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

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.

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.

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.