第三代算法与 FreeStyle Libre 连续血糖监测设备第一代算法的准确性差异。

Difference in the accuracy of the third-generation algorithm and the first-generation algorithm of FreeStyle Libre continuous glucose monitoring device.

机构信息

Department of Clinical Nutrition, NHO Kyoto Medical Center, Kyoto, Japan.

Diabetes Center, NHO Kyoto Medical Center, Kyoto, Japan.

出版信息

J Med Invest. 2024;71(3.4):225-231. doi: 10.2152/jmi.71.225.

DOI:10.2152/jmi.71.225

PMID:39462556

Abstract

BACKGROUND

FreeStyle Libre uses the algorithm to calculate the sensor glucose (SG) levels. The manufacturer announced that they had changed the algorithm from the first generation (Gen. 1) to the third generation (Gen. 3). To assess the difference, we conducted an observational study to analyze the characteristics of the measurements by these two algorithms compared to the capillary blood glucose (BG) levels.

METHODS

Participants with type 1 diabetes wore two FreeStyle Libre sensors, one on the left arm used with Gen. 3 algorithm, and another on the right arm used in combination with the FreeStyle Libre Reader with Gen. 1 algorithm.

RESULTS

Data were collected from 11 participants. The Bland-Altman analysis of the measurements by Gen. 3 algorithm showed bias of 7.4 mg/dl and no proportional bias was observed (r=0.130). In contrast, the Bland-Altman analysis of the measurements by Gen. 1 algorithm showed bias of 4.4 mg/dl and proportional bias was observed (r=0.424). The MARD of Gen. 3 algorithm and Gen. 1 algorithm was 11.9±9.0% and 9.7±8.3%, respectively (P=0.053).

CONCLUSION

No proportional bias in the measurements by Gen. 3 algorithm was observed, but in those by Gen. 1 algorithm. J. Med. Invest. 71 : 225-231, August, 2024.

摘要

背景

FreeStyle Libre 使用算法来计算传感器血糖（SG）水平。制造商宣布他们已经将算法从第一代（Gen.1）更改为第三代（Gen.3）。为了评估差异，我们进行了一项观察性研究，以分析这两种算法与毛细血管血糖（BG）水平相比的测量特征。

方法

11 名 1 型糖尿病患者佩戴了两个 FreeStyle Libre 传感器，一个在左臂上使用 Gen.3 算法，另一个在右臂上与 Gen.1 算法的 FreeStyle Libre Reader 一起使用。

结果

从 11 名参与者中收集了数据。Gen.3 算法测量值的 Bland-Altman 分析显示偏差为 7.4mg/dl，且未观察到比例偏差（r=0.130）。相比之下，Gen.1 算法测量值的 Bland-Altman 分析显示偏差为 4.4mg/dl，且观察到比例偏差（r=0.424）。Gen.3 算法和 Gen.1 算法的 MARD 分别为 11.9±9.0%和 9.7±8.3%（P=0.053）。