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

• DOI: 10.1016/j.diabres.2022.110147
• Publication Date: 2022-11-14T07:17:46Z
• Authors: Takashi Murata; Kiminori Hosoda; Kunihiro Nishimura; Yoshihiro Miyamoto; Naoki Sakane; Noriko Satoh-Asahara; Masao Toyoda; Yushi Hirota; Munehide Matsuhisa; Akio Kuroda; Ken Kato; Ryuji Kouyama; Junnosuke Miura; Atsuhito Tone; Masato Kasahara; Shu Kasama; Shota Suzuki; Yukie Ito; Tomokazu Watanabe; Akiko Suganuma; Zhuo Shen; Hiroko Kobayashi; Satoshi Takagi; Sari Hoshina; Kanako Shimura; Yukiko Tsuchida; Moritsugu Kimura; Nobumichi Saito; Akira Shimada; Yoichi Oikawa; Atsushi Satomura; Akifumi Haisa; Satoshi Kawashima; Shu Meguro; Hiroshi Itoh; Yoshifumi Saisho; Junichiro Irie; Masami Tanaka; Masanori Mitsuishi; Yuya Nakajima; Jun Inaishi; Kenichiro Kinouchi; Shintaro Yamaguchi; Arata Itoh; Kazutoshi Sugiyama; Kazuma Yagi; Tami Tsuchiya; Noriko Kodani; Ikki Shimizu; Tetsuya Fukuda; Yoshiki Kusunoki; Tomoyuki Katsuno; Yuka Matoba; Yumi Hitaka; Kentaro Abe; Natsuko Tanaka; Ryoko Taniguchi; Toshihiko Nagao; Kazuyuki Hida; Izumi Iseda; Masaya Takeda; Yuichi Matsushita; Masafumi Tenta; Tsuyoshi Tanaka; Kunichi Kouyama; Michiru Fukunaga
• Keywords: Adult; Blood Glucose; Cross-Over Studies; Blood Glucose Self-Monitoring; Time below range; 16. Peace & justice; Hypoglycemia; Education; 3. Good health; 03 medical and health sciences; Diabetes Mellitus, Type 1; 0302 clinical medicine; Intermittent-scanning continuous glucose monitoring; Humans; Insulin; Hypoglycemic Agents; Randomized trial

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