13C glucose breath test for the diagnosis of diabetic indications and monitoring glycemic control
First Claim
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10. The use of 13C-enriched glucose for the determination of glycemic control in a subject.
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Abstract
Use of 13C glucose in an analytical assay to monitor glucose metabolism by measurement of labeled exhaled CO2 is provided. 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.
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Citations
23 Claims
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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.
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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:
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(a) a predetermined quantity of 13C-enriched glucose;
(b) a breath collection container; and
(c) a blood sampling device.
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17. A method of diagnosing a condition in a subject, said condition selected from the group consisting of diabetes, insulin resistance impaired glucose tolerance, impaired fasting glucose and gestational diabetes, said method comprising:
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a) collecting a first breath sample from said subject in a first breath collection container;
b) administering 13C-enriched glucose to said subject;
c) collecting a second breath sample from said subject in a second breath container at a time point after administration of said 13C-enriched glucose;
d) measuring the 13CO2 in each of said first and second breath samples; and
e) comparing the amount of 13CO2 in said second breath sample with the amount of 13CO2 in said first breath sample, wherein the presence of less 13CO2 in said second breath sample compared to normal control values indicates the presence of said condition. - View Dependent Claims (18, 19, 20)
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21-1. The method of claim 21, wherein said comparison is made by choosing a cutoff of ROC values wherein the sensitivity and specificity are such as to maximize diagnostic accuracy.
Specification