Method for infusing insulin to a subject to improve impaired hepatic glucose processing

• US 7,682,351 B2
• Filed: 12/17/2003
• Issued: 03/23/2010
• Est. Priority Date: 12/17/2003
• Status: Active Grant

• Current Assignee: Thomas T. Aoki
• Original Assignee: Thomas T. Aoki
• Inventors: Aoki, Thomas T.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/738,897
• Publication Number:
  US 20050137572A1
• Time in Patent Office: 2,288 Days
• Field of Search: 604/500, 604 65- 67, 604/503, 604/504, 604/507
• US Class Current: 604/504
• CPC Class Codes: A61K 38/28 Insulins

Abstract

The present invention is a method for delivering insulin to a subject to improve impaired hepatic glucose processing. The method delivers a series of pulses of insulin to the subject over a period of time accompanied by ingestion of glucose in the form of a carbohydrate containing meal. The amount of insulin in each pulse, the interval between pulses and the amount of time to deliver each pulse to the subject are selected so that the hepatic processing of glucose is restored in the subject. In subjects whose hepatic glucose processing has been restored there is a subsequent fall in circulating blood glucose levels of 50 mg/dl or more directly as a result of improved hepatic glucose processing.

Claims

1. A method for infusing insulin intravenously to a subject to improve impaired hepatic glucose processing comprising the steps of:

a. determining a baseline circulating glucose level of the subject and obtaining a subsequent circulating glucose level at least every 30 minutes,

b. having the subject ingest a carbohydrate containing meal to cause a rise in circulating glucose levels,

c. administering a series of insulin pulses until the rise in circulating glucose levels falls a threshold of at least 50 to 100 milligram per deciliter within two hours of administering an initial pulse of insulin;

the series of insulin pulses having an amount of insulin in each pulse, an interval of time between pulses and a total time to deliver the series of pulses;

d. repeating steps a, b and c at least one more time during a treatment day when said threshold is met;

e. changing the amount of ingested carbohydrate of step b or changing the amount of insulin in each pulse, the interval of time between pulses or the total time to deliver the series of pulses of step c when said threshold is not met and repeating steps a, b, c and d;

the threshold of 50 milligrams per deciliter fall in circulating glucose levels being an indicator that the amount of ingested carbohydrate, the amount of insulin in each pulse, the interval of time between pulses, and the total time to deliver the series of pulses is sufficient to achieve an improvement in hepatic glucose processing,

wherein said method measures in real time when the subject has actually activated hepatic glucose processing allowing positive confirmation of successful patient response.

2. The method of claim 1, wherein the carbohydrate containing meal contains 40 to 100 grams of glucose.

3. The method of claim 1, wherein the amount of insulin in each pulse is 10 to 200 milliunits of insulin per kilogram of body weight of said subject.

4. The method of claim 1, wherein the interval of time between pulses is 3 to 30 minutes.

5. The method of claim 1, wherein the total time to deliver the series of pulses is 6 to 180 minutes.

6. The method of claim 1, wherein the administering the series of insulin pulses is by an intravenous infusion device.

7. The method of claim 1, wherein the administering the series of insulin pulses is by a syringe.

8. The method of claim 1, wherein the amount of insulin in each pulse, the interval of time between pulses and the total time to deliver the series of insulin pulses to the subject are controlled by a programmable processor unit of an intravenous infusion pump.

9. The method of claim 8, wherein the step for obtaining the subsequent circulating glucose levels and the step for administering the series of insulin pulses are coordinated through a communications link between a circulating blood glucose sensor and said programmable processor unit of the intravenous infusion pump.