1,5-Anhydroglucitol (1,5-Ag) Assay and A1C/1,5-Ag Assay Combination For Measuring Blood Glucose Excursions in General and Postprandial Hyperglycemia in Diabetic Patients

• US 20080187943A1
• Filed: 04/21/2006
• Published: 08/07/2008
• Est. Priority Date: 04/22/2005
• Status: Active Grant

• Current Assignee: Nippon Kayaku Company Limited
• Original Assignee: Nippon Kayaku Company Limited, Toyota Tsusho America Incorporated (Toyota Tsusho Corporation)
• Inventors: Tanabe, Toshio, Button, Eric A., Kato, Shuhei, Buse, John B., Dungan, Kathleen, Wittlin, Steven D.
• Granted Patent: US 8,178,312 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: C12Q 1/54 involving glucose or galactose
• CPC Class Codes: G01N 2800/042 Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

The invention is a method of measuring blood glucose excursions in general, and postprandial hyperglycemia in diabetic patients in particular, by the 1,5-anhydroglucitol assay (1,5-AG) or A1C/1,5-AG assay combination. 1,5-AG levels and percent changes of 1,5-AG levels in short period are indicative of differing postmeal glucose levels in moderately-controlled diabetic patients with similar A1C levels. Thereby 1,5-AG assay is useful to identify diabetic patients who may be at risk for cardiovascular complications which would not be identifiable by A1C levels alone. Furthermore, ratios of A1C divided by 1,5-AG in each patient are superior indicators to 1,5-AG levels.

Claims

1. A method of evaluating blood glucose excursion in a person, said method comprising the step of measuring a 1,5-anhydroglucitol value in the person'"'"'s blood.

2. The method of claim 1, wherein the blood glucose excursion in a person is postprandial hyperglycemia in a diabetic patient.

3. The method of claim 2, further comprising the step of estimating a mean maximum postprandial blood glucose level in the diabetic patient, said step of estimation comprising the steps of:

using the 1,5-anhydroglucitol value; and

using a calculation formula or a table.

4. The method of claim 2, further comprising the step of measuring a value of one additional glycemic control marker.

5. The method of claim 4, further comprising the step of calculating a ratio of the value of the additional glycemic control marker to the 1,5-AG value.

6. The method of claim 4, wherein the additional glycemic control marker is at least one of A1C, fructosamine, and fasting plasma glucose.

7. The method of claim 5, wherein the additional glycemic control marker is A1C.

11. The method of claim 2, wherein the diabetic patient has an A1C level of between 6.5 and 8.0% inclusive.

12. The method of claim 3, wherein the diabetic patient has an A1C level of between 6.5 and 8.0% inclusive.

15. A method of estimating the risk of a cardiovascular complication in a diabetic patient, said method comprising the method of claim 2.

17. The method of claim 2, wherein the diabetic patient is either a type 1 diabetic patient or a type 2 diabetic patient.

8. A method of evaluating blood glucose excursion in a person, said method comprising the steps of:

taking more than one measurement of a 1,5-anhydroglucitol (“

1,5-AG”

) value in the person'"'"'s blood over a period of time; and

computing a change or a percent change in the person'"'"'s 1,5-AG value.

9. The method of claim 8, wherein the blood glucose excursion in a person is postprandial hyperglycemia in a diabetic patient.

10. The method of claim 9, wherein the period of time over which the measurements are taken is between 2 and 7 days inclusive.

13. The method of claim 9, wherein the diabetic patient has an A1C level of between 6.5 and 8.0% inclusive.

14. The method of claim 10, wherein the diabetic patient has an A1C level of between 6.5 and 8.0% inclusive.

16. A method of estimating the risk of a cardiovascular complication in a diabetic patient, said method comprising the method of claim 9.

18. The method of claim 9, wherein the diabetic patient is either a type 1 diabetic patient or a type 2 diabetic patient.

19. A device to evaluate blood glucose excursion in a person, said device comprising a unit to measure a 1,5-anhydroglucitol value in the person'"'"'s blood.

20. The device of claim 19, wherein the blood glucose excursion in a person is postprandial hyperglycemia in a diabetic patient.