Abbott Diabetes Care, Alameda, CA, USA.
Sansum Diabetes Research Institute, Santa Barbara, CA, USA.
J Diabetes Sci Technol. 2021 Jul;15(4):768-774. doi: 10.1177/19322968211008185. Epub 2021 Apr 9.
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.
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.
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. Additional studies are required to evaluate the performance in intended patient populations, including conditions of ketosis and diabetic ketoacidosis.
描述了一种使用连续酮监测（CKM）传感器在 14 天内无需进一步调整即可通过单次校准测量 ISF 中 β-羟丁酸的可行性。
使用带有β-羟丁酸脱氢酶化学的有线酶技术开发了 CKM 传感器。在 37°C 的磷酸盐缓冲盐水中对传感器进行了体外特性描述。在 12 名低碳水化合物饮食的健康参与者中评估了体内性能，他们在手臂背部佩戴了 3 个酮传感器，以连续测量 14 天的酮水平。使用 Precision Xtra®测试条每天至少进行 8 次参考毛细血管酮测量。
传感器在 14 天内稳定，线性响应范围为 0-8mM。传感器的操作稳定性非常好，14 天内信号变化为 2.1%。CKM 传感器的首次人体研究表明，传感器可以在整个 14 天佩戴过程中很好地连续跟踪酮。对传感器进行单次回顾性校准的性能显示，82.4%的数据对在 0.225mM/20%和 91.4%在 0.3mM/30%的毛细血管酮参考值范围内（<1.5mM 时以 mM 表示，1.5mM 及以上时以百分比表示）。这表明传感器可以在 14 天的使用过程中使用单次校准。
使用连续酮传感器测量 ISF 中的酮是可行的。需要进一步研究以评估在预期患者人群中的性能，包括酮症和糖尿病酮症酸中毒的情况。
