An investigational device that measures acetone in the breath could one day represent a viable alternative to finger-stick blood glucose self-monitoring for people with diabetes, new research indicates.
Early results from a study in 50 adults with and without diabetes showed strong correlation with blood glucose measurements using a device for detecting breath acetone that works with disposable nanotechnology-based sensor slides, which "read" the acetone levels.
The durable part has now been developed into a portable, hand-held model — a breathalyzer.
"Many companies are looking into noninvasives, whether through skin, eye, or breath. Through advances in nanotechnology there's a strong possibility one of those will be on the market," Ronny Priefer, PhD, who is CEO and cofounder of New England Breath Technologies, which is developing this latest device, told Medscape Medical News.
Device Could Be on the Market by 2020
Breath acetone analysis may hold advantages over other noninvasive approaches in development, including contact lenses that measure glucose in tears and skin fluorescence glucose measurement technologies, as these have been hampered by issues such as biofilm build-up for the former and reproducibility problems for the latter, Dr Priefer noted.
Other technologies have also been developed to measure breath acetone levels, but moisture is always a limiting factor. Some have used filters or other methods for removing the water, but this particular device eliminates the need for that, he explained.
"We look at water as an opportunity. Our device uses moisture in breath to activate the sensor slide. At that point, it can interact with acetone in a liquid state, allowing us to be precise and specific. Because the breath arena is so difficult, what makes ours special is that the problem of the water has been alleviated. With that hurdle overcome, there's a greater chance of ultimate success," he said.
The stage 1 study — the results of which Dr Priefer presented as a poster November 14 at the annual meeting of the American Association of Pharmaceutical Scientists held in Denver — involved 50 individuals aged 21 to 75, including 26 without diabetes, 16 with type 2 diabetes, and eight with type 1 diabetes.
Each subject breathed 200 mL of expired air within approximately 5 seconds into the device with the sensor slide in place. After 5 seconds the detector was turned on and the reading taken immediately.
Blood glucose levels were also measured.
Two subjects, both smokers, produced breath acetone levels far greater than their blood glucose levels. This is not surprising because acetone is a combustion product of tobacco smoke, Dr Priefer noted.
With those two individuals removed, correlation between the breath acetone and blood glucose readings were 100% aligned, within the range of 70 to 250 mg/dL (R=0.99, P < .001).
Dr Priefer told Medscape Medical News that the next steps will be to make final revisions to the actual device that will be submitted to the US Food and Drug Administration (FDA), then conduct a study of daily use of the device in larger populations — including smokers and people with lung conditions — as well as in conditions of varying latitude and humidity.
In addition, studies examining performance of the device at the extremes of blood glucose values will need to be conducted in hospital settings.
If all goes well, he anticipates submission to the FDA for device approval by 2019 and, pending approval, possible marketing by 2020.
There is already a minimally invasive system called the Abbott Freestyle Libre "flash" glucose monitoring device on the market in the European Union, which consists of a small round glucose sensor worn for up to 14 days on the back of the upper arm and a scanner device that the patient waves over the sensor to obtain a reading of glucose concentrations in the interstitial fluid.
The system was granted a CE Mark in Europe in 2014 as a replacement for finger-stick glucose monitoring in people with diabetes (any type) down to 4 years of age and is now available in all 28 countries in the European Union, with almost 200,000 users globally. Glucose measurements can be taken through clothing, and the sensor is water-resistant and can be worn while swimming and bathing.
Dr Priefer is CEO and cofounder of New England Breath Technologies.
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Annual Meeting of the American Association of Pharmaceutical Scientists. November 14, 2016; Denver, Colorado. Abstract 04M1130.
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Cite this: A Breathalyzer for Diabetes? Acetone in Breath Reflects Blood Glucose - Medscape - Nov 22, 2016.
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