Clinical variable determination

• US 10,016,561 B2
• Filed: 03/15/2013
• Issued: 07/10/2018
• 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
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): Schell, Laura
• Application Number:
  US13/842,005
• Publication Number:
  US 20140276556A1
• Time in Patent Office: 1,943 Days
• Field of Search: 600347, 600365, 604 31, 604 65- 67, 604500, 604503-504, 6048901, 6048921, 705 1- 3
• 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. An 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 a user to ingest a quantity of carbohydrates;

receiving an input from the user indicating the quantity of carbohydrates ingested;

receiving input data related to a second blood glucose measurement at a time after the input indicating the quantity of carbohydrates ingested;

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 user as to a quantity of carbohydrates to be ingested at a subsequent meal after saving the carbohydrate factor into memory;

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

causing the pump to infuse the insulin dose,

wherein the time of the second blood glucose measurement is determined based on an identification of a peak of a postprandial rise in blood glucose based on input from a continuous glucose monitoring system.

2. The automated ambulatory infusion pump as claimed in claim 1, wherein the algorithm further executes:

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

3. The automated ambulatory infusion pump as claimed in claim 1, wherein the algorithm further executes:

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

4. An 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 a user to ingest a quantity of carbohydrates;

receiving an input from the user indicating the quantity of carbohydrates ingested;

receiving input data related to a second blood glucose measurement at a time after the input indicating the quantity of carbohydrates ingested;

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 user as to a quantity of carbohydrates to be ingested at a subsequent meal after saving the carbohydrate factor into memory;

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

causing the pump to infuse the insulin dose,

wherein the time of the second blood glucose measurement is determined based on an identification of when blood glucose level has stabilized after a postprandial rise in blood glucose based on input from a continuous glucose monitoring system.

5. The automated ambulatory infusion pump as claimed in claim 4, wherein the algorithm further executes:

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

6. The automated ambulatory infusion pump as claimed in claim 4, wherein the algorithm further executes:

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