{"title":"1型糖尿病成人间歇性扫描连续血糖监测低血糖的成本效益分析：一项ISCHIA随机临床试验","authors":"Naoki Sakane, Munehide Matsuhisa, Akio Kuroda, Junnosuke Miura, Yushi Hirota, Ken Kato, Masao Toyoda, Ryuji Kouyama, Kunichi Kouyama, Akira Shimada, Satoshi Kawashima, Yuka Matoba, Shu Meguro, Yoshiki Kusunoki, Kazuyuki Hida, Tsuyoshi Tanaka, Masayuki Domichi, Akiko Suganuma, Shota Suzuki, Atsuhito Tone, Kiminori Hosoda, Takashi Murata","doi":"10.1007/s13340-024-00762-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Patients: </strong>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).</p><p><strong>Results: </strong>Compared to the SMBG arm, clinically relevant hypoglycemia and SH risks over daytime (2.7 ± 1.7 vs. 2.4 ± 1.6 times; <i>P</i> = 0.008 and 3.1 ± 3.2 vs. 2.2 ± 2.7; <i>P</i> = 0.001) and night-time periods (2.1 ± 1.6 → 1.7 ± 1.2; <i>P</i> < 0.001 and 5.1 ± 4.0 → 4.2 ± 3.8; <i>P</i> = 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.</p><p><strong>Conclusion: </strong>The findings suggest that isCGM use for Japanese T1D adults treated with MDI is cost saving relative to SMBG.</p>","PeriodicalId":11340,"journal":{"name":"Diabetology International","volume":"16 1","pages":"78-85"},"PeriodicalIF":1.2000,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11769919/pdf/","citationCount":"0","resultStr":"{\"title\":\"Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial.\",\"authors\":\"Naoki Sakane, Munehide Matsuhisa, Akio Kuroda, Junnosuke Miura, Yushi Hirota, Ken Kato, Masao Toyoda, Ryuji Kouyama, Kunichi Kouyama, Akira Shimada, Satoshi Kawashima, Yuka Matoba, Shu Meguro, Yoshiki Kusunoki, Kazuyuki Hida, Tsuyoshi Tanaka, Masayuki Domichi, Akiko Suganuma, Shota Suzuki, Atsuhito Tone, Kiminori Hosoda, Takashi Murata\",\"doi\":\"10.1007/s13340-024-00762-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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).</p><p><strong>Methods: </strong>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.</p><p><strong>Patients: </strong>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).</p><p><strong>Results: </strong>Compared to the SMBG arm, clinically relevant hypoglycemia and SH risks over daytime (2.7 ± 1.7 vs. 2.4 ± 1.6 times; <i>P</i> = 0.008 and 3.1 ± 3.2 vs. 2.2 ± 2.7; <i>P</i> = 0.001) and night-time periods (2.1 ± 1.6 → 1.7 ± 1.2; <i>P</i> < 0.001 and 5.1 ± 4.0 → 4.2 ± 3.8; <i>P</i> = 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.</p><p><strong>Conclusion: </strong>The findings suggest that isCGM use for Japanese T1D adults treated with MDI is cost saving relative to SMBG.</p>\",\"PeriodicalId\":11340,\"journal\":{\"name\":\"Diabetology International\",\"volume\":\"16 1\",\"pages\":\"78-85\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2024-10-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11769919/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Diabetology International\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1007/s13340-024-00762-1\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q4\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetology International","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s13340-024-00762-1","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q4","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Cost-effective analysis focused on hypoglycemia of intermittent-scanning continuous glucose monitoring in type 1 diabetes adults: a ISCHIA randomized clinical trial.
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.
期刊介绍：
Diabetology International, the official journal of the Japan Diabetes Society, publishes original research articles about experimental research and clinical studies in diabetes and related areas. The journal also presents editorials, reviews, commentaries, reports of expert committees, and case reports on any aspect of diabetes. Diabetology International welcomes submissions from researchers, clinicians, and health professionals throughout the world who are interested in research, treatment, and care of patients with diabetes. All manuscripts are peer-reviewed to assure that high-quality information in the field of diabetes is made available to readers. Manuscripts are reviewed with due respect for the author''s confidentiality. At the same time, reviewers also have rights to confidentiality, which are respected by the editors. The journal follows a single-blind review procedure, where the reviewers are aware of the names and affiliations of the authors, but the reviewer reports provided to authors are anonymous. Single-blind peer review is the traditional model of peer review that many reviewers are comfortable with, and it facilitates a dispassionate critique of a manuscript.
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