# US 2008/0187943 A1 · 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

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- Number: US 2008/0187943 A1
- Document ID: US20080187943A1
- Status: Published application
- Kind: A1
- Application number: 11/912,171
- Filed: 2006-04-21
- Published: 2008-08-07
- Earliest claimed: 2005-04-22
- Assignees: Nippon Kayaku Kabushiki Kisha; Toyota Tsusho America, Inc.
- Inventors: John B. Buse; Kathleen Dungan; Steven D. Wittlin; Eric A. Button; Shuhei Kato; Toshio Tanabe
- Web page: https://patentgrep.com/patent/US20080187943A1

## CPC

- C12Q 1/54: involving glucose or galactose
- G01N 33/66: involving blood sugars, e.g. galactose
- G01N 2800/042: Disorders of carbohydrate metabolism, e.g. diabetes, glucose metabolism
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 2)

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.

### Claim 4 (depends on 2)

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

### Claim 5 (depends on 4)

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.

### Claim 6 (depends on 4)

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

### Claim 7 (depends on 5)

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

### Claim 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.

### Claim 9 (depends on 8)

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

### Claim 10 (depends on 9)

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

### Claim 11 (depends on 2)

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

### Claim 12 (depends on 3)

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

### Claim 13 (depends on 9)

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

### Claim 14 (depends on 10)

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

### Claim 15 (depends on 2)

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

### Claim 16 (depends on 9)

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

### Claim 17 (depends on 2)

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

### Claim 18 (depends on 9)

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

### Claim 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.

### Claim 20 (depends on 19)

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