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2025年 新着論文 3　糖尿病診療分野から論文が発表されました

Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial

Diabetol Int. 2024 Oct 16;16(1):78-85. doi: 10.1007/s13340-024-00762-1. eCollection 2025 Jan.

Authors

Naoki Sakane  1 , Munehide Matsuhisa  2 , Akio Kuroda  2 , Junnosuke Miura  3 , Yushi Hirota  4 , Ken Kato  5 , Masao Toyoda  6 , Ryuji Kouyama  7 , Kunichi Kouyama  8 , Akira Shimada  9 , Satoshi Kawashima  10 , Yuka Matoba  11 , Shu Meguro  12 , Yoshiki Kusunoki  13 , Kazuyuki Hida  14 , Tsuyoshi Tanaka  15 , Masayuki Domichi  1 , Akiko Suganuma  1 , Shota Suzuki  16 , Atsuhito Tone  17 , Kiminori Hosoda  18 , Takashi Murata  19   20 ; ISCHIA Study Group

Affiliations

  • 1 Division of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, 1-1Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555 Japan.
  • 2 Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, 3-18-15 Kuramotocho, Tokushima, Tokushima 770-8503 Japan.
  • 3 Division of Diabetology and Metabolism, Department of Internal Medicine, Tokyo Women’s Medical University School of Medicine, 8-1 Kawadacho, Shinjuku-ku, Tokyo, 162-8666 Japan.
  • 4 Division of Diabetes and Endocrinology, The Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunokicho Chuo-ku, Kobe, Hyogo 650-0017 Japan.
  • 5 Diabetes Center, National Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka, 540-0006 Japan.
  • 6 Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1193 Japan.
  • 7 Division of Endocrinology and Metabolism, Department of Internal Medicine, Tsuchiura Kyodo General Hospital, 4-1-1 Otsuno, Tsuchiura, Ibaraki 300-0028 Japan.
  • 8 Department of Diabetes and Metabolism, National Hospital Organization Hyogo-Chuo National Hospital, 1314 Ohara, Sanda, Hyogo 669-1515 Japan.
  • 9 Department of Endocrinology and Diabetes, Saitama Medical University, 38 Morohongo Moroyama-machi, Iruma, Saitama 350-0495 Japan.
  • 10 Kanda Naika Clinic, 5-21-3 Hannancho Abeno-ku, Osaka, Osaka 545-0021 Japan.
  • 11 Department of Diabetes, Endocrinology and Metabolism, National Hospital Organization Kokura Medical Center, 10-1 Harugaoka, Kitakyushu Kokuraminami-ku, Fukuoka, 802-0803 Japan.
  • 12 Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-0016 Japan.
  • 13 Department of Diabetes, Endocrinology and Clinical Immunology, Hyogo Medical University, 1-1 Mukogawacho, Nishinomiya, Hyogo 663-8501 Japan.
  • 14 Department of Diabetology and Metabolism, National Hospital Organization Okayama Medical Center, 1711-1 Tamasu, Okayama Kita-ku, Okayama, 701-1192 Japan.
  • 15 Department of Internal Medicine, National Hospital Organization Mie Chuo Medical Center, 2158-5 Hisai Myojincho, Tsu, Mie 514-1101 Japan.
  • 16 Department of Social & Community Pharmacy, School of Pharmaceutical Sciences, Wakayama Medical University, 25-1 Shichiban-cho, Wakayama, Wakayama 640-8156 Japan.
  • 17 Department of Internal Medicine, Okayama Saiseikai General Hospital, 2-25 Kokutaicho Kita-ku, Okayama, Okayama 700-0021 Japan.
  • 18 Division of Diabetes and Lipid Metabolism, National Cerebral and Cardiovascular Center, 6-1 Kishibe-Shimmachi, Suita, Osaka 564-8565 Japan.
  • 19 Department of Clinical Nutrition, National Hospital Organization Kyoto Medical Center, 1-1Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555 Japan.
  • 20 Diabetes Center, National Hospital Organization Kyoto Medical Center, 1-1Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto, 612-8555 Japan.

Abstract

Background: This study aimed to compare the economic value of intermittent-scanning continuous glucose monitoring (isCGM) with self-monitoring of blood glucose (SMBG) in adults with type 1 diabetes (T1D).

Methods: Participants were placed on either an isCGM or SMBG arm for 84 days, in a randomized, crossover setup with a 28-day washout period. Clinically relevant hypoglycemia (<54 mg/dL) and severe hypoglycemia (SH) risks were calculated by analyzing the data from isCGM. The effectiveness variable was quality-adjusted life years (QALYs), and costs included medical costs related to the SMBG device. In addition, we performed a sensitivity analysis using a tornado diagram to confirm the robustness of the results.

Patients: A total of 93 Japanese T1D adults (51.4 ± 15.3 years old, male 47.3%, and HbA1c 7.3 ± 0.7%) treated with multiple daily insulin injection (MDI).

Results: Compared to the SMBG arm, clinically relevant hypoglycemia and SH risks over daytime (2.7 ± 1.7 vs. 2.4 ± 1.6 times; P = 0.008 and 3.1 ± 3.2 vs. 2.2 ± 2.7; P = 0.001) and night-time periods (2.1 ± 1.6 → 1.7 ± 1.2; P < 0.001 and 5.1 ± 4.0 → 4.2 ± 3.8; P = 0.013) were reduced with isCGM treatment. The isCGM system was associated with an incremental gain in quality-adjusted life expectancy (QALE) of 0.8 QALYs compared with the SMBG arm (74.6 vs. 73.8 QALYs). The resulting incremental cost-effectiveness ratio was JPY 4,398,932 (US$41,212) per QALY gained, which is well below the generally accepted cost-effectiveness threshold. SH during the daytime period was the primary driver of the incremental QALE.

Conclusion: The findings suggest that isCGM use for Japanese T1D adults treated with MDI is cost saving relative to SMBG.

Keywords: Cost analysis; Hypoglycemia; Insulin; Type 1 diabetes mellitus.

© The Japan Diabetes Society 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Conflict of interest statement

Conflict of interestAS received lecture fees from Terumo and Abbott. SM received lecture fees from Novo Nordisc, Eli Lilly and Boehringer Ingelheim. AT received lecture fees from Eli Lilly, Abbott, Sanofi and Terumo. AK received lecture fees from Eli Lilly. JM received lecture fees from Terumo. YH received lecture fees from Eli Lilly, Sanofi, Abbott, Terumo and Sumitomo Pharma, and research expenses and grants from Sumitomo Pharma. MT received lecture fees from Abbott, Eli Lilly, Sumitomo Pharma, Novo Nordisc and Boehringer Ingelheim and subsides or donations from Cocokara fine Healthcare Inc, LifeScan Japan, Roche DC Japan, SUPER LIGHT WATER CO., LTD. TT received lecture fees from Eli Lilly, and research expenses and grants from AstraZeneca.

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