2024年11月6日 / 最終更新日 : 2024年11月6日 ad_y ニュース

2024年 新着論文 53　糖尿病診療分野から論文が発表されました

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

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

Authors

Takashi Murata  1   2 , Naoki Sakane  3 , Yushi Hirota  4 , Masao Toyoda  5 , Munehide Matsuhisa  6 , Akio Kuroda  6 , Arata Itoh  7 , Shu Meguro  7 , Junnosuke Miura  8 , Yuka Matoba  9 , Ken Kato  10 , Shota Suzuki  11   12 , Akira Shimada  13

Affiliations

  • 1 Department of Clinical Nutrition, NHO Kyoto Medical Center, Kyoto, Japan.
  • 2 Diabetes Center, NHO Kyoto Medical Center, Kyoto, Japan.
  • 3 Division of Preventive Medicine, Clinical Research Institute, NHO Kyoto Medical Center, Kyoto, Japan.
  • 4 Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
  • 5 Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.
  • 6 Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.
  • 7 Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
  • 8 Division of Diabetology and Metabolism, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan.
  • 9 Department of Diabetes, Endocrinology and Metabolism, NHO Kokura Medical Center, Fukuoka, Japan.
  • 10 Diabetes Center, NHO Osaka National Hospital, Osaka, Japan.
  • 11 Department of Social & Community Pharmacy, School of Pharmaceutical Sciences, Wakayama Medical University, Wakayama, Japan.
  • 12 Institute for Clinical and Translational Science, Nara Medical University Hospital, Nara, Japan.
  • 13 Department of Endocrinology and Diabetes, Saitama Medical University, Saitama, Japan.

Free article

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.

Keywords: FreeStyle Libre; accuracy; algorithm; continuous glucose monitoring.

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