Means for monitoring the status of control of ketoacidosis-prone diabetics

• US 4,397,956 A
• Filed: 12/10/1981
• Issued: 08/09/1983
• Est. Priority Date: 12/10/1981
• Status: Expired due to Fees

• Current Assignee: Edward T. Maggio
• Original Assignee: Edward T. Maggio
• Inventors: Maggio, Edward T.
• Primary Examiner(s): Marantz, Sidney
• Application Number:
  US06/329,392
• Time in Patent Office: 607 Days
• Field of Search: 422/56, 23/230 R, 23/230 B, 436/34, 436/95, 436/128, 436/130, 436/131
• US Class Current: 436/34
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 33/64 involving ketones
• CPC Class Codes: Y10T 436/144444 Glucose
• CPC Class Codes: Y10T 436/200833 Carbonyl, ether, aldehyde or ketone containing
• CPC Class Codes: Y10T 436/202499 Formaldehyde or acetone
• CPC Class Codes: Y10T 436/203332 Hydroxyl containing

Abstract

Method and test system for monitoring the status of control of ketoacidosis-prone diabetics using pseudo-kinetic methods. Pseudo-kinetic clinical information is obtained by analysis of a single blood sample in which the blood glucose level is determined along with one or more additional indicator analytes present in patient blood, serum or plasma. The additional indicator analyte(s) provide a "historical" picture of recent events within the patient relating to glucose metabolism which, when analyzed in conjunction with the blood glucose level, provides, from a single sample, a holistic view of the degree of metabollic control in the diabetic patient which is otherwise obtainable at the present time only by the much less desirable process of drawing and analyzing multiple samples over a period of time. The additional indicator analyte may be ketone bodies.

Claims

1. A method for monitoring the status of control of ketoacidosis-prone diabetics comprising measuring, on a single body fluid sample, the concentration levels of glucose and at least one additional indicator analyte, the additional indicator analyte being present in the body fluid in response to changes in the glucose metabolism of the diabetic within from about 5 minutes to about 12 hours of such change, and using the measured concentration level of the additional indicator analyte in conjunction with the measured concentration level of the glucose to calculate the instantaneous determination of the slope of the change of the glucose concentration and consequently reporting on the status of control of the diabetic.

2. A method as in claim 1 wherein an algorithm is used to calculate the instantaneous determination of the slope of the change of the glucose concentration.

3. A method as in claim 1 wherein the body fluid is blood.

4. A method as in claim 1 wherein the additional indicated analyte is ketone bodies.

5. A test system for monitoring the status of control of ketoacidosis-prone diabetics comprising, in combination, a test means for measuring, on a single body fluid sample, the concentration levels of glucose and at least one additional indicator analyte, the additional indicator analyte being present in the body fluid in response to changes in the glucose metabolism of the diabetic within from about 5 minutes to about 12 hours of such change, and analyzing means for calculating the instantaneous determination of the slope of the change of the glucose concentration and reporting the status of control of the diabetic.

6. A test system as in claim 5 wherein the additional indicator analyte is ketone bodies.

7. A test system as in claim 5 wherein the body fluid is whole blood and the test means comprises reagent pads coated with a membrane and a reflectance meter to measure the response of the reagent pads to the presence of glucose and the additional indicator analyte.

8. A test system as in claim 5 wherein the analyzing means comprises an algorithm for calculating the instantaneous determination of the slope of the glucose concentration.