Zschornack Eva, Schmid Christina, Pleus Stefan, Link Manuela, Klötzer Hans-Martin, Obermaier Karin, Schoemaker Michael, Strasser Monika, Frisch Gerhard, Schmelzeisen-Redeker Günther, Haug Cornelia, Freckmann Guido
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
J Diabetes Sci Technol. 2013 Jul 1;7(4):815-23. doi: 10.1177/193229681300700403.
The performance of a continuous glucose monitoring (CGM) system in the early stage of development was assessed in an inpatient setting that simulates daily life conditions of people with diabetes. Performance was evaluated at low glycemic, euglycemic, and high glycemic ranges as well as during phases with rapid glucose excursions.
Each of the 30 participants with type 1 diabetes (15 female, age 47 ± 12 years, hemoglobin A1c 7.7% ± 1.3%) wore two sensors of the prototype system in parallel for 7 days. Capillary blood samples were measured at least 16 times per day (at least 15 times per daytime and at least once per night). On two subsequent study days, glucose excursions were induced. For performance evaluation, the mean absolute relative difference (MARD) between CGM readings and paired capillary blood glucose readings and precision absolute relative difference (PARD), i.e., differences between paired CGM readings were calculated.
Overall aggregated MARD was 9.2% and overall aggregated PARD was 7.5%. During induced glucose excursions, MARD was 10.9% and PARD was 7.8%. Lowest MARD (8.5%) and lowest PARD (6.4%) were observed in the high glycemic range (euglycemic range, MARD 9.1% and PARD 7.4%; low glycemic range, MARD 12.3% and PARD 12.4%).
The performance of this prototype CGM system was, particularly in the hypoglycemic range and during phases with rapid glucose fluctuations, better than performance data reported for other commercially available systems. In addition, performance of this prototype sensor was noticeably constant over the whole study period. This prototype system is not yet approved, and performance of this CGM system needs to be further assessed in clinical studies.
在模拟糖尿病患者日常生活条件的住院环境中，对连续血糖监测（CGM）系统在开发早期的性能进行了评估。在低血糖、血糖正常和高血糖范围以及血糖快速波动阶段对性能进行了评估。
30名1型糖尿病患者（15名女性，年龄47±12岁，糖化血红蛋白7.7%±1.3%）每人同时佩戴两个原型系统的传感器，持续7天。每天至少测量16次毛细血管血样（白天至少15次，晚上至少1次）。在随后的两个研究日，诱导血糖波动。为了评估性能，计算了CGM读数与配对毛细血管血糖读数之间的平均绝对相对差异（MARD）以及精确绝对相对差异（PARD），即配对CGM读数之间的差异。
总体汇总MARD为9.2%，总体汇总PARD为7.5%。在诱导血糖波动期间，MARD为10.9%，PARD为7.8%。在高血糖范围观察到最低MARD（8.5%）和最低PARD（6.4%）（血糖正常范围，MARD为9.1%，PARD为7.4%；低血糖范围，MARD为12.3%，PARD为12.4%）。
该原型CGM系统的性能，特别是在低血糖范围和血糖快速波动阶段，优于其他商用系统报告的性能数据。此外，该原型传感器的性能在整个研究期间明显保持稳定。该原型系统尚未获批，该CGM系统的性能需要在临床研究中进一步评估。
