System for determining insulin dose using carbohydrate to insulin ratio and insulin sensitivity factor

• US 8,246,540 B2
• Filed: 07/01/2008
• Issued: 08/21/2012
• Est. Priority Date: 09/11/2002
• Status: Active Grant

• Current Assignee: Embecta Corporation
• Original Assignee: Becton, Dickinson & Co
• Inventors: Ginsberg, Barry H.
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US12/216,231
• Publication Number:
  US 20080269585A1
• Time in Patent Office: 1,512 Days
• Field of Search: 600/347, 600/365, 604/66
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2230/201 Glucose concentration
• 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: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

An apparatus and method are provided for determining a patient'"'"'s carbohydrate to insulin ratio (CIR) and insulin sensitivity factor (ISF), and using these values, along with values for current blood glucose level and deviation from target blood glucose level, for determining insulin dose in view of carbohydrate intake during a particular time period. The apparatus and method employ algorithms that can be implemented in any of a personal computer, personal data assistant, hand held computing device, blood glucose monitor, infusion pump, medication delivery pen, meter, calculator, among other therapeutic, diagnostic or informational devices used for managing a patient'"'"'s blood glucose levels.

Claims

1. A computer-implemented method of determining factors used for insulin therapy comprising the steps of:

storing at least one data set in a memory device, the data set comprising blood glucose readings taken, respectively, at substantially the beginning of and substantially the end of a selected period of time, a value corresponding to the patient'"'"'s food intake for the selected period, and the amount of insulin administered to the patient during the selected period;

calculating a delta blood glucose level corresponding to the difference between the blood glucose readings taken, respectively, at substantially the beginning of and substantially the end of the selected period; and

determining, using the computer, a correct insulin amount using the delta blood glucose level divided by an insulin sensitivity factor, and the result of the division being added to the amount of insulin administered to the patient during the selected period.

2. A method as claimed in claim 1, wherein the selected period of time corresponds to a period of time occurring within one day.

3. A method as claimed in claim 1, wherein the selected period of time comprises one meal time selected from the group consisting of breakfast, lunch, dinner, or snack.

4. A method as claimed in claim 1, further comprising the step of generating an initial estimate of the insulin sensitivity factor using at least one number selected from the range of numbers equal to or between 1500 and 1800, and dividing the at least one number by the daily insulin dose.

5. A method as claimed in claim 1, further comprising the steps of:

determining a plurality of daily carbohydrate to insulin ratios corresponding to respective ones of a plurality of days, the daily carbohydrate to insulin ratios each being based on the correct insulin amount and the value corresponding to the patient'"'"'s food intake for the selected period from the data set of the corresponding one of the plurality of days; and

determining a carbohydrate to insulin ratio for the selected period from an average of the daily carbohydrate to insulin ratios.

6. A method as claimed in claim 5, wherein the step of determining a carbohydrate to insulin ratio for the selected period comprises the step of calculating a weighted average of the plurality of daily carbohydrate to insulin ratios.

7. A method as claimed in claim 1, further comprising the step of determining a plurality of daily carbohydrate to insulin ratios corresponding to respective ones of a plurality of days, the daily carbohydrate to insulin ratios each being based on the correct insulin amount divided into the value corresponding to the patient'"'"'s food intake for the selected period from the data set of the corresponding one of the plurality of days.

8. A method as claimed in claim 7, further comprising the step of determining a carbohydrate to insulin ratio for the selected period from an average of the daily carbohydrate to insulin ratios.

9. A method as claimed in claim 8, further comprising the steps of:

determining the amount of insulin not needed for carbohydrates consumed on a given day; and

determining an estimate of the insulin sensitivity factor for the given day using the delta blood glucose divided by the amount of insulin not needed for the given day.

10. A method as claimed in claim 9, wherein the determining step for determining the amount of insulin not needed for carbohydrates consumed on a given day comprises the steps of:

dividing the value corresponding to the patient'"'"'s food intake by the carbohydrate to insulin ratio for the selected period, the value for the patient'"'"'s food intake being the value for the selected period obtained from the data set of one of the plurality of days corresponding to the given day; and

subtracting the result of the dividing step from the an estimate of the insulin sensitivity factor for the given day.

11. A method as claimed in claim 10, further comprising the step of generating an initial estimate of the insulin sensitivity factor using at least one number selected from the range of numbers equal to or between 1500 and 1800, and dividing the at least one number by the daily insulin dose.

12. A method as claimed in claim 9, further comprising the step of determining the insulin sensitivity factor for the selected period from an average of the insulin sensitivity factor for each of a plurality of days.

13. A method as claimed in claim 12, wherein the step of determining an insulin sensitivity factor for the selected period comprises the step of calculating a weighted average of the insulin sensitivity factor for each of a plurality of days.