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