Integrated insulin delivery system with continuous glucose sensor

• US 9,457,146 B2
• Filed: 12/30/2013
• Issued: 10/04/2016
• 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:
  US14/144,373
• Publication Number:
  US 20140114278A1
• Time in Patent Office: 1,009 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 managing diabetes, 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 in the host; and

an insulin delivery device configured to deliver insulin to the host as determined by a controller module, wherein the controller module is configured to;

continuously instruct the basal insulin therapy at a pre-programmed insulin delivery rate responsive to the sensor data meeting one or more predetermined basal criteria;

adaptively calculate a bolus insulin therapy responsive to the sensor data meeting a present or predicted hyperglycemic glucose value or range of values, wherein the bolus insulin therapy is calculated based on the sensor data; and

immediately terminate insulin therapy responsive to the sensor data meeting one or more predetermined off criteria.

2. The integrated system of claim 1, wherein the one or more predetermined basal criteria comprise a present or predicted euglycemic glucose value or range of values.

3. The integrated system of claim 1, wherein the one or more predetermined off criteria comprise a present or predicted hypoglycemic glucose value or range of values.

4. The integrated system of claim 1, wherein the system further comprises at least one of a selectable button configured to allow a user to engage an engageable bolus constraint, a scroll wheel configured to allow a user to engage an engageable bolus constraint, or a menu selection configured to allow a user to engage an engageable bolus constraint.

5. The integrated system of claim 1, wherein the combination of basal insulin therapy and bolus insulin therapy are constrained to a maximum total insulin dose per unit of time.

6. The integrated system of claim 1, comprising a user interface configured to issue prompts, messages, warnings and alarms associated with the insulin therapy instruction determined by the controller module.

7. The integrated system of claim 6, wherein the user interface is configured to sound an alarm responsive to termination of insulin delivery.

8. A method for managing diabetes, the method comprising:

substantially continuously receiving sensor data from a continuous glucose sensor indicative of the glucose concentration in the host; and

delivering insulin therapy to the host, using an insulin delivery device, according to instructions;

continuously instructing the basal insulin therapy at a pre-programmed insulin delivery rate responsive to the sensor data meeting one or more predetermined basal criteria;

adaptively calculating a bolus insulin therapy responsive to the sensor data meeting a present or predicted hyperglycemic glucose value or range of values, wherein the bolus insulin therapy is calculated based on the sensor data; and

immediately terminating insulin therapy responsive to the sensor data meeting one or more predetermined off criteria.

9. The method of claim 8, wherein the one or more predetermined basal criteria comprise a present or predicted euglycemic glucose value or range of values.

10. The method of claim 8, wherein the one or more predetermined off criteria comprise a present or predicted hypoglycemic glucose value or range of values.

11. The method of claim 8, wherein the method further comprises at least one of selecting a button to allow a user to engage an engageable bolus constraint, selecting a scroll wheel to allow a user to engage an engageable bolus constraint, or selecting a menu selection to allow a user to engage an engageable bolus constraint.

12. The method of claim 8, wherein the instructions further comprise constraining the combination of basal insulin therapy and bolus insulin therapy to a maximum total insulin dose per unit of time.

13. The method of claim 8, comprising prompting, messaging, warning or alarming, on a user interface, based on the insulin therapy instruction determined by the controller module.

14. The integrated method of claim 8, comprising sounding an alarm responsive to termination of insulin delivery.