Continuous ketone sensor may be useful for early identification of DKA: Study

Published On 2021-05-15 05:15 GMT   |   Update On 2021-05-15 08:59 GMT

USA: The use of a continuous ketone sensor for measuring ketone in interstitial fluid (ISF) is feasible, finds a recent study in the Journal of Diabetes Science and Technology.

According to the study, during a 14-day period, the sensor provided ketone level results similar to a ketone test strip. However, the researchers add that additional studies are needed to evaluate its performance in the intended patient population, including diabetic ketoacidosis and ketosis conditions. 

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"This first human study suggests that a continuous ketone sensor similar to continuous glucose sensors is achievable," wrote the authors. 

The continuous ketone monitoring (CKM) sensor was developed by Abbott using wired enzyme technology with β-hydroxybutyrate dehydrogenase chemistry. It is similar to a continuous glucose monitor in structure and dimensions. In vitro characterization of the sensor was performed in phosphate-buffered saline at 37°C.

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In vivo performance was evaluated by Shridhara Alva, Abbott Diabetes Care, Alameda, CA, USA, and colleagues, in 12 healthy participants on low carbohydrate diets, who wore 3 ketone sensors on the back of their upper arms to continuously measure ketone levels over 14 days. Reference capillary ketone measurements were performed using Precision Xtra test strips at least 8 times a day. 

Key findings of the study include:

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  • The sensor is stable over 14 days and has a linear response over the 0-8 mM range.
  • The operational stability of the sensor is very good with a 2.1% signal change over 14 days.
  • The first human study of the CKM sensor demonstrated that the sensor can continuously track ketones well through the entire 14 days of wear.
  • The performance with a single retrospective calibration of the sensor showed 82.4% of data pairs within 0.225 mM/20% and 91.4% within 0.3 mM/30% of the capillary ketone reference (presented as mM at <1.5 mM and as percentage at or above 1.5 mM).
  • This suggests that the sensor can be used with a single calibration for the 14 days of use.
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"Measuring ketones in ISF using a continuous ketone sensor is feasible," wrote the authors. Additional studies are required to evaluate the performance in intended patient populations, including conditions of ketosis and diabetic ketoacidosis.

Reference:

The study titled, "Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue using a Ketone Sensor," is published in the Journal of Diabetes Science and Technology.

DOI: https://journals.sagepub.com/doi/10.1177/19322968211008185

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Article Source : Journal of Diabetes Science and Technology

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