Integrated insulin delivery system with continuous glucose sensor

• US 10,835,672 B2
• Filed: 05/05/2020
• Issued: 11/17/2020
• Est. Priority Date: 02/26/2004
• Status: Expired due to Term

• 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:
  US16/867,476
• Publication Number:
  US 20200261650A1
• Time in Patent Office: 196 Days
• Field of Search: 604504
• 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 measured glucose data from a transcutaneous glucose monitor;

receiving external data; and

controlling insulin delivery to a host, using a processor, by iteratively evaluating the received glucose data and the received external data relative to a predetermined glucose boundary, and

selectively controlling the insulin delivery responsive to the iteratively evaluating, wherein the external data comprises one or more of time of day, meals, sleep, calories, exercise, or sickness, whereby outside influences are considered in therapy instructions.

2. The method of claim 1, wherein the controlling insulin delivery includes selectively turning a controller on or off and selectively turning the insulin delivery off when the glucose data meets a predetermined criterion relative to the predetermined glucose boundary.

3. The method of claim 2, wherein the predetermined criterion for selectively turning the controller off comprises the host'"'"'s glucose falling below the glucose boundary.

4. The method of claim 2, wherein the selectively turning the controller on or off comprises selectively turning the insulin delivery on when the glucose data meets a predetermined criterion relative to the predetermined glucose boundary.

5. The method of claim 4, wherein the predetermined criterion for selectively turning the controller module on comprises the host'"'"'s glucose surpassing the glucose boundary.

6. The method of claim 1, wherein the predetermined glucose boundary comprises a set point.

7. The method of claim 6, wherein the predetermined glucose boundary comprises more than one set point.

8. The method of claim 7, wherein the more than one set point comprises a first set point to select an on instruction and a second set point to select an off instruction.

9. The method of claim 1, wherein the glucose data is generated by one or more auxiliary sensors.

10. The method of claim 9, wherein the one or more auxiliary sensors comprises an auxiliary glucose sensor.

11. The method of claim 1, further comprising adaptively adjusting the glucose boundary.

12. The method of claim 11, further comprising requesting validation from a user prior to applying an adaptive adjustment to the glucose boundary.

13. The method of claim 1, wherein the controlling comprises controlling insulin delivery at a faster rate or a slower rate based on the glucose data.

14. The method of claim 1, wherein the iteratively evaluating includes iteratively evaluating internally derived data, where the internally derived data comprises insulin on-board information, and wherein the iteratively evaluating comprises iteratively evaluating the insulin on board information.

15. The method of claim 1, wherein the external data is user-entered.

16. The method of claim 1, wherein the method is fully automated or operates in a fully automated mode.

17. The method of claim 1, wherein the external data is exercise, and wherein the iteratively evaluating includes iteratively evaluating an effect of exercise on insulin sensitivity.

18. The method of claim 1, wherein the iteratively evaluating includes iteratively evaluating an effect of a variety of factors including one or more of changes in a host'"'"'s health, weight and/or exercise routine, changes in a type of insulin used and medications, and dietary changes exercise on insulin sensitivity.

19. The method of claim 1, wherein the iteratively evaluating includes iteratively optimizing amounts of slow and fast acting insulin for a variety of situations including one or more of glucose level, rate of change, acceleration, and behavioral factors such as diet, exercise, and time of day, wherein the iteratively optimizing includes adapting the amount of slow and fast acting insulin to an individual host'"'"'s metabolic profile.

20. A diabetes management system, the system comprising:

a transcutaneous glucose monitor; and

processing circuitry configured to control insulin delivery to a host based on an iterative evaluation of internally derived data relative to a predetermined glucose boundary, the internally derived data including received glucose data from the transcutaneous glucose monitor and external data, wherein the external data comprises one or more of time of day, sleep, calories, exercise, or sickness, wherein the controller module is further configured to selectively turn the controller on or off responsive to the iterative evaluation.

21. The system of claim 20, further comprising an insulin delivery device.

22. The system of claim 20, further comprising a continuous glucose monitor.

23. The system of claim 20, wherein the controller module comprises a basal controller module.