1 Diablo Clinical Research , Walnut Creek, California.
Diabetes Technol Ther. 2013 Oct;15(10):881-8. doi: 10.1089/dia.2013.0077. Epub 2013 Jun 18.
Use of continuous glucose monitoring (CGM) systems can improve glycemic control, but widespread adoption of CGM utilization has been limited, in part because of real and perceived problems with accuracy and reliability. This study compared accuracy and performance metrics for a new-generation CGM system with those of a previous-generation device.
Subjects were enrolled in a 7-day, open-label, multicenter pivotal study. Sensor readings were compared with venous YSI measurements (blood glucose analyzer from YSI Inc., Yellow Springs, OH) every 15 min (±5 min) during in-clinic visits. The aggregate and individual sensor accuracy and reliability of a new CGM system, the Dexcom(®) (San Diego, CA) G4™ PLATINUM (DG4P), were compared with those of the previous CGM system, the Dexcom SEVEN(®) PLUS (DSP).
Both study design and subject characteristics were similar. The aggregate mean absolute relative difference (MARD) for DG4P was 13% compared with 16% for DSP (P<0.0001), and 82% of DG4P readings were within ± 20 mg/dL (for YSI ≤ 80 mg/dL) or 20% of YSI values (for YSI >80 mg/dL) compared with 76% for DSP (P<0.001). Ninety percent of the DG4P sensors had an individual MARD ≤ 20% compared with only 76% of DSP sensors (P=0.015). Half of DG4P sensors had a MARD less than 12.5% compared with 14% for the DSP sensors (P=0.028). The mean absolute difference for biochemical hypoglycemia (YSI <70 mg/dL) for DG4P was 11 mg/dL compared with 16 mg/dL for DSP (P<0.001).
The performance of DG4P was significantly improved compared with that of DSP, which may increase routine clinical use of CGM and improve patient outcomes.
使用连续血糖监测（CGM）系统可以改善血糖控制，但由于准确性和可靠性方面的实际和感知问题，CGM 的广泛应用受到限制。本研究比较了新一代 CGM 系统与上一代设备的准确性和性能指标。
受试者参加了一项为期 7 天的、开放性、多中心关键研究。在诊所就诊期间，每隔 15 分钟（±5 分钟）将传感器读数与静脉 YSI 测量值（来自 YSI Inc.，俄亥俄州扬斯敦的血糖仪）进行比较。与上一代 CGM 系统 Dexcom SEVEN® PLUS（DSP）相比，新型 CGM 系统 Dexcom(®)（圣地亚哥，CA）G4™ PLATINUM（DG4P）的传感器整体准确性和可靠性进行了比较。
研究设计和受试者特征相似。与 DSP 相比，DG4P 的平均绝对相对差异（MARD）为 13%，而 DSP 为 16%（P<0.0001），82%的 DG4P 读数在±20mg/dL（对于 YSI≤80mg/dL）或 20%的 YSI 值（对于 YSI>80mg/dL）范围内，而 DSP 为 76%（P<0.001）。90%的 DG4P 传感器的个体 MARD≤20%，而仅 76%的 DSP 传感器的个体 MARD≤20%（P=0.015）。一半的 DG4P 传感器的 MARD 小于 12.5%，而 DSP 传感器的 MARD 为 14%（P=0.028）。对于生化性低血糖（YSI<70mg/dL），DG4P 的平均绝对差值为 11mg/dL，而 DSP 的平均绝对差值为 16mg/dL（P<0.001）。
与 DSP 相比，DG4P 的性能有了显著提高，这可能会增加 CGM 的常规临床应用，并改善患者的治疗结果。
