Integrated insulin delivery system with continuous glucose sensor

• US 9,572,935 B2
• Filed: 10/25/2013
• Issued: 02/21/2017
• 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
• Application Number:
  US14/063,753
• Publication Number:
  US 20140052091A1
• Time in Patent Office: 1,215 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. An integrated system for monitoring a glucose concentration in a host and for delivering insulin to the host, the system comprising:

a continuous glucose sensor, wherein the continuous glucose sensor is configured to substantially continuously measure a glucose concentration in a host, and to provide sensor data associated with the glucose concentration of the host;

an electronics module comprising a basal controller module configured to iteratively determine an insulin therapy instruction in response to an evaluation of a relationship of internally derived data and a basal profile, wherein the basal profile comprises at least one time block associated with a maximum insulin delivery rate; and

an insulin delivery device configured to deliver insulin to the host, wherein the insulin delivery device is at least one of physically connected to a receiver and/or operably connected to a receiver, wherein the insulin delivery device is configured to receive the insulin therapy instruction from the basal controller module, and wherein the insulin therapy instruction is constrained by a maximum insulin delivery rate associated with a current time block.

2. The integrated system of claim 1, wherein the insulin therapy instruction is determined solely on internally derived data and the basal profile.

3. The integrated system of claim 1, wherein the maximum insulin delivery rate is an insulin delivery rate of from about 0.01 U/hour to about 6.0 U/hour.

4. The integrated system of claim 1, wherein the insulin delivery device is configured to deliver insulin automatically in response to receiving the insulin therapy instruction.

5. The integrated system of claim 1, wherein the insulin therapy instruction instructs delivery of insulin at less than the maximum insulin delivery rate associated with the current time block.

6. The integrated system of claim 1, wherein the basal controller module is configured to iteratively determine the insulin therapy instruction in response to internally derived data and the basal profile, wherein the basal controller module comprises programming to adjust the basal profile in response to internally derived data.

7. The integrated system of claim 6, wherein the basal controller module is further configured to iteratively determine the insulin therapy instruction in response to a host'"'"'s metabolic response to an insulin therapy, wherein the basal controller module comprises programming to adjust the basal profile in response to the host'"'"'s metabolic response.

8. The integrated system of claim 1, wherein the insulin delivery device is configured to provide delivery device data associated with insulin delivery.

9. The integrated system of claim 8, wherein the internally derived data comprises at least one of sensor data, processed sensor data, delivery device data, or processed delivery device data.

10. The integrated system of claim 9, wherein the internally derived data further comprises at least one of a glucose concentration, a glucose concentration range, a change in glucose concentration, a glucose concentration rate of change, an acceleration of a glucose concentration rate of change, a host insulin sensitivity, a change in host insulin sensitivity, a host metabolic response to insulin therapy, an amount of insulin delivered, a time of insulin delivery, an insulin on board, or a time.

11. An method for monitoring a glucose concentration in a host and for delivering insulin to the host, the method comprising:

receiving sensor data associated with a glucose concentration of a host;

evaluating of a relationship of internally derived data and a basal profile;

determining, using a basal controller module of a processor, an insulin therapy instruction in response to the evaluation, wherein the basal profile comprises at least one time block associated with a maximum insulin delivery rate; and

delivering insulin to the host based on the insulin therapy instruction from the basal controller module, wherein the insulin therapy instruction is constrained by a maximum insulin delivery rate associated with a current time block.

12. The method of claim 11, wherein the determining is based solely on the internally derived data and the basal profile.

13. The method of claim 11, wherein the maximum insulin delivery rate is an insulin delivery rate of from about 0.01 U/hour to about 6.0 U/hour.

14. The method of claim 11, wherein the delivering insulin is automatic in response to determining the insulin therapy instruction.

15. The method of claim 11, w wherein the insulin therapy instruction instructs delivery of insulin at less than the maximum insulin delivery rate associated with the current time block.

16. The method of claim 11, wherein the determining comprises iteratively determining the insulin therapy instruction and adjusting the basal profile in response to internally derived data.

17. The method of claim 16, wherein the determining comprises iteratively determining the insulin therapy instruction and adjusting the basal profile in response to a host'"'"'s metabolic response to an insulin therapy.

18. The method of claim 11, comprising providing delivery device data associated with insulin delivery.

19. The method of claim 18, wherein the internally derived data comprises at least one of sensor data, processed sensor data, delivery device data, or processed delivery device data.

20. The method of claim 19, wherein the internally derived data comprises at least one of a glucose concentration, a glucose concentration range, a change in glucose concentration, a glucose concentration rate of change, an acceleration of a glucose concentration rate of change, a host insulin sensitivity, a change in host insulin sensitivity, a host metabolic response to insulin therapy, an amount of insulin delivered, a time of insulin delivery, an insulin on board, or a time.