2023年新着論文 7　糖尿病診療分野から論文が発表されました

Prevention of hypoglycemia by intermittent-scanning continuous glucose monitoring device combined with structured education in patients with type 1 diabetes mellitus: A randomized, crossover trial

Diabetes Res Clin Pract. 2023 Jan;195:110147. doi: 10.1016/j.diabres.2022.110147. Epub 2022 Nov 14.

Author

ISCHIA Study Group

Collaborators

ISCHIA Study Group:
Takashi Murata¹, Kiminori Hosoda², Kunihiro Nishimura³, Yoshihiro Miyamoto⁴, Naoki Sakane⁵, Noriko Satoh-Asahara⁶, Masao Toyoda⁷, Yushi Hirota⁸, Munehide Matsuhisa⁹, Akio Kuroda⁹, Ken Kato¹⁰, Ryuji Kouyama¹¹, Junnosuke Miura¹², Atsuhito Tone¹³, Masato Kasahara¹⁴, Shu Kasama¹⁴, Shota Suzuki¹⁴, Yukie Ito¹⁵, Tomokazu Watanabe¹⁶, Akiko Suganuma⁵, Zhuo Shen¹², Hiroko Kobayashi¹², Satoshi Takagi¹², Sari Hoshina¹², Kanako Shimura¹², Yukiko Tsuchida¹², Moritsugu Kimura⁷, Nobumichi Saito⁷, Akira Shimada¹⁷, Yoichi Oikawa¹⁷, Atsushi Satomura¹⁷, Akifumi Haisa¹⁷, Satoshi Kawashima¹⁸, Shu Meguro¹⁹, Hiroshi Itoh¹⁹, Yoshifumi Saisho¹⁹, Junichiro Irie¹⁹, Masami Tanaka¹⁹, Masanori Mitsuishi¹⁹, Yuya Nakajima¹⁹, Jun Inaishi¹⁹, Kenichiro Kinouchi¹⁹, Shintaro Yamaguchi¹⁹, Arata Itoh¹⁹, Kazutoshi Sugiyama¹⁹, Kazuma Yagi¹⁹, Tami Tsuchiya¹⁹, Noriko Kodani¹⁹, Ikki Shimizu²⁰, Tetsuya Fukuda²⁰, Yoshiki Kusunoki²¹, Tomoyuki Katsuno²¹, Yuka Matoba²², Yumi Hitaka²², Kentaro Abe²², Natsuko Tanaka²², Ryoko Taniguchi²², Toshihiko Nagao²², Kazuyuki Hida²³, Izumi Iseda²³, Masaya Takeda²³, Yuichi Matsushita²³, Masafumi Tenta²³, Tsuyoshi Tanaka²⁴, Kunichi Kouyama²⁵, Michiru Fukunaga²⁵

Affiliations

¹ Department of Clinical Nutrition, National Hospital Organization Kyoto Medical Center, Kyoto, Japan; Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan. Electronic address: drmurata@nifty.com.
² Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, Osaka, Japan.
³ Department of Preventive Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.
⁴ Open Innovation Center, National Cerebral and Cardiovascular Center, Osaka, Japan.
⁵ Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
⁶ Department of Endocrinology, Metabolism, and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
⁷ Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan.
⁸ Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
⁹ Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.
¹⁰ Diabetes Center, National Hospital Organization Osaka National Hospital, Osaka, Japan.
¹¹ Division of Endocrinology and Metabolism, Department of Internal Medicine, Tsuchiura Kyodo General Hospital, Ibaraki, Japan.
¹² Diabetes Center, Tokyo Women’s Medical University School of Medicine, Tokyo, Japan.
¹³ Department of Internal Medicine, Okayama Saiseikai General Hospital, Okayama, Japan.
¹⁴ Institute for Clinical and Translational Science, Nara Medical University Hospital, Nara, Japan.
¹⁵ Bioethics Supervisory Office, Nara Medical University Hospital, Nara, Japan.
¹⁶ Diabetes Center, National Hospital Organization Kyoto Medical Center, Kyoto, Japan.
¹⁷ Department of Endocrinology and Diabetes, Saitama Medical University, Saitama, Japan.
¹⁸ Kanda Naika Clinic, Osaka, Japan.
¹⁹ Division of Endocrinology, Metabolism and Nephrology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
²⁰ Department of Diabetes, Sakakibara Heart Institute of Okayama, Okayama, Japan.
²¹ Division of Diabetes, Endocrinology and Clinical Immunology, Hyogo College of Medicine, Hyogo, Japan.
²² Department of Diabetes, Endocrinology and Metabolism, National Hospital Organization Kokura Medical Center, Fukuoka, Japan.
²³ Department of Diabetology and Metabolism, National Hospital Organization Okayama Medical Center, Okayama, Japan.
²⁴ Department of Diabetes and Endocrinology, National Hospital Organization Mie Chuo Medical Center, Mie, Japan.
²⁵ Department of Diabetes and Metabolism, National Hospital Organization Hyogo-Chuo National Hospital, Hyogo, Japan.

PMID: 36396114
DOI: 10.1016/j.diabres.2022.110147

Free article

Abstract

Aims: We conducted a randomized, crossover trial to compare intermittent-scanning continuous glucose monitoring (isCGM) device with structured education (Intervention) to self-monitoring of blood glucose (SMBG) (Control) in the reduction of time below range.

Methods: This crossover trial involved 104 adults with type 1 diabetes mellitus (T1DM) using multiple daily injections. Participants were randomly allocated to either sequence Intervention/Control or sequence Control/Intervention. During the Intervention period which lasted 84 days, participants used the first-generation FreeStyle Libre (Abbott Diabetes Care, Alameda, CA, USA) and received structured education on how to prevent hypoglycemia based on the trend arrow and by frequent sensor scanning (≥10 times a day). Confirmatory SMBG was conducted before dosing insulin. The Control period lasted 84 days. The primary endpoint was the decrease in the time below range (TBR; <70 mg/dL).

Results: The time below range was significantly reduced in the Intervention arm compared to the Control arm (2.42 ± 1.68 h/day [10.1 %±7.0 %] vs 3.10 ± 2.28 h/day [12.9 %±9.5 %], P = 0.012). The ratio of high-risk participants with low blood glucose index >5 was significantly reduced (8.6 % vs 23.7 %, P < 0.001).

Conclusions: The use of isCGM combined with structured education significantly reduced the time below range in patients with T1DM.

Keywords: Education; Intermittent-scanning continuous glucose monitoring; Randomized trial; Time below range.

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. The potential conflicts of interest concerning all individual investigators were reviewed by the Certified Review Board in accordance with the Clinical Trials Act [22].

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