Wearable Continuous Ketone Monitoring Appears Feasible
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Continuous measurement of ketone levels with a wearable device is feasible, new research suggests.

The feasibility of measuring Beta-hydroxybutyrate in ISF using a continuous ketone monitoring (CKM) sensor using a single calibration without further adjustments over 14-days is described.

A CKM sensor was developed using wired enzyme technology with Beta-hydroxybutyrate dehydrogenase chemistry. In vitro characterization of the sensor was performed in phosphate buffered saline at 37°C. In vivo performance was evaluated 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.

Results:
-- 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 less than 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.

Conclusively, measuring ketones in ISF using a continuous ketone sensor is feasible. Additional studies are required to evaluate the performance in intended patient populations, including conditions of ketosis and diabetic ketoacidosis.

Source: https://journals.sagepub.com/doi/10.1177/19322968211008185?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub 0pubmed
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