13C glucose breath test for the diagnosis of diabetic indications and monitoring glycemic control

• US 20030044993A1
• Filed: 08/27/2002
• Published: 03/06/2003
• Est. Priority Date: 05/06/1998
• Status: Active Grant

• Current Assignee: Isotechnika Inc. (Endo International PLC)
• Original Assignee: Isotechnika Inc. (Endo International PLC)
• Inventors: Foster, Robert T., Yatscoff, Randall W., Lewanczuk, Richard, Aspeslet, Launa J.
• Granted Patent: US 6,602,715 B2
• Time in Patent Office: Days
• US Class Current: 436/56
• CPC Class Codes: A61B 5/0813 Measurement of pulmonary parameters by tracers, e.g. radioactive tracers
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61K 51/1206 Administration of radioactive gases, aerosols or breath tests
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/13 Tracers or tags
• CPC Class Codes: Y10T 436/24 Nuclear magnetic resonance, electron spin resonance or other spin effects or mass spectrometry
• CPC Class Codes: Y10T 436/25875 Gaseous sample or with change of physical state

Abstract

A breath test and kit for performing the breath test are described for the diagnosis of diabetic indications and monitoring of glycemic control. The breath test utilizes the measurement of expired ¹³C-labeled CO₂ following the ingestion of a ¹³C-enriched glucose source.

Claims

1. A diagnostic kit for the determination of glycemic control in a subject comprising:

a predetermined quantity of ¹³C-enriched glucose and

a breath collection container.

2. A diagnostic kit according to claim 1 further comprising a plurality of breath collection containers.

3. A diagnostic kit according to claims 1 or 2 for use in the diagnosis of diabetes.

4. A diagnostic kit according to claims 1 or 2 for use in the diagnosis of insulin resistance.

5. A diagnostic kit according to claims 1 or 2 for use in the diagnosis of gestational diabetes.

6. A diagnostic kit according to claims 1 or 2 for use in the determination of adequacy of antihyperglycemic therapy.

7. A diagnostic kit according to claims 1-6 wherein the ¹³C-enriched glucose is uniformly enriched.

8. A diagnostic kit according to claims 1-6, further comprising a tube that is adapted for the transfer of the breath of a subject into the breath collection container.

9. A diagnostic kit according to claims 1-8 further comprising a set of instructions wherein the instructions direct the subject to collect a first breath sample in a first breath collection container, ingest the ¹³C-enriched glucose and collect a second breath sample at a time point that is about 90 minutes after ingestion of the ¹³C-enriched glucose.

10. The use of ¹³C-enriched glucose for the determination of glycemic control in a subject.

11. ¹³C-Enriched glucose for use in the manufacture of a diagnostic kit for the determination of glycemic control in a subject.

12. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the detection of diabetes.

13. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the detection of gestational diabetes.

14. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the detection of insulin resistance.

15. The ¹³C-enriched glucose of claim 11 for use in the manufacture of a diagnostic kit for the determination of adequacy of antihyperglycemic therapy.

16. A diagnostic kit for the determination of glycemic control in normal, diabetic and insulin resistant subjects by comparing blood glucose levels with breath levels of ¹³C-enriched CO₂ comprising:

a predetermined quantity of ¹³C-enriched glucose,

a breath collection container and

a blood sampling device.