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变异系数作为衡量自动化胰岛素输送系统 MiniMed 780G 在真实世界使用者中低血糖风险和血糖控制的指标的意义。

The significance of coefficient of variation as a measure of hypoglycaemia risk and glycaemic control in real world users of the automated insulin delivery MiniMed 780G system.

机构信息

Medtronic Bakken Research Center, Maastricht, The Netherlands.

Medtronic International Trading Sàrl, Tolochenaz, Switzerland.

出版信息

Diabetes Obes Metab. 2023 Sep;25(9):2545-2552. doi: 10.1111/dom.15139. Epub 2023 May 29.

DOI:10.1111/dom.15139
PMID:37246797
Abstract

AIM

Use of the MiniMed 780G system (MM780G) can result in a reduction in mean and standard deviation (SD) of sensor glucose (SG) values. We assessed the significance of the coefficient of variation (CV) as a measure of hypoglycaemia risk and glycaemic control.

MATERIALS AND METHODS

Data from 10 404 MM780G users were analysed using multivariable logistic regression to assess the contribution of CV to (a) hypoglycaemia risk, measured as not reaching target <1% for time below range (TBR), and (b) achieving targets of time-in-range (TIR) >70% and glucose management indicator <7%. CV was compared with SD and low blood glucose index. To assess the relevance of CV <36% as a therapeutic threshold, we identified the CV cut-off point that optimally discriminated users at risk of hypoglycaemia.

RESULTS

The contribution of CV was the smallest in terms of risk of hypoglycaemia (vs. low blood glucose index and SD) and TIR and glucose management indicator targets (vs. SD). In all cases the models with SD showed the best fit. A CV <43.4% (95% CI: 42.9-43.9) was the optimal cut-off point with a correct classification rate of 87.2% (vs. 72.9% for CV <36%).

CONCLUSION

For MM780G users, CV is a poor marker for hypoglycaemia risk and glycaemic control. We recommend using, for the former, TBR and whether the TBR target is met (and not using CV <36% as a therapeutic threshold for hypoglycaemia); for the latter, TIR, time above range, whether targets are met and a discrete description of mean SG and SD of SG values.

摘要

目的

使用 MiniMed 780G 系统(MM780G)可降低传感器葡萄糖(SG)值的平均值和标准差(SD)。我们评估了变异系数(CV)作为低血糖风险和血糖控制衡量指标的意义。

材料和方法

使用多变量逻辑回归分析了 10404 名 MM780G 用户的数据,以评估 CV 对(a)低血糖风险的贡献,低血糖风险的衡量标准为未达到目标范围内时间(TBR)<1%,以及(b)实现 TIR >70%和血糖管理指标<7%的目标。将 CV 与 SD 和低血糖指数进行了比较。为了评估 CV <36%作为治疗阈值的相关性,我们确定了最佳区分低血糖风险用户的 CV 截止值。

结果

CV 在低血糖风险(与低血糖指数和 SD 相比)和 TIR 和血糖管理指标目标(与 SD 相比)方面的贡献最小。在所有情况下,SD 模型的拟合度最好。CV <43.4%(95%CI:42.9-43.9)是最佳截断点,正确分类率为 87.2%(与 CV <36%相比为 72.9%)。

结论

对于 MM780G 用户,CV 是低血糖风险和血糖控制的不良标志物。我们建议使用 TBR 和 TBR 目标是否达到(而不是将 CV <36%作为低血糖治疗阈值)来评估前者;对于后者,使用 TIR、范围以上时间、目标是否达到以及平均 SG 和 SG 值的 SD 的离散描述。

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