1 Menlo Park , California.
2 Dexcom, Inc. , San Diego, California.
Diabetes Technol Ther. 2015 Aug;17(8):548-54. doi: 10.1089/dia.2014.0415. Epub 2015 May 11.
Accuracy of continuous glucose monitoring (CGM) devices in hypoglycemia has been a widely reported shortcoming of this technology. We report the accuracy in hypoglycemia of a new version of the Dexcom (San Diego, CA) G4 Platinum CGM system (software 505) and present results regarding the optimum setting of CGM hypoglycemic alerts.
CGM values were compared with YSI analyzer (YSI Life Sciences, Yellow Springs, OH) measurements every 15 min. We reviewed the accuracy of the CGM system in the hypoglycemic range using standard metrics. We analyzed the time required for the CGM system to detect biochemical hypoglycemia (70 mg/dL) compared with the YSI with alert settings at 70 mg/dL and 80 mg/dL. We also analyzed the time between the YSI value crossing 55 mg/dL, defined as the threshold for cognitive impairment due to hypoglycemia, and when the CGM system alerted for hypoglycemia.
The mean absolute difference for a glucose level of less than 70 mg/dL was 6 mg/dL. Ninety-six percent of CGM values were within 20 mg/dL of the YSI values between 40 and 80 mg/dL. When the CGM hypoglycemic alert was set at 80 mg/dL, the device provided an alert for biochemical hypoglycemia within 10 min in 95% of instances and at least a 10-min advance warning before the cognitive impairment threshold in 91% of instances in the study.
Use of an 80 mg/dL threshold setting for hypoglycemic alerts on the G4 Platinum (software 505) may provide patients with timely warning of hypoglycemia before the onset of cognitive impairment, enabling them to treat themselves for hypoglycemia with fast-acting carbohydrates and prevent neuroglycopenia associated with very low glucose levels.
连续血糖监测(CGM)设备在低血糖方面的准确性一直是该技术的一个广泛报道的缺点。我们报告了新一代 Dexcom(圣地亚哥,CA)G4 Platinum CGM 系统(软件 505)在低血糖方面的准确性,并介绍了关于 CGM 低血糖警报最佳设置的结果。
每隔 15 分钟将 CGM 值与 YSI 分析仪(YSI 生命科学,Yellow Springs,OH)的测量值进行比较。我们使用标准指标来分析 CGM 系统在低血糖范围内的准确性。我们分析了 CGM 系统检测生化性低血糖(70mg/dL)所需的时间,与在 70mg/dL 和 80mg/dL 时设置警报的 YSI 进行比较。我们还分析了 YSI 值降至 55mg/dL(定义为由于低血糖导致认知障碍的阈值)与 CGM 系统发出低血糖警报之间的时间间隔。
血糖水平低于 70mg/dL 时的平均绝对差值为 6mg/dL。在 40 至 80mg/dL 之间,96%的 CGM 值与 YSI 值相差 20mg/dL 以内。当 CGM 低血糖警报设置为 80mg/dL 时,在研究中 95%的情况下,该设备在 10 分钟内发出生化性低血糖警报,在 91%的情况下,在认知障碍阈值之前至少提前 10 分钟发出警告。
在 G4 Platinum(软件 505)上使用 80mg/dL 的低血糖警报阈值设置可能会为患者提供在认知障碍发生之前及时警告低血糖的机会,使他们能够用快速作用的碳水化合物治疗自己的低血糖,并防止与非常低的血糖水平相关的神经低血糖症。