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

Murata, Takashi; Hosoda, Kiminori; Nishimura, Kunihiro; Miyamoto, Yoshihiro; Sakane, Naoki; Satoh-Asahara, Noriko; Toyoda, Masao; Hirota, Yushi; Matsuhisa, Munehide; Kuroda, Akio; Kato, Ken; Kouyama, Ryuji; Miura, Junnosuke; Tone, Atsuhito; Kasahara, Masato; Kasama, Shu; Suzuki, Shota; Ito, Yukie; Watanabe, Tomokazu; Suganuma, Akiko; Shen, Zhuo; Kobayashi, Hiroko; Takagi, Satoshi; Hoshina, Sari; Shimura, Kanako; Tsuchida, Yukiko; Kimura, Moritsugu; Saito, Nobumichi; Shimada, Akira; Oikawa, Yoichi; Satomura, Atsushi; Haisa, Akifumi; Kawashima, Satoshi; Meguro, Shu; Itoh, Hiroshi; Saisho, Yoshifumi; Irie, Junichiro; Tanaka, Masami; Mitsuishi, Masanori; Nakajima, Yuya; Inaishi, Jun; Kinouchi, Kenichiro; Yamaguchi, Shintaro; Itoh, Arata; Sugiyama, Kazutoshi; Yagi, Kazuma; Tsuchiya, Tami; Kodani, Noriko; Shimizu, Ikki; Fukuda, Tetsuya; Kusunoki, Yoshiki; Katsuno, Tomoyuki; Matoba, Yuka; Hitaka, Yumi; Abe, Kentaro; Tanaka, Natsuko; Taniguchi, Ryoko; Nagao, Toshihiko; Hida, Kazuyuki; Iseda, Izumi; Takeda, Masaya; Matsushita, Yuichi; Tenta, Masafumi; Tanaka, Tsuyoshi; Kouyama, Kunichi; Fukunaga, Michiru

doi:10.1016/j.diabres.2022.110147

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ID	118711
Author	Murata, Takashi National Hospital Organization Kyoto Medical Center Hosoda, Kiminori National Cerebral and Cardiovascular Center Nishimura, Kunihiro National Cerebral and Cardiovascular Center Miyamoto, Yoshihiro National Cerebral and Cardiovascular Center Sakane, Naoki National Hospital Organization Kyoto Medical Center Satoh-Asahara, Noriko National Hospital Organization Kyoto Medical Center Toyoda, Masao Tokai University Hirota, Yushi Kobe University Matsuhisa, Munehide Tokushima University Tokushima University Educator and Researcher Directory KAKEN Search Researchers Kuroda, Akio Tokushima University Tokushima University Educator and Researcher Directory KAKEN Search Researchers Kato, Ken National Hospital Organization Osaka National Hospital Kouyama, Ryuji Tsuchiura Kyodo General Hospital Miura, Junnosuke Tokyo Women’s Medical University Tone, Atsuhito Okayama Saiseikai General Hospital Kasahara, Masato Nara Medical University Kasama, Shu Nara Medical University Suzuki, Shota Nara Medical University Ito, Yukie Nara Medical University Watanabe, Tomokazu National Hospital Organization Kyoto Medical Center Suganuma, Akiko National Hospital Organization Kyoto Medical Center Shen, Zhuo Tokyo Women’s Medical University Kobayashi, Hiroko Tokyo Women’s Medical University Takagi, Satoshi Tokyo Women’s Medical University Hoshina, Sari Tokyo Women’s Medical University Shimura, Kanako Tokyo Women’s Medical University Tsuchida, Yukiko Tokyo Women’s Medical University Kimura, Moritsugu Tokai University Saito, Nobumichi Tokai University Shimada, Akira Saitama Medical University Oikawa, Yoichi Saitama Medical University Satomura, Atsushi Saitama Medical University Haisa, Akifumi Saitama Medical University Kawashima, Satoshi Kanda Naika Clinic Meguro, Shu Keio University Itoh, Hiroshi Keio University Saisho, Yoshifumi Keio University Irie, Junichiro Keio University Tanaka, Masami Keio University Mitsuishi, Masanori Keio University Nakajima, Yuya Keio University Inaishi, Jun Keio University Kinouchi, Kenichiro Keio University Yamaguchi, Shintaro Keio University Itoh, Arata Keio University Sugiyama, Kazutoshi Keio University Yagi, Kazuma Keio University Tsuchiya, Tami Keio University Kodani, Noriko Keio University Shimizu, Ikki Sakakibara Heart Institute of Okayama Fukuda, Tetsuya Sakakibara Heart Institute of Okayama Kusunoki, Yoshiki Hyogo College of Medicine Katsuno, Tomoyuki Hyogo College of Medicine Matoba, Yuka National Hospital Organization Kokura Medical Center Hitaka, Yumi National Hospital Organization Kokura Medical Center Abe, Kentaro National Hospital Organization Kokura Medical Center Tanaka, Natsuko National Hospital Organization Kokura Medical Center Taniguchi, Ryoko National Hospital Organization Kokura Medical Center Nagao, Toshihiko National Hospital Organization Kokura Medical Center Hida, Kazuyuki National Hospital Organization Okayama Medical Center Iseda, Izumi National Hospital Organization Okayama Medical Center Takeda, Masaya National Hospital Organization Okayama Medical Center Matsushita, Yuichi National Hospital Organization Okayama Medical Center Tenta, Masafumi National Hospital Organization Okayama Medical Center Tanaka, Tsuyoshi National Hospital Organization Mie Chuo Medical Center Kouyama, Kunichi National Hospital Organization Hyogo-Chuo National Hospital Fukunaga, Michiru National Hospital Organization Hyogo-Chuo National Hospital
Keywords	Time below range Intermittent-scanning continuous glucose monitoring Education Randomized trial
Content Type	Journal Article
Description	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.
Journal Title	Diabetes Research and Clinical Practice
ISSN	01688227 18728227
NCID	AA1152533X AA1044374X
Publisher	Elsevier
Volume	195
Start Page	110147
Published Date	2022-11-14
Rights	This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
EDB ID	399424
DOI (Published Version)	10.1016/j.diabres.2022.110147
URL ( Publisher's Version )	https://doi.org/10.1016/j.diabres.2022.110147
FullText File	diabres_195_110147.pdf 546 KB
language	eng
TextVersion	Publisher
departments	Institute of Advanced Medical Sciences