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Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor
BACKGROUND: The feasibility of measuring β-hydroxybutyrate in ISF using a continuous ketone monitoring (CKM) sensor using a single calibration without further adjustments over 14 days is described. METHODS: A CKM sensor was developed using wired enzyme technology with β-hydroxybutyrate dehydrogenase...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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SAGE Publications
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252149/ https://www.ncbi.nlm.nih.gov/pubmed/33832353 http://dx.doi.org/10.1177/19322968211008185 |
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author | Alva, Shridhara Castorino, Kristin Cho, Hyun Ou, Junli |
author_facet | Alva, Shridhara Castorino, Kristin Cho, Hyun Ou, Junli |
author_sort | Alva, Shridhara |
collection | PubMed |
description | BACKGROUND: The feasibility of measuring β-hydroxybutyrate in ISF using a continuous ketone monitoring (CKM) sensor using a single calibration without further adjustments over 14 days is described. METHODS: A CKM sensor was developed using wired enzyme technology with β-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 <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. CONCLUSIONS: 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. |
format | Online Article Text |
id | pubmed-8252149 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-82521492021-07-13 Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor Alva, Shridhara Castorino, Kristin Cho, Hyun Ou, Junli J Diabetes Sci Technol Original Articles BACKGROUND: The feasibility of measuring β-hydroxybutyrate in ISF using a continuous ketone monitoring (CKM) sensor using a single calibration without further adjustments over 14 days is described. METHODS: A CKM sensor was developed using wired enzyme technology with β-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 <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. CONCLUSIONS: 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. SAGE Publications 2021-04-09 /pmc/articles/PMC8252149/ /pubmed/33832353 http://dx.doi.org/10.1177/19322968211008185 Text en © 2021 Diabetes Technology Society https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Articles Alva, Shridhara Castorino, Kristin Cho, Hyun Ou, Junli Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor |
title | Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor |
title_full | Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor |
title_fullStr | Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor |
title_full_unstemmed | Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor |
title_short | Feasibility of Continuous Ketone Monitoring in Subcutaneous Tissue Using a Ketone Sensor |
title_sort | feasibility of continuous ketone monitoring in subcutaneous tissue using a ketone sensor |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8252149/ https://www.ncbi.nlm.nih.gov/pubmed/33832353 http://dx.doi.org/10.1177/19322968211008185 |
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