Integrated insulin delivery system with continuous glucose sensor

• US 9,452,259 B2
• Filed: 10/25/2013
• Issued: 09/27/2016
• Est. Priority Date: 10/09/2007
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Dobbles, John Michael, Kamath, Apurv Ullas, Mahalingam, Aarthi, Brauker, James H.
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US14/063,941
• Publication Number:
  US 20140052095A1
• Time in Patent Office: 1,068 Days
• Field of Search: 604 65- 67, 604/131, 604/151, 128/DIG.12, 128/DIG.13, 600/316, 600/365, 600/300
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• 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 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/0068 Indicating or counting the number of dispensed doses or of remaining doses
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/0083 Timers
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• 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 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/587 Lighting arrangements
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 35/00 : Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61M 5/003 : Kits for diabetics
• CPC Class Codes: A61M 5/1413 : Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 : specially adapted for implantation
• 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 5/178 : Syringes
• CPC Class Codes: A61M 5/20 : Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/30 : Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Systems and methods for integrating a continuous glucose sensor 12, including a receiver 14, a medicament delivery device 16, a controller module, and optionally a single point glucose monitor 18 are provided. Integration may be manual, semi-automated and/or fully automated.

Claims

1. A method for diabetes management of a host, the method comprising:

receiving sensor data generated by a continuous glucose monitoring device, wherein the sensor data is indicative of a glucose concentration;

tracking and/or evaluating a system error of the continuous glucose monitoring device over time;

determining an insulin therapy instruction, using a controller module of a processor, based on the sensor data and a system error; and

delivering insulin, using an insulin infusion device, to the host based on the insulin therapy instruction from the controller module.

2. The method of claim 1, wherein the sensor data comprises a possible variation of glucose concentration based on the system error.

3. The method of claim 1, comprising monitoring an error associated with the system, whereby the system error is determined.

4. The method of claim 3, comprising iteratively evaluating the determined system error over time and adjusting one or more system parameters based on the iterative evaluation.

5. The method of claim 4, wherein the one or more system parameters are selected from the group consisting of target range, glucose boundary, bolus constraint, basal profile, rate of insulin delivery, and time of insulin delivery.

6. The method of claim 1, wherein the system error is associated with the sensor data.

7. The method of claim 1, wherein determining an insulin therapy instruction is further based on a comparison of the sensor data to a target glucose range, and wherein the target glucose range is adjusted based on the system error.

8. The method of claim 1, wherein the determining an insulin therapy instruction based on the sensor data and a system error comprises applying the system error as a weighted sum for providing a graded dose adjustment.

9. A system for diabetes management of a host, the system comprising:

a processor comprising a controller module configured to track and/or evaluate a system error of a continuous glucose monitoring device over time, and determine an insulin therapy instruction based on sensor data and the system error, wherein the sensor data is generated by a continuous analyte sensor associated with a glucose concentration of a host; and

an insulin delivery device configured to deliver insulin to the host based on the insulin therapy instruction from the processor.

10. The system of claim 9, wherein the sensor data comprises a possible variation of glucose concentration based on the system error.

11. The system of claim 9, wherein the processor is configured to monitor an error associated with the system, whereby the system error is determined.

12. The system of claim 11, wherein the processor is configured to iteratively evaluate the determined system error over time and to adjust one or more system parameters based on the iterative evaluation.

13. The system of claim 12, wherein the one or more system parameters are selected from the group consisting of target range, glucose boundary, bolus constraint, basal profile, rate of insulin delivery, and time of insulin delivery.

14. The system of claim 9, wherein the system error is associated with the sensor data.

15. The system of claim 9, wherein the controller module is configured to determine an insulin therapy instruction based on a comparison of the sensor data to a target glucose range, and wherein the target glucose range is adjusted based on the system error.

16. The system of claim 9, wherein the controller module is configured to determine an insulin therapy instruction based on the sensor data and a system error by applying the system error as a weighted sum to provide a graded dose adjustment.

17. The system of claim 9, further comprising a continuous glucose monitoring device.

18. The system of claim 9, wherein the continuous glucose monitoring device is configured to monitor an error associated with the system, whereby the system error is determined.

19. A system for diabetes management of a host, the system comprising:

a continuous glucose monitoring device;

a processor comprising a controller module configured to track and/or evaluate a system error of the continuous glucose monitoring device over time, and determine an insulin therapy instruction based on sensor data and the system error, wherein the sensor data is generated by the continuous analyte sensor and is associated with the glucose concentration of the host; and

an insulin delivery device configured to deliver insulin to the host based on the insulin therapy instruction from the processor.