Ambulatory insulin infusion system with bolus administration delay

• US 9,629,957 B2
• Filed: 12/16/2010
• Issued: 04/25/2017
• Est. Priority Date: 12/28/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics International AG (Roche Holding AG)
• Inventors: Remde, Axel, Sigrist, Reto, Bernini, Nicole
• Primary Examiner(s): OSINSKI, BRADLEY JAMES
• Application Number:
  US12/969,664
• Publication Number:
  US 20110160695A1
• Time in Patent Office: 2,322 Days
• Field of Search: 6048901, 604 65- 67
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

In one embodiment, an ambulatory insulin infusion system may include an administration module for insulin administration, a data collection module for collecting data relevant for the bolus amount, and a delay module. The administration module may administer insulin continuously according to a basal profile and a bolus on demand. The bolus has a bolus amount. The data collection module may be operatively coupled to the administration module. The delay module may trigger administration of the bolus a therapeutically significant delay interval after the data is collected.

Claims

1. An ambulatory insulin infusion system, comprising:

an administration module for insulin administration, wherein the administration module administers insulin continuously according to a basal profile and a bolus on demand, the bolus having a bolus amount;

a data collection module for collecting data relevant for the bolus amount, wherein the data collection module is operatively coupled to the administration module; and

a delay module operatively coupled to the administration module and the data collection module, wherein the delay module triggers administration of the bolus automatically by the administration module upon expiry of a therapeutically significant delay interval started by the delay module after the data is collected by the data collection module, wherein the delay module is designed to also trigger the administration of the bolus in the delay interval upon receipt of an acknowledgment user input.

2. The ambulatory insulin infusion system of claim 1 further comprising a bolus determination module that determines the bolus amount based, at least in part, on the data.

3. The ambulatory insulin infusion system of claim 2, wherein the data collection module comprises a blood glucose measurement module that measures a blood glucose value and the bolus determination module determines the bolus amount based, at least in part, on the blood glucose value measured by the blood glucose measurement module.

4. The ambulatory insulin infusion system of claim 3, wherein the bolus determination module determines a correction bolus amount of a correction bolus based on the blood glucose value measured by the blood glucose measurement module, and the administration module triggers a correction bolus administration.

5. The ambulatory insulin infusion system of claim 2, wherein the data collection module comprises a user interface that collects meal characterizing data, and the bolus determination module determines the bolus amount based, at least in part, on the meal characterizing data.

6. The ambulatory insulin infusion system of claim 1, wherein the therapeutically significant delay interval is a pre-defined time interval.

7. The ambulatory insulin infusion system of claim 1, wherein the delay module terminates a running delay interval without triggering the administration of the bolus when a maximum delay interval has expired without receipt of the acknowledgement user input.

8. The ambulatory insulin infusion system of claim 1 further comprising an alert module that generates an alert during the therapeutically significant delay interval and/or when the therapeutically significant delay interval is terminated.

9. The ambulatory insulin infusion system of claim 1, wherein the delay module has a disabled mode.

10. The ambulatory insulin infusion system of claim 1, wherein the ambulatory insulin infusion system receives further data that is relevant for a determination of the bolus amount at an end of the therapeutically significant delay interval and determines the bolus amount, at least in part, based on the further data.

11. The ambulatory insulin infusion system of claim 1, wherein the administration module and the data collection module are located in separate housings.

12. The ambulatory insulin infusion system of claim 11, wherein the delay module and the administration module are located in a same housing.

13. The ambulatory insulin infusion system of claim 1, wherein the ambulatory insulin infusion system is operatively coupled to a continuous glucose monitoring unit that measures a blood glucose value at one or more of a beginning of the therapeutically significant delay interval, during the therapeutically significant delay interval, and at an end of the therapeutically significant delay interval, and the bolus amount is determined based, at least in part, on the blood glucose value.

14. The ambulatory insulin infusion system of claim 1, wherein the delay module stores a minimum delay interval that is a lower limit for a length of the therapeutically significant delay interval.

15. An ambulatory insulin infusion system, comprising:

an administration module for insulin administration, wherein the administration module administers insulin continuously according to a basal profile and a bolus on demand, the bolus having a bolus amount;

a data collection module;

a delay module operatively coupled to the administration module and the data collection module and which is configured to start automatically a therapeutically significant delay interval after collecting the data by the data collection module, wherein the delay module triggers the administration of the bolus and the data collection module collects further data relevant for the bolus amount after the therapeutically significant delay interval ends, and the delay module also triggers the administration of the bolus by the administration module upon receipt of an acknowledgement user input during the therapeutically significant delay interval; and

a bolus determination module that determines the bolus amount based, at least in part, on at least one of the data and the further data.

16. A method for ambulatory insulin infusion, comprising:

administering insulin substantially continuously according to a basal profile via an administration module;

collecting a blood glucose value via a data collection module;

starting automatically a therapeutically significant delay interval after the blood glucose value is collected via a delay module;

determining, automatically with a processor that is operatively coupled to the administration module, the data collection module and the delay module, a bolus amount of insulin based, at least in part, on the blood glucose value received from the data collection module;

administering, via the administration module, the bolus amount of insulin, automatically, upon one of;

after the therapeutically significant delay interval expires, and receipt of an acknowledgement user input during the therapeutically significant delay interval.

17. The method of claim 16 further comprising:

receiving further data relevant to the bolus amount of insulin after the therapeutically significant delay interval expires, wherein the bolus amount of insulin is based, at least in part, on the further data.

18. The method of claim 16 further comprising:

determining a correction bolus amount of insulin based on the blood glucose value; and

administering the correction bolus amount substantially immediately after the correction bolus amount is determined.