Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm , Ulm, Germany .
Diabetes Technol Ther. 2018 Aug;20(8):550-556. doi: 10.1089/dia.2018.0112.
Continuous interstitial glucose monitoring (CGM) systems often provide glucose trend indicators (e.g., arrows) in addition to current glucose values. These indicators are recommended to be used in therapeutic decisions, because they are ascribed predictive qualities by CGM system manufacturers and expert committees. This study assessed how reliably trend indicators match future glucose change, because such information is missing.
In a clinical trial, two different CGM systems were used by 20 participants, with two sensors of each system per patient. Participants used the systems for 14 days with three study site visits (48 h each). During study site visits, glucose trend indicators, as displayed by the CGM systems, were recorded at least once per hour during daytime and once at night in a diary. In addition, CGM data were downloaded from the devices. Trend indicators were compared with glucose change calculated from CGM data >30 min after recording the trend indicator.
Approximately 60% of trend indicators matched the glucose change calculated from CGM data. More than 10% of trend indicators differed by at least two trend indicator categories. Focusing on trend indicators recorded around carbohydrate (CHO) intake and insulin deliveries resulted in approximately half of trend indicators matching the calculated glucose change.
Trend indicators do not always match future glucose change, especially within the first few hours after CHO intake and insulin deliveries. Manufacturers' labeling and recommendations should reflect this, so that CGM users can make informed decisions.
连续间质葡萄糖监测(CGM)系统除了提供当前葡萄糖值外,通常还提供葡萄糖趋势指标(例如箭头)。这些指标被推荐用于治疗决策,因为 CGM 系统制造商和专家委员会赋予了它们预测性质。本研究评估了趋势指标与未来葡萄糖变化的匹配程度,因为这方面的信息是缺失的。
在一项临床试验中,20 名参与者使用了两种不同的 CGM 系统,每个患者使用两种系统的两个传感器。参与者使用系统进行了 14 天的监测,共进行了 3 次研究点访问(每次 48 小时)。在研究点访问期间,将 CGM 系统显示的葡萄糖趋势指标至少每小时记录一次,并在日记中记录一次夜间的趋势指标。此外,从设备中下载 CGM 数据。将趋势指标与记录趋势指标后至少 30 分钟的 CGM 数据计算出的葡萄糖变化进行比较。
约 60%的趋势指标与从 CGM 数据计算出的葡萄糖变化相匹配。超过 10%的趋势指标相差至少两个趋势指标类别。关注围绕碳水化合物(CHO)摄入和胰岛素输送记录的趋势指标,约有一半的趋势指标与计算出的葡萄糖变化相匹配。
趋势指标并不总是与未来的葡萄糖变化相匹配,尤其是在 CHO 摄入和胰岛素输送后的最初几个小时内。制造商的标签和建议应反映这一点,以便 CGM 用户能够做出明智的决策。