CLINICAL VARIABLE DETERMINATION

• US 20140276556A1
• Filed: 03/15/2013
• Published: 09/18/2014
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Tandem Diabetes Care Incorporated
• Original Assignee: Tandem Diabetes Care Incorporated
• Inventors: Saint, Sean, Rosinko, Mike
• Granted Patent: US 10,016,561 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A computer implemented method of determining a clinical variables utilizing an insulin pump that includes initiating blood glucose measurements, initiating ingestion of carbohydrates and receiving input data based on the blood glucose measurements and the ingestion of carbohydrates and utilizing the data to calculate clinical variables. The invention may include presenting instructions to a patient to take various actions and to input various data. The clinical variables determined may be stored in memory and then used to calculate insulin doses and to send a signal to an insulin pump to infuse the insulin dose calculated.

Claims

1. A computer-implemented method of determining a carbohydrate factor utilizing an ambulatory infusion pump, the method comprising:

receiving input data related to a first blood glucose measurement;

presenting instructions to ingest a quantity of carbohydrates;

receiving an input indicating the quantity of carbohydrates ingested;

waiting a length of time;

receiving input data related to a second blood glucose measurement;

calculating a change in blood glucose between the first blood glucose measurement and the second blood glucose measurement;

calculating a carbohydrate factor by dividing the change in blood glucose by the quantity of carbohydrates ingested;

saving the carbohydrate factor in memory;

receiving input as to a quantity of carbohydrates to be ingested at a meal;

utilizing the carbohydrate factor in memory to calculate an insulin dose to be infused prior to the meal; and

sending a signal to an infusion device controller to infuse the insulin dose.

2. The method as claimed in claim 1, further comprising presenting instructions to initiate the first blood glucose measurement.

3. The method as claimed in claim 1, further comprising receiving the input data related to the first blood glucose measurement from a continuous glucose monitoring system.

4. The method as claimed in claim 1, further comprising presenting instructions at a second time to take a second blood glucose measurement.

5. The method as claimed in claim 1, further comprising receiving the input data related to the second blood glucose measurement from a continuous glucose monitoring system.

6. The method as claimed in claim 1, further comprising receiving input from a continuous glucose monitoring system that identifies a peak of a postprandial rise in blood glucose and instructing taking of a blood glucose measurement at that time.

7. The method as claimed in claim 1, further comprising receiving input from a continuous glucose monitoring system that identifies when blood glucose level has flattened or stabilized after a postprandial rise in blood glucose and instructing the taking of a blood glucose measurement at that time.

8. A computer implemented method of determining an insulin sensitivity factor utilizing an insulin pump, the method comprising:

receiving input data related to a first blood glucose measurement;

initiating an infusion of a known preselected quantity of insulin;

recording a time of the infusion of the known quantity of insulin;

waiting a length of time;

receiving input data related to a second blood glucose measurement;

calculating a change in blood glucose between the first blood glucose measurement and the second blood glucose measurement;

calculating an insulin sensitivity factor by dividing the change in blood glucose by the quantity of insulin infused;

saving the insulin sensitivity factor in memory;

receiving input of a current blood glucose level and target blood glucose level;

utilizing the insulin sensitivity factor to calculate an insulin dose to be infused;

sending a signal to an infusion device controller to infuse the insulin dose.

9. The method as claimed in claim 8, further comprising initiating the first blood glucose measurement by presenting instructions to perform the measurement.

10. The method as claimed in claim 8, further comprising initiating the second blood glucose measurement based on input from a continuous glucose monitoring system that identifies when blood glucose level has flattened or stabilized after the infusion of insulin and instructing taking of a blood glucose measurement at that time.

11. The method as claimed in claim 8, further comprising initiating the first blood glucose measurement based on input from a continuous glucose monitoring system that identifies that the blood glucose level is flat or stable and instructing the taking of a blood glucose measurement at that time.

12. The method as claimed in claim 8, further comprising initiating the second blood glucose measurement by presenting instructions to perform the measurement.

13. An automated ambulatory infusion pump for infusing insulin into a living being, the pump having a controller, the controller being programmed with an algorithm that executes the following:

receiving input data related to a first blood glucose measurement;

presenting instructions to ingest a quantity of carbohydrates;

receiving an input indicating the quantity of carbohydrates ingested;

waiting a length of time;

receiving input data related to a second blood glucose measurement;

calculating a change in blood glucose between the first blood glucose measurement and the second blood glucose measurement;

calculating a carbohydrate factor by dividing the change in blood glucose by the quantity of carbohydrates ingested;

saving the carbohydrate factor in memory;

receiving input from the patient as to a quantity of carbohydrates to be ingested at a meal;

utilizing the carbohydrate factor in memory to calculate an insulin dose to be infused prior to the meal;

sending a signal to an infusion device controller to infuse the insulin dose.

14. The automated ambulatory infusion pump as claimed in claim 13, the controller being further programmed with an algorithm that executes the following:

receiving the input data related to the first blood glucose measurement or the second blood glucose measurement from a continuous glucose monitoring system.

15. The automated ambulatory infusion pump as claimed in claim 13, the controller being further programmed with an algorithm that executes the following:

presenting instructions to initiate the first blood glucose measurement or the second blood glucose measurement.

16. The automated ambulatory infusion pump as claimed in claim 13, the controller being further programmed with an algorithm that executes the following:

receiving input from a continuous glucose monitoring system that identifies a peak of a postprandial rise in blood glucose or that identifies when blood glucose level has flattened or stabilized after a postprandial rise in blood glucose and instructing taking of a blood glucose measurement at that time.

17. An automated ambulatory infusion pump for infusing insulin, into a living being, the insulin pump having a controller, the controller being programmed with an algorithm that executes the following:

receiving input data related to a first blood glucose measurement;

initiating an infusion of a known preselected quantity of insulin;

recording a time of the infusion of the known quantity of insulin;

waiting a length of time;

receiving input data related to a second blood glucose measurement;

calculating a change in blood glucose between the first blood glucose measurement and the second blood glucose measurement;

calculating an insulin sensitivity factor by dividing the change in blood glucose by the quantity of insulin infused;

saving the insulin sensitivity factor in memory;

receiving input of a current blood glucose level and target blood glucose level;

utilizing the insulin sensitivity factor in memory to calculate an insulin dose to be infused;

sending a signal to an infusion device controller to infuse the insulin dose.

18. The automated ambulatory infusion pump as claimed in claim 17, the controller being further programmed with an algorithm that executes the following:

initiating the first blood glucose measurement or the second blood glucose measurement by presenting instructions to perform the measurement.

19. The automated ambulatory infusion pump as claimed in claim 17, the controller being further programmed with an algorithm that executes the following:

initiating the first blood glucose measurement based on input from a continuous glucose monitoring system that identifies that the blood glucose level is flat or stable or initiating the second blood glucose measurement based on input from a continuous glucose monitoring system that identifies when blood glucose level has flattened or stabilized after the infusion of insulin and instructing the taking of a blood glucose measurement at that time.