The CGM metrics of MiniMedTM 770G users in Japan: the baseline data of a multicenter, prospective, observational study (ESA-J Study)

Murata, Takashi; Masahito Ogura; Yushi Hirota; Akane Yamamoto; Ken Kato; Atsuhito Tone; Munehide Matsuhisa; Akio Kuroda; Noriko Kodani; Junnosuke Miura; Masao Toyoda; Moritsugu Kimura; Ryuji Kouyama; Takafumi Osaka; Yoshihiko Yuyama; Kunichi Kouyama; Yoshiki Kusunoki; Mana  Ohigashi; Shu Meguro; Arata Itoh; Hiroshi Okada; Shota Suzuki; Naoki Sakane

doi:10.51094/jxiv.6918

##article.authors##

Murata, Takashi 東海大学医学部付属八王子病院
Masahito Ogura Diabetes Center, NHO Kyoto Medical Center
Yushi Hirota Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Akane Yamamoto Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Ken Kato Diabetes Center, NHO Osaka National Hospital
Atsuhito Tone Department of Internal Medicine, Okayama Saiseikai General Hospital
Munehide Matsuhisa Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University
Akio Kuroda Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University
Noriko Kodani Department of Diabetes, Endocrinology and Metabolism, National Center for Global Health and Medicine, Japan Institute for Health Security
Junnosuke Miura Division of Diabetology and Metabolism, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine
Masao Toyoda Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Moritsugu Kimura Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Ryuji Kouyama Division of Endocrinology and Metabolism, Department of Internal Medicine, Tsuchiura Kyodo General Hospital
Takafumi Osaka Department of Endocrinology and Diabetology, Ayabe City Hospital
Yoshihiko Yuyama Department of Developmental Pediatrics, Osaka Metropolitan University Graduate School of Medicine
Kunichi Kouyama Diabetes Internal Medicine, NHO Hyogo-Chuo National Hospital
Yoshiki Kusunoki Department of Diabetes, Endocrinology and Clinical Immunology, School of Medicine, Hyogo Medical University
Mana Ohigashi Department of Diabetes, Endocrinology and Clinical Immunology, School of Medicine, Hyogo Medical University
Shu Meguro Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Keio University School of Medicine
Arata Itoh Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Keio University School of Medicine
Hiroshi Okada Department of Social & Community Pharmacy, School of Pharmaceutical Science, Wakayama Medical University
Shota Suzuki Department of Social & Community Pharmacy, School of Pharmaceutical Science, Wakayama Medical University
Naoki Sakane Division of Preventive Medicine, Clinical Research Institute, NHO Kyoto Medical Center

DOI:

https://doi.org/10.51094/jxiv.6918

キーワード:

automated insulin delivery、 continuous glucose monitoring、 insulin pump

抄録

Aim: Here, we report the CGM metrics of MiniMed^TM 770G users in Japan, as the baseline data of The Effectiveness and Safety of Advanced Hybrid Closed-Loop Insulin Pump MiniMed ^TM780G used in Japan: A Multicenter, Prospective, Observational Study (ESA-J study).

Methods: Inclusion criteria are having type 1 diabetes, aged no less than 18 years old, planning to use MiniMed^TM 780G, had used MiniMed 770G^TM no less than 1 year.

Results: We analyzed the data of 162 participants registered at 14 sites. Mean age was 49.0 ± 14.8 years old, 75.9% were female, and HbA1c was 7.2± 0.7%. The incidence of severe hypoglycemia and diabetic ketoacidosis was 0.034 per 1,000 patient-days and 0.034 per 1,000 patient-days, respectively. The proportion of MiniMed^TM 770G users with TIR > 70% was 64.2%. Regarding HbA1c levels, 37.7% had HbA1c < 7%, 49.4% had HbA1c ≥ 7% and < 8%, and 13.0% had HbA1c ≥ 8%. Mean TAR, TIR, and TBR were 24.8 ± 12.4%, 71.6 ± 11.9%, and 3.6 ± 3.5%, respectively. The proportions of the participants with TBR < 1%, ≥ 1% to < 4%, ≥ 4% to < 8%, and ≥ 8% were 11.7%, 48.1%, 27.8%, and 12.3%, respectively.

Conclusions: Approximately 60% of MiniMed^TM 770G users had TIR > 70%, and TBR < 4%, respectively. However, approximately 10% of the users had excess TBR of 8% or more.

利益相反に関する開示

Takashi Murata reported lecture fees from Dexcom, research grants from Medtronic, Terumo, Raxi. Yushi Hirota reported lecture fees from Eli Lilly, Sanofi, Terumo,　Sumitomo Pharma, Novo Nordisk Pharma, Abbott, Dexcom, research grants from Sumitomo Pharma, Medtronic, Boehringer Ingelheim, Sanofi, and Eli Lilly. Atsuhito Tone reported lecture fees from Abbott, Dexcom, MiniMed, Novo Nordisk Pharma. Munehide Matsuhisa reported lecture fees from Sanofi, Abbott, Sumitomo Pharma, Novo Nordisk Pharma, Terumo, Dexcom, Orizuru Therapeutics. Akio Kuroda reported lecture fees from Sanofi, Abbott, Novo Nordisk Pharma, Terumo, Eli Lilly, Medtronic. Noriko Kodani reported consulting fees from Novo Nordisk Pharma, MiniMed and lecture fees from MiniMed, Dexcom, Abbott, Novo Nordisk Pharma, Sanofi. Junnnosuke Miura reported grants from Terumo, Sanofi, consultation fee from Tanabe Mitsubishi Pharma, lecture fees from LifeScan, Abott, Terumo, Novo Nordisk Pharma, Kowa, Arkray, Sanofi, Eli Lilly, Tanabe Mitsubishi, Medtronic, Nipro, Sumitomo Pharma, Dexcom. Masao Toyoda reported grants from Dexcom, LifeScan, and lecture fees from Eli Lilly, Tanabe Pharma, Sumitomo Pharma, Novo Nordisk Pharma, Dexcom, Abbott. Shu Meguro reported lecture fees from Novo Nordisk Pharma, Kowa, Bayer, Sumitomo Pharma, Tanabe Pharma. Hiroshi Okada’s position at Kyoto University is supported by industry–academia collaborative research funding from Soramichi System Co., Ltd. and corte Co., Ltd, and he reported lecture fees from NIHON CHOUZAI, Evergreen Kojin, and scholarship donations from YUYAMA, MEDIBRAIN. Masahito Ogura, Akane Yamamoto, Ken Kato, Moritsugu Kimura, Takafumi Osaka, Yoshihiko Yuyama, Kunichi Kouyama, Yoshiki Kusunoki, Mana Ohigashi, Arata Itoh, Shota Suzuki, Naoki Sakane declare that they have no conflict of interest.

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引用文献

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