Method and device utilizing insulin delivery protocols

Patent metadata

Field	Value
Publication number	US-9492608-B2
Application number	US-201313841432-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Mar 15, 2013
Publication date	Nov 15, 2016
Grant date	Nov 15, 2016

Abstract

A method of infusing liquid medicaments including insulin via an insulin pump, includes identifying an insulin delivery protocol associated with ingestion of carbohydrates wherein the insulin delivery protocol is likely to lead to a postprandial drop in blood glucose to a level below a basal level, then proposing at least one alternative insulin delivery protocol to inhibit the postprandial drop in blood glucose by delivering a metered amount of insulin that is appropriate to facilitate the metabolism of the carbohydrates without the postprandial blood glucose level drop. The invention further includes querying the patient as to whether to apply the alternative insulin delivery protocol, receiving instructions from the patient in response to the query, and applying the alternative insulin delivery protocol following receiving instructions from the patient to apply the alternative insulin delivery protocol.

First claim

The invention claimed is:

1. A computer-implemented method of infusing insulin via an infusion pump, comprising:
identifying, with an electronic controller, a type of drug therapy for treatment of diabetes likely to cause an insulin delivery protocol associated with ingestion of carbohydrates to lead to a postprandial drop in blood glucose to a level below a basal level that is likely to deprive a patient of sufficient blood glucose to function normally, wherein the type of drug therapy is identified prior to delivery of the insulin delivery protocol; and
proposing, on a user interface, at least one alternative insulin delivery protocol to inhibit the postprandial drop in blood glucose level by delivering a metered amount of insulin that is appropriate to facilitate metabolism of the carbohydrates without the postprandial blood glucose level drop; and
causing an infusion pump to deliver insulin according to the alternative insulin delivery protocol.

2. The computer-implemented method as claimed in claim 1 , further comprising causing the infusion pump to deliver insulin according to the alternative insulin delivery protocol as follows:
delivering a first bolus of the insulin having a first volume at a time t 1 ;
delivering a second bolus of the insulin having a second volume at a time t 2 ;
delivering a third bolus of the insulin having a third volume at a time t 3 .

3. The computer-implemented method as claimed in claim 2 , wherein the first volume is less than the second volume and the third volume is less than the second volume and time t 1 is followed by time t 2 and time t 2 is followed by time t 3 .

4. The computer-implemented method as claimed in claim 1 , further comprising causing the infusion pump to deliver insulin according to the alternative insulin delivery protocol as follows:
delivering insulin at a rate based on an expected postprandial rise in blood glucose level that approximates the expected postprandial rise in blood glucose level, whereby blood glucose is metabolized such that blood glucose level is maintained to be substantially constant following the ingestion of carbohydrates.

5. The computer-implemented method as claimed in claim 1 , further comprising causing the infusion pump to deliver insulin according to the alternative insulin delivery protocol as follows:
delivering insulin at a rate based on an expected postprandial rise in blood glucose level that approximates the expected postprandial rise in blood glucose level such that the rate of infusion as a function of time generally resembles a Gaussian curve.

6. The computer-implemented method as claimed in claim 5 , wherein identifying a type of drug therapy comprises identifying the use of a dose of an agent that slows gastric emptying as a factor that is likely to lead to a postprandial drop in blood glucose to a level below a basal level, and
wherein the rate of infusion that generally resembles the Gaussian curve is flattened to conform with the slowed rate of gastric emptying.

7. The computer-implemented method as claimed in claim 6 , wherein the agent that slows gastric emptying is selected from a group of agents consisting of pramlintide, Glucagon Like Peptide-1 agonists and combinations thereof.

8. The computer-implemented method as claimed in claim 6 , further comprising delivering an initial bolus of insulin followed by an insulin bolus extension, the insulin bolus extension being delivered over a period of time that is generally proportional to the dose of the agent that slows gastric emptying.

9. The computer-implemented method as claimed in claim 6 , further comprising delivering an initial bolus of insulin followed by an insulin bolus extension if the dose of the agent that slows gastric emptying exceeds a predetermined threshold.

10. The computer-implemented method as claimed in claim 6 , further comprising delivering the dose of the agent that slows gastric emptying via the infusion pump such that the infusion pump is configured as a dual hormone therapy device.

11. The computer-implemented method as claimed in claim 1 , further comprising receiving an input that the patient has ingested or is about to ingest a quantity of carbohydrates and an input enumerating the quantity of carbohydrates; and
causing the infusion pump to deliver insulin according to the alternative insulin delivery protocol if the enumerated quantity of carbohydrates exceeds a predetermined threshold.

12. The computer implemented method as claimed in claim 1 , wherein identifying a type of drug therapy comprises identifying use of an insulin action time modifier as a factor that is likely to lead to the postprandial drop in blood glucose to a level below a basal level.

13. The computer implemented method as claimed in claim 12 , further comprising delivering an initial bolus of insulin followed by an insulin bolus extension, the insulin bolus extension being delivered over a period of time that is directly proportional to a dose of the insulin action time modifier.

14. The computer implemented method as claimed in claim 1 , wherein identifying a type of drug therapy comprises identifying use of an ultra-rapid acting insulin as a factor that is likely to lead to the postprandial drop in blood glucose to a level below a basal level.

15. The computer implemented method as claimed in claim 1 , wherein causing the infusion pump to deliver insulin according to the alternative insulin delivery protocol includes combining two or more of the following insulin delivery protocols:
a) delivering a first bolus of the insulin having a first volume at a time t 1 ;
delivering a second bolus of the insulin having a second volume at a time t 2 ;
delivering a third bolus of the insulin having a third volume at a time t 3 ;

b) delivering a volume of insulin at a rate based on an expected postprandial rise in blood glucose that approximates the expected postprandial rise in blood glucose;
c) delivering a insulin at a rate based on the expected postprandial rise in blood glucose that approximates the expected postprandial rise in blood glucose whereby blood glucose is metabolized such that the volume rate of infusion generally resembles a Gaussian curve;
d) delivering an initial bolus of insulin followed by a bolus extension, the bolus extension being delivered over a period of time that is directly proportional to a dose of an agent that slows gastric emptying;
e) delivering an initial bolus of insulin followed by a bolus extension only if the dose of the agent that slows gastric emptying exceeds a predetermined threshold;
f) receiving an input from the patient that the patient has ingested or is about to ingest a quantity of carbohydrates and an input from the patient enumerating the quantity of carbohydrates; and
causing the infusion pump to deliver insulin according to the alternative insulin delivery protocol only if the enumerated quantity of carbohydrates exceeds a predetermined threshold; and

g) delivering an initial bolus of insulin followed by a bolus extension, the bolus extension being delivered over a period of time that is directly proportional to a dose of an insulin action time modifier.

16. An automated ambulatory infusion pump for infusing insulin into a living being having a controller, the controller being programmed with an algorithm that causes the automated ambulatory infusion pump to execute the following:
identifying, with an electronic controller of the ambulatory infusion pump, a type of drug therapy for treatment of diabetes likely to cause an insulin delivery protocol associated with ingestion of carboh

Assignees

• Tandem Diabetes Care Inc

Inventors

• Saint Sean

Classifications

• G16H20/17

  delivered via infusion or injection · CPC title

• A61M5/152

  pressurised by contraction of elastic reservoirs {(containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/7711)} · CPC title

• A61M5/14244 Primary

  adapted to be carried by the patient, e.g. portable on the body · CPC title

• A61M2005/14268

  with a reusable and a disposable component · CPC title

• A61M2005/14208

  with a programmable infusion control system, characterised by the infusion program · CPC title