Methods of monitoring glucose levels in a subject and uses thereof

• US 6,862,466 B2
• Filed: 04/23/2003
• Issued: 03/01/2005
• Est. Priority Date: 08/28/2000
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Ackerman, Neil
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US10/421,440
• Publication Number:
  US 20030208114A1
• Time in Patent Office: 678 Days
• Field of Search: 600345-348, 600/353, 600/354, 600/362, 600/364, 600/365, 600/366
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant

Abstract

Methods of frequently monitoring glucose amounts and/or concentrations in a subject who is at risk for hypoglycemia, hyperglycemia, and/or glucose level fluctuations that put the subject at risk are provided. Also provided are methods of monitoring the effects of one or more pharmaceutical compositions on the levels of glucose in a subject.

Claims

1. A method for achieving a weight management goal in a subject, said method comprising

determining a reference range of glucose amounts or concentrations that correspond to achieving the weight management goal in the subject, said range of glucose amounts or concentrations comprising a high threshold glucose value and a low threshold glucose value;

monitoring glucose amount or concentration in the subject by a glucose monitoring method comprising

transdermally extracting a sample comprising glucose from the subject using a sampling system that is in operative contact with a skin or mucosal surface of said subject, wherein the extracting is carried out using an iontophoretic system comprising first and second iontophoretic electrodes;

contacting the sample with a sensor element in the presence of glucose oxidase that reacts with glucose to produce hydrogen peroxide;

detecting the hydrogen peroxide with the sensor element that reacts electrochemically with the hydrogen peroxide to produce a detectable signal, wherein said detectable signal is specifically related to glucose amount or concentration in the subject;

measuring the detectable signal;

correlating the detectable signal to an amount or concentration of glucose in the subject; and

repeating said glucose monitoring method to obtain a series of glucose amounts or concentrations, in the subject, at selected time intervals;

maintaining a record of at least caloric intake; and

comparing said series of glucose amounts or concentrations, said record, and said reference range to evaluate compliance with the reference range of glucose amounts or concentrations to achieve the weight management goal of the subject.

2. The method of claim 1, wherein said weight management goal is selected from the group consisting of weight gain in the subject, weight reduction in the subject, and weight maintenance in the subject.

3. The method of claim 1, wherein said maintaining a record further comprises maintaining a record of caloric output.

4. The method of claim 1, wherein said monitoring glucose amount or concentration in the subject by a glucose monitoring method further comprises providing an alert to the subject when a glucose amount or concentration, in the subject, at a selected time interval falls outside of the reference range.

5. A method for improving prognosis and/or reduction of adverse side-effects associated with a disease state or condition in a subject, said method comprising

determining a reference range of glucose amounts or concentrations that correspond to achieving an improved prognosis or reduction of adverse side-effects associated with said disease state or condition in the subject, said range of glucose amounts or concentrations comprising a high threshold glucose value and a low threshold glucose value;

monitoring glucose amount or concentration in the subject by a glucose monitoring method comprising

transdermally extracting a sample comprising glucose from the subject using a sampling system that is in operative contact with a skin or mucosal surface of said subject, wherein the extracting is carried out using an iontophoretic system comprising first and second iontophoretic electrodes;

contacting the sample with a sensor element in the presence of glucose oxidase that reacts with glucose to produce hydrogen peroxide;

detecting the hydrogen peroxide with the sensor element that reacts electrochemically with the hydrogen peroxide to produce a detectable signal, wherein said detectable signal is specifically related to glucose amount or concentration in the subject;

measuring the detectable signal;

correlating the detectable signal to an amount or concentration of glucose in the subject; and

repeating said glucose monitoring method to obtain a series of glucose amounts or concentrations, in the subject, at selected time intervals; and

comparing said series of glucose amounts or concentrations and said reference range to evaluate compliance with the reference range of glucose amounts or concentrations to achieve an improved prognosis or reduction of adverse side-effects associated with said disease state or condition in the subject, wherein said disease state or condition is not type I or type II diabetes.

6. The method of claim 5, wherein said monitoring glucose amount or concentration in the subject by a glucose monitoring method further comprises providing an alert to the subject when a glucose amount or concentration, in the subject, at a selected time interval falls outside of the reference range.

7. The method of claim 5, wherein the condition is cancer remission.

8. The method of claim 5, wherein the disease state is infection with human immunodeficiency virus (HIV).

9. The method of claim 5, wherein the disease state is infection with Candida.

10. The method of claim 5, wherein the condition is long distance driving.

11. The method of claim 5, wherein the condition is organ transplantation.

12. The method of claim 5, wherein the condition is growth hormone therapy.

13. The method of claim 5, wherein the disease state is renal failure.

14. The method of claim 5, wherein the disease state is infection with malaria.

15. The method of claim 5, wherein the condition is alcoholism.

16. The method of claim 5, wherein the condition is intense exercise.

17. The method of claim 5, wherein the disease state is cardiovascular disease.

18. The method of claim 5, wherein the disease state is cystic fibrosis.

19. The method of claim 5, wherein the disease state is stroke or ischemia.

20. The method of claim 5, wherein the disease state is an eating disorder.