AUTOMATED SYSTEM AND METHOD FOR DIABETES CONTROL

• US 20090281519A1
• Filed: 05/12/2009
• Published: 11/12/2009
• Est. Priority Date: 05/12/2008
• Status: Abandoned Application

• Current Assignee: Department of Veterans Affairs The United States of Government As Represented By
• Original Assignee: Department of Veterans Affairs The United States of Government As Represented By
• Inventors: Cunningham, Candace, Perreiah, Peter, RAO, R. Harsha
• Application Number:
  US12/464,344
• Publication Number:
  US 20090281519A1
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14296 Pharmacokinetic models
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

An automated method and system of diabetes control. The method includes establishing a blood glucose target for an insulin user, measuring an existing blood glucose level for the insulin user, and inputting the existing blood glucose level into a computer processor formed to execute an algorithm designed to calculate a corrective amount of insulin to be administered intravenously in an integrated basal-bolus manner to the insulin user if the existing blood glucose level exceeds the blood glucose target. The algorithm is based on a plurality of factors that contribute to a non-linear glucose response. The method further includes automatically delivering the corrective amount of insulin to the insulin user, and further repeating the measuring, inputting, and delivering steps one or more times to maintain the insulin user within the blood glucose target range.

Claims

1. An automated method for diabetes control comprising the steps of:

establishing a blood glucose target for an insulin user;

measuring an existing blood glucose level for the insulin user;

inputting the existing blood glucose level into at least one computer processor, the at least one computer processor being formed to execute at least one algorithm designed to calculate a corrective amount of insulin to be administered intravenously in an integrated basal-bolus manner to the insulin user if the existing blood glucose level exceeds the blood glucose target, wherein the at least one algorithm is based on a plurality of factors that contribute to a non-linear glucose response;

automatically delivering the corrective amount of insulin to the insulin user; and

,

repeating the measuring, inputting, and delivering steps one or more times to maintain the insulin user within the blood glucose target range.

2. The method of claim 1, wherein the blood glucose target is 80-110 mg/dl (milligrams per deciliter).

3. The method of claim 1, wherein the blood glucose target is 90-140 mg/dl (milligrams per deciliter).

4. The method of claim 1, wherein the plurality of factors comprise a magnitude of the existing blood glucose level, the preceding blood glucose level, a time between the existing blood glucose level and a preceding blood glucose level, a calculated rate of change in the blood glucose, a total insulin dose, and a fractional change in total insulin dose.

5. The method of claim 1, further comprising the step of progressively reducing the corrective amount of insulin to the insulin user as insulin sensitivity improves as the existing blood glucose level reaches the blood glucose target.

6. The method of claim 1, further comprising the step of providing a safety warning in an integrated user interface to recheck the existing blood glucose level at a variable predetermined time.

7. The method of claim 1, wherein the method is designed for use in a hospital intensive care unit.

8. An automated method for diabetes control comprising the steps of:

establishing a blood glucose target for an insulin user;

establishing a carbohydrate target for the insulin user;

measuring an existing blood glucose level for the insulin user;

measuring an existing amount of carbohydrate consumed by the insulin user;

inputting the existing blood glucose level into at least one computer processor, the at least one computer processor being formed to execute at least one algorithm designed to calculate a corrective amount of insulin to be administered subcutaneously in an integrated basal-bolus manner to the insulin user if the existing blood glucose level exceeds the blood glucose target in relation to the existing amount of carbohydrate consumed;

automatically delivering the corrective amount of insulin to the insulin user after the insulin user eats a meal; and

,

repeating the measuring, inputting, and delivering steps one or more times to maintain the insulin user within the blood glucose target range.

9. The method of claim 8, wherein the blood glucose target is 90-140 mg/dl (milligrams per deciliter).

10. The method of claim 8, wherein the carbohydrate target is 75 gm (grams) of carbohydrate per meal.

11. The method of claim 8, wherein the corrective amount of insulin to be administered subcutaneously comprises a bolus dose of a fast-acting analog insulin and a basal dose of a 24-hour insulin.

12. The method of claim 11, wherein the bolus dose of the fast-acting analog insulin is selected from the group comprising aspart insulin, lispro insulin and glulisine insulin.

13. The method of claim 11, wherein the basal dose of the 24-hour insulin comprises glargine.

14. The method of claim 8, wherein the method is designed for use in a hospital non-intensive care unit setting.

15. An automated system for diabetes control comprising:

a database for obtaining a blood glucose target for an insulin user;

a glucose measuring device for measuring an existing blood glucose level for the insulin user;

an insulin delivery unit; and

,

a computer having a computer processor that receives blood glucose level measurements from the glucose measuring device, executes a software program that calculates a corrective amount of insulin to be administered intravenously in an integrated basal-bolus manner to the insulin user if the existing blood glucose level exceeds the blood glucose target, wherein the software program is based on a plurality of factors that contribute to a non-linear glucose response, and further wherein the software program has a communication element that communicates to the insulin delivery unit the corrective amount of insulin to be administered to the insulin user.

16. The system of claim 15, wherein the blood glucose target is 80-110 mg/dl (milligrams per deciliter).

17. The system of claim 15, wherein the blood glucose target is 90-140 mg/dl (milligrams per deciliter).

18. The system of claim 15, wherein the plurality of factors comprise a magnitude of the existing blood glucose level, a magnitude of the preceding blood glucose level, a calculated rate of change in the blood glucose, a time between the existing blood glucose level and a preceding blood glucose level, a total insulin dose, and a fractional change in total insulin dose.

19. An automated system for diabetes control comprising:

a database for obtaining a blood glucose target for an insulin user;

a database for obtaining a carbohydrate target for the insulin user;

a glucose measuring device for measuring an existing blood glucose level for the insulin user;

a carbohydrate measuring device for measuring an existing amount of carbohydrate consumed by the insulin user;

an insulin delivery unit; and

,

a computer having a computer processor that receives blood glucose level measurements from the glucose measuring device and receives carbohydrate consumed measurements from the carbohydrate measuring device, and executes a software program that calculates a corrective amount of insulin to be administered subcutaneously in an integrated basal-bolus manner to the insulin user if the existing blood glucose level exceeds the blood glucose target in relation to the existing amount of carbohydrate consumed, wherein the software program has a communication element that communicates to the insulin delivery unit the corrective amount of insulin to be administered to the insulin user after the insulin user eats a meal.

20. The system of claim 19, wherein the blood glucose target is 90-140 mg/dl (milligrams per deciliter).