Thomas Andreas, Shin John, Jiang Boyi, McMahon Chantal, Kolassa Ralf, Vigersky Robert A
1 Medtronic GmbH, Pirna, Germany.
2 Medtronic Diabetes, Northridge, CA, USA.
J Diabetes Sci Technol. 2018 Jan;12(1):69-75. doi: 10.1177/1932296817721242. Epub 2017 Jul 27.
Quantifying hypoglycemia has traditionally been limited to using the frequency of hypoglycemic events during a given time interval using data from blood glucose (BG) testing. However, continuous glucose monitoring (CGM) captures three parameters-a Hypo-Triad-unavailable with BG monitoring that can be used to better characterize hypoglycemia: area under the curve (AUC), time (duration of hypoglycemia), and frequency of daily episodes below a specified threshold.
We developed two new analytic metrics to enhance the traditional Hypo-Triad of CGM-derived data to more effectively capture the intensity of hypoglycemia (IntHypo) and overall hypoglycemic environment called the "hypoglycemia risk volume" (HypoRV). We reanalyzed the CGM data from the ASPIRE In-Home study, a randomized, controlled trial of a sensor-integrated pump system with a low glucose threshold suspend feature (SIP+TS), using these new metrics and compared them to standard metrics of hypoglycemia.
IntHypo and HypoRV provide additional insights into the benefit of a SIP+TS system on glycemic exposure when compared to the standard reporting methods. In addition, the visual display of these parameters provides a unique and intuitive way to understand the impact of a diabetes intervention on a cohort of subjects as well as on individual patients.
The IntHypo and HypoRV are new and enhanced ways of analyzing CGM-derived data in diabetes intervention studies which could lead to new insights in diabetes management. They require validation using existing, ongoing, or planned studies to determine whether they are superior to existing metrics.
传统上，低血糖的量化仅限于利用血糖（BG）检测数据，计算给定时间间隔内低血糖事件的发生频率。然而，持续葡萄糖监测（CGM）可获取三个参数——一个血糖监测所没有的低血糖三联征，可用于更好地表征低血糖：曲线下面积（AUC）、时间（低血糖持续时间）以及低于特定阈值的每日发作频率。
我们开发了两种新的分析指标，以强化源自CGM数据的传统低血糖三联征，从而更有效地捕捉低血糖强度（IntHypo）以及称为“低血糖风险量”（HypoRV）的整体低血糖环境。我们使用这些新指标重新分析了来自ASPIRE居家研究的CGM数据，该研究是一项关于具有低血糖阈值暂停功能（SIP+TS）的传感器集成泵系统的随机对照试验，并将其与低血糖的标准指标进行比较。
与标准报告方法相比，IntHypo和HypoRV能提供有关SIP+TS系统对血糖暴露益处的更多见解。此外，这些参数的可视化显示提供了一种独特且直观的方式，来理解糖尿病干预对一组受试者以及对个体患者的影响。
IntHypo和HypoRV是糖尿病干预研究中分析源自CGM数据的全新且强化的方法，可能会为糖尿病管理带来新的见解。它们需要通过现有、正在进行或计划中的研究进行验证，以确定它们是否优于现有指标。
