Assessment of the accuracy of an intermittent-scanning continuous glucose monitoring device in patients with type 2 diabetes mellitus undergoing hemodialysis (AIDT2H) study

Masao Toyoda; Takashi Murata; Nobumichi Saito; Moritsugu Kimura; Hiroo Takahashi; Naoto Ishida; Makoto Kitamura; Miho Hida; Akinori Hayashi; Ibuki Moriguchi; Naoyuki Kobayashi; Daisuke Tsuriya; Yukitoshi Sakao; Takaya Matsushita; Yukie Ito; Shota Suzuki; Shu Kasama; Masato Kasahara; Tadashi Yamakawa; Katsuhito Mori; Akio Kuroda; Junnosuke Miura; Yushi Hirota; Masanori Abe; Masafumi Fukagawa; Naoki Sakane; Kiminori Hosoda

doi:10.1111/1744-9987.13618

Assessment of the accuracy of an intermittent-scanning continuous glucose monitoring device in patients with type 2 diabetes mellitus undergoing hemodialysis (AIDT2H) study

Ther Apher Dial. 2021 Oct;25(5):586-594. doi: 10.1111/1744-9987.13618. Epub 2021 Feb 2.

Authors

Masao Toyoda¹, Takashi Murata², Nobumichi Saito¹, Moritsugu Kimura¹, Hiroo Takahashi³, Naoto Ishida⁴, Makoto Kitamura⁵, Miho Hida⁵, Akinori Hayashi⁶, Ibuki Moriguchi⁷, Naoyuki Kobayashi⁷, Daisuke Tsuriya⁸, Yukitoshi Sakao⁹, Takaya Matsushita¹⁰, Yukie Ito¹¹, Shota Suzuki¹², Shu Kasama¹², Masato Kasahara¹², Tadashi Yamakawa¹³, Katsuhito Mori¹⁴, Akio Kuroda¹⁵, Junnosuke Miura¹⁶, Yushi Hirota¹⁷, Masanori Abe¹⁸, Masafumi Fukagawa¹, Naoki Sakane¹⁹, Kiminori Hosoda²⁰

Affiliations

¹ Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.
² Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
³ Jinken Clinic, Kanagawa, Japan.
⁴ Seichi Clinic, Kanagawa, Japan.
⁵ Kurata Hospital, Kanagawa, Japan.
⁶ Department of Endocrinology, Diabetes and Metabolism, Kitasato University School of Medicine, Kanagawa, Japan.
⁷ Sohbudai Nieren Clinic, Kanagawa, Japan.
⁸ 2nd Department of Internal Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan.
⁹ Hamana Clinic, Shizuoka, Japan.
¹⁰ Department of Diabetology, Endocrinology and Metabolism, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan.
¹¹ Bioethics Supervisory Office, Nara Medical University Hospital, Nara, Japan.
¹² Institute for Clinical and Translational Science, Nara Medical University Hospital, Nara, Japan.
¹³ Department of Endocrinology and Diabetes, Yokohama City University Medical Center, Yokohama, Japan.
¹⁴ Department of Nephrology, Osaka City University Graduate School of Medicine, Osaka, Japan.
¹⁵ Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.
¹⁶ Diabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.
¹⁷ Division of Diabetes and Endocrinology, Kobe University Graduate School of Medicine, Kobe, Japan.
¹⁸ Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
¹⁹ Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
²⁰ Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Osaka, Japan.

Abstract

FreeStyle Libre has been approved for use in patients undergoing hemodialysis (HD) in Japan, unlike Europe and the United States; however, evidence regarding its accuracy in such patients is sparse. Forty-one participants with type 2 diabetes undergoing HD were recruited. The overall mean absolute relative difference and mean absolute difference were 23.4% and 33.9 mg/dL, respectively. Sensor glucose levels and capillary glucose levels were significantly correlated (r = 0.858, P < .01), although the sensor glucose levels were significantly lower than the capillary glucose levels. The accuracy of FreeStyle Libre in patients undergoing HD became deteriorated with the days of usage. The percentage of sensor results in Zones A and B in the consensus error grid analysis and in the Clarke error grid analysis were 99.7% and 99.0%, respectively. Its insufficient accuracy necessitates adjunct usage of FreeStyle Libre with self-monitoring of blood glucose in patients undergoing HD.

Keywords: FreeStyle Libre; accuracy; continuous glucose monitoring; diabetic nephropathy; hemodialysis; type 2 diabetes.

Publication types

Observational Study

MeSH terms

Aged
Blood Glucose Self-Monitoring / instrumentation*
Blood Glucose Self-Monitoring / methods*
Diabetes Mellitus, Type 2 / blood*
Female
Humans
Male
Prospective Studies
Renal Dialysis*
Reproducibility of Results

Abstract

Publication types

MeSH terms

Grants and funding