13C glucose breath test for the diagnosis of diabetic indications and monitoring glycemic control
First Claim
Patent Images
1. A diagnostic kit for the determination of baseline glucose metabolism in the absence of an indication of glucose intolerance, diabetes or gestational diabetes in a subject comprising:
- a predetermined quantity of uniformly labeled 13C-enriched glucose; and
a breath collection container.
1 Assignment
0 Petitions
Accused Products
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.
-
Citations
42 Claims
-
1. A diagnostic kit for the determination of baseline glucose metabolism in the absence of an indication of glucose intolerance, diabetes or gestational diabetes in a subject comprising:
-
a predetermined quantity of uniformly labeled 13C-enriched glucose; and
a breath collection container. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
and a second breath collection container for receiving a breath sample after the uniformly labeled 13C-enriched glucose is ingested.
-
-
4. A diagnostic kit according to claim 3, said diagnostic kit further comprising a set of instructions wherein the instructions direct the subject to collect a first breath sample in said first breath collection container, ingest the uniformly labeled 13C-enriched glucose and collect a second breath sample at a time point that is after ingestion of the uniformly labeled 13C-enriched glucose, in said second breath collection container.
-
5. A diagnostic kit according to claim 1, said diagnostic kit further comprising a tube that transfers the breath of the subject into the breath collection container.
-
6. A diagnostic kit according to claim 1, said diagnostic kit further including analysis means for measuring 13CO2 metabolized from said uniformly labeled 13C-enriched glucose, in a breath sample, said analysis means being selected from the group consisting of an isotope ratio mass spectroscope (IRMS), a continuous flow isotope ratio mass spectroscope (CF-IRMS) and a non-dispersive infrared spectroscopy (NDIRS).
-
7. The diagnostic kit of claim 6 wherein said analysis means is CF-IRMS.
-
8. The diagnostic kit of claim 6 wherein said analysis means is NDIRS.
-
9. A diagnostic kit according to claim 1, wherein said predetermined quantity contains 25 mg or less of the uniformly labeled 13C-enriched glucose.
-
10. A diagnostic kit according to claim 1, further comprising about 15 g of unlabeled glucose.
-
11. A diagnostic kit according to claim 1, wherein said predetermined quantity comprises about 25 mg of the uniformly labeled 13C-enriched glucose.
-
12. A diagnostic kit according to claim 11, said diagnostic kit comprising a breath collection container for receiving a baseline breath sample taken from the subject prior to ingestion of any of the predetermined quantity of the uniformly labeled 13C-enriched glucose;
- and
at least two breath collection containers for receiving a breath sample at predetermined time points after ingestion of the uniformly labeled 13C-enriched glucose.
- and
-
13. A diagnostic kit according to claim 11, said diagnostic kit comprising a first breath collection container for receiving a baseline breath sample taken from the subject prior to ingestion of any of the predetermined quantity of the uniformly labeled 13C-enriched glucose;
a second breath collection container for receiving a breath sample at a first time point after ingestion of the uniformly labeled 13C-enriched glucose and a third breath collection container for receiving a breath sample at a second time point after ingestion of the uniformly labeled 13C-enriched glucose.
-
14. A diagnostic kit for the determination of glucose metabolism in a subject comprising a predetermined quantity of uniformly labeled 3C-enriched glucose;
-
a breath collection container for receiving a baseline breath sample taken from the subject prior to ingestion of any of the predetermined quantity of the uniformly labeled 3C-enriched glucose; and
at least two breath collection containers for receiving a breath sample at predetermined time points after ingestion of the uniformly labeled 13C-enriched glucose. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 22)
-
-
23. A diagnostic kit for the determination of glucose metabolism in a subject comprising a predetermined quantity of uniformly labeled 13C-enriched glucose;
-
a first breath collection container for receiving a baseline breath sample taken from the subject prior to ingestion of any of the predetermined quantity of the uniformly labeled 13C-enriched glucose;
a second breath collection container for receiving a breath sample at a first time point after ingestion of the uniformly labeled 13C-enriched glucose and a third breath collection container for receiving a breath sample at a second time point after ingestion of the uniformly labeled 13C-enriched glucose. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31)
-
-
32. A method for the determination of glucose metabolism in a subject comprising:
-
a) collecting a first breath sample from said subject in a first breath collection container;
b) administering uniformly labeled 13C-enriched glucose to said subject;
c) collecting a second breath sample from said subject in a second breath collection container at a time point after administration of said uniformly labeled 13C-enriched glucose;
d) collecting a third breath sample from said subject in a third breath collection container at a second time point after administration of said uniformly labeled 13C-enriched glucose;
e) measuring 13CO2 in each of said first, second, and third breath samples; and
f) comparing the amount of 13CO2 in said first, second and third breath samples wherein the difference between said amounts of 13CO2 determines the glucose metabolism in the subject. - View Dependent Claims (33)
-
-
34. 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, gestational diabetes and normal glucose metabolism, said method comprising:
-
a) collecting a first breath sample from said subject in a first breath collection container;
b) measuring a first blood glucose level;
c) administering uniformly labeled 13C-enriched glucose to said subject;
d) collecting at least a second and third breath sample from said subject in at least a second and third breath collection container, each at a time point after administration of said uniformly labeled 13C-enriched glucose;
e) measuring 13CO2 in each of said first and at least said second and third breath samples and comparing said measurements to obtain delta over baseline (DOB) values;
f) measuring at least a second and third blood glucose level, each at a time point after administration of said uniformly labeled 13C-enriched glucose;
g) plotting said first and at least said second and third blood glucose levels over time to define a blood glucose test curve;
h) plotting said DOB values over time to define a breath test curve;
i) measuring the areas between said breath test curve and said blood glucose test curve; and
k) comparing said areas between said breath test curve and said blood glucose test curve with such areas measured from patients having a condition selected from the group consisting of diabetes, insulin resistance, impaired glucose tolerance, impaired fasting glucose, gestational diabetes and normal glucose metabolism to diagnose said conditions in said subject. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41)
a predetermined quantity of uniformly labeled 13C-enriched glucose;
a breath collection container; and
a blood sampling device.
-
-
41. A diagnostic kit according to claim 40, the diagnostic kit comprising a first breath collection container for receiving a baseline breath sample taken from the subject prior to ingestion of any of the predetermined quantity of the uniformly labeled 13C-enriched glucose;
- and
a second breath collection container for receiving a breath sample after the uniformly labeled 13C-enriched glucose is ingested.
- and
-
42. A diagnostic kit for the determination of glucose metabolism in a subject by comparing blood glucose levels with breath levels of 13C-enriched CO2, said diagnostic kit comprising a predetermined quantity of uniformly labeled 13C-enriched glucose;
-
a blood sampling device;
a breath collection container for receiving a baseline breath sample taken from the subject prior to ingestion of any of the predetermined quantity of the uniformly labeled 13C-enriched glucose; and
at least two breath collection containers for receiving a breath sample at predetermined time points after ingestion of the uniformly labeled 13C-enriched glucose.
-
Specification