INTEGRATED INSULIN DELIVERY SYSTEM WITH CONTINUOUS GLUCOSE SENSOR

• US 20140052094A1
• Filed: 10/25/2013
• Published: 02/20/2014
• 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.
• Granted Patent: US 9,586,004 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• 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, the method comprising:

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

calculating an insulin therapy instruction based on the sensor data, using a controller module of a processor;

comparing the determined insulin therapy instruction to one or more criteria;

constraining the determined insulin therapy instruction if the insulin therapy instruction fails the one or more criteria; and

providing the constrained insulin therapy instruction if the insulin therapy instruction fails the one or more criteria.

2. The method of claim 1, further comprising delivering the constrained insulin therapy instruction using an insulin delivery device.

3. The method of claim 1, further comprising prompting a user to validate the determined insulin therapy instruction or the constrained insulin therapy instruction.

4. The method of claim 1, wherein the one or more criteria comprises a predetermined basal profile comprising a schedule of one or more time blocks, wherein each time block is associated with a maximum insulin delivery rate.

5. The method of claim 4, wherein the determined insulin therapy instruction fails the one or more criteria if the insulin therapy instruction exceeds the maximum insulin delivery rate for the current time block.

6. The method of claim 5, wherein the constraining comprises adjusting the insulin delivery rate of the determined insulin therapy to no more than the maximum delivery rate associated with a time block of the basal profile, whereby the constrained insulin therapy instruction is obtained.

7. The method of claim 1, wherein the one or more criteria comprises a predetermined bolus constraint.

8. The method of claim 7, wherein one or more criteria comprises two or more bolus constraints.

9. The method of claim 8, wherein the two or more constraints are associated with different types of meals and/or with different events.

10. The method of claim 7, wherein the determined insulin therapy instruction fails the one or more criteria if the insulin therapy instruction exceeds a maximum total insulin dose of the engaged bolus constraint.

11. The method of claim 10, where constraining comprises adjusting the insulin therapy to no more than the maximum total insulin dose of the engaged bolus constraint.

12. The method of claim 7, wherein the bolus constraint is engaged by at least one of pressing a button or key, actuating a switch or selecting from a menu.

13. The method of claim 1, wherein the receiving, calculating, comparing, constraining and providing are performed iteratively

14. A system for diabetes management, the system comprising:

a processor comprising a controller module configured to calculate an insulin therapy instruction based on the sensor data generated by a continuous glucose monitoring device, wherein the sensor data is indicative of glucose concentration, wherein the controller module is configured to compare the determined insulin therapy instruction to one or more criteria, constrain the determined insulin therapy instruction if the insulin therapy instruction fails the one or more criteria, and provide the constrained insulin therapy instruction if the insulin therapy instruction fails the one or more criteria.

15. The system of claim 14, further comprising an insulin delivery device for delivering the constrained insulin therapy instruction.

16. The system of claim 14, wherein the processor is configured to prompt a user to validate the determined insulin therapy instruction or the constrained therapy instruction.

17. The system of claim 14, wherein the one or more criteria comprises a predetermined basal profile comprising a schedule of one or more time blocks, wherein each time block is associated with a maximum insulin delivery rate.

18. The system of claim 17, wherein the determined insulin therapy instruction fails the one or more criteria if the insulin therapy instruction exceeds the maximum insulin delivery rate for the current time block.

19. The system of claim 18, wherein the processor module is configured to constrain by adjusting the insulin delivery rate of the determined insulin therapy to no more than the maximum delivery rate associated with a time block of the basal profile, whereby the constrained insulin therapy instruction is obtained.

20. The system of claim 14, wherein the one or more criteria comprises a predetermined bolus constraint.

21. The system of claim 20, wherein one or more criteria comprises two or more bolus constraints.

22. The system of claim 21, wherein the two or more constraints are associated with different types of meals and/or with different events.

23. The system of claim 20, wherein the determined insulin therapy instruction fails the one or more criteria if the insulin therapy instruction exceeds a maximum total insulin dose of the engaged bolus constraint.

24. The system of claim 23, wherein the processor module is configured to constrain by adjusting the insulin therapy to no more than the maximum total insulin dose of the engaged bolus constraint.

25. The system of claim 20, wherein the bolus constraint is configured to be engaged by at least one of pressing a button or key, actuating a switch or selecting from a menu.