor and a medicament delivery device, comprising:

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

calculating a medicament therapy recommendation based at least in part on the sensor data;

validating the calculated medicament therapy recommendation based on at least one of data input into a receiver or data obtained from a single point glucose monitor; and

outputting information reflective of the calculated medicament therapy recommendation responsive to a validated calculated medicament therapy recommendation.

2. The method according to claim 1, further comprising detecting an impending clinical risk.

3. The method according to claim 1, wherein outputting information comprises outputting the calculated medicament therapy recommendation to a user interface.

4. The method according to claim 1, wherein outputting information comprises transmitting the calculated medicament therapy recommendation to a medicament delivery device.

5. The method according to claim 1, wherein outputting information comprises delivering the calculated medicament therapy recommendation via a medicament delivery device.

6. A method for treating diabetes with an integrated glucose sensor and a medicament delivery device, comprising:

receiving medicament delivery data associated with medicament delivery from a medicament delivery device;

receiving sensor data from a glucose sensor for a time period before and after a time of the medicament delivery, the sensor data comprising one or more sensor data points;

determining a host'"'"'s metabolic response to the medicament delivery;

receiving subsequent sensor data from the glucose sensor, the subsequent sensor data comprising one or more sensor data points; and

calculating a medicament therapy based at least in part on the host'"'"'s metabolic response and the subsequent sensor data.

7. The method according to claim 6, wherein determining a host'"'"'s metabolic response comprises using a pattern recognition algorithm.

8. The method according to claim 6, wherein determining a host'"'"'s metabolic response is repeatedly determined when additional medicament delivery data are received.

9. The method according to claim 8, wherein determining a host'"'"'s metabolic response is iteratively determined for a time period exceeding one week.

10. A method for estimating glucose levels from an integrated glucose sensor and medicament delivery device, comprising:

receiving sensor data associated with a glucose sensor, the sensor data comprising one or more sensor data points;

receiving medicament delivery data associated with a medicament delivery device;

evaluating the medicament delivery data with the sensor data corresponding to delivery and/or release of the medicament delivery data to determine one or more individual metabolic patterns associated with medicament delivery; and

estimating glucose values based at least in part on the individual metabolic patterns and the sensor data.

11. The method according to claim 10, wherein the individual'"'"'s metabolic patterns are calculated using a pattern recognition algorithm.

12. The method according to claim 10, wherein the individual'"'"'s metabolic patterns are repeatedly determined when additional medicament delivery data are received.

13. The method according to claim 12, wherein the individual'"'"'s metabolic patterns are iteratively determined for a time period exceeding one week.