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

ISCHIA Study Group

doi:10.1016/j.diabres.2022.110147

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

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.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Blood Glucose
Blood Glucose Self-Monitoring
Cross-Over Studies
Diabetes Mellitus, Type 1* / drug therapy
Humans
Hypoglycemia* / prevention & control
Hypoglycemic Agents / therapeutic use
Insulin

Substances

Blood Glucose
Insulin
Hypoglycemic Agents