New England Breath Technologies, LLC is developing a device that will accurately detect breath acetone and which will mimic the current size and footprint of the common personal alcohol breathalyzer. The first generation breathalyzer (pictured above and which is currently being miniaturized) includes a tube that the patient breathes into as well as a disposable coated slide which is inserted in the top of the device in the direct line of the patient’s breath.
In the field of materials science there is a push towards progressively smaller, ordered, multifunctional, economical, and easily tailored systems. For approximately 20 years, multilayering of polyelectrolyte systems has been of interest in many technological and scientific areas. By designing a film with the suitable polyelectrolytes it is possible to crosslink them with acetone resulting in an alteration in the physicochemical nature of these multilayered films. By quantifying these changes (e.g. spectrally) the amount of acetone that was originally introduced to the system can be determined. A major advantage of using this approach is that no other breath volatile containing a reactive carbonyl is found in concentrations above 0.5% of that of acetone, and none have shown variability with disease states. Therefore, when developed into a breathalyzer, the degree of ketogenesis, and thus blood glucose level, can be determined. Unlike other techniques, some of which suffered from selectivity or interference from humidity, this approach will only detect/react with ketones and/or aldehydes.
For healthy individuals, an acetone concentration of 300 – 900 ppb in the breath has been reported, compared to 1800 ppb for individuals with diabetes. This 100-500% increase has prompted numerous groups around the globe to attempt to develop a cheap and reliable device that could accurately diagnosis diabetes via breath acetone. A more ambitious goal has been to develop a Point-Of-Care (POC) device for monitoring blood glucose level using breath acetone. Phenomenal correlations of acetone with blood glucose levels (R=0.98, P<0.02) and A1C levels (R=0.99, P<0.02) have been reported with T1DM patients.