Condensate Glucose Analyzer

Abstract

Systems and methods for analyzing glucose present in exhaled breath condensate (EBC). In certain embodiments, electrochemical- or coulometnc-based sensing technologies are used to analyze EBC for the presence and / or concentration of glucose. Based on the detected glucose m EBC, the subject invention provides systems and methods for non-invasive, accurate assessment of blood glucose levels.

Description

FIELD OF INVENTION[0001]The present invention relates to non-invasive monitoring of glucose concentrations in blood; and more particularly, to a system and method utilizing a breath condensate detection system for the frequent monitoring of glucose concentrations in subjects who are at risk for hypoglycemia, hyperglycemia, and / or glucose level fluctuations that put the subject at medical risk.BACKGROUND INFORMATION[0002]Abnormal levels of glucose in the blood of humans can have a number of consequences. For example, fluctuations of blood glucose levels outside of the physiological range can result in one of two states, hypoglycemia and hyperglycemia. Hypoglycemia is defined as plasma glucose levels below normal (70 mg / dL). Hypoglycemia can be symptomatic or asymptomatic. For example, subjects suffering from postprandial hypoglycemia generally have symptoms of adrenergic stimulation including diaphoresis, anxiety, irritability, palpitations, tremor, and hunger. Such symptoms typicall...

AI Technical Summary

Benefits of technology

The present invention provides non-invasive methods and systems for monitoring glucose levels in a subject's body. This is useful for diagnosing and managing diseases such as hypoglycemia, hyperglycemia, and fluctuations in glucose levels. The methods involve collecting samples of exhaled breath from the subject and extracting the glucose from the sample using a sensor that can detect and quantify the glucose present. This technology offers a non-invasive and convenient way to monitor glucose levels, which can help improve management of diabetic disease states and reduce the risk of complications.

Problems solved by technology

In more severe cases, hypoglycemia can progress to confusion, blurring of vision, seizure, and ultimately loss of consciousness or seizure.

In diabetic subjects, glucose cannot enter the cells and subsequently, glucose builds up in the blood and the body's cells literally starve to death.

It has been observed that complications resulting from diabetes are the third leading cause of death in most developed countries.

The healthcare costs associated with the treatment of diabetes and diabetic complications are enormous and projected to increase with the number of American living to older ages and the increased incidence of obesity.

Present devices available for SMBG are complicated and difficult for many diabetics to use and often require them to obtain an adequate blood sample.

Most diabetics, even those aware of the complications of hypo- and hyperglycemia, do not test frequently enough (for Type I [insulin dependent] diabetics this may be 6-8 times / D and for Type II diabetics controlled with oral agent testing should ideally be performed at least 2 times / D) because they consider obtaining blood to be significantly more painful than the self-administration of insulin and SMBG is far more time consuming and complicated.

The FDA is fully aware of the many shortcomings of the devices used for SMBG, but newer technologies or matrices have not proven any more reliable.

Unfortunately, tears, saliva and sweat have failed as viable matrices for use as surrogates for blood in monitoring glucose levels.

It is less likely to be associated with the transfer of serious infections than other bodily fluids and collection of samples is straightforward and painless.

Such technology has not been effective because they have not been able to derive sufficient concentrations of target compounds (such as glucose) in the liquid EBC sample to afford accurate detection and quantification.

Further, such technology requires large sampling (roughly 75 breaths) to derive a sufficient amount of liquid EBC sample for testing.

Finally, such technology does not take into account variable humidity in exhaled breath and in the air when samples are taken as well as the random microparticle density of the sample, which can significantly effect the accuracy of measured target analyte in the sample as well as the correlation between the concentration of the target analyte in EBC versus blood concentration.

Thus, truly simple, non-invasive methods of measuring target analytes, specifically glucose, are not commercially available.

Further, no successful system or method has been developed that can accurately correlate glucose found in exhaled breath with the concentration found in blood.

Images