Disclosures: The authors report no relevant financial disclosures.
September 17, 2021
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Breath ketone analyzer may accurately detect ketosis in type 1 diabetes

Disclosures: The authors report no relevant financial disclosures.
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A breath ketone analyzer could be used as a noninvasive way for adults with type 1 diabetes to screen for ketosis, according to findings published in the Journal of Diabetes and Its Complications.

Data from a proof-of-concept study showed breath ketone analyzer measurements for adults with type 1 diabetes were associated with elevated blood ketone monitoring results.

Data were derived from Akturk HK, et al. J Diabetes Complications. 2021;doi:10.1016/j.jdiacomp.2021.108030.

“Currently available ways of ketone monitoring are blood ketone monitoring and urine ketone monitoring,” Halis Kaan Akturk, MD, assistant professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado and communications director of the American Diabetes Association, Diabetes Technology Interest Group, told Healio. “Blood ketone monitoring is considered the gold standard, but is expensive and not covered with many insurance plans. On the other hand, urine ketone monitoring is cheaper, but not a good way to assess ketonemia instantaneously. We tested an FDA-cleared, commonly sold noninvasive breath ketone analyzer to detect ketosis in adults and children and compared results to the gold standard FDA-approved blood ketone monitor.”

Akturk and colleagues analyzed data from eight adults and six children aged 6 years or older who had type 1 diabetes for at least 1 year. Participants were given a breath ketone analyzer (Ketonix) and a blood ketone meter (Precision Xtra, Abbott) to measure ketones for 90 days. For 90 days, participants were asked to check ketones at least once daily, if their blood glucose was more than 300 mg/dL, or if they were having diabetic ketoacidosis symptoms. Measurements taken in the morning were considered fasting measurements, whereas all others were considered nonfasting.

Halis Kaan Akturk, MD

There were 500 paired blood ketone monitor and breath ketone analyzer results included in the analysis, with 372 provided by adult participants and 128 from children.

Measurements from the breath ketone analyzer were associated with elevated blood ketone monitor results for adults (P = .0066). There were no associations observed among adults for fasting measurements or for children.

“We found that morning fasting results in adults can be falsely higher in some individuals,” Akturk said. “We also included some adults with type 1 diabetes using SGLT2 inhibitors that already have higher ketone levels at baseline. A breath ketone analyzer can be a good screening tool in patients that are at high risk for ketosis.”

In receiver-operating characteristic analysis of elevated breath ketone monitor levels by blood ketone analyzer measurements, adult samples yielded an area under the curve of 0.73. A cutoff of 3.9 ppm on the breath ketone analyzer maximized the Youden index, with a sensitivity of 94.7% and a specificity of 54.2%.

Akturk noted the study was converted to be done at-home due to the COVID-19 pandemic. This caused a limitation where participants’ technique with use of the breath ketone analyzer could not be observed. In addition, each participant was also using a separate device for the study.

“We need to find alternative, cost-effective ways for ketone monitoring,” Akturk said. “We need larger clinical studies to better test breath ketone analyzers to confirm these findings and to understand the differences in our results with fasting vs. nonfasting.”

For more information:

Halis Kaan Akturk, MD, can be reached at halis.akturk@cuanschutz.edu.