Vigersky Robert A, Shin John, Jiang Boyi, Siegmund Thorsten, McMahon Chantal, Thomas Andreas
1 Medtronic Diabetes, Northridge, CA, USA.
3 Isar Klinikum, Munich, Germany.
J Diabetes Sci Technol. 2018 Jan;12(1):114-123. doi: 10.1177/1932296817718561. Epub 2017 Jul 27.
Composite metrics have the potential to provide more complete and clinically useful information about glycemic control than traditional individual metrics such as hemoglobin A1C, %/time/area under curve of hypoglycemia and hyperglycemia.
Using five key metrics that are derived from continuous glucose monitoring, we developed a new, multicomponent composite metric, the Comprehensive Glucose Pentagon (CGP) that demonstrates glycemic control both numerically and visually. Two of its axes are composite metrics-the intensity of hypoglycemia and intensity of hyperglycemia. This approach eliminates the use of the surrogate marker, hemoglobin A1C (A1C), and replaces it with glucose-centric metrics.
We reanalyzed the data from two randomized control trials, the STAR 3 and ASPIRE In-Home studies using the CGP. It provided new insights into the effect of sensor-augmented pumping (SAP) in the STAR 3 trial and sensor-integrated pumping with low-glucose threshold suspend (SIP+TS) in the ASPIRE In-Home trial.
The CGP has the potential to enable health care providers, investigators and patients to better understand the components of glycemic control and the effect of various interventions on the individual elements of that control. This can be done on a daily, weekly, or monthly basis. It also allows direct comparison of the effects on different interventions among clinical trials which is not possible using A1C alone. This new composite metric approach requires validation to determine if it provides a better predictor of long-term outcomes than A1C and/or better predictor of severe hypoglycemia than the low blood glucose index (LBGI).
与传统的单一指标（如糖化血红蛋白、低血糖和高血糖的%/时间/曲线下面积）相比，综合指标有可能提供关于血糖控制更完整且临床上有用的信息。
我们使用从连续血糖监测中得出的五个关键指标，开发了一种新的多组分综合指标——综合血糖五边形（CGP），它能在数值和视觉上展示血糖控制情况。其两条轴是综合指标——低血糖强度和高血糖强度。这种方法摒弃了替代标志物糖化血红蛋白（A1C）的使用，并用以葡萄糖为中心的指标取而代之。
我们使用CGP重新分析了两项随机对照试验（STAR 3和ASPIRE居家研究）的数据。它为STAR 3试验中传感器增强型胰岛素泵治疗（SAP）的效果以及ASPIRE居家试验中具有低葡萄糖阈值暂停功能的传感器集成胰岛素泵治疗（SIP + TS）的效果提供了新的见解。
CGP有可能使医疗保健提供者、研究人员和患者更好地理解血糖控制的组成部分以及各种干预措施对该控制中各个要素的影响。这可以按日、周或月进行。它还允许直接比较不同临床试验中不同干预措施的效果，而仅使用A1C是无法做到这一点的。这种新的综合指标方法需要进行验证，以确定它是否比A1C能更好地预测长期结果，以及是否比低血糖指数（LBGI）能更好地预测严重低血糖。
