Methods of monitoring glucose levels in a subject and uses thereof

• US 7,228,163 B2
• Filed: 11/05/2004
• Issued: 06/05/2007
• Est. Priority Date: 08/28/2000
• Status: Expired due to Term

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Animas Technologies LLC (Johnson & Johnson)
• Inventors: Ackerman, Neil
• Primary Examiner(s): Marmor, II; Charles A.
• Assistant Examiner(s): Natnithithadha; Navin
• Application Number:
  US10/982,549
• Publication Number:
  US 20050124874A1
• Time in Patent Office: 942 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 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, wherein the pharmaceutical composition is not used in the subject for the treatment of diabetes and is selected from the group consisting of pentamidine, quinine, saquinavir and indomethacin.

2. The method of claim 1 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.

3. The method of claim 2, 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.

4. The method of claim 1, wherein the subject is also receiving insulin.