Methods of monitoring glucose levels in a subject and uses thereof

• US 20030208114A1
• Filed: 04/23/2003
• Published: 11/06/2003
• Est. Priority Date: 08/28/2000
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Animas Technologies LLC (Johnson & Johnson)
• Inventors: Ackerman, Neil
• Granted Patent: US 6,862,466 B2
• Time in Patent Office: Days
• 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 evaluating compliance with a weight management program in a subject, said method comprising

determining a reference range of glucose amounts or concentrations that correspond to achieving a 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 signal measurement 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 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 recording 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 monitoring an effect of at least one non-insulin-containing pharmaceutical composition on glucose levels in a subject receiving said pharmaceutical composition, the method comprising,

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 signal measurement 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 treatment with the pharmaceutical composition; and

comparing said series of glucose amounts or concentrations and said record to evaluate the effect of the pharmaceutical composition on glucose levels in the subject receiving said pharmaceutical composition.

6. The method of claim 5 further comprising, determining a reference range of glucose amounts or concentrations that correspond to maintaining a desired range of glucose amounts or concentrations in the subject during a treatment course with said pharmaceutical composition, wherein said reference range comprises a high threshold glucose value and a low threshold glucose value.

7. The method of claim 6, 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.

8. The method of claim 5, wherein the pharmaceutical composition is pentamidine.

9. The method of claim 5, wherein the pharmaceutical composition is quinine.

10. The method of claim 5, wherein the pharmaceutical composition is saquinavir.

11. The method of claim 5, wherein the pharmaceutical composition is indomethacin.

12. The method of claim 5, wherein the subject is also receiving insulin.

13. 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 signal measurement 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.

14. The method of claim 13, 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.

15. The method of claim 13, wherein the condition is cancer remission.

16. The method of claim 13, wherein the disease state is infection with human immunodeficiency virus (HIV).

17. The method of claim 13, wherein the disease state is infection with Candida.

18. The method of claim 13, wherein the condition is long distance driving.

19. The method of claim 13, wherein the condition is organ transplantation.

20. The method of claim 13, wherein the condition is growth hormone therapy.

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

22. The method of claim 13, wherein the disease state is infection with malaria.

23. The method of claim 13, wherein the condition is alcoholism.

24. The method of claim 13, wherein the condition is intense exercise.

25. The method of claim 13, wherein the disease state is cardiovascular disease.

26. The method of claim 13, wherein the disease state is cystic fibrosis.

27. The method of claim 13, wherein the disease state is stroke or ischemia.

28. The method of claim 13, wherein the disease state is an eating disorder.