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

IF 0.7 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Takashi Murata, Naoki Sakane, Yushi Hirota, Masao Toyoda, Munehide Matsuhisa, Akio Kuroda, Arata Itoh, Shu Meguro, Junnosuke Miura, Yuka Matoba, Ken Kato, Shota Suzuki, Akira Shimada
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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.

FreeStyle Libre 血糖连续监测仪第三代算法与第一代算法的准确性差异。
背景:FreeStyle Libre 使用算法计算传感器葡萄糖 (SG) 水平。制造商宣布已将算法从第一代(Gen.1)改为第三代(Gen.3)。为了评估两者之间的差异,我们进行了一项观察研究,分析这两种算法的测量结果与毛细血管血糖 (BG) 水平相比的特点:方法:1 型糖尿病患者佩戴两个 FreeStyle Libre 传感器,一个在左臂上使用第 3 代算法,另一个在右臂上与 FreeStyle Libre 阅读器结合使用第 1 代算法:结果:共收集了 11 名参与者的数据。通过对 Gen.3 算法的测量结果进行 Bland-Altman 分析,发现偏差为 7.4 mg/dl,且未观察到比例偏差(r=0.130)。相比之下,用 Gen.1 算法进行的测量结果的 Bland-Altman 分析显示偏差为 4.4 毫克/分升,并观察到比例偏差(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):结论:第三代算法的测量结果没有比例偏差,但第一代算法的测量结果存在比例偏差。J. Med.Invest.71 : 225-231, August, 2024.
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来源期刊
JOURNAL OF MEDICAL INVESTIGATION
JOURNAL OF MEDICAL INVESTIGATION MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
1.20
自引率
0.00%
发文量
55
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